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1. 1 37 VET 1 39 System Configurable Settings ipee E Ud Dette e ER C de den 1 40 Troubleshooting and Maintenance rto tens uM misma etur rede a 1 45 Alaris Systems Manager Connections sssssssssssssseeeeeen nennen nennen nennen nennen nnns 1 45 Alarms Errors Messages rine ei a 1 46 Display Go o scc cc 1 46 Definitions cette etin shes P EE tay cas re teats Pea Mies iai D ee etre CO A ETUR TD uet 1 46 Audio Gharacteristics na cioe vt ee vr lee Prec aede raa 1 47 PASTE ME TEM 1 48 EITOLS o ir D tem RN ID edd edere ev ep e PEDE dde EE UON 1 48 Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 49 Eire M ele i aad aed el ee Aoi ate 1 51 Battery Gare and Mainternarice doc adia 1 51 Battery Type and Charging rede cce el adele 1 51 Battery Chaftge i rre O orte eis 1 51 Battery Care ue ae det aed eo a ee Eo Ue eM tege Bo 1 52 Battery Cautions and Disposal redeo eint etie edt neta teens 1 52 Inspection Requirements ete see Rede edere de doe dde sapie de nai e sedie e de e ead donee 1 53 Alaris Sy
2. 3 55 Bee eal etat aep t b oet neq e te 3 56 Contig rable Settlngs 3 5 ion det dede ood dati cte et ce ette ears 3 56 Specifications and Symbols eee ie ad HR Ideo cup beoe cepe eode d e ae nei ede 3 58 SpecifIcations et eod d a ch c Oe PA 3 58 Sins 3 60 Trumpetiand Start Up Curvesiiis un ederet ie e redis hes tee d ae et ege ex exe Pon 3 61 Troubleshooting and Maintenance Generals un teh t tr eL D xit Mu tT 3 65 Alarms Errors Messages rie ced t rh deca add 3 65 Detinitlons oett teet n ca 3 66 Alartris Ae so af n cid mer 3 66 EROS e el e UM E mte M LIA E 3 68 MICEEpIrd PEUT 3 68 15 611 5 3 70 3 ii Table of Contents Alaris System User Manual with v9 17 Model 8015 PCA Module Section Introduction Getting Started troduction i This section of the User Manual provides PCA module Model ETSI 8120 instructions and information It is used in conjunction with Read all instructions for both the Alaris product administration set instructions PCA module and PC unit before us
3. es x 8 T E Syringe Barrel Clamp Open Drive Head Fully Extended gt Gripper Control Drive Head Release in Open Position Plunger Grippers Open Before loading the syringe check it for damage or defects f caution JAN When initially loading the syringe allow for the volume of fluid contained in the administration set and retained in the syringe at the end of an infusion as this dead space will not be infused 3 4 Getting Started Alaris System User Manual with v9 17 Model 8015 PCA Module Section Prepare and Load Syringe and Administration Set Continued Load Syringe and Administration Set Continued Lock syringe in place a Pull syringe barrel clamp out and hold b Rotate clamp to right clockwise or counter clockwise until it lines up with syringe c Gently release clamp against syringe Lower drive head and lock plunger in place with plunger grippers a Twist gripper control clockwise and hold in position b While holding gripper control in open position gently lower drive head until it makes contact with plunger flange Gently release gripper control Ensure that plunger grippers lock and hold plunger in place NOTE The gripper control is spring loaded When
4. Guardrails IV Fluids Oncology 2 Press soft key next to IV fluid to be delivered Q Packed Red cols P HO Platelets a Q dE o 5 0 THO gt Select IV Fluid 000 3 To confirm selection press Yes soft key Guarras Fd Sep OR Qn Q was selected To return to IV Fluid library list press No soft key o this gorreet If Yes was selected and facility has defined a Clinical Q Advisory for that drug a message appears To indicate Q 0 information has been noted and continue programming press CONFIRM soft key TEN UDIN 0000 4 Start applicable infusion as described in following procedures Rate Volume Infusion Volume Duration Infusion Rate Volume Infusion 1 enter flow rate press RATE soft key and use numeric data entry keys A Guardrails Fluid Setup TPN 00000 gt Select RATE maA 0000 2 40 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued IV Fluid Infusion Continued Rate Volume Infusion Continued 2 To enter VTBI press VTBI soft key and use numeric data ent ke s IA Cusrdralls Fluid Setup Primary INFUSION o 79 9 9 3 O o 9 gt Enter p PRAS starr 000 Syringe module A
5. 00000 0000 System Options 1 of 3 Q Display Contrast nt ID Clinician ID Power Down All Channels o Anesthesia Mode 00000 gt Select an Option or EXIT EXIT POAN 0000 Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 15 System Options Continued Clinician ID Continued 4 To verify correct entry press CONFIRM soft key Clinician ID Entry Q aE QO 9 QO o gt pt QO 0 123456789CD gt Enter Clinician ID and Press CONFIRM Power Down All Channels 1 Press OPTIONS key System Options 1 of 3 2 Press Power Down All Channels soft key Display Contrast Patient ID ooo Power Down All Channels 00000 Anesthesia Mode gt Select an Option or EXIT e 0000 3 Press Yes soft key System Options During power off sequence Main Display flashes POWERING DOWN Power Down Yes All Channels 5 90000 oodo gt Press Yes or No 0000 1 16 Alaris System User Manual with v9 17 Model 8015 PC Unit Section System Options Continued Anesthesia Mode When the Anesthesia Mode is enabled and then the pause ENDA feature is used the module remains in an indefinite pause until restarted When the Alaris System is set up for use in Anesthesia Mode it is Whe
6. 4 Verify correct infusion parameter entry and press START soft key If the programmed IV Fluid is outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed Ifthe programmed IV Fluid is outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion needs to be reprogrammed Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 5 4 Syringe module Unclamp tubing and attach administration set to ER patient Unclamping tubing and starting infusion before 5 i attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming 2 44 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued IV Fluid Infusion Continued Volume Duration Infusion Continued NOTES The infusion can be paused by pressing the PAUSE soft key See Pause Change Restart Infusion Pause and Restart Infusion procedure To view infusion Time Left
7. dudo e aa 2 93 Operating Features Controls Indicators ssssssssssssseeeeeen eene 2 99 T EE 2 102 Drug Calculation Definitions and Formulas ssssseeeee eene nennen 2 103 Configurable Settings reiner deeded dere edad due drag dt d dd d e dde 2 104 Shared Inf slor e e e ER UTE E a do a REOR Fere dae 2 105 Pump Mod le ecce Lee Ret 2 106 Sytirige Module 9 et dude ea Red 2 107 Specifications t ee e ee een 2 108 Pumip Module 3c rer edt hber etm eter 2 108 Syringe cn ape aide A eene o dede A p qe dev Va dn 2 111 Symbols ite ttt n sia sed aee etude tete de deae toe N dee 2 115 Trumpet and Start Up Curves ec ede I eid ee Eae oe ue id env e ond da aged oe 2 116 Pump Module ss Ee re erro et pa p rove t o tarte E dti aly 2 116 Syringe Module etri ecce t eee eee s aude e dires e su de a eee voee ea gei 2 117 eje 2 118 Troubleshooting and Maintenance eeeeseseseseesseeseeeneen nennen nenne nnne nnn nnn nnne nnn nnns 2 121 e t mue MC e mE 2 121 Alarmns Emors MES aAA etri 2 121 Definitions erm 2 122 Audio Characteristics 5 ennemi nmi 2 122 Alarms aoo ea oe USC e usn c MU dI LL E Es 2 122 cc 2 127 MO SSAGCS MEE 2 127
8. If no key is pressed main screen appears after 30 seconds Clearing volume infused on a PCA module does not clear patient history PCA Pause Protocol Feature The PCA Pause Protocol is an optional hospital configurable feature that is intended to align with the healthcare facility s current protocol for patient monitoring during PCA Therapy All programming data entry and validation of PCA Pause Protocol parameters are performed by a healthcare professional according to hospital defined protocol procedure or a physician s order If a monitoring module is not attached or started the PCA Pause Protocol does not activate Program an Infusion If the PCA Pause Protocol feature is enabled perform the following procedure Perform steps 1 8 in Prepare Infusion Program an Infusion 2 Confirm drug and concentration selections and press Yes soft key Alaris System User Manual with v9 17 Model 8015 Programming 3 37 PCA Module Section Guardrails PCA Pause Protocol Feature Continued Program an Infusion Continued 3 Review Clinical Advisory continue press CONFIRM soft key activate PCA Pause Protocol attach and start an an EtCO module and or SpO2 module per facility protocol To continue press CONFIRM soft key 4 Verify correct parameters and press NEXT soft key to confirm Prompt appears 5 Press CONFIRM soft key 6 Start applicable infusion as de
9. 000 7 Verify correct parameters and press START soft key If the programmed Bolus Dose and or Bolus Dose duration is outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed LY aieplase programming continues if No soft key is pressed 9 Bolus pose Fa infusion needs to be reprogrammed 0 090 mgg Q e If the programmed Bolus Dose and or Bolus Dose Q us i e O duration is outside the Hard Limit for that care area an Q porron 1 min Bolus 9 i Q rose AT 0 09 mg kg min Q audio alert sounds and a visual prompt appears before PE e programming can continue Infusion needs to be Press START to Begin reprogrammed Infusing Bolus Dose P 9 PAUSE CONT 000 Alaris System User Manual with v9 17 Model 8015 Programming 2 31 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Bolus Dose Continued Ifa Bolus Dose outside of Soft Limits has been entered and verified as correct Message Display also shows either LLL for a low dose or 111 for a high dose e Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 8 4 Syringe module If Bolus Dose was programmed at beginning of ES infusion unclamp tubing and attach administration l se
10. Aminophyliine F J o o Amphoterocin B K O 9 o Carboplatin Q Cyclophosphamide uvz o gt Select Drug 3 To enter DRUG AMOUNT use numeric data entry keys 4 Press soft key for appropriate unit of measure for drug amount 2 54 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section 10 11 12 13 14 Infusion NO Guardrails Suite MX Protection Continued Continuous Infusion Drug Calculation Continued To enter diluent volume use numeric data entry keys Press PATIENT WEIGHT soft key To indicate whether or not patient weight is to be used in Drug Calculation press either Yes or No soft key To enter patient weight if required in kilograms use numeric data entry keys Press TIME UNITS soft key To select time base for drug calculation press either Min Hour or Day soft key Press soft key next to desired DOSING UNITS Verify correct infusion parameters and press NEXT soft key 4 Syringe module If ALL Mode is enabled VTBI ALL is displayed To make a rate or dose entry press applicable soft key RATE or DOSE and use numeric data entry keys other value is calculated and displayed To enter volume to be infused press VTBI soft key and use numeric data entry keys Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 55 Infusion NO Guardrails Suite MX Protection Continued
11. Infusion Continued 8 Open clamp on secondary administration set WARNING The clamp on the secondary administration set must be opened If 9 Verify correct parameters and press START soft key the clamp is not opened the fluid is If the programmed duration is outside the Soft Limit for delivered from the primary container that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed If the programmed duration is outside Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion needs to be reprogrammed Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 10 Verify drops are flowing from the secondary container drip chamber NOTES The facility can choose to pre populate standard drug concentrations or leave a custom concentration mL and allow the clinician to enter the desired concentration Patient weight or BSA is not editable during a Secondary Infusion G Once a patient weight or BSA is entered and the infusion started the patient weight or BSA is automatically entered for any additional weight based or BSA calculation Prior to the start of infusion the patient weight or BSA key remains
12. Pursuant to Directive 2002 96 EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment WEEE Authorized representative in European Community 1 44 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Troubleshooting and Maintenance Troubleshooting and maintenance are intended to be performed only by qualified personnel using the Alaris System Technical Service Manuals and the System Maintenance software The Service Manuals and System Maintenance software are available from CareFusion The Service Manuals include routine service schedules interconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instrument s repairable components The System Maintenance software is used to perform a new instrument check in preventive maintenance tests calibration checks calibration and other maintenance functions Alaris Systems Manager Connections When an Alaris Systems Manager connection is made the Wireless Network Indicator on the PC unit lights up If connection to the Alaris Systems Manager is interrupted the indicator light is extinguished Some of the causes for a communications failure include Alaris Systems Manager is not accessible in network server services are not running or server has been shut down Wi
13. The instrument case should only be opened by qualified personnel using proper grounding techniques Prior to performing maintenance disconnect attached module from the Alaris System and the PC unit from AC power During servicing an instrument s configuration settings might be reset to the factory defaults Qualified hospital facility personnel are responsible for checking in the instrument and ensuring the current hospital approved Data Set is loaded Alaris System User Manual with v9 17 Model 8015 Appendix Section Maintenance A 7 WARRANTY CareFusion warrants that A Each new Alaris System product is free from defects in material and workmanship under normal use and service for a period of one 1 year from the date of delivery by CareFusion to the original purchaser B The battery and each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety 90 days from the date of delivery by CareFusion to the original purchaser If any product requires service during the applicable warranty period the purchaser should communicate directly with CareFusion to determine the appropriate repair facility Except as provided otherwise in this warranty repair or replacement will be carried out at CareFusion s expense The product requiring service should be returned promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipme
14. gt Select an Option or EXIT EXIT 0000 Guardrails Drugs EQ channel Options 1 of 2 Q Guardrails IV Fluids 2 Pressure Limit 550 mmHg 00000 7 Prime Set with Syringe gt Select an Option or EXIT EXIT BARK 0000 4 Start applicable infusion as described in following procedures Volume Duration Enabled Volume Duration Disabled Alaris System User Manual with v9 17 Model 8015 Programming 2 73 Pump and Syringe Modules Section Multidose Mode Continued Volume Duration Enabled 1 If Current time displayed is correct press CONFIRM soft key otherwise press Change Time and enter correct time See System Options Time of Day in PC unit section of this User Manual 5 Ly Multidose Time of Day lt Current tife Change 0 4 99000 o gt CONFIRM Time of Day TO 2 Press VOLUME DURATION soft key 3 To enter volume to be infused for each dose use numeric data entry keys 4 Toenter duration for each dose press DURATION soft key and use numeric data entry keys 5 To enter time interval 1 to 24 hours between doses press DOSE INTERVAL soft key and use numeric data entry keys 6 To enter number of doses press OF DOSES soft key and use numeric data entry keys If Delay Options is enabled DELAY OPTIONS soft key appears 9 7 To begin multidose infusion press START soft
15. 2001 07 06 ETCO2 TIME AVG MN AVG _ 2228ra 40 34 12 2158ra 41 435 13 2 20 28 39 12 1 19 58 39 7 ZOOM 120 60 5 1 minutes gt Press UP DOWN Keys Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Programming 5 7 Monitoring Mode Continued Navigate Trend Data Continued 5 To return to ETCO2 Main display press ETCO2 MAIN soft key 6 To return to Main Display press MAIN SCREEN soft key Navigate PCA Alaris EtCO ModuleTrend Data To access and view shared trend data when a PCA module is present perform the following steps 1 To view ETCO2 Main display press CHANNEL SELECT key 2 To access option to view trend data press OPTIONS key 3 To view Trend Data press PCA EtCO2 Trend data soft key EX channel Options Following information is displayed Q Limit Mode u Qo Waveform height 80 mmHg o TIME period for data review SLvewomminascale ssec O Average ETCO2 Average respiratory rate RR Alarm icon a Option or TOTAL DOSE of medication infused through Lex PCA module includes Continuous Infusion loading o 9 9 dose bolus and PCA dose 4 See Navigate Trend Data procedure for instructions on Mophine 09 00 how to Q x59 MCN mel RR 9 08 01 40 138 e Navigate from page to page e ac P Change TI
16. A Channel Label Library with text alphanumeric labels which allows identification on modules that can be used to indicate route of delivery for example epidural Profile settings are established by the facility s own multi disciplinary team prior to system implementation Profile parameters are used to create a Data Set which is then transferred to the PC unit System Configuration Allows system settings to be customized If Profiles feature is enabled system settings defined for selected profile are automatically activated Tamper Resist Provides a quick one touch lockout of front panel keypad 1 36 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Features and Displays Continued Operating Features Controls Indicators lUI Connector Left IUI Connector Right not visible Main Display Soft Keys When pressed allows selection of options or infusion parameters appearing on Main Display adjacent to soft key Silence Key When pressed during an alarm silences audio System On Key When for 2 minutes pressed changes Alaris System from standby to operating mode Options Key When pressed allows access to available Up Key When pressed System or Channel Options increases parameter with each key press or scrolls up when pressed and held Soft Keys see above Down Key n pressed decreases parameter with each key press or scrolls down when
17. TOTAL DOSE alternates with INFUSE AT rate ents CORA 0000 Alaris System User Manual with v9 17 Model 8015 Programming 2 57 Pump and Syringe Modules Section Infusion NO Guardrails Suite MX Protection Continued Bolus Dose Continued 6 Verify correct parameters and press START soft key To see details during bolus infusion press CHANNEL SELECT key 7 Syringe module f Bolus Dose was programmed at beginning of T infusion unclamp tubing and attach administration set to patient Unclamping tubing and starting infusion before attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming Stop and Restore Bolus Dose See Primary Infusion With Guardrails Suite MX Protection Bolus Dose procedure Secondary Infusion NO Guardrails Suite MX Protection 5 Pump Module i See Secondary Infusion With Guardrails Suite MX Protection for a description of the secondary infusion mode and for setup instructions The following procedure should be used only when drug to be infused is not listed in Drug Library e primary infusion is running and acheck valve administration set is being used To program a primary infusion see Primary Infusion With Guardrails Suite MX Protection IV Fluid Infusion procedure To program a basic infusion see Infusion NO Guardrails
18. uA AL M Itu A 4 Regulations and Standards 2 cai eiie i eei Dei dace paie A 5 CLERI A 5 Tradenmiarks 2 a eite d e tese ei ets A 14 Order Numbers CD Version 49000259 Printed Copy P00000080 2005 2014 CareFusion Corporation or one of its subsidiaries All rights reserved Alaris System User Manual with v9 17 Model 8015 General Contact Information CareFusion 10020 Pacific Mesa Blvd 92121 San Diego California United States Authorized European Representative CareFusion UK 305 Ltd The Crescent Jays Close Basingstoke Hampshire RG22 4BS UK Authorized Australian New Zealand Representative CareFusion Australia and New Zealand Unit 3 167 Prospect Highway Seven Hills NSW 2147 Australia carefusion com Customer Advocacy North America C Clinical and technical feedback 0086 Phone 888 812 3266 E mail CustomerFeedback g carefusion com Technical Support North America Maintenance and service information support troubleshooting Phone United States 888 812 3229 Phone Canada 800 387 8309 Technical Support United Kingdom Maintenance and service information support troubleshooting Phone 0800 389 6972 E mail UK Technical Support carefusion com Customer Order Management North America Product return service assistance and order placement Phone United States 800 482 4822 Phone Canada 800 387 8309 Customer Care U
19. Continuous Infusion Drug Calculation Continued Pump module When VTBI is less than 10 mL h entry can be to two decimal places one hundredth of a mL In Drug Calculation mode system infuses at calculated rate rounded to nearest one hundredth of a mL per hour as displayed on programming screen Rate shown in Rate Display is rounded to nearest one tenth of a mL per hour Syringe module f ALL Mode is enabled for syringe configuration in Data Set ALL is displayed in VTBI field and estimated available volume in syringe is displayed OR If ALL Mode is disabled for syringe configuration in Data Set estimated available volume in syringe is displayed when VTBI soft key is pressed Toenter or change a numeric VTBI value press VTBI soft key and use numeric data entry keys deliver entire contents of syringe Keep an ALL VTBI value or press ALL soft key to change a numeric VTBI value to ALL BOLUS soft key appears only if Bolus Dose is enabled within selected profile drug is bolusable and a VTBl is entered 15 Verify correct parameters and press START soft key Ly Drug Calculation CONTINUOUS INFUSION RATE 4 2 mL h vmi 60 m Dose 5 mcg kg min Conc 5000 mcg mL 2Press START PAUSE seTuP BOL fe 000 90000 60000 2 56 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section
20. For IUI cleaning instructions see the Cleaning Section in Appendix A Alaris System User Manual with v9 17 Model 8015 Troubleshooting and Maintenance 2 131 Pump and Syringe Modules Section THIS PAGE INTENTIONALLY LEFT BLANK 2 132 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Alaris PCA Module Model 8120 Alaris System User Manual with v9 17 Model 8015 Section 3 THIS PAGE INTENTIONALLY LEFT BLANK Table of Contents Getting Started Introductio EE 3 1 Attach and Detach Dose Request Cord sssssssssssssssssse eene em ener enn nennen nennen 3 2 Prepare and Load Syringe and Administration Set sssssssssssee een 3 3 Prepare Syringe and Administration Set esssssssssse eene nennen 3 3 Load Syringe and Administration Set esssssssssssseeeeeen e nennen nene nnns 3 3 Security Lock Key POSItOTS iiic certe ete rores te teda te e e detur tad sea TO hada 3 6 Programming Prepare Infusiopis eee dert eet e avian 3 7 Select Syringe Type arid Siza rd e c eee 3 7 Prine obe eiat eoe ERE COL e EP LED 3 8 Program an Irif slon Upon s roro dte tbe ciii m 3 10 Infusion MOdeS E 3 12 Prog
21. No operator intervention is required for routine moisture or condensate All Microstream Disposables contain an inline hydrophobic filter to extract condensate and or patient secretions while maintaining measurement and waveform integrity For humid conditions within the operating parameters of the EtCO module and Microstream Disposables humidity has no quantitative effect on the CO concentration given the small 50 mL min sample size rate In high humidity environments or extended monitoring periods 24 72 hours only Microstream Disposables designed for those instances should be Alaris System User Manual with v9 17 Model 8015 General Information 5 25 EtCO Module Section Principle of Operation Continued used In the event of humidity or condensate outside the EtCO module s operating specifications the EtCO2 module will present a Remove Blocked Disposable message Due to the relatively small sampling size needed for EtCO readings partial pressure does not affect the ability of the EtCO module to measure EtCO as long as the 50 mL min rate can be achieved Microstream Disposables are single use disposables which must be changed with each use The manufacturer s sample flow 50 mL min does not affect the disposable s life however humidity and specific patient conditions can shorten the effective life of the disposables Microstream Disposables are rated for up to 24 hours and 72 hours use depending
22. TIME period for data review Average ETCO2 with high and low values Average respiratory rate RR with high and low values Alarm icon a with Fi in TIME column to indicate high FiCO alarm limit has been exceeded Alarm icon a to indicate an alarm limit has been exceeded Alarm icon in RR column to indicate a no breath amp alarm limit has been triggered Dashes if no EtCO or respiratory rate values are available for time period displayed Tabular information is not updated while Trend Data view is displayed Tabular data is updated using new trend data stored in EtCO module after leaving Trend Data view To view latest data return to Trend Data view To navigate from page to page press PAGE UP and PAGE DOWN soft keys To scroll data one row at a time press or key To change TIME increments for data review move cursor to desired time period and press ZOOM soft key New time increments display Each press of ZOOM soft key changes time increments 00000 Trend Data 00 Adult Mode oY 2001 07 06 ETCO2 RR Q Ec MN AG MN Q 2258116 40 3 19 22 28Fia 40 44 12 Bao Q 2128 41 al 11 1 20 58 est o 2028 39 12 4 Zoom 120 60 Kf 5 1 minutes gt Press UP DOWN Keys to Move Cursor PAGE ETCO2 PAGE uP Zoom MAIN DOWN 20 58 o o OQ O EEEN o o o0 Trend Data Adult Mode 09 00
23. WARNING JAN Variations of head height back pressure or any combination of these can affect rate accuracy Factors that can influence head height and back pressure are Administration set configuration IV solution viscosity and IV solution temperature Back pressure can also be affected by type of catheter See Trumpet and Start Up Curves for data on how these factors influence rate accuracy Type CF Defibrillator Proof patient applied part Pressure Limit mmHg Rate mL h Time to Alarm lt 5 minutes lt 15 seconds 45 minutes 2 minutes Range mL Increments mL 0 1 9 99 10 999 9 1000 9999 2 5 Ibs NOTE The minimum Volume To Be Infused VTBI for both LVP and Syringe module applicable to all syringe sizes is 0 1mLs This applies to Continuous Infusions Bolus Dose Intermittent Infusions and IV Fluids 2 110 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Specifications Continued Syringe Module ae Lr Bolus Volume Maximum after Occlusion Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient Without Pressure Sensing Disc Pressure Setting Bolus Volume mL Low Medium High With Pressure Sensing Disc Bolus Volume mL Pressure Setting Back Off Disabled Back Off Enabled 300 mmHg 500 mmHg 1000 m
24. 3 Ensure that window is dry before returning to use If the instrument shows evidence of damage in transit notify the carriers agent immediately Do not return damaged equipment to the factory before the carrier s agent has authorized repairs If the instrument fails to respond as described in this document and the cause cannot be determined do not use the instrument Contact qualified CareFusion service personnel If itis necessary to return the instrument for service obtain a return authorization number prior to shipment Carefully package the instrument preferably in the original packaging refer to the return authorization information and return it to the appropriate service or distribution center CareFusion does not assume any responsibility for loss of or damage to returned instruments while in transit Technical Support Technical support service information applications and manuals can be obtained by contacting a CareFusion representative 888 812 3229 When submitting any request for service include model number a description of difficulty experienced instrument settings administration set lot number e solution s used message displayed at time of difficulty Do not use abrasive wipes or tissues on the scanner s window Do not use solvents such as acetone benzene ether phenol based agents These can damage the scanner s finish and window Do not immerse in fluids WARNING
25. 9 Patient History m Dose Request Setup o o Drug Event History Q gt Select an Option or EXIT PAGE EXIT DOWN A Patient History 09 01 History from 07 01 09 01 LAST CLEARED 07 00 2003 6 10 Total Drug Total Demands Delivered 09999 SHIFT TOTALS 22 mg 5 2 00000 ZOOM 24 12 8 4 E 1 hours Alaris System User Manual with v9 17 Model 8015 PCA Module Section Programming 3 27 Infusion Modes Continued View Patient History Continued 7 Toreturn to Main Display press EXIT soft key NOTES Total drug delivered includes applicable loading dose PCA dose continuous dose and Bolus Dose Total drug delivered does not include priming volume Patient History stores a rolling 24 hour log and is automatically cleared when selecting Yesto New Patient during startup A different drug from the Drug Library The same drug with different dosing units from the Drug Library Anew Therapy for an mL based drug Same patient with a new profile The Patient History defaults to the 8 hour view Clear Patient History 1 Press CHANNEL SELECT key From Main Display press OPTIONS key 2 3 Press Patient History soft key 4 Press CLEAR HISTORY soft key Patient History 09 01 A confirmation screen appears Q o SHIFT TOTALS o o Ta id E mg o Del
26. Assess patient s condition Confirm correct alarm limit values are selected High SpO Alarm High SpO alarm limit has been exceeded Assess patient s condition Confirm correct alarm limit values are selected Low Pulse Rate Alarm Low pulse rate alarm limit has been exceeded Assess patient s condition Confirm correct alarm limit values are selected Low 5 02 Alarm Low SpO alarm limit has been exceeded Assess patient s condition Confirm correct alarm limit values are selected No Sensor Sensor not properly attached to patient cable or patient cable not properly attached to SpO module Attach sensor to patient cable or attach patient cable to SpOz module No Signal Failure to find a patient signal after 30 seconds of searching Check sensor Confirm correct sensor placement Remove Module Max 1 More than one SpO module attached Remove additional SpOz module Sensor Off Sensor not properly attached to patient Model 8210 NELLCOR Reattach sensor to patient Check Sensor High Pulse Amplitude Meaning Artifact interfering with pulse reading Response Check sensor Relocate sensor to a site with less artifact interference Check Sensor Excessive Ambient Light Light interference on sensor Check sensor Remove or reduce lighting Cover or reposition sensor 4 30 Troubleshooting and Maintenance Alar
27. Features Continued Operating Features Controls Indicators IUI Connector Left Module Release Latch When pressed allows module to be removed IUI Connector Right not visible READY Indicator Green LED illuminates to provide visual confirmation that module or handheld scanner is ready to scan SCAN CANCEL Key When initially pressed scanning is initiated by embedded scanner Subsequent press cancels scan Image Scanning Window Handheld external scanner connection port Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section General Information 6 15 Configurable Settings See the PC unit section of this User Manual for system configurable settings If the configuration settings need to be changed from the Factory default settings refer to the applicable Technical Service Manual or contact CareFusion Technical Support for technical troubleshooting and preventive maintenance information With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice Data Set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all Profiles Specifications and Symbols Specifications Auto ID Module and Handheld Scanner Symbols Meaning Operating Storage Transport Environmental Conditions Atmospheric 525 4560 mmHg 375 760 mmHg Pressure 700 6080
28. OST 1 Press Sensitivity Mode soft key Channel Options Q Limit Mode Adult o Pulse Beep Volume Off eraging Time 8 o Sensitivity Mode Normal 0000 gt Select an Option or EXIT 0000 4 10 Programming Alaris System User Manual with v9 17 Model 8015 SpO Module Section Channel Options Continued OST 2 To change Sensitivity Mode press applicable soft key e Normal Normal patient monitoring Maximum Improved low perfusion performance NOTE The sensitivity mode is displayed on the SPO2 Main display only when Maximum is selected 8220 Es o gt 1 o Co gt Sa Sensitivity Mode Maximum gt Select an Option or EXIT EXIT 0000 Alaris System User Manual with v9 17 Model 8015 SpO Module Section Programming 4 11 THIS PAGE INTENTIONALLY LEFT BLANK 4 12 Programming Alaris System User Manual with v9 17 Model 8015 SpO Module Section General Setup and Operation P System Start Up Setup System Start Up Setup See the PC unit section of this User Manual General Setup and Operation for various system start up and setup procedures Alaris System User Manual with v9 17 Model 8015 General Setup and Operation 4 13 SpO Module Section THIS PAGE INTENTIONALLY LEFT BLANK 4 14 General Setup and Operation Alaris
29. 2 To disable tamper resist press SCAN CANCEL key on the Auto ID module or the SCAN trigger on handheld scanner and scan clinician ID badge In a very low battery condition with less than 5 minutes of battery time remaining scanner is disabled In this situation disable tamper resist by pressing Tamper Resist Switch on back of PC unit for approximately 2 seconds 6 6 Programming Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Authorized User Mode Continued 3 Program infusion When no keys have been pressed on PC unit for a 5 minute period tamper resist mode is automatically enabled NOTE There are three events that make the Authorized User Mode unavailable a channel error system error or a discharged battery alarm Alaris System User Manual with v9 17 Model 8015 Programming 6 7 Auto ID Module Section Primary Infusion Using the Auto ID module to scan IV medication containers provides the ability to select the correct medication and Drug Amount Diluent Volume from the drug library and enhances safety through the use of the Guardrails Suite MX It compares the medication identifier from the IV container barcode with the medication identifier from the Drug Library If the patient ID is in the IV container barcode the system also compares the patient in the barcode with the patient identifier in the PC unit When the green READY indicator illuminates t
30. 6 19 MCECELI GM DET 6 20 InspectioniRequiremients decet me P 6 20 Alaris System User Manual with v9 17 Model 8015 Table of Contents 6 i Auto ID Module Section THIS PAGE INTENTIONALLY LEFT BLANK 6 ii Table of Contents Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Getting Started troduction o Introduction This section of the User Manual provides Auto ID module CENA Model 8600 instructions and information It is used in conjunction with Read all instructions for both the Auto ID module and PC unit before Auto ID Label Specification using the Alaris System e Auto ID Module Technical Service Manual e Module specific chapters of this User Manual CAUTION AN PC unit section of this User Manual R Only System Maintenance software and its instructions for Alaris System check in maintenance and wireless configuration The addition of the Auto ID module to the Alaris System combines Guardrails Suite MX with dose limit technology and barcode technology to provide a new level of medication safety The Auto ID module contains an internal barcode image scanner and supports an optional handheld scanner supplied by CareFusion Scanning a barcoded clinician ID and or a barcoded patient identification band supports verification of the correct patient and associates the CQI event logs with the clinician and or patient In addition using the scanner allows an
31. Symbols Continued Meaning Alaris Pump Module and Alaris Syringe Module Product is latex free Approximate administration set priming volume Expiration date for product is identified near hourglass symbol Do not use if package is damaged Product contains micron filter where XX represents filter size Trumpet and Start Up Curves In this instrument as with all infusion systems the Trumpet curves are named for their characteristic action of the pumping mechanism and variations shape They display discrete accuracy data in individual syringes and administration sets averaged over particular time periods or cause short term fluctuations in rate accuracy observation windows not continuous data The following graphs show typical performance of versus operating time the system as follows Over long observation windows short term Accuracy during various time periods over fluctuations have little effect on accuracy as which fluid delivery is measured trumpet represented by the flat part of the curve As curves the observation window is reduced short term Delay in onset of fluid flow when infusion fluctuations have greater effect as represented by commences start up curves the mouth of the trumpet Knowledge of system Trumpet and start up curves have been accuracy over various observation windows l provided for 0 1 mL h 1 0 mL h and 5 0 mL h might be of intere
32. gives an alert when delayed infusion has _ Delay for Before completed o Delay until 09 00 esc Before and After gives an alert when delay period is Eet completed and infusion needs to be initiated and when gt delayed infusion has completed gt Select a Callback Option The default callback After or the callback for the current EAT profile appears on the Main Display To schedule a different Q callback 1 Prior to pressing CONFIRM soft key to initiate delay during Delay for or Delay until programming process press CALL BACK soft key 2 Press soft key corresponding to desired callback option Scheduled callback appears on Main Display 3 To initiate delay press CONFIRM soft key If Delay until programming time infusion is scheduled to start appears on Main Display OR If Delay for programming delay period counts down on Main Display If Before option was selected An audio prompt sounds when delay period has ended Yellow Standby Status Indicator flashes DELAY COMPLETE scrolls in Message Display and appears on Main Display 2 70 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Delay Options Continued Schedule a Callback Continued f After option was selected o An audio prompt sounds when delayed infusion completes and continues to sound until responded to Yellow Standby Status Indicator fla
33. i 80 f Infusion NO Guardrails Suite MX Protection Continued Continuous Infusion Drug Calculation Continued 16 Syringe module 4 Unclamp tubing and attach administration set to patient Unclamping tubing and starting infusion before attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming NOTE Do not enter a patient weight if weight is not used in the calculation Bolus Dose 1 Setup infusion as described in Continuous Infusion Drug Calculation procedure but do not start infusion 2 Press BOLUS soft key 3 To enter Bolus Dose use numeric data entry keys Bias Canela After a Bolus Dose and weight if used are entered Q BOLUS DOSE bolus VTBI and concentration conc alternate in Main C 2000 Display O Q DURATION o Conc 5000 mcg mL gt Select the Desired Dosing Units CONT SETUP 0000 4 Press soft key next to appropriate unit of measure for dose Drug Calculation BoLus Dose If mcg or mg is selected as dosing unit a PATIENT 2000 WEIGHT entry cannot be made If mcg kg or mg kg Q ss is selected as dosing unit a PATIENT WEIGHT entry is o required o Conc 5000 mcg mL 5 To enter bolus duration use numeric data entry keys
34. 99 minutes increments 3 56 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Specifications and Symbols Continued Feature Default Setting Options Max Accumulated Dose Range 4 hour limit Disabled 1 2 or 4 hour limit Max Rate for Continuous Dose 999 mL h 0 1 99 9 mL h in 0 1 mL h increments 100 999 mL h in 1 mL h increments NEIO Alert Time Disable Enabled Disabled 5 25 of remaining infusion Occlusion Pressure Set Point High 800 mmHg Low 200 mmHg Medium 500 mmHg High 800 mmHg PCA Pause Protocol PCA Pause Protocol Monitoring Module Attach Enforcement PCA Pause Protocol Text SpO Settings 9o SpOsLow Limit Initial Value EtCO Settings Respiratory Rate Lower Limit bpm Initial Value Disabled None PCA infusion has paused due to a decline in respiratory status Check patient None None None None Enabled Disabled Enabled Disabled Editable per hospital protocol 20 99 20 99 0 149 0 149 Priming Enabled Enabled Disabled Security Access Level NOTES Level 1 This configuration setting is a shared setting between the PCA module and the Syringe module These values are configured in the SpO z module settings within the Editor Software and can be changed by the clinician by accessing Channel Options on the PCA mod
35. Before use read the sensor User Manual including all warnings cautions and instructions f caution JAN Do not immerse or dampen the sensor or cable Clean per manufacturer s instructions 4 16 General Information Alaris System User Manual with v9 17 Model 8015 SpO Module Section Cables and Sensors LLCOR Nellcor Patient Cables and OxiMAx Sensors The Nellcor DOC 10 and OC 3 patient cables interface the SpO module with the patient sensors When selecting a sensor consider the patient s weight the adequacy of perfusion the available sensor sites and the duration of monitoring Use only OXIMAX sensors Select an appropriate sensor apply it as directed and observe all warnings and cautions presented in the User Manual accompanying the sensor For a list of compatible sensors and cables refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com SEL 8220 Reusable patient cables of various lengths are available All cables that display the Masimo SET logo are designed to work with an SpOs module displaying the Masimo SET logo When selecting a sensor consider the patient s weight the adequacy of perfusion the available sensor sites and the duration of monitoring Use only Masimo SET sensors Select an appropriate sensor apply it as directed and observe all warnings and cautions presented in the User Manual accompanying the sensor For a list of compa
36. Not Used is displayed in PATIENT WEIGHT field If hospital facility practice guidelines identify selected Guardrails Drug Setup drug as weight based prompt for a patient weight in kn 6840 kilograms or BSA appear as in illustrated example EED 20 which reflects use of Methotrexate 9 E v pos mg m 90000 66600 Conc 1 7 mg mL gt Enter BSA 0000 5 Verify correct parameters and press NEXT soft key to confirm If the programmed total dose drug amount is outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed If the programmed total dose drug amount is outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion needs to be reprogrammed Ifa dose outside of Soft Limits has been entered and verified as correct Message Display also shows either LLL for a low dose or 777 for a high dose e Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed Alaris System User Manual with v9 17 Model 8015 Programming 2 49 Pump and Syringe Modules Section Secondary Infusion With Guardrails Suite MX Protection IE Pump Module Continued In
37. OR gt 1 Limit Mode Setup 0 T To leave Limit Mode Setup unchanged and return to Neonatal ETCO2 Main display press EXIT soft key O o gt Select an Option or EXIT EXIT 0000 Change Waveform Height 1 Press Waveform height soft key EX channel Options peel Adult Waveform height 80 mmHg M lt Waveform time scale 5 sec Q PCA EICO2 Trend data O o gt Select an Option or EXIT EXIT I 0000 2 To change Waveform Height select applicable range limit n e 60 mmHg Displays a waveform for values Q Waveform Height 9 within 0 60 mmHg range If EtCO value exceeds 60 mmHg 0 that range Waveform Out of Range Adjust Scaling Q 9 message is displayed until waveform falls back into Q 9 range or 0 99 mmHg option is selected Q 99 mmHg Displays a waveform for full EtCO value range 0 99 mmHg 3 Toreturn to ETCO2 Main display press EXIT soft key 5 10 Programming Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Change Waveform Time Scale 1 Channel Options Continued Press Waveform time scale soft key To change Waveform Time Scale select applicable time scale OR To leave Waveform Time Scale unchanged and return to ETCO2 Main display press EXIT soft key Channel Options opo Limit Mode Adult height 80 mmHg Waveform time scale 5 sec O2 Trend data
38. SpO5 and pulse rate measured by an 5 02 sensor The SpO modules and accessories are indicated for use with adult pediatric and neonatal patients and for patients who are well or poorly perfused in hospitals and hospital type facilities The Model 8220 SpO module is also indicated for use during motion and no motion conditions Only one SpO module can be connected to the Alaris System The majority of user interface programming is identical for both SpO modules If a procedure information applies to a specific module the following identifiers indicate the applicable model Model 8210 NELLCOR 8210 Model 8220 liso 8220 Cables and Sensors See General Information for Cables and Sensors information Alarms and Messages See Troubleshooting and Maintenance for module specific Alarms and Messages Contraindications The SpO modules are contraindicated for use as apnea monitors Electromagnetic Environment See Appendix section of this User Manual Regulations and Standards Compliance Alaris System User Manual with v9 17 Model 8015 Getting Started 4 1 SpO Module Section Attach Cable and Sensor 1 Attach applicable patient cable to 5 02 module Ensure a secure connection and that patient cable is not twisted ENJA sliced or frayed Model 8210 Use only approved OxiMAx sensors and DOC 10 and OC 3 pulse oximetry cables Model 8220 2 Attach applicable sensor to p
39. System User Manual with v9 17 Model 8015 SpO Module Section General Information Warnings and Cautions aA The SpO module is not to be used as an apnea monitor Pulse oximetry readings and pulse signal can be affected by certain ambient conditions sensor application errors and certain patient conditions The SpO module is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms The 5002 module should be considered an early warning device As a trend towards patient deoxygenation is indicated blood samples should be analyzed by a laboratory CO Oximeter to completely understand the patient s condition Interfering Substances Carboxyhemoglobin and methemoglobin can erroneously increase readings The level of increase is approximately equal to the amount of carboxyhemoglobin present Dyes or any substance containing dyes that change usual arterial pigmentation can cause erroneous readings The SpO module is not rated for defibrillation use Disconnect the sensor from the patient or patient cable from the module prior to defibrillation Do not lift the SpO module by the cable because it could disconnect from the instrument causing it to drop on the patient Do not place the SpO module in any position that could cause it to fall onto the patient Respond immediately to system alarms patient monitoring can cease under certain alarm conditions Ala
40. and Voltage Variations Table 2 Continued Electromagnetic Immunity IEC 60601 1 2 Test Level 596 UT gt 95 dip in UT for 0 5 cycle Compliance Level 596 UT gt 95 dip in UT for 0 5 cycle 40 UT 6096 dip in UT for five cycles 4096 UT 6096 dip in UT for five cycles 70 UT 3096 dip in UT for 25 cycles 70 UT 3096 dip in UT for 25 cycles 596 UT gt 95 dip in UT for 5 sec lt 5 UT gt 95 dip in UT for 5 sec Electromagnetic Environment Guidance Mains power quality should be that of a typical commercial or hospital environment If continued operation of Alaris System is required during power mains interruptions it is recommended that Alaris System be powered from an uninterruptible power supply or a battery Alaris System does employ an internal short duration battery A 12 Regulations and Standards Alaris System User Manual with v9 17 Model 8015 Appendix Section Compliance Continued Electromagnetic Environment Continued Alaris System Continued Table 3 Electromagnetic Immunity Life Support Equipment IEC 60601 1 2 Compliance Electromagnetic Environment Test Level Level Guidance Immunity Test IEC 61000 4 6 20 Vrms Portable and mobile RF communications Conducted RF equipment should be used no closer to Alaris System including cables than recommended separation distance calculated IEC 610
41. e eee t 6 1 Programming Patient IdentifiICatiori zs tieu Ree nae nA 6 3 New Paltlent RENE 6 3 While InfusioniiS YI EE e te tee deci a ee teile trea eee adn 6 4 Authorized User Modet 2 oit ede cte tt ea ote ct RO saa 6 6 Primary INTuSion 2 3 nowt alec uelit ett alata ede tenet tad 6 8 Secondary Infusion RR 6 9 General Setup and Operation e tlc tco eot 6 11 General Information Warnings and Cautions ss 2 Se rete tutte dco Ead 6 13 Handheld Scanners ci i eee etc t cl el deed ae eed uie Ub acta ec 6 13 EE 6 14 Features and Definitlons 2 1 epica Ade de dines d da ere du nudos 6 14 Operating Features Controls Indicators sssssssssssssssee enne 6 15 Configurable Settings etnia a Loud de a deb ee a ca iva a Leda iet aeo e Pa suede 6 16 Speorfications and Symbols etri dee cr idee ad abe e e ea RR 6 16 ee ee 6 16 Symbolology ee a e 6 17 Symbols ici dione an ert aee eel eie eel pe t dece ei A 6 17 Troubleshooting and Maintenance General nodum ttn R 6 19 Errors and Message S SA RE ARCEM UE 6 19 zr U
42. enter new value Syringe module gt If ALL Mode is enabled for syringe configuration in Data Set ALL is displayed in VTBI field and estimated available volume in syringe is displayed H OR S If ALL Mode is disabled for syringe configuration in Data Set estimated available volume in syringe is displayed when VTBI soft key is pressed To enter or change a numeric VTBI value press VTBI soft key and enter value deliver entire contents of syringe Keep an ALL VTBI value or press ALL soft key to change a numeric VTBI value to ALL Methotrexate Guardrails Drug Setup primary INFUSION mL h 505 1200 mgm Conc 136 8 mg mL Available 49 2 mL 00000 gt Select DURATION ATE Methotrexate A Guardrails Drug Setup PRIMARY INFUSION RATE mL oo 99 2 mL O E ALL ALL DURATION DOSE 12007 man Conc 136 8 mg mL 9 gt Select DURATION She SETUP T o 0 Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 37 Intermittent Infusion Continued 6 If an optional hospital defined and editable starting value Guardrails Drug Setup Methotrexate PRIMARY INFUSION o JRATE 4 mL h 9 r Available mL 9 6 00 hh mm pesca 1200 Conc 136 8 mg mL gt Press
43. gt Press DISABLE CODE or EXIT oe 9 D S CHANNEL X SELECT aM X EN RESTART A P Second Nurse Summary Morphine Q PCA Dose 2 mg Q eral 20 minutes O Q Max Limit 25 mg 4 h O Conc 1 mg mL gt Press START Pose Xs af Alaris System User Manual with v9 17 Model 8015 PCA Module Section Programming 3 33 Infusion Modes Continued Pause Infusion Continued 2 Toreinitiate infusion RATE UR Press RESTART key J OR Press CHANNEL SELECT key and then press START soft key on Main Display Mcr CHANNEL OFF 7 Change Syringe and Restore Infusion 1 If syringe requires replacement a Unlock security door b Remove existing syringe and prepare new syringe see Getting Started Prepare and Load Syringe and Administration Set If drug and or drug concentration is different from previous syringe attach and prime new administration set c Load syringe and administration set see Getting Started Prepare and Load Syringe and Administration Set Load Syringe and Administration Set d Select syringe type and size see Prepare Infusion Select Syringe Type and Size 2 Torestart infusion using restored parameters press Pio RESTORE soft key and continue with next step Morphine AELQ OR Q Meperidine Es
44. o 9 gt Press REPROGRAM 0000 Ifa dose outside of the Soft Limits has been entered and verified as correct Message Display also shows either LLL for a low dose or 111 for a high dose e Ifa Soft Limit is overridden G icon is displayed When Midtown Hospital G soft key is pressed all applicable out of range limits A vezom are listed o 9 0000 Alaris System User Manual with v9 17 Model 8015 Programming 2 27 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued fT tao ac f Hil E 1 5 Continuous Infusion Continued 8 4 Syringe module Unclamp tubing and attach administration set to y patient Unclamping tubing and starting infusion before uel y attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming NOTES The facility can choose to pre populate standard drug concentrations or leave a custom concentration _ mL and allow the clinician to enter the desired concentration Patient weight can be edited during a Continuous Infusion Once a patient weight is entered and an infusion is started for any module the patient weight is automatically entered for any additional weight based calculation The patient weight remains an editable field therefore patient weight can be adjusted for any mo
45. o To start a new infusion select drug from Drug Library and Pr O follow steps for Infusion Modes Q uz e gt Select Drug RESTORE Yer 0 2 0 0 3 34 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Change Syringe and Restore Infusion Continued 3 Verify restored drug concentration Press NEXT soft key 4 Prime administration set see Prepare Infusion Prime 5 Forrestored parameters verify valid parameters and press CONFIRM soft key To change a restored parameter a Press applicable soft key b Enter desired parameter using numeric data entry keys Press CONFIRM soft key 6 Close and lock security door 7 Verify correct programming parameters on summary Second Nurse Summary orphine screen and press START soft key Pose 2mg 9 Q Tre 10 minutes Q 9 Q veut 2 Q Conc 1 mg mL gt Press START Pause EROI Press and hold CHANNEL OFF key until a beep is heard approximately 1 5 seconds If no other channel is active the system powers down when the CHANNEL OFF key is released CHANNEL SELECT Soe EY PAUSE IN P nS RESTART P Alaris System User Manual with v9 17 Model 8015 Programming 3 35 PCA Module Section Infusion Modes Continued Select Pressure Limit 1 Press CHANNEL SELECT key 2 Press OPTIONS
46. software is used to perform a new instrument check in preventive maintenance tests calibration checks calibration and other maintenance functions Artifacts It is normal for an infusion device to produce nonhazardous currents when infusing electrolytes These currents vary proportional to the infusion device flow rate When an ECG monitoring system is not functioning under optimal conditions these currents might appear as artifacts simulating actual ECG readings To determine if abnormalities are caused by patient condition or the ECG equipment place the infusion device on hold If the ECG readings become normal the ECG equipment requires attention Proper setup of the ECG equipment should eliminate these artifacts Refer to the appropriate ECG monitoring system documentation for instructions on setup and maintenance Alarms Errors Messages See the PC unit section of this User Manual for the following system references Alarms Errors Messages Audio Characteristics Definitions Display Color Radio Frequency Note Alaris System User Manual with v9 17 Model 8015 Troubleshooting and Maintenance 2 121 Pump and Syringe Modules Section Alarms Errors Messages Continued Alert Clinical Advisory Audio Characteristics Switchover taoa i Six short beeps secondary switching to primary Two short beeps bolus switching to continuous Pump and Syringe Modules A vis
47. stops on affected module Syringe barrel clamp opened during infusion and then closed Infusion stops on affected module Syringe plunger not captured while in idle state System alarms after 30 seconds to indicate potential siphoning condition Securely lock plunger grippers press CHANNEL SELECT key and reselect syringe Securely lock syringe barrel clamp and press RESTART key Check for potential siphoning Ensure that administration set clamp roller slide is in closed position Securely lock plunger grippers over syringe plunger Drive Not Engaged Drive system disengaged during operation Open and close plunger grippers and syringe barrel clamp Ensure that syringe is properly installed Alaris System User Manual with v9 17 Model 8015 PCA Module Section Troubleshooting and Maintenance 3 67 Alarms Errors Messages Continued Error Meaning Response Channel Error Syringe Calibration Required Error detected Operation stops on affected module Error on infusing module indicating calibration is required Infusion stops on affected module CALIBRATE scrolls in Message Display To silence alarm and continue operation of unaffected module s press CONFIRM soft key Replace module as needed To silence alarm and continue operation of unaffected module s press CONFIRM soft key Replace module as needed Syringe Driver Head Error Noninfusing module
48. the CF Wireless Module is approved for operation when there is more than 20 cm between the antenna and the user s or patient s body EtCO module ISO 9918 ASTM F 1456 01 ASTM F 1463 EN 475 EN 864 PCA Pump and Syringe modules IEC 60601 2 24 ANSI AAMI ID 26 SpO module EN 865 Alaris System User Manual with v9 17 Model 8015 Regulations and Standards A 17 Appendix Section CareFusion Alaris Guardrails SmartSite and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries All other trademarks are the property of their respective owners A 18 Regulations and Standards Alaris System User Manual with v9 17 Model 8015 Appendix Section Alaris System User Manual with v9 17 Model 8015
49. 00000 gt Select an Option or EXIT 90000 Waveform Time Scale 10 sec 00000 gt Select an Option or EXIT EXIT 02000 Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Programming 5 11 THIS PAGE INTENTIONALLY LEFT BLANK 5 12 Programming Alaris System User Manual with v9 17 Model 8015 EtCO Module Section General Setup and Operation P System Start Up Setup System Start Up Setup See the PC unit section of this User Manual General Setup and Operation for various system start up and setup procedures Alaris System User Manual with v9 17 Model 8015 General Setup and Operation 5 13 EtCO Module Section THIS PAGE INTENTIONALLY LEFT BLANK 5 14 General Setup and Operation Alaris System User Manual with v9 17 Model 8015 EtCO Module Section General Information Warnings and Cautions aA EtCO2 and respiratory rate readings can be affected by certain ambient environmental and patient conditions The EtCO module is not to be used as an apnea monitor The EtCO module is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms If uncertain about measurement accuracy assess patient s condition and vital signs by alternate means then ensure that EtCO module is functioning correctly Do not lift the EtCO module b
50. 17 Model 8015 SpO Module Section Inspection Requirements To ensure that the Alaris System remains in good operating condition both regular and preventive maintenance inspections are required Refer to the System Maintenance software for detailed instructions REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECT FOR DAMAGE Exterior Surfaces Eachusage UI Connector Eachusage Keypad Eachusage CLEANING As required START UP Each usage NOTE While visually inspecting the IUI connectors look for fractures on the connectors black colored plastic If you see any damage do not use an instrument with fractured IUI connectors The IUI connector must be replaced before the instrument can be used again Inspect IUI Connectors If any surface contaminants or blue or green deposits are visible the connector must be replaced Figure 1 Male IUI Connector Figure 2 Male IUI Connector right side 1 Visually inspect the right side male IUI connector for cracks on the entire surface of the black colored plastic housing See Figures 1 and 2 for the male IUI inspection area and typical cracks 2 Visually inspect the left side female IUI connector for cracks on the edges of the black colored plastic housing 3 If cracks are found replace the IUI connector before use For IUI cleaning instructions see the Cleaning Section in Appendix A WARNING Failure to perform these inspection
51. 2 113 Pump and Syringe Modules Section Specifications Continued Syringe Module Continued r Rate Accuracy 2 of full scale plunger travel not including syringe variation WARNING Syringe size and running force variations of back pressure or any combination of these can affect rate accuracy Factors that can influence back pressure are Administration set configuration IV solution viscosity and IV solution temperature Back pressure can also be affected by type of catheter See Trumpet and Start Up Curves for data on how these factors influence rate accuracy Shock Protection Type CF Defibrillator Proof No Disc With Disc Highest Rate mL h High Setting 1000 mmHg Setting 120 minutes 105 minutes 30 minutes 30 minutes Time to Alarm Maximum 4 Maximum Time to Alarm specifications are based on following standard operating conditions Atmospheric Pressure 645 795 mmHg Back Pressure 0 mmHg before producing occlusion Disposable Type No Pressure Disc 30914 With Pressure Disc 30920 Humidity 20 90 Syringe Type BD 50 60 mL Temperature 68 4 F Volume to be Infused Programming Increments Range mL Increments mL 0 01 9 99 0 01 10 60 0 1 Weight 4 5 lbs NOTE The minimum Volume To Be Infused VTBI for both LVP and Syringe module applicable to all syringe sizes is 0 1mL s This applies to Continuous Infusions Bolus Dose Interm
52. 25 seconds Measurement Range Perfusion 0 03 20 Pulse Rate 20 250 bpm SpOz 1 100 Pulse Amplitude Display Visual indicators for pulse signals represent proportional pulse amplitude strength Sensor Emitted light wavelength range is within 500 1000 nm Output power does not exceed 15 mw Model 8220 Accuracy and Motion Tolerance Low Perfusion Motion No Motion Display Update Period Measurement Range Pulse Rate 25 240 bpm Adults Pediatrics Neonates 3 digits 25 240 bpm Adults Pediatrics Neonates 5 digits 25 240 bpm Adults Pediatrics Neonates 3 digits Saturation 70 100 Adults Pediatrics 32 digits Neonates 3 digits Approximately 1 second Perfusion 0 02 20 Pulse Rate 25 240 bpm SpO 1 10096 70 10096 Adults Pediatrics Neonates 3 digits 70 100 Adults Pediatrics 2 digits Neonates 3 digits Alaris System User Manual with v9 17 Model 8015 SpO Module Section General Information 4 25 Specifications and Symbols Continued Specifications Continued Model 8220 Mw Pulse Amplitude Display Proportional to height of I Q signal Sensor Emitted light wavelength range is within 500 1000 nm Output power does not exceed 1 mw NOTES Specification applies to monitor performance Adult specifications are shown for MAX A and MAX N sensors Neonate specifi
53. 36 View and Clear Volume Infused ssssssssssssseeneneemeneeenen emere nnne nennen 3 36 PCA Pause Protocol Feature ed tene eii ieii et gue a eene ved eaae 3 37 Programan MUSON ei rte t the e a eet edet p e 3 37 Review or Change PCA Pause Alarm Limits sesssssssseeeenee enne nennen 3 39 Disable FPCA Pause Alarm ierra tire db iecit tita et Pee Par ETE 3 40 General Setup and Operation System Start p Set p eerie ERR D RN AR ERR 3 43 General Information Warnings and Cautions eredni eere eene pese o Up sete dede an tel e ede ea ch ea ee ER ede 3 45 aa 9 45 Administration Sets eee d eee ca ee 9 45 Epidural Administrations aii teet de od tnde ee ea 3 47 Dose Request Cord ien eee e A eg aede ege ge ee 3 47 Guardrails Software eret e D ade aaa ai 3 48 Alaris System User Manual with v9 17 Model 8015 Table of Contents 3 i PCA Module Section Administration Set Syringe Information essen eene 3 48 Compatible Syringes eden Leid a db ea pu deve o uidit bead ee xa eal uo deb be acd 3 49 Features and DIsplays eie dat seeded aad ea teg de ee 3 49 Features and Definitions iae eret edet ae lala eee 9 49 Operating Features Controls
54. 85 Temperature 41 104 F 4 140 F Range 5 40 C 20 60 C To ensure proper operation Alaris System must remain in an upright position 3 58 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Specifications and Symbols Continued Specifications Continued Flow Rate Programming Fluid Ingress Protection Loading Dose Range Maximum Dose Range Occlusion Alarm Thresholds Operating Principle PCA Dose Range Rate Accuracy Shock Protection Flow rate range is from 0 1 to 999 mL h and can be selected as follows Flow Rates mL Selectable Increments mL h 0 10 9 99 10 99 9 100 999 Rate Restriction by Syringe Size Syringe Size mL Flow Rate Range mL h 20 0 1 500 30 35 0 1 650 50 60 0 1 999 IPX1 Drip Proof Configured according to hospital best practice guidelines Configured according to hospital best practice guidelines Three settings Low Medium High Positive displacement Configured according to hospital best practice guidelines 2 of full scale plunger travel not including syringe variation mA Syringe size and running force variations of back pressure or any combination of these can affect rate accuracy Factors that can influence back pressure are Administration set configuration IV solution viscosity and IV solution temperature Back pressure can also b
55. AM FM radio broadcast TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Alaris System is used exceeds the applicable RF compliance level the Alaris System should be observed to verify normal operation If abnormal performance is observed additional measures might be necessary such as reorienting or relocating the Alaris System Over the frequency range 150 kHz 80 MHz field strengths should be less than V4 V m The ISM Industrial Scientific and Medical bands between 150 kHz and 80 MHz are 6 765 6 795 MHz 13 553 13 567 MHz 26 957 27 283 MHz and 40 66 40 70 MHz Compact Flash Wireless Networking Module The CF Wireless Module contains a radio frequency wireless local area network interface RF card The RF card allows the Alaris System to communicate with the Alaris Systems Manager connected to the hospital information system The RF card is compliant with the rules and regulations in the locations where the CF Wireless Module is sold and is labeled as required The United States Federal Communications Commission FCC and Industry Canada IC identification numbers are visible through the CIB s clear plastic cover If an international country approval stamp is required it is placed adjacent to the identificati
56. Administration Set Pump Module sssssese enne 2 3 Borm 2 3 MU Em 2 5 se X C ETE 2 5 Prepare Administration Set Pump Module sse eene 2 3 Morc DLE 2 7 Pririe Using Optlons Mer condat rete cem ete exa ede pu ema eR re ee bn etd 2 11 Prime Martal 5 2 peut eo epe 2 16 Programming Primary Infusion With Guardrails Suite MX Protection sssssseee mnn 2 19 Continuous InfusiOrn eei ie e lane RE ERR ERR UR EL Ha E enReE nra ftam 2 21 sette oet etim tette ecd i 2 28 IV Eluid Infusionc ec tenni i MEN Er 2 40 Secondary Infusion With Guardrails Suite MX Protection Pump 2 46 Selupi aee niti C iC cae 2 46 eer RONDE LIII ITI 2 47 Stop Secondary and Return to Primary sssssssesssseeeeene enemies 2 52 Infusion NO Guardrails Suite MX Protection sssssssssssessseeeenemene eene nnns 2 52 Basic Inf siODz z etae tete to tore ula pte S 2 53 Promote Basic Infusion to Guardrails Software Protection Infusion ssssssssssssss 2 54 Continuous Infusion Drug Calculation esessneeeenne eene nnns 2 54 Bolus DOS sic 2 57 Secondary Infusion NO Guardrails Su
57. Alaris System should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary monitor the Alaris System to verify that it is operating normally in that setup Portable and mobile RF communications can affect medical electrical equipment Interconnected data communications systems must be certified to IEC 60950 data processing equipment or IEC 60601 1 electromedical equipment The Alaris System is intended for use by healthcare professionals only This is a CISPR 11 Class B Group 1 medical system In a domestic environment this system can cause radio interference Reorienting relocating or shielding the system or filtering the connection to the public mains network are examples of steps that can be taken to reduce or eliminate interference Medical electrical equipment needs special precautions regarding emc and needs to be installed and used according to the EMC information provided in the Appendix section of this User Manual see Regulations and Standards Compliance Features and Displays Features and Definitions See the product specific section of this User Manual that applies to the attached module s for features and definitions specific to that module Definition Clinician ID An optional alphanumeric 16 character clinician identifier that can be entered and displayed Data Set Created using Editor Software authoring tool and then transferred to PC unit A Data S
58. Continued Messages Model 8210 NELLCOR Message Check Sensor Electrical or Optical Interference Meaning External interference on sensor Response Check sensor Identify source of external interference if other than sensor Check Sensor High Pulse Amplitude Artifact interfering with pulse reading Check sensor Relocate sensor to a site with less artifact interference Check Sensor Excessive Ambient Light Light interference on sensor Check sensor Remove or reduce lighting Cover or reposition sensor Check Sensor Motion Interference Patient s motion has inhibited monitoring Check sensor Move sensor to a site with less motion Check Sensor Weak Pulse Patient s low perfusion has inhibited monitoring Check sensor Move sensor to a better perfused site Check Sensor Weak Signal Low quality of signal being measured Model 8220 Check sensor Confirm correct sensor placement Move sensor to a better perfused site Message Check Sensor Low Perfusion Meaning Patient s low perfusion has inhibited monitoring Response Check sensor Move sensor to a better perfused site Check Sensor Low Signal Low signal quality being measured Check sensor Confirm correct sensor placement Move sensor to a better perfused site 4 32 Troubleshooting and Maintenance Alaris System User Manual with v9
59. Disabled Bolus Dose Disabled Enabled Disabled Multidose Disabled Enabled Disabled Callback None None Before After Before and After Pressure Dynamic Disabled Enabled Disabled Dynamic Pressure Display Volume Duration Disabled Enabled Disabled Alaris System User Manual with v9 17 Model 8015 General Information 2 105 Pump and Syringe Modules Section Configurable Settings Continued Pump Module isl LA Feature Default Setting Options Accumulated Air Enabled Enabled Disabled Air in Line Settings 75 mcL 50 75 or 250 mcL single bolus Anesthesia Mode only 500 mcL Auto Restart Attempts 0 9 attempts Anesthesia Mode only 9 attempts KVO Keep Vein Open 1 mL h 0 1 20 mL h Max Rate 999 mL h 0 1 99 9 mL h in 0 1 mL h increments 100 999 mL h in 1 mL h increments Max VTBI 9999 mL h 0 1 9999 mL Pressure Mode Mode Selection Pump Pump Selectable Lock Status Unlocked Locked Unlocked Max Occlusion Pressure 525 mmHg 50 525 mmHg in 25 mmHg increments adjustable only in Selectable Pressure Mode Default Starting Occlusion 525 mmHg 50 525 mmHg in 25 mmHg increments configured Pressure by profile and adjustable only in Selectable Pressure Mode SEC to PRI Alert Enabled Enabled Disabled Secondary Dual Rate Disabled Enabled Disabled Sequential Piggybacking 2 106 General Information Alaris System User Manual with v9 17 M
60. Drug concentration drug amount diluent volume Rate VTBI duration Alaris System User Manual with v9 17 Model 8015 General Information 2 103 Pump and Syringe Modules Section Drug Calculation Definitions and Formulas Continued e Total Bolus Dose Bolus Dose not weight based Bolus Dose entered Bolus Dose weight based Bolus Dose x patient weight Total dose Drug amount Drug amount patient body surface area BSA Drug amount patient weight Configurable Settings See the PC unit section of this User Manual for system configurable settings If the configuration settings need to be changed from the Factory default settings refer to the applicable Technical Service Manual or contact CareFusion Technical Support for technical troubleshooting and preventive maintenance information With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice Data Set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles 2 104 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Configurable Settings Continued Shared Infusion i T a Feature Default Setting Options Delay Options Disabled Enabled Disabled Callback After None Before After Before and After Drug Calculation Disabled Enabled
61. EtCO module has been verified to operate with no malfunction alarms due to the hyperbaric chamber environment or unintentional key presses when used in a hyperbaric chamber o The healthcare facility s hyperbaric safety director is responsible for all equipment used in the hyperbaric chamber environment Should an instrument or accessory be dropped or severely jarred it should be immediately taken out of use and inspected by qualified service personnel to ensure its proper function prior to reuse Ifan instrument appears damaged contact CareFusion for authorization to return it for repair Electromagnetic Compatibility Do not use the Alaris System near Magnetic Resonance Imaging MRI including Stereotaxis technology Do not use the Alaris System near Therapeutic Radiation equipment such as Linear Accelerators Use of any accessory transducer or cable other than those specified can result in increased emissions or decreased Alaris System immunity Donotuse an RF device within 7 8 inches 20 cm of the Radio Card on the PC unit FCC approval of the Radio Card excludes co location with any other transmitter e Per FCC regulations maintain a distance of at least 7 8 inches 20 cm between the Radio Card on the PC unit and a human bogy 1 34 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Warnings and Cautions Continued Electromagnetic Compatibility Continued SZXHISTEB N The
62. Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion must be reprogrammed e If there is a potential for a programmed __ __ mL parameter to result in an excessive volume or dose being delivered following prompt appears Cannot proceed due to incorrect concentration or dosing parameters Remove syringe verify concentration and reprogram The prompt can be a the result of an incorrect drug amount and or diluent volume entry or b can occur if hospital established Guardrails limits are very wide Be sure to enter either a drug amount per 1 mL or total drug amount per total volume for example a 30 mL syringe with a concentration of 1 mg 1 mL can be entered in one of two ways Drug Amount 1 mg Diluent Volume 1 mL OR Drug Amount 30 mg Diluent Volume 30 mL Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 9 Close and lock security door 99000 Al PCA Only Morphine PCA DOSE 2 mg LOCKOUT NERAL 10 minutes MAX _ 25 mgi4 h ER None Conc 1 mg mL 000 gt Close and Lock Then Press CHANGE MODE 3 14 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Set Up PCA Dose Only Continued 10 Verify correct parameters on second nurse s
63. Module Release Latch If alarm is still present replace module Very Low Battery lt 5 minutes to system shutdown Audio System Error Battery has five minutes or less of power at current power consumption rate before operation stops Meaning Main speaker failure Connect AC power cord to power source alarm silenced Very low battery will continue to display after AC is plugged in until the battery has built up enough of a charge to run Alaris System for 5 minutes To verify AC is charging look at the AC LED on front panel and verify that it is on Response Visually check alarm status to determine whether or not an operational alarm also needs to be addressed red Alarm Status Indicator lit Replace PC unit Channel Error Error detected Operation stops on affected module To silence alarm and continue operation of unaffected modules press CONFIRM soft key Replace module Defective Battery Defective battery To continue temporary operation press SILENCE key Replace PC unit Hardware Detected Error Error detected on PC unit Operation stops on all modules Replace PC unit 1 48 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Alarms Errors Messages Continued Errors Continued Meaning Missing Battery Battery not present or not connected Response To continue temporary operation press SILENCE key Replac
64. New Patient screen appears Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 5 Start Up Continued Power On System Continued e If either of the following conditions is observed PC unit or affected attached module must be removed from use and inspected by qualified personnel System fails any part of self test Main Display does not appear backlit appears irregular or has evidence of a row of pixels not functioning properly NOTE Previous infusion parameters are automatically cleared after 8 hours 1 6 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Start Up Continued Respond to Maintenance Reminder If the Preventive Maintenance PM Reminder option is enabled and the PC unit or an attached module is due for preventive maintenance a MAINTENANCE REMINDER message appears at power up If necessary the reminder can be temporarily bypassed by pressing the CONFIRM soft key Notify the appropriate facility personnel when a MAINTENANCE REMINDER occurs and remove instrument requiring maintenance see Attach and Detach Module N If Alaris System was powered off to replace PC unit reinitiate start up process OR If an attached module such as a Pump Module was powered off and removed MAINTENANCE REMINDER display reflects removal of that module To continue start up process press CONFIRM soft key Adjust Display Contrast 1 Pre
65. PCA DOSE CONTINUOUS soft key from Infusion FA Guarras Drug Setup Morphi Mode screen INFUSION MODES o PCA Dose only PCA Dose Continuous 00000 Loading Dose Only gt Select an Option 0000 Alaris System User Manual with v9 17 Model 8015 Programming 3 17 PCA Module Section Infusion Modes Continued Set Up PCA Dose and Continuous Infusion Continued 3 To enter PCA dose press PCA DOSE soft key and use FN PCA Continuous us P t nit k l Morphine umeric data entry keys 1 mo o __ minutes CONT Dose __ mg h MAX LIMIT None ADING None 99000 60000 Conc 1 mg mL gt Enter Lockout Interval 0000 4 To enter lockout interval press LOCKOUT INTERVAL soft key and use numeric data entry keys 5 Toenter continuous dose press CONT DOSE soft key and use numeric data entry keys PCA Continuous 6 enter maximum limit press MAX LIMIT soft key press Yes soft key and use numeric data entry keys Morphine 1 mg meal 10 minutes K M van Yes O gt gt gt gt If No is selected then no MAX LIMITS will be available for GONG None O this infusion Conc 1 mg mL gt Select Max Limit Option Time in hours associated with Max Limit is automatically entered based on setup in system configuration 90000 7 To enter loading dose press LOAD D
66. Possible End of Infusion Messages and Alerts Syringe Module eene 2 129 Inspection 5 2 130 2 ii Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Getting Started troduction Introduction This section of the User Manual provides Pump module Model 8100 and Syringe module Model 8110 instructions and Erg information It is used in conjunction with Read all instructions for both the Alaris product administration set instructions infusion modules and PC unit before Drug product labeling using the Alaris System PC unit section of this User Manual e CareFusion IV sets and accessories catalog May be CAUTION downloaded from www carefusion com Ro Pump Module Technical Service Manual nly e Syringe Module Technical Service Manual e System Maintenance software and its instructions for Alaris System check in maintenance and wireless configuration The Pump and Syringe modules are intended for facilities that utilize infusion and or syringe pumps for the delivery of fluids medications blood and blood products using continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous IV intra arterial subcutaneous ep
67. Q Qu 5 o A o NAVAS O MS g 100 SatSeconds to Alarm gt Press ENTER tg IRglain Current View 00000 TREND MAN 4 4 Programming Alaris System User Manual with v9 17 Model 8015 SpO Module Section Monitoring Mode Continued Set Alarm Limits Continued 2 To change a limit setting press soft key next to applicable parameter 9 gt Select Parameter Limit 0000 3 Enter a numeric value for selected alarm limit SPO2 HIGH limit can be Off or a numeric value Adut Alarm Limits 9 i o 98 or 9 4 To move to next limit press ENTER key Oo 5 90 O 150 E 5 Toconfirm alarm settings and return to SPO2 Main display 50 9 press CONFIRM soft key gt Press CONFIRM to Apply ae 6 Toreturn to Main Display press MAIN SCREEN soft key Navigate Trend Data 1 view Trend Data press TREND soft key E3sPozwein Tabular information is not updated while Trend Data O nso 97 9 view is displayed Tabular data is updated using new 82 9 trend data stored in 5 02 module after leaving Trend AAAA ANAT Data view To view latest data return to Trend Data OHV VV view Omm O is displayed if an alarm limit is reached ENTER t Alarm View f no SPO2 or PULSE rate values are available for time
68. Set s safety clamp fitment automatically closes to prevent accidental free flow m e MCA i j White Slide Clamp shown in closed position 3 Remove set as follows a Gently pull tubing below Air in Line Detector forward and out b Lift upper fitment from upper fitment receptacle 4 If set is being removed to begin a gravity flow a Depress blue ridged release tab on upper side of safety clamp device b Slide white slide clamp into blue fitment open position c Adjust flow rate using set s roller clamp 1 Prepare primary solution container in accordance with manufacturer s User Manual 2 Open administration set package remove set and close roller clamp Refer to set s User Manual 3 Insert administration set spike into prepared fluid container following accepted hospital facility procedure and hang container 20 inches above Pump module 4 Fill drip chamber to full Alaris System User Manual with v9 17 Model 8015 Getting Started 2 5 Pump and Syringe Modules Section Prepare Administration Set Pump Module Continued Ar Prime Continued 5 If container requires venting open vent cap on administration set spike 6 To prime tubing and clear air from injection sites and tubing fitments slowly open roller clamp 7 When priming is complete close roller clamp 8 Verify no fluid flow T Prepare Syringe and Administration Set Syringe Module l E To decrease
69. Soft Limit is a programmed Limit that can be overridden Loading Dose Allows a bolus infusion to be programmed prior to initiation of PCA infusion Can be programmed from Infusion Modes menu or applicable PCA PCA continuous or continuous only programming screen prior to start of a new PCA infusion program 3 50 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Features and Displays Continued Features and Definitions Continued Feature Definition Lockout Interval Allows programming of a predetermined interval of time that must elapse between delivery of PCA doses Max Dose Limit Max Accumulated Dose Range Optional configuration that limits total amount of drug allowed to be delivered to patient in a defined period 1 2 or 4 hours Should be configured in Data Set before Drug Library is developed Once drugs are in Profile PCA Drug Library Max Accumulated Dose Limit cannot be changed Applies to all drug setups within Profile PCA Drug Library Includes PCA Dose Continuous Dose and optional Bolus Dose if selected to be included Loading Dose is not included Module Location Enforcement Tamper resistant security feature that ensures PCA Module is in a tamper evident position When enabled PCA Module must be located to direct right of PC Unit to allow programming an infusion Near End of Infusion NEOI Allows an alert to
70. U S Certification Mark Products bearing this mark have been tested and certified in accordance with applicable U S and Canadian electrical safety and performance standards Communications connector for RS 232 attachment E A Consult operating instructions ai E Type CF defibrillation proof patient applied part Electrostatic discharge ESD Fuse Replacement Replace fuse only with same type and rating Protection against fluid ingress Drip Proof IUI Connector Inter Unit Interface connector used to establish power and communications between PC unit and attached modules z Q2 b MM YYYY Manufacturing Date Number adjacent to symbol indicates month and year of manufacture Manufacturer E Potential Equalization Conductor if so equipped Note If integrity of PEC or Hospital Earth System is in question operate instrument using internal battery power 29 Radio frequency RF transmission Alaris System PC Unit Section User Manual with v9 17 Model 8015 1 43 Specifications and Symbols Continued Symbols Continued Meaning Caution Federal U S A law restricts this device to sale by or on order of a physician Tamper Resist activate deactivate switch Conformit Europ enne CE marking notified body 0086 British Standards Institution Australian Communications Authority Federal Communications Commission
71. When loading a Data Set with the Guardrails Suite MX ensure that the correct profile for patient care area is selected prior to starting an infusion Failure to use the appropriate profile could cause serious consequences Administration Set Syringe Information The PCA module uses standard single use disposable syringes with luer lock connectors and administration sets with anti siphon valves designed for use on syringe type PCA pumps For specific administration set instructions and set replacement interval refer to User Manual provided with set Foralist of compatible syringes see Compatible Syringes Foralist of compatible administration sets refer to CareFusion IV Sets and Accessories may be downloaded from www carefusion com Use aseptic techniques when handling sets and syringes e Administration sets are supplied with a sterile and nonpyrogenic fluid path for one time use Do not resterilize Discard administration set per facility protocol For lV push medication put instrument on hold clamp tubing above port Flush port s per facility protocol 3 48 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Compatible Syringes The PCA module is calibrated and labeled for use with the following single use disposable luer lock syringes Use only the syringe size and type specified on the Main Display The full list of permitted syringe models is
72. above 60 bpm Microstream neonatal airway adapter M1996A must be used Following liquid anesthetics have been tested and were found to have no effect Desflurane Enflurane Halothane Isoflurane Sevoflurane Operating time fully charged 5 5 hours EtCO 0 99 mmHg 2 0 99 mmHg Respiratory Rate 0 150 bpm Continuous Alaris System User Manual with v9 17 Model 8015 EtCO Module Section General Information 5 21 Specifications and Symbols Continued Specifications Continued Shock Protection Type BF Defibrillator Proof patient applied part System Response Time EtCO module response 2 9 seconds typical includes rise time of 190 msec maximum and delay time of 2 7 seconds typical PC unit display response approximately 72 second longer than module response Warm Up Time 30 seconds typical Weight 2 5 lbs 0 91 kg Symbols See the PC unit section of this User Manual for system symbols Meaning Type BF patient applied part Gas inlet Gas outlet Silenced alarm Note When displayed the dashed lines through the symbol might appear as solid lines due to the small display size Is displayed in Trend Data screen to identify an exceeded alarm limit Is displayed in Trend Data screen to identify an exceeded no breath alarm limit 5 22 General Information Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Me
73. be configured to sound anywhere between 5 25 volume remaining NEOI Alert Alert Time can be set to occur when 5 2596 of VTBI remains Occlusion Pressure Downstream occlusion alarm threshold can be set to low medium or high Alaris System User Manual with v9 17 Model 8015 General Information 3 51 PCA Module Section Features and Displays Continued Features and Definitions Continued Operating Modes Four operating modes are available PCA only Continuous Infusion PCA Continuous Infusion loading dose only All programming of infusions in each of four modes are completed using Drug Library as defined by hospital established best practice Patient History PCA Module records and displays patient history for up to 24 hours and can be trended to following intervals 1 hr 2 hr 4 hr 8 hr 12 hr 24 hr Patient history includes following trending information total demands delivered demands total drug delivered time and date patient history last cleared average drug per hour default view is 8 hr total amount of drug delivered via PCA dose Continuous Infusion loading dose Bolus Dose 3 52 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Features and Displays Continued Features and Definitions Continued Feature Definition PCA Dose Enables a patient to self administer a bolus infusio
74. can result in increased emissions or decreased immunity of the Alaris System 2 Power on PC unit 3 To select New Patient press Yes soft key 4 To accept current Profile press Yes soft key OR To proceed to Profile selection screen press No soft key 5 To accept Profile selection press CONFIRM soft key Patient ID Entry screen appears e Green READY indicator illuminates indicating system is ready to scan READY ae indicator Do 7 Alaris System User Manual with v9 17 Model 8015 Programming 6 3 Auto ID Module Section Patient Identification Continued New Patient Continued 6 scan barcode on patient identification band press scan trigger on handheld scanner 29 If scan is successful an audible tone sounds and patient ID appears on Main Display If profile is configured in Authorized User Mode PANEL LOCKED screen appears When a questionable barcode is scanned at main screen and panel is unlocked a prompt to confirm type of barcode scanned appears This occurs whether Authorized User Mode is enabled or disabled To unlock panel clinician s ID must be scanned NOTES Automatic display of Patient ID Entry screen should be enabled in the System Configuration settings Ifthe patient ID is not entered at this time it can still be entered later G Patient ID can be entered manually using the PC unit key
75. can result in improper instrument operation Preventive maintenance inspections should only be performed by qualified service personnel Alaris System User Manual with v9 17 Model 8015 Appendix Section Maintenance A 3 Cleaning Continued Alaris System Continued Procedure Continued NOTE Use the recommended healthcare grade solutions and DO NOT use chemicals that can damage the surfaces of the instrument Cleaning the Case 1 Make sure the instrument is turned off unplug the power cord and wipe all of the exposed device surfaces EXCEPT the inter unit interface IUI connectors DO NOT use an oversaturated cloth Be sure to squeeze out excess liquid 2 Use a dedicated soft bristled brush to clean the case to remove any visible residue The brush may also be used to clean narrow or hard to reach areas DO NOT use any hard abrasive or pointed objects to clean any part of the instrument f caution The use of chemicals that can damage the surface of the instrument and failure to follow the Alaris product cleaning procedures and the cleaning solution manufacturer s recommended dilutions can result in an instrument malfunction or product damage such as weakening and cracking of the case and could void the warranty Do not allow the cleaning solution to contact the IUI connector when cleaning the instrument Do not use hard abrasive or pointed objects to c
76. continue programming press Yes soft key OR To change selection press No soft key If Yes was selected and facility has defined a Clinical Advisory for that drug a message appears To indicate information has been noted and continue programming press CONFIRM soft key If Yes was selected to continue programming drug amount and diluent volume if defined in Drug Library are automatically entered for selected drug Guardrails Fluid Setup 0 9 NaCl 90000 j veg 1000 mL PRIMARY INFUSION RAE 40 mL h gt Press START DELAY VOLUMI OPTIONS DURATI UM SECOND d TART o0 00000 Guardrails Drugs Peds Oncology 99000 Amifostine A E Azathioprine F J Bleomycin K O Cytarabine P T Daunorbicin U Z 0000 gt Select Drug BASIC PAGE SEC PRIMARY DOWN 0000 Guardrails Drug Set Peds Oncology Q Methotrexate Yes mg mLwhbhs selected No Q Is this correct Q Be mg m 00000 gt Press Yes or No 0000 2 48 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Secondary Infusion With Guardrails Suite MX Protection IE Pump Module Continued IH Infusion Continued e If selected drug had mL concentration drug amount and diluent volume need to be entered e If selected drug is not weight based
77. default syringe list has been enabled and correct EAR n TARM INFUSING Sas CHANNED SELECT RATE mL h manufacturer and syringe size correctly identify the installed syringe Mismatches might i cause an under infusion or over infusion to the patient that could result in serious injury and or death For a list of compatible syringes see General Information Compatible Syringes If the installed syringe is displayed and selected but is not recognized servicing is required see Maintenance Service Information in Appendix section of this User Manual Ensure that the displayed 2 Land ie Selection BD 30 mL Monoject 30 m 00000 syringe cannot be found press ALL SYRINGES soft Q key o gt Select Syringe Size paas 0000 2 20 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued b To accept press CONFIRM soft key PS yringe Selection gt BD 30 mL Monoject 30 mL 9000 0000 gt Confirm Syringe Size 6 Start applicable infusion as described in following procedures Continuous Infusion Bolus Dose Intermittent Infusion IV Fluid Infusion NOTE Atthe start of a Syringe module infusion program the system prompts to
78. dependent on the PCA module s software version Syringe variability can impact occlusion pressure sensing The variability can reduce the device s time to alarm and or might require that a higher alarm pressure limit be programmed Manufacturer B D Plastipak IMS Pump Jet MonoJect Terumo NOTE Prefilled Morphine Sulfate 1 mg mL Features and Displays Features and Definitions See the PC unit section of this User Manual for system features and definitions Feature Definition Auto Pressure Limit When a bolus is delivered pressure alarm limits are temporarily raised to Adjustment maximum limit Auto Syringe System automatically detects syringe size and narrows down syringe Identification selection list Bolus Delivery Rate Rate at which PCA bolus and loading doses boluses are infused Bolus Dose Allows an additional amount of medication to be programmed once PCA infusion has begun Current PCA infusion resumes following delivery of a Bolus Dose Alaris System User Manual with v9 17 Model 8015 General Information 3 49 PCA Module Section Features and Displays Continued Features and Definitions Continued Feature Definition Concentration Drug amount per volume of fluid For example a 30 mL syringe with a concentration of 1 mg 1 mL can be entered in one of two ways Drug Amount 1mg Diluent Volume 1 mL OR Drug Amount 30 mg Dil
79. due to incorrect concentration or dosing parameters Remove syringe verify concentration and reprogram The prompt can be a the result of an incorrect drug amount and or diluent volume entry or b can occur if hospital established Guardrails limits are very wide Be sure to enter either a drug amount per 1 mL or total drug amount per total volume for example a 30 mL syringe with a concentration of 1 mg 1 mL can be entered in one of two ways 3 16 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Set Up Continuous Infusion Only Continued Drug Amount 1 mg Diluent Volume 1 mL OR Drug Amount 30 mg Diluent Volume 30 mL e Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 7 Close and lock security door 8 Verify correct programming parameters and press START Second Nurse Summary orphine soft key Q 9 Green Infusing Status Indicator illuminates Q Infusion mode and drug name scroll in Channel o aig 5 Message Display If a loading dose has been entered ee M en DELIVERING LOAD scrolls Oie e Volume infused in mL h is displayed in Rate Display SIART Main Display alternates between volume remaining P and infusion mode with drug name Set Up PCA Dose and Continuous Infusion 1 Perform steps in Prepare Infusion 2 Press
80. during a volume duration infusion A Gue e s Fid Setup press CHANNEL SELECT key To return to previous screen 4 17 mlh 9 Q VTBI ALL I NOTE o Time Left 00 h 45 min It is possible to program an infusion with a rate that is o 9 displayed with two decimal places one hundredth of 8 mL per o hour on the PC unit for the Pump module However due to sPress START space limitations on the Pump module rate display the rate is displayed to the nearest one tenth of a mL per hour on the PAUSE DRAN Pump module This value is only used for display purposes and the Pump module is actually infusing at the more precise rate noted on the PC unit Alaris System User Manual with v9 17 Model 8015 Programming 2 45 Pump and Syringe Modules Section Secondary Infusion With Guardrails Suite MX Protection Pump Module This mode is designed to support automatic secondary infusions piggybacking in the same instrument A secondary infusion can be programmed as a Basic Infusion or Drug Library Infusion When the secondary VTBI reaches zero an audio tone sounds if enabled indicating completion of the secondary infusion The primary infusion resumes automatically When the instrument is programmed and delivering in the secondary mode the primary infusion is temporarily stopped and fluid is drawn from the secondary container Delivery from the primary container resumes when the fluid level in the
81. e en r Primary at least 972 Container 7 NOTE The top of the fluid container should never be lower than the Y site port to reduce the risk of air entering the primary set The following procedure should be used only when drug to be infused is listed in Drug Library e primary infusion is running and acheck valve administration set is being used To program a primary infusion see IV Fluid Infusion procedure To program a basic infusion see Infusion NO Guardrails Suite MX Protection procedure 1 Press CHANNEL SELECT key Alaris System User Manual with v9 17 Model 8015 Programming 2 47 Pump and Syringe Modules Section Secondary Infusion With Guardrails Suite MX Protection Pump Module Continued Infusion Continued Press SECONDARY soft key Press soft key next to desired drug To view additional drugs press a soft key next to a letter group to navigate through alphabet and or PAGE UP and PAGE DOWN soft keys e If applicable an optional hospital defined therapy or clinical indication for delivery of this infusion could appear Different limits can be defined for same drug with different therapeutic indications If applicable a weight based non weight based or BSA based option for delivery of this infusion could appear If applicable multiple concentration listings for delivery of this infusion could appear To
82. for cracks on the entire surface of the black colored plastic housing See Figures 1 and 2 for the male IUI inspection area and typical cracks 2 Visually inspect the left side female IUI connector for cracks on the edges of the black colored plastic housing 3 If cracks are found replace the IUI connector before use For IUI cleaning instructions see the Cleaning Section in Appendix A 3 70 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 PCA Module Section Alaris SpO Module Models 8210 and 8220 Alaris System User Manual with v9 17 Model 8015 Section 4 THIS PAGE INTENTIONALLY LEFT BLANK Table of Contents Getting Started IMNTPODUCUON EE 4 1 Attach Cable arid Sensors del ee aee d dde et cte dade dace need aa etes t etes 4 2 Programming Monitoring Mode ett ecce Lt ce eene clue ad cet ae dee uet e e a ee ev ee amada 4 3 Set Alarm Limits hc sse elt cc det aet dem tque 4 4 Navigate Trend Data ire eere eei e tede dera doe d dudo dee edd doe 4 5 Navigate PCA Alaris 5002 ModuleTrend Data ssssssssse eene 4 6 Presilenee iod eot t e eo Eo Ue ae ted tu etas 4 7 Ghannel Optlons e ete aet e era i I eter d eut vo 4 8 Change Limit Mode Rt ted ie C pd e oe de api donauit IN a ete repa 4 8 Change Pulse Beep Volume x
83. h User Input Rates Device Calculated Rates 10 99 9 100 999 IPX1 Drip Proof Ultrasonic Air in Line Detection Maximum single bolus size selectable 50 75 or 250 microliters nominal 500 microliters in Anesthesia Mode 654 mmHg Maximum Occlusion Alarm Threshold plus tolerance Factory default setting is 1 mL h if set rate is 1 mL h or above or set rate if rate is 0 9 mL h or below KVO rate can be set in System Configuration from 0 1 20 mL h in 0 1 mL h increments Pump Mode 525 mmHg at rates 330 mL h Varying level based on rate and patient back pressure at rates 30 mL h Selectable Mode User selected 50 525 mmHg in 25 mmHg increments Positive displacement Alaris System User Manual with v9 17 Model 8015 General Information 2 109 Pump and Syringe Modules Section Specifications Continued Pump Module Continued Rate Accuracy Shock Protection Time to Alarm Maximum Volume to be Infused Programming Increments Weight Rate accuracy of Alaris System is 5 at rates between 1 and 999 mL h and 5 5 at rates 1 mL h 95 of the time with 95 confidence under conditions listed below Infusion Rate Range 0 1 999 mL h Ambient Temperature 68 4 F 20 2 C Source Container Height 20 inches above top of Pump module Test Solution Distilled Water Distal Back pressure 0 mmHg 0 kPa Needle 18 gauge Administration Set Model 2210
84. hPa 500 1013 hPa Relative Humidity 20 9096 5 85 Avoid prolonged Noncondensing Noncondensing exposure to relative humidity 28596 Temperature 41 104 F 4 140 F Range 5 40 C 20 60 C LED Light Class 1 LED product Aiming LED 523 nm cw 0 412 mW average radiant power Illumination LED 635 nm cw 2 226 mW average radiant power Alaris Auto ID Module Dimensions 2 0 W x 7 25 H x 5 0 D 5 1 cm W x 19 8 cm H x 12 7 cm D 6 16 General Information Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Specifications and Symbols Continued Specifications Continued Alaris Auto ID Module Electronic Memory System configuration parameters stored in volatile memory are retained for at least 6 months by PC unit internal backup lithium battery Module specific Auto ID parameters are stored for 8 hours by PC unit when system is turned off After 8 hours of continuous off time or if module is changed system automatically purges module specific information Fluid Ingress Protection IPX1 Drip Proof Mode of Operation Continuous Shock Protection Type BF patient applied part Weight 1 30 1 Ibs 436 5 143 65 g Handheld Scanner Dimensions 3 25 W X 7 25 H X 4 25 L 8 3 cm W x 18 4 cm H x 10 8 cm L Housing UL 94V0 flammability rating Weight 6 5 oz 178 g Symbolology The Auto ID module supports an optional handheld scanner that can be used to sca
85. hour as displayed on programming SETUP BOLUS screen Rate shown in Rate Display is rounded to nearest one tenth of a mL per hour BOLUS soft key appears only if Bolus Dose is enabled within selected profile drug is bolusable and a VTBI is entered Alaris System User Manual with v9 17 Model 8015 Programming 2 25 Pump and Syringe Modules Section Continuous Infusion Continued Syringe module d roke If ALL Mode is enabled for syringe configuration in Q continuous Fusion Data Set ALL is displayed in VTBI field and Q 567 mun estimated available volume in syringe is displayed Q AL Geo g h o DOSE _ 0 81 mg kg h O M mE o If ALL Mode is disabled for syringe configuration in Conc 1 mg mL Data Set estimated available volume in syringe is displayed when VTBI soft key is pressed Pause SETUP BOLUS START enter or change a numeric VTBI value press Q 6 VTBI soft key and enter value deliver entire contents of syringe Keep an ALL Guardrals Drug Setup VTBI value or Aer soft key to change a couniNUGUE INFUSION LO numeric VTBI value to ALL Q e 567 my e o EJ 13 ER Qos _ 0 81 mg kg m o Conc 1 mg mL gt Select START PAUSE SETUP BOLUS START 0000 7 Verify correct parameters and press START soft key Atep
86. includes one hour of Continuous Dose Guardrails Drug Setu IMS Pre fill 30mL i Cont Dose 2 mg h Max Limit 30 mg 4 h Bolus 1 Dose mg Conc 1 mg mL gt Press START 90000 66600 PAUSE Sa tos 000 AF 8 Reprogr Cannot proceed due to incorrect concentration or dosing parameters Remove syringe verify concentration PCA Dose Bolus Dose or Loading Dose If the programmed and reprogram volume is 3596 or more of the capacity of the installed syringe Press REPROGRAM during initial or subsequent programming the clinician is presented with an alert which requires a reprogram 3 24 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued PCA syringe sizes and the correlating 35 of the syringe capacity Syringe Size 35 of Syringe Capacity 60mL 21mL 35mL 12 25mL 30mL 10 5mL 25mL 8 75mL 20mL 7mL Stop a Loading PCA or Bolus Dose 1 Press CHANNEL SELECT key 2 Press STOP LOAD STOP PCA or STOP BOLUS soft key as Summary applicable o Available soft key and stop confirmation screen are gt 9 dependent on type of dose currently infusing and current o 0 infusion mode o O Q bese 1 ms Conc 1 mg mL gt Press START to Close START 3 To stop dose and resume current program press Yes soft o o o o key Alaris System User M
87. injury and or death For a list of compatible syringes see Compatible Syringes Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient NOTE Fora list of compatible syringes see Compatible Syringes For a list of compatible administration sets refer to CareFusion IV Sets and Accessories may be downloaded from www carefusion com 2 86 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Warnings and Cautions Continued Administration Sets Continued CAUTION JAN Before operating the instrument verify that the administration set is free from kinks and correctly installed Epidural Administration Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient It is strongly recommended that the source container administration set and Pump module used for epidural drug delivery be clearly differentiated from those used for other types of administration administration set and Syringe module used for epidural drug delivery be clearly differentiated from those used for other types of administration It is strongly recommended that the syringe The Alaris System can be used for epidural administration of anesthetic and analgesic drugs This application is only appropriate when using anesthetics and analgesics labeled fo
88. is a positive displacement delivery system capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice including resistances to flow imposed by small gauge catheters filters and intra arterial infusion It is neither designed nor intended to detect infiltrations and does not alarm under infiltration conditions The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site can impede the flow of common gravity only systems affecting their performance Hospital facility personnel must ensure that the performance of the common IV site is satisfactory under these circumstances e Toprevent a potential free flow condition ensure that no extraneous object for example bedding tubing glove is enclosed or caught in the Pump module door Administration Sets When priming Ensure that administration set is not connected to patient Ensure that air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequences Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient Discard if packaging is not intact or protector caps are unattached Alaris System User Manual with v9 17 Model 8015 General Information 2 85 Pump and Syringe Modules Section Wa
89. is loaded Serial Numbers 1 Press OPTIONS key 2 Press PAGE DOWN soft key 3 Press Serial Numbers soft key System Options 2 of 3 Serial numbers for PC unit and all attached modules Q Battery Runtime System Configurations display 9 g Serial Numbers gt gt o Software Versions o Time of Day 00000 gt Select an Option or EXIT PAGE PAGE vel EXIT DOWN 000 1 22 Alaris System User Manual with v9 17 Model 8015 PC Unit Section System Options Continued Serial Numbers Continued 4 To return to main screen press EXIT soft key NOTE GO nnnn nnnnnnnn in the illustrated display represents a serial number Software Versions 1 Press OPTIONS key 2 Press PAGE DOWN soft key 3 Press Software Versions soft key 4 To review software version information press View soft key next to applicable module 90000 Serial Number Review PC Unit Module A nnnn nnnnnnnn Module B nnnn nnnnnnnn Module C nnnn nnnnnnnn Module D nnnn nnnnnnnn gt Press CANCEL or EXIT o o o o 00000 System Options 2 of 3 Battery Runtime Q System Configurations Software Versions Time of Day 00000 gt Select an Option or EXIT PAGE PAGE vel EXIT DOWN 0000 Software Rev Revi Q Pc unit vie
90. key 3 Press Pressure Limit soft key FEW Crrannel UPTO of 2 3 Pressure Limit High 9 o Prime Set with Syringe Q 9 gt Select an Option or EXIT lcd 4 select a pressure limit press appropriate soft key 5 Press CONFIRM soft key Q Pressure Limit Selection O Q Low md o ro o High O 999 Option to change pressure limit can be selected after drug is selected and before infusion mode is selected and infusion starts or after infusion starts View and Clear Volume Infused 1 To view volume infused press VOLUME INFUSED soft key from Main Display Total volume infused and time and date volume infused was last cleared is displayed for each channel 9 3 36 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued View and Clear Volume Infused Continued 2 clear volume infused 9 9 e If only selected channels are to be cleared press soft key next to applicable channel s and press CLEAR CHANNEL soft key Ifall channels are to be cleared press CLEAR ALL soft key Volume Infused TOTAL VOLUME mL SL A 401 10 B 42 50 C D 3 Toreturn to main screen press MAIN SCREEN soft key 478 10 1559529 789 10 1888310 90090 00000 NOTES Date format is year month day
91. not been reached SatSeconds alarm management With SatSeconds alarm management technology upper and lower alarm limits are set in the same way as with traditional alarm management A SatSeconds limit can be set to allow monitoring of SpO below selected low alarm limit for a period of time before an audible alarm sounds Alaris System User Manual with v9 17 Model 8015 General Information 4 19 SpO Module Section Features and Displays Continued Features and Definitions Continued Model 8220 Mew Feature Fast SAT Definition When Fast SAT is enabled and there is one data point that is significantly different from a previous data point averaging is disregarded and most recent data point is displayed For example if readings were 97 96 95 and 85 displayed saturation level would be 85 Perfusion Index PI is a scaled numeric value derived from magnitude of pulsations displayed on plethysmographic pleth waveform It is calculated as a percentage of pulsatile signal to nonpulsatile signal PI is used to find best perfused site for sensor placement larger the PI stronger the perfusion Operating range is 0 02 to 20 Desired number is greater than 1 or as large as possible Saturation Averaging Time Averaging time can be set to 2 4 8 10 12 14 or 16 seconds Sensitivity Mode Sensitivity mode normal or maximum of current monitoring configuration is displayed i
92. pressed and held ww illuminated indicates Alaris System is operating on battery power Enter K y When pressed p current parameter entry Cancel Key When pressed sequentially backs out of current setup sequence Power Indicator When illuminated indicates Alaris System is connected to an AC power source Clear Key When pressed clears current selected parameter setting to 0 Decimal Key When pressed inserts a decimal point in numeric data Wireless Network Indicator When illuminated indicates Alaris System is connected to Alaris Systems Manager When blinking indicates data transfer Module Release Latch When pressed allows module to be removed Numeric Keypad Alaris System User Manual with v9 17 Model 8015 1 37 PC Unit Section Features and Displays Continued Operating Features Controls Indicators Continued IUI Connector Left IUI Connector Right Power Cord Strap Use this bolt to reorient Pole Clamp 90 for attachment to a bed rail instead of a pole Wireless Network Card see illustration below for LED location Primary Audio Speaker LER aja E Connector Plug over RJ45 Communication Data Port N Tamper Resist Switch X gt ss Wireless Network Card LED Flashes green when A
93. programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed Ifthe programmed continuous dose infusion is outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue The infusion needs to be reprogrammed 3 An optional hospital defined and editable starting value DS for Bolus Dose and or bolus rate duration might already be 80Lus DOSE entered O DR Q 9 To enter Bolus Dose use numeric data entry keys o o Conc 1 mg mL After a Bolus Dose and weight if used are entered gt Enter Bolus Dose bolus VTBI and concentration conc alternate in Main n Display l SETUP ous If no weight has previously been programmed in o system and Bolus Dose is weight based weight entry is empty Ifthe programmed continuous dose is weight based programmed weight is displayed If Bolus Dose is not weight based Not Used is displayed in PATIENT WEIGHT field A Bolus Dose can be either weight based or non weight based independent of whether the Continuous Infusion is weight based or non weight based 4 Toenter or change patient weight if used use applicable following procedure depending on whether or not continuous dose is weight based Alaris System User Manual with v9 17 Model 8015 Programming 2 29 Pump and Syringe Modules S
94. set is removed from the instrument Safety Clamp Fitment in Open Position When a new Pump module Gemini Infusion System Blue Fitment administration set is removed from the package the safety clamp fitment is in the open position white slide clamp aligned with blue fitment In this open position flow is not occluded but is allowed as required for the priming process The roller clamp is used to control flow during the priming process White Slide Clamp shown in open position Safety Clamp Fitment in Closed Position When an Pump module Gemini Infusion System administration Blue Fitment set is removed from the Pump module the instrument automatically engages the safety clamp fitment in the closed position white slide clamp projects out from under blue fitment In this closed position flow is occluded RE White Slide Clamp shown in open position 2 90 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Administration Set Syringe Information Continued Compatible Syringes Syringe Module
95. settings type of administration set in use hospital defined Data Set uploaded using the Guardrails Suite MX programmed drug calculation parameters and many other variables Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages Main Display See the PC unit section of this User Manual Dynamic Pressure Display caress CAUTION 20 Q l Dynamic Pressure Display Q Although the dynamic pressure display bars for the Syringe module o o Current operating pressure is and Pump module both use the full indicated by solid bar P width of the screen for display they ec 9 each represent different ranges Patient side occlusion pressure The Pump module s range is 50 to set point is indicated by tick mark Fm y 525 mmHg and the Syringe module s The tick mark moves when the o 9 range is 25 to 1000 mmHg Pressure Limit changes 2 102 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section ANNE The Pump Module and Syringe module use the following parameters ENJA entered during the drug calculation setup procedure The Drug Calculation feature is to be used only by personnel properly trained in the administration of Bolus Dose duration Time period over which Bolus Dose is to be administered Bolus Dose units Units used in calculatin
96. the instrument in use Prior to placing the Alaris System in use 1 Perform check in procedure using System Maintenance software 2 Whether or not Profiles feature has been enabled see PC unit section System Options System Configurations NOTE To enable the Profiles feature a hospital defined best practice Data Set must be uploaded to the PC unit viii Alaris System User Manual with v9 17 Model 8015 Alaris PC Unit Model 8015 9 CareFusion Alaris PC Guardrails Alaris System User Manual with v9 17 Model 8015 THIS PAGE INTENTIONALLY LEFT BLANK Table of Contents Getting Started Introductio RR ET EE E 1 1 General Setup and Operation Attach and Detach Module 5 43 ite t ttt t tn 1 3 fupe ure cC 1 3 Detach Modu ule eco e t Hp e tee PR REP t 1 4 Add Module While System is Powered On sss enm ennemis 1 5 SiCIEB 1 5 Power On SySter c ou ec e Dead eee ee 1 5 Respond to Maintenance REMINCEL c cccssessesesecececeecececeeeeeeeeeeeseesesesesesseeeeeasseseseeeeeseseseeeess 1 7 Adjust Display Contrast ide Unde ete died evel Laden ts edet ba ced dea Lin iai eaa sd 1 7 Select New Patient and Profile Options sssssssssssssssseeeeee nene 1 8 Adjust Audio Volume siecle abe pdt ple aede ey 1 10 Lock Unlock Tamper RESISt iuo ie Ree te e P
97. the sides of the PC unit and modules can prevent proper latching _ Position free module at a 45 angle aligning IUI connectors Aligned IUI Connectors IUI Connector Top View IUI Connectors Not Aligned Front View Top View Alaris System User Manual with v9 17 Model 8015 1 3 PC Unit Section Attach and Detach Module Continued Attach Module Continued 2 Rotate free module down against PC unit or attached WARNING AN module until release latch snaps in place When properly secured snapped the release latch provides a very secure connection between modules If not properly latched a module can be dislodged during operation eee RE m I ry Oo ro 6 9 F 2 00600 O Oooo NMCOCOCOCO I oooO Detach Module Ensure that module is powered off before detaching N Push module release latch and then rotate module up and away from PC unit or attached module opposite to motion shown in Attach Module procedure to disengage connectors Alaris System reidentifies and shows appropriate module identification A B C or D from left to right Appropriate module position s A B or C for remaining module s appear on Main Display 1 4 Alaris System User Manual with v9 17 Mod
98. tubing toward back of Air in Line AIL Detector 4 Close door and latch as follows a Close door and hold in a closed position by grasping door and instrument case with one hand b Gently lower latch Safety clamp device is automatically disengaged 5 Open roller clamp 6 Verify that no fluid is flowing through drip chamber 5 f caution JAN To reduce the potential for nuisance AIL alarms ensure that tubing is fully inserted in the AIL Detector Safety Clamp Fitment L PA LA Push tubing toward back of AIL Detector Ge PAN Do not touch the administration set while closing the door Failure to follow this instruction can result in infusion rate inaccuracy To prevent a potential free flow condition ensure that no extraneous object for example bedding tubing glove is enclosed or caught in the Pump module door 2 4 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Prepare Administration Set Pump Module Continued Remove 1 Close roller clamp 2 Open Pump module door EB
99. twisted to the open position and then released it and the plunger grippers returns to the closed position WARNING Ensure that syringe barrel flange and plunger are installed and secured correctly Failure to install syringe correctly can result in uncontrolled fluid flow to the patient and can cause serious injury or death gt Ec l 1 c 2 EE a Gripper Control in Closed Position Drive Head Flush yy with Plunger Flange mj Plunger Grippers Closed EAR 2 o B 2 Alaris System User Manual with v9 17 Model 8015 PCA Module Section Getting Started 3 5 Prepare and Load Syringe and Administration Set Continued Security Lock Key Positions There are three key positions associated with the security lock UNLOCK unlocks security door Key must be in this position when loading or changing a syringe e PROGRAM allows for changes in programming without unlocking security door or interrupting current infusion e LOCK locks security door Key must be in this position to start an infusion 3 6 Getting Started Alaris System User Manual with v9 17 Model 8015 PCA Module Section Programming References throughout this procedure to specific drugs and drug doses are for illustration purposes only Refer to specific
100. 00 gt Press and Hold PRIME c Alaris System User Manual with v9 17 Model 8015 Getting Started 2 13 Pump and Syringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued Prime Using Options Menu Continued Administration Set With Pressure Sensing Disc Continued 8 Gently massage pressure sensing disc to ensure that all air is expelled The disc must remain inverted only until the air is expelled Continue to gently massage disc throughout priming to ensure that it does not become under or over filled 9 Continue to prime until fluid flows and priming is complete Fluid is delivered during priming only while PRIME soft key is pressed Each press of PRIME soft key delivers up to 2 mL of priming fluid per continuous press To deliver additional amounts press PRIME soft key again A 10 When priming is complete release pressure sensing disc Prime Set with Syringe 6 and PRIME soft key Q inen disposable se Volume used during priming is displayed but not added to d mim CD P VTBI or VI Prime Volume 2mL gt Press and Hold PRIME PRIME EXIT 0000 a Orient pressure sensing disc as follows 11 Reinstall pressure sensing disc as follows e fluid side up patient side down n cavity forward membrane toward instrument b Gently slide pre
101. 00 4 3 from equation applicable to frequency of Radiated RF transmitter Recommended Separation Distance 12 __d P V2 12 __d VP 80 MHz 800 MHz Ey 12 d VP 80 MHz 2 5 GHz Ey d recommended separation distance in meters hg P maximum output power rating of transmitter in watts W according to transmitter manufacturer Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than compliance level in each frequency range 20 Interference might occur in vicinity of equipment marked with following symbol K 3 Alaris System User Manual with v9 17 Model 8015 Regulations and Standards A 13 Appendix Section Compliance Continued Electromagnetic Environment Continued Alaris System Continued Table 499699 Recommended Separation Distances Reduce the potential for electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Alaris System as recommended in this table based on the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed in this table the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W based o
102. 4 T TNT MH mode Trumpet Curve at 0 1 mL h initial 80 4 mL h flow rate error 5 0 06 4 0 amy 1 D ar 1 0 00 0 02 0 20 40 60 80 100 120 0 5 10 15 20 25 30 observation interval min time min Mode Start up at 1 mL h initial Mode Trumpet Curve at 1 mL h initial 134 1 E 34 o3 07 g 4 4 SR x2 153 gt 1 E 36 32 34 qd 44 3 42 4 0 2 t t i t t t 1 0 20 40 60 80 100 120 Lis Neen he a time min 0 5 10 15 20 25 30 observation interval min Mode Trumpet Curve at 5 mL h initial a Mode Start up at 5 mL initia 9 8 7 x 8 5 5 8 3 z o 1 0 1 t A t A t t A t i L4 d pa pia 0 20 40 60 80 100 120 40 45 20 time min observation interval min Legend E Maximum rate error mm Overall rate error Minimum rate error Alaris System User Manual with v9 17 Model 8015 General Information 3 63 PCA Module Section THIS PAGE INTENTIONALLY LEFT BLANK 3 64 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Troubleshooting and Maintenance eer LR Troubleshooting and maintenance are intended to be performed only by qualified personnel using the PCA module Technical Se
103. A appears as in illustrated S ps ii I example which reflects the use of Methotrexate o i Qs mgm Conc 136 8 mg mL gt Enter BSA LIBRARY 0000 4 Verify correct parameters and press NEXT soft key to confirm If the programmed total dose drug amount is outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed If the programmed total dose drug amount is outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion needs to be reprogrammed 2 36 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Intermittent Infusion Continued If a dose outside of Soft Limits has been entered and verified as correct Message Display also shows either LLL for a low dose or 17 for a high dose Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 5 VTBI entry 5 Pump module gt When VTBI is less than 10 mL h entry can be to two decimal places one hundredth of a mL VTBlis prepopulated with diluent volume of infusion To change VTBI press VTBI soft key and
104. ABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION See packing inserts for international warranty if applicable A 8 Maintenance Alaris System User Manual with v9 17 Model 8015 Appendix Section Regulations and Standards Compliance Electromagnetic Environment Alaris System This system complies with part 18 of the FCC Rules US version only Operation is subject to the following two conditions This system might not cause harmful interference This system must accept any interference received including interference that might cause undesired operation The digital apparatus does not exceed the Class B limits for radio noise emissions from digital apparatus set out in the radio interference regulations of the Canadian Department of Communications DOC Le present appareil numerique n emet pas de bruits radiolelectriques depassant les limites applicables aux appareils numeriques de la Classe B prescrites dans le reglement sur le brouillage radioelectrique edicte par le Ministere des Communications du Canada This system has been tested and found to comply with the limits for a Class B digital device pursuant to Part 18 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the system is operated in a commercial environment This system generates uses and can radiate radio frequency energy If itis not installed and used
105. E key PAUSE scrolls in Message Display PAUSED appears on Main Display e Yellow Standby Status Indicator illuminates U sem After 2 minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status de Indicator flashes amp 2 60 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Pause Change Restart Infusion Continued Pause and Restart Infusion Continued 2 Toreinitiate infusion Press RESTART key OR Press CHANNEL SELECT key and then press START soft key NOTES To stop a Bolus Dose see the Bolus Dose procedure The Pump module keypad is used in the illustrations but the keys are the same for the Syringe module An infusion can also be paused by pressing the PAUSE soft key on PC unit if the Delay Options are disabled To pause an infusion programmed with Delay Options enabled see Delay Options Pause Infusion Change Rate or VTBI During Infusion 1 Press CHANNEL SELECT key 2 Press either RATE or VTBI soft key 3 Toenter desired parameter use up down arrows for rate titration or numeric data entry keys 4 Verify correct infusion parameter entry and press START soft key Restore Infusion 1 Torestart infusion using stored parameters press RESTORE soft key 2 Verify correct parameters and press START soft key NOTE To restore
106. ER OTHER THAN 70 IPA TO CONTACT THE IUI CONNECTORS Alaris System User Manual with v9 17 Model 8015 Appendix Section Maintenance A 5 Cleaning Continued Alaris System Continued Drying and Inspection D Confirm that the instruments and IUI connectors are thoroughly dry before using them again DO NOT attach devices that have not fully dried to one another Wet mating can hinder proper instrument operation Fully inspect the instrument during each cleaning Look for any visible external damage such as a cracked or broken door handle or latch Open the door of each pump module and inspect the platen and hinge for cracks or other damage DO NOT use a device with any damage Send it to Biomedical Engineering for repair Inspect the IUI connectors on each PC unit and module prior to use Replace any IUI connector with surface contaminants blue or green deposits or cracks DO NOT use a device with any cracks or surface contaminants on the IUI connectors Rather send it to Biomedical Engineering for repair A 6 Maintenance Alaris System User Manual with v9 17 Model 8015 Appendix Section Service Information CAUTION P N Handheld Scanner 1 056 a clean soft cloth or lens tissue dampened with warm water or a mild nonabrasive detergent water solution to clean all exposed surfaces N Use a clean soft cloth or lens tissue dampened with water to rinse off cleaning solution
107. IV solution drug and concentration to be automatically selected from the Drug Library Scanned solution containers can be used for Pump Syringe and PCA infusions Only one Auto ID module can be connected to the Alaris System but it can be added as a fifth module The Alaris System with the Auto ID module is intended to provide trained healthcare caregivers a way to automate infusion parameter input thereby decreasing the number of manual steps necessary to enter infusion data All data entry and infusion parameter validation is performed by the trained healthcare professional according to a physician s order Electromagnetic Environment See Appendix section of this User Manual Regulations and Standards Compliance Alaris System User Manual with v9 17 Model 8015 Getting Started 6 1 Auto ID Module Section THIS PAGE INTENTIONALLY LEFT BLANK 6 2 Getting Started Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Programming Patient Identification Associating the PC unit with a patient provides a means of identifying the module s that will deliver IV medications to that particular patient New Patient To associate the PC unit with a new patient ID 1 Attach handheld scanner to connection port on Auto ID WARNING le Ensur re circuit connection module SULE st SR CUP CICO CONNMECUO Use only the handheld external scanner supplied by CareFusion Using other accessories
108. If enabled it graphically displays current patient side occlusion pressure set point and current patient side operating pressure for that module See Displays for additional Dynamic Pressure Display information Event Logging Event Logging records instrument operations Initial Value An optional and editable starting value for Continuous Infusion dose duration Bolus Dose bolus rate of administration or Bolus Dose duration IV Fluid Library An optional library consisting of IV Fluids for example TPN and limits around rate of delivery Limit A programming Limit or best practice guideline determined by hospital health system and entered into system s Data Set Supports concentration Limits for all infusions that utilize concentration Profile specific Limits can be defined for flow rate patient weight body surface area BSA maximum and minimum continuous dose or total dose and duration for each drug in a Drug Library Dose and duration Limits can be defined by hospital health system as a Hard and or Soft Limits A Hard Limit is a programmed Limit that cannot be overridden except in anesthesia mode A Soft Limit is a programmed Limit that can be overridden Multidose Mode Allows 2 24 doses to be programmed at equally spaced intervals on the same module over a 24 hour period This mode is designed to allow delivery of multiple equal doses from the same IV container at regularly scheduled int
109. Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Drug amount and diluent volume must be reprogrammed If there is a potential for a programmed mL parameter to result in an excessive volume or dose being delivered following prompt appears Cannot proceed due to incorrect concentration or dosing parameters Remove syringe verify concentration and reprogram The prompt can be a the result of an incorrect drug amount and or diluent volume entry or b can occur if hospital established Guardrails limits are very wide Be sure to enter either a drug amount per 1 mL or total drug amount per total volume for example a 30 mL syringe with a concentration of 1 mg 1 mL can be entered in one of two ways Guardrails Drugs Med Surg Morphine o9 1 mg mL 5 mg mL 10 mg mL 900 60000 gt Select Concentration 0000 Alaris System User Manual with v9 17 Model 8015 PCA Module Section Programming 3 11 Prepare Infusion Continued Program an Infusion Continued Drug Amount 1 mg Diluent Volume 1mL OR Drug Amount 30 mg Diluent Volume 30 mL Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 10 Verify correct parameters and press NEXT soft key to confirm 11 Prime syringe using Prime feature if desired Infusion Modes Prog
110. Liwrrs S period displayed dashes display O O 2 navigate from page to page press PAGE UP and PAGE DOWN soft keys Alaris System User Manual with v9 17 Model 8015 Programming 4 5 SpO Module Section Monitoring Mode Continued Navigate Trend Data Continued 3 To scroll data one row at a time press lt or key 4 Tochange TIME increments for data review move cursor 09 00 to desired time period and press ZOOM soft key OR Ww wr Q 07 01 97 00 82 150 9 New time increments display oso 97 82 9 i E ake Each press of ZOOM soft key changes time oe O increments Q e O zoom KE 60 30 5 1 minutes gt Press UP DOWN Keys 5 Toreturn to SPO2 Main display press SPO2 MAIN soft key 6 Toreturn to Main Display press MAIN SCREEN soft key Navigate PCA Alaris SpO ModuleTrend Data To access and view shared trend data when a PCA module is present perform the following steps 1 To access option to view trend data press OPTIONS key while in SPO2 Main display 2 To view Trend Data press PCA SpO2 Trend data soft EX channel Options key Q Limit Mode Adult o Tabular information is not updated while Trend Data Puse Beep voume 6 view is displayed Tabular data is updated using new P 10 trend data stored in SpO5 module after leaving Tre
111. ME increments fe tle e Return to ETCO2 MAIN display 2 ZOOM 120 60 30 5 BEN vices Return to Main Display Press UP DOWN Keys to Move Cursor ZOOM an DOWN 0000 5 8 Programming Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Monitoring Mode Continued Presilence Alarm 1 To presilence alarm press SILENCE key All monitoring alarms are silenced for 120 seconds Subsequent infusion alarms are not silenced 2 To cancel presilence alarm and return to alarmable mode Press CHANNEL SELECT key e Press CANCEL SILENCE soft key FAQETCO2 Main RR ETco2 34 R mmHg 13 S breaths min 00000 2 Time sec 4 5 Channel Options Change Limit Mode The following procedure can be performed only when the Guardrails Suite MX is not enabled profile option not being used for programming 1 Press Limit Mode soft key 00996 LX Channel Options du aveform height 80 mmHg Waveform time scale 5 sec PCA EtCO2 Trend data 00000 gt Select an Option or EXIT EXIT 000 Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Programming 5 9 Channel Options Continued Change Limit Mode Continued 2 To change Limit Mode Setup press applicable soft key Al
112. Mea tere ap Sed dit ech TO 5 23 Principle ot Operatlon ito tete ec oe tle eise Eu ey oco pape LL der oboe ba eut 5 25 Troubleshooting and Maintenance General ettet en hU ea t etui pu uen 5 27 Alarms arid Messages 4 iade coti o eon eed eec rb i Pea gae uad 5 27 Bier c T MM 5 27 Audio Characteristics neret e e d eds ae 5 28 RET 5 28 MessagoS m IEEE 5 29 Inspection ka dura dade Ea dede nad 5 30 Alaris System User Manual with v9 17 Model 8015 5 i EtCO Module Section THIS PAGE INTENTIONALLY LEFT BLANK 5 ii Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Getting Started troduction o Introduction This section of the User Manual provides EtCO module ENDA Model 8300 instructions and information It is used in conjunction with Read all instructions for both the 2 module and PC unit before e EtCO module Technical Service Manual using the Alaris System e CareFusion IV Sets and Accessories may be downloaded from www carefusion com CAUTION AN Covidien s Microstream disposable instructions PC unit section of this User Manual R Only System Maintenance software and its instructions for Alaris System check in maintenance and wireless configuration The EtCO module is a capnograph indicated for conti
113. O2 or DISABLE ETCO2 soft key as appropriate e Disabling SpOs or EtCO from this screen discontinues PCA Pause feature only without interrupting monitoring functionality Once disabled alarm limits are grayed out and are not editable 90000 90000 PCA Pause Limits PCA SPO2 ETCO2 PAUSE LIMITS ALARM LIMITS CU 88 97 4 5 00000 gt Enter a Pause Limit Between 2 4 DISABLE DISABLE SPO2 conrirm ETCO2 0000 PCA Pause Limits PCA SPO2 ETCO2 PAUSE LIMITS ALARM LIMITS ier 88 97 4 5 00000 gt Enter a Pause Limit n2 4 DISABLE DISABLE SPO2 cone ETCO2 ao 3 40 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Guardrails PCA Pause Protocol Feature Continued Disable PCA Pause Alarm Continued 5 Press CONFIRM soft key 6 Press START soft key 7T Toenable PCA Pause feature follow steps 1 3 above and press ENABLE SPO2 or ENABLE ETCO2 soft key as appropriate Alaris System User Manual with v9 17 Model 8015 Programming 3 41 PCA Module Section THIS PAGE INTENTIONALLY LEFT BLANK 3 42 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section General Setup and Operation D SystemStartUp Setup System Start Up Setup See the PC unit section of this User Manual General Setup and Operation for various system start up and setu
114. OSE soft key press Yes soft key and use numeric data entry keys Loading dose is included in VTBI but is not included in A ETE a 1m 8 Verify correct parameters and press CONFIRM soft key qn 10 i INTERVAL minutes If the programmed parameters are outside the Soft O 2 man Limit for that care area an audio alert sounds and a O 20 mgn O visual prompt appears before programming can Q ER None O continue If Yes soft key is pressed programming Conc 1 mg mL continues if No soft key is pressed infusion needs to Nan be reprogrammed EE 9 ON 60 6 3 18 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Set Up PCA Dose and Continuous Infusion Continued If the programmed parameters are outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion must be reprogrammed If there is a potential for a programmed __ __ mL parameter to result in an excessive volume or dose being delivered following prompt appears Cannot proceed due to incorrect concentration or dosing parameters Remove syringe verify concentration and reprogram The prompt can be a the result of an incorrect drug amount and or diluent volume entry or b can occur if hospital established Guardrails limits are very wide Be sure to enter
115. OTE There is a potential for a discrepancy in precision between the numeric values displayed on the Alaris System PC unit Pump module and Syringe module and in the electronic medical record EMR hospital information system HIS due to different rounding rules NOTE There is a potential that the concentration displayed on the Alaris System PC unit will use different units of measure than the concentration displayed in the EMR HIS The Alaris System PC unit displays the concentration drug amount per 1 mL using the dosing units assigned to that Guardrails drug entry Note The Alaris System allows Continuous Infusions to be dosed in different units than the units used in the Drug Amount However the Alaris System sends the concentration to the EMR HIS using the units of the Drug Amount It is important to note that the concentration displayed on the Alaris System PC unit should be equivalent to the concentration displayed in the EMR HIS even if different units of measure are used The following example is for a continuous drug that has a Drug Amount in grams but is dosed in mg Displayed on Alaris Infusion information sent System PC unit to EMR HIS Drug Amount 1 gram Drug Amount 1 gram Diluent Volume 100 mL Diluent Volume 100 mL Conc 10 mg mL Conc 0 01 gram mL 2 92 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Features and Displays Fea
116. P E 1 10 Power Off SVSLeIm uii ee ouo er mde a aad ede et ede o a uude rego E det TEE aate ya ndn 1 11 System tono S e ue ctt ind tt e ee eae 1 12 Display Contiast seiren EE ee ee ee 1 12 Patient ID e e ir nn ier Piet adi na oett ric d pex teo ei reas 1 12 Clinician ID itid ite see coal e dede eot Lade ce eed 1 15 Power Down All Channels 21 irre io a ru casa dente Re eo ea PR Rao ts 1 16 System Config ratiorns 2 2 3 ot del d e e ined de ev dee ne dva eed ee 1 20 Serial Numbers iet te e ie rre dee D a 1 22 Software Versions 2 tra tiara ga ete tee ia et qoe vues Tid cbe 1 23 HUME OF PIU 1 24 Morse E 1 25 Witeless GonnectlOn iem teo re ER ETE E THREE te 1 28 DataSet Status sc eoe meet es v ue eel 1 29 Maintenance De eei ea dade este cete diae fade et eee 1 30 General Information Warnings and Gautions eet et Pa d dtc tp in dd 1 33 Ie Uc 1 33 Electromagnetic Compatibility osise riras T AA AT A 1 34 Features and Displays iri teet da metit pte date ertet ets 1 35 1 1 1 35 Operating Features Controls
117. Pump module Gemini Infusion System administration sets The use of any other set can cause improper instrument operation resulting in an inaccurate fluid delivery or other potential hazard For a list of compatible administration sets please refer to the current CareFusion IV Sets and Accessories Catalog May be downloaded from www carefusion com 3 Load administration set as follows a Hold upper fitment above fitment recess and lower into recess b Ensure that tubing is not twisted Discard if packaging is not intact or protector caps are Yr i unattached 5 Jum P N Failure to follow proper administration set loading instructions might lead to an instrument malfunction Before operating the instrument verify that the administration set is free from kinks and correctly installed Insert upper fitment before installing safety clamp fitment When reloading an administration set leave the safety clamp fitment in the closed position see General Information Safety Clamp Alaris System User Manual with v9 17 Model 8015 Getting Started 2 3 Pump and Syringe Modules Section Prepare Administration Set Pump Module Continued Load Continued c Press safety clamp fitment into recess below mechanism d Using a finger tip firmly push
118. RT key Occlusion Increased back pressure sensed while infusing Infusion stops on affected module Clear occlusion Press RESTART key or press CHANNEL SELECT key and then START soft key PCA Pause Alarm PCA infusion has paused due to a decline in respiratory status Assess patient status per hospital policy Press CONFIRM once patient status and monitoring values have been addressed Press RESTART key per hospital policy 3 66 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 PCA Module Section Alarms Errors Messages Continued Alarms Continued Meaning Syringe Empty Syringe is empty If syringe is not empty other possibility is Syringe plunger travel impeded Syringe Adjustment Alarms When a syringe installation problem is detected a visual signal is displayed Text in the display blinks to indicate the location of the problem When problem is corrected press CONFIRM soft key Alarm Meaning Response Set up new infusion or press CHANNEL OFF key Verify that syringe plunger movement is unimpeded If syringe is not empty and above actions do not correct alarm replace module Syringe Installation lever plunger flange clamp 99000 66600 gt Press CONFIRM Eh Response Check Syringe Plunger grippers opened during infusion and then closed Infusion
119. START for intermittent duration is not already entered enter Q duration or rate as follows enter duration press DURATION soft key and use numeric data entry keys rate value is calculated and displayed To enter rate press RATE VOLUME soft key and enter OR infusion rate RATE E vaie Y ETUP START 7 Verify correct parameters and press START soft key If the programmed duration is outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed Ifthe programmed duration is outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion needs to be reprogrammed Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 2 38 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Intermittent Infusion Continued 8 4 Syringe module Unclamp tubing and attach administration set to Unclamping tubing and starting infusion before i attaching administration set to patient minimizes any potential bolus that can be released from pressu
120. Suite MX Protection 1 Press SECONDARY soft key and then BASIC SEC soft key 2 58 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Secondary Infusion NO Guardrails Suite MX Protection E Pump Module Continued ir Infusion Continued 2 Enter secondary infusion rate or duration as follows enter secondary infusion rate press RATE soft key and use numeric data entry keys enter duration press DURATION soft key and use numeric data entry keys 3 To enter secondary volume to be infused press VTBI soft key and use numeric data entry keys 4 Open clamp on secondary administration set 5 Verify correct infusion parameters and press START soft key Change Primary Infusion Parameter 1 Press CHANNEL SELECT key 2 Press PRIMARY soft key 3 To change primary infusion parameter press applicable soft key RATE or VTBI and use numeric data entry keys 4 Verify correct primary infusion parameters and press SECONDARY soft key Secondary setup screen is displayed 5 Toresume secondary infusion press START soft key Stop Secondary and Return to Primary See Secondary Infusion With Guardrails Suite MX Protection Alaris System User Manual with v9 17 Model 8015 Programming 2 59 Pump and Syringe Modules Section Pause Change Restart Infusion il Pause and Restart Infusion Ke 1 Press PAUS
121. System Options Q Network Status Status CONNECTED Q Uptime 03 45 35 Co Profile Site 1 Bytes Sent 13 890 o Bytes Received 1 200 150 gt Press CANC WIRELESS STATUS 00000 v9 5 and later PC unit System Options MAC Address DHCP IP Address Subnet Mask Gateway 99000 DNS Primary DNS Secondary Network Address 00 0A B3 36 9F 88 Yes 192 168 0 55 255 255 255 0 192 168 0 1 192 168 0 1 192 168 0 3 00000 gt Press CANCEL to Exit WIRELESS STATUS STATUS SERVER STATUS PC Unit Section Alaris System User Manual with v9 17 Model 8015 1 27 o System Options Continued Network Status Continued Information based on a status of DISABLED DISCONNECTED CONNECTING or CONNECTED is displayed e If status is CONNECTED PC unit is connected to Alaris Systems Manager and the following information is displayed Uptime length of time PC unit has been connected Server Address IP Address of Alaris Systems Manager TCP Port being used to establish connection Encryption type AES 128 bit used to encode data on payload and protect patient sensitive information sent through wireless network Bytes Sent cumulative total of data sent Bytes Received cumulative total of data received Server Name first 20 characters of fully qu domain name of Alaris Sys
122. T FOR DAMAGE Preventive maintenance Exterior Surfaces Each usage inspections should only be IUI Connector Each usage performed by qualified service Keypad Each usage personnel Mechanical Parts Each usage Membrane Frame Assembly Each usage Pump module CLEANING As required START UP Each usage NOTE While visually inspecting the IUI connectors look for fractures on the connectors black colored plastic If you see any damage do not use an instrument with fractured IUI connectors The IUI Gone connector must be replaced before the instrument can be used again Failure to follow these instructions Inspect IUI Connectors may result in potential hazards associated with damaged IUI If any surface contaminants or blue or green deposits are connectors visible the connector must be replaced Figure 1 Male IUI Connector Figure 2 Male IUI Connector right side 1 Visually inspect the right side male IUI connector for cracks on the entire surface of the black colored plastic housing See Figures 1 and 2 for the male IUI inspection area and typical cracks 2 Visually inspect the left side female IUI connector for cracks on the edges of the black colored plastic housing 3 If cracks are found replace the IUI connector before use 2 130 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Inspection Requirements Continued
123. TE 40 mL h 250 00000 gt Press START ELAY 0 0 00 _40 muh EN vac 50 mL ALL 00000 Alaris System User Manual with v9 17 Model 8015 Programming 2 67 Pump and Syringe Modules Section Delay Options Continued Delay Infusion Continued Specify by Minutes Continued 2 Press Delay for soft key 3 Toenter number of minutes up to 120 infusion is delayed for use numeric data entry keys 4 Press CONFIRM soft key Delay period counts down on Main Display Ifa Before callback has not been scheduled EY Delay Options 08 00 OW Delay for v Deftay until oo 00000 gt Select a Delay Option i ee 000 to be see Schedule a Callback procedure infusion automatically initiates at end of delay period Specify by Time of Day The Delay until option is used to program an infusion delay for a minimum of 1 minute and up to 23 hours 59 minutes 1 Press DELAY OPTIONS soft key 2 Press Delay until soft key E Delay Options 08 00 Pause elay for Delay until 00000 gt Select a Delay Option exit 0000 2 68 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Delay Options Continued Delay Infusion Continued Specify by Minutes Cont
124. Troubleshooting and Maintenance 2 123 Alarms Errors Messages Continued Alarms Continued Pump Module Continued Pump Chamber Blocked Meaning Tubing blocked inside Pump module in pump chamber Response Close roller clamp and open door Remove tubing 3 Massage tubing from top to bottom to restore flow Reload set and close door Press NEXT soft key Press CONFIRM soft key Open roller clamp and press RESTART key Verify flow in drip chamber after restarting infusion Change set if not able to establish flow Restart Channel Safety Clamp Open Close Door Door opened and closed during an infusion Infusion stops on affected module Module paused for 2 minutes Safety clamp device is in open position while door is open Syringe Module Close door Press RESTART key or press CHANNEL SELECT key and then START soft key Press RESTART key or press CHANNEL SELECT key and then START soft key Close roller clamp on administration set or close door Occlusion Meaning Increased back pressure sensed while infusing Infusion stops on affected module Response Clear occlusion Press RESTART key or press CHANNEL SELECT key and then START soft key Pressure Disc Installed Pressure sensing disc installed during an infusion Infusion stops on affected module Press CONFIRM soft key and RESTART key 2 124 Troubleshooting and M
125. User Manual Alaris System with Alaris PC unit Model 8015 Supports Guardrails Suite MX with Guardrails Point Of Care software and v9 17 Operating System software November 2014 THIS PAGE INTENTIONALLY LEFT BLANK Table of Contents Each of the Alaris infusion product specific sections has its own table of contents General Contact Information 0 00 0 iv ITROGUICTIOM saeco es ees TE V InstallatiObi oe erret he EE me cce ect eee aa viii Alaris PPG B ST RERO E TORT Section 1 Alaris Pump Module Model 8100 Alaris Syringe Module Model 8110 Section 2 Alaris POCA Modul t o o eme imet Section 3 Alarns SpOs M d le sy i ih ee Do s ean sprint tubi Section 4 Alaris EIGOSMOdUIS aer tmt Section 5 Alaris Auto ID Module Model 8600 Section 6 Appendix MaintenanGe ERROR TONO E E A A 1 Cleaning tete tiene tmt mot eite tndin fie re d oet sic Er T Meet alas A 1 Service Information reete deu ete ie adda edere edet A 3 Wattranty
126. When problem is corrected press CONFIRM soft key Check Syringe Drive Not Engaged Meaning Plunger grippers opened during infusion and then closed Infusion stops on affected module Syringe barrel clamp opened during infusion and then closed Infusion stops on affected module Syringe plunger not captured while in idle state System alarms after 30 seconds to indicate potential siphoning condition Drive system disengaged during operation Syringe Installation O p lever plunger flange clamp 9000 6000 gt Press CANCEL or Adjust Syringe 00 0 Response Securely lock plunger grippers press CHANNEL SELECT key and reselect syringe Securely lock syringe barrel clamp and press RESTART key Check for potential siphoning Ensure that administration set clamp roller slide is in closed position Securely lock plunger grippers over syringe plunger Open and close plunger grippers and syringe barrel clamp Ensure that syringe is properly installed 2 126 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Alarms Errors Messages Continued Pump Module and Syringe Modules Channel Error Meaning Error detected Operation stops on affected module Syringe Module Response To silence alarm and continue operation of unaffected modul
127. XI T 000 4 Press Channel Labels soft key T LEY Channel options li E Qo Guardrails Drugs 0 2 4 Guararails IV Fluids Q Q Multidose o Pressure Limit P na o 9 gt Select an Option or EXIT EXIT 0000 4 E channel Options 2 of 2 KG OF o gt Select an Option or EXIT PAGE exit 0000 2 64 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section i ao f Channel Labels Continued Select Continued 5 Press soft key for desired label LY ERIS Selected label is highlighted and scrolls in Message Q Broviac aE 0 Display Q cc FJ Q Q c k o 6 PT O ie Port u z Q gt Select Channel Label ExT E31 0000 6 Tocontinue infusion press START soft key OR Program infusion as previously described NOTE To view additional labels press a soft key next to a letter group to navigate through the alphabet and or PAGE UP and PAGE DOWN soft keys 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Syringe module Press PAGE DOWN soft key E fi il i 4 Press Channel Labels soft key Alaris System User Manual with v9 17 Model 8015 Programming 2 65 Pump and Syringe Modules Section Channel Labels Continued Remove Continued 5 Press CLEAR LABEL soft key iene Channel Label Display NICU Label stops scrolling in Message Di
128. a Bolus Dose see the Bolus Dose procedure The restore option is only available if the system is powered up within 8 hours of the last use and when the prompt for New Patient is selected as No Alaris System User Manual with v9 17 Model 8015 Programming 2 61 Pump and Syringe Modules Section View and Clear Volume Infused i Ion 1 To view volume infused press VOLUME INFUSED soft key Midtown Hospital Total volume infused primary secondary and time Q A seo o and date volume infused was last cleared display for Q B vs5 27o0n 9 each module 29 Q C vez som O Q D vrei 249 0 mL O o 0 000 2 Pump module To view primary and secondary Uum PES volume s infused press PRI SEC VOLUME soft key ome mm 55 O9 L Q A 4011 Z5 Q9 O B 42 5 Sf O Qo C 478 1 223 107 7891 22e gt Select Channels to Clear Prs CLEAR ALL e SCREEN 3 To clear volume infused Volume Infused e If only selected module is to be cleared press soft key QTAL VOLUME mb ao O next to applicable module and press CLEAR CHANNEL 42 5 8 9 soft key 48 1 2 4 6 Volume clears on selected module eS Ifall modules are to be cleared press CLEAR ALL soft key 2 62 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section View and Clear Volume Infused Continued Toret
129. adio Frequency Note Alaris System User Manual with v9 17 Model 8015 Troubleshooting and Maintenance 3 65 PCA Module Section Alarms Errors Messages Continued Alert A visual message to help reduce programming errors by indicating a Limit Soft or Hard has been exceeded A response is required before programming can continue Clinical Advisory A visual message defined by the facility for a designated drug and displayed when that drug is selected for an infusion The message provides instructions related to specific drug use and or facility standards of practice when programming an IV medication A specific Clinical Advisory and or message can be associated with a selected drug within any of the patient care profiles Clinical Advisories are not displayed in Anesthesia mode Attach Dose Request Cord Meaning Dose Request Cord detached from device Dose Request Cord required for PCA only and PCA Continuous Infusion modes Response Reattach Dose Request Cord and press RESTART key Channel Disconnected Module disconnected while in operation or have a communication problem To silence alarm and clear message from screen press CONFIRM soft key Reattach module if desired ensuring it is securely clicked into place at Channel Release Latch If alarm is still present replace module Lock Door Door unlocked during infusion system does not infuse with door unlocked Lock door and press RESTA
130. age Alert and Standby Red Visual message indicating an error or system inconsistency occurred See the product specific section of this User Manual that applies to the attached module s for alarm error and message definitions specific to that module Advisory Message A sequence of audio and or visual signals indicating system operating status Alarm An audio and visual signal that a potentially unsafe condition is present Immediate action is required Alarm Silence Alarms can be silenced for up to 120 seconds by pressing SILENCE key Error An audio and or visual signal that a failure has been detected Immediate action is required 1 46 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Alarms Errors Messages Continued Definitions Continued Maintenance Reminder A visual message that when enabled appears at startup when scheduled preventive maintenance is due overdue for component of Alaris System PC unit or attached module Prompt An audio signal and or a visual message appearing on bottom line of Main Display or in Message Display Audio signal can be silenced for 12 seconds by pressing SILENCE key Audio Characteristics The Alaris System provides various types of alert information See the product specific section of this User Manual that applies to the attached module s for audio characteristics specific to that module Advisory Message One short beep every 2 seconds Variabl
131. age Display provides an indicator 1113 or LLL that dose is beyond current Soft Limit Smart Dose Checking option causes an initial soft Alert to occur when a dose limit is exceeded Subsequent programming beyond dose limit does not receive an Alert Drug label in Message Display provides an indicator 1113 or LLL that dose is beyond current Soft Limit Drug Calculation Allows entry of drug dose for a Continuous Infusion Alaris System calculates correct flow rate to achieve desired dose OR entry of flow rate for a Continuous Infusion Alaris System calculates corresponding drug dose Alaris System User Manual with v9 17 Model 8015 General Information 2 93 Pump and Syringe Modules Section Feature Features and Displays Continued Features and Definitions Continued e e Definition Pump and Syringe Modules i b Drug Library When Profiles feature is enabled it provides a hospital defined list of drugs and concentrations appropriate for use in as many as ten profiles Drug Library use automates programming steps including drug name drug amount and diluent volume and activates hospital established best practice limits Drug Library entries can be delivered as a primary or secondary or both as determined by hospital health system Duration Limits Dynamic Pressure Display Hospital established limits around duration of an Intermittent Infusion Appears on Main Display
132. aintenance Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Alarms Errors Messages Continued Alarms Continued Syringe Module Continued Meaning Pressure Disc Removed Pressure sensing disc removed Infusion stops on affected module Response Reinsert pressure sensing disc and press RESTART key Syringe Empty Syringe is empty If syringe is not empty other possibilities are Pressure sensing disc inappropriate defective Syringe plunger travel impeded Pressure transducer defective Syringe Adjustment Alarms a When a syringe installation problem is detected a visual signal Set up new infusion or press CHANNEL OFF key Verify that appropriate pressure sensing disc is in use and functioning properly Verify that syringe plunger movement is unimpeded If syringe is not empty and above actions do not correct alarm replace module e A is displayed Text in the display blinks to indicate the location of Q syringe instalation LO the problem Q k lever o lunger o 9 Q flange Q 7 clamp 9 gt Press CANCEL or Adjust Syringe 0000 Alaris System User Manual with v9 17 Model 8015 Troubleshooting and Maintenance 2 125 Pump and Syringe Modules Section Alarms Errors Messages Continued Alarms Continued Syringe Adjustment Alarms Continued d
133. alarms and timely response to occlusions To avoid interruptions in therapy the limit should be set at a value higher than the expected actual working pressure which will allow normal events such as patient movement and titrations to occur without alarms The working pressure presented to a pump by the IV cannula depends on several factors combined rate of all infusions running into a single vascular access point resistance of the fluid path elevation differential and vascular pressure dynamics Resistance to flow is determined by the catheter s length and inner diameter and the viscosity of the fluid Kinking and clotting might also elevate the resistance to flow over time The Syringe module allows both fixed and customized approaches to pressure limits to be configured Each profile can be programmed with its own maximum pressure value supporting a fixed limit approach Customized limits can be set either manually by reading the current pressure following stabilization and adding a margin or by use of the Auto Pressure feature which on activation sets a margin of 30 mmHg for initial pressures under 100 mmHg or 30 of the initial pressure at higher initial values The margin must be larger when variations in flow resistance and vascular pressure are anticipated When pumping through high resistance access devices such as central line catheters the Auto Pressure margin might be inadequate With these devices ten minutes or mo
134. alled as part of a second Alaris System setup Before changing the infusion line at the patient end start the infusion and wait for fluid to drip from the end of the tubing 1 To stop infusion press PAUSE key 2 Open plunger grippers and syringe barrel clamp An audio prompt sounds to silence press SILENCE key Red Alarm Status Indicator flashes CHECK SYRINGE scrolls in Message Display 3 Remove syringe and separate administration set from syringe 4 Reattach administration set to new syringe and load new syringe see Getting Started Prepare Syringe and Administration Set 5 Select syringe type and size see Programming Primary Infusion With Guardrails Suite MX Protection 6 Press CONFIRM soft key 7 Prime administration set using options menu or manually see Getting Started Prepare Syringe and Administration Set 8 Press RESTORE soft key OR To enter VTBI and rate press RATE soft key and use numeric data entry keys and then VTBI soft key and use numeric data entry keys 9 To begin infusion press START soft key 2 84 General Setup and Operation Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section General Information Warnings and Cautions ici WARNINGS PAN The Pump and Syringe modules are designed to stop fluid flow under alarm conditions Periodic patient monitoring must be performed to ensure that the infusion is proceeding as expected It
135. an editable field so that patient weight or BSA can be adjusted for any module Changing the patient weight or BSA on one module will not affect the patient weight or BSA on any other NOTE It is possible to program an infusion with a rate that is displayed with two decimal places one hundredth of a mL per hour on the PC unit for the Pump module However due to space limitations on the Pump module rate display the rate is displayed to the nearest one tenth of a mL per hour on the Pump module This value is only used for display purposes and the Pump module is actually infusing at the more precise rate noted on the PC unit Alaris System User Manual with v9 17 Model 8015 Programming 2 51 Pump and Syringe Modules Section Secondary Infusion With Guardrails Suite MX Protection Pump Module Continued Stop Secondary and Return to Primary Press CHANNEL SELECT key Press SETUP soft key 1 2 3 Press PRIMARY soft key 4 Close clamp on secondary administration set set OR Disconnect secondary administration set from upper injection port 5 Press START soft key 6 To stop secondary infusion and begin infusing primary press Yes soft key e Secondary infusion stops and primary infusion begins Main screen appears NOTE The SEC to PRI alert does not sound when the infusion is manually ended and returned to primary Infusion NO O Guardrails Suite MX Protection The following p
136. an be used again Inspect IUI Connectors If any surface contaminants or blue or green deposits are visible the connector must be replaced Figure 1 Male IUI Connector Figure 2 Male IUI Connector right side 1 Visually inspect the right side male IUI connector for cracks on the entire surface of the black colored plastic housing See Figures 1 and 2 for the male IUI inspection area and typical cracks 2 Visually inspect the left side female IUI connector for cracks on the edges of the black colored plastic housing 3 If cracks are found replace the IUI connector before use For IUI cleaning instructions see the Cleaning Section in Appendix A WARNING Failure to perform these inspections can result in improper instrument operation f caution N Preventive maintenance inspections should only be performed by qualified service personnel WARNING Failure to follow these instructions may result in potential hazards associated with damaged IUI connectors 5 30 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Alaris Auto ID Module Model 8600 READY Alaris System User Manual with v9 17 Model 8015 Section 6 THIS PAGE INTENTIONALLY LEFT BLANK Table of Contents Getting Started Introduction
137. ance Level 8 kV contact 15 kV air Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material relative humidity should be at least 3096 If connector testing exemption is used following ESD sensitivity symbol appears adjacent to each connector Alaris System User Manual with v9 17 Model 8015 Do Not Touch Aten IEC 61000 4 4 Electrical Fast Transient Burst EFT 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 5 Power Line Surge 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 8 Power Frequency Magnetic Field 50 60 Hz 3 A m 400 A m 50 Hz 400 A m 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Alaris System User Manual with v9 17 Model 8015 Appendix Section Regulations and Standards A 11 Compliance Continued Electromagnetic Environment Continued Alaris System Continued Emissions Test IEC 61000 4 11 Voltage Dips Short Interruptions
138. anual with v9 17 Model 8015 Programming 3 25 PCA Module Section Infusion Modes Continued Change Programming Parameters During an Infusion Press CHANNEL SELECT key 2 Press PROGRAM soft key 3 Setkey to program position or if Authorization Code is enabled enter 4 digit code 4 Press CHANGE MODE soft key Guardrails Drug Setup OE 2m Q 20 minutes Q 2 mg h o 25 mg 4 h Conc 1 mg mL gt Press CONFIRM esl 0 0 00 5 Select desired infusion mode 6 Continue programming See applicable procedure Set Up PCA Dose Only Set Up Continuous Infusion Only Set Up PCA Continuous Infusion 7 Verify or change program settings and press CONFIRM soft key 8 Close and lock door 9 Verify correct programming parameters on summary screen and press START soft key NOTE Previously programmed values are carried over to new program 3 26 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued View Patient History 1 Press CHANNEL SELECT key 2 3 4 To select desired time period press ZOOM soft key 99 5 To view detailed patient history press DETAIL soft key 9 6 From Main Display press OPTIONS key Press Patient History soft key To return to main patient history press MAIN HISTORY soft key Channel Options 10f2 Qo Pause Limits
139. asurement Accuracy The 2 module has been designed and manufactured to exacting standards and should perform well within given environmental and performance standards There are certain e If uncertain about measurement conditions under which an inaccurate measurement or the loss accuracy assess patient s of respiratory rate signal can occur condition and vital signs by alternate means then ensure An inaccurate EtCO measurement can be caused by that eec module is functioning correctly t licati i ncorrect disposable application or use beaksorinteralventiag e Microstream Disposable disconnected or not securely sampled gas can affect connected to EtCO module accuracy Airway connection clogged twisted or leaking Placement too close to electrosurgery equipment e Mechanically ventilated patient breathes spontaneously Loss of a respiratory rate signal can occur in any of the following situations Incorrect disposable application or use e Microstream Disposable disconnected or not securely connected to EtCO module Airway connection clogged twisted or leaking Patient not breathing Placement too close to electrosurgery equipment Waveform Analysis The 2 module provides the option to display EtCO readings 85 a waveform The following graph is an example of a normal waveform normal ventilation 35 45 mmHg In the event the EtCO value is above the wav
140. at Causes Volume mL that Setting mcL mL Alarm Causes Alarm 50 2 8 10 0 28 75 8 0 20 1 6 8 0 30 24 12 0 30 24 NOTE Ina standard bore tubing set 50 mcL is approximately 0 34 inches of air 75 mcL is approximately 0 51 inches of air 250 mcL is approximately 1 7 inches of air In Anesthesia Mode only Pressure Limit mmHg Rate mL h m Bolus Volume mL Volume Bolus Volume mL 0 3 0 6 Maximum over infusion that can occur in the event of a single fault condition is 0 6 mL 3 3 W x 8 9 H x 5 5 D Operating Storage Transport Atmospheric Pressure 525 4560 mmHg 375 760 mmHg 700 6080 hPa 500 1013 hPa Relative Humidity 20 90 5 85 Avoid prolonged Noncondensing Noncondensing exposure to relative humidity 28596 Temperature Range 41 104 F 4 140 F 5 40 C 20 60 C To ensure proper operation Alaris System must remain in an upright position 2 108 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Specifications Continued Pump Module Continued Flow Rate Programming Increments Fluid Ingress Protection Infusion of Air Means to Protect Patient from Infusion Pressure Maximum KVO Keep Vein Open Rate KVO Selection Range Occlusion Alarm Thresholds Operating Principle Rate Range Increments mL h mL
141. ate within the desired occlusion detection parameter s Administration Sets Use only standard single use disposable syringes with luer lock connectors and non dedicated administration sets with integrated anti siphon valves designed for use on syringe type PCA pumps The use of any other syringe or administration set can cause improper instrument operation resulting in an inaccurate fluid delivery or pressure sensing or other potential hazards For a list of compatible syringes see Compatible Syringes For a list of compatible sets refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com Alaris System User Manual with v9 17 Model 8015 General Information 3 45 PCA Module Section Warnings and Cautions Continued Administration Sets Continued Before loading or unloading the syringe always turn off fluid flow to the patient using the tubing clamp or stopcock Uncontrolled fluid flow can occur when the administration set is not clamped or turned off and can cause serious injury or death When an occlusion occurs there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion To avoid an inadvertent bolus relieve the pressure before restarting the infusion When priming Ensure that the patient is not connected Ensure that air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequ
142. atic barometric pressure compensation There are no quantitative effects of barometric pressure for this device Measures and reports partial pressures of CO in the range of 0 99 mmHg at sea level EtCO and FiCO values are calculated for all valid breaths 5 20 General Information Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Specifications and Symbols Continued Specifications Continued Dimensions Environmental Conditions Flow Rate Fluid Ingress Protection Frequency Response Gas Interference Internal Power Source Measurement Range Mode of Operation 3 3 W x 8 9 H x 5 5 D 8 4 cm W x 22 6 cm H x 14 cm D Meaning Operating Storage Transport Altitude 380 4570 m 380 4570 m 1250 15 000 ft 1250 15 000 ft Atmospheric Pressure 525 4560 mmHg 700 6080 hPa 375 760 mmHg 500 1013 hPa 20 90 Noncondensing 5 8596 Noncondensing Relative Humidity Avoid prolonged exposure to relative humidity 28596 41 104 F b 40 C 4 140 20 60 C Temperature Range Nominally 50 mL min 7 5 15 mL min IPX1 Drip Proof 2 accuracy applies for breath rates of up to 80 bpm For maintaining accuracy for respiration rates above 80 bpm accuracy is 4 mmHg or 12 of reading whichever is greater for EtCO values exceeding 18 mmHg achieve specified accuracies for breath rates
143. atient cable Refer to sensor s User Manual for detailed instructions Use only approved Masimo Patient Cable sensors and patient cables Use of sensors transducers cables and accessories other than those specified can cause improper SpO module performance os as Attach sensor leSulting in inaccurate readings l here increased emission and or decreased immunity and degraded electromagnetic compatibility performance of the SpO module 3 Attach sensor to patient Refer to sensor s User Manual for For a list of compatible sensors detailed instructions and cables refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com 4 2 Getting Started Alaris System User Manual with v9 17 Model 8015 SpO Module Section Display references throughout this procedure are for illustration purposes only See General Information Features and Displays and the PC unit section of this User Manual for information about Displays Operating Features Controls Indicators The majority of user interface programming is identical for both SpO modules Monitoring Mode Perform following steps see PC unit section of this User Manual General Setup and Operation Start Up a Power on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required N Attach patient cable a
144. ation 4 26 General Information Alaris System User Manual with v9 17 Model 8015 SpO Module Section Specifications and Symbols Continued Symbols See the PC unit section of this User Manual for system symbols Meaning Silenced alarm Note When displayed the dashed lines through the symbol might appear as solid lines due to the small display size Is displayed in Trend Data screen to identify an exceeded alarm limit Type BF patient applied part Measurement Accuracy If the accuracy of any measurement does not seem reasonable first check the patient s vital signs by alternate means and then check the SpO module to ensure that it is functioning properly An inaccurate measurement can be caused by Incorrect sensor application or use Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin e Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as a surgical lamp especially one with a xenon light source bilirubin lamp fluorescent light infrared heating lamp or direct sunlight 9 e Prolonged and or excessive patient movement e Venous pulsations e Sensor placed on an extremity with a blood pressure cuff arterial catheter intravascular line or other causes of insufficient perfusion Nail irregularity such as nail polish or fungus Remove nail polish and or move sensor to an una
145. ation vs VTBI 250 0 mL G D 99000 60000 PANEL UNLOCKED 0000 Power Off System Press and hold CHANNEL OFF key until a beep is heard approximately 1 5 seconds and then release to initiate power down During power off sequence Main Display flashes Powering Down interrupt power down sequence quickly press any key except SYSTEM ON on PC unit Once all attached modules are powered off PC unit automatically powers down Alaris System User Manual with v9 17 Model 8015 1 11 PC Unit Section System Options JT F Wa 1 Press OPTIONS key 2 Press Display Contrast soft key 3 Adjust display and return to main screen see Start Up Adjust Display Contrast procedure Patient ID Enter 1 Press OPTIONS key 2 Press Patient ID soft key 1 of 3 Patient ID o9 Clinician ID Q Power Down All Channels o Anesthesia Mode gt Select an Option or EXIT ER o000 System Options 1 of 3 aes Contrast Patient ID Clinician ID Power Down All Channels Anesthesia Mode 00000 gt Select an Option or EXIT PAGE EXIT DOWN 0000 1 12 Alaris System User Manual with v9 17 Model 8015 PC Unit Section System Options Continued Patient ID Continued Enter Continued 3 Scan or manually enter patient identifier To manually ent
146. ayed for more than 8 hours and all doses in the multidose program must be completed within a 24 hour program Syringe module If NEOI is enabled the Near End of infusion message appears near the end of the last dose 2 76 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Select Pressure Limit 2 3 4 Press CHANNEL SELECT key Press OPTIONS key Press Pressure Limit soft key Press either Pump or Selectable pressure soft key If Selectable is pressed continue with next step otherwise proceed to last step Pump Module in 1 A Channel Options Q Guardrails Drugs o cuardrails iv Fluids o L Multidose 9 Pressure Limit P 0 Channel Labels 9 gt Select an Option or EXIT EXIT 0000 Q Pressure Limit Sg on o Co Selectable o o gt Select an Option or EXIT exr 0000 Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 77 Select Pressure Limit Continued Pump Module Continued 5 5 To select occlusion pressure limit press either Up or LA Down soft key Pressure Limit Selection 0 6 Verify correct occlusion pressure limit input and press o g o ae CONFIRM soft key o o s 7 Press START soft key Syringe Module E dM Pressure Sensing Disc Instal
147. cations are shown for OXIMAX MAX N sensors Saturation accuracy varies by sensor type Masimo Board performance has been validated for low perfusion accuracy in bench top testing against a BIO TEK simulator and a Masimo simulator Masimo Board performance has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 4 Hz at an amplitude of 1 2 cm and a nonrepetitive range of 70 100 SpO against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population Masimo Board performance with Masimo LNOP Neo and Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonate s foot at 2 4 Hz at an amplitude of 1 2 cm against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population Masimo Board performance has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 10096 SpO against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the popul
148. cclusion occurs there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion To avoid an inadvertent bolus relieve the pressure before restarting the infusion Sensing Disc Housing A Pressure S y Sensing Disc j Patient Side H ae er T Pressure Sensing Disc 2 10 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued Load Continued NOTES The gripper control is spring loaded When twisted to the open position and then released it and the plunger grippers returns to the closed position The following Syringe module features are available only with extension sets fitted with a pressure sensing disc See General Information Features and Displays for definitions Auto Pressure Back Off upon occlusion Customized Pressure Alarm Settings see Occlusion Pressure feature definition Dynamic Pressure Display see Pressure Tracking feature definition Fast Start Prime Using Options Menu The Priming option can be enabled at the time the Alaris System is configured for use The Priming selection PRIME soft key is available only after the syringe and infusion type have been selected and prior to beginning an infusion If a pressure sensing di
149. certain trademarked products and product features Product Feature Defined Term Alaris Auto ID module Auto ID module Alaris EtCO module 2 module Alaris PCA module PCA module Alaris PC unit PC unit Alaris Pump module Pump module vi Alaris System User Manual with v9 17 Model 8015 Introduction Continued DEFINED TERMS Continued Product Feature Defined Term Alaris SpO module SpO module Alaris Syringe module Syringe module Alaris System Maintenance System Maintenance Alaris Systems Manager Systems Manager Guardrails alert Alert Guardrails clinical advisory Clinical Advisory Guardrails CQI Reporter CQI Reporter Guardrails data set Data Set Guardrails drug library Drug Library Guardrails Editor Editor Software Guardrails hard limit Hard Limit Guardrails IV fluid IV Fluid Guardrails limit Limit Guardrails PCA pause protocol PCA Pause Protocol Guardrails soft limit Soft Limit SmartSite needle free valve Needle Free Valve Alaris System User Manual with v9 17 Model 8015 vii Installation Instruments are tested and calibrated before they are packaged for shipment To ensure proper operation after shipment it is recommended that an incoming inspection be performed before placing
150. cters hyphen underscore space press PAGE DOWN soft key To verify correct entry press CONFIRM soft key Patient ID Entry New Patient ID Entry verification screen appears AE F J A B c K O D P T E 2945678941 gt Enter Patient ID and Press CONFIRM 90000 00000 Alaris System User Manual with v9 17 Model 8015 PC Unit Section System Options Continued Patient ID Continued Modify Continued 6 accept modified Patient ID press Yes soft key Main screen appears with new Patient ID OR To retain original old Patient ID press No soft key Main screen appears with old Patient ID Clinician ID 1 Press OPTIONS key 2 Press Clinician ID soft key e Scan or manually enter clinician identifier To manually enter clinician identifier use numeric data entry keys and or alpha speed keys An alphanumeric identifier of up to 16 characters can be entered Press soft key next to a letter group to list letters in that group Press soft key next to an individual letter to enter that letter To access letter Z and special characters hyphen underscore space press PAGE DOWN soft key clear an entire entry press CLEAR key e Toback up a single character at a time press CANCEL key Patient ID Entry Q Patient iD Yes 123456789CD o will be changed to No Q 234567891EF o Is this correct gt Press Yes or No
151. d delivered module running at KVO rate Response Set up a new infusion or press CHANNEL OFF key Panel Locked Tamper Resist feature is active and a key was pressed If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of PC unit Panel Unlocked Tamper Resist feature deactivated None Pause Pause control pressed infusion stopped To resume infusion press RESTART key or press CHANNEL SELECT key and then START soft key Start time for next dose has passed Start of next dose passed Pump Module Press CONFIRM soft key Message Checking Line Meaning Patient side occlusion occurred Auto Restart feature monitoring downstream pressure to determine if infusion can continue Response Secondary Secondary infusion in progress on indicated module None When secondary VTBI 0 infusion reverts to programmed primary parameters 2 128 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Alarms Errors Messages Continued Messages Continued Syringe Module Message After Call Back Meaning Infusion completed Response Press CONFIRM soft key NEOI Near End of Infusion Syringe almost empty This is a timed event that can be Set To set or change this option see General Information Configurable Settings T
152. d as volume to be infused VTBI entire contents of syringe is delivered Auto Pressure When enabled and a pressure sensing disc is in use Auto Pressure option is displayed in Pressure Limit screen Auto Pressure automatically sets alarm limit for a shorter time to alarm as follows If current pressure is 100 mmHg or less system adds 30 mmHg to current pressure to create a new alarm limit If current pressure is greater than 100 mmHg system adds 30 to current pressure to create a new alarm limit Auto Pressure Limit Adjustment When a bolus is delivered pressure alarm limits are temporarily raised to maximum limit Auto Syringe Size Identification System automatically detects syringe size and narrows down syringe selection list Back Off This feature is only available when administration set in use has a pressure sensing disc When enabled motor reverses plunger movement during an occlusion until pressure returns to preocclusion levels automatically reducing bolus flow Fast Start When Fast Start is enabled and an administration set having a pressure sensing disc is used instrument runs at an increased rate when an infusion is first started taking up any slack in drive mechanism Infusion Complete An alert is given when current infusion is complete and VTBI has reached zero Near End of Infusion NEOI Allows an alert to be configured to sound anywhere from 1 to 60 minutes before inf
153. d only when setting a BOLUS DOSE using the Drug Library The BOLUS DOSE soft key is only available once an infusion has begun in PCA dose only Continuous Infusion or PCA Continuous Infusion modes 1 Press CHANNEL SELECT key 3 22 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Set Bolus Dose Continued 2 Press BOLUS DOSE soft key Summary Morphine ContDose 2 mg h Max Limit 30 mg 4h 99090 66660 Conc 1 mg mL gt Press START to Close Summary 3 Setkey to PROGRAM position or enter 4 digit authorization code and press CONFIRM soft key B To enter dose value use numeric data entry keys Press CONFIRM soft key Ifthe programmed Bolus Dose is outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed Ifthe programmed Bolus Dose is outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion must be reprogrammed e If there is a potential for a programmed parameter to result in an excessive volume or dose being delivered following prompt appears Cannot proceed due to incorrect concentration or dosing parameters Remove syringe verify c
154. d or PAGE UP and PAGE DOWN soft keys Q dosutamine 9 Q DOPamine 9 o Heparin uz e gt Select Drug 0000 e If applicable an optional hospital defined therapy or D eda oves clinical indication for delivery of this infusion could Q Alteplase 9 appear as in illustrated example which reflects use Qm of Alteplase Different limits can be defined for same sre drug with different therapeutic indications o Therapy indication appears on drug or IV fluid gt 1 0 confirmation screen Once drug or IV fluid has been 7 Select Th Ty confirmed therapy indication appears in title bar PORN ETRY TYRE 0000 2 22 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Continuous Infusion Continued If applicable a weight based or non weight based option for delivery of this infusion could appear as in illustrated example which reflects use of Heparin If applicable multiple concentration listings for delivery of this infusion could appear as in illustrated example which reflects use of Dopamine 3 Tocontinue programming press Yes soft key Bolus Dose units appear if Bolus Dose is enabled OR To change selection press No soft key 9000 Guardrails Drugs Adult ICU Heparin Non Weight based dosing Wei
155. dH The Syringe module is calibrated and labeled for use with im the following single use disposable luer lock syringes Use only CAUTION AN the syringe size and type specified on the Main Display The full list of permitted syringe models is dependent on the Smale software version of the Syringe module syringe CareFusion strongly recommends using an extension set with a pressure disc for improved pressure monitoring and shorter times to occlusion alarm Manufacture 1mL 3mL 5mL 10mL 12mL 20mL 30mL 35mL 50mL 60mL r AstraZeneca x9 x9 BDPlastipak x x x x x x x x IVAC x Monoject x9 x x x x x Terumo x x x9 x x x x NOTES Prefilled Diprivan The Monoject SoftPack Luer Lock Syringe blister pack is the only currently supported Monoject 3 mL The Terumo 5 mL can also be used as a 6 mL and the 10 mL as a 12 mL Refer to the Alaris Syringe module compatible syringes and flow rate ranges Tip Sheet provided separately regarding the use of BD 10 mL syringes manufactured only in the United States Alaris System User Manual with v9 17 Model 8015 General Information 2 91 Pump and Syringe Modules Section Interoperability Interoperability refers to the ability of the Alaris System Pump module and Syringe module to Receive infusion order parameters from a third party system for pre population Publish infusion status messages for consumption by third party systems N
156. dard or pre filled single use disposable syringes with luer lock connectors and non dedicated administration sets with integrated anti siphon valves designed for use on syringe type PCA devices without a Y connector or injection port for epidural infusions Epidural administration of anesthetic drugs Use indwelling catheters specifically indicated for short term 96 hours or less anesthetic epidural drug delivery o Epidural administration of analgesic drugs Use indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery Dose Request Cord Only the patient should press the Dose Request Cord Carefully locate the Dose Request Cord to reduce the possibility of patient entanglement or strangulation Alaris System User Manual with v9 17 Model 8015 General Information 3 47 PCA Module Section Warnings and Cautions Continued Guardrails Software The Guardrails Suite MX incorporates dosing limits and instrument configuration parameters based on hospital facility protocol The software adds a test of reasonableness to drug programming based on the limits defined by the hospital facility Qualified personnel must ensure the appropriateness of drug dosing limits drug compatibility and instrument performance as part of the overall infusion Potential hazards include drug interactions inaccurate delivery rates and pressure alarms and nuisance alarms
157. dentifier of up to 16 characters can be entered o Press soft key next to a letter group to list letters in that group Press soft key next to an individual letter to enter that letter To access letter Z and special characters hyphen underscore space press PAGE DOWN soft key clear an entire entry press CLEAR key To back up a single character at a time press CANCEL key To scan barcode on patient identification band see Alaris Auto ID Module Model 8600 section 6 of this User Manual Midtown Hospital Profiles p 1of2 Adult General Care Neonatal Peds ICU Neonatal ICU gt Press CONFIRM 99999 00000 Patient ID Entry gt Enter Patient ID and Press CONFI EXIT CONFIRM N QO Alaris System User Manual with v9 17 Model 8015 PC Unit Section Start Up Continued Adjust Audio Volume 1 Press AUDIO ADJUST soft key 2 Tochange volume to desired level press either Louder or Softer soft key To sample alarm loudness level press Test soft key 3 Toreturn to PC unit screen press MAIN SCREEN soft key After 30 seconds without a key press Main Display appears Lock Unlock Tamper Resist 1 Initiate operation of applicable module 2 Press and hold Tamper Resist Switch on back of PC unit for 3 to 4 seconds see General Information Features and Displays Operating Features Cont
158. drug product labeling for information concerning appropriate administration techniques and dosages See General Information Features and Displays and the PC unit section of this User Manual for information about Displays Operating Features Controls Indicators Prepare Infusion Select Syringe Type and Size At the start of an infusion program the system prompts the A user to select and confirm the syringe type and size The system automatically detects the syringe size and lists syringe Ensure that the displayed syringe types and sizes that most closely match the installed syringe manufacturer and size correctly If the syringe is not recognized Syringe not recognized is identifies the installed syringe displayed Mismatches can cause an under infusion or over infusion to the patient that could result in serious injury and or death For a list of compatible syringes see General Information Compatible Syringes If the installed syringe is displayed and selected but is not recognized servicing is required see Service Information in Appendix section of this User Manual 1 Press CHANNEL SELECT key Key must be in PROGRAM Rate ny position 09 Alaris System User Manual with v9 17 Model 8015 Programming 3 7 PCA Module Section Prepare Infusion Continued Select Syringe Type and Size Continued Press soft key next to installed syringe type and size If
159. dule Changing the patient weight on one module does not affect the patient weight on any other module NOTE It is possible to program an infusion with a rate that is displayed with two decimal places one hundredth of a mL per hour on the PC unit for the Pump module However due to space limitations on the Pump module rate display the rate is displayed to the nearest one tenth of a mL per hour on the Pump module This value is only used for display purposes and the Pump module is actually infusing at the more precise rate noted on the PC unit Alteplase Bolus Dose Stroke continuous Fusion Q A Bolus Dose can be programmed at the beginning of or 56 7 mun o during an infusion The drug being programmed must be a Q 100 m bolusable drug selected from the Drug Library or a non library os 0 81 nog o drug as described in the following procedures 9 9 99 O Conc 1 mg mL 1 Setup infusion as described in Continuous Infusion gt Press START procedure but do not start infusion 2 28 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Bolus Dose Continued 2 Press BOLUS soft key fthe programmed continuous dose infusion is outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before
160. e PC unit Power Supply Error Power supply system malfunction Disconnect AC power immediately To continue operation under battery power press SILENCE key Replace PC unit System Error Error detected on Alaris PC unit Operation continues on all attached modules Messages Message Battery Run Time X X hours Meaning AC power cord is disconnected from power source Approximate remaining battery run time under current power consumption rate is displayed To continue temporary operation press SILENCE key Replace PC unit Response Connect AC power cord to power source as soon as possible Low Battery Low battery threshold sensed remaining battery run time is limited Connect to power source alarm silenced Low battery will continue to display after AC is plugged in until the battery has built up enough of a charge to run Alaris System for 30 minutes To verify AC is charging look at the AC LED on front panel and verify that it is on Panel Locked Tamper Resist feature is active and key was pressed If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of PC unit Panel Unlocked Tamper Resist feature deactivated None Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 49 Alarms Errors Messages Continued Messages Continued messas Meaning J Response Powering Dow
161. e 802 11n 5 GHz or 2 4 GHz band up to 72 Mbps physical RF specification The registration numbers are identified on the RF card installed in the rear of the PC unit Tables The Alaris System is intended for use in the electromagnetic environments specified in the following tables Table 1 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance Alaris System uses RF energy only for its internal function in normal product offering Following icon appears on product Refer to network card s user manual for further information CISPR 11 RF Emissions RF emissions are very low and are not likely to cause interference with nearby electronic equipment Alaris System is suitable for use in all establishments including CISPR 11 domestic establishments and those directly connected to a public low RF Emissions voltage power supply network that supplies buildings used for domestic purposes IEC 61000 3 2 Harmonic Emissions IEC 61000 3 2 Voltage Fluctuations Complies Flicker Emissions Class A A 10 Regulations and Standards Alaris System User Manual with v9 17 Model 8015 Appendix Section Compliance Continued Electromagnetic Environment Continued Alaris System Continued Emissions Test IEC 61000 4 2 Electrostatic Discharge ESD Table 2 Electromagnetic Immunity IEC 60601 1 2 Test Level 36 kV contact 8 kV air Compli
162. e affected by type of catheter See Trumpet and Start Up Curves for data on how these factors influence rate accuracy Type CF Defibrillator Proof patient applied part PCA module Type BF Defibrillator Proof patient applied part Dose Request Cord Alaris System User Manual with v9 17 Model 8015 PCA Module Section General Information 3 59 Specifications and Symbols Continued Specifications Continued Time to Alarm Maximum Rate mL High ESSE 120 minutes 37 minutes 30 minutes 7 minutes Maximum Time to Alarm specifications are based on following standard operating conditions Atmospheric Pressure 645 795 mmHg Back Pressure 0 mmHg before producing occlusion Disposable Type 30883 Humidity 20 90 Syringe Type BD 50 60 mL Temperature 68 4 F Weight 5 5 Ibs Symbols See the PC unit section of this User Manual for system symbols Meaning Alaris Pump Module and Alaris Syringe Module Type CF defibrillation proof patient applied part PCA module Type BF defibrillation proof patient applied part Dose Request Cord gt Manufacturer o 3 e LJ i Single Use Do not re use DEHP in fluid pathway Non DEHP plasticizer in fluid pathway No DEHP in fluid pathway amp 3 60 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Specifications and Symbols Continued
163. e drug gt Select Drug with different therapeutic indications ext 8598 T 8888 e If applicable a weight based non weight based or 0000 BSA based option for delivery of this infusion could appear If applicable multiple concentration listings for delivery of this infusion could appear 3 To continue programming press Yes soft key Sete OR Q Methotrexate Osica NN change selection press No soft key lap o en Qo UNITS mg m o gt Press Yes or No Alaris System User Manual with v9 17 Model 8015 Programming 2 35 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Intermittent Infusion Continued f Yes was selected and facility has defined a Clinical Advisory for that drug a message appears To indicate information has been noted and continue programming press CONFIRM soft key If Yes was selected to continue programming drug amount and diluent volume if defined in Drug Library are automatically entered for selected drug e If selected drug had mL concentration drug amount and diluent volume need to be entered e If selected drug is not weight based Not Used is displayed in PATIENT WEIGHT field e If hospital facility practice guidelines identify selected Digs drug as weight based or by BSA a prompt for a patient an Methotrexate weight in kilograms or BS
164. e ee eee ee ner retire mee 5 8 Presilence Alain m e ai e dir D ach eee 5 9 Channel Gptlons ees cee etic iol t doro Se na aues eat eed ee A 5 9 Change Limit Mode cic benc e ied e dote etti ea diese erue atate teet usen Pene mb ai nates 5 9 Change Waveform Height oie tite te ee ule e ede deeper ede need ei 5 10 Change Waveform Time Scale eerte t pe PO TTE 5 11 General Setup and Operation 5 13 General Information Warnings and Cautions oiee Hae eie rap ite ee de xe enr ee de 5 15 eas att saya tan 5 15 Microstream Disposable sie rie va edge e vb b UR LOL ed Pea oa den reed 5 15 Microstream Disposable nor incen rd iet e e i ak edad edi me eens Gee tea 5 16 Features and Displays aee acr ace bed ac e et de e vance c e ud ed 5 17 Features arid Definitloris or Re 5 17 Operating Features Controls Indicators ssssssssssssssssesee enne 5 18 DIS Play Sic fesse E E AET AEE AT E A E AE 5 19 Configurable Settings let E ddnde uade undue ithe ua pda a neve a d 5 19 Specifications and eU ER RED TRU EE Pie Deere 5 20 SPECINCALONS re 5 20 Mr emm 5 22 Measurement edet nido eue d eie d idu ode eed e ed e a de eds 5 23 Waveform Analysis ett eun e
165. e for current Security Access Level NEOI Near End of Infusion Syringe almost empty This is a timed event that can be set or changed see General Information Configurable Settings To silence alarm press SILENCE key PCA module remains functional and continues infusion Green indicator light is lit when programmed in PCA Dose plus continuous mode or flashes when programmed in PCA Dose only and yellow light flashes PCA module is silent until Syringe Empty alarm sounds see Syringe Empty alarm response Panel Locked Tamper Resist feature is active and a key was pressed If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of PC unit Panel Unlocked Tamper Resist feature deactivated None Pause Pause control pressed infusion stopped To resume infusion press RESTART key or press CHANNEL SELECT key and then START soft key PCA Complete Current PCA dose complete Channel running in continuous dose if programmed None PCA Not In Secure Location PCA module is not in preferable location to allow locking to PC unit Device is not in a tamper evident position Detach PCA module from current position and reattach to immediate right of PC unit Syringe Not Recognized Installed syringe of unknown type and size Select and confirm correct syringe type and size and then press CONFIRM soft key or use a syringe type and s
166. e s press CONFIRM soft key Replace module as needed Syringe Calibration Required Meaning Error on infusing module indicating calibration is required Infusion stops on affected module CALIBRATE scrolls in Message Display Response To silence alarm and continue operation of unaffected module s press CONFIRM soft key Replace module as needed Syringe Driver Head Error Noninfusing module with plunger grippers open senses excessive pressure being applied downward on Drive Head OCCLUSION scrolls in Message Display Messages Pump and Syringe Modules To silence alarm and continue normal operation press CONFIRM soft key Message Anesthesia Mode Meaning Anesthesia Mode discontinued when disconnected from AC Response Press CONFIRM soft key Bolus Dose Complete Module running in Continuous Infusion mode if programmed None Delay Complete Delay time completed Press RESTART key or press CHANNEL SELECT key and then START soft key Infusion Complete Current infusion completed Set up a new infusion or press CHANNEL OFF key Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Troubleshooting and Maintenance 2 127 Alarms Errors Messages Continued Messages Continued Pump and Syringe Modules Continued Message InfusionComplete KVO Meaning Programmed volume to be infuse
167. e volume can be silenced for 2 minutes Alarm Choice of three alarm audio Variable volume can be silenced for profiles selectable in System 2 minutes Configuration Error Hardware Detected Pairs of long beeps Fixed maximum decibel volume cannot be silenced Error Software Detected Pairs of long beeps Fixed maximum decibel volume can be silenced for 2 minutes Illegal Key Press Two short beeps Variable volume cannot be silenced Key Click One short beep Fixed minimum volume can be silenced and disabled in System Configuration Prompt One short beep every 2 seconds Variable volume can be silenced Volume in decibels db Level 1 is greater than 55 db at one meter Level 5 is greater than 65 db and less than 85 db at one meter Level 2 3 and 4 are between Levels 1 and 5 Alaris System User Manual with v9 17 Model 8015 1 47 PC Unit Section Alarms Errors Messages Continued Battery Discharged Meaning Operation of all modules stopped due to insufficient battery charge Response Connect AC power cord to power source alarm silenced To continue operation of paused modules press RESTART key on affected module Channel Disconnected Module disconnected while in operation or have a communication problem To silence alarm and clear message from screen press CONFIRM soft key Reattach module if needed ensuring it is securely clicked into place at
168. eam to strike patient s face Always verify that information displayed on the PC unit matches scanned data Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Programming 6 5 Authorized User Mode Authorized User Mode is a feature that Combines PC unit tamper resist feature with Auto ID application Is designed to ensure that only clinicians with a barcode on their ID badge can program Alaris System e Is available only if it is enabled in selected Profile and there is an Alaris Auto ID module attached When this feature is enabled the PC unit automatically enables the tamper resist mode upon power on and 5 minutes after programming is completed If the system is configured to do so the Authorized User Mode can be disabled without scanning a clinician s ID press and hold the Tamper Resist Switch on back of PC unit for 3 4 seconds To unlock the keypad the user must scan their ID badge or use the OPTIONS menu to manually input their ID number When a questionable barcode is scanned at the main screen and the keypad is unlocked a prompt to confirm the type of barcode scanned appears This occurs whether the Authorized User Mode is enabled or disabled To use Alaris System with Authorized User Mode enabled 1 Power on system and associate patient ID see Patient Identification procedure Upon successful entry of patient ID PC unit automatically enables tamper resist feature
169. ecking Line function occurs when downstream pressure exceeds pressure limit n Selectable Pressure Mode Pressure limit is either user adjustable or locked in system configuration n Pump Pressure Mode Pressure limit is a function of flow rate and is automatically determined by device If downstream pressure decreases to a predetermined level below 5096 pressure limit during 15 second Checking Line period infusion automatically continues If condition is not cleared within 15 seconds a Partial Occlusion Patient Side alarm occurs Using Editor software system can be configured to allow 0 zero to 9 restart attempts within a rolling 10 minute period If allowable number of restarts is exceeded or if feature is set to zero an Occluded Patient Side alarm occurs when system detects downstream pressure that exceeds pressure limit NOTE Auto Restart for Anesthesia Mode is set to 9 and is not configurable Default Occlusion Pressure Starting occlusion pressure limit which can be configured by profile in 25 mmHg increments Alaris System User Manual with v9 17 Model 8015 General Information 2 95 Pump and Syringe Modules Section Features and Displays Continued Features and Definitions Continued Feature Definition Pump Module Free Flow Protection All Pump module Gemini Infusion System administration sets utilize a unique clamping device safety clamp on the lower fitment to preven
170. ection Primary Infusion With Guardrails Suite MX Protection Continued Bolus Dose Continued To enter a weight when continuous dose is not weight based a Press PATIENT WEIGHT soft key b To enter patient weight use numeric data entry keys OR Alteplase e To change weight when continuous dose is o Se e weight based Q aiaosa LO if required a Press SETUP soft key Q Accept weight change 4 b Press PATIENT WEIGHT soft key o Yes i i Q c change patient weight use numeric data entry keys d Press NEXT soft key gt Select Yes or No 0000 If a Continuous Infusion is running a prompt to confirm weight change appears e Press BOLUS soft key f To enter Bolus Dose use numeric data entry keys 5 Press DURATION soft key 2 30 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Bolus Dose Continued 6 enter bolus duration use numeric data entry keys OR ae To deliver Bolus Dose at maximum safe rate possible for EE Ib selected drug and setup and automatically calculate cx s bs bolus duration press Rapid Bolus soft key Lg M apis Q mm Bolus TOTAL DOSE alternates with INFUSE AT rate Q TOTAL vos 6 3M BOLUS VTBI 6 3 mL gt Enter Duration OR SETUP uous
171. eform display range the top of the waveform will be clipped Numerical EtCO values continue to be displayed on both the EtCO module and PC unit B baseline period of no CO end of inhalation C rapid rise in CO D alveolar plateau end of expiration end tidal CO EtCO E inhalation Alaris System User Manual with v9 17 Model 8015 General Information 5 23 EtCO Module Section Waveform Analysis Continued Waveforms can be used to troubleshoot problems with equipment or monitor configuration as well as to monitor a patient s clinical status The following graphs are examples of common problems identifiable through waveform analysis These are examples only and do not represent all potential abnormal waveforms Abnormal waveforms are not always associated with alarms Waveform Possible Causes Hypoventilation overmedication respiratory distress Partial Airway Obstruction relaxation of upper airway head position Hypoventilation with Shallow Breathing medication effect low tidal volume No Breath Detected apnea very shallow breathing overmedication displaced cannula 5 24 General Information Alaris System User Manual with v9 17 Model 8015 Module Section Principle of Operation The 2 module uses Covidien s patented Microstream nondispersive infrared NDIR spectroscopy to continuously measure the amount of CO during every breath the amo
172. either a drug amount per 1 mL or total drug amount per total volume for example a 30 mL syringe with a concentration of 1 mg 1 mL can be entered in one of two ways Drug Amount 1 mg Diluent Volume 1 mL OR Drug Amount 30 mg Diluent Volume 30 mL e Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 9 Close and lock security door Alaris System User Manual with v9 17 Model 8015 Programming 3 19 PCA Module Section Infusion Modes Continued Set Up PCA Dose and Continuous Infusion Continued 10 Verify correct parameters on second nurse summary screen and press START soft key During PCA dose Continuous Infusion e Green Infusing Status Indicator illuminates DELIVERING PCA scrolls in Channel Message Display when initiated Continuous and PCA drug name scrolls in Channel Message Display between PCA doses e Volume infused for continuous dose is displayed in Rate Display Main Display alternates between volume remaining and infusion mode with PCA drug name When PCA dose is complete PCA COMPLETE scrolls in Channel Message Display and resumes continuous dose Set Loading Dose Only The following procedures should be used when setting a LOADING DOSE ONLY using the Drug Library Perform steps in Prepare Infusion N Press LOADING DOSE ONLY soft key from Infusion Mode screen e To enter dose value use
173. el 8015 PC Unit Section Attach and Detach Module Continued Add Module While System is Powered On Add module as described in Attach Module System tests module causing all LED segments and indicator lights of displays to illuminate briefly Appropriate module identification display A B C or D illuminates Modules are always labeled left to right so if a module is added to left of other modules all modules are reidentified Module reidentification does NOT interrupt or affect infusion or monitoring on active modules Module positions A B C or D appear on Main Display If any of the following conditions are observed affected module must be removed from use and inspected by qualified personnel LED segments are not illuminated on displays during power on test o Indicator lights do not illuminate o gt Appropriate module identification does not appear Power On System Connect PC unit to an external AC power source N Press SYSTEM ON key w System self test begins Diagnostics test causes all LED display segments and Status Indicator lights of attached module s to illuminate briefly e Power Indicator illuminates Appropriate module identification A B C or D is displayed on attached module s e An audio tone sounds If PM Reminder option is enabled and scheduled preventive maintenance is due MAINTENANCE REMINDER screen appears e At completion of system on test
174. el 8015 PC Unit Section System Options Continued 4 Press PC Unit soft key 5 To review various system configuration settings press PAGE DOWN and PAGE UP soft keys 22 System Configuration Module Factory Default Yes Shared Infusion Settings ump Module SPO2 Module 00000 gt Press CANCEL or EXIT 0000 System Config PCU 1 of 3 99990 Alarm audio Profile 1 Anesthesia Mode Disabled Battery meter Disabled Clock setup 09 00 Limit Checking ALWAYS 0000 gt Press CANCEL or EXIT EXIT DOWN o 9 System Config PCU 2 of 3 99000 Key click audio Enabled Max Pt BSA 2m Max Pt weight 500 kg Patient ID Entry Disabled Pending IV Orders Enabled 00000 gt Press CANCEL or EXIT Page Ae E55 0 0 0 0 Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 21 System Options Continued System Configurations Continued 6 return to main screen press CANCEL key or EXIT soft key System Config PCU 3 of 3 PM Reminder Disabled Tamper resist Disabled 99999 66600 gt Press CANCEL or EXIT C Lens 0000 NOTE The Profiles option is listed only if it is disabled The Limit Checking or Dose Checking and Max Pt BSA options are listed only if the Profiles option is enabled and a valid Data Set
175. ences Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient Ensure that the syringe manufacturer and syringe size displayed matches syringe manufacturer and syringe size installed in the PCA module Mismatches can cause an under infusion or over infusion to the patient that could result in serious injury and or death For a list of compatible syringes see Compatible Syringes Discard if packaging is not intact or protector caps are unattached IET JAN Before operating instrument verify that administration set is free from kinks and installed correctly in instrument 3 46 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Warnings and Cautions Continued Epidural Administration Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient e Itis strongly recommended that the syringe administration set and PCA module used for epidural drug delivery be clearly differentiated from those used for other types of administration The Alaris System can be used for epidural administration of anesthetic and analgesic drugs This application is only appropriate when using anesthetics and analgesics labeled for continuous epidural administration and catheters intended specifically for epidural use Use only stan
176. enter either a drug amount per 1 mL or total drug amount per total volume for example a 30 mL syringe with a concentration of 1 mg 1 mL can be entered in one of two ways Drug Amount 1 mg Diluent Volume 1 mL OR Drug Amount Diluent Volume 30 mg 30 mL Guardrails Drug Setup IMS Pre fill 30ML 99000 LOADING DOSE Conc 1 mg mL 1 mo gt Close and Lock Door Then Press CONFIFUC eee Alaris System User Manual with v9 17 Model 8015 PCA Module Section Programming 3 21 Infusion Modes Continued Set Loading Dose Only Continued Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 5 Close and lock security door 6 Verify correct parameters on summary screen and press RESO Nurse Summary START soft key Q O DELIVERING LOAD scrolls in Channel Message 9 Display el p Infusion mode and drug name alternate with VTBI in Q m 9 Main Display Cong 1 mg mL gt Press START When loading dose is complete The Loading Dose has Completed appears on Main Display Pause GRAN 7T Press CONFIRM soft key When CHANNEL SELECT key is pressed Infusion Mode Tre loading dose has 0 screen becomes available for selection of infusion mode Q eme O o gt Press CONFIRM Set Bolus Dose The following procedure should be use
177. er hospital protocol 2 When priming is complete no air exists close set clamp Eliminate Mechanical Slack To eliminate mechanical slack or free play and minimize delays in the delivery of medication especially when infusing at a rate lower than 1 0 mL h it is recommended that the instrument be primed per the following procedure 1 Load syringe see Load procedure If a pressure sensing disc is being used do not install disc until priming is complete 2 Select syringe and infusion type see Programming chapter 3 Open administration set clamp 4 Prime as follows using Priming option see Prime Using Options Menu a Follow applicable procedure based on whether or not pressure sensing disc is installed through step to press and hold PRIME soft key b Prime until fluid drips from end of tubing c Complete procedure installing pressure sensing disc if applicable and exiting options menu 2 18 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section References throughout this procedure to specific drugs and drug doses are for illustration purposes only Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages See General Information Features and Displays and the PC unit section of this User Manual for information about Displays Operating Features Controls Indicato
178. er patient identifier use numeric data entry keys and or alpha speed keys An alphanumeric identifier of up to 16 characters can be entered o Press soft key next to a letter group to list letters in that group Press soft key next to an individual letter to enter that letter To access letter Z and special characters hyphen underscore space press PAGE DOWN soft key clear an entire entry press CLEAR key To back up a single character at a time press CANCEL key Toscan barcode on patient identification band see AUTO ID section of this User Manual 4 To verify correct entry press CONFIRM soft key Q aE O uo O o gt Q uY Q 123456789CD gt Enter Patient ID and Press Ey o0 o Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 13 System Options Continued Patient ID Continued Modify 1 N Press OPTIONS key Press Patient ID soft key To clear entire entry press CLEAR key OR To back up a single character at a time press CANCEL key To enter modified patient identifier use numeric data entry keys and or alpha speed keys An alphanumeric identifier of up to 16 characters can be entered Press soft key next to a letter group to list letters in that group Press soft key next to an individual letter to enter that letter To access letter Z and special chara
179. ersonnel The approved Data Sets are maintained by the Editor Software for future updates and reference Read all instructions before using the Alaris System KH R Only Alaris System User Manual with v9 17 Model 8015 Introduction Continued Information about an Alert that occurs during use is stored within the PC unit and can be accessed using the Guardrails CQI Reporter software Documentation provided with Alaris System products might reference product not present in your facility or not yet available for sale in your area A superscript number for example D identifies additional information provided as a NOTE at the end of the procedure WARNINGS AND CAUTIONS Product specific warnings and cautions covered in the applicable sections of this User Manual provide information needed to safely and effectively use the Alaris System Bis us is an alert to an imminent hazard which could result in serious personal injury and or product damage if proper procedures are not followed Wubi is an alert to a potential hazard which could result in serious personal injury and or product damage if proper procedures are not followed MEUS is an alert to a potential hazard which could result in minor personal injury and or product damage if proper procedures are not followed DEFINED TERMS The following table identifies the defined terms used throughout this document for
180. ervals Rapid Bolus Fastest rate at which Bolus Dose should be delivered as defined by facility s clinical best practice guidelines Restore To simplify programming can be used to recall previous rate and volume settings for same patient This option is only available if patient is not new and system is powered up within 8 hours of last usage 2 94 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Feature Therapies Features and Displays Continued L Features and Definitions Continued A Definition Pump and Syringe Modules An optional hospital defined therapy or clinical indication for delivery of that infusion Different Limits can be defined for same medication with different therapeutic indications Total Dose Limits Hospital established Limits around total dose of infusion Volume Duration Feature Allows a volume to be infused VTBI and duration infusion time to be programmed Flow rate is automatically calculated wol 1 Definition Pump Module Auto Restart Part of Alaris System s Downstream Occlusion Detection system designed to minimize nuisance patient side occlusion alarms Allows system to automatically continue an infusion following detection of a patient side occlusion if downstream pressure falls to an acceptable level within a 15 second Checking Line period If this feature is enabled Ch
181. ess EXIT Maintenance Due 1 Press OPTIONS key 2 Press PAGE DOWN soft key two times 3 Press Maintenance Due soft key SURE o Network Status O Co Wireless Connection Q Data Set Status o Maintenance Due Yes O gt Select an Option or EXIT PAGE UP 4 return to main screen press EXIT soft key System Options System Options Q Maintenance Due Dates o Q Maintenance Due Dates Q Q cu Q BarCode YYYY MM DD 60 MosuleA YYYY MM DD 9 Q Barcode YYYY MM DD Q Quine B YYYY MM DD 9 am held Module C YYYY MM DD Module D YYYY MM DD 9 9 gt Press CANCEL or EXIT gt Press CANCEL or EXIT 0000 0 6 1 30 Alaris System User Manual with v9 17 Model 8015 PC Unit Section System Options Continued Maintenance Due Continued NOTE PAGE DOWN soft key appears only if an Auto ID module is attached Alaris System User Manual with v9 17 Model 8015 PC Unit Section THIS PAGE INTENTIONALLY LEFT BLANK Alaris System User Manual with v9 17 Model 8015 PC Unit Section General Information Warnings and Cautions Explosion risk if used in the presence of flammable anesthetic agents or gasses Assess patient s condition before silencing an alarm Do not silence alarm if patient safety might be compromised Before each use verify that the alarm limits are appropriate for the patient The Alaris System performs a self check d
182. et reflects facility s best practice guidelines for IV Drug administration and includes Profile Drug Libraries Clinical Advisories instrument configurations and Channel Label Libraries Alaris System User Manual with v9 17 Model 8015 1 35 PC Unit Section Features and Displays Continued Features and Definitions Continued Feature Definition Guardrails Suite MX Designed to help prevent programming errors by Customizing device configurable settings to meet need of selected hospital facility area unit profile Comparing user programming with hospital defined best practice guidelines Providing a visual and audio prompt if an out of limits entry is made Patient ID An optional alphanumeric 16 character patient identifier that can be entered and displayed When enabled ID entry defaults to Startup screen When disabled ID entry is only accessible from System Options screen Profile A unique set of system configuration settings and best practice guidelines for a specific patient population or patient type and can consist of following components Instrument configuration settings A Drug Library which includes drug names standard concentrations dosing units duration limits and optional associated Clinical Advisories for both continuous and Bolus Dose infusion An IV Fluid library an optional library consisting of IV Fluids for example TPN and limits around rate of delivery
183. f data is stored 4 18 General Information Alaris System User Manual with v9 17 Model 8015 SpO Module Section Features and Displays Continued Features and Definitions Continued Model 8210 NELLCOR Feature SatSeconds Definition SatSeconds limits controls time SpOz level can fall outside the alarm limits before an audible alarm sounds Method of calculation is as follows Number of percentage points SpO falls outside of the alarm limit is multiplied by number of seconds 9o SpO level remains outside that limit Points x Seconds SatSeconds Points SpO percentage points outside of limit Seconds number of seconds SpO remains at that point outside of the limit Saturation levels might fluctuate rather than remain steady for a period of several seconds SpOz levels might fluctuate above and below alarm limit reentering nonalarm range several times During such fluctuations SpO module integrates number of SpO points both positive and negative until either SatSeconds limit SatSeconds time setting is reached or SpO level returns to within a normal range and remains there SatSeconds Safety Net is for patients with saturation levels having frequent excursions below limit but not staying below limit long enough for SatSeconds time setting to be reached When three or more limit violations occur within 60 seconds an alarm sounds even if SatSeconds time setting has
184. f this User Manual for system configurable settings If the configuration settings need to be changed from the Factory default settings refer to the applicable Technical Service Manual or contact CareFusion Technical Support for technical troubleshooting and preventive maintenance information With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice Data Set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles Models 8210 NELLCOR and 8220 QOMisw tl Feature Default Setting Options Limit Mode Adult Neonatal Pulse Beep Volume 1 1 2 3 Off Pulse Rate Alarm Limit High Adult Mode 120 bpm Neonatal Mode 200 bpm 31 240 bpm Pulse Rate Alarm Limit Low Adult Mode 50 bpm Neonatal Mode 100 bpm 30 239 bpm SpO Alarm Limit High Adult Off Neonatal 95 pred n Adult 9096 Neonatal 8096 SpO Alarm Limit Low 20 99 Model 8210 9 NELLCOR Default Setting Options 10 25 50 100 seconds Off Feature SatSeconds Alaris System User Manual with v9 17 Model 8015 SpO Module Section General Information 4 23 Configurable Settings Continued Model 8220 Miu T Default Setting Feature Options Saturation Averaging Time 8 seconds 2 4 8 10 12 14 16 seconds display update period Sensitivity Mode Norma
185. ffected site Alaris System User Manual with v9 17 Model 8015 General Information 4 27 SpO Module Section Measurement Accuracy Continued Placement is too close to electrosurgery equipment Defibrillation The loss of a pulse signal can occur in any of the following situations e Sensor is too tight Exposure to excessive illumination such as a surgical lamp especially one with a xenon light source bilirubin lamp fluorescent light infrared heating lamp or direct sunlight Sensor placed on an extremity with a blood pressure cuff arterial catheter intravascular line or other causes of insufficient perfusion e Patient has hypotension severe vasoconstriction severe anemia or hypothermia is in cardiac arrest or is in shock There is an arterial occlusion proximal to sensor Placement is too close to electrosurgery equipment NOTE Exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material 4 28 General Information Alaris System User Manual with v9 17 Model 8015 SpO Module Section Troubleshooting and Maintenance Troubleshooting and maintenance are intended to be performed only by qualified personnel using the SpO module Technical Service Manual and the System Maintenance software The Service Manual and System Maintenance software are available from CareFusion The Service Manual includes routine service schedules inte
186. fusion Continued 6 VTBI entry When VTBI is less than 10 mL h entry can be to two decimal places one hundredth of a mL e VTBlis prepopulated with diluent volume of infusion To change VTBI press VTBI soft key and use numeric data entry keys 7 If an optional hospital defined and editable starting value for intermittent duration is not already entered enter duration or rate as follows To enter duration press DURATION soft key and use numeric data entry keys rate value is calculated and displayed enter rate press RATE VOLUME soft key and use numeric data entry keys The secondary VTBI settings require consideration of such variables as factory overfill medication additions Underestimating the volume causes the remaining secondary solution to be infused at the primary rate overestimating results in the primary solution being infused at the secondary rate Multiple doses from a single container are not possible Guardrails Drug Setup Methotrexate seconpary 06556 Q pose 1200 mg m Conc 136 8 mg mL gt Enter Duration Ble SETUP 0000 A Guardrails Drug Setup Methotrexate Q seconpary Q Rae 4mun 00000 2 50 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Secondary Infusion With Guardrails Suite MX Protection Pump Module Continued i
187. g an infusion temporarily stops infusion on that module After approximately 2 minutes a visual and audio prompt begins Channel module Off Key When pressed and held until a beep is heard Restart Key When pressed resumes operation of a previously paused or alarmed infusion on that module SS Standby yellow LN c ALARM INFUSE STANDg dn Gripper Control Drive Head Release shown in closed position za Plunger Grippers shown in closed position Barrel Flange Grippers Syringe Barrel Sensor RATE mL h When pressed selects ius EE OO Br Connector Right Te Syringe Barrel Clamp Sizer 1 stops infusion on that module deselects that module and if only that module had been operating system powers down D Repeat for other operating modules to ZZ power off each module P ressure Transducer Pressure Sensing Disc Housing Module Release Latch When pressed allows module to be removed Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section General Information 2 101 Features and Displays Continued Tq EG 3B The displays illustrated throughout this document are for ds illustration purposes only The display content varies depending on configuration
188. g Bolus Dose continuously infused medications Bolus Dose units are selected from alternatives provided Extreme caution should be exercised Diluent volume Volume of fluid used as diluent for drug to ensure the correct entry of the mL drug calculation infusion parameters e Dosing units Units used to calculate Continuous Infusion drug dose Dosing Units are selected from alternatives provided Drug amount Amount of drug in IV container gram mg mcg mEq or units Patient weight Weight of patient kg this is an optional parameter that is not needed unless drug dose is normalized for patient weight Time units Time base for all calculations minute hour or day The Bolus Dose drug dose and flow rate parameters are calculated using the above parameters as follows Bolus Dose Bolus Dose x patient weight if used e Bolus Dose administration rate INFUSE AT When duration is entered total dose duration in minutes When Max Rate is used Max Rate 60 x concentration Bolus Dose duration bolus VTBI bolus rate Bolus Dose VTBI bolus dose drug concentration Bolus rate bolus VTBI duration e Continuous drug dose flow rate x drug concentration normalized for patient weight if specified by entering a patient weight e Continuous flow rate drug dose drug concentration normalized for patient weight if specified by entering a patient weight Duration VTBI rate
189. ge has been increased to 100 E Maximum rate error to allow visualization of the graph mm Overall rate error Minimum rate error 2 118 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Trumpet and Start Up Curves Continued Graphs Pump Module Continued Pump Module Flow Rate mL h Flow Rate Error 96 Start Up at 25 mL h initial 0 10 20 30 40 50 60 70 80 90 100110 120 Time min Trumpet Curve at 25 mL h initial 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 999 mL h 72 hrs o a a a Flow Rate Error a a 0 5 10 15 20 25 30 Observation Interval min Flow Rate Error Flow Rate Error Flow Rate mL h Start Up at 999 mL h initial 2000 1800 1600 1400 1200 1000 800 600 400 200 200 0 10 20 30 40 50 60 70 80 90 100 110 120 Time min Trumpet Curve at 999 mL h initial a eo a eo n a 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 999 mL h 24 hrs 0 5 10 15 20 25 30 Observation Interval min Legend E Maximum rate error mm Overall rate error Minimum rate error Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section General Information 2 119 Trumpet and Start Up Curves Continued Graphs Continued s yi Syringe Mod
190. ged battery the system operates as follows before a BATTERY DISCHARGED message occurs 6 hours with one Pump module infusing at 25 mL h 6 hours with one Pump module infusing at 25 mL h and one Auto ID module 3 hours with four Pump modules infusing at 25 mL h 3 hours with four Pump modules infusing at 25 mL h and one Auto ID module 4 5 hours with one active SpO module 6 hours with one Syringe module or PCA module infusing at 5 mL h 3 hours with four Syringe modules or one PCA module and three Syringe modules infusing at 5 mL h 4 hours with one active EtCO module Alaris System User Manual with v9 17 Model 8015 1 41 PC Unit Section Specifications and Symbols Communication Data Port Dimensions Electric Classification Electronic Memory Environmental Conditions Equipment Orientation Fluid Ingress Protection Mode of Operation Power Requirements Shock Protection Weight RS 232 with an RJ45 connector 6 9 W x 8 8 H x 9 D including pole clamp Class 1 Internally Powered Equipment Module specific parameters are stored for 8 hours when system is turned off After 8 hours of continuous off time or if a module is detached module specific trend data if applicable and module specific operating parameters are automatically purged If a PCA SpO or EtCOs module is detached and replaced with another PCA SpOs or EtCOs module its module specific trend data is purged Memory w
191. ght based dosing ooo gt Select Dose Unit Type DRUG EXIT LIBRARY 0000 Guardrails Drugs Adult ICU 90000 DOPamine 400mg 250mL 800mg 250mL 00000 gt Select Concentration o 100 mg in 100 m 0000 Guardrails Drug Setup Adult ICU Alteplase Is this correct DOSING unts mg kg h BOLUSABLE BOLUS gt Press YesorNo 0000 Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 23 00 posiNe mg kg 9 UNITS Primary Infusion With Guardrails Suite MX Protection Continued Continuous Infusion Continued f YES was selected and facility has defined a Clinical Alteplase Advisory for that drug a message appears To indicate cinica Advisor information has been noted and continue This dosingisforacute programming press CONFIRM soft key Ischemic STROKE o o o gt Press CONFIRM KO f Yes was selected to continue programming drug Aleplase amount and diluent volume if defined in Drug Library Q 888 100 mg 9 are automatically entered for selected drug Q ss 1004 O Q S used gt UNITS hour Q R molkgih Q Conc 1 mg mL gt Press NEXT to Confirm uBRaRy NEXT 0000 e If selected drug had mL concentration drug amount and diluent volume need to be entered If selected d
192. had been operating system powers down Repeat for other operating modules Module Release Latch When pressed allows module to be removed Patient Cable Connector General Information 4 21 Alaris System User Manual with v9 17 Model 8015 SpO Module Section Features and Displays Continued Displays The displays illustrated throughout this document are for illustration purposes only The display content varies depending on configuration settings hospital defined Data Set uploaded using the Guardrails Suite MX programmed parameters and many other variables Main Display See the PC unit section of this User Manual SPO2 Main Display NELLCOR Adult o XI EXsPo2wen 4 sPo2 97 o PULSE 82 150 RATE 50 A AN A nf NUN I NC ACA I I yf U y Y V Vy y V m Pleth Waveform 700 SatSeconds to Alarm gt Press ENTER to Retain Current View TREND Limits EN o 0 99000 if Evene om 8220 c x sPo2 97 Of PULSE 90 150 RATE 82 50 00000 gt Press ENTER to Retain Current View 0 AJ NAA A A f i i a Pleth Waveform o PI 10 56 Signal LQ PI TREND LIMITS n 0000 4 22 General Information Alaris System User Manual with v9 17 Model 8015 SpO Module Section Configurable Settings See the PC unit section o
193. harging and fully discharging Some temporary reduction in capacity might become apparent if the battery is partially discharged repeatedly Doing one or two cycles of full discharge and full charge can restore full performance Battery Cautions and Disposal Battery replacement should be performed by qualified service personnel while the instrument is not in use f caution AN Do not open incinerate or short circuit Worn out batteries must be disposed of properly according to local regulations 1 52 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Inspection Requirements To ensure that the Alaris System remains in good operating ENJA condition both regular and preventive maintenance inspections are required Refer to the System Maintenance software for Failure to perform these detailed instructions inspections can result in improper instrument operation REGULAR INSPECTIONS CAUTION N INSPECT FORIDAMAGE Preventive maintenance inspections should only be performed by qualified service Pole Clamp Each usage personnel Power Cord Each usage CLEANING As required START UP Each usage Exterior Surfaces Each usage IUI Connector Each usage Keypad Each usage NOTE While visually inspecting the IUI connectors look for fractures on the connectors black colored plastic If you see any damage do not use an instrument with fractured IUI connectors The IUI c
194. he system is ready to scan NOTE There is a prompt to accept or decline the change of patient ID if it is different from the patient ID already associated to the PC unit OAuto ID green READY scan light on the Auto ID module illuminates indicating the screens that allow scanning The green ready scan light does not illuminate when the programming steps have passed the point of being able to scan the medication 1 Toscan barcode on IV container press the SCAN CANCEL key on Alaris Auto ID module or scan trigger on handheld scanner The PC unit displays the scanned medication fluid information 2 Press CHANNEL SELECT key on appropriate module Alaris System determines if module selected is appropriate for scanned medication type If selection is not appropriate a pop up message is displayed with a request to CONFIRM message and scan is cancelled 3 Program infusion see applicable module specific section of this User Manual cuns CLASS 1 LED PRODUCT Do not stare into the beam or allow beam to strike patient s face Always verify that information displayed on the PC unit matches scanned data 6 8 Programming Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Subsequent Primary Infusion A subsequent primary infusion may be scanned with the Pump module running if the following criteria match between the scanned label and the running infusion Drug or Fluid name Alias o
195. his User Manual uses a new generation PC unit Model 8015 which provides wireless connectivity right out of the box and an enhanced display including color to clearly communicate critical programming infusion monitoring and hospital defined policy information Alaris System wireless communication makes it easier than ever to increase the safety of IV medication and continuously improve clinical best practices regardless of existing wireless infrastructure Guardrails Suite MX for the Alaris System brings a new level of medication error prevention to the point of patient care The Guardrails Suite MX features medication dosing concentration delivery rate and optional initial programming guidelines for up to 30 patient specific care areas referred to as Profiles Each Profile contains a specific Drug Library an IV Fluid library and channel labels as well as instrument configurations appropriate for the care area Optional drug or IV Fluid specific Clinical Advisories provide visual messages Dosing limits for each Guardrails drug entry or rate limits for each IV Fluid entry can be a Hard Limit that cannot be overridden during infusion programming and or a Soft Limit that can be overridden based on clinical requirements A Data Set is developed and approved by the facility s own multi disciplinary team using the Guardrails Editor software the PC based authoring tool A Data Set is then transferred to the Alaris System by qualified p
196. idural enteral or irrigation of fluid spaces The Pump and Syringe modules are indicated for use on adults pediatrics and neonates Up to four Pump and or Syringe modules can be connected to the Alaris System If a procedure information applies to a specific module the following identifiers indicate the module it applies to Pump module 5 Syringe module Administration Sets Syringes See General Information for specific Administration Set Syringe Information Alaris System User Manual with v9 17 Model 8015 Getting Started 2 1 Pump and Syringe Modules Section Introduction Continued Alarms Errors Messages Troubleshooting and Maintenance for module specific alarms errors and messages Contraindications None known Electromagnetic Environment See Appendix section of this User Manual Regulations and Standards Compliance 2 2 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Prepare Administration Set Pump Module 5 For instructions on how to go from checking in a Pump module ENA to preparing it for an infusion setup see General Setup and Operation To prevent a potential free flow condition ensure that no bedding tubing glove is 1 If anew set is being loaded prime set see Prime enclosed or caught in the Pump procedure module door 2 Open Pump module door Administration Sets Use only
197. ill not be lost due to a week discharged battery as data is stored on flash memory as noted Compact flash memory Stores application software audio wave files Data Set and hex files data for operating system software all needed to operate the Alaris System On board flash memory Contains software needed to initially turn on Alaris System Stores boot software application and events errors and battery logs Meaning Operating Storage Transport Atmospheric Pressure 525 4560 mmHg 700 6080 hPa 375 760 mmHg 500 1013 hPa 20 90 Noncondensing 5 85 Noncondensing Relative Humidity Avoid prolonged exposure to relative humidity gt 85 41 104 F 6 40 C 4 140 F 20 60 C Temperature Range To ensure proper operation Alaris System must remain in an upright position IPX1 Drip Proof Continuous 100 240V 50 60 Hz 150 VA MAX Type CF Defibrillator Proof patient applied part 7 2 lbs 1 42 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Specifications and Symbols Continued Symbols See the product specific section of this User Manual that applies to the attached module s for symbols specific to that module Meaning Alternating Current Indicates device should be attached to alternating current source 50 60 Hz only P Caution Refer to accompanying documentation v 9 Canadian and
198. ime Network Status The displayed status updates immediately when a status change takes place 1 Press OPTIONS key 2 Press PAGE DOWN soft key two times 99000 O 9000 System Options Time ocn Change Time 00000 gt Enter Current Time System Options Time of Day Current time Change 14 30 Time gt Press CONFIRM enfe 9 00000 Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 25 System Options Continued Network Status Continued 3 view network status and wireless status information aysen onions 3 of 3 press Network Status soft key Network Status 9 Wireless Connection Q Q Data Set Status Q Q Maintenance Due Yes 0 gt Select an Option or EXIT 4 Enter password refer to v9 5 or later System Maintenance System Options software instructions and press CONFIRM soft key Q B 9 Information based on a wireless status of DISABLED G ening Network Status DISASSOCIATED ASSOCIATING ASSOCIATED or aualified personnel 9 AUTHENTICATING is displayed S mu If wireless status is ASSOCIATED following information is displayed ee o Wireless connectivity SSID Channel zc CONFIRM Authentication and Encryption types being 0 used BSSID MAC address of access point tha
199. in accordance with the applicable user manual it might cause harmful interference to radio communications Operation of this system in a residential area is likely to cause harmful interference in which case the user is required to correct the interference at their own expense The authority to operate this system is conditioned by the requirement that no modifications are made to the system unless the changes or modifications are expressly approved by CareFusion Corporation This Class B digital apparatus meets all requirements of the Canadian Interference Causing Equipment Regulation f caution JAN Any changes or modifications not expressly approved by the personnel responsible for compliance could void the user s authority to operate the system Alaris System User Manual with v9 17 Model 8015 Appendix Section Regulations and Standards A 9 Compliance Continued Electromagnetic Environment Continued Cet appareil numerique de la Classe B respecte toutes les exigences du Reglement sur le materiel brouilleur du Canada The Alaris System includes an IEEE 802 11 RF transmitter as designated by the icon on the rear of the system It operates on the following frequencies with a maximum radiated power of 100 mW e 802 113 5 GHz band up to 54 Mbps physical RF specification 802 110 2 4 GHz band up to 11 Mbps physical RF specification 802 119 2 4 GHz band up to 54 Mbps physical RF specification
200. ing Invert pressure sensing disc so that patient side is up Hold pressure sensing disc between 2 fingers Slowly prime set while gently massaging pressure sensing disc to ensure that all air is expelled The disc must remain inverted only until the air is expelled Continue to gently massage disc throughout priming to ensure that it does not become under or over filled When priming is complete no air exists close set clamp NOTE When manually priming per hospital facility protocol and an administration set having a pressure sensing disc is in use depress the disc between 2 fingers while priming and prime uphill distal end of pressure sensing disc tubing pointing upward f caution The pressure sensing disc if left installed during priming can trap air that might not be totally expelled To ensure that entrapped air is eliminated it is recommended that the pressure sensing disc be removed prior to priming and the membrane gently massaged with a finger while priming After priming is completed reinstall the pressure sensing disc Patient Side I xN ZAR N 7 Ou EM A i NA V Nd Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Getting Started 2 17 Prepare Syringe and Administration Set Syringe Module Continued Prime Manual Continued Administration Set With No Pressure Sensing Disc 1 Prime p
201. ing Products Refer to the following website for cleaning product information www carefusion com alarissystemcleaning Procedure Inspect IUI Connectors 1 Visually inspect the right side male IUI connector for cracks on the entire surface of the black colored plastic housing See Figures 1 and 2 for the male IUI inspection area and typical cracks Figure 1 Male IUI Connector Figure 2 Male IUI Connector right Side 2 Visually inspect the left side female IUI connector for cracks on the edges of the black colored plastic housing 3 If cracks are found replace the IUI connector before use NOTE While visually inspecting the IUI connectors look for fractures on the connectors black colored plastic If you see any damage do not use an instrument with fractured IUI connectors The IUI connector must be replaced before the instrument can be used again WARNING To prevent an electrical hazard o Turn the instrument off and unplug the power cord from AC power before cleaning Do not spray fluids directly onto the instrument or into the IUI connectors Do not steam autoclave EtO sterilize immerse the instrument in fluids or allow fluids to enter the instrument case Do not connect a module until the IUI connectors are thoroughly dry Do not use compressed air to dry the instrument this could force fluid into the instrument Failure to perform these inspections
202. ing continues if No soft key is pressed infusion needs to be reprogrammed If the programmed IV fluid is outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion needs to be reprogrammed Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 4 Syringe module Unclamp tubing and attach administration set to Unclamping tubing and starting infusion before del r attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming Volume Duration Infusion 1 Press VOLUME DURATION soft key EX eres rui Setup TPN o PRIMARY INFUSION o mLh vs 9 o o gt Select RATE 2 42 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued IV Fluid Infusion Continued Volume Duration Infusion Continued 2 To enter VTBI press VTBI soft key and use numeric data Fluid Setup entry keys d PRIMARY INFUSION Q mL h O min 9 gt Enter VTBI EA START o s Syringe module ARETE Fluid Setup fat emulsio
203. ing the Alaris System e CareFusion IV Sets and Accessories may be downloaded from www carefusion com CAUTION PCA Module Technical Service Manual B Oniy PC unit chapter of this User Manual e System Maintenance software and its instructions for Alaris System check in maintenance and wireless configuration The PCA module is intended for facilities that use syringe pumps for the delivery of medications or fluids The PCA module is indicated for use on adults pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous IV subcutaneous or epidural Only one PCA module can be connected to the Alaris System Administration Sets Syringes See General Information for specific administration set and syringe instructions e Administration Set Information Compatible Syringes Alarms Errors Messages See Troubleshooting and Maintenance for module specific alarms errors and messages Contraindications None known Electromagnetic Environment See Appendix section of this User Manual Regulations and Standards Compliance Alaris System User Manual with v9 17 Model 8015 Getting Started 3 1 PCA Module Section Attach and Detach Dose Request Cord The Dose Request Cord must be attached to the PCA module Erg when delivering a PCA dose or PCA continuous dose infusion Carefully locate the Dose Request Cord to
204. inge and administration set see Getting Started Load Syringe and Administration Set b Select and confirm syringe type and size see Select Syringe Type and Size 7T Press soft key next to desired drug Guardrail Drugs Drug Concentration screen appears Q Morphine EO Q Meperidine F J Q oO eTO o gt Select Drug 3 10 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Prepare Infusion Continued Program an Infusion Continued 8 Press soft key next to desired concentration Drug Concentration confirmation screen appears To view additional drugs concentrations press PAGE UP and PAGE DOWN soft keys Facility can choose to prepopulate standard drug concentrations or leave a custom concentration mL and allow clinician to enter drug amount and diluent volume 9 Confirm drug and concentration selection and press Yes soft key To change selection press No soft key f Yes was selected and facility has defined a Clinical Advisory for that drug a message appears To continue programming press CONFIRM soft key Ifthe programmed mL concentration is the outside the Soft Limit an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion must be reprogrammed Ifthe programmed mL concentration is outside the Hard
205. installed syringe is not listed press ALL SYRINGES soft key and select syringe from list N Selection is highlighted CONFIRM soft key is activated o To accept press CONFIRM soft key Drug Library screen is displayed The Priming option can be enabled at the time the Alaris System is configured for use The Priming selection PRIME soft key is available only after the syringe type and medication selection prior to infusion mode selection Selection O Q O Q O o PSelect Syringe Size CONFIRM When priming Ensure that patient is not connected Ensure that air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequences Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient f caution JAN During priming the pressure limit alarms are temporarily increased to their maximum level 3 8 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Prepare Infusion Continued Prime Continued 1 Press OPTIONS key 2 Press Prime Set with Syringe soft key LQ channe Options 2 of 2 gt ML Ligh Q gt Select an Option or EXIT Pope EXIT 3 Press and ho
206. inued 3 lf Current time displayed is correct press CONFIRM soft key otherwise press Change Time and enter correct time See System Options Time of Day in PC unit section of this User Manual Ly Delayed Options O Time of Day Current ti 08 00 Time A 9 9900 o gt CONFIRM Time of Day EXIT o 4 enter time of day infusion is to be initiated up to 23 hours 59 minutes use numeric data entry key 5 Press CONFIRM soft key Time infusion is scheduled to start appears on Main Display e f a Before callback has not been scheduled see Schedule a Callback procedure infusion automatically initiates at end of delay period NOTE Ifthe current time has been previously confirmed the TIME OF DAY screen does not display Ifa delay is canceled before the delay ends the Alaris System will alarm when the VTBI reaches zero and then changes to KVO rate Alaris System User Manual with v9 17 Model 8015 Programming 2 69 Pump and Syringe Modules Section Delay Options Continued Schedule a Callback When programming a Delay for or Delay until infusion a callback can be scheduled for that infusion There are three types of callback Before gives an alert when delay period is completed and infusion needs to be initiated Ly Delay Options 08 00 Q Pause After
207. ion stops on affected module Ensure that tubing is properly installed in Air in Line Detector If air is present clear air from administration set Press RESTART key or press CHANNEL SELECT key and then START soft key Check IV Set Administration set is not properly installed Infusion stops on affected module Close roller clamp remove and reinstall administration set close door open roller clamp and then press RESTART key Close Door Door opened during an infusion Infusion stops on affected module Close door Press RESTART key or press CHANNEL SELECT key and then START soft key Occluded Fluid Side Empty Container Indicates either upstream occlusion or empty container Infusion stops on affected module Clear occlusion on fluid side of instrument If necessary refill drip chamber Press RESTART key or press CHANNEL SELECT key and then START soft key Occluded Patient Side Increased back pressure sensed while infusing in pump delivery mode Infusion stops on affected module Clear occlusion Press RESTART key or press CHANNEL SELECT key and then START soft key Partial Occlusion Patient Side Partial occlusion of patient side of IV line detected by Auto Restart feature Clear occlusion Press RESTART key or press CHANNEL SELECT key and then START soft key Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section
208. ions or decreased immunity of the Alaris System Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section General Information 6 13 Features and Definitions See the PC unit section of this User Manual for system features and definitions Feature Definition Audible Scan Indicator Provides audible confirmation of a successful scan Barcode A machine readable label used for automatic identification Automatic identification Auto ID is the broad term given to a host of technologies used to help machines identify objects and is often coupled with automatic data capture These technologies include barcodes smart cards voice recognition some biometric technologies for example retinal scans optical character recognition and others Built In Optical Scan Engine Employs technology similar to a digital camera to read barcodes Allows use of two dimensional barcodes Handheld Scanner with Allows scanning of patient ID and of IV containers that have already Optical Scan Engine been hung on IV pole Light Emitting Diode LED Barcode scanner uses an array of high intensity LEDs to illuminate barcode image see Specifications Two Dimensional Barcode Can contain more information and is more easily read by Auto ID module for example patient ID and drug ID can be in same barcode 6 14 General Information Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section
209. is System User Manual with v9 17 Model 8015 SpO Module Section Alarms and Messages Continued Alarms Continued Model 8210 NELLCOR Check Sensor Motion Interference Meaning Patient s motion has inhibited monitoring Response Check sensor Move sensor to a site with less motion Check Sensor No signal Sensor not properly attached to patient cable or patient cable not properly attached to SpO module Attach sensor to patient cable or attach patient cable to SpO module Check Sensor Weak Pulse Patient s low perfusion has inhibited monitoring Check sensor Move sensor to a better perfused site Check Sensor Weak Signal Low quality of signal being measured Model 8220 Muyo Check sensor Confirm correct sensor placement Move sensor to a better perfused site Check Sensor Light Meaning Light interference on sensor Response Check sensor Remove or reduce lighting Cover or reposition sensor Check Sensor Low Perfusion Patient s low perfusion has inhibited monitoring Check sensor Move sensor to a better perfused site Check Sensor Low Signal Low signal quality being measured Check sensor Confirm correct sensor placement Move sensor to a better perfused site Alaris System User Manual with v9 17 Model 8015 SpO Module Section Troubleshooting and Maintenance 4 31 Alarms and Messages
210. ite MX Protection Pump Module poet 2 58 Stop Secondary and Return to Primary sssssssesssseeeneeeeene nennen enne 2 59 Pause Cliange Restart InfUusiori 5 5 cet enti baee e hdd 2 60 Pause and Restart Infusion oo cceccecceesccssesseceecssecoecssecsesusessesessecsecsaecsecuaecsseesescsecseecaeeaeeeeeaeens 2 60 Change Rate or VTBI During Infusion ssssssseee nem enne nennen 2 61 Restore Infusion ss toos Lm ubere Tes 2 61 View and Clean Volume Infused i tec tite td ERR a ORT ATI ERR RE EUER EIE 2 62 CharnneliEabels rn tbe tt it ra tee e 2 63 Select ode 2 63 ou E c eq 2 65 Anesthesia Mode ee etie a a 2 66 Delay2Opulon s 42 25 TP 2 66 Delay InfU sior dente a dete eds Statt eate 2 67 oSchedule a Callback no t ERE 2 70 Pause te t pt bine 2 71 Multidose MOGS s ite p ies Alar eect a aide ii eme 2 72 Vol me Duration Enabled ree ett et ta eet ree e Meier 2 74 Volume Duration DiSabled 2 75 Select Pressure daniel id 2 77 P mbp Module itt de sre tiri eua teure niis ond 2 77 Syringe Modile s c etna Rn teg nene Rede oii eed 2 78 Alari
211. ittent Infusions and IV Fluids 2 114 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Symbols See the PC unit section of this User Manual for system symbols E al Symbol Meaning Pump and Syringe Modules m Type CF defibrillation proof patient applied part Single Use Single Use Do not reuse Product contains micron filter where XX represents filter size DEHP in fluid pathway Non DEHP plasticizer in fluid pathway No DEHP in fluid pathway Product is latex free 0 amp 5 Product incorporates Needle Free Valve ports and should not be accessed by a needle a X X 3 T Approximate administration set priming volume Expiration date for product is identified near hour glass symbol Do not use if package is damaged Manufacturer Meaning Pump Module Drops per milliliter specification for product is identified on drop symbol Alaris System User Manual with v9 17 Model 8015 General Information 2 115 Pump and Syringe Modules Section Trumpet and Start Up Curves In this instrument as with all infusion systems the action of the pumping mechanism and variations in individual administration sets cause short term fluctuations in rate accuracy The following graphs show typical performance of the system as follows Accuracy during variou
212. ivered 2 o ZOOM 24 12 8 4 i hours gt Press ZOOM to Change 5 To continue and clear patient history press Yes soft key ME To cancel and return to patient history press No soft key pow exr 3 28 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Clear Patient History Continued 6 Once patient history is cleared last 24 hours of patient history data can be retrieved and viewed To retrieve last Eo 24 hours press 24 h Totals soft key from Patient History Q Histor PR TTE 9 screen Q CLEARED 9e io SHIFT TOTALS 24 h Totals soft key appears only if shift total is cleared Q Total Drug om and additional patient history information exists up to Oana S previous 24 hours oO sPmesZ DOM o Grige i Time Scale NOTE eor ZOOM EXIT DETAIL 24 h Totals displays a rolling 24 hour history regardless of how many times the Patient History has been cleared 7 Toreturn to Patient History screen press SHIFT TOTALS soft key Alaris System User Manual with v9 17 Model 8015 Programming 3 29 PCA Module Section Infusion Modes Continued View Drug Event History 1 Press CHANNEL SELECT key 2 From Main Display press OPTIONS key 3 Press Drug Event History soft key B ros UE PCA Pause Limits Infusion Modes Patient History Do
213. ize that system can automatically and correctly identify Alaris System User Manual with v9 17 Model 8015 PCA Module Section Troubleshooting and Maintenance 3 69 Inspection Requirements To ensure that the Alaris System remains in good operating ENJA condition both regular and preventive maintenance inspections are required Refer to the System Maintenance software for Failure to perform these detailed instructions inspections can result in improper instrument operation REGULAR INSPECTIONS CAUTION N INSPECT FOR DAMAGE Exterior Surfaces Each usage UI Connector Each usage Preventive maintenance inspections should only be Keypad Each usage performed by qualified service Mechanical Parts Each usage personnel CLEANING As required START UP Each usage NOTE While visually inspecting the IUI connectors look for fractures on the connectors black colored plastic If you see any damage do not use an instrument with fractured IUI connectors The IUI EZGIIB connector must be replaced before the instrument can be used again Failure to follow these instructions Inspect IUI Connectors may result in potential hazards If any surface contaminants or blue or green deposits are associated with damaged IUI visible the connector must be replaced connectors Figure 1 Male IUI Connector Figure 2 Male IUI Connector right side 1 Visually inspect the right side male IUI connector
214. key Main Display shows remaining VTBI for that dose Atcompletion of a multidose program MULTIDOSE COMPLETE appears on Main Display 9 8 4 Syringe module Unclamp tubing and attach administration set to ar patient e Unclamping tubing and starting infusion before attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming 2 74 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Multidose Mode Continued Volume Duration Enabled Continued 9 To see detail screen during or between infusions press CHANNEL SELECT key During infusion Volume Remaining is displayed Between infusions o Number of doses completed and when next dose starts display o Yellow Standby Status Indicator illuminates NOTES Ifthe current time has been previously confirmed the Time of Day screen does not display RATE is calculated with each keystroke for DURATION See Delay Options procedure to program an infusion delay When delaying an infusion a multidose cannot be delayed for more than 8 hours and all doses in the multidose program must be completed within a 24 hour program Syringe module If NEOI is enabled the Near End of infusion message appears near the end of the last dose Volume Duration Disabled 1 enter rate use numeric data e
215. l m pour fat emulsion 2 Jf ALL Mode is enabled for syringe configuration INFUSION 9 in Data Set ALL is displayed in VTBI field and Q v 08mn T estimated available volume in syringe is displayed L 9 OR 2 9 W o If ALL Mode is disabled for syringe configuration in Data Set VTBI ALL option is not available and did d estimated available volume in syringe is displayed Pause pes sue when VTBI soft key is pressed 9 Toenter or change a numeric VTBI value press VTBI soft key and use numeric data entry keys To deliver entire contents of syringe Keep an A REESE ALL VTBI value or press ALL soft key to change a fat emulsion 2 primary INFUSION o numeric VTBI value to ALL Q 0 81 OEB 2m _ uration __h__ mM lt 4 DOSE 0 2 gram mL Conc 0 2 gram mL gt Select DURATION PAUSE vate START 0000 Alaris System User Manual with v9 17 Model 8015 Programming 2 41 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued IV Fluid Infusion Continued Rate Volume Infusion Continued 3 Verify correct infusion parameter entry and press START soft key If the programmed IV fluid is outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programm
216. l Normal Maximum Specifications and Symbols Specifications Models 8210 9 NELLCOR and 8220 Ust Alarms Alarm Limits Dimensions Environmental Conditions Fluid Ingress Protection Mode of Operation Shock Protection Audible and visual alarms for high and low saturation and pulse rate sensor condition system failure and low battery conditions Pulse Rate 30 239 bpm 31 240 bpm SpO 20 99 21 100 3 3 W x 8 9 H x 5 5 D 8 4 cm W x 22 6 cm H x 14 cm D Meaning Operating Storage Transport Atmospheric Pressure 525 4560 mmHg 700 6080 hPa 375 760 mmHg 500 1013 hPa Relative Humidity Avoid prolonged exposure to relative humidity gt 85 20 90 Noncondensing 5 85 Noncondensing Temperature Range IPX1 Drip Proof Continuous Type BF patient applied part 41 104 F 5 40 C 4 140 F 20 60 C 4 24 General Information Alaris System User Manual with v9 17 Model 8015 SpO Module Section Specifications and Symbols Continued Specifications Continued Models 8210 NELLCOR and 8220 Sigl Weight 2 Ibs 0 91 kg Model 8210 NELLCOR Accuracy Tolerance 20 250 bpm 3 digits 70 100 3 digits 20 250 bpm 20 250 bpm 3 digits 70 100 2 digits Pulse Rate 3 digits 70 100 2 digits Functional Saturation Display Update Period 2
217. laris System is powered up Alaris System User Manual with v9 17 Model 8015 PC Unit Section Features and Displays Continued Displays The displays illustrated throughout this document are for illustration purposes only The display content varies depending on configuration settings hospital defined Data Set uploaded using the Guardrails Suite MX and many other variables A color versus monochrome display option is available when creating a hospital defined best practice Data Set If no Data Set is present or the Profiles feature is disabled the default is a color display During normal operation the title and prompt bars are blue when a color display is enabled See Troubleshooting and Maintenance Alarms Errors Messages for additional color categories Main Display Title Bar Midtown Hospital Adult ICU Module Status VTBI 250 0 mL a Q o n A solid letter display indicates module is operating cC An outlined letter display 00000 indicates module is attached and ready for use Soft Keys VOLUME INFUSED Module Selected Indicator 00 7D Infusion Setup Inactive Soft Key Q wt 40mun Non highlighted indicates a 250m non selected soft key QO Active Soft Key Highlighted indicates a o selected soft key Press START Prompt Bar M LL uu mu RP emer Look here for user pro
218. lase Fora Continuous Infusion the drug name and dose b will scroll on the module Message Display o E Foran Intermittent Infusion the drug name and dose x d c will scroll on the module Message Displa 9 play Q O Conc 1 mg mL NOTE gt Press START Depending on how the drug library is programmed the dose PAUSE SETUP BOLUp may display as a total dose drug amount kg or drug amount BSA 2 26 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Continuous Infusion Continued Ifthe programmed continuous dose infusion is outside Alteplase roke the Soft Limit for that care area an audio alert sounds Dose exceeds Yes O and a visual prompt appears before programming can Q Guardrail limit OF No t continue If Yes soft key is pressed programming Q Proceed l O continues if No soft key is pressed infusion needs to Q O be reprogrammed Q gt Press Yes or No 0000 e Ifthe programmed continuous dose infusion is outside LY spes roke the Hard Limit for that care area an audio alert sounds Q Dose exceeds Revera and a visual prompt appears before programming can G1 hard limit of 0 82 mg kg h continue Infusion needs to be reprogrammed Q
219. ld PRIME soft key until fluid flows and priming n of syringe administration set is complete Q Prime Set with Syringe o e Volume used during priming is displayed but is not 9 added to VTBI Qm O m x 7 5 7 ow 9 Fluid is delivered during priming only while PRIME soft i key is pressed Each press of PRIME soft key delivers o Om up to 2 mL of priming fluid per continuous press To Press and Hold PRIME deliver additional amounts press PRIME soft key 075 o 4 When priming is complete release PRIME soft key 5 Toreturn to main screen press EXIT soft key Guardrails Drug Setup screen is displayed 6 Select infusion mode Alaris System User Manual with v9 17 Model 8015 Programming 3 9 PCA Module Section Prepare Infusion Continued Program an Infusion 1 Perform steps in Getting Started Prepare Syringe and Administration Set 2 Perform following steps see PC unit section of this User Manual General Setup and Operation Startup a Power on system b Choose Yes or No to New Patient c Select profile if required d Enter patient identifier if required 3 Press CHANNEL SELECT key 4 Unlock security door or set key to PROGRAM position 5 Confirm time of day or change time if necessary Pca Q mme of Day 4 uy K 9 o gt CONFIRM Time of Day EXIT o 9 6 Perform following steps a Load syr
220. ld cause serious consequences Administration Set Syringe Information 4 Infusion modules For specific administration set instructions and C earn replacement interval refer to User Manual Ziel provided with set w sc Fora list of compatible administration sets refer to CareFusion IV Sets and Accessories may be downloaded from www carefusion com Use aseptic techniques when handling sets and syringes Administration sets are supplied with a sterile and nonpyrogenic fluid path for one time use Do not resterilize Discard administration set per facility protocol For IV push medication put instrument on hold clamp tubing above port Donotadminister IV pushes through ports that are above the Alaris System Flush port s per facility protocol 2 88 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Administration Set Syringe Information Continued The Pump module uses a wide variety of Pump module Gemini Infusion System administration sets The sets are designed for use with the Pump module as well as for gravity flow stand alone use Primary set must be primed before use It can be loaded into Pump module to deliver a large volume infusion or it can be set up to deliver a gravity infusion Safety clamp fitment is a unique clamping device on the pumping segment that is part of all Pump module Gemini Infusion System set
221. lean any part of the instrument f caution N Do not allow cleaning solutions to collect on the instrument Residue buildup might cause the moving parts to become sticky and hinder their operation over time Certain chemicals can damage the surfaces of the instrument Refer to the following website for a list of chemicals that should NOT be used www carefusion com alarissystemcleaning Do not use chemicals that can damage the surface of the instrument When possible use cleaning products that are recommended for use by CareFusion A 4 Maintenance Alaris System User Manual with v9 17 Model 8015 Appendix Section Cleaning Continued Alaris System Continued 3 Follow the cleaner manufacturer s instructions on the time to leave it on the device surface Then remove the cleaner using a soft cloth dampened with water DO NOT allow the cleaner to collect on the instrument Cleaning the IUI 4 Apply 70 isopropyl alcohol directly to the dedicated IUI cleaning brush To prevent cross contamination do not dip the brush into the IPA DO NOT use the same brush used on the case to clean the IUI connectors Doing so could inadvertently transfer the cleaner or contaminants to the electrical contacts 5 Clean both IUls with the dedicated IUI cleaning brush To avoid accidentally depositing fluid on the connectors DO NOT use any spray cleaners anywhere near the IUI connectors NEVER ALLOW ANY CLEAN
222. led 1 Ensure that pressure sensing disc is installed correctly 2 Press CHANNEL SELECT key Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient 3 Press OPTIONS key 2 78 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Select Pressure Limit Continued Syringe Module Continued Ju Pressure Sensing Disc Installed Continued 4 Press Pressure Limit soft key 5 To enter a new pressure limit value press Change Value soft key OR If Auto Pressure feature is enabled press Auto Pressure soft key 6 Verify correct pressure limit input and press CONFIRM soft key O LN channel Options 1 of 2 Co Guardrails Drugs m o Guardrails IV Fluids Pressure Limit 550 mmHg Yringe gt Select an Option or EXIT Exit PAGE DOWN 00 o 0 99000 Pressure Limit Selection Current pressure 30 mmHg Current limit E 550 mmHg o lt Auto Pressure Change MIT cones o 0 Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 79 Select Pressure Limit Continued Syringe Module Continued Pressure Sensing Disc Installed Continued NOTES The optimal occlusion alarm limit setting achieves a balance between the risk of false
223. lockwise and hold in position b While holding gripper control in open position gently use extra care to close off lower drive head until it makes contact with plunger administration set tubing and flange gently lower drive head against Gently release gripper control syringe plunger Forsmaller syringes such as 1 Ensure that plunger grippers lock and hold plunger in POUR RM 3 or5 mL stabilize the syringe place plunger with thumb and index pisi a finger while carefully lowering N the drive head Ensure that the Drive Head Flush xag syringe plunger head makes with Plunger Flange contact with the small black T sensor located on the bottom of the drive head between the Plunger Grippers Closed 5 li Alaris System User Manual with v9 17 Model 8015 Getting Started 2 9 Pump and Syringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued Load Continued 7 Insert pressure sensing disc if used as follows a Orient pressure sensing disc as follows fluid side up patient side down e cavity forward membrane toward instrument b Gently slide pressure sensing disc up into slot in pressure sensing disc housing c Apply firm upward pressure on pressure sensing disc not tubing until disc snaps into place WARNING JAN When the pressure sensing disc is not being used and an o
224. m limit press MAX LIMIT soft key press FA Continuous Yes soft key and use numeric data entry keys Morphine Time in hours associated with Max Limit is automatically 4 entered based on setup in system configuration 2m Qe 0 gt gt gt gt No If No is selected no MAX LIMITS are available for this cc None 9 infusion Conc 1 mg mL gt Select Max Limit Option 5 To enter loading dose press LOAD DOSE soft key press Yes soft key and use numeric data entry keys Loading dose is included in volume infused but is not included in Max Limit 6 Verify correct parameters and press CONFIRM soft key Continuous If the programmed parameters are outside the Soft o 9 Limit for that care area an audio alert sounds and a TN 9 visual prompt appears before programming can OQ 2 mgh 9 continue If Yes soft key is pressed programming O imr 30 mgr hn 9 continues if No soft key is pressed infusion needs to cime be reprog rammed Boso Door Then Press CONFIRA e If the programmed parameters are outside the Hard GHANGE Limit for that care area an audio alert sounds and a P3 o visual prompt appears before programming can continue Infusion must be reprogrammed e If there is a potential for a programmed mL parameter to result in an excessive volume or dose being delivered following prompt appears Cannot proceed
225. mHg Alaris System has a back off safety feature that when enabled and a pressure sensing disc is in use is designed to reduce bolus volume on occlusion release Alaris System User Manual with v9 17 Model 8015 General Information 2 111 Pump and Syringe Modules Section Specifications Continued Syringe Module Continued T Bolus Volume Maximum after Occlusion Continued Critical Volume Dimensions Environmental Conditions Equipment Orientation E Maximum Bolus Volume specifications are based on following standard operating conditions Atmospheric Pressure Disposable Type 645 795 mmHg No Pressure Disc 30914 With Pressure Disc 30920 Humidity 20 90 Rate 5 mL h Syringe Type BD 50 60 mL Temperature 68 4 F Volume Collection Time approximately 2 minutes Maximum over infusion which can occur in the event of a single fault condition will not exceed 2 of nominal syringe fill volume during loading and 1 of maximum syringe travel after syringe loading 4 5 W x 15 0 H x 7 5 D 525 4560 mmHg 700 6080 hPa Atmospheric Pressure Storage Transport 375 760 mmHg 500 1013 hPa Relative Humidity Avoid prolonged exposure to relative humidity gt 85 20 90 Noncondensing 5 85 Noncondensing Temperature Range 41 104 F 5 40 C 4 140 F 20 60 C To ensure proper operation Alaris System must
226. mary Infusion With Guardrails Suite MX Protection 1 Press CHANNEL SELECT key 2 Press Basic Infusion soft key Infusion Setup screen appears 3 Start applicable infusion as described in following procedures see Primary Infusion With Guardrails Suite MX Protection IV Fluid Infusion procedure Rate Volume Infusion Volume Duration Infusion WARNING When the pressure sensing p disc is not being used and an I occlusion occurs there is a MIN risk of infusing pressurized Es buildup of infusates upon S correction of the occlusion avoid an inadvertent bolus relieve the pressure before restarting the infusion Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 53 Infusion NO Guardrails Suite MX Protection Continued Promote Basic Infusion to Guardrails Software Protection Infusion 1 Press CHANNEL SELECT key on module running infusion to be promoted 2 Press OPTIONS key 3 Press Guardrails Drugs soft key 4 Continue programming see Primary Infusion With Guardrails Suite MX Protection NOTE Basic infusions can only be promoted to a Guardrails Continuous Infusion A Basic Infusion cannot be promoted to a Guardrails intermittent drug Continuous Infusion Drug Calculation 1 Press Guardrails Drugs soft key 2 Press DRUG CALC soft key Acyclovir 0
227. ment by sliding flat edge of syringe barrel flange between barrel flange grippers Drive Head Fully Extended r Gripper Control Drive e Head Release in Open Position Plunger Grippers Open WARNING Before loading the syringe check it for damage or defects f caution N When initially loading the syringe allow for the volume of fluid contained in the administration set and retained in the syringe at the end of an infusion as this dead space will not be infused 2 8 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued Load Continued 5 Lock syringe in place ELI a Pull syringe barrel clamp out and hold Ensure that syringe barrel flange b Rotate clamp to right clockwise or counter clockwise and plunger are installed and until it lines up with syringe secured correctly Failure to install syringe correctly can result in uncontrolled fluid flow to the patient and can cause serious injury or death c Gently release clamp against syringe 6 Lower drive head and lock plunger in place with plunger CAUTION grippers a Twist gripper control c
228. ment s repairable components The System Maintenance software is used to perform a new instrument check in preventive maintenance tests and other maintenance functions Errors and Messages See the PC unit section of this User Manual for the following system references Alarms Errors Messages Audio Characteristics Definitions Display Color Radio Frequency Note Error Meaning Response Clinician ID is invalid Clinician ID is not recognized Ensure that ID label is legible Enter ID manually Patient ID is invalid Patient ID is not recognized Ensure that ID label is legible Enter ID manually Scanned label is invalid Profile feature might be disabled Ensure that Profile is enabled Barcode might not be readable or Ensure that ID label is legible Inform a supported symbology pharmacy of problem Scanned medication label is invalid Barcode might not be readable or Ensure that ID label is legible Inform a supported symbology pharmacy of problem Alaris System User Manual with v9 17 Model 8015 Troubleshooting and Maintenance 6 19 Auto ID Module Section Errors and Messages Continued Message Meaning Response Drug or Fluid not in current Profile Drug and its concentration might Ensure that correct Profile is not be in currently selected Profile selected and that it has correct drug and concentration Channel Unavailable Channel is currently infusing and If secondary infusion wa
229. mit is automatically entered based on setup in system configuration 99 99099 Guardrails Drug Setup Morphine SSHOMIVIODES Q PCA Dose only L9 Continuous Infusion PCA Dose Continuous Loading Dose Only 00000 gt Select an Option DRUG SETUP LIBRARY 0000 PCA Only Morphine 00000 bose _ 20 mg LOCKOUT minutes None LOADING None Conc 1 mg mL gt Select LOCKOUT INTERVAL CHANGE MODE 0000 A Guardrails Drug Setup IMS Pre fill 30ML 90000 vos 20 mg INTERVAL 10 minute K MAX E Limit 2323 9 b OADING None Conc 1 mg mL o gt Select Max Limit Option CHANGE MODE 0000 Alaris System User Manual with v9 17 Model 8015 PCA Module Section Programming 3 13 Infusion Modes Continued Set Up PCA Dose Only Continued N To enter loading dose press LOAD DOSE soft key press Yes soft key and use numeric data entry keys Loading dose is included in volume infused but is not included in Max Limit m Verify correct parameters and press CONFIRM soft key If the programmed parameters are outside the Soft Limit an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion must be reprogrammed If the programmed parameters are outside the Hard
230. mpts Alaris System User Manual with v9 17 Model 8015 1 39 PC Unit Section System Configurable Settings If the configuration settings need to be changed from the Factory default settings refer to the applicable Technical Service Manual or contact CareFusion Technical Support for technical troubleshooting and preventive maintenance information With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice Data Set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles Feature Default Setting Options Alarm Audio Profile 1 Profile 1 2 or 3 Anesthesia Mode Disabled Enabled Disabled Battery Meter Disabled Enabled Disabled Clock Setup Date and Time Not Applicable Set date and time Dose Checking Always Always Smart Key Click Audio Enabled Enabled Disabled Max Patient Weight 500 kg 0 1 500 kg Patient ID Entry Disabled Enabled Disabled PM Reminder Enabled Enabled Disabled Preventive Maintenance Profiles Disabled Enabled Disabled Tamper Resist Disabled Enabled Disabled 1 40 Alaris System User Manual with v9 17 Model 8015 PC Unit Section System Configurable Settings Continued Battery Operation Battery run time is a function of the number of modules attached and module activity With a new fully char
231. n FAQETCO2 Main faut o Capnography waveform scale adjustable Q coz 34 m O o EtCO value as well as minimum and maximum ea RR 135 sei 4 EtCO alarm limits o ibis 60 Limit Mode Adult or Neonatal 8 5 0 0 i 0 1 2 Time sec 4 5 Respiratory rate RR breaths min as well as Press ENTER to Retain minimum and maximum RR alarm limits Current View TREND LIMITS ee NOTE 0000 PC unit display response time is approximately 72 second longer than the EtCO module response time Set Alarm Limits 1 Press LIMITS soft key ETCO2 Main Adu Q ETco2 34 D mmHg Q S RR 13 S breaths min o 9 0 2 Time sec 4 5 2 To change a limit setting press soft key next to applicable parameter 3 Enter a numeric value for selected alarm limit 4 To move to next limit press ENTER key 5 To confirm alarm settings and return to ETCO2 Main o AE aos Mode o display press CONFIRM soft key LE mms d uu 35 4 o HIGH 25 breaths min O Q 3 5 breaths min o Oh 10 seconds FiCO2 High 10 mmHg gt Press CONFIRM Apply Chang 9 9 9 6 Toreturn to Main Display press MAIN SCREEN soft key 5 6 Programming Alaris System User Manual with v9 17 Model 8015 Module Section Navigate Trend Data Monitoring Mode Continued To view Trend Data press TREND soft key Following information is displayed
232. n Warnings and Cautions aA Do not open the handheld scanner case If the case is opened an electrical shock hazard and possible exposure to potentially hazardous LED light exists which can result in serious personal injury and product damage Carefully locate the handheld scanner to reduce the possibility of patient entanglement or strangulation Use only the handheld external scanner supplied by CareFusion Using other accessories can result in increased emissions or decreased immunity of the Alaris System f caution JAN Class 1 LED devices are safe under reasonably foreseeable conditions of operation including the use of optical instruments for intrabeam viewing To avoid potential harm avoid looking into the beam or allowing the beam to strike the patient s face Handheld Scanners The handheld external scanners supplied by CareFusion are the only handheld scanners approved for use with the Auto ID WARNINGS module 1st Generation 2nd Generation Scanner Scanner CAUTION CLASS 1 LED PRODUCT Do not stare into the beam or allow beam to strike patient s face Do not open the handheld scanner case If the case is opened an electrical shock hazard and possible exposure to potentially hazardous LED light exists which can result in serious personal injury and product damage Use only the handheld external scanner supplied by CareFusion Using other accessories can result in increased emiss
233. n 2 T If ALL Mode is enabled for syringe configuration O arem in Data Set ALL is displayed in VTBI field and Q 0 81 estimated available volume in syringe is displayed vs ALL au O W OR Q DURATION h min o o DOSE 0 2 gram mL 0 n If ALL Mode is disabled for syringe configuration Conc 0 2 gram mL in Data Set VTBI ALL option is not available and estimated available volume in syringe is displayed PAUSE yGME START when VTBI soft key is pressed o enter or change a numeric VTBI value press VTBI soft key and use numeric data entry keys deliver entire contents of syringe Keep an A Sears Fluid Setup ALL VTBI value or press ALL soft key to change a primary NFusion O numeric VTBI value to ALL Q we 4 o A cae vre mL ALL Q wnow m Q DOSE 0 2 gram mL 9 Conc 0 2 gram mL gt Select DURATION Pause iie START 0000 Alaris System User Manual with v9 17 Model 8015 Programming 2 43 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued IV Fluid Infusion Continued Volume Duration Infusion Continued 3 To enter volume duration press DURATION soft key and Eee Fui Setup use numeric data entry keys PRwaRvwrUsON O Rate is automatically calculated 417 mun 9 p EET 4 0 9 gt 9 gt Enter Duration 000
234. n Anesthesia Mode is enabled important to select the profile that corresponds with the care area the patient will be taken to when the Dose checking mode is set to Smart Anesthesia Mode is discontinued Key press audio is turned off This ensures that the Alaris System will be in the correct profile following the use of the Anesthesia Mode All limits are set to Soft Auto Restart for Anesthesia Mode is set to 9 and is not configurable e Panel Lock through Tamper Resist Mode or Authorized User Mode is not available e Guardrails drug list defaults to drugs designated by Editor Software as anesthesia only All Guardrails drugs in a profile can be viewed by pressing ALL DRUGS soft key Bolus Dose is automatically available for Guardrails drugs that have Bolus Dose limits defined o generic drug calculation setup Anesthesia Mode alternating with other required prompts is displayed in prompt bar of Main Display Callback audio for paused module is permanently silenced e Review of drug calculation setup page is omitted when restoring a stopped drug calculation Clinical Advisories are not displayed NOTE If an infusion is paused in regular mode and then the anesthesia mode is enabled the device will alarm at the 2 minute warning System Options 1 of 3 Enable CE Display Contrast Q 1 Press OPTIONS key 8 Patient ID Clinician ID 2 Press Anesthesia Mode soft key P
235. n Last module powering off System Press any key except SYSTEM shuts off in indicated number of ON key to cancel power down seconds sequence Replace Battery Occurs at System On Battery has To continue normal operation with less than 50 of original capacity reduced battery capacity press CONFIRM soft key Replace PC unit 1 50 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Storage Plug the PC unit into an AC outlet during storage to ensure a fully charged battery The AC indicator light is on when the PC unit is plugged in Battery Care and Maintenance Battery Type and Charging The PC unit is equipped with a 12 volt 4000 mAh nickel metal hydride battery The battery is charging whenever the instrument is plugged into an AC receptacle The life expectancy of the battery is dependent on the amount of use the depth of discharge and the state of the charge that is maintained Generally the battery has the longest life if the instrument is plugged in and battery use is infrequent Frequent use of battery power and insufficient battery charge cycles significantly decrease the life of the battery The quality of the battery is also a significant factor in determining battery life and runtime The battery cannot be repaired and should not be opened Replace the battery with the same type size and voltage rating Use only CareFusion batteries and accessories Batteries should be cha
236. n a patient s ID medication labels and clinician badges The Auto ID module and handheld scanner read printed barcodes which are within the barcode print quality guidelines specified by ANSI X 3 182 CEN EN 1635 and ISO IEC 15416 international standards Some manufacturer applied barcodes on IV bags are not compliant with these quality standards and might not be readable with the Auto ID module and handheld scanner Refer to the Auto ID Label Guidelines for more detailed barcode label information Symbols See the PC unit section of this User Manual for system symbols Meaning Input Handheld connection point Type BF patient applied part Alaris System User Manual with v9 17 Model 8015 General Information 6 17 Auto ID Module Section THIS PAGE INTENTIONALLY LEFT BLANK 6 18 General Information Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Troubleshooting and Maintenance Troubleshooting and maintenance are intended to be performed only by qualified personnel using the Auto ID Module Technical Service Manual and the System Maintenance software The Service Manual and System Maintenance software are available from CareFusion The Service Manual includes routine service schedules interconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instru
237. n it clockwise until tightly secured to module Disposables Use of a disposable other than those specified can cause improper EtCO module performance resulting in inaccurate readings For a list of compatible disposables refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com 5 2 Getting Started Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Connect Microstream Disposable Continued 3 Release door 4 Connect Microstream Disposable to patient Connection site and manner are dependent on patient intubation status and type of Microstream Disposable being used refer to disposable s User Manual NOTE The Covidien Disposable may be used with 5 liters of oxygen with a nasal cannula This disposable is not intended to be used with high flow oxygen through a nasal cannula The use of a mask with high flow oxygen is recommended Two nasal cannulas should not be used at one time Alaris System User Manual with v9 17 Model 8015 Getting Started 5 3 EtCO Module Section Attach Gas Scavenging System In the presence of high oxygen or anesthesia concentrations it might be necessary to connect a gas scavenging system to the EtCO module 1 Open gas inlet outlet door by turning door counterclockwise until gas outlet is clearly visible Hold in open position Gas outlet is located on lower right corner of instrument and is marked
238. n options mode Normal setting is used for normal patient monitoring purposes aximum setting is used for improved low perfusion performance SET Technology Signal Extraction Technology SET uses adaptive filters to separate arterial signal from nonarterial noise SET provides for accurate readings under extreme conditions such as low perfusion and motion Signal I Q Feature A visual indication of pulsation at sensor site Vertical bar height indicates quality of measured signal Signal 1 Q feature is related to proper sensor application adequate arterial signal and intensity of motion Use Signal Q feature to verify optimal sensor placement 4 20 General Information Alaris System User Manual with v9 17 Model 8015 SpO Module Section Features and Displays Continued Operating Features Controls Indicators Status Indicators Alarm Monitoring Standby red green yellow IUI Connector Right IUI Connector Left not visible SpOz Display Pulse Bar Display Pulse Rate Display Channel module Identification Channel module Message Display Channel module Select Key When pressed selects corresponding module for patient monitoring and setup Monitor Key When pressed begins patient monitoring W Channel module Off Key When pressed and held until a beep is heard stops operation of that module deselects that module and if only that module
239. n order Midtown Hospital Med Surg O 9000 A PCA Cont Morphine B VTBI ALL 30 mL C 2 D sPo2 PCA Pause Protocol ON 0000 VOLUME AUDIO INFUSED ADJUST 0000 9 999 PCA Pause Limits Infusion Modes Patient History Dose Request Setup Drug Event History 00000 gt Select an Option or EXIT PAGE EXIT DOWN E PCA Pause Limits 90000 PCA SPO2 ETCO2 PAUSE LIMITS ALARM LIMITS 88 97 4 5 00000 gt Press CONFIRM to Apply Changes DISABLE DISABLE SPO2 conri ETCO2 0000 Alaris System User Manual with v9 17 Model 8015 PCA Module Section Programming 3 39 Guardrails PCA Pause Protocol Feature Continued Review or Change PCA Pause Alarm Limits Continued 5 To change PCA pause limits press soft key that 6 7 corresponds to alarm limit and enter a value within acceptable range Press CONFIRM soft key Press START soft key NOTE The acceptable range for PCA Pause Protocol is configurable and defined by the hospital within the Data Set using the Guardrails Suite MX The PCA PAUSE LIMITS must be lower than the SPO2 ETCO2 ALARM LIMITS A prompt is provided if the PCA PAUSE LIMITS must be modified Disable PCA Pause Alarm 1 2 3 4 From Main Display press CHANNEL SELECT Press OPTIONS key Press PCA Pause Limits soft key Press DISABLE SP
240. n that module Module Release Latch Door Handle When pressed allows module to be removed Alaris System User Manual with v9 17 Model 8015 General Information 2 99 Pump and Syringe Modules Section Features and Displays Continued Operating Features Controls Indicators Continued 5 i IUI Connector Left not visible Upper Tubing Fitment Retainer n s I Platen IUI Connector Right Upper Pressure Sensor Upper Occluder Upper Pumping Finger Door Latch Cam Slide Lower Occluder Lower Pumping Finger Lower Pressure Sensor Safety Clamp Sensor and Door Sensor Tubing Keeper Air in Line Sensor 2 100 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Features and Displays Continued Operating Features Controls Indicators Continued Status Indicators Alarm red Infusing green IUI Connector Left Rate Display Message Display Channel module Identification Channel module Select Key module for infusion parameter entry and infusion setup Pause Key When pressed durin
241. n the transmitter manufacturer Separation Distance Based on Transmitter Frequency m 150 kHz 80 MHz 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz Rated Maximum Outside ISM In ISM Bands Output Power of Bands Transmitter W A 14 Regulations and Standards Alaris System User Manual with v9 17 Model 8015 Appendix Section Compliance Continued Electromagnetic Environment Continued Alaris System Continued NOTES Compliance levels raised by IEC 60601 2 24 Performed at the minimum and maximum rated input voltage U1 is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies 0 089 These guidelines might not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and mobile radios amateur radio
242. n to be delivered at programmed lockout intervals through Dose Request Cord When programmed in PCA continuous mode Continuous Infusion resumes following PCA dose PCA Pause Protocol An optional and hospital configurable feature intended to align with hospital health system s current protocol for patient monitoring during PCA therapy When enabled PCA infusion pauses and alarms when defined monitoring values SpO and or Respiratory Rate low for SpO and or 2 module are exceeded and sustained Pressure Limit Downstream occlusion alarm threshold can be set to low medium or high Syringe variability might impact occlusion pressure sensing Variability can reduce device s time to alarm and or can require that a higher alarm pressure limit be programmed Priming Allows a limited volume of fluid to be delivered in order to prime administration set prior to being connected to a patient or after changing a syringe When priming a single continuous press of PRIME soft key delivers up to 2 mL of priming fluid Restore To simplify programming can be used to recall previous PCA programming parameters for same patient This option is only available if patient is not new and system is powered up within 8 hours of last usage Security Access Level Security Code Profile specific security access level can be configured to provide varying levels of access to device Security access is accomplished either thr
243. nd Data view view latest data return to Trend Data gt 9 view gt Select an Option or is displayed if an alarm limit is reached EXT m SPO2 or PULSE rate values are available for time period displayed dashes display 4 6 Programming Alaris System User Manual with v9 17 Model 8015 SpO Module Section Monitoring Mode Continued Navigate PCA SpO Trend Data Continued 3 See Navigate Trend Data procedure for instructions on Trend Data eu how to pm m ro e Navigate from page to page Oana a aa 9 o 21 28 4 a 11 i Change TIME increments Q m 20 28 39 4 12 4 e Return to SPO2 Main display Q 9 25 HO Return to Main Display gt Press UP DOWN Keys to Move Cursor Pte zoom reo FARE 0000 Presilence Alarm 1 To presilence alarm press SILENCE key All monitoring alarms are silenced for 120 seconds Subsequent infusion alarms are not silenced 2 To cancel presilence alarm and return to alarmable mode e Press CHANNEL SELECT key e Press CANCEL SILENCE soft key SPO2 Main fut Mode SPO2 97 PULSE 150 RATE 82 50 N VA N N A N VV 00000 0 100 SatSeconds to Alarm gt Press E R to Retain Alaris System User Manual with v9 17 Model 8015 Programming 4 7 SpO Module Section Channel Options Change Limit Mode The followi
244. nd Symbols ele ele iaa Lee ce eieae a ed adu Lee d n te ee desee 4 24 Specifications ireen n dert den ode ded tte 4 24 Yin 4 27 Measurement ACCuracy 53 uc tet t ro OO E eo odd ede eU Ee eue 4 27 Troubleshooting and Maintenance General EE 4 29 Alarms and ei DEI 4 29 eT pem LP 4 29 PAIS P 4 29 CECI 4 32 lnspection Requirements 5 cet e ee ra RE ER dee ro OP Pu e ERE ARR REPRE aes 4 33 Alaris System User Manual with v9 17 Model 8015 4 i SpO Module Section THIS PAGE INTENTIONALLY LEFT BLANK Alaris System User Manual with v9 17 Model 8015 SpO Module Section Getting Started troduction Introduction This section of the User Manual provides SpO module ENBA Models 8210 and 8220 instructions and information It is used in conjunction with Read all instructions for the SpO module and PC unit before e Nellcor and Masimo cable and sensor instructions using the Alaris System PC unit section of this User Manual e CareFusion IV Sets and Accessories may be downloaded from CAUTION A www carefusion com R Only e SpOs module Technical Service Manual e System Maintenance software and its instructions for Alaris System check in maintenance and wireless configuration The SpO modules are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin
245. nd sensor see Getting Started 3 Press CHANNEL SELECT key SEARCHING might appear in Channel Message display until SpOs and pulse readings stabilize approximately 15 seconds L If sensor is not attached to a site SENSOR OFF is C Gg D displayed MONITOR prevent screen from reverting to Main Display oe press ENTER key within 30 seconds after SPO2 Main screen is displayed E If sensor is not attached during message display module goes into sleep mode To begin monitoring once module is in this mode press MONITOR key 4 Ensure that sensor s red LED is on Alaris System User Manual with v9 17 Model 8015 Programming 4 3 SpO Module Section Monitoring Mode Continued 5 Alarm limits NELLCOR sPo2 Main 4e To change settings see Set Alarm Limits procedure 8210 sro2 97 9 kae 82 9 O ARAARA NA vvv VV o i Pe PI 10 56 gt Press ENTER to Retain Current View TREND LIMITS SCREEN 0000 YMSE ISPO Man 8220 o SPO2 O7 a o PULSE 82 150 RATE 50 Q AA AR e NNNSNNSS o lo 100 SatSeconds to Alarm gt Press ENTER to Retain Current View TREND LIMITS ER 00000 000 To accept settings and begin monitoring press ENTER key Set Alarm Limits 1 Press LIMITS soft key SPO2 Main faut Mode SPO2 97 97
246. neral Setup and Operation System Start Up Setup See the PC unit section of this User Manual General Setup and Operation for various system start up and setup procedures Set Up for Gravity Infusion Pump Module z Prime administration set see Getting Started Prime procedure 2 Adjust container to hang 20 inches above patient s vascular access device 3 Attach administration set to patient s vascular access device 4 Adjust flow rate with administration set roller clamp Change Solution Container Pump Module 1 To stop infusion press PAUSE key L 2 Close roller clamp 3 Remove empty solution container 4 Insert administration set spike into prepared fluid container following accepted hospital facility procedure and hang container 20 inches above Pump Module 5 Press CHANNEL SELECT key 6 Toenter VTBI press VTBI soft key and use numeric data entry keys 7 Open roller clamp 8 Toresume infusion press START soft key Alaris System User Manual with v9 17 Model 8015 General Setup and Operation 2 83 Pump and Syringe Modules Section System Start Up Setup Continued Change Syringe During Infusion Syringe Module T If a critical medication is being infused at a flow rate less E than 1 0 mL h and the patient is not stable enough to experience even a short period of time without the drug it is recommended that the new syringe and administration set be inst
247. ng system references Alarms Errors Messages Audio Characteristics Definitions Display Color Radio Frequency Note Alarm Silence Alarms can be silenced for up to 120 seconds by pressing SILENCE key Alarm indicators remain on and alarm silence symbol is displayed Silence period can be ended by pressing CANCEL SILENCE soft key Calibration Check A technical procedure outlined in Technical Service Manual to verify instrument calibration Alaris System User Manual with v9 17 Model 8015 Troubleshooting and Maintenance 5 27 EtCO Module Section Alarms and Messages Continued Audio Characteristics EtCO Alarm HIGH PRIORITY A sequence of five beeps Variable volume can be silenced for 2 minutes EtCO Alarm LOW PRIORITY One long beep approximately every 4 seconds Variable volume can be silenced for 2 minutes EtCO Error Hardware Detected A single alarm tone volume Fixed maximum decibel volume cannot be silenced EtCO gt Error Software Detected Pairs of long beeps Fixed maximum decibel volume can be silenced for 2 minutes High Priority Alarm Meaning Response CHANNEL ERROR Hardware failure detected by software To silence alarm and continue operation of unaffected instrument press CONFIRM soft key Replace module as needed DISPOSABLE DISCONNECTED Microstream Disposable removed from instrument during monitoring mode Attach Microstream Disp
248. ng procedure can be performed only when the Guardrails Suite MX is not enabled profile option not being used for programming 1 Press Limit Mode soft key EMT gt Pulse Beep Volume Off SatSeconds Setup 10 code 66600 gt Select an Option or EXIT 2 To change Limit Mode Setup press applicable soft key n OR Limit Mode Setup Q To leave Limit Mode Setup unchanged and return to EN SPO2 Main display press EXIT soft key o o O gt Select an Option or EXIT EXIT 0000 Change Pulse Beep Volume 1 Press Pulse Beep Volume soft key FEV channel Options emi Adult Pulse Beep Volume Off Q SatSeconds Setup 10 M o o gt Select an Option or EXIT EXIT 0000 4 8 Programming Alaris System User Manual with v9 17 Model 8015 SpO Module Section Channel Options Continued Change Pulse Beep Volume Continued 2 Totest or change n a To test volume level when not attached to patient Pulse Beep Volume Test press Test soft key 9 of O Pulse beep must be on to test volume level To turn 8 pulse beep on press Louder soft key and adjust as needed o Softer Louder o b To increase volume press Louder soft key until desired volume level is attained 1 2 or 3 CONFI c To decrease volume press Softer soft key
249. nited Kingdom Product return service assistance and order placement Phone 0800 917 8776 E mail UK Customer Service carefusion com Technical Support and Customer Service International Maintenance and service information support Product return service assistance and order placement www carefusion com customer support customer service Technical Support Australia New Zealand Maintenance and service information support troubleshooting service assistance Phone 61 1300 729 258 E mail techservice au carefusion com Customer Care Australia Product return and order placement Phone 61 1800 110 511 E mail customerservice au carefusion com Customer Care New Zealand Product return and order placement Phone 64 0 508 422 734 E mail nz customers carefusion com Alaris System User Manual with v9 17 Model 8015 iv Introduction The Alaris PC unit section of this User Manual provides procedures and information applicable to the Alaris System and the PC unit Each of the other major sections provides product specific procedures and information The Alaris System is a modular system intended for adult pediatric and neonatal care in today s growing professional healthcare environment It consists of the PC unit the Guardrails Suite MX and up to four detachable infusion and or monitoring modules channels The Alaris Auto ID module can be included as a fifth module The Alaris System supported by t
250. nnection Module Release Latch When pressed allows module to be removed 5 18 General Information Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Features and Displays Continued The displays illustrated throughout this document are for illustration purposes only The display content varies depending on configuration settings type of disposable in use hospital defined Data Set uploaded using the Guardrails Suite MX programmed parameters and many other variables Main Display See the PC unit section of this User Manual Configurable Settings See the PC unit section of this User Manual for system configurable settings If the configuration settings need to be changed from the Factory default settings refer to the applicable Technical Service Manual or contact CareFusion Technical Support for technical troubleshooting and preventive maintenance information With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice Data Set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles Feature Default Setting Options EtCO Alarm Limit High Adult 60 mmHg Neonatal 60 mmHg 5 99 mmHg EtCO Alarm Limit Low Adult 10 mmHg H Neonatal 10 mmHg Bep MMEO Alarm Limit High Adult 8 mmHg H Neonatal 8 mmHg 2 99 mmHg Limit Mode Adult Adult
251. nt to the repair facility shall be at purchaser s risk In no event shall CareFusion be liable for any incidental indirect or consequential damages in connection with the purchase or use of any Alaris System product This warranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and CareFusion shall not be responsible for any loss or damage arising in connection with the purchase or use of any Alaris System product which has been 1 repaired by anyone other than an authorized CareFusion Service Representative 2 altered in any way so as to affect in CareFusion s judgment the product s stability or reliability 3 subjected to misuse or negligence or accident or which has had the product s serial or lot number altered effaced or removed or 4 improperly maintained or used in any manner other than in accordance with the written instructions furnished by CareFusion This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of CareFusion and CareFusion does not give or grant directly or indirectly the authority to any representative or other person to assume on behalf of CareFusion any other liability in connection with the sale or use of Alaris System products CAREFUSION DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANT
252. ntinued Prime Using Options Menu Continued 3 Press and hold PRIME soft key until fluid flows and priming is complete Fluid is delivered during priming only while PRIME soft key is pressed Each press of PRIME soft key delivers up to 2 mL of priming fluid per continuous press To deliver additional amounts press PRIME soft key again 4 Release PRIME soft key Volume used during priming is displayed but not added to VTBI or VI 5 Toreturn to main screen press EXIT soft key Use the following procedures to manually prime the ENBA administration set When priming Ensure that administration set is not connected to patient Ensure that air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequences Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the 2 16 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued Administration Set With Pressure Sensing Disc 1 2 Ensure that administration set is not connected to patient If installed remove pressure sensing disc from instrument Using a finger apply firm downward pressure on pressure sensing disc not tubing until disc snaps loose from slot in pressure sensing disc hous
253. ntry keys 2 Toenter volume to be infused for each dose press VOLUME DOSE soft key and use numeric data entry keys 3 Toenter time interval 1to 24 hours between doses press DOSE INTERVAL soft key and and use numeric data entry keys 4 Toenter number of doses press OF DOSES soft key and use numeric data entry keys If Delay Options is enabled DELAY OPTIONS soft key appears 5 To begin multidose infusion press START soft key Main Display shows remaining VTBI for that dose Atcompletion of a multidose program MULTIDOSE COMPLETE appears on Main Display 9 Alaris System User Manual with v9 17 Model 8015 Programming 2 75 Pump and Syringe Modules Section Multidose Mode Continued Volume Duration Disabled Continued 6 4 Syringe module Unclamp tubing and attach administration set to Unclamping tubing and starting infusion before i attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming 7 To see detail screen during or between infusions press CHANNEL SELECT key e During infusion Volume Remaining is displayed Between infusions o Number of doses completed and when next dose starts are displayed Yellow Standby Status Indicator illuminates NOTES See Delay Options procedure to program an infusion delay When delaying an infusion a multidose cannot be del
254. numeric data entry keys Second Nurse Summary Morphine 99000 PCA Dose Lockout Interval Cont Dose Max Limit Conc 1 mg mL 1 mg 10 minutes 2 mg h 8 mg4 n 00000 gt Press START Pause GRAN 3 20 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Set Loading Dose Only Continued 4 Verify correct dose value and then press CONFIRM soft key Loading dose is included in VTBI but is not included in Max Limit If the programmed parameters are outside the Soft Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed If the programmed parameters are outside the Hard Limit for that care area an audio alert sounds and a visual prompt appears before programming can continue Infusion must be reprogrammed If there is a potential for a programmed mL parameter to result in an excessive volume or dose being delivered following prompt appears Cannot proceed due to incorrect concentration or dosing parameters Remove syringe verify concentration and reprogram The prompt can be a the result of an incorrect drug amount and or diluent volume entry or b can occur if hospital established Guardrails limits are very wide Be sure to
255. nuous noninvasive monitoring of end tidal carbon dioxide EtCO gt fractional inspired carbon dioxide 2 and respiratory rate RR The 2 module and disposables are indicated for use with intubated and nonintubated adult pediatric and neonatal patients It is not intended for direct connection to ventilator or breathing systems Only one EtCO module can be connected to the Alaris System The EtCO module is used with Covidien s patented Microstream Disposables circuits for sidestream capnography Microstream Disposable See General Information for Microstream Disposable Information Alarms and Messages See Troubleshooting and Maintenance for module specific alarms and messages Contraindications None known Electromagnetic Environment See Appendix section of this User Manual Regulations and Standards Compliance Alaris System User Manual with v9 17 Model 8015 Getting Started 5 1 EtCO Module Section Connect Microstream Disposable 1 Open gas inlet outlet door by turning door counterclockwise until gas inlet is clearly visible Hold in open position Gas inlet is located on lower left corner of instrument and is marked with a gas inlet symbol 6 Closed Position 16 q LM Gas Inlet f Vi Open Position im 2 Connect Microstream Disposable ENJA a Press brightly colored end of disposable into gas inlet Use only Microstream b Tur
256. o silence alarm press SILENCE key Syringe module remains functional and continues infusion Syringe Not Recognized Possible End of Infusion Messages and Alerts Ini Syringe Module Delayed All Installed syringe of unknown type and size Select and confirm correct syringe type and size and then press CONFIRM or use a syringe type and size that system can automatically and correctly identify Alaris PC unit Display Syringe Empty Module Display Syringe Empty Audio Visual Alert Yes Yes All Syringe Empty Syringe Empty Yes Yes All Syringe Empty Syringe Empty Yes Yes Numeric Complete Infusion complete Yes Yes Numeric Syringe Empty Syringe Empty Yes Yes If an After callback is scheduled Numeric Complete Infusion complete Yes Yes Numeric Syringe Empty Syringe Empty Yes Yes Numeric Syringe Empty Syringe Empty Yes Yes Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Troubleshooting and Maintenance 2 129 Inspection Requirements To ensure that the Alaris System remains in good operating ENJA condition both regular and preventive maintenance inspections are required Refer to the System Maintenance software for Failure to perform these detailed instructions inspections can result in improper instrument operation REGULAR INSPECTIONS S A INSPEC
257. ode is automatically disabled currently running infusions continue A prompt appears as an alert that Anesthesia Mode has been discontinued 2 Press CONFIRM soft key Q Anesthesia mode was discontinued Q when AC power cord was Co disconnected Press CONFIRM to continue normal operation gt Press CONFIRM Alaris System User Manual with v9 17 Model 8015 1 19 PC Unit Section System Options Continued Battery Runtime 1 Press OPTIONS key 2 Press PAGE DOWN soft key 3 Press Battery Runtime soft key em Options 2 of 3 Q Battery Runtime System Configurations o Serial Numbers Q Software Versions o Time of Day gt Select an Option or EXIT PAGE PAGE UP EXIT DOWN 00000 4 Toreturn to main screen press CANCEL key or EXIT soft key System Options Estimated battery runtime at current operating parameters 9 5 hours 90000 66600 gt Press CANCEL or EXIT EXIT 0000 System Configurations 1 Press OPTIONS key 2 Press PAGE DOWN soft key 3 Press System Configuration soft key System Options 2 of 3 Battery Runtime Q System Configurations L9 Serial Numbers Software Versions o o Time of Day 00000 gt Select an Option or EXIT PAGE vel EXIT DOWN o 1 20 Alaris System User Manual with v9 17 Mod
258. odel 8015 Pump and Syringe Modules Section Configurable Settings Continued Syringe Module d Feature Default Setting Options ALL Mode Disabled Enabled Disabled Auto Pressure Disabled Enabled Disabled Back Off after occlusion Enabled Enabled Disabled Fast Start Enabled Enabled Disabled KVO Keep Vein Open Disabled Enabled Disabled Rate Adjust 1 mL h 0 01 2 5 mL h 0 01 0 09 mL h available for 1 mL and 3 mL syringes Volume Adjust 596 0 5 5 Based on the total syringe size not the volume of fluid in the syringe Max Rate 999 mL h 0 1 99 9 mL h in 0 1 mL h increments 100 999 mL h in 1 mL h increments Near End NEOI Disabled Enabled Disabled Alert Time 60 1 60 minutes or 2596 of remaining infusion time whichever comes later Occlusion Pressure Set Point With Disc 1000 mmHg 25 1000 mmHg in 1 mmHg increments NoDisc High Low 200 mmHg Medium 500 mmHg High 800 mmHg Priming Disabled Enabled Disabled NOTE Occlusion Pressure Point cannot be set higher than the default setting Alaris System User Manual with v9 17 Model 8015 General Information 2 107 Pump and Syringe Modules Section Specifications Pump Module 5 Accumulated Air Window Bolus Volume Maximum after Occlusion Critical Volume Dimensions Environmental Conditions Equipment Orientation L Single Bolus Volume Window Air th
259. of day in a 24 hour clock format military time Multidose Mode IE Since by definition a multidose infusion does not infuse for a programmed period of time it is assumed that another infusing IV line keeps the vein open until the beginning of the first dose and between subsequent doses There is no keep vein open KVO infusion at the completion of a programmed Delay until infusion 4 Syringe module ALL Mode is not supported in Multidose Mode Na lel Gee The Multidose feature is to be used only by personnel properly trained in using multidose infusions Caution labels which clearly differentiate single dose and multidose containers must be utilized Single dose piggybacking systems employing check valve sets are not designed for use with multidose 2 72 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Multidose Mode Continued The Delay Options function for multidose infusions is similar to Delay Options for continuous drug infusions with the following differences Delay for option when scheduling a callback is not available in Multidose Mode e Maximum allowable delay on a multidose infusion is 8 hours 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Multidose soft key S cranra Options o Guardrails Drugs Guardrails IV Fluids Q Multidose Lg Pressure Limit P 1 Channel Labels 00000
260. ogramming and starting a Bolus Dose deletes any programmed delay amp f no continuous rate is entered or if the Bolus Dose VTBI equals the Continuous Infusion VTBI the infusion ends when the bolus has been delivered No KVO infusion follows G To see details during the bolus infusion press the CHANNEL SELECT key The Pump module keypad is used in the illustration but the key is the same for the Syringe module 2 34 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Intermittent Infusion When using a drug listed in the Drug Library the drug parameters are automatically delivered based on drug selected e weight or body surface area BSA entry if required dose entry rate or duration dose entry e VTBI entry Syringe module The KVO option is disabled when an Intermittent Infusion is programmed 1 Press Guardrails Drugs soft key 2 Press soft key next to desired drug N ETSEEEETS To view additional drugs press a soft key next to a Q niosine letter group to navigate through alphabet and or PAGE etiopi O UP and PAGE DOWN soft keys din Eo P Cytarabine P T If applicable an optional hospital defined therapy or _Daunorbicin clinical indication for delivery of this infusion could appear Different limits can be defined for sam
261. on numbers in the area provided If the FCC identification number or country approval stamp is not easily visible the RF card cover may be removed so that the information provided can be read If the RF card cover is removed ensure that it is reattached using the screws that Alaris System User Manual with v9 17 Model 8015 Regulations and Standards A 15 Appendix Section Compliance Continued Electromagnetic Environment Continued Compact Flash Wireless Networking Module Continued were removed to ensure that the RF card is securely retained and protected against liquid ingress and damage The Class B digital device limits are designed to provide reasonable protection against harmful interference when the device is operated as intended This device generates uses and can radiate radio frequency energy If it is not installed and used in accordance with the applicable user manual it might cause harmful interference to radio communications Operation of this device in a residential area is likely to cause harmful interference in which case the user is required to correct the interference at their own expense There is however no guarantee that interference will not occur in a particular installation If the device does cause harmful interference to radio or television reception determined by powering system off and on one or more of the following corrective actions should be taken e Reorient or
262. on parameter entry and infusion setup Pause Key When pressed during an infusion temporarily stops infusion on that module After approximately 2 minutes a visual and audio prompt begins Channel module Off Key When pressed and held until a beep is heard stops infusion on that module deselects that module and if only that module had been operating system powers down Repeat for other operating modules to power off each module RATE mL h Gripper Control Drive Head Release shown in closed position a ale T Juss Plunger Grippers j shown in closed position H Barrel Flange A Gripper E Syringe Barrel CHANNEL SELECT G Sensor eu C Syringe Barrel H Clamp Sizer H Restart Key When JU o pressed resumes C operation of a previously paused or J P Jl alarmed infusion on that module Module Release Latch When pressed allows module to be removed Dose Request Cord Attachment Alaris System User Manual with v9 17 Model 8015 PCA Module Section General Information 3 55 Feature
263. on the specific Microstream Disposable The EtCO module provides readings in compliance with BTPS body temperature pressure saturation standards There is no affect on accuracy due to cyclic pressure up to 10 kPa NOTE BTPS body temperature pressure saturation assumed 37 C 47 mmHg calculations are made according to PCO FCO x Pb 47 Where is fractional concentration of CO in dry gas and CO4 100 Pb is ambient pressure PCO is partial pressure of CO at BTPS 5 26 General Information Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Troubleshooting and Maintenance eer oL Troubleshooting and maintenance are intended to be performed only by qualified personnel using the module Technical Service Manual and the System Maintenance software The Service Manual and System Maintenance software are available from CareFusion The Service Manual includes routine service schedules interconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instrument s repairable components The System Maintenance software is used to perform a new instrument check in preventive maintenance tests calibration checks calibration and other maintenance functions Alarms and Messages See the PC unit section of this User Manual for the followi
264. oncentration and reprogram The prompt can be a the result of an incorrect drug amount and or diluent volume entry or b can occur if hospital established Guardrails limits are very wide Be sure to enter either a drug amount per 1 mL or total drug amount per total volume for example a 30 mL syringe with a concentration of 1 mg 1 mL can be entered in one of two ways Alaris System User Manual with v9 17 Model 8015 Programming 3 23 PCA Module Section Infusion Modes Continued Set Bolus Dose Continued Drug Amount 1 mg Diluent Volume 1 mL OR Drug Amount 30 mg Diluent Volume 30 mL Ifa Soft Limit is overridden G icon is displayed When G soft key is pressed all applicable out of range limits are listed 6 If Authorization Code is disabled door must be locked before starting Bolus Dose 7 Verify correct dose value and then press START soft key Delivering Bolus scrolls in Channel Message Display Bolus and drug name alternate with VTBI in Main Display When Bolus Dose is complete BOLUS COMPLETE scrolls in Channel Message Display Programmed infusion resumes PCA Volume Check To reduce the instances of programming errors the PCA checks the total volume of all programmed PCA parameters against a percentage 35 of the capacity of the installed syringe A PCA infusion can only be started when the total programmed volume is less than 3596 of the syringe capacity The PCA volume check
265. onnector must be replaced before the instrument can be used again Failure to follow these instructions Inspect IUI Connectors may result in potential hazards If any surface contaminants or blue or green deposits are associated with damaged IUI visible the connector must be replaced connectors Figure 1 Male IUI Connector Figure 2 Male IUI Connector right side 1 Visually inspect the right side male IUI connector for cracks on the entire surface of the black colored plastic housing See Figures 1 and 2 for the male IUI inspection area and typical cracks 2 Visually inspect the left side female IUI connector for cracks on the edges of the black colored plastic housing 3 If cracks are found replace the IUI connector before use For IUI cleaning instructions Cleaning on page A 3 Alaris System User Manual with v9 17 Model 8015 1 53 PC Unit Section THIS PAGE INTENTIONALLY LEFT BLANK Alaris System User Manual with v9 17 Model 8015 PC Unit Section Alaris Pump Module Model 8100 Alaris Syringe Module Model 8110 Alaris System User Manual with v9 17 Model 8015 Section 2 THIS PAGE INTENTIONALLY LEFT BLANK Table of Contents Getting Started eec ae ea ct 2 1 Prepare
266. or Neonatal No Breath Alarm Adult 30 seconds Neonatal 20 seconds 10 60 seconds Alaris System User Manual with v9 17 Model 8015 General Information 5 19 EtCO Module Section Configurable Settings Continued Feature Default Setting Options Adult Mode 35 bpm Neonatal Mode 80 bpm Respiratory Rate Alarm Limit High 1 150 bpm Respiratory Rate Alarm Limit Low Adult Mode 6 bpm Neonatal Mode 12 bpm 0 149 bpm Specifications and Symbols Accuracy Alarm Limits Alarms Barometric Pressure CO Range EtCO readings CO Partial Pressure at sea level 0 38 mmHg Accuracy 2 mmHg 39 99 mmHg 5 of reading 0 08 for every 1 mmHg above 38 mmHg Above 55 C module temperature x1 mmHg or 2 596 whichever is greater has to be added to tolerance of accuracy specifications Respiration rate measured in range of 0 150 bpm with following accuracy 0 70 bpm 71 120 bpm 121 150 bpm EtCO9 1 bpm 2 bpm 3 bpm 0 98 mmHg 5 99 mmHg 2 Not Applicable 2 99 mmHg No Breath 10 60 sec Not Applicable Respiration Rate 0 149 breaths min 1 150 breaths min Audible and visual alarms for high and low and respiratory rate high FiCO9 Microstream Disposable condition system failure no breath and low battery conditions EtCO module is equipped with autom
267. osable to instrument HIGH ETCO2 EtCO value is above specified limit Assess patient condition Confirm correct alarm limit values are selected HIGH FICO2 FiCO value is above specified limit Assess patient condition Confirm correct alarm limit values are selected HIGH RR Respiratory rate is above specified limit Assess patient condition Confirm correct alarm limit values are selected LOW ETCO2 EtCO value is below specified limit Assess patient condition Confirm correct alarm limit values are selected 5 28 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 EtCOs Module Section Alarms and Messages Continued Alarms Continued High Priority Alarm Meaning Respiratory rate is below specified limit Response Assess patient condition Confirm correct alarm limit values are selected NO BREATH DETECTED Low Priority Alarm Disconnect Occluded Disposable No breath detected for a specified period of time Purging operation failed Messages Message Autozero in progress Meaning EtCO module performs a baseline by sampling CO present in ambient air Assess patient condition Check Microstream Disposable Confirm correct disposable is chosen and correct disposable placement Check Microstream Disposable Obtain a new Microstream Disposable Attach Microstream Disposable to patien
268. ough use of key or a 4 digit authorization code For security level information see Programming Infusion Modes Security Access Levels Four character code assigned to allow access to PC unit for setting Bolus Doses and subsequent programming changes Ability to use profile specific code is dependent upon configured Security Access Level Syringe Empty Instrument gives an alert and stops when an empty syringe is detected Syringe Volume Detection System automatically detects fluid volume in a syringe when it is inserted Alaris System User Manual with v9 17 Model 8015 General Information 3 53 PCA Module Section Features and Displays Continued Features and Definitions Continued Feature Definition Therapies An optional hospital defined therapy or clinical indication for delivery of that infusion Different Limits can be defined for same medication with different therapeutic indications Time Window h 1 2 or 4 hours 3 54 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Features and Displays Continued Operating Features Controls Indicators Security Lock Status Indicators Infusing green Alarm red Standby yellow IUI Connector Left Rate Display Message Display Channel module Identification Channel module Select Key When pressed selects corresponding module for infusi
269. ower Down All Channels gt Select an Option or EXIT 0000 00000 Alaris System User Manual with v9 17 Model 8015 1 17 PC Unit Section System Options Continued Anesthesia Mode Continued Enable Continued 3 Press Enable soft key System Options 4 Press CONFIRM soft key ao 715 Enable o lt Pump Module Air Detection Change 75 microliters gt Select an Option or Press CONFIRM Disable The Anesthesia Mode can be disabled and normal operation resumed using either of the following three methods e System Options menu Disconnecting from AC power Connecting to AC power From System Options Menu 1 Press OPTIONS key 2 Press Anesthesia Mode soft key 3 Press Disable soft key 4 Press CONFIRM soft key Anesthesia Mode no longer appears on Main Display indicating it has been disabled 1 18 Alaris System User Manual with v9 17 Model 8015 PC Unit Section System Options Continued Anesthesia Mode Continued Disable Continued Connect to AC Power 1 Connect system to AC power 2 To continue using Anesthesia Mode press Yes soft key OR To discontinue Anesthesia Mode press No soft key AC power cord wag connected Continue ANESTHESIA MODE 90000 gt Select Yes or No 0000 Disconnect from AC Power 1 Disconnect system from AC Anesthesia M
270. p procedures Alaris System User Manual with v9 17 Model 8015 General Setup and Operation 3 43 PCA Module Section THIS PAGE INTENTIONALLY LEFT BLANK 3 44 General Setup and Operation Alaris System User Manual with v9 17 Model 8015 PCA Module Section General Information Warnings and Cautions WARNING The PCA module is designed to stop fluid flow under alarm conditions Periodic patient monitoring must be performed to ensure that the infusion is proceeding as expected Itis a positive displacement delivery system capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice including resistances to flow imposed by small gauge catheters filters and intra arterial infusion It is neither designed nor intended to detect infiltrations and does not alarm under infiltration conditions The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site can impede the flow of common gravity only systems affecting their performance Hospital facility personnel must ensure that the performance of the common IV site is satisfactory under these circumstances Each time the Alaris System is turned on verify and or set the monitoring mode resistance alert and or pressure alarm limit If the monitoring mode resistance alert and or pressure alarm limit are not verified the instrument might not oper
271. pad see PC unit section of this User Manual NOTE There is a prompt to accept or decline the change of patient ID if it is different from the patient ID already associated to the PC unit While Infusion is in Progress To associate the PC unit with a patient ID when patient ID screen is not shown 1 Attach handheld scanner to connection port on Auto ID module Ensure a secure circuit connection The green READY indicator illuminates indicating the system is ready to scan 1st Generation Scanner Scan Trigger 2nd Generation Scanner CLASS 1 LED PRODUCT Do not stare into the beam or allow beam to strike patient s face Always verify that information displayed on the PC unit matches scanned data 6 4 Programming Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Patient Identification Continued New Patient Continued 2 To scan barcode on patient identification band press scan trigger on handheld scanner If scan is successful an audible tone sounds and patient ID appears on Main Display NOTE Patient ID can be entered manually using the PC unit keypad see PC unit section of this User Manual NOTE There is a prompt to accept or decline the change of patient ID if it is different from the patient ID already associated to the PC unit CLASS 1 LED PRODUCT Do not stare into the beam or allow b
272. pital NEW PATIENT 7 Yes Yes Clears Previous Patient Data No 99000 0000 gt Select Yes or No DISPLAY CONTRST 0000 Midtown Hospital Adult ICU accept current profile press Yes soft key Q aauit cu Yes Q Yes Confirms Same Main screen appears di Profile Tochange profile press No soft key and continue with Oo next step o Profile selection screen appears gt Select Yes or No 0000 1 8 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Start Up Continued Select New Patient and Profile Options Continued 3 To select a profile press corresponding left soft key To view additional choices press PAGE DOWN soft key 4 To confirm profile selection press CONFIRM soft key Main screen appears Patient ID Entry Feature The option to enter and display a 16 character alphanumeric patient identifier is always available The instrument can be configured to automatically display the Patient ID Entry screen during start up or to provide access only through the Systems Options menu see System Options If Yes was selected to indicate programming for a new patient perform one of following steps f patient identifier is not required press CONFIRM or EXIT soft key To manually enter patient identifier use numeric data entry keys and or alpha speed keys An alphanumeric i
273. r NDC Drug Amount Drug Amount Units Diluent Volume Secondary Infusion To start a secondary infusion while a primary infusion is in progress 1 To scan barcode on IV container press SCAN CANCEL CAUTIONS key on Alaris Auto ID module or scan trigger on handheld A scanner CLASS 1 LED PRODUCT Do not stare into the beam or allow beam The PC unit displays the scanned medication fluid to strike patient s face information Always verify that information 2 Press CHANNEL SELECT key on appropriate module displayed on the PC unit matches scanned data Primary infusion parameters display Press SECONDARY soft key gt Program secondary infusion see Pump module section of this User Manual Alaris System User Manual with v9 17 Model 8015 Programming 6 9 Auto ID Module Section THIS PAGE INTENTIONALLY LEFT BLANK 6 10 Programming Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section General Setup and Operation a SystemStartUp Setup System Start Up Setup See the PC unit section of this User Manual General Setup and Operation for various system start up and setup procedures Alaris System User Manual with v9 17 Model 8015 General Setup and Operation 6 11 Auto ID Module Section THIS PAGE INTENTIONALLY LEFT BLANK 6 12 General Setup and Operation Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section General Informatio
274. r continuous epidural administration and catheters intended specifically for epidural use Use only a Pump module Gemini Infusion System administration set or syringe set without a Y connector or injection port for epidural infusions Epidural administration of anesthetic drugs Use indwelling catheters specifically indicated for short term 96 hours or less anesthetic epidural drug delivery Epidural administration of analgesic drugs Use indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery Alaris System User Manual with v9 17 Model 8015 General Information 2 87 Pump and Syringe Modules Section Warnings and Cautions Continued Guardrails Suite MX The Guardrails Suite MX incorporates dosing limits and instrument configuration parameters based on hospital facility protocol The software adds a test of reasonableness to drug programming based on the limits defined by the hospital facility Qualified personnel must ensure that the appropriateness of drug dosing limits drug compatibility and instrument performance as part of the overall infusion Potential hazards include drug interactions inaccurate delivery rates and pressure alarms and nuisance alarms When loading a Data Set with the Guardrails Suite MX ensure that the correct profile for patient care area is selected prior to starting an infusion Failure to use the appropriate profile cou
275. r siiri ORB PERSE 4 8 Change SatSeconds Limit iiec rete aou ee sive A Eae dee adr e is 4 9 Change Saturation Averaging Time ssssssssssesseeeneeeene eene enne ener nennen 4 10 Change Sensitivity Mode eR eii cuti ede ta uode 4 10 General Setup and Operation System Start p Set p eit te tertie tita elei orti t Edda 4 13 General Information Warnings and Cautions fonti c doeet tede pide eine deret Deere AAA oes etude tend ea 4 15 Seti eral oe eoo ten teer dS ae rabie oe T ede 4 15 Sensors ANG Cables s 1x x ers edd decus 4 16 Cables and Sensors ico eee v recens laetus a 4 17 Nellcor Patient Cables and OxiMax 96 6 8 nemen nnm ener 4 17 Masimo Patient Cables and 86 5 5 4 17 Features and Displays onte te ro id d TAI RE ie 4 18 Features and Definitions ueteri er ser dist te Severe et bet eee Ee ed deve bue terea er 4 18 Operating Features Controls Indicators ssssssssssssssssesseeee enne 4 21 Display Siha a LT a A 4 22 Gonfigurable Settings esaa E AEO O O tie eh boo tet aue ds 4 23 Specifications a
276. ramming Parameters The PCA module uses the following programming parameters depending on infusion mode selected See General Information Features and Definitions for infusion mode definitions and features PCA Dose patient self administered dose Lockout Interval programmed time elapse between availability of PCA doses Continuous Dose basal rate dose Max Limit optional total amount of drug which can be infused over a specified time period Loading Dose optional Bolus Dose infused prior to initiation of PCA infusion Bolus Dose optional additional dose programmed after initiation of PCA infusion When the PC unit is in the Infusion Mode Selection Infusion Setup or Bolus Setup screens a patient dose request from the Dose Request Cord is handled as an unmet demand 3 12 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Set Up PCA Dose Only 1 Perform steps in Prepare Infusion 2 Press PCA Dose Only soft key from Infusion Mode Screen 3 enter PCA dose use numeric data entry keys 4 To enter lockout interval press LOCKOUT INTERVAL soft key and use numeric data entry keys 5 enter maximum limit press MAX LIMIT soft key and then Yes soft key If No is selected then no MAX LIMITS will be available for this infusion 6 Enter maximum limit using numeric data entry keys Time in hours associated with Max Li
277. ramming Parameters cde ecd eode t er eer d te cete d agile eden dee exe epu tesa 3 12 Set Up PCA Dose Only vinci ci ace ae ee a 3 13 Set Up Continuous Infusion 3 15 Set Up PCA Dose and Continuous Infusion ssssssssssssssssseeeeeeem ener 3 17 Set 3 20 Set Bolus Dose npa eda igi da ed deep 3 22 Stop a Loading PCA or Bolus Dose nieten i aa eene nnne 3 25 Change Programming Parameters During an Infusion sssssee en 3 26 View Patlent HISTON sataa onia nite em m dee rie em e d ed e metet Sn ae 3 27 Glear Patient HIStOry blc re ger 3 28 View Drug Event HIStory ne eoe ROO EO RE RU Go obe e Does 3 30 Configure Dose Request Cord ssssssssssssssssss eee eee en nennen enr nnne 3 30 Sec rity Access Levels rd tea a e due t asc diea dct det he 3 32 Disable Security Access Code one ene Lia ceed reed a uda cebat 3 32 Pause Inf sion 5 ier an s portet d be eas tm e tb d eet 3 33 Change Syringe and Restore Infusion sssssssssssssseeeenee eene eene enne 3 34 eminem M 3 35 Select Pressure Elit ii eu eee erit eset ee ua eee 3
278. rconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instrument s repairable components The System Maintenance software is used to perform a new instrument check in and preventive maintenance tests Alarms and Messages See the PC unit section of this user manual for the following system references Alarms Errors Messages Audio Characteristics Definitions Display Color Radio Frequency Note Definition Alarm Silence Alarms can be silenced for up to 120 seconds by pressing SILENCE key Alarm indicators remain on and alarm silence symbol is displayed Silence period can be ended by pressing CANCEL SILENCE soft key Models 8210 NELLCOR and 8220 Meaning Response Bad Sensor Broken unknown or nonsystem Check sensor and patient cable sensor or patient cable attached Confirm correct sensor and patient cable are chosen Alaris System User Manual with v9 17 Model 8015 Troubleshooting and Maintenance 4 29 SpO Module Section Alarms and Messages Continued Alarms Continued Models 8210 NELLCOR and 8220 Qs tl Check Sensor Electrical or Optical Interference Meaning External interference on sensor Response Check sensor Identify source of external interference if other than sensor High Pulse Rate Alarm High pulse rate alarm limit has been exceeded
279. re built up in set due to normal syringe loading and priming NOTES The facility can choose to prepopulate standard drug concentrations or leave a custom concentration mL and allow the clinician to enter the desired concentration Patient weight or BSA is not editable during an Intermittent Infusion G Once a patient weight or BSA is entered and the infusion started the patient weight or BSA is automatically entered for any additional weight based or BSA calculation Prior to the start of infusion the patient weight or BSA key remains an editable field so that patient weight or BSA can be adjusted for any module Changing the patient weight or BSA on one module will not affect the patient weight or BSA on any other NOTE It is possible to program an infusion with a rate that is displayed with two decimal places one hundredth of a mL per hour on the PC unit for the Pump module However due to space limitations on the Pump module rate display the rate is displayed to the nearest one tenth of a mL per hour on the Pump module This value is only used for display purposes and the Pump module is actually infusing at the more precise rate noted on the PC unit Alaris System User Manual with v9 17 Model 8015 Programming 2 39 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued IV Fluid Infusion 1 Press Guardrails IV Fluids soft key
280. re might be required to allow the pressure to stabilize following flow rate changes as required for the use of Auto Pressure Therefore caution should be used when using Auto Pressure for life sustaining fluids to prevent unexpected interruptions of infusion due to occlusion alarms f Auto Pressure is selected and current pressure is 100 mmHg or less system adds 30 mmHg to current pressure to create a new alarm limit greater than 100 mmHg system adds 30 to current pressure to create a new alarm limit 2 80 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Select Pressure Limit Continued Syringe Module Continued T Pressure Sensing Disc NOT Installed 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Pressure Limit soft key 4 To select a pressure limit press appropriate soft key 5 Press CONFIRM soft key channel Options 1 of 2 Q Guardrails Drugs Q Guardrails IV Fluids Pressure Limit High Prime Set with Syringe 00000 gt Select an Option or EXI T PAGE DOWN 000 99000 Pressure Limit Seleg Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 81 THIS PAGE INTENTIONALLY LEFT BLANK 2 82 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Ge
281. ream Disposable e The Microstream Disposables are designed for single patient use and are not to be reprocessed Do not attempt to disinfect or flush the disposable as the EtCO module can be damaged Microstream Disposable When selecting a Microstream Disposable consider the patient s weight condition and intubation status For more information on Microstream Disposables contact Covidien at http www covidien com rms or 1 800 635 5267 For a list of compatible disposables refer to the Sensor and Cable Compatibility Card provided separately 5 16 General Information Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Features and Displays Features and Definitions See the PC unit section of this User Manual for system features and definitions Feature Definition BPM Breaths per minute Capnography Waveform Real time graphical display of CO concentration throughout respiration Data Display Waveforms trended data and numerical values are displayed EtCO CO concentration in mmHg at end of exhalation FiCO Fractional inspired CO CO concentration present during inhalation Limit Mode Configurable mode that can be set to display either adult or neonatal monitoring mode See Configurable Settings for additional configurable features Microstream Disposable Covidien s line of Microstream Disposables are available for neonatal pediat
282. reduce the possibility of patient entanglement or strangulation Red alignment marks To attach Dose Request Cord Insert latching connector into Dose Request Cord attachment Red marking on latching connector should be aligned with red marking on Dose Request Cord receptacle Latching Connector Dose Request Cord receptacle To detach Dose Request Cord Hold body of latching connector and pull straight out without twisting or turning from Dose Request Cord receptacle 3 2 Getting Started Alaris System User Manual with v9 17 Model 8015 PCA Module Section Prepare and Load Syringe and Administration Set For instructions on how to go from checking in a PCA module to preparing it for an infusion setup see General Setup and Operation Prepare Syringe and Administration Set 1 Prepare syringe see General Information Compatible Syringes in accordance with manufacturer s User Manual 2 Prepare administration set in accordance with manufacturer s User Manual 3 Attach upper fitting of administration set to syringe tip Load Syringe and Administration Set Gwe PAN Use only standard or pre filled single use disposable syringes with luer lock connectors and nondedicated administration sets with integrated anti siphon valves designed for use on syringe type PCA pumps The use of any other syringe or administration set can cause improper instrument operation resulting in inacc
283. reless connection to access point is down due to wireless network changes Local interference PC unit has been moved outside the wireless coverage area Wireless network card has been damaged 9 If an interruption to the Alaris Systems Manager connection continues the facility s information technology department should be informed Alaris System User Manual with v9 17 Model 8015 1 45 PC Unit Section Alarms Errors Messages To enhance safety and ease of operation the Alaris System provides a full range of audio and visual alarms errors and messages Operating the system near equipment which radiates high energy radio frequencies such as electrosurgical cauterizing equipment portable radios cellular telephones might cause false alarm conditions If this happens reposition the Alaris System away from the source of interference or turn off the system and manually regulate the flow with the clamp and or monitor the vital parameters using an appropriate clinical alternative IB STO AVAL To o g If the option to have a color display is enabled color is used in the title and prompt bars to help communicate the following types of information Communication Description Normal Operation Blue All messages other than noted above normal operating displays Guardrails limit Yellow Visual message indicating a Limit was exceeded Informative Green Visual message requiring a response to clear mess
284. relocate receiving antenna e Increase separation distance between system and receiver Connect system into an outlet on a circuit different from that to which receiver is connected This Class B digital device meets the requirements of the Canadian Interference Causing Equipment Regulations Cet appareil num rique de la Classe B respecte toutes les exigences du Reglement sur le Mat riel Brouilleur du Canada This Class B digital device meets the requirements of the International community Australian Communications Authority C Tick mark N12875 Applicant CareFusion Australia 316 Pty LTD P O Box 355 Seven Hills West NSW Australia 2147 Phone 02 9838 0255 Fax 02 9674 4444 A 16 Regulations and Standards Alaris System User Manual with v9 17 Model 8015 Appendix Section Compliance Continued Standards The Alaris System has been assessed and complies with the following standards PC unit and overall System UL 60601 1 CAN CSA C22 2 No 601 1 M90 IEC 60601 1 Auto ID module IEC 60825 1 LEDs used in Auto ID module are not regulated by FDA in the United States however they are classified as a CLASS 1 LED PRODUCT in other countries under this standard Compact Flash Wireless Networking Module Class B digital device limits pursuant to Parts 15 RF Devices and Computing Devices and 18 Medical Devices of the FCC Rules and Regulations To comply with FCC and Industry Canada exposure requirements
285. remain in an upright position 2 112 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Specifications Continued Syringe Module Continued i E Flow rate range is from 0 01 to 999 mL h and can be selected as follows Flow Rates mL Selectable Increments mL h 0 01 9 99 0 01 Flow Rate Programming Fluid Ingress Protection Infusion Pressure Maximum KVO Keep Vein Open Rate KVO Selection Range Occlusion Alarm Thresholds Operating Principle 10 99 9 0 1 100 999 Rate Restriction by Syringe Size Syringe Size mL Flow Rate Range mL h 0 1 999 0 1 650 0 1 500 0 1 250 0 1 150 0 01 100 0 01 30 IPX1 Drip Proof Without Pressure Sensing Disc approximately 800 mmHg actual occlusion pressure varies based on syringe size and manufacturer With Pressure Sensing Disc 1060 mmHg Factory default setting is 1 mL h if set rate is 1 mL h or above or set rate if rate is 0 9 mL h or below KVO rate can be set in System Configuration in 0 01 mL h increments as follows 0 01 2 5 mL h 0 01 0 09 mL h available for 1 mL and 3 mL syringes Without Pressure Sensing Disc Three settings Low Medium High With Pressure Sensing Disc User selected 25 1000 mmHg in 1 mmHg increments Positive displacement Alaris System User Manual with v9 17 Model 8015 General Information
286. rged in a room with a temperature between 50 80 6 F 10 27 C to minimize charge time and maximize battery life Battery Charge The PC unit is shipped with the battery in a discharged condition Before the PC unit is released for use it should be plugged into a hospital grade AC outlet and the battery charged for at least 8 hours This ensures proper battery operation when the Alaris System is first set up for patient use Whenever possible leave the power cord connected to an external AC power source while operating the instrument Alaris System User Manual with v9 17 Model 8015 1 51 PC Unit Section Battery Care and Maintenance Continued Battery Care The battery capacity should be checked at least once every 12 months Refer to the Alaris System Technical Service Manual for test and replacement procedures If the PC unit is to be stored at temperatures in excess of 86 F 30 C for one or more months the battery should be removed and placed in an environment of 50 86 F 10 30 C If the batteries are to be stored for more than 1 year they should be charged at least once per year to prevent leakage and deterioration in performance due to self discharge When the battery is first being put into use or has been out of use for one or more months it will not have full capacity due to deactivation of reactants Restore such batteries to original performance by repeating one or two cycles of fully c
287. ric and adult patients Patients can be intubated or nonintubated Programmable Alarm Limits Alarm limits for EtCO FiCO respiration rates and No Breath time periods are programmable Respiratory Rate Patient s respiratory rate in breaths per minute breaths minute Trend Data Tabular display of EtCO and respiratory rate Display shows average high and low values and alarm conditions for time period displayed Up to 24 hours of data is stored Alaris System User Manual with v9 17 Model 8015 EtCO Module Section General Information 5 17 Features and Displays Continued Operating Features Controls Indicators Status Indicators Alarm Monitoring Standby red green yellow IUI Connector Left IUI Connector Right not visible 2 mmHg Display Respiratory Rate Display Channel module Message Display Channel module Identification Channel module Select Key When pressed selects corresponding module for patient monitoring setup Monitor Key When pressed begins patient monitoring Channel module Off Key When pressed and held until a beep is heard stops operation on that module deselects that module and if only that module had been operating system powers down Repeat for other operating modules to power off each module Protective Door Microstream Disposable Connector Gas Inlet Gas Exhaust Gas scavenging system co
288. ris System User Manual with v9 17 Model 8015 General Information 4 15 SpO Module Section Warnings and Cautions Continued Sensors and Cables Inspect the SpO sensor site regularly to ensure correct sensor positioning application and site integrity Tissue damage could occur over prolonged time periods depending on the patient profile such as neonates and method of application Refer to the sensor instructions for additional information Do not use a sensor cable or connector that appears damaged Do not use a sensor with exposed optical components The sensor disconnect error message and associated alarm indicate the sensor is either disconnected or the wiring is faulty Check the sensor connection and if necessary replace the sensor e Model 8210 Use only approved OxiMAX sensors and DOC 10 and OC 3 pulse oximetry cables Model 8220 Use only approved Masimo sensors and patient cables Use of sensors transducers cables and accessories other than those specified can cause improper 5 02 module performance resulting in inaccurate readings increased emission and or decreased immunity and degraded electromagnetic compatibility performance of the SpO module For a list of compatible sensors and cables refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com e Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation
289. rnings and Cautions Continued Administration Sets Continued Use only Pump module Gemini Infusion System administration sets with the Pump module The use of any other set can cause improper instrument operation resulting in an inaccurate fluid delivery or other potential hazard For a list of compatible sets refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com Use only standard single use disposable syringes with luer lock connectors and administration sets designed for use on syringe pumps The use of any other syringe or administration set can cause improper instrument operation resulting in an inaccurate fluid delivery or pressure sensing or other potential hazards Before loading or unloading the syringe always turn off fluid flow to the patient using the tubing clamp or stopcock Uncontrolled fluid flow can occur when the administration set is not clamped or turned off and can cause serious injury or death When the pressure sensing disc is not being used and an occlusion occurs there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion To avoid an inadvertent bolus relieve the pressure before restarting the infusion Ensure that the displayed syringe manufacturer and syringe size correctly identify the installed syringe Mismatches can cause an under infusion or over infusion to the patient that could result in serious
290. rocedures should be used only when the drug to be infused is not listed in the Drug Library When programming a drug not listed in the Drug Library the drug calculation must be programmed using the DRUG CALC soft key within the Drug Library There are no limits associated with any non library drug calculation The illustrations in this procedure assume e ALL Mode Syringe module Drug Calculation Dynamic Pressure Display Profiles and Volume Duration configurable settings are enabled e Syringe module and Delay Options configurable settings are disabled 2 52 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Infusion NO O Guardrails Suite MX Protection Continued If Delay Options is enabled the PAUSE soft key becomes DELAY OPTIONS 1 see PC unit section of this User Manual General Setup and Operation Start Up a Power on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required 2 Prepare and load syringe administration set see Getting Started 3 Prime see Getting Started 4 Start applicable infusion as described in following procedures Basic Infusion Continuous Infusion Drug Calculation Bolus Dose Basic Infusion The following procedure should be used only to set up a Basic Infusion To program an infusion using Guardrails Drugs see Pri
291. rols Indicators An advisory tone if Key Click Audio is enabled and a three second PANEL LOCKED prompt on Main Display confirm activation Midtown Hospital Adult ICU 90000 A VTBI 250 0 mL GAG VOLUME INFUSED 00000 f caution JAN Setting the audio volume to the lowest level will lower all system alarms including secondary alarms such as End of Infusion Q o o 43 Audio Volume Adj 3 9 z gt Change Setting or Cancel MAIN SCREEN o 6 9 Midtown Hospital Adult ICU 99000 A VTBI 250 0 mL 3 c D 00000 PANEL LOCKED VOLUME AUDIO INFUSED ADJUST 0000 1 10 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Start Up Continued Lock Unlock Tamper Resist Continued When Tamper Resist is active keypad panel is locked however clinician can Silence audio alarm o View volume s infused View and test audio alarm setting o View selected parameters on attached modules Any other key press results in a visual PANEL LOCKED prompt and if Key Click Audio is enabled an illegal key press audio advisory p To unlock keypad panel press and hold Tamper Resist Switch for 3 to 4 seconds An advisory tone if Key Click Audio is enabled and a Vic Hospi three second PANEL UNLOCKED prompt on Main Display Adult ICU confirm activ
292. rs The majority of user interface programming is identical for both the Pump module and Syringe module When referring to both modules the term infusion modules is used The following procedures are to be used only when the drug A to be infused is listed in the Drug Library To access the Drug WARNING VAMC Library a hospital defined best practice Data Set must be transferred to the Alaris System and the Profile feature must be disc is not being used and an enabled occlusion occurs thereisa risk of infusing pressurized E When the pressure sensing 4 1 Perform following steps see PC unit section of this General Setup and Operation Start Up buildup of infusates upon correction of the occlusion To a Poweron system avoid an inadvertent bolus relieve b Choose Yes or No to New Patient the pressure before restarting the infusion c Confirm current profile or select a new profile d Enter patient identifier if required 2 Prepare and load syringe administration set see Getting Started 3 Prime see Getting Started Alaris System User Manual with v9 17 Model 8015 Programming 2 19 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued 4 Press CHANNEL SELECT key 5 4 Syringe module Select syringe type and size as follows otherwise proceed to step 6 9 a Press soft key next to installed syringe type and size If a
293. ructions including those for the attached module s and applicable accessories before using the Alaris System f caution R Ony Alaris System User Manual with v9 17 Model 8015 PC Unit Section Introduction Continued Alarms Errors Messages See Troubleshooting and Maintenance for specific PC unit alarms errors and messages Contraindications None known Electromagnetic Environment See Appendix section of this User Manual Regulations and Standards Compliance 1 2 Alaris System User Manual with v9 17 Model 8015 PC Unit Section General Setup and Operation P Attach and Detach Module Attach and Detach Module Modules can be attached to either side of the PC unit or to either side of another module The process to attach or detach is the same for either side whether attaching detaching to from a PC unit or another module An individual hospital facility can choose to permanently attach modules To remove permanently attached modules contact qualified service personnel Attach Module The Alaris System is designed to operate a maximum of four infusion or monitoring modules Modules added in excess of four are not recognized by the system The Auto ID module can be included as a fifth module A module can be attached in any position however when mounted on an IV pole it is recommended that a balanced configuration be maintained Application of adhesive tape or other materials to
294. rug is not weight based Not Used is displayed in PATIENT WEIGHT field If hospital facility practice guidelines identify selected Alteplase drug as weight based prompt for a patient weight in QES 100mg 9 kilograms appears as in illustrated example which ss 4004 reflects use of Alteplase 9 o E 9 Q UNIS hour 9 OQ WS mgkgh Conc 1 mg mL gt Enter Patient Weight 0000 4 Verify correct parameters and press NEXT soft key to confirm 2 24 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Continuous Infusion Continued 5 An optional hospital defined and editable starting value for Continuous Infusion dose might already be entered OR To make a rate or dose entry press applicable soft key n RATE or DOSE and use numeric data entry keys other value is calculated and displayed UR Conc 1 mg mL gt Select Rate or Dose 00000 SETUP BOLUS 0000 6 enter volume to be infused press VTBI soft key and Afeplase enter value Q continuous iwrusios Q Pump module a RATE 56 7 mun O Im When VTBI is less than 10 mL h entry can be to be i two decimal places one hundredth of a mL 0 gt n Drug Calculation mode system infuses at RU calculated rate rounded to nearest one hundredth Gi NE of a mL per
295. rvice Manual and the System Maintenance software The Service Manual and System Maintenance software are available from CareFusion The Service Manual includes routine service schedules interconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instrument s repairable components The System Maintenance software is used to perform a new instrument check in preventive maintenance tests calibration checks calibration and other maintenance functions Artifacts It is normal for an infusion device to produce nonhazardous currents when infusing electrolytes These currents vary proportionally to the infusion device flow rate When an ECG monitoring system is not functioning under optimal conditions these currents might appear as artifacts simulating actual ECG readings To determine if abnormalities are caused by patient condition or the ECG equipment place the infusion device on hold If the ECG readings become normal the ECG equipment requires attention Proper setup of the ECG equipment should eliminate these artifacts Refer to the appropriate ECG monitoring system documentation for instructions on setup and maintenance Alarms Errors Messages See the PC unit section of this User Manual for the following system references Alarms Errors Messages Audio Characteristics Definitions Display Color R
296. s System User Manual with v9 17 Model 8015 2 i Pump and Syringe Modules Section General Setup and Operation System Start Up Setup ssssssssssssssssssssseseeernre enhn enne n nenne rerr trn ns ness n nenne tenter seni neis nne 2 83 Set Up for Gravity Infusion Pump Module sse nemen 2 83 Change Solution Container Pump Module sse 2 83 Change Syringe During Infusion Syringe Module see 2 84 General Information Warnings and Gautioris intr E d dte t dte ED ene 2 85 Generale tee E tellure Meet ceca Lege Stel ea eei aede ext oe hd ee 2 85 Administration Sets 1 idee ted o de dat tte e edad tete o de n ta 2 85 Epidural Administration eoe eei oe ead eae seals ce epi e eee ale adda 2 87 Guardrails Suite MX sisi itr bo e PO Le dtd b d o FO P Re Pee ete acd 2 88 Administration Set Syringe Information enne nennen eene 2 88 SmartSite Infusion Set Pump Module sssssssseeeeeene eene nens 2 89 Safety Clamp Fitment Pump 2 90 Compatible Syringes Syringe Module sse eene 2 91 Interoperability ieina iniaiaiai iiaia a einai 2 92 Features and Displays rte itr tee rr prt epe red E ERR eR 2 93 Features and Definitions
297. s see Safety Clamp Fitment 4 The Syringe module uses standard single use disposable syringes with luer lock connectors and 1 administration sets designed for use on syringe pumps Fora list of compatible syringes see Compatible Syringes SmartSite Infusion Set Pump Module le 7 1 Prior to every access swab top of Needle Free Valve port M CAUTION AN with 70 isopropyl alcohol a 2 seconds and allow to dry approximately 30 seconds If the Needle Free Valve is accessed by a needle in an emergency the valve will be damaged causing leakage 2 Prime valve port If applicable attach syringe to Needle Free Valve port and aspirate miniscule air bubbles 3 Replace every 72 hours or after 100 activations whichever Replace the Needle Free Valve occurs first For infusions of blood blood products or lipid immediately emulsions replace every 24 hours The Needle Free Valve is contraindicated for blunt cannula NOTE systems Dry time is dependent on area temperature humidity and Donotleave slip luer syringes ventilation Alaris System User Manual with v9 17 Model 8015 General Information 2 89 Pump and Syringe Modules Section Administration Set Syringe Information Continued Safety Clamp Fitment Pump Module 5 The primary administration set s safety clamp fitment is L a unique clamping device on the pumping segment that prevents inadvertent free flow when the administration
298. s and Displays Continued The displays illustrated throughout this document are for illustration purposes only The display content varies depending on configuration settings type of administration set in use hospital defined Data Set uploaded using the Guardrails Suite MX programmed drug calculation parameters and many other variables Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages Configurable Settings See the PC unit section of this User Manual for system configurable settings The configuration settings are selected during Data Set development and then uploaded to the Alaris System as part of the data With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice Data Set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles Feature Default Setting Options Authorization Code None 4 digits 0 9 One code applies to all profiles Bolus Delivery Rate 150 mL h 75 500 mL h limited by syringe size Bolus Dose Disabled Enabled Disabled Bolus Dose include in Max Limit Disabled Enabled Disabled Dose Request Cord Configuration Profile 2 Profile 1 2 3 Forced Module Location Enabled Enabled Disabled Loading Dose Disabled Enabled Disabled Lockout Interval 1 99 minutes in 1 minute Min Max 1
299. s can result in improper instrument operation f caution N Preventive maintenance inspections should only be performed by qualified service personnel WARNING Failure to follow these instructions may result in potential hazards associated with damaged IUI connectors Alaris System User Manual with v9 17 Model 8015 SpO Module Section Troubleshooting and Maintenance 4 33 THIS PAGE INTENTIONALLY LEFT BLANK 4 34 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 SpO Module Section Alaris EtCO Module Model 8300 EE udi ALARM TANDBY EN EtCO mm Hg RR breaths min 4 A Wu E EL SELECT Alaris System User Manual with v9 17 Model 8015 Section 5 THIS PAGE INTENTIONALLY LEFT BLANK Table of Contents Getting Started Introduction aee eia ee i anaiai aa ee a aada a ae viet a 5 1 Connect Microstream Disposable ssssssssssssesseeeneeeeneem ener nnne nnne n nennen nrnna nnen 5 2 Attach Gas Scavenging System sssssssssssssssseseeeee nennen enne nennen nennen nnne nnns 5 4 Programming Monitoring Mode 2 natin nae E RD OE REESE hates i pU ERE E OA 5 5 ISTAM a 5 6 Navigate Trend Data ocn e cede coeptae e eret Biter eatin dah tend 5 7 Navigate PCA Alaris EtCO ModuleTrend Data 0 cec
300. s scanned cannot support scanned infusion select a channel with a primary infusion that supports the secondary If primary infusion was scanned select an idle channel to program Patient ID will be changed The Patient ID is not the same If the Patient ID associated to the Patient ID that is currently PC unit should be changed press associated with the device Yes If the Patient ID associated to the PC unit should not be changed press No Inspection Requirements To ensure that the system remains in good operating condition ENBA both regular and preventive maintenance inspections are required Refer to the System Maintenance software for Failure to perform these detailed instructions inspections can result in improper instrument operation REGULAR INSPECTIONS CAUTION JAN INSPECT FOR DAMAGE Exterior Surfaces Each usage Preventive maintenance IUI Connector Each usage inspections should only be Keypad Each usage performed by qualified service Mechanical Parts Eachusage personnel CLEANING As required START UP Each usage 6 20 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Inspection Requirements Continued NOTE While visually inspecting the IUI connectors look for fractures on the connectors black colored plastic If you see any damage do not use an instrument with fractured IUI connectors The IUI connector mus
301. s time periods over which fluid delivery is measured trumpet curves Delay in onset of fluid flow when infusion commences start up curves Trumpet curves are named for their characteristic shape They display discrete accuracy data averaged over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effect as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows might be of interest when certain drugs are being administered Because the clinical impact of short term fluctuations on rate accuracy depends on the half life of the drug being infused and on the degree of intravascular integration the clinical effect cannot be determined from the trumpet curves alone Knowledge of the start up characteristics should also be considered The start up curves represent continuous flow rate versus operating time for 2 hours from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data Pump Module lm Effects of Pressure Variations Lbs Under conditions of 100 mmHg pressure the Pump module
302. sc is in use it should be removed from the instrument before priming See the applicable procedure as follows depending on whether or not a pressure sensing disc is used WARNING When priming Ensure that administration set is not connected to patient Ensure that air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequences Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the IET JAN During priming the pressure limit alarms are temporarily increased to their maximum level Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Getting Started 2 11 Prepare Syringe and Administration Set Syringe Module Continued Prime Using Options Menu Continued Administration Set With Pressure Sensing Disc 1 Ensure that administration set is not connected to patient 2 If installed remove pressure sensing disc from instrument Using a finger apply firm downward pressure on pressure sensing disc not tubing until disc snaps loose from slot in pressure sensing disc housing 3 Press OPTIONS key 4 Press Prime Set with Syringe soft key f caution JAN The pressure sensing disc if left installed during priming can trap air that might not be totally expelled To ensure
303. scribed in following procedures Set Up PCA Dose Only Set Up Continuous Infusion Only Set Up PCA Dose Continuous Infusion Set Loading Dose Only 90000 90000 Clinical Advisory Attach an SpO2 or EtCO2 module now The drug selected will activate the PCA Pause Protocol once a monitoring device is operating 00000 gt Press CONFIRM exif nen 9 9 PCA Pause Limits should be reviewed Press PAUSE LIMITS to review the current settings Press CONFIRM to continue programming the PCA infusion 00000 gt Press CONFIRM PAUSE LIMITS 9 9 3 38 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Review or Change PCA Pause Alarm Limits 1 From Main Display press CHANNEL SELECT 2 3 4 Guardrails PCA Pause Protocol Feature Continued Program an Infusion Continued NOTES To review PCA pause limits see Review or Change PCA Pause Alarm Limits Q Once the START soft key is pressed the Main Display screen alternates between volume remaining VTBI Volume to be Infused and PCA drug name with the infusion code The Main Display displays PCA Pause Protocol ON If Patient ID is entered Patient ID alternates with PCA Pause Protocol ON Press OPTIONS key Press PCA Pause Limits soft key Verify that PCA pause limits as per facility protocol or physicia
304. se Request Setup Q Drug Event History gt Select an Option or EXIT PAGE EXIT DOWN 00000 4 To scroll through history press PAGE DOWN soft key o _ 2003 06 10 DRUG EVENT i o 5 Toreturn to Main Display press EXIT soft key c CONI Cor A 08 38 Unmet demands 500 o 07 08 Continuous 2 mg h I O 07 08 PCA Cont infusion 08 08 New syringe o 06 0 Bolus Dose stopped o 06 08 Bolus Dose 1mg 06 00 History cleared gt Press PAGE DOWALA NOTE The Drug Event History stores approximately 12 hours of events and is automatically cleared upon selection of New Patient Yes during start up or upon changing drug in Drug Library Configure Dose Request Cord The Dose Request Cord can be configured to provide both audio and visual prompts to the patient Visual prompts are provided through the LED indicator on the Dose Request Cord Default configuration for the Dose Request Cord is established in the system configuration To change Dose Request Cord configuration 1 Press CHANNEL SELECT key 3 30 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Configure Dose Request Cord Continued 2 From Main Display press OPTIONS key 3 Press DOSE REQUEST SETUP soft key UENIT PCA Pause Limits Q o Infusion Modes Dose Request Setup 00000 Drug Event Histor
305. secondary line is level with the fluid in the primary container NOTE When primary sets are used without a check value set the clinician must manually clamp off the primary line during the secondary infusion 1 Open secondary administration set package remove set and close clamp 2 Insert administration set spike into prepared fluid container and hang secondary container following accepted hospital facility procedure 3 Fill drip chamber to full 4 Open secondary administration set clamp and prime set Close clamp 5 Attach secondary administration set to upper injection site on primary set 6 Using hanger provided with secondary administration set lower primary fluid container to height indicated in following illustrations Automatic secondary applications require the use of a check valve set on the primary IV line The secondary administration set must be primed prior to beginning the secondary infusion WARNING The secondary solution container must be higher than the primary solution container 2 46 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Secondary Infusion With Guardrails Suite MX Protection E Pump Module Continued J Setup Continued Hanger A A Secondary Container 7 A x Secondary Container ND i Mini Bag GA 4 Bottle Primary atleast 914 A Container
306. select and confirm the syringe type and size The system automatically detects the syringe size and lists syringe types and sizes that most closely match the installed syringe If the syringe is not recognized Syringe not recognized is displayed NOTE It is possible to program an infusion with a rate that is displayed with two decimal places one hundredth of a mL per hour on the PC unit for the Pump module However due to space limitations on the Pump module rate display the rate is displayed to the nearest one tenth of a mL per hour on the Pump module This value is only used for display purposes and the Pump module is actually infusing at the more precise rate noted on the PC unit Continuous Infusion When using a drug listed in the Drug Library the drug parameters are automatically calculated based on drug selected weight entry if required rate or dose entry e entry Syringe module if other than All Alaris System User Manual with v9 17 Model 8015 Programming 2 21 Pump and Syringe Modules Section Continuous Infusion Continued 1 Press Guardrails Drugs soft key Basic infusion 00000 gt Select an Option or EXIT 0000 2 Press soft key next to desired drug Guardrails Drugs To view additional drugs concentrations press a soft o ARIES key next to a letter group to navigate through alphabet Q AmiopArone O an
307. shes until audio is silenced Infusion completed message appears on Main Display Infusion Complete scrolls in Message Display f Before and After option was selected same prompts and indicators mentioned above for both Before and After options are exhibited 4 To respond to a callback Before callback Press CHANNEL SELECT key and then START soft key OR Press RESTART key After callback Press CONFIRM soft key Before and After callback Respond as indicated above for both Before and After Pause Infusion 1 Press DELAY OPTIONS soft key 2 Press Pause soft key o meDelay Options 09 30 Ifan alert has occurred pause is not initiated by system qg 5 p until alert is addressed Delay for Q belay until o gt Select a Delay Option 0000 Alaris System User Manual with v9 17 Model 8015 Programming 2 71 Pump and Syringe Modules Section Delay Options Continued Pause Infusion Continued 3 Press CONFIRM soft key PAUSE scrolls in Message Display PAUSED appears on Main Display e Yellow Standby Status Indicator illuminates After 2 minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status Indicator flashes 4 Toreinitiate infusion Press RESTART key OR Press CHANNEL SELECT key and then START soft key NOTE The time displayed in the upper right corner of the screen is the time
308. splay QO v ro Q cc E 9 Q c 9 Q 0 Q white u z Q gt Select Channel Label 6 To begin infusion press START soft key OR Program infusion as previously described Anesthesia Mode 7 B See the PC unit section of this User Manual Delay Options Delay Options can be enabled at the time the Alaris System is configured for use If Delay Options is enabled a primary infusion can be programmed to be delayed for a specified period of time and a callback can be scheduled as described in the following procedures Since by definition an infusion with Delay Options infuses for a programmed period of time it is assumed that another infusing IV line keeps the vein open until the delayed infusion begins When a delay is programmed the infusion stops when complete and no KVO is delivered 2 66 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Delay Options Continued Delay Infusion The delay period for an infusion can be programmed as a specific number of minutes or a time of day as described in the following procedures An infusion delay can be programmed prior to or after an infusion is initiated Specify by Minutes The Delay for option is used to program an infusion delay for a minimum of 1 minute and up to 120 minutes 1 Press DELAY OPTIONS soft key A J infusion Setup RA
309. ss DISPLAY CONTRST soft key MAINTENANCE REMINDER 90000 Module s due for routine preventive maintenance Module A YYYY MM DD 000 oo CONFIRM 0000 MAINTENANCE REMINDER 90000 Module s due for routine preventive maintenance 00000 CONFIRM 9 9 Midtown Hospital NEW PATIENT Yes Yes Clears Previous Patient Data No 99000 00000 gt Select Yes or No DISPLAY CONTRST Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 7 Start Up Continued Adjust Display Contrast Continued 2 To adjust display for optimum viewing use Lighter Darker soft keys 3 Toreturn to main screen press CONFIRM soft key Select New Patient and Profile Options The following procedures assume the Profiles feature is enabled 1 Select required NEW PATIENT option e indicate programming is for a new patient and clear all stored patient parameters from memory press Yes soft key confirm programming is for same patient and retain all stored patient parameters press No soft key Last used profile is displayed o Jf Profiles feature is disabled main menu appears 2 Acceptor change current profile o 9000 System Options Display Contras Lighter Darker gt Adjust Display to Midtown Hos
310. ssure sensing disc up into slot in Slot in Pressure pressure sensing disc housing Sensing Disc Housing 1 Pressure LORS Sensing Disc d oo Patient Side 2 14 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued Prime Using Options Menu Continued Administration Set With Pressure Sensing Disc Continued c Apply firm upward pressure on pressure sensing disc not tubing until disc snaps into place 12 To return to main screen press EXIT soft key If EXIT soft key is pressed before pressure sensing disc is reinstalled a prompt to reinstall pressure sensing disc is displayed Administration Set With No Pressure Sensing Disc 1 Press OPTIONS key 2 Press Prime Set with Syringe soft key o o o Pressure Sensing Disc Re install Pressure Sensing Disc 00000 gt Press CONFIRM CONFIRM 0000 EQ channel Options 1 of 2 Guardrails Drugs Guardrails IV Fluids Multidose Pre Limit 550 mmHg Prime Set with Syringe 00000 gt Select an Option or EXIT 0000 Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Getting Started 2 15 Prepare Syringe and Administration Set Syringe Module Co
311. st when certain drugs are being Measurements for trumpet curve rates above administered 5 0 mL h are also not provided as the syringe volume is displaced in a very short time with a rate up to 999 mL h Accuracy however is assured with the design implementation Because the clinical impact of short term fluctuations on rate accuracy depends on the half life of the drug be ing infused and on the degree of intravascular integration the clinical effect cannot be determined from the trumpet curves alone Knowledge of the start up characteristics should also be considered Alaris System User Manual with v9 17 Model 8015 General Information 3 61 PCA Module Section Trumpet and Start Up Curves Continued The start up curves represent continuous flow rate versus operating time for two hours from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data Under conditions of 100 mmHg 100 mmHg and 300 mmHg pressures the PCA module typically exhibits a long term accuracy offset of approximately 0 296 or less from the mean value 3 62 General Information Alaris System User Manual with v9 17 Model 8015 PCA Module Section Trumpet and Start Up Curves Continued 0 20 mode Start up at 0 1 mL h initial 0 18 4 0 16 4 0 14 4 os ib att 008
312. start up delays when infusing at a rate less than 1 0 mL h the following actions are recommended WARNING PAN Enable Fast Start with Data Set development of System Use only standard single use Configuration per profile disposable syringes with luer lock connectors and administration sets designed for use on syringe pumps The use of any other syringe or Prime Syringe module as well as administration set see administration set can cause Prime Using Options Menu improper instrument operation resulting in inaccurate fluid delivery or pressure sensing or other potential hazards Use smallest syringe size possible for example if infusing 7 2 mL of fluid use a 10 mL syringe For instructions on how to go from checking in a Syringe module to preparing it for an infusion setup including how to change a syringe during infusion see General Setup and Operation 1 Prepare syringe see General Information Compatible Syringes in accordance with manufacturer s User Manual 2 Prepare administration set in accordance with manufacturer s User Manual 3 Attach upper fitting of administration set to syringe tip NOTE Fora list of compatible syringes see Compatible Syringes For a list of compatible administration sets refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com 2 6 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and S
313. stem User Manual with v9 17 Model 8015 PC Unit Section Getting Started troduction o Introduction This section of the User Manual provides PC unit Model 8015 and Alaris System instructions and information It is used in conjunction with PC Unit Pump Module Technical Service Manual Product specific sections of this User Manual e System Maintenance software and its instructions for Alaris System check in maintenance and wireless configuration The PC unit is the core of the Alaris System and provides a common user interface for programming infusions and monitoring which helps to reduce complexity at the point of care The display uses color to clearly communicate critical programming infusion monitoring and hospital defined policy information The wireless network card provides wireless communication capability between the Alaris System and Alaris Systems Manager The combined use of the Alaris System and Alaris Systems Manager is integrated into a facility s existing network infrastructure When enabled the Alaris Systems Manager allows the exchange of information between the Alaris Systems Manager and the Alaris System The PC unit can be operated manually or in concert with the information exchanged with the Alaris Systems Manager If communication with the wireless network is interrupted for example out of range the Alaris System can be used as intended in the manual mode WARNING PAN Read all inst
314. t inadvertent free flow when administration set is removed from instrument KVO Rate Adjust Used to select KVO Keep Vein Open rate 0 1 to 20 mL h allowed which is rate of fluid flow after an Infusion Complete occurs KVO rate never exceeds infusion rate Occlusion Pressure A complete range of downstream occlusion detection options is provided Pump mode Downstream occlusion alarm threshold is 525 mmHg at flow rates of 30 mL h or greater For rates less than 30 mL h occlusion pressure is rate dependent to ensure rapid response to occlusions Selectable pressure mode Downstream occlusion alarm threshold can be adjusted in 25 mmHg increments from 50 mmHg up to maximum occlusion pressure of 525 mmHg Auto Restart See Auto Restart definition In addition Alaris System provides fluid side occlusion detection Secondary Infusions Dual rate sequential piggyback secondary infusions can be infused with limits at delivery rates and volumes independent of primary infusion parameters Automatic changeover occurs to primary infusion parameters when secondary infusion is complete if an Pump module Gemini Infusion System check valve administration set is used 2 96 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Features and Displays Continued Features and Definitions Continued Feature All Mode Definition Syringe Module When ALL is selecte
315. t system is connected to Speed transfer rate up to 54 Mbps for 802 11a g and 11 Mbps for 802 11b o Link Quality a minimum of 20 recommended for good wireless connectivity Signal Strength greater than 20 recommended for good wireless connectivity 5 To view network connectivity information press NET STATUS soft key Co Wireless Status o A status of DISABLED DISCONNECTED Q iso Auswerroox O CONFIGURING INVALID CONFIG or CONNECTED is gt displayed Eepo EE O If status is CONNECTED oO zO PC unit is connected to wireless network CS a Profile being used is displayed EE 1 26 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Network Status Continued 6 7 System Options Continued To view network address information press NET ADDRESS soft key MAC Address of wireless RF card attached to PC unit is displayed f DHCP displays NO PC unit is set to use a Static IP address When PC unit is connected to wireless network IP Address Subnet Mask Gateway and DNS information is displayed To view server connectivity information press SERVER STATUS soft key System Opti ons Status Uptime 990 O Bytes Sent Bytes Recv Network Status CONNECTED 03 45 35 13 890 1 200 150 00000 gt Press CANCEL to Exit WIRELESS STATUS Pre v9 5 PC unit
316. t and module Response Wait for instrument to complete its auto zeroing function After auto zero cycle is complete instrument begins measurement again No user intervention is required Clearing Disposable Microstream Disposable blocked Check Microstream Disposable Wait for purging to complete Disposable Disconnected No Microstream Disposable present and instrument not in monitoring mode Attach Microstream Disposable to patient and instrument to begin monitoring Patient Not Detected Monitor or Channel Select key pressed and patient not detected Assess patient condition Check disposable Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Troubleshooting and Maintenance 5 29 Inspection Requirements To ensure that the Alaris System remains in good operating condition both regular and preventive maintenance inspections are required Refer to the System Maintenance software for detailed instructions REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECT FOR DAMAGE Exterior Surfaces Eachusage UI Connector Eachusage Keypad Eachusage CLEANING As required START UP Each usage NOTE While visually inspecting the IUI connectors look for fractures on the connectors black colored plastic If you see any damage do not use an instrument with fractured IUI connectors The IUI connector must be replaced before the instrument c
317. t be replaced before the instrument can be used again Inspect IUI Connectors If any surface contaminants or blue or green deposits are EENIA visible the connector must be replaced Failure to follow these instructions may result in potential hazards associated with damaged IUI connectors Figure 1 Male IUI Connector Figure 2 Male IUI Connector right side 1 Visually inspect the right side male IUI connector for cracks on the entire surface of the black colored plastic housing See Figures 1 and 2 for the male IUI inspection area and typical cracks 2 Visually inspect the left side female IUI connector for cracks on the edges of the black colored plastic housing 3 If cracks are found replace the IUI connector before use For IUI cleaning instructions see the Cleaning Section in Appendix A Alaris System User Manual with v9 17 Model 8015 Troubleshooting and Maintenance 6 21 Auto ID Module Section THIS PAGE INTENTIONALLY LEFT BLANK 6 22 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 Auto ID Module Section Appendix Maintenance Regulations and Standards Alaris System User Manual with v9 17 Model 8015 Section THIS PAGE INTENTIONALLY LEFT BLANK Cleaning Maintenance Inspect and clean the product per the following procedures Read all warnings and cautions before continuing with this procedure Alaris System Clean
318. t restoring a Bolus Dose which was programmed using the Drug Library Even where the displays are different when restoring a Bolus Dose which was programmed using a non library drug the procedure is the same 1 Bolus Dose completed module not turned off a Press CHANNEL SELECT key b Verify infusion parameters and press BOLUS soft key 55 Stroke Stop Bolus and S Cs OD Continuous infusio 99090 000d gt Press Yes or No 000 Granned ARS PAUSE f l Il RESTART NE ee JJ i Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 33 Primary Infusion With Guardrails Suite MX Protection Continued Bolus Dose Continued Restore Bolus Dose Continued c Press RESTORE soft key d Verify dosing parameters and press START soft key 2 Bolus Dose completed module turned off Press CHANNEL SELECT key Press RESTORE soft key Verify parameters and press NEXT soft key Verify infusion parameters and press BOLUS soft key Press RESTORE soft key Verify dosing parameters and press START soft key 0oo0o0c9 NOTES Ifthe Bolus Dose feature is enabled the BOLUS soft key appears in the Continuous Infusion screen and becomes active when a VTBI is entered Q The bolus VTBI cannot exceed the programmed Continuous Infusion VTBI Pr
319. t to patient Unclamping tubing and starting infusion before attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming Stop Bolus Dose The display examples in this procedure represent stopping a Bolus Dose which was programmed using the Drug Library Even where the displays are different when stopping a Bolus Dose which was programmed using a non library drug the procedure is the same 1 Press CHANNEL SELECT key 2 Press STOP BOLUS soft key Alteplase e Stro BOLUS DOSE Dose Remaining 0 090 mg kg Pt Weight 70 kg Time Left 1 min TOTAL DOSE 6 3 mg BOLUS VTBI 6 3 mL gt Press START to Continue 99000 66000 2 32 Programming Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Primary Infusion With Guardrails Suite MX Protection Continued Bolus Dose Continued Stop Bolus Dose Continued 3 To stop bolus and start Continuous Infusion press Yes soft key 4 To stop Continuous Infusion press and hold CHANNEL OFF key until a beep is heard approximately 1 5 seconds Restore Bolus Dose A Bolus Dose can be restored after it has completed either prior to or after the module has been turned off as indicated in the following procedures The display examples in this procedure represen
320. tems Manager v9 5 and later PC unit System Options 99090 Server Status Status CONNECTED Uptime 00 00 02 Server Address 192 168 0 2 Server Name AlarisServer1 JDhospit 13 rt Local Timeout 20 5 Server Timeout 20 Encryption AES 128 bit Bytes Sent 1 103 470 776 Bytes Received 94 300 Last Disconnect UNKNOWN 00000 gt Press CANCEL to Exit WIRELESS NET STATUS ADDRESS alified Wireless Connection 0000 1 Press OPTIONS key 2 Press PAGE DOWN soft key two times 3 Press Wireless Connection soft key System Options 3 of 3 If Wireless Connection soft key is inactive grayed a E o out System Maintenance software was used to disable wireless connection To enable wireless connection use D v9 5 or later System Maintenance software Q nenn xw o gt Select an Option or EXIT PAGE UP 0000 1 28 Alaris System User Manual with v9 17 Model 8015 PC Unit Section System Options Continued Wireless Connection Continued 4 Wireless connection can be disabled or enabled To disable wireless communication press Disable soft key o f wireless connection is disabled it remains disabled until PC unit is powered off Setting defaults to Enable when PC unit is powered back on e v9 5 or later System Maintenance software instructions also includes a procedure on how to disable a wireless RF card on a v9 0 or la
321. ter PC unit being used in a non wireless environment Wireless connection remains disabled until System Maintenance software is used to enable it e enable wireless connection press Enable soft key Pre v9 5 PC unit View Network Status after pressing Enable soft key If a Status of DISABLED is identified System Maintenance software was used to disable wireless connection Use v9 5 or later System Maintenance software to enable wireless connection Data Set Status 1 Press OPTIONS key 2 Press PAGE DOWN soft key two times 3 To view Data Set status press Data Set Status soft key System Options Wireless Enable Connection Disable 90000 gt Press ENABLE or DISABLE 000 System Options 3 of 3 o Network Status Wireless Connection v Data Set Status L9 Maintenance Due Yes 00000 EXIT gt Select an Option or PAGE UP EXIT 000 Alaris System User Manual with v9 17 Model 8015 PC Unit Section 1 29 System Options Continued Data Set Status Continued A status of Current Pending Transferring or Not f System Options Activated is displayed Q Data Set Status oO Q Current none available O Pending Midtown Hospital Q Dataset iD 8344288 o Q Not Activated 9 gt Pr
322. that entrapped air is eliminated it is recommended that the pressure sensing disc be removed prior to priming and the membrane gently massaged with a finger while priming After priming is completed reinstall the pressure sensing disc EQ channel Options 1 of 2 gt Guardrails Drugs o Guardrails IV Fluids Multidose Pre nit 550 mmHg Prime Set with Syringe 00000 gt Select an Option or EXIT PAGE EXIT 556 0000 2 12 Getting Started Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued Prime Using Options Menu Continued Administration Set With Pressure Sensing Disc Continued If pressure sensing disc was not removed prior to pressing A Prime Set with Syringe soft key a pressure sensing disc removal prompt is displayed It is recommended that the Pressure Sensing Disc be removed during priming Press CONFIRM and continue priming 99000 66600 gt Press CONFIRM 0000 5 Invert pressure sensing disc so that patient side is up 6 Hold pressure sensing disc between two fingers Patient Side 7 Press and hold PRIME soft key Prime Set with Syringe CAUTION Do not prime with connected to 0 patient n Prime Volume 9 Om 900
323. tible sensors and cables refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com Alaris System User Manual with v9 17 Model 8015 SpO Module Section General Information 4 17 Features and Displays Features and Definitions See the PC unit section of this User Manual for system features and definitions Models 8210 9 NELLCOR and 8220 Feature SpOs Alarm Limits Definition Upper and lower saturation limits for SpO alarm can be adjusted by clinician 7 SpO Display Functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO Limit Mode Configurable mode that can be set to display either adult or neonatal monitoring mode See Configurable Settings for additional configurable features Pleth Waveform Plethysmographic pleth waveform is a graphic representation of changes in extremity blood volume during cardiac cycle events Displayed waveform is a simulated signal non normalized Pulse Beat Volume Sound of each pulse beep can be configured to be off or to a volume level of 1 2 or 3 Pulse Rate Displayed in beats per minute bpm Pulse Rate Alarm Limits Upper and lower pulse rate alarm limits can be adjusted by clinician Trend Data Tabular display of SpO and pulse rate Display shows average high and low values and alarm conditions for time period displayed Up to 24 hours o
324. tures and Definitions See the PC unit section of this User Manual for system features and definitions Feature Anesthesia Mode Definition Pump and Syringe Modules p na When operating in Anesthesia Mode a module can be paused indefinitely without an alarm Anesthesia Mode also makes it possible to have additional drugs in each profile which are only accessible when operating in that mode Bolus Dose Allows a bolus infusion to be programmed using either Drug Library or drug calculation feature It can be programmed with or without a Continuous Infusion following a bolus Callback A callback for a programmed delay see Delay Options definition can be scheduled to give an alert Before an infusion is to be initiated After an infusion is completed Before and After an infusion or no alert None Channel Labels Available when Profiles feature is enabled It provides a hospital defined list of labels displayed in Channel module Message Display and identifies module with catheter location or other helpful information Concentration Limits Limits specified for range of concentrations allowed for a particular drug in a profile Delay Options Allows system to be programmed to delay start of an infusion a for up to 120 minutes or b for a specific time up to 23 hours 59 minutes Dose Checking Always Dose Checking option causes an Alert to occur each time a dose limit is exceeded Drug label in Mess
325. typically exhibits a long term accuracy offset of approximately 0 7 from mean values 2 116 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Trumpet and Start Up Curves Continued Pump Module Continued j Under conditions of 300 mmHg pressure the Pump module L typically exhibits a long term accuracy offset of approximately 4 2 from mean values Under conditions of 100 mmHg pressure the Pump module typically exhibits a long term accuracy offset of approximately 4 4 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under these pressure conditions Effects of Negative Solution Container Heights With a negative head height of 0 5 meters the Pump module typically exhibits a long term accuracy offset of approximately 3 1 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under negative head height conditions Syringe Module H E Trumpet and start up curves have been provided for 1 0 mL h and 5 0 mL h Measurements for trumpet curve rates below 1 0 mL h are not provided because of the difficulty in measuring extremely small volumes over a large duration of time In this case the linear relationship of the plunger position and velocit
326. ual message to help reduce programming errors by indicating a Limit or Soft or Hard has been exceeded A response is required before programming can continue A visual message when a designated drug is selected to remind clinician of specific hospital facility standards of practice when programming an IV medication A specific Clinical Advisory and or message can be associated with a selected drug within any of the patient care profiles Clinical Advisories are not displayed in Anesthesia mode Variable volume can be silenced and disabled in System Configuration Channel Disconnected Meaning Module disconnected while in operation or have a communication problem Response To silence alarm and clear message from screen press CONFIRM soft key Reattach module if desired ensuring it is securely clicked into place at Module Release Latch If alarm is still present replace module 2 122 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Alarms Errors Messages Continued Alarms Continued Pump Module Accumulated Air in Line Meaning A large number of air bubbles smaller than current air in line limit has recently passed detector Response Clear air from line To continue infusion press RESET soft key and then RESTART key Air in Line Air has been detected in administration set during an infusion Infus
327. uent Volume 30 mL Continuous Dose Basal rate dose Dose Request Cord Allows a patient to self administer a PCA dose to be delivered according to programmed PCA parameters PATIENT USE ONLY label is available for optional attachment to cord Dose Request Cord features an indicator light that can be configured to provide feedback to patient on requested PCA doses Dose Request Cord is enabled in PCA only and PCA continuous modes Drug Event History Records and displays sequential device events for a typical 12 hours subject to change upon usage and number of modules Drug Library When Profiles feature is enabled it provides a hospital defined list of drugs and concentrations appropriate for use in as many as ten profiles Drug Library use automates programming steps including drug name drug amount and diluent volume and activates hospital established best practice limits A Data Set that includes a Drug Library is required prior to using PCA module Event Logging Event Logging records instrument operations Initial Value An optional and editable starting value for PCA dose continuous dose lockout internal or maximum limit Limit A programming limit or best practice guideline determined by hospital health system and entered into system s Data Set Dose limits can be defined by hospital health system as Hard or Soft Limits A Hard Limit is a programmed Limit that cannot be overridden A
328. ule Start Up Curve at 1 mL h initial 1 g mL Da 0 20 40 60 80 Time min Trumpet Curve at 1 mL h initial 100 1 20 co o i Flow Rate Error 96 N A N 1 3 10 15 20 Observation Interval min 25 30 Start Up Curve at 5 mL h initial 1 g mL 10 9 8 7 6 amp E 4 3 4 2 1 0 l 1 t t t t 1 0 20 40 60 80 100 120 Time min Trumpet Curve at 5 mL h initial 15 SS 10 B s5 ul o T a iL 10 4 15 0 5 10 15 20 25 30 Observation Interval min Legend B Maximum rate error mm Overall rate error Minimum rate error 2 120 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Troubleshooting and Maintenance eer oL Troubleshooting and maintenance are intended to be performed only by qualified personnel using the Pump module and Syringe Module Technical Service Manuals and the System Maintenance software The Service Manuals and System Maintenance software are available from CareFusion The Service Manuals include routine service schedules interconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instrument s repairable components The System Maintenance
329. ule These values are configured in the EtCO module settings within the Editor Software and can be changed by the clinician by accessing Channel Options on the PCA module Level 1 2 3 Alaris System User Manual with v9 17 Model 8015 PCA Module Section General Information 3 57 Specifications and Symbols Bolus Dose Range Bolus Volume Maximum after Occlusion Critical Volume Delivery Units Dimensions Environmental Conditions Equipment Orientation Configured according to hospital best practice guidelines Occlusion Pressure Limit Bolus Volume mL Low 0 994 High 0 396 Maximum Bolus Volume specifications are based on following standard operating conditions Atmospheric Pressure 645 795 mmHg Disposable Type 30883 Humidity 20 90 Rate 5 mL h Syringe Type BD 50 60 mL Temperature 68 4 F Volume Collection Time approximately 2 minutes Maximum over infusion which can occur in the event of a single fault condition will not exceed 2 of nominal syringe fill volume during loading and 1 of maximum syringe travel after syringe loading mcg mcg h mg mg h mL mL h 4 5 W x 15 0 H x 7 5 D exclusive of security door Meaning Operating Storage Transport Atmospheric 525 4560 mmHg 375 760 mmHg Pressure 700 6080 hPa 500 1013 hPa Relative Humidity 20 90 5 85 Avoid prolonged Noncondensing Noncondensing exposure to relative humidity gt
330. ummary n screen and press START soft key Second Nurse Summary Morphine Pca Dose 2 mg Infusion mode and PCA drug name scroll in Channel Oeut 10mues LO Message Display If a loading dose has been entered oO scrolls DELIVERING LOAD Q eut 25 mgan Q Main Display alternates between volume remaining o j Conc 1 mg mL and PCA drug name with infusion mode gt Press START When PCA dose is delivered PAUSE PRO starr GRAM Green Infusing Status Indicator illuminates Rate display flashes r DELIVERING PCA scrolls in Channel Message Display o When PCA dose is complete PCA COMPLETE scrolls in Channel Message Display Set Up Continuous Infusion Only 1 Perform steps in Prepare Infusion 2 Press CONTINUOUS INFUSION soft key from Infusion Quargrails Drug Setup Mode screen Q INFUSION MODES o Continuous Infusion I O A Dose Continuous 0 Q Loading Dose Only gt Select an Option SETUP LIBRARY 3 enter Continuous Infusion dose press CONT DOSE soft atmos key and use numeric data entry keys o Morphine O o 9 9 None o 59 None Conc 1 mg mL gt Enter Continuous Dose Alaris System User Manual with v9 17 Model 8015 Programming 3 15 PCA Module Section Infusion Modes Continued Set Up Continuous Infusion Only Continued 4 To enter maximu
331. unt of CO present at the end of exhalation EtCO and during inhalation FiCO gt and the Respiratory Rate The EtCO module is a side stream capnograph The Microstream Disposables deliver a sample of the inhaled and exhaled gases from the ventilator disposable or directly from the patient via an oral nasal cannula into the monitor for CO measurement Moisture and patient secretions are extracted from the sample by the Microstream inline filter while maintaining the shape of the CO waveform The 50 mL min sampling flow rate reduces liquid and secretion accumulation decreasing the risk of obstruction in the sample pathway in humid ICU environments The small sample size eliminates the need for water traps and prevents excess fluid accumulation The EtCO module draws a gas sample through a microsample cell 15 microliters This extremely small volume is quickly flushed allowing for a rise time of approximately 190 ms and accurate CO readings even at high respiration rates The Microbeam IR source illuminates the microsample cell and the reference channel This proprietary IR light source generates only the specific wavelengths characteristic of the CO absorption spectrum The IR light that passes through the microsample cell and the IR light that passes through the reference channel are measured by IR detectors The microcomputer in the EtCO module calculates the CO concentration by comparing the signals from both channels
332. until 0000 desired volume level is attained d To turn off pulse beep press Off soft key 3 Toreturn to SPO2 Main display press CONFIRM soft key Change SatSeconds Limit vue 1 Press SatSeconds Setup soft key EN channel Options o Limit Mode Adult O Pulse Beep Volume Off O 8 gt O o 9 gt Select an Option or EXIT EXIT 0000 2 To change SatSeconds press applicable soft key Al Selectable Increase and Decrease options are 10 25 50 nS E o p and 100 seconds o SPO2 Increase Q Q 10 Seconds D o 3 Toreturn SPO2 Main display press CONFIRM soft key on O gt Press CONFIRM 0000 Alaris System User Manual with v9 17 Model 8015 Programming 4 9 SpO Module Section Channel Options Continued 4 Change Saturation Averaging Time Niso 1 Press Saturation Averaging Time soft key Channel Options o Limit Mode Adult ep Volume Off Sat Averaging Time J8 ensitivity Mode Normal 00000 gt Select an Option or 5m 02000 2 Tochange Saturation Averaging Time press applicable n soft key Selectable options are 2 4 8 10 12 14 and Fer ro STOOP 16 seconds Time 4 Seconds Decrease with Fast SAT o0 Increase FAST SAT is enabled when 2 or 4 seconds is selected o 000 oo 3 Toreturn SPO2 Main display press CONFIRM soft key gt Press CONFIRM CONFIRM 0000
333. urate fluid delivery pressure sensing or other potential hazards For a list of compatible syringes see General Information Compatible Syringes For a list of compatible administration sets refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com WARNING JAN Before loading or unloading the syringe always turn off fluid flow to the patient using the tubing clamp or stopcock Uncontrolled fluid flow can occur when the administration set is not clamped or turned off and can cause serious injury or death Alaris System User Manual with v9 17 Model 8015 PCA Module Section Getting Started 3 3 Prepare and Load Syringe and Administration Set Continued Load Syringe and Administration Set Continued 1 Open syringe barrel clamp a Pull syringe barrel clamp out and hold b Rotate clamp to left clockwise or counter clockwise until it clears syringe chamber c Gently release clamp 2 Raise drive head to its fully extended position a Twist gripper control clockwise and hold in position b While holding gripper control in open position raise drive head to full extension c Gently release gripper control 3 Insert syringe from front of instrument by sliding flat edge of syringe barrel flange between barrel flange grippers
334. uring power up The PC unit should beep no errors should occur and if a module is connected all LED segments should flash If the Alaris System fails the self check remove the failing PC unit or module from use When properly secured snapped the release latch provides a very secure connection between modules If not properly latched a module can be dislodged during operation Disconnect from main AC and battery power when performing maintenance Electrical shock hazard Do not open case Refer to qualified service personnel Due to the intermittent nature of a wireless environment some data can be lost if a connection cannot be established or is lost The Alaris Systems Manager and wireless network card are designed to minimize these incidents but cannot eliminate them The Alaris System is not intended to replace supervision by medical personnel The user must become thoroughly familiar with the Alaris System features operation and accessories prior to use Alaris System User Manual with v9 17 Model 8015 1 33 PC Unit Section Warnings and Cautions Continued General Continued SZXHISTEB N Always use a grounded three wire receptacle Where the integrity of the protective earth grounding system is in doubt operate on internal battery Hyperbaric Chamber Operation o gt The Alaris System is not certified for use in oxygen enriched environments o gt The Alaris System with the exclusion of the
335. urn to main screen press MAIN SCREEN soft key NOTES Date format is year month day Pump module A PRI SEC VOLUME soft key is available to allow secondary volume infused to be displayed If no key is pressed main screen appears after 30 seconds amp The illustrated example is a Syringe module display A Pump module display has a PRI SEC VOLUME soft key The Channel Labels option is not available if a Guardrails IV fluids or Guardrails drugs infusion is running on the module A channel label is removed when the Basic Infusion is promoted to a Guardrails IV fluids or Guardrails Drugs infusion 1 Press CHANNEL SELECT key 2 Press OPTIONS key 00000 egt Ap Volume Infused PRI mL SEC mL o 0 0 00 0 B 0 0 0 0 9 C 00 0 D 0 0 00 0 gt Select Channels to Clear or Press CLEAR AL PRI SEC CLEAR VOLUME ALL egt Channel Labels IE ie Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Programming 2 63 Tac wol f Channel Labels Continued Select Continued 3 4 Syringe module Press PAGE DOWN soft key EQ channet Options 1 of 2 Q Guararails Drugs o Guardrails IV Fluids 9 BS Q Multidose E Q Pressure Limit High Q o Prime Set with Syringe o gt Select an Option or E
336. usion is complete Alert occurs at configured time or when 25 of VTBI remains whichever comes later Occlusion Pressure A complete range of downstream occlusion detection options is provided With pressure sensing disc Downstream occlusion alarm threshold is selectable between 25 and 1000 mmHg in 1 mmHg increments Without pressure sensing disc Downstream occlusion alarm threshold can be set to low medium or high Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section General Information 2 97 Features and Displays Continued Features and Definitions Continued Feature Definition Syringe Module Pressure Sensing Disc When installed pressure sensing disc significantly improves instrument s pressure sensing capabilities for a faster occlusion detection time and makes following features available Auto Pressure Back Off Customizable Pressure Alarm Settings see Occlusion Pressure Fast Start Pressure Tracking Pressure Tracking Dynamic current pressure display is numerical and only available when pressure sensing disc is inserted Priming Allows a limited volume of fluid to be delivered in order to prime administration set prior to being connected to a patient or after changing a syringe When priming a single continuous press of PRIME soft key delivers up to 2 mL of priming fluid Selectable KVO Allows some infusions to a
337. utomatically switch into KVO mode upon completion KVO option setting cannot be changed after instrument is powered on and a profile selected Syringe Empty Instrument gives an alert and stops when an empty syringe is detected Syringe Volume Detection System automatically detects fluid volume in a syringe when it is inserted 2 98 General Information Alaris System User Manual with v9 17 Model 8015 Pump and Syringe Modules Section Features and Displays Continued Operating Features Controls Indicators Status Indicators Alarm Infusing Standby red green yellow IUI Connector Right FUSE STANDS Channel module Message Display E Channel module Select Key When TU on ll pressed selects corresponding module IUI Connector Left BA SELECT for infusion parameter entry and infusion setup dne CHANNEL Pause Key When pressed during an 2 infusion temporarily stops infusion on that RESTART module After approximately 2 minutes a visual and audio prompt begins Channel module Off Key When pressed and held until a beep is heard stops infusion on that module deselects that module and if only that module had been operating system powers down Repeat for other operating modules to power off each module Restart Key When pressed resumes operation of a previously paused or alarmed infusion o
338. vel Initial Programming Setting Bolus Dose Subsequent Programming Level 1 Key Key Level 2 Code or Key Key Key Level 3 Code or Key Disable Security Access Code The security code can be disabled for a specific infusion by using the following procedure 1 Press CHANNEL SELECT key 2 From Main Display press OPTIONS key Code or Key 3 Press Security Code Access soft key Pressure Limit High Q Gii i S A O Security Code Access gt Select an Option or EXIT 3 32 Programming Alaris System User Manual with v9 17 Model 8015 PCA Module Section Infusion Modes Continued Disable Security Access Code Continued Press DISABLE CODE soft key o Press CONFIRM soft key Security access code remains disabled until New Patient Yes is selected in infusion startup or when instrument remains powered off for more than 8 hours Pause Infusion 1 Press PAUSE key OR From Second Nurse Summary screen press PAUSE soft key PAUSE scrolls in Channel Message Display e PAUSED appears on Main Display e Yellow Standby Status Indicator illuminates After 2 minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status Indicator flashes 90000 Security Code Access Press DISABLE CODE to temporarily turn off code access capabilities for current patient 5000 Disable Code
339. w Q OR Module a view To return to main screen press EXIT soft key Q vosue B view Q Q Module c view Q Co Module D View gt Select an Option or EXIT OR EXIT Alaris System User Manual with v9 17 Model 8015 1 23 PC Unit Section System Options Continued Software Versions Continued 5 return to previous screen press EXIT soft key Software Rev Review Q Module Software A Q Q Main processor nn nn Q Q Main boot block nn nn Keyboard mm Q gt Press CANCEL or EXIT nn nn in the illustrated display represents a software version Time of Day 1 Press OPTIONS key 2 Press PAGE DOWN soft key 3 Press Time of Day soft key System Options 2 of 3 Q Battery Runtime Q Q System Configurations O o Serial Numbers o Software Versions 9 gt Select an Option or EXIT Pace uP EXIT AON o0 4 If time is correct press CONFIRM soft key System Options OR Time of Day Q Current tif e Change To change time press Change Time soft key o ons o gt CONFIRM Time of Day EXIT 1 24 Alaris System User Manual with v9 17 Model 8015 PC Unit Section Time of Day Continued System Options Continued 5 Enter current Time of Day 6 Press CONFIRM soft key NOTE The format is a 24 hour clock military t
340. with a gas outlet symbol gt gt 2 Secure gas scavenger system tubing to EtCO module by firmly pushing tubing into fitting on gas outlet Gas Scavenger System Tubing 3 Release door 5 4 Getting Started Alaris System User Manual with v9 17 Model 8015 EtCO Module Section Display references throughout this procedure are for illustration purposes only See General Information Features and Displays and PC unit section of this User Manual for information about Displays Operating Features Controls Indicators Monitoring Mode Perform following steps see PC unit section of this User Manual General Setup and Operation Start Up Power on system a b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required N Connect Microstream Disposable see Getting Started e Press CHANNEL SELECT key EICO mm SENSOR WARMING and then SEARCHING appear in BR reatheinin Channel Message display until EtCO and respiratory rate readings stabilize up to 60 seconds A Alarm limits Tochange settings see Set Alarm Limits procedure Alaris System User Manual with v9 17 Model 8015 Programming 5 5 EtCO Module Section Monitoring Mode Continued accept settings and begin monitoring press ENTER key ETCO2 Main screen displays following informatio
341. with plunger grippers open senses excessive pressure being applied downward on Drive Head OCCLUSION scrolls in Message Display Messages Message Meaning To silence alarm and continue normal operation press CONFIRM soft key Response Bolus Complete Incorrect concentration or dosing Current Bolus Dose completed Channel running in continuous dose if programmed The PCA Volume Check has detected that an incorrect concentration or dose parameter may have been programmed see PCA Volume Check on page 24 Remove syringe Verify that concentration listed on syringe matches concentration DRUG AMOUNT and DILUENT VOLUME programmed into PCA module 3 Reprogram Infusion Complete Current infusion completed Set up a new infusion or press CHANNEL OFF key Load Complete Current loading dose completed Infusion mode menu available or programmed infusion running None 3 68 Troubleshooting and Maintenance Alaris System User Manual with v9 17 Model 8015 PCA Module Section Alarms Errors Messages Continued Messages Continued Message Meaning Response Max Limit Reached Programmed maximum limit has been reached over time period specified Infusion paused until time limit has expired To silence alarm press SILENCE key To change Max Limit press CHANNEL SELECT press PROGRAM soft key and unlock door or enter Authorization Code applicabl
342. y gt Select an Option or PE Ed 0000 Dose Request Setup 4 Review and select Profile soft key for desired operation of Dose Request Cord o Select the desired mx functional profile for the Q operation of the Profile 20 Dose Request Cord Q Profile 5 0 Profile 1 o Audio good demands 9 Visual PCA available ON gt PCAdelivery FLASHES a Lockout interval OFF gt Select an Option Profile 1 Profile 2 Profile 3 Dose request cord audio single beep met demands only all demands all demands Dose request cord led indicator PCA available On On off PCA delivery Flashing On Off Lockout interval off On Off 5 Press CONFIRM soft key Alaris System User Manual with v9 17 Model 8015 Programming 3 31 PCA Module Section Infusion Modes Continued Security Access Levels The security access level can be configured to provide varying levels of access to the device Security access is accomplished either through the use of the key or a 4 digit authorization code Default configuration for the security access level is established for each profile or care area and can be changed in the system configuration The 4 digit authorization code is established and can be changed in the system configuration The 4 digit authorization code is configured for each profile with Level 2 or Level 3 security access Security Access Le
343. y Microstream Disposable because it could disconnect from the instrument causing it to drop on the patient Do not place the EtCO module in any position that could cause it to fall onto the patient Do not use the EtCO module or Microstream Disposable inside a hyperbaric chamber Respond immediately to system alarms patient monitoring can cease under certain alarm conditions Microstream Disposable Do not use a connector or Microstream Disposable that appears damaged The Microstream Disposable disconnect error message and associated alarm indicate the Microstream Disposable is disconnected Check the Microstream Disposable connection and if necessary replace the Microstream Disposable Use only Microstream Disposables Use of a disposable other than those specified can cause improper EtCO module performance resulting in inaccurate readings For a list of compatible disposables refer to the CareFusion IV Sets and Accessories may be downloaded from www carefusion com Alaris System User Manual with v9 17 Model 8015 General Information 5 15 EtCO Module Section Warnings and Cautions Continued Microstream Disposable Continued Before use read Microstream Disposable User Manual including all warnings cautions and instructions Carefully locate the patient Microstream Disposable to reduce the possibility of patient entanglement or strangulation Cums Do not immerse or dampen the Microst
344. y to syringe volume and rate is verified and is a function of the accuracy of the design Measurements for trumpet curve rates above 5 0 mL h are also not provided as the syringe volume is displaced in a very short time with a rate up to 999 mL h Accuracy however is assured with the design implementation Under conditions of 100 mmHg 100 mmHg and 300 mmHg pressures the Syringe module typically exhibits a long term accuracy offset of approximately 0 296 or less from the mean value Alaris System User Manual with v9 17 Model 8015 General Information 2 117 Pump and Syringe Modules Section Trumpet and Start Up Curves Continued Pump Module 5 Start Up at 0 1mL h initial Start Up at 1mL h initial 0 20 0 18 0 16 0 14 0 12 0 10 0 08 0 06 0 04 0 02 0 00 0 02 40 50 60 70 80 90 100 110 120 Time min Flow Rate mL h Flow Rate mL h e o N e eo 0 10 20 30 40 50 60 70 80 90 100 110 120 Time min Trumpet Curve at 0 1mL h initial Trumpet Curve at 1mL h initial 100 Flow Rate Error 96 Flow Rate Error 96 0 5 10 15 20 25 30 d 3 Ts 20 25 1 Observation Interval min Observation Interval min Trumpet Curve at 0 1mL h 72 hrs Trumpet Curve at 1mL h 72 hrs 100 A c oo o Flow Rate Error 96 Flow Rate Error 96 0 5 10 15 20 25 30 d Observation Interval min Observation Interval min Legend NOTE The plot ran
345. yringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued o EN Load uN Before loading or unloading the syringe always turn off fluid flow to the patient using the tubing clamp or stopcock Uncontrolled fluid flow can occur when the administration set is not clamped or turned off and can cause serious injury or death 1 Ensure that instrument is as close to level of patient as possible patient should be in line with CHANNEL SELECT key Keep the Alaris System level with or slightly lower than the patient to maintain positive pressure with Patient 2 Open syringe barrel clamp a Pull syringe barrel clamp out and hold b Rotate clamp to left clockwise or counter clockwise until it clears syringe chamber c Gently release clamp C3 e Syringe Barrel Clamp Open Alaris System User Manual with v9 17 Model 8015 Getting Started 2 7 Pump and Syringe Modules Section Prepare Syringe and Administration Set Syringe Module Continued Load Continued 3 Raise drive head to its fully extended position Twist gripper control clockwise and hold in position While holding gripper control in open position raise drive head to full extension c Gently release gripper control 4 Insert syringe from front of instru

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