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Alaris Medley PCA Module 8120

1. edge of syringe barrel flange between barrel flange gripper d E 7 ln SNE E io a E 0 GH Ici z P O 2 os O Si z e a E cil i A ES NOTE Ensure syringe is loaded to allow syringe labeling and gradation marks to face forward for easier viewing 4 Lock syringe in place a Pull syringe barrel clamp out and hold O Q 1N O Hor b Rotate clamp to right clockwise or counter clockwise until it lines up with syringe pa c Gently release clamp against syringe inpr rni O WwW o QN A OD 20 GETTING STARTED Preparing Infusion Continued Loading Syringe and Administration Set Continued 5 Lower drive head and lock plunger in place with plunger grippers a Twist gripper control clockwise and hold in position NOTE The gripper control is spring loaded When twisted to the open position and then released it and the plunger grippers will return to the closed 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 plunger grippers lock and hold plunger in place Security Lock Key Positions
2. m z Q 6 To enter Max Limit press MAX LIMIT soft key press YES 9 soft key and use numeric data entry keys Ls m NOTES Time in hours associated with Max Limit will 10 minutes m automatically be entered based on set up in system 2 malh a configuration us 7 Toenter Loading Dose press LOAD DOSE soft key press LB None YES soft key and use numeric data entry keys ali A gt Close and lock door then Press CONFIRM NOTE Loading Dose is included in the VTBI but is not included in the MAX LIMIT 8 Verify parameters are correct and press CONFIRM soft key A tise _1m NOTES If the programmed PCA Dose Lockout Interval 10 minutes Continuous Dose Max Limit or Loading Dose are outside the Guardrails Soft Limit for that care area a prompt appears before programming can continue If the Yes soft key is pressed programming continues if the No Conc 1 mg mL soft key is pressed the infusion needs to be gt Press CONFIRM reprogrammed CHANGE MODE CONFIRM If the programmed PCA Dose Lockout Interval Continuous Dose Max Limit or Loading Dose are outside the Guardrails Hard Limit for that care area a prompt appears before programming can continue The infusion needs to be reprogrammed 9 Close and lock security door GETTING STARTED 35 PCA Infusion Modes Continued Setting Up PCA Dose Continuous Infusion Continued 10 Verify parameters on second nurse summary screen are
3. NOTE The 24 h Totals soft key appears only if the shift total is cleared and additional patient history information exists up to the previous 24 hours History from 07 01 09 01 CLEARED 2003 6 10 24 h TOTALS Total Drug 09 01 22 mg Total Demands 5 2 Delivered Shift Totals ZOOM 24 12 8 4 MEM 1 hours Time Scale 46 GETTING STARTED PCA Infusion Modes Continued Viewing Drug Event History The following procedures should be used to view detailed drug event history 1 Press CHANNEL SELECT key Midtown Hospital Med Surg A Cont Morphine VOLUME AUDIO INFUSED ADJUST 2 From Main Display press OPTIONS key 3 Press Drug Event History soft key 4 Press PAGE DOWN soft key to scroll through history 5 To return to Main Display press EXIT soft key NOTE The Drug Event History stores approximately 12 hours of events Drug Event History is automatically cleared upon selection of New Patient Yes in Start Up section Summary Morphine Cont Dose 2 mg h Max Limit 25 mg 4h Conc 1 mg mL gt Press START PRO BOLUS GRAM DOSE START FY channe Options 1 of 2 Infusion Modes Patient History Dose Request Setup Drug Event History gt Select an Option or EXIT PAGE 2 A Drug Event History 1 2003 06 10 DRUG EVENT Morphine 1mg mL PCA Dose 1 mg Unmet demands 5 Continuous 2 mg h PCA Cont infusion New syringe Bolus Dose sto
4. gt P START When Bolus Dose is complete BOLUS COMPLETE scrolls in Channel Message Display e Programmed infusion resumes Stopping a Loading PCA or Bolus Dose The following procedure should be used to stop a Loading PCA or Bolus Dose 1 Press CHANNEL SELECT key on PCA Module 2 Press STOP LOAD STOP PCA or STOP BOLUS soft key as applicable NOTE Soft key will reflect the type of dose that is l currently infusing 3 To stop dose and resume current program press YES soft key 40 GETTING STARTED PCA Infusion Modes Continued Changing Programming Parameters During an Infusion The following procedures should be used only when changing programming parameters during an infusion 1 Press CHANNEL SELECT key Midtown Hose A PCA Cont Morphine VOLUME AUDIO INFUSED ADJUST 2 Press PROGRAM soft key CER ARS DONILLAS Summary Morphin 20 minutes 2 mg h 25 mg 4 h Conc 1 mg mL Press START PRO BOLUS START 3 Setkey to program position or if Authorization Code is enabled enter 4 digit code Set key to Program position gt Set Key to PROGRAM Position GETTING STARTED 41 PCA Infusion Modes Continued Changing Programming Parameters During an Infusion Continued 4 Press CHANGE MODES softkey IMS Pre fill 30m 2 mg 20 minutes 2 mg h 25 mg 4 h A Guardrails Drug Library Conc 1 mg mL Close and lock door then Press CONFIRM 5 Selec
5. 90 GETTING STARTED PCA Infusion Modes Continued 1 Press PAUSE key on PCA Module PCADose 2 mg En Ia 20 minutes From Second Nurse Summary screen press PAUSE soft Cont Dose 2 mg h key Max Limit 20 mg 4h PAUSE scrolls in Channel Message Display Conci moimi PAUSED appears on Main Display Yellow Standby Status Indicator illuminates e After two minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status Indicator flashes 2 Toreinitiate infusion Second Nurse Summar Press RESTART key on PCA Module PCADose 2 mg Lockout G m Z Q d gt JJ m O Interval 20 minutes Cont Dose 2 mg h OR Max Limit 20 mg 4h Conc 1 mg mL gt Press START PRO BOLUS PAUSE START Press CHANNEL SELECT key and then press START soft key on Main Display GETTING STARTED 51 PCA Infusion Modes Continued Restoring Infusion Following Syringe Empty 1 If syringe requires replacement a Unlock security door b Remove existing syringe and prepare new syringe reference Preparing Syringe and Administration Set section c Load syringe and administration set reference Preparing Infusion section d Select syringe type and size reference Preparing Infusion section e Prime reference Preparing Infusion section 2 To restart infusion using restored parameters press RESTORE soft key and continu
6. Securely lock syringe barrel clamp and press RESTART key Check for potential siphoning Ensure administration set clamp roller slide is in closed position Securely lock plunger grippers over syringe plunger Open and close plunger grippers Ensure syringe is properly installed 60 ALARMS ERRORS MESSAGES Errors Error Meaning Channel Error Syringe Calibration Required Syringe Driver Head Error Error detected on infusing channel Infusion stops on affected channel Error on infusing channel indicating calibration is required Infusion stops on affected channel CALIBRATE scrolls in Channel Message Display Noninfusing channel with plunger grippers open senses excessive pressure being applied downward on Drive Head OCCLUSION scrolls in Channel Message Display Response To silence alarm and continue operation of unaffected channels press CONFIRM soft key Replace channel with an operational instrument as required Service by qualified personnel is required To silence alarm and continue operation of unaffected channels press CONFIRM soft key Replace channel with an operational instrument as required Service by qualified personnel is required To silence alarm and continue normal operation press CONFIRM soft key Messages Message Meaning Bolus Complete Infusion Complete Load Complete Max Limit Reached NEOI Near End of Infusion Current Bolus Dose
7. 3 Press Patient History soft key ARS Options 1 of 2 Infusion Modes Patient History Dose Request Setup Drug Event History gt Select an Option or EXIT PAGE Em 4 Press ZOOM soft key to select desired time period f Patient Hist 09 01 e Patient History contains History from 07 01 09 01 Total Drug Delivered CLEARED 5003 6 10 Total Demands Delivered demands Delivered NOTE Total Drug Delivered includes applicable Loading ZOOM 241284 WENN 1 hours Dose PCA Dose Continuous Dose and Bolus Dose oe Total Drug Delivered does not include priming volume o Press DETAIL soft key to view Detailed Patient History Detailed Patient History contains Total Drug Delivered History from 07 01 09 01 Total Drug 22 mg f T PCA Dose 14 mg Total Drug Delivered via Coin ou Annisa A 50 gt PCA Dose Loading Dose 2 mg Bolus Dose 2 mg gt Continuous Infusion Average Drug per Hr 11 mg ZOOM 24 12 8 4 MEM 1 hours een gt Bolus Dose Average Drug Per Hour 6 To return to Main Patient History press MAIN HISTORY soft key History from 07 01 09 01 LAST 07 00 CLEARED 2003 6 10 SHIFT TOTALS Delivered ZOOM 24 12 8 4 MEM 1 hours gt Press ZOOM to Change Time Scale CLEAR History ZOOM EXIT DETAIL 44 GETTING G STARTED PCA Infusion Modes Continued Viewing Patient History Continued 7 To return to Main Displ
8. There are three key positions associated with the security lock UNLOCK unlocks the security door The key must be in this position when loading or changing a syringe e PROGRAM allows for changes in programming the device without unlocking the security door or interrupting the current infusion e LOCK locks the security door They key must be in this position to start an infusion Gripper Control in Closed Position N Drive Head Flush with Plunger Flange Plunger Grippers Closed 5 r i mum Ti GETTING STARTED 21 Q m Z O A gt JJ m m O Preparing Infusion Continued Selecting Syringe Type and Size At the start of an infusion program the system prompts user to select and confirm the syringe type and size NOTE 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 displays 1 Press CHANNEL SELECT key Key must be in PROGRAM position WARNING 1 Ensure the displayed syringe manufacturer and size correctly identifies the installed syringe Mismatches may 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 refer to the Compatible Syringes se
9. infusion which helps to reduce complexity at the point of care The Medley Patient Controlled Analgesia PCA Module Model 8120 is intended for facilities that utilize syringe pumps for the delivery of medications or fluids using continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous IV subcutaneous or epidural The Guardrails Safety Software for the Medley System brings a new level of medication error prevention to the point of patient care The Guardrails Safety Software features hospital defined medication dosing guidelines for up to ten patient specific care areas referred to as profiles Each profile contains a specific drug library and channel labels as well as instrument configurations appropriate for the care area Optional drug specific Guardrails Clinical Advisories provide visual messages Dosing limits for each drug entry may be either Guardrails Hard Limits that cannot be overridden during infusion programming or Guardrails Soft Limits that can be overridden based on clinical requirements A data set is developed and approved through the facility s own multi disciplinary team using the Guardrails Editor the PC based authoring tool A data set is then transferred to the Medley System by qualified personnel The approved data sets are maintained by the Guardrails Editor for future updates and reference A data set is required prior to using the Medley
10. OPTIONS key 2 Press Prime Set with Syringe soft key AREE Options 2 of 2 Pressure Limit High Prime Set with Syringe gt Select an Option or EXIT PAGE op EXIT 3 Set key to PROGRAM position Set the key to Program position gt Set Key to PROGRAM Position EXIT 4 Press and hold PRIME soft key until fluid flows and priming of syringe administration set is complete NOTE Fluid is delivered during priming only while the PRIME soft key is pressed Each press of the PRIME soft key delivers up to 2 mL of priming fluid per continuous press To deliver additional amounts press the PRIME soft key again e Volume used during priming is displayed but not added to VTBI Prime Set with Syringe CAUTION Do not prime with disposable set connected to patient A Prime Volume 0 mL gt Press and Hold PRIME PRIME EXIT 24 GETTING STARTED Preparing Infusion Continued Priming Continued 5 When priming is complete release PRIME soft key 6 To return to main screen press EXIT soft key Prime Set with Syringe l l CAUTION Do e Guardrails Drug Library screen displays Na eund PRIME EXIT 7 Select Infusion Mode Morphine INFUSION MODE PCA Dose only CERAS ONILLAS Continuous Infusion PCA Dose Continuous Loading Dose Only gt Select an Option or CANCEL Programming An Infusion The following procedures should be used when programmi
11. PAUSE key on PCA Module 2 Unlock the door 3 Open plunger grippers and syringe barrel clamp e An audio prompt sounds e Red Alarm Status Indicator flashes CHECK SYRINGE scrolls in Channel Message Display 4 Remove syringe and separate administration set from syringe NOTE If drug and or drug concentration is different from previous syringe attach and prime new administration set 5 Reattach administration set to new syringe refer to Preparing Infusion section Q m Zz O A gt JJ m O 6 Load new syringe refer to Preparing Infusion section 7 Select syringe type and size refer to Preparing Infusion section 8 Press CONFIRM soft key 9 Prime administration set refer to Preparing Infusion section 10 Press RESTORE soft key press NEXT soft key and confirm programming parameters OR Press applicable soft key and use numeric data entry keys 11 Lock the door 12 To begin infusion press START soft key GETTING STARTED 55 Powering Off Powering Off Channel Refer to the Medley Point of Care Unit Directions for Use Powering Off System Refer to the Medley Point of Care Unit Directions for Use 96 GETTING STARTED ALARMS ERRORS MESSAGES To enhance safety and ease of operation the Medley System provides a full range of audio and visual alarms errors and messages Advisory A sequence of audio and or visual signal
12. PCA Module Information about Guardrails Alerts that occur during use are stored within the Medley PCU and can be accessed using the Guardrails Continuous Quality Improvement COI Event Tracker and Guardrails CQI Reporter INTRODUCTION 1 About the System Continued This document provides directions for use for the Medley PCA Module Read all instructions for both the Medley PCA Module and the Medley PCU before using the Medley System The Medley PCA Module uses non dedicated standard or pre filled single use disposable syringes with luer lock connectors and administration sets with anti siphon valves designed for use on syringe type PCA devices For specific administration set instructions refer to the directions for use provided with the set For set priming and loading instructions refer to the Preparing Infusion section in the Getting Started chapter of this document Contraindications None known 2 INTRODUCTION Features and Definitions Refer to the Alarms Errors Messages chapter of this Directions for Use for the definitions of various alerts Refer to the Medley PCU Directions For Use for system features and definitions Auto Pressure Limit Adjustment Auto Syringe Identification Bolus Dose Dose Request Cord Drug Event History Event Logging Guardrails Clinical Advisory Guardrails Drug Library When a bolus is delivered the pressure alarm limits are
13. completed Channel running in Continuous Dose if programmed Current infusion completed Current Loading Dose completed Infusion mode menu available or programmed infusion running Programmed Max Limit has been reached over time period specified Infusion paused until time limit has expired Syringe almost empty Response None Set up a new infusion or press CHANNEL OFF key None None This is a timed event that can be set To change Max Limit press CHANNEL SELECT press SETUP soft key and unlock door or enter Authorization Code applicable for current Security Access Level None This is a timed event that can be set To set or change this option see Configurable Settings section ALARMS ERRORS MESSAGES 61 gt gt o y 9 gt m m 3 0o JJ 9 Messages Continued Message Meaning Panel Locked Panel Unlocked Pause PCA Complete Syringe Not Recognized Tamper Resist feature is active and a key was pressed Tamper Resist feature deactivated Pause control pressed infusion stopped Current PCA Dose complete Lockout interval begins Channel running in Continuous Dose if programmed Installed syringe of unknown type and size Response If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of Point of Care Unit None To resume infusion press RESTART key None Select and confirm correct syringe type
14. gt Press START PAUSE START FN channe Options 2012 Pressure Limit High Prime Set with Syringe gt Select an Option or EXIT PAGE GETTING STARTED 53 G m Z Q d gt JJ m O PCA Infusion Modes Continued Selecting Pressure Limit Continued 4 To select a pressure limit press appropriate soft key Low Med or High A Pressure Limit Selection e Press CONFIRM soft key Low High CONFIRM Viewing and Clearing Volume Infused 1 To view volume infused press VOLUME INFUSED soft key from the Main Display e Total volume infused and time and date volume A PCA Morphine infused was last cleared is displayed for each channel i NOTE Date format is year month day VOLUME AUDIO INFUSED ADJUST 2 To clear volume infused NOTE If no key is pressed main screen appears after 401 10 1558 3 10 Scans 42 50 8s e f only selected channels are to be cleared press soft 478 10 55 so key next to applicable channel s and press CLEAR 789 10 158 310 CHANNEL soft key Volume clears on selected channel s or Mess CLEA ALL e f all channels are to be cleared press CLEAR ALL soft key To return to main screen press MAIN SCREEN soft key NOTE Clearing volume infused on a PCA Module does not clear patient history 94 GETTING STARTED PCA Infusion Modes Continued Changing Syringe During Infusion 1 To stop infusion press
15. humidity 28596 Atmospheric Pressure 525 to 4560 mmHg 375 to 760 mmHg 700 to 6080 hPa 500 to 1013 hPa Equipment Orientation To ensure proper operation the Point of Care Unit must remain in an upright position Flow Rate Programming _ The flow rate range is from 0 1 to 999 mL h as follows Flow Rates mL Selectable Increments mL h 0 10 9 99 0 01 gt 10 99 9 0 1 z 100 999 1 0 u Rate Restriction by Syringe Size E Syringe Size mL Flow Rate Range mL h 2 50 60 0 1 999 30 35 0 1 650 20 0 1 500 Fluid Ingress Protection IPX1 Drip Proof Loading Dose Range Configured according to hospital best practice guidelines MAINTENANCE 63 Specifications Continued Max Limit Range Configured according to hospital best practice guidelines Occlusion Alarm Thresholds Three settings Operating Principle PCA Dose Range Rate Accuracy Shock Protection Time to Alarm Maximum Low Medium High Positive displacement Configured according to hospital best practice guidelines The Medley PCA Module accuracy rate is 2 of full scale plunger travel not including syringe variation WARN NG 1 0o Syringe size and running force variations of back pressure or any combination of these may affect rate accuracy Factors that can influence back pressure are Administration set configuration IV solution viscosity and IV solution temperature Back pressure may also be affected by type
16. in onset of fluid flow when infusion commences start up curves Trumpet and start up curves have been provided for 0 1 mL h 1 0 mL h and 5 0 mL h Measurements for trumpet curve rates above 5 0 mL h are also not provided as the volume of the syringe will be displaced in a very short time with a rate of up 999 mL h Accuracy however is assured with the design implementation 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 may 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 two hours from the start of the infusion They exhibit the delay in onset of delivery due t
17. temporarily raised to the maximum limit The system automatically detects the syringe size and narrows down the syringe selection list The Bolus Dose feature enables a clinician to program an additional amount of medication once the PCA infusion has begun The current PCA infusion will resume following the delivery of a bolus dose When attached the dose request cord allows a patient to self administer a PCA dose to be delivered according to programmed PCA parameters The dose request cord features an indicator light which can be configured to provide feedback to the patient on requested PCA doses The dose request cord is enabled in PCA only and PCA Continuous modes Records and displays sequential device events for a typical 12 hours subject to change upon usage and number of modules Event Logging records instrument operations A Guardrails Clinical Advisory is a visual message that appears when a designated drug is selected to remind a clinician of specific hospital standards of practice when programming an IV medication A specific clinical advisory can be associated with a selected drug within any of the patient care profiles The Guardrails Drug Library feature is a drug calculation mode available when the Profiles feature is enabled It provides a hospital defined list of drugs and concentrations appropriate for use in as many as 10 profiles Using the Drug Library automates programming steps including the drug na
18. 2 17 0 20 40 60 80 100 120 0 5 10 45 20 25 30 time min observation interval min gt Mode Start up at 5 mL h initial ES Mode Trumpet Curve at 5 mL h initial 9 8 10 7 S c 6 5 5 3 5 9 E 34 4 9 3 2 5 2 2 8 1 10 x 15 0 20 40 60 80 100 120 0 5 10 15 20 25 30 time min observation interval min Legend B Maximum rate error Overall rate error Minimum rate error 2 APPENDIX ALARIS MEDICAL SYSTEMS ALARIS Medical Systems Inc 10221 Wateridge Circle San Diego California 92121 U S A Mail P O Box 85335 San Diego California 92186 5335 U S A ALARIS ALARIS Medical Systems Guardrails and Medley are trademarks and registered trademarks of ALARIS Medical Systems Inc All other trademarks belong to their respective owners Patents Brevets Brevet Patente Brevetti Brevettato 4 Ned Octrooi Sv US 5 601 445 5 713 856 5 781 442 5 800 387 5 836 910 5 941 846 AU 693 662 703 178 703 203 719 254 728 366 AT 0 225 158 BE 0 225 158 CA 1 258 212 2 026 518 CH 0 225 158 DE P3686558 3 FR 0 225 158 GB 0 225 158 IT 0 225 158 JP 1 816 872 NL 0 225 158 SE 0 225 158 TW NI 107963 Other Patents Pending 10010720 02004 ALARIS Medical Systems Inc All Rights Reserved
19. 309 Technical Support Technical support service information applications and manuals may be obtained by contacting an ALARIS Medical Systems representative United States 800 854 7128 extension 6003 Canada Eastern 800 908 9918 Western 800 908 9919 When submitting any request for service include full description of difficulty experienced instrument settings administration set lot number solution s used message displayed at time of difficulty P z zz m z gt z O m Product Return If it is necessary to return the instrument for service obtain a return authorization number prior to shipment Carefully package the instrument preferably in the original packaging reference the return authorization information and return it to the appropriate service or distribution center ALARIS Medical Systems does not assume any responsibility for loss of or damage to returned instruments while in transit MAINTENANCE 69 THIS PAGE INTENTIONALLY LEFT BLANK 70 MAINTENANCE APPENDIX A AE Trumpet and Start Up Curves In this instrument as with all infusion systems the action of the pumping mechanism and variations in individual syringes and administration sets cause short term fluctuations in rate accuracy The following graphs show typical performance of the system as follows 1 Accuracy during various time periods over which fluid delivery is measured trumpet curves m Delay
20. Directions for Use Patient Controlled Analgesia PCA Module 8120 Series ALARIS Medical Systems Inc Medley Medication Safety System 0218 1SGON J INGOIW vod THIS PAGE INTENTIONALLY LEFT BLANK TABLE OF CONTENTS INTRODUCTION ABOUT THE SYSTEM tne een eee Cee te eee eee een ul ee ee eee eae eee ene Sen ey e ee de loo oia 1 gt FEATURES ANDIDEFINITIONS 00 A A Sa eec Lo LE tM ales 3 IB OS c 6 3 GETTING STARTED E WARNINGS AND GAUTIONS 35655 erint dede ax EEE dale BERT n Pes td tte wane ee Ans EE E utem quiete 7 O CONTROLS AND INDICATORS a E 14 5 INSTALLATION 1 circuncisi n la a alos calar a n risotto taria 15 gt Unpack FOCA MOdUE ARMANI RR ERE 15 ATTACHING AND DETACHING MODBDULES rre hene ne dac eate cos e peo rd pa ue a uaque re ux oder tee tehetet 15 BISERA ve d RPM EL RR MM EM f UR EE 15 MGI Display TTE 16 O PREPARING SYRINGE AND ADMINISTRATION SET 00 16 m ATTACHING AND DETACHING DOSE REQUEST CORD ccoo nooo 17 4 STARTUP Lauda A ae betes UU E e REL RD LE CM eR EUM A NA 18 Z POWETING On SVSICM susciten chera nds edited egin bli ea it hes arai e r d elis petri tota 18 Q Responding to Maintenance Reminder aaoo 18 o Choosing YES or NO to New Patient and Profile sisse 18 gt Saleen Rolls ise cenit E tan mu RAD M SEM DLP M gated anios RS fite M M ETSA 18 x iouis mnm 18 m PREPARING INFUSION teca ui is A a a
21. PCA Dose only Continuous Infusion PCA Dose Continuous Loading Dose Only gt Select an Option or CANCEL DRUG SETUP GETTING STARTED 29 PCA Infusion Modes Continued Setting Up PCA Dose Only Continued 3 To enter PCA Dose use numeric data entry keys _ _ _ _ minutes None 4 To enter Lockout Interval press LOCKOUT INTERVAL soft key and use numeric data entry keys 20 mg 10 minutes Press CONFIRM 5 To enter Max Limit press MAX LIMIT soft key press YES soft key and use numeric data entry keys NOTE Time in hours associated with Max Limit will MS Pres SOME Y automatically be entered based on set up in system 2 mg configuration 10 minutes 6 To enter Loading Dose press LOAD DOSE soft key press ___ mg 4h YES soft key and use numeric data entry keys NOTE Loading Dose is included in VTBI but is not included in MAX LIMIT gt Enter Max Limit 30 GETTING STARTED PCA Infusion Modes Continued Setting Up PCA Dose Only Continued 7 Verify parameters are correct and press CONFIRM soft key NOTES If the programmed PCA Dose Lockout Interval Max Limit or Loading Dose are outside the Guardrails Soft Limit a prompt appears before programming can continue If the Yes soft key is pressed programming continues if the No soft key is pressed the infusion must Le ii be reprogrammed _ 25 mg 4h If the programmed PCA Dose Lockout Interval Max Limit or Loading Dose ar
22. SEI VICcE 68 INSPECTION REQUIREMENTS S 4o en tanta a picas 68 SERVIGEINECORIVATION St is 69 APPENDIX TRUMPET AND START UP CURVES ni tata 71 Il TABLE OF CONTENTS GENERAL CONTACT INFORMATION Customer Advocacy North America Clinical and technical feedback Phone 800 854 7128 Ext 7812 E Mail CustomerFeedback alarismed com Technical Support North America Maintenance and service information support troubleshooting United States Canada Phone Phone 858 458 6003 Eastern 800 908 9918 800 854 7128 Ext 6003 Western 800 908 9919 Customer Care North America Instrument return service assistance and order placement United States Canada Phone Phone 800 482 4822 800 387 8309 THIS PAGE INTENTIONALLY LEFT BLANK INTRODUCTION SCout the System About the System The Medley Medication Safety System is a modular infusion and monitoring system intended for use in today s growing professional healthcare environment for use in adult pediatric and neonatal care The Medley Medication Safety System consists of the Point of Care Unit PCU 8000 Series the Guardrails Safety Software and up to four detachable modules which provide infusion or monitoring capabilities Z zs o i C O i9 Z The Medley PCU controls the Medley System and provides a common user interface for programming and monitoring an
23. The case should only be opened by qualified service personnel using proper grounding techniques 10 GETTING STARTED Warnings and Cautions Continued User Precautions Continued Epidural Administration The Medley PCA Module can be used for epidural EZENN administration of anesthetic and analgesic drugs This application is only appropriate when using analgesics and Epidural administration of drugs other anesthetics labeled for continuous epidural administration and than those indicated for epidural use catheters intended specifically for epidural use Use only could result in serious injury to the standard single use disposable syringes with luer lock patient connectors and administration sets designed for use on syringe pumps and without a Y connector or injection port EZENN for epidural infusions long term analgesic epidural drug delivery It is strongly recommended that the 2 e Epidural administration of anesthetic drugs Use indwelling syringe administration set and the J catheters specifically indicated for short term anesthetic Medley PCA Module used for gt epidural drug delivery epidural drug delivery be clearly 7 e Epidural administration of analgesic drugs Use indwelling differentiated from those used for catheters specifically indicated for either short term or other types of administration 3 m g Dose Request Cord Use e Only the patient should press the do
24. Z Q d gt JJ m O GETTING STARTED 9 Warnings and Cautions Continued EZENN When the Medley PCA Module is used with a primary IV line use of an appropriate Y set with a backcheck valve is highly recommended Failure to properly use a Y set may result in retrograde analgesic flow into the primary line during a partial or complete downstream occlusion This may subsequently result in an inadvertent bolus to the patient when the occlusion is cleared Parallel Infusions There are no contraindications regarding the use of the Medley M System with any other positive displacement infusion device when ported together into a common IV site location User Precautions To ensure proper performance of the Medley System and to reduce potential injury observe the following precautions e Potent analgesic medications are used with this device Refer to drug package insert for precautions and possible adverse reactions e Refer to analgesic package enclosure for possible incompatibility with fluid or drug being delivered through the maintenance line e It is recommended that highly viscous solutions and drugs colloidal suspensions and emulsions should not be delivered through the inline backcheck valve on the maintenance side of the PCA set Valve functionality may be compromised by the presence of residue e Disconnect from main AC power when performing maintenance e Do not open the instrument case
25. ad Release shown in closed position Security Lock Plunger Grippers shown in closed position LL IE LI 17 Joly Syringe Barrel Sensor Syringe Barrel Clamp Sizer a Security Door Channel Release Lever i Dose Request Cord p Attachment X ES O Dose Request Cord 14 GETTING STARTED 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 the instrument into use Unpacking PCA Module 1 Remove the Medley M PCA Module from its carton 2 Verify gripper control drive head release plunger grippers and syringe barrel clamp sizer operate freely and correctly 3 Verify control surface and instrument housing is not damaged 4 Check for loose parts 5 Perform Periodic Inspections see Inspection Requirements section in Maintenance chapter 6 Perform check in procedure provided separately contact ALARIS Medical Systems for further information If the Medley PCA Module fails initial test it must be removed from service and inspected by qualified personnel If the Medley M PCA Module is damaged contact ALARIS Medical Systems for authorization to return the instrument for repair Attaching and Detaching Channels Refer to the Medley Point of Care Unit Directions for Use Displays The displa
26. all previous PCA programming parameters for the same patient This option is only available if the patient is not new and the system is powered up within 8 hours of last usage The instrument gives an alert and stops when an empty syringe is detected The system automatically detects the fluid volume in a syringe when it is inserted INTRODUCTION 5 JJ O O C O Z Symbols Canadian and U S Certification Mark Products bearing this mark have been tested A qa and certified in accordance with applicable U S and Canadian electrical safety and performance standards CSA C22 2 No 601 1 UL 60601 1 and IEC 60601 2 24 Y Electrical Shock Protection Rating Type CF Defibrillation proof PCA Module IE Electrical Shock Protection Rating Type BF Defibrillation proof Dose Request Cord IPXI Protection against fluid ingress Drip Proof N Attention Refer to accompanying documentation gt IUI Connector Inter Unit Interface connector used to establish power and communications between the Point of Care Unit and attached channels Manufacturing Date Number adjacent to symbol indicates the month and year of MM YYYY manufacture i Consult operating instructions R Only CAUTION Federal U S A law restricts this device to sale by or on the order of a physician Single Use Single Use Do not re use Product contains a particular element such as DEHP in fluid pathway N Product DOES NOT contain a parti
27. and is the same in all profiles Refer to the Medley Point of Care Unit Directions for Use m Z gt Z O m MAINTENANCE 65 Configurable Settings Continued PCA Module Settings Feature Default Setting Options Authorization Code Bolus Delivery Rate Bolus Dose Bolus Dose include in Max Limit Dose Request Cord Configuration Loading Dose Lockout Interval Max Accumulated Dose Range Max Rate NEOI e Alert Time Occlusion Pressure Set Point Priming Forced Module Location Security Access Level None 150 mL hr Enabled Disabled Profile B Enabled 1 180 minutes in 1 minute increments 1 hour limit 999 mL h Disabled High 800 mmHg Disabled Enabled Level 1 4 digits between 0 9 One code applies to all profiles 75 500 mL hr limited by syringe size Enabled Disabled Enabled Disabled Profile A B C Enabled Disabled Min Max 1 180 minutes Disabled 1 2 or 4 hour limit 0 1 99 9 mL h in 0 1 mL h increments 100 999 mL h in 1 mL h increments Enabled Disabled 5 2596 of remaining infusion Low 200 mmHg Medium 500 mmHg High 800 mmHg Enabled Disabled Enabled Disabled Level 1 2 3 66 MAINTENANCE Compatible Syringes The Medley PCA Module is calibrated and labeled for use with the following single use disposable luer lock syringes Use only the syringe size and type s
28. and size and then press CONFIRM or use a syringe type and size that system can automatically and correctly identify Ensure compatible syringe is loaded For a list of compatible syringes refer to Compatible Sets section of this Directions for Use 62 ALARMS ERRORS MESSAGES MAINTENANCE Medley System Technical Service Manuals are available from ALARIS Medical Systems They include routine service schedules interconnect diagrams component parts lists and descriptions test procedures and or references and other technical information to assist qualified service personnel in repair and maintenance of each instrument s repairable components Maintenance procedures are intended to be performed only by qualified personnel using the service manual and Medley Maintenance Software Specifications Bolus Dose Range Configured according to hospital best practice guidelines Delivery Units mg mcg mL mg h mcg h mL h Critical Volume The 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 Dimensions 4 5 W x 15 0 H x 7 5 D exclusive of security door Environmental Conditions Operating Storage Transport Temperature Range 41 to 104 F 4 to 140 F 5 to 40 C 20 to 60 C Relative Humidity 20 to 90 5 to 85 Avoid prolonged exposure Noncondensing Noncondensing to relative
29. aracteristics The Point of Care Unit and Main Display provide various types of alert information The characteristics of the accompanying audio sounds are as follows Type Sound Notes Advisory Alarm Error Hardware Detected Error Software Detected Illegal Key Press Key Click Prompt Switchover One short beep every two seconds Choice of three alarm audio profiles selectable in System Configuration Pairs of long beeps Pairs of long beeps Two short beeps One short beep One short beep every two seconds Two short beeps e g Bolus switching to Continuous Variable volume can be silenced for two minutes Variable volume can be silenced for two minutes Fixed maximum decibel volume cannot be silenced Fixed maximum decibel volume can be silenced for two minutes Variable volume cannot be silenced Fixed minimum volume can be silenced and disabled in System Configuration Variable volume can be silenced Variable volume can be silenced and disabled in System Configuration 98 ALARMS ERRORS MESSAGES Attach Dose Request Cord Channel Disconnected Check Syringe Lock Door Occlusion Syringe Empty Unit Location Alarm Dose Request Cord is detached from device Dose Request Cord is required for PCA only and PCA Continuous Infusion modes Channel s disconnected while in operation or have a communication problem Plunger grippers opened d
30. ay press EXIT soft key Summary Morphin NOTE The Patient History stores a rolling 24 hour log Patient history is automatically cleared upon selection of New Patient Yes in Start Up Section or upon changing drug selection in Guardrails Drug Library Cont Dose 2 mg h Max Limit 25 mg 4h Conc 1 mg mL gt Press START to Close Summary G m Z G 9 Clearing Patient History gt The following procedures should be used to clear patient u history 1 a Press CLEAR HISTORY soft key Patient History 09 01 A confirmation screen appears e BI T CLEARED 2003 6 10 SHIFT TOTALS Total Drug 22 mg Total Demands 5 Delivered 2 ZOOM 24 12 8 4 MEM 1 hours gt Press ZOOM to Change Time Scale CLEAR ZOOM EXIT DETAIL 2 To continue and clear patient history press YES soft key To cancel and return to patient history press NO soft key Are you sure you would like to clear the Patient History Press Yes or No GETTING STARTED 45 PCA Infusion Modes Continued Clearing Patient History Continued 3 Once patient history is cleared the last 24 hours of patient history data may be retrieved and viewed Select 24 h Totals soft key from Patient History screen to retrieve the last 24 hours ZOOM 24 12 8 4 MEM 1 hours gt Press ZOOM to Change Time Scale CLEAR ZOOM EXIT DETAIL 4 Press SHIFT TOTALS soft key to return to Patient History view
31. cock Uncontrolled fluid flow can occur when the administration set is not clamped or turned off and may cause serious injury or death CAUTION 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 GETTING STARTED 19 G m Z Q d gt JJ m O Preparing Infusion Continued Loading Syringe and Administration Set Continued 2 Raise drive head to its fully extended position Drive Head Fully Extended a Twist gripper control clockwise and hold in position oo Gripper Control A NOTE The gripper control is spring loaded When Head Release in Open AN twisted to the open position and then released it and Position the plunger grippers will return to the closed position y b While holding gripper control in open position raise Plunger Grippers drive head to full extension Open c Gently release gripper control 3 Insert syringe from front of instrument by sliding flat
32. correct and press START key During PCA Dose Continuous Infusion 4 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 Volume infused for continuous dose is displayed in ml h 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 Second Nurse Summary Morphine PCADose 1 mg Lockout Interval 10 minutes Cont Dose 2 mg h Max Limit 8 mg 4 h Conc 1 mg mL gt Press START PRO PAUSE GRAM START 36 GETTING STARTED PCA Infusion Modes Continued Setting Loading Dose Only The following procedures should be used when setting a Loading Dose Only using the Guardrails Drug Library Setting Loading Dose from Infusion Mode Screen 1 Perform steps in Preparing Infusion section of this Directions for Use 2 Press LOADING DOSE ONLY soft key from Infusion Mode screen INFUSION MODE PCA Dose only Continuous Infusion PCA Dose Continuous Loading Dose Only gt Select an Option DRU EU CER ARS ONILLAS 3 Use numeric data entry keys to enter dose value 4 Verify dose value is correct and then press CONFIRM soft key NOTES Loading dose is included in the VTBI but is n
33. ction in the Maintenance chapter If the installed syringe is displayed and selected but is not recognized servicing is required refer to Service Information section in Maintenance chapter Midtown Hospital Med Surg gt Select Channel AUDIO ADJUST 22 GETTING STARTED Preparing Infusion Continued Selecting Syringe Type and Size Continued 2 Press soft key next to installed syringe type and size e Selection is highlighted IMS Pre fill 30 mL gt Select Syringe Size 3 To accept press CONFIRM soft key Guardrails Drug Library screen displays IMS Pre fill 30 mL G m Z Q d gt JJ m O Confirm Syringe Size The Priming option can be enabled at the time the Medley wae A oystem IS configured for use The Priming selection PRIME When priming soft key is available only after the syringe type and medication selection prior to infusion mode selection Ensure patient is not connected Ensure 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 CAUTION During priming the pressure limit alarms are temporarily increased to their maximum level GETTING STARTED 23 Preparing Infusion Continued Priming Continued 1 Press
34. ctions for use 2 Prepare administration set reference Set Compatibility Card provided separately and in this Directions for Use in accordance with manufacturer s directions for use 3 Attach upper fitting of administration set to syringe tip Use only standard or pre filled single use disposable syringes with luer lock connectors and non dedicated administration sets with anti siphon valves designed for use on syringe type PCA devices The use of incompatible syringe or administration set may cause improper instrument operation resulting in inaccurate fluid delivery or other potential hazards For a list of compatible syringes refer to the Compatible Syringes section in the Maintenance chapter For a list of compatible administration sets refer to the Set Compatibility Card provided separately and in this Directions for Use 16 GETTING STARTED Attaching and Detaching Dose Request Cord The Dose Request Cord must be attached to the PCA Module when delivering a PCA Dose or PCA Continuous Dose infusion To attach the Dose Request Cord e Insert latching connector into Dose Request Cord attachment The red marking on the latching connector should be aligned with the red marking on the Dose Request Cord attachment To detach the Dose Request Cord Hold the body of latching connector and pull straight away without twisting or turning from the Dose Request Cord attachment Red alignment mark
35. cular element such as administration set is latex free XXml Approximate administration set priming volume Expiration date for product will be identified near hour glass symbol Do not use if package is damaged Administration set with filter may be used 6 INTRODUCTION GETTING STARTED NOTE Although the Medley Medication Safety System is built R Only and tested to exacting specifications it is not intended to replace the supervision of IV infusions by medical personnel The user should become thoroughly familiar with the features and operation of the Medley System and exercise vigilance in its utilization A MULTI DICE is an alert describing the potential for serious consequences to the patient or user such as death injury or adverse reactions MUNI is an alert to take special care for the safe and effective use of the device For WARNINGS and CAUTIONS for the The Medley Point of Care Unit refer to the The Medley Point of Care Unit Directions for Use Warnings and Cautions When properly secured snapped the bottom latch provides a very secure connection between modules If not properly latched a module can be dislodged during operation KB k3 hAMA Do not use the Medley System in close proximity of Magnetic Resonance Imaging MRI WARN NG This instrument is designed to stop fluid flow under alarm conditions Periodic patient monitoring
36. ditional drugs concentrations press PAGE UP and PAGE DOWN soft keys e The facility may choose to prepopulate standard drug concentrations or leave an open entry __ _ _ mL and allow the clinician to enter the drug amount and diluent volume GETTING STARTED 27 Preparing Infusion Continued Programming An Infusion Continued 8 Confirm the drug and concentration selection and press Yes soft key To change selection press No soft key Is this correct gt Press Yes or No f Yes was selected and facility has defined a Clinical Advisory for that drug a message appears To continue programming press CONFIRM soft key f Yes was selected to continue programming drug amount and diluent volume as defined in Guardrails Drug Library are automatically entered for selected drug e f selected drug had mL concentration drug amount and diluent volume will need to be entered NOTES e Ifthe programmed mL concentration is outside the Guardrails Soft Limit a prompt appears before programming can continue If the YES soft key is pressed programming continues if the NO soft key is pressed the infusion must be reprogrammed e Ifthe programmed mL concentration is outside the Guararails Hard Limit for that care area a prompt appears before programming can continue The drug amount and diluent volume must be reprogrammed 9 Verify parameters are correct and press NEXT soft k
37. e outside the Guardrails Hard Limit for that care area a prompt appears before programming can continue The infusion must be reprogrammed G m Z Q d gt JJ m O 8 Close and lock security door Close and lock the door 9 Verify parameters on second nurse summary screen are correct and press START key e Infusion mode and PCA drug name scroll in Channel 10 minutes Message Display Main Display alternates between Volume Remaining Max Limit 25 mg 4h and PCA drug name with infusion mode Conc 1 mg mL e When PCA dose is delivered Green Infusing Status Indicator illuminates Rate display flashes DELIVERING PCA scrolls in channel message display When PCA Dose is complete PCA COMPLETE scrolls in Channel Message Display GETTING STARTED 31 PCA Infusion Modes Continued Setting Up Continuous Infusion Only The following procedures should be used when programming a Continuous Infusion Only infusion Perform steps in Preparing Infusion section of this Directions for Use 2 Press CONTINUOUS INFUSION soft key from Infusion Mode screen INFUSION MODE PCA Dose only Continuous Infusion PCA Dose Continuous Loading Dose Only gt Select an Option DRUG setur BRS 3 To enter continuous infusion dose press CONT DOSE soft Continuous key and use numeric data entry keys CONT ness mg h gs Limit None Conc 1 mg mL gt Ent
38. e with next step OR To start a new infusion select drug from the Guardrails Drug Library and follow steps for PCA Infusion Modes Al Guardrails Drug Library Med Sur Morphine 1 mg mL Morphine 5 mg mL Meperidine 10 mg mL gt Select Drug Concentration or Restore Previous Infusion 3 For restored parameters verify parameters are valid and press CONFIRM soft key NOTE To change a restored parameter a Press applicable soft key b Enter desired parameter using numeric data entry keys c Press CONFIRM soft key 25 mg 4 h Conc 1 mg mL Close and Lock Door Then Press CONFIRM CHANGE MODE CONFIRM 92 GETTING STARTED PCA Infusion Modes Continued Restoring Infusion Following Syringe Empty Continued 4 Close and lock security door 5 Verify programming parameters on summary screen are correct and press START key Stopping Infusion Press and hold CHANNEL OFF key on PCA Module for 1 second until a beep is heard NOTE If no other channel is active the System powers down when the CHANNEL OFF key is released Selecting Pressure Limit 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Pressure Limit soft key NOTE Option can be selected to change pressure limit e Before Infusion Mode is selected e Before Infusion starts Second Nurse Summary Morphine PCADose 2 mg Lockout Interval 10 minutes Max Limit 25 mg 4h Conc 1 mg mL
39. er Continuous Dose CHANGE MODE 4 To enter Max Limit press MAX LIMIT soft key press YES Soft key and use numeric data entry keys Continuous Morphine NOTE Time in hours associated with Max Limit will automatically be entered based on set up in system configuration 32 GETTING STARTED PCA Infusion Modes Continued Setting Up Continuous Infusion Only Continued 5 To enter Loading Dose press LOAD DOSE soft key press YES soft key and use numeric data entry keys Continuous Morphine NOTE Loading Dose is included in the VTBI but is not included in the MAX LIMIT 2 mg h 30 mg 4 Q m J 6 Verify parameters are correct and press CONFIRM soft gt key Q o NOTES If the programmed Continuous Dose Max Limit gt or Loading Dose are outside the Guardrails Soft Limit 2 mg h x for that care area a prompt appears before programming 30 mg 4h u can continue If the Yes soft key is pressed programming continues if the No soft key is pressed the infusion needs to be reprogrammed If the programmed Continuous Dose Max Limit or Loading Dose are outside the Guardrails Hard Limit for that care area a prompt appears before programming can continue The infusion needs to be reprogrammed 7 Close and lock security door 8 Verify programming parameters are correct and press START key Green Infusing Status Indicator illuminates e Infusion mode and drug name sc
40. ey to Guardrails Drug Lib confirm A cares rug Library AMOUNT 30 mg vame 30 mL Us Hour Units mg Conc 1 mg mL Press NEXT to Confirm DRUG 28 GETTING STARTED PCA Infusion Modes PCA Module Programming Parameters The Medley M PCA Module uses the following programming parameters depending on infusion mode selected Refer to the Features and Definitions of this Directions for Use for the definitions and features of the infusion modes 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 the initiation of PCA infusion Q m Z Q d gt JJ m O NOTE When the Medley Point of Care Unit is in the Infusion Mode Selection Infusion Setup or Bolus Setup screens a patient dose request from the dose request cord will be handled as an unmet demand Setting Up PCA Dose Only The following procedures should be used when programming a PCA Dose Only infusion 1 Perform steps in Preparing Infusion section of this Directions for Use 2 Press PCA Dose Only soft key from Infusion Mode screen Monae Drug Library INFUSION MODE
41. ge Empty sssssssssssssssssssssssssIR e lr 52 Oo SLOP OIC IMUSION ns hes emu i ML DDR LM A CIL LLLI DD least 53 m Selecting Pressure Iba es ssec ee ere A tuis db toile E uoo e ed 59 Viewing and Clearing Volume Infused ooooooocccccccccooooccccconn e e e e eren 54 Changing Syringe During Infusion oooooooccccccccoccccconcorcn II he ees 55 POWERING OE NEIN CEPR 56 POWErNG Of CHANG M 56 OMY SRC Oif oy SUS MN TRE RIT A A ETATE ENES 56 gt 5 m Z z gt lt TABLE OF CONTENTS ALARMS ERRORS MESSAGES DE FINITION St Sead dg sent Booey ee Spee she eres c 57 AUDIO CHARACTERISTICS Ari eset ee CO te ILL LI LE S A MIU OTOP 58 ALARMO O bum uM SELL CC E E A m Ia d Ua A LU renee eee dae tm IAM ME UA neat 59 Svyrmge AdiBdstimenAIBrs ses aet ii aa debet edo Dee a pos ate ties yt oldies uds cid 60 A MNERITMHHKH AAVEEAMMU 61 MESSAGES Siem A aL LM Duet M Ml i eC CE EE EE M MU D IA E MU 61 MAINTENANCE vim UONG c Q m 63 CONFIGURABLE SETTINGS sch pri NS Past EUREN ELO ai Eu RED ease 65 SEE apes dt Ioa e Prank petet Danai a et Sukie tRM UO VOLO cuta edu C A ci oU Rar eN 65 PCA Module Seting NE E TU rp 66 COMPATIBLE SYRINGES ciate tetera de tence eaten vers Vr MER a eee he tones etu Leda te eei Le nM D edd 67 COMPATIBLE SET enemy Rae ee ee femen qt reti ds ct tet S dS LEE 67
42. iggle blades to verify they are secure If any damage is suspected replace entire cord 4 Keypad Check membrane switches for damage Periodic inspections of the hardware are required For detailed instructions on performing periodic inspections and maintenance refer to the Medley Medication Safety System Technical Service Manual and supplemental service bulletins and Medley Maintenance Software WARNING k Failure to perform these inspections may result in improper instrument operation CAUTION Periodic inspections should only be performed by qualified service personnel 68 MAINTENANCE Service Information NOTE If the instrument shows evidence of damage in transit WARNING notify the carrier s agent immediately Do not return damaged Instruments returned from the equipment to the factory before the carrier s agent has service depot to your facility may be gM Een et set to factory defaults and not have If the instrument fails to respond as described in this a hospital defined data set loaded document and the cause cannot be determined do not use Biomedical personnel in the facility the instrument Contact ALARIS Medical Systems Technical ene responsible for checking in the Support instrument and ensuring the current hospital approved data set is Information or assistance may be obtained by calling one of the following Customer Service numbers United States 800 482 4822 Canada 800 387 8
43. ine 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 WARN NG 1 Ensure the syringe manufacturer and syringe size displayed matches the syringe manufacturer and syringe size installed in the Medley M PCA Module Mismatches may 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 refer to the Compatible Syringes section in the Maintenance chapter GWG The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site may impede the flow of common gravity only systems affecting their performance Hospital personnel must ensure the performance of the common IV site is satisfactory under these circumstances GG Each time the Medley System is turned on verify and or set the pressure alarm limit If the pressure alarm limit is not verified the instrument may not operate within the desired occlusion detection parameter s WARN NG 2 V Jh References in this document 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 G m
44. me drug amount and diluent volume and activates the hospital established best practice Guardrails Limits A Guardrails Safety Software data set is required prior to using the Medley PCA Module INTRODUCTION 3 Z zs o i C O i9 Z Features and Definitions Continued Guardrails Limit Loading Dose Lockout Interval Occlusion Pressure Operating Modes Near End of Infusion NEOI A Guardrails Limit is a programming limit or best practice guideline for programming a dose limit parameter or instrument configuration determined by the hospital health system and entered into the system s data set Dose limits can be defined by the hospital health system as either hard or soft limits e A Guardrails Hard Limit is a programmed limit that cannot be overridden e A Guardrails Soft Limit is a programmed limit that can be overridden The Loading Dose enables a clinician to program a bolus infusion prior to initiation of the PCA infusion The Loading Dose may be programmed from the Infusion Modes menu or applicable PCA PCA Continuous or Continuous Only programming screen prior to the start of a new PCA infusion program Allows the clinician to program a pre determined interval of time that must elapse between delivery of PCA doses Downstream occlusion alarm threshold can be set to low medium or high The PCA Module has four operating modes available e PCA only e Continuous Infu
45. must be performed to ensure the infusion is proceeding as expected WARN NG h The Guardrails Safety Software incorporates dosing limits and instrument configuration parameters based on hospital protocol The software adds a test of reasonableness to drug programming based on the limits defined by the hospital Qualified personnel must ensure the appropriateness of the drug dosing limits the compatibility of the drugs and the performance of each instrument as part of the overall infusion Potential hazards include drug interactions and inappropriate delivery rates and pressure alarms G m Z Q d gt JJ m O GETTING STARTED Warnings and Cautions Continued CANNA O10 a When loading a data set with the Guardrails Safety Software ensure the correct profile for patient care area is selected prior to starting an infusion Failure to use the appropriate profile could cause serious consequences WARN NG 1 1 l1 The Medley PCA Module 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 and filters It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions CANNA 1 01 Hospital personnel must ensure the compatibility of the drugs as well as the pe
46. ng an infusion 1 Perform steps in Preparing Syringe and Administration Set section NEW PATIENT Ww Yes Clears Previou 2 Perform steps in Start Up section to Patient Data S a Power on system b Choose Yes or No to New Patient gt Select Yes or No DISPLAY ONTRS GETTING STARTED 25 Preparing Infusion Continued Programming An Infusion Continued c Select profile if required i er i Midtown Hospital d Enter patient identifier if required Med Surg p NDS Same gt Select Yes or No Midtown Hospital 3 Press CHANNEL SELECT key VOLUME AUDIO INFUSED ADJUST 4 Unlock security door or set key to PROGRAM position Set key to Program position gt Set key to PROGRAM Position 5 Confirm time of day or change time if necessary Time of Day Current time 08 00 Time 26 GETTING STARTED Preparing Infusion Continued Programming An Infusion Continued 6 Perform steps in Preparing Infusion section to a Load syringe and administration set b Select and confirm syringe type and size c Prime syringe using Prime feature if desired Q m Z Q d gt JJ m O Press soft key next to desired drug and concentration e Drug Concentration screen access confirmation Al Guardrails Drug Library appears Med Surg Morphine 1 mg mL Morphine 5 mg mL NOTES Meperidine 10 mg mL e To view ad
47. o 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 Medley PCA Module typically exhibits a long term accuracy offset of approximately 0 296 or less from the mean value NOTE Tests conducted in accordance with IEC EN 60601 2 24 Particular requirements for safety of infusion pumps and controllers and AAMI ID26 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers using B D Plastipak 60cc Syringe and ALARIS Medical Systems Administration Set 30910 APPENDIX 71 gt U U m Z z gt lt Trumpet and Start Up Curves Continued mode Start up at 0 1 mL h initial 0 20 mode Trumpet Curve at 0 1 mL h initial 0 18 80 0 16 0 14 9 0 12 o M cm 0 10 i i 4 ij ly Ii ll i la D E oO E 0 08 IM l I li Il S 90 0 06 8 0 04 70 0 02 0 00 0 02 120 0 20 40 60 80 100 120 bs Ls T e m time min observation interval min Mode T tC t 1 mL h initial Mode Start up at 1 mL h initial E A 1 8 E 1 6 8 14 y E E 3 os 3 1 0 2 Bi c E ts 26 14 1 8 0 8 z 2 5 3 D 0 4 7 l 0 2 0 0 ae 0
48. of catheter Refer to Trumpet and Start Up Curves section in the Appendix for data on how these factors influence rate accuracy Type CF Defibrillator Proof PCA Module Type BF Defibrillator Proof Dose Request Cord Occlusion Pressure Limit pate mun NOTE The Maximum Time to Alarm specifications are based on ALARIS Medical Systems standard operating conditions Atmospheric Pressure 645 795 mmHg Back Pressure 0 mmHg before producing occlusion Humidity 20 9096 Temperature 68 4 F 64 MAINTENANCE Specifications Continued Bolus Volume after Occlusion Maximum Bolus Volume at Intermediate Rate 5 mL h Occlusion Pressure Limit Bolus Volume Weight 5 5 lbs NOTE Compliance to Standards The Medley Medication Safety System complies with the following standards UL 60601 1 including A1 and A2 CSA C22 2 No 601 1 including A1 and A2 IEC EN 60601 2 24 IEC EN 60601 1 2 and AAMI ID26 Configurable Settings If the configuration settings need to be changed from the Factory Default settings refer to the Guardrails Editor Software User Manual or contact ALARIS Medical Systems Technical Support for technical troubleshooting and preventive maintenance information NOTE With the Profiles feature enabled the settings are configured independently for each profile A hospital defined data set must be uploaded to enable the Profiles feature Date and Time is a system setting
49. on sets protocol and or government standards such as CDC refer to the Set Compatibility Card guidelines in the United States provided separately and in this pd Directions for Use e For IV push medication put instrument on hold clamp tubing above the port e Flush port s per facility protocol e Discard administration set per facility protocol GETTING STARTED 11 Warnings and Cautions Continued User Precautions Continued 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 the ECG monitoring system is not functioning under optimal conditions these currents may appear as artifacts simulating actual ECG readings To determine if ECG 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 Reference the appropriate ECG monitoring system documentation for instructions on setup and maintenance Radio Frequency Interference Operating the system near equipment which radiates high energy radio frequencies electrosurgical cauterizing equipment portable radios cellular telephones etc may cause false alarm conditions If this happens reposition the infusion device away from the source of interference or
50. on valve 30893 PCA Administration Set 113 Microbore w yellow striped tubing and anti siphon valve MAINTENANCE 67 Refer to the Medley Point of Care Unit Directions for Use Inspection Requirements To ensure the system remains in good operating condition both regular and periodic inspections are required Regular inspections consist of a visual inspection for damage and cleanliness and performing the procedure described in the Start Up section of this Directions for Use before each usage of the instrument Regular inspections must be performed by the hospital facility and if any damage is found service is required REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECT FOR DAMAGE Exterior Surface Each usage Pole Clamp Each usage Power Cord Each usage Keypad Each usage CLEANING As required START UP Each usage Exterior Surfaces examine for overall condition and verify here is no damage cracks or deformities Case is clean and free from IV solution residue Labels and markings are legible e No tape or other foreign material is on sides of case anything of this nature could prevent proper latching of modules e IUI Connectors have not been damaged 2 Pole Clamp Pole Clamp should be secure and functioning 3 Power Cord Assembly examine for e Signs of damage cuts or deformities in cord If damaged replace entire cord e Integrity of hospital grade power plug Attempt to w
51. or appropriate select control and then press START soft key Set up new infusion or press CHANNEL OFF key Verify syringe plunger movement is unimpeded Detach PCA Module from current position and reattach to the immediate right of the Medley Point of Care Unit ALARMS ERRORS MESSAGES 59 P gt o y 9 gt m m 3 vo JJ 9 Alarms Continued oyringe 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 e When problem is corrected press CONFIRM soft key Alarm Meaning Check Syringe Plunger grippers opened during infusion and then closed Infusion stops on affected channel Syringe barrel clamp opened during infusion and then closed Infusion stops on affected channel Syringe plunger not captured while in idle state System alarms after 30 seconds to indicate potential siphoning condition If security door is closed and syringe plunger is not captured the system will immediately alarm Drive Not Engaged Drive system disengaged during operation Syringe Installation y lever plunger flange clamp gt Check Syringe aa Syringe Installation Z lever plunger JL fl ange J jigi gt Press CONFIRM CONFIRM Response Securely lock plunger grippers press CHANNEL SELECT key and reselect syringe
52. ot included in the Max Limit If the programmed Loading Dose is outside the Guardrails Soft Limit for that care area a prompt appears before programming can continue If the Yes soft key is pressed programming continues if the No a CON soft key is pressed the infusion needs to be reprogrammed If the programmed Loading Dose is outside the Guararails Hard Limit for that care area a prompt appears before programming can continue The infusion needs to be reprogrammed 5 Close and lock security door GETTING STARTED 37 PCA Infusion Modes Continued Setting Loading Dose Continued Setting Loading Dose from Infusion Mode Screen Continued 6 Verify parameters on summary screen are correct and press START key e DELIVERING LOAD scrolls in Channel Message Display e Infusion mode and Drug name appear in Main Display e When Loading Dose is complete The Loading Dose has Completed appears on Main Display PRO PAUSE GRAM START 7 Press CONFIRM e Upon pressing Channel Select on PCA Module Infusion Mode screen becomes available for selection hei a dose has of Infusion Mode gt Press CONFIRM 38 GETTING STARTED PCA Infusion Modes Continued Setting Bolus Dose The following procedures should be used only when setting a Bolus Dose using the Guardrails Drug Library NOTES The BOLUS DOSE soft key is only available once an infusion has begun in PCA Dose Only Continu
53. ous Infusion or PCA Continuous Infusion Modes 1 Press CHANNEL SELECT on PCA Module 2 Press BOLUS DOSE soft key Summary Morphin Cont Dose 2 mg h Max Limit 30 mg 4h CER ARS DONILLAS Conc 1 mg mL gt Press START to Close Summary O PRO BOLUS dose START 3 Set key to PROGRAM position or enter 4 digit authorization code and press CONFIRM Set key to Program position or enter authorization code X kk xk gt Set Key to PROGRAM position or enter code CONFIRM 4 Use numeric data entry keys to enter dose value BOLUS DOSE 5 Press CONFIRM C3 NOTES If the programmed Bolus Dose is outside the Guararails Soft Limit for that care area a prompt appears before programming can continue If the Yes soft key is pressed programming continues if the No Cond 1 mami soft key is pressed the infusion needs to be ibid BEEN If the programmed Bolus Dose is outside the Guardrails Hard Limit for that care area a prompt appears before programming can continue The infusion needs to be reprogrammed GETTING STARTED 39 PCA Infusion Modes Continued Setting Bolus Dose Continued 6 If Authorization Code is disabled door must be locked prior to starting Bolus Dose 7 Verify dose value is correct and then press START soft key Cont Dose 2 mg h Max Limit 30 mg 4h e Delivering Bolus scrolls in Channel Message Display Bolus and drug name appears in Main Display
54. pecified on the Main Display The full list of permitted syringe models is dependent on the PCA Module s software version Manufacturer 20cc S0cc S5cc 50cc 60cc B D Plastipak v v v v IMS Pump Jet v Monoject v v v Terumo v v v v Prefilled Morphine Sulfate 1 mg ml NOTE Syringe variability may impact occlusion pressure sensing The variability may reduce the device s time to alarm and or may require that a higher alarm pressure limit be programmed Compatible Sets The following administration sets are for use with the GUNT Medley PCA Module For additional configurations contact Use only standard single use ALARIS Medical Systems Customer Care at 800 482 4822 disposable non dedicated administration sets with anti siphon valves designed for use on syringe type PCA devices The use of incompatible administration set may Cause improper instrument operation resulting in inaccurate fluid delivery or other potential hazards MODEL SET DESCRIPTION 30843E PCA Extension Set 12 Y Connector with SmartSite Needle Free Valve Port and backcheck valve 30853 PCA Administration Set 70 Microbore w Anti siphon valve Y Connector with backcheck valve P z zm m z gt z O m 30863 PCA Administration Set 63 Microbore w Anti siphon valve 30873 PCA Administration Set 90 Microbore w Anti siphon valve Y Connector with backcheck valve 30883 PCA Administration Set 92 Microbore w Anti siph
55. pped Bolus Dose 1mg History cleared gt Press PAGE DOWN or PAGE UP to View Events EXIT GETTING STARTED 47 CER ARS DSNILLAS PCA Infusion Modes Continued Configuring 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 the Dose Request Cord configuration 1 Press CHANNEL SELECT key ru RC caine 2 From Main Display press OPTIONS key 20 minutes Max Limit 25 mg 4h Conc 1 mg mL gt Press START oe PRO START 3 Press Dose Request Setup soft key Infusion Modes Patient History Dose Request Setup Drug Event History gt Select an Option or EXIT PAGE E 48 GETTING STARTED PCA Infusion Modes Continued Configuring the Dose Request Cord Continued 4 Review and select the Profile soft key for the desired operation of the dose request cord A Dose Request Setup Select the desired Profile 1 functional profile for the operation of the Dose Request Cord PCA delivery FLASHES Lockout interval OFF PROFILE 1 PROFILE 2 PROFILE 3 Dose Request Cord Met demands only All Demands All Demands CA Available CA Delivery ON FLASHING ockout Interva G m Z Q d gt JJ m O 5 Press CONFIRM
56. rformance of each channel as part of the overall infusion Potential hazards include drug interactions inaccurate delivery rates inaccurate pressure alarms and nuisance alarms CANNA 01 Use only standard or pre filled single use disposable syringes with luer lock connectors and non dedicated administration sets with anti siphon valves designed for use on syringe type PCA devices The use of any other syringe or administration set may cause improper instrument operation resulting in inaccurate fluid delivery or other potential hazards For a list of compatible syringes refer to the Compatible Syringes section in the Maintenance chapter For a list of compatible administration sets refer to the Set Compatibility Card provided separately and in this Directions for Use EZB 0 D 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 may cause serious injury or death AA J 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 8 GETTING STARTED Warnings and Cautions Continued WARN NG S When priming Ensure patient is not connected Ensure air is expelled from l
57. roll in Channel Message Display If a Loading Dose has been entered scrolls DELIVERING LOAD e Volume Infused in mL h in Rate Display PRO Main Display alternates between volume remaining and Infusion mode with drug name Cont Dose 2 mg h 30 mgi4 h Press START GETTING STARTED 33 PCA Infusion Modes Continued Setting Up PCA Dose Continuous Infusion The following procedures should be used when programming a PCA Dose Continuous Infusion 1 Perform steps in Preparing Infusion section of this Directions for Use 2 Press PCA DOSE CONTINUOUS soft key from Infusion Mode screen INFUSION MODE PCA Dose only Continuous Infusion PCA Dose Continuous Loading Dose Only gt Select an Option or CANCEL serue BEvS 3 To enter PCA Dose press PCA DOSE soft key and use numeric data entry keys l mg LOCKOUT minutes CONT Dose __ mg h C LIMIT None 4 To enter Lockout Interval press LOCKOUT INTERVAL soft key and use numeric data entry keys LOCKOUT uS 0 minutes CONT Dose J _ _ _ mg h MAX LIMIT None Conc 1 mg mL gt Select CONT DOSE CHANGE MODE 34 GETTING STARTED PCA Infusion Modes Continued Setting Up PCA Dose Continuous Infusion Continued 5 To enter Continuous Dose press CONT DOSE soft key press and use numeric data entry keys 1 mg O 10 minutes __2 mgh Conc 1 mg mL gt Dose 20 Will Exceed Max Flow Rate
58. s Dose Request Cord Attachment Latching Connector ai GETTING STARTED 17 Q m Z O A gt JJ m m O Powering On System Refer to the Medley Point of Care Unit Directions for Use Responding to Maintenance Reminder Refer to the Medley Point of Care Unit Directions for Use Choosing Yes or No to New Patient and Profile Refer to the Medley Point of Care Unit Directions for Use Selecting Profile Refer to the Medley Point of Care Unit Directions for Use Entering Patient ID Refer to the Medley Point of Care Unit Directions for Use 18 GETTING STARTED 1 Preparing Infusion Loading Syringe and Administration Set 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 Syringe Barrel Clamp Open CGN D Before loading the syringe check it for damage or defects Ensure 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 may cause serious injury or death Before loading or unloading the syringe always turn off fluid flow to the patient using the tubing clamp or stop
59. s device 12 GETTING STARTED Warnings and Cautions Continued User Precautions Continued Dropping Jarring Should an instrument 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 Operating Environment Not for use in the presence of flammable anesthetics lt DANGER amp Explosion risk if used in the presence of flammable anesthetics DANGER Q m Z O A gt JJ m m O EXPLOSI N HAZARD GETTING STARTED 13 Controls and Indicators Status Indicators Alarm Infusing red green IUI Connector Left Rate Display Channel Message Display Channel Identification Channel Select Key When pressed selects corresponding channel for infusion parameter entry and infusion setup Pause Key When pressed during an infusion temporarily stops infusion on that channel After approximately 2 minutes a visual and audio prompt begins Channel Off Key When pressed and held for one second and then released stops infusion on that channel deselects that channel and if only that channel had been operating system powers down Repeat for other operating channels to power off each channel Restart Key When pressed resumes operation of a previously paused or alarmed infusion on that channel Standby yellow as ES Gripper Control Drive He
60. s 19 OU Loading Syringe and Administration Set ooooooccccccccccccocccccccnn cnn ocn rr 19 Secumty LOCK Wey POSINONS sci festa suds adeno I SLE Ee AAN id 21 Selecting Syringe Type and Size ooo 22 gt AEI ANII TE nc ie ETE 23 gt Programming an Infusion ooo 25 I m PCAINFUSION MODES cio sri nit ests See pa doo gs ye Rade mendo qms deme iui uds oo uai ace E EE 29 i o PCA Module Programming Parameters sss e eres 29 gt m sating Up PCA Dose Vo dina RA Sd datei a o os ta Re rtm 29 Q y Setting Up Continuous Infusion ONIY aaao eee ee eme e e e elle e e a ler anio 32 y 3 Setting Up PCA Dose Continuous Infusion ooooooococcccccccccncnooccrnnnnn none ner rre 34 y Setting Loading DOSE Only 00 A A A KM E addas sis 37 o SECUN BOU S DO A cdi Ree Eres pig edu Ra APUD E AG eat teed EMI 39 Stopping a Loading PCA or Bolus Dose 15 eret DI t eu ld sates Crus A C Deb ata 40 Changing Programming Parameters During an Infusion sssssssssssssssssssssse 41 VIEWING Patient HIStory MT 43 Gleanng Patent FHIStON AAA tobias AER UM LEAL Sade ered ede be 45 gt Viewing Drug Event HISIOLV 2 ean rettet bp e het ee E Pete ee eet ti pe bale kac eer Het al e datu a 47 Configurng Dose Regduest Cord c eiae tee ta Send dein actes tae miles AA a diet ad Sie ina e es bone LA 48 Secutity ACCESS LEVEI A edP Meer 50 mic Uc Re IIMUSION it Ne Udo Ue in tra tad base ee Boy 51 i Restoring Infusion Following Syrin
61. s indicating the operating status of the Medley Medication Safety System The audio may be silenced for approximately two minutes by pressing the SILENCE key Alarm An audio and visual signal that a potentially unsafe condition is present Immediate action is required The audio may be silenced for approximately two minutes by pressing the SILENCE key Error An audio and or visual signal that a failure has been detected Immediate action is required Guardrails Alert A visual message to help reduce programming errors by indicating a Guardrails Limit soft or hard has been exceeded A response is required before programming can continue Guardrails Clinical Advisory A visual message when a designated drug is selected to remind clinician of specific hospital standards of practice when programming an IV medication A specific clinical advisory can be associated with a selected drug within any of the patient care profiles Maintenance Reminder A visual message that when enabled appears at startup when scheduled preventive maintenance is due overdue for any part of the Medley System Point of Care Unit or attached module Prompt A visual message appearing on the bottom line of the Main Display or in the Message Display The message may be accompanied by an audio signal that can be silenced for twelve seconds by pressing the SILENCE key ALARMS ERRORS MESSAGES 5 P gt o y 9 gt m E 0o JJ 9 Audio Ch
62. se request cord button Administration Sets and Syringes e For a list of compatible syringes refer to Compatible Syringes section in Maintenance chapter e For a list of compatible administration sets refer to Set Compatibility Card provided separately and in this Directions for Use Cie For specific administration set instructions refer to Use only standard or pre filled single Directions For Use provided with set For set priming and use disposable syringes with luer loading instructions refer to Preparing Infusion section of lock connectors and non dedicated this document administration sets with anti siphon valves designed for use on syringe type PCA devices The use of incompatible syringe or administration set may cause improper instrument operation resulting in inaccurate fluid delivery or other potential hazards Before operating instrument verify that administration set is free from kinks and installed correctly in instrument e The administration sets compatible with the Medley M PCA Module are supplied with a sterile fluid path for one time use Do not resterilize e Fluid path is STERILE and NONPYROGENIC For a list of compatible syringes refer e Discard if packaging is not intact or protector caps are to the Compatible Syringes section unattached in the Maintenance chapter For a For administration set replacement interval refer to facility list of compatible administrati
63. sion e PCA Continuous Infusion e Loading Dose Only All programming of infusions in each of the four modes are completed using the Guardrails Drug Library The NEOI option allows an alert to be configured to sound anywhere between 5 25 volume remaining 4 INTRODUCTION Features and Definitions Continued Patient History PCA Dose Priming Hestore oyringe Empty Syringe Volume Detection The PCA Module records and displays patient history for up to 24 hours and may be trended to the following intervals 1hr 2hr 4hr 8hr 12hr 24hr Patient history includes the following trending information e Total demands e Delivered demands e Total drug delivered e Time and date patient history last cleared e Average drug per hour e Total amount of drug delivered via PCA Dose Continuous Infusion Loading Dose Bolus Dose The PCA Dose enables a patient to self administer a bolus infusion to be delivered at programmed lockout intervals through the dose request cord When programmed in the PCA Continuous mode the continuous infusion will resume following the PCA dose The Priming option allows a limited volume of fluid to be delivered in order to prime the administration set prior to being connected to a patient or after changing a syringe When priming a single continuous press of the PRIME soft key delivers up to 2 mL of priming fluid To simplify programming the Restore feature can be used to rec
64. soft key GETTING STARTED 49 PCA 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 four 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 four digit authorization code is established and can be changed in the system configuration The four digit authorization code is the same for all profiles with Level 2 or Level 3 security access Security Access Level Initial Programming Setting Bolus Dose Subsequent Programming iwi XR 1 Rm Koy Key Rey Code or Key Rey Code or Key Code or Key The security code may be disabled for a specific infusion by using the following procedure 1 Press CHANNEL SELECT key 2 From Main Display press OPTIONS key 3 Press Security Code Access soft key Pressure Limit High Prime Set with Syringe Security Code Access gt Select an Option or EXIT PAGE 4 Press DISABLE CODE soft key 9 Press CONFIRM soft key ndi En cc ress O temporarily turn off code access The security access code will remain disabled until New il ae Patient Yes is selected in the Start Up of an infusion or if the unit remains powered off for more than eight hours gt Press DISABLE CODE or EXIT
65. t desired Infusion Mode sony INFUSION MODE PCA Dose only Continuous Infusion PCA Dose Continuous gt Select an Option or Cancel 6 Continue programming as outlined in Setting Up PCA Dose Only PCA Continuous Infusion or Continuous Infusion Only sections NOTE Previously programmed values are carried over to new program 7 Verify or change program settings and press CONFIRM key PCADose 2 mg Lockout Interval 20 minutes 8 Close and lock door Max Limit 25 mg 4h Conc 1 mg mL gt Press START PRO BOLUS PAUSE START 42 GETTING STARTED PCA Infusion Modes Continued Changing Programming Parameters During an Infusion Continued 9 Verify programming parameters on summary screen are A Second Nurse Summary correct and press START key Morph PCADose 2 mg Lockout Interval 20 minutes Max Limit 25 mg 4h Conc 1 mg mL gt Press START PRO BOLUS PAUSE zii Viewing Patient History CER ARS ONILLAS The following procedures should be used to view patient history 1 Press CHANNEL SELECT key Midtown Hospital Med Surg A Cont Morphine VOLUME AUDIO INFUSED ADJUST 2 From Main Display press OPTIONS key Summary Morphin Cont Dose 2 mg h Max Limit 25 mg 4h Conc 1 mg mL gt Press START to Close Summary PRO BOLUS GRAM DOSE START GETTING STARTED 43 PCA Infusion Modes Continued Viewing Patient History Continued
66. turn off the infusion device and manually regulate the flow with the clamp and or monitor the vital parameters using an appropriate clinical alternative Electromagnetic Compatibility EMC When using the Medley PCA Module in combination with a Medley Point of Care Unit which is interconnected to hospital data communications equipment and or nurse call systems signal input and signal output ports the external systems must be certified to applicable standards to ensure correct operation and electromagnetic compliance integrity Interconnected data communications systems must be certified to IEC 60950 data processing equipment or IEC 60601 1 electromedical equipment Nurse call systems must be certified to UL 1069 hospital signaling and nurse call equipment or comply with the requirements specified in IEC 60601 1 Compliance with the electromagnetic compatibility standard IEC 60601 1 2 is a function of all interconnected equipment including cabling and as such it is the responsibility of the hospital facility to ensure external equipment complies with the applicable EMC standards Failure to verify that external equipment meets applicable EMC standards may result in degraded electromagnetic compatibility refer to Radio Frequency Interference warning for additional information WARNING 1 Use of accessories or cables other than those specified may result in degraded electromagnetic compatibility performance of thi
67. uring infusion and then closed Infusion stops on affected channel Syringe barrel clamp opened during infusion and then closed Infusion stops on affected channel Syringe plunger not captured while in idle state System alarms immediately to indicate potential siphoning condition If security door is closed and syringe plunger is not captured the system will immediately alarm Door unlocked during infusion System will not infuse with door unlocked Increased back pressure sensed while infusing Infusion stops on affected channel Syringe is empty If syringe is not empty the syringe plunger travel may be impeded PCA Module is not in the preferable location to allow locking to the Point of Care Unit Device is not in a tamper evident position Reattach Dose Request Cord and press RESTART key To silence alarm and clear message from screen press CONFIRM soft key Reattach channel if desired ensuring it is securely clicked into place at Channel Release Latch If alarm is still present replace channel with an operational instrument 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 administration set clamp roller slide is in closed position Securely lock plunger grippers over syringe plunger Lock door and press RESTART key Clear occlusion press RESTART key
68. ys illustrated throughout this document are for illustration purposes only The display content will vary depending on configuration settings type of disposable in use hospital defined data set uploaded using the Guardrails Safety Software programmed drug calculation parameters and many other variables GETTING STARTED 15 G m Z Q d gt JJ m O Main Display Refer to the Medley Point of Care Unit Directions for Use for general information on the Main Display Title Bar Channel Status Midtown Hospital Med Surg B VTBI ALL 30 mL An outlined Channel Letter display indicates channel is attached and ready for use A solid Channel Letter display indicates channel is operating Soft Keys i rt INFUSED AUDIO ADJUST Channel Selected Indicator Active Soft Key Highlighted indicates a selected soft key Guardrails Drug Library Fentanyl _ _30 mcg mL A Inactive Soft Key Nonhighlighted indicates a nonselected soft key wits Hour DOSING UNITS mcg Prompt Bar Look here for user prompts gt Select DILUENT VOLUME LIBRARY Preparing Syringe and Administration Set 00 99999 NOTE Use Aseptic Technique 1 Prepare syringe reference Compatible Syringes section in Maintenance chapter in accordance with manufacturer s dire

Alaris Medley PCA Module 8120

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