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Alaris® Syringe Pump (with Plus Software)

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1. Alaris Editor Software Part Number Description 10005P01462 Alaris Editor and Alaris Transfer Tool Software Kit 10005P01463 Alaris Transfer Tool Software Kit 1000DF00545 Issue 1 44 46 Service Contacts For service contact your local Affiliate Office or Distributor AE CareFusion PO Box 5527 Dubai United Arab Emirates Tel 971 4 28 22 842 Fax 971 4 28 22 914 AU CareFusion 3 167 Prospect Highway PO Box 355 Seven Hills NSW 2147 Australia Tel 61 2 9838 0255 Fax 61 2 9674 4444 BE CareFusion Leuvensesteenweg 248 D 1800 Vilvoorde Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 CA CareFusion 235 Shields Court Markham Ontario L3R 8V2 Canada Tel 1 905 752 3333 Fax 1 905 752 3343 CH CareFusion Switzerland 221 S rl Critical Care A One Business Centre Zone d activiti s Vers la Pi ce n 10 1180 Rolle Switzerland Ph 0848 244 433 Fax 0848 244 100 CN CareFusion Shanghai Representative Office Suite A Floor 24 Shanghai Times Square Office Building No 500 Zhangyang Road Shanghai 200122 China Tel 86 21 58368028 Fax 86 21 58368017 DE CareFusion Pascalstr 2 52499 Baesweiler Deutschland Tel 49 2401 604 0 Fax 49 2401 604 121 DK CareFusion Firskovvej 25 B 2800 Lyngby Danmark TIf 45 70 20 30 74 Fax 45 70 20 30 98 ES CareFusion Edif
2. 121 mm h x 200 mm d Weight 2 7 kg excluding power cable Protection against fluid ingress IPX1 Protected against vertically falling drops of water 1000DF00545 Issue 1 30 46 Alarm Conditions Alaris Syringe Pumps Specifications Pressure Disc Out cc Drive Disengaged Occlusion Attention Nurse Callback Check Syringe Battery Low Titration not confirmed CC Battery Empty VTBI Done Line Occlusion Near End Of Infusion End of Infusion AC Power Fail Internal Malfunction Dose Under Dose Would Exceed Dose not Permitted Bolus Dose not Permitted Bolus Dose Under Bolus Dose Over Rate not Permitted Concentration not Permitted Weight Outside Limit Add Drug Not Complete Environmental Specifications Operating Temperature 0 C 40 C Operating Relative Humidity 20 90 Operating Atmospheric Pressure 700hPa 1060hPa Transport amp Storage Temperature 30 C 50 C Transport amp Storage Relative Humidity 10 95 Transport amp Storage Atmospheric Pressure 500hPa 1060hPa Electrical Mechanical Safety Complies with EN IEC60601 1 and EN IEC60601 2 24 EMC Complies with EN IEC60601 1 2 and EN IEC60601 2 24 1000DF00545 Issue 1 31 46 Alaris Syringe Pumps Compatible Syringes Compatible Syringes The pump is calibrated and labelled for use with single use
3. Alaris Syringe Pumps Products and Spare Parts Products and Spare Parts Alaris Infusion System Range of products in the Alaris Infusion System product family are Part Number Description 80013UN01 Alaris GS Syringe Pump 8002MEDO1 Alaris GH Syringe Pump with Plus Software 8003MEDO1 Alaris CC Syringe Pump with Plus Software 80043UNO1 Alaris TIVA Syringe Pump 80053UNO1 Alaris PK Syringe Pump 8003MEDO1 G Alaris CC Guardrails Syringe Pump with Plus Software 8002MEDO1 G Alaris GH Guardrails Syringe Pump with Plus Software 9002MEDO1 Alaris GP Volumetric Pump with Plus Software 9002MED01 G 80203UNSOx xx Alaris GP Guardrails Volumetric Pump with Plus Software Alaris Gateway Workstation For Workstation contact local customer services representative to obtain configurations availability and part numbers Spare Parts A comprehensive list of spare parts for this pump is included within the Technical Service Manual The Technical Service Manual 1000SM00001 is now available in electronic format on the World Wide Web at www carefusion com alaris intl A username and password are required to access our manuals Please contact a local customer services representative to obtain login details Part Number Description 10005P01122 Internal Battery Pack 1001FAOPT91 AC Power Lead UK 1001FAOPT92 AC Power Lead European
4. Configured Options menu using the keys and press the OK softkey 2 Use the keys to select a contrast ratio value The contrast of the display will change when scrolling through the numbers 3 When the desired value has been reached press the OK softkey to return to the Configured Options menu General Options 1 Select GENERAL OPTIONS from the Configured Options menu using the keys and press the OK softkey 2 Select the option required to enable disable or adjust and press the MODIFY softkey 3 When all the required modifications have been carried out press the QUIT softkey 4 Either select the next configuration option from the menu or turn the pump OFF returning it to operation as required NURSE CALL FITTED Enables Nurse Call hardware option NURSE CALL INVERT When enabled the nurse call output is inverted RS232 SELECTED Sets the pump s communications to use RS232 hardware option The NURSE CALL FITTED option must be enabled to allow RS232 to be enabled 1000DF00545 Issue 1 24 46 A Alaris Syringe Pumps Configured Options laris Editor Software Profile Configuration The following options are only configurable via the Alaris Editor Software PC based see Alaris Editor Directions For Use for details on how to configure Profile Configurations Data Set Configuration Settings Hospital Name Configure the name of the facility to be displayed on the pump Profile F
5. Curve BD Plastipak 50 ml 1 0 ml h Rate ml h Error 96 Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 1 8 Start up Trend BD Plastipak 50 ml 5 0 ml h Trumpet Curve BD Plastipak 50 ml 5 0 ml h E 3 85 o si S o We E l q g 40 g MN o LI a cc 30 Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 0 1 1000DF00545 Issue 1 42 46 Alaris Syringe Pumps Trumpet Curves and Start up Curves Alaris GH Syringe Pump and Alaris GH Guardrails Syringe Pump Rate ml h Rate ml h Rate ml h Start up Trend BD Plastipak 5ml 0 1ml h 0 2 0 1 0 0 0 20 40 60 80 100 120 Time mins Start up Trend BD Plastipak 50 ml 1 0 ml h Time mins Start up Trend BD Plastipak 50 ml 5 0 ml h Time mins Error 96 Error 96 Error 96 Trumpet Curve BD Plastipak 5ml e 0 1ml h o 5 10 15 20 25 30 35 Observation Window mins Maximum Error Minimum Error Linear Mean 2 5 Trumpet Curve BD Plastipak 50 ml 1 0 ml h Observation Window mins Maximum Error e Minimum Error Linear Mean 1 8 Trumpet Curve BD Plastipak 50 ml 5 0 ml h Observation Window mins Maximum Error Minimum Error Linear Mean 40 296 1000DF00545 Issue 1 43 46
6. G40020B Standard disposable extension set The following graphs show the typical values for time to alarm and bolus volume that can be expected in the event of an occlusion when the BD Plastipak 50 ml syringe is selected with a G40020B standard extension set hr min sec ml Time to alarm 1 0 ml h 2 00 typical 1 30 1 00 0 30 0 00 o M 4 6 8 10 Occlusion Level Bolus Volume without back off 200 typical 1 50 1 00 0 50 0 00 o N 4 6 8 10 Occlusion Level hr min sec ml Time to alarm 5 0 ml h 2 00 typical 1 30 1 00 0 30 0 00 0 2 4 6 8 10 Occlusion Level Bolus Volume with back off 200 typical 1 50 1 00 0 50 0 00 0 2 4 6 8 10 Occlusion Level Tests at low alarm levels may alarm immediately the force at these levels is commonly less than the friction in the syringe with no additional fluid pressure The result is that the pressure relating to the low forces will be less than the nominal quoted occlusion pressure Bolus volume following occlusion will be minimised by the back off feature if enabled The back off will reduce the line pressure by removing the volume stored in the occluded line and deduct this volume from the volume infused Back off will terminate if the pressure reaches the level recorded by the pump when the infusion was last started or a maximum back off volume has been withdrawn from the extension set It will also terminate if the volume in
7. Profile with defaults minimum limits maximum limits and occlusion alarm level Up to 100 drug set ups can be entered for each of the available 30 Profiles Pump configuration settings General Options and Units for Dosing Only 4 Review Approve and Export Data Set Using the Alaris Editor Review and Approve Export It is recommended that the entire data set report is printed reviewed and signed as proof of approval by an authorised person according to hospital protocol A signed copy of the data set report should be archived by the hospital for future reference Once a data set has been agreed it must be approved within the Alaris Editor using a secure password Export data set to allow data set to be uploaded to a pump by the Alaris Transfer Tool 5 Upload data set to the pump Using the Alaris Transfer Tool Note Selection of one profile will be required when uploading the data set to the Alaris GH Syringe Pump or the Alaris CC Syringe Pump 6 Prior to clinical use check that the Data Set ID on the approved data set report matches the Data Set ID shown on the pump 7 Switch the pump off 8 Switch the pump on and verify that the software version screen displays the correct data set version The pump is now ready to use 1 Drug parameters have to be in accordance to local protocols and prescribed information Data set transfers should only be performed by qualified technical personnel 100
8. To ensure that this pump remains in good operating condition it is important to keep it clean and carry out the routine maintenance procedures described below Interval Routine Maintenance Procedure Thoroughly clean external surfaces of the pump before and after prolonged period of As per Hospital Policy storage 1 Inspect AC power supply plug and cable for damage Each usage 2 Inspect case keypad and plunger for damage 3 Check Start up self test operation is correct Before the transfer of the pump toa Clean the pump by wiping over with a lint free cloth lightly dampened with warm water and new patient and as required a standard disinfectant detergent solution 1 If the pump is dropped damaged subjected to excessive moisture or high temperature immediately take it out of service for examination by a qualified service engineer All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied CareFusion will not be responsible should any of these actions be performed outside the instructions or information supplied by CareFusion For Preventative and Corrective Maintenance instructions please refer to the Technical Service Manual TSM All preventative and corrective maintenance and all such activities should be performed by a qualified service engineer only with reference to the TSM Please refer
9. be stored for an extended period it should be first cleaned and the internal battery fully charged Store in a clean dry atmosphere at room temperature and if available employ the original packaging for protection Once every 3 months during storage carry out functional tests as described in the Technical Service Manual and ensure that the internal battery is fully charged 1 Before cleaning always switch OFF and disconnect from the AC power supply Never allow liquid to enter the casing and avoid excess fluid build up on the pump Do not use aggressive cleaning agents as these may damage the exterior surface of the pump Do not steam autoclave ethylene oxide sterilise or immerse this pump in any fluid If the pump has visible cracks or damage to the case do not clean and immediately take it out of service for examination by a qualified service engineer Ensure the pressure transducer is free from residues which may prevent correct operation of the disc detector Disposal Information on Disposal for Users of Waste Electrical 8 Electronic Equipment This X symbol on the product and or accompanying documents means that used electrical and electronic products should not be mixed with household waste Ifyou wish to discard electrical and electronic equipment please contact your CareFusion affiliate office or distributor for further information Disposing of this product correctly will help to save valuable resources and prev
10. delivery of the preset bolus The display will show the bolus being delivered the bolus counting down and revert to main infusion display upon completion of the bolus 5 Toterminate a bolus being delivered press STOP softkey This will stop the bolus and continue infusing at the set rate Press the button to stop the bolus delivery and place the pump on hold 6 Ifthe bolus volume reaches the set bolus volume the bolus will stop and the pump will revert to infuse at the set infusion rate and continue infusing If the Hands Free bolus option is active then this feature will be cancelled following any interruption in delivery e g occlusion even if the bolus delivery is incomplete If the volume to be infused VTBI is reached during a bolus the VTBI complete alarm will sound Press to silence the alarm or CANCEL to acknowledge the alarm See VTBI section for more details on VTBI operation Any Hands Free Bolus dose setting which exceeds or is under a Guardrails Soft Alert must be confirmed before operation can be continued Manual Bolus The Manual Bolus is delivered by moving the plunger drive mechanism forward while the pump is infusing This method of delivering a bolus is not recommended as best clinical practice The syringe must be confirmed and the plunger mechanism has to move from an engaged position to disengage and then re engage position A minimum travel of 1mm leadscrew pitch must be detected to register m Guard
11. g 24h Disabled g kg 24h Disabled mU min Disabled mU kg min Disabled mU h Disabled mU kg h Disabled mU 24h Disabled mU kg 24h Disabled U min Disabled U kg min Disabled Unit Based U h Enabled U kg h Enabled U 24h Disabled U kg 24h Disabled kU min Disabled kU kg min Disabled kU h Disabled kU kg h Disabled kU 24h Disabled kU kg 24h Disabled mmol min Disabled mmol kg min Enabled mmol h Enabled mmol kg h Enabled mmol Based mmol 24h Disabled mmol kg 24h Disabled ml min Disabled ml kg min Disabled ml h Always ml kg h Disabled Volume Based Enabled ml 24h Disabled ml kg 24h Disabled 1000DF00545 Issue 1 27 46 Alaris Editor Software Profile Drug library Alaris Syringe Pumps Configured Options The following drug parameters are only configurable via the Alaris Editor Software see Alaris Editor Directions For Use for details on how to configure Profile Drug Library and are used when the pump is operated with a drug name selected Concentration Units The unit for concentration parameters Concentration Limits Min and Max These define the range over which the drug concentration can be modified during programming of the pump Continuous Dose Rate Units The continuous dose rate units Can be based on patient weight Soft Min The continuous dose rate value below which override confirmation is required Default The default continuous dose rate offered when t
12. is set or current VTBI is cleared Clear Volume This option enables the volume infused to be cleared The Dose Infused for a drug is displayed if the Volume Infused is attributable to a single drug setup Clearing the volume will display the Dose Infused 1 Press the VOLUME softkey to display the CLEAR VOLUME option 2 Pressthe YES softkey to clear the volume Press the NO softkey to retain the volume Note Selecting YES resets the volume infused in the 24H LOG option Rate Lock If Rate Lock is enabled when the infusion rate has been set and the infusion started the rate lock prompt will appear on the display following any rate titrations or bolus infusions To select the rate lock function press the YES softkey Press the NO softkey if the rate lock is not required When rate lock is enabled the following are unavailable Changing the infusion rate titration Bolus purge Switching the pump off VTBlover time infusions To disable the rate lock if selected 1 Press the button to access the options menu 2 Select the UNLOCK RATE option using the amp 227 32 keys and press the OK softkey To enable the rate lock if not selected 1 Press the button to access the options menu 2 Select RATE LOCK option using the AY keys and press the OK softkey Rate Titration If Rate Titration is enabled the rate can be adjusted while infusing 1 Selectthe new rate using the keys 2 The message lt START TO CO
13. on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effects 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 Short term fluctuations in rate accuracy may have clinical impact depending on the half life of the drug being infused therefore the clinical effect cannot be determined from the trumpet curves alone Start up and trumpet curves may not be indicative of operation under negative pressure 1 Differences in factors such as size and plunger force in compatible syringes produced by other manufacturers can cause variations in accuracy and trumpet curves as compared to those represented Additional curves for compatible syringes are available upon written request For applications where flow uniformity is a concern rates of 1 0ml h or above are recommended Alaris CC Syringe Pump and Alaris CC Guardrails Syringe Pum Start up Trend BD Plastipak 5ml 0 1ml h Trumpet Curve BD Plastipak 5ml 0 1ml h 30 0 0 2 20 0 T c 10 0 2 01 0 0 4 A o Ae ees siete eee ERN to i 10 0 cc 20 0 0 0 30 0 T T T T T T 1 0 20 40 60 80 100 120 0 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 4 0 Start up Trend BD Plastipak 50 ml 1 0 ml h Trumpet
14. oxide 1000DF00545 Issue 1 8 46 Alaris Syringe Pumps Operating Precautions Operating Pressure e This is a positive pressure pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system The pumping pressure alarm system is not designed to provide protection against or detection of IV complications which can occur Alarm Conditions TS Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating Guardrails Safety Software The Guardrails Safety Software incorporates soft dosing limits and pump 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 pump as part of the overall infusion Potential hazards include drug interactions and inappropriate delivery rates and pressure alarms When loading a data set with the Guardrails Safety Software the user must ensure the correct profile is selected prior to starting an infusion Hazards An explosion hazard exists if the pump is used in the presence of flammable anaesthe
15. review pump information 1 Press the button to access the options menu 2 Select PUMP DETAILS 3 Review the information and then press the QUIT softkey Note The following information will be displayed UNIT REFERENCE An identifier configured in Technician Mode by qualified technical personnel SN The Serial Number of the pump e S W Software version of the pump 1000DF00545 Issue 1 19 46 Alaris Syringe Pumps Basic Features Add Drug This option allows the user to add a drug whilst the pump is running a ml h infusion Note This option will not be available when operating the Alaris CC Syringe Pump or the Alaris CC Guardrails Syringe Pump in semi dedicated mode and using an extension set without pressure disc Press the button to access the options menu Select ADD DRUG option using the AY keys and press the OK softkey Select from Drug from the displayed list using the keys press OK to confirm Select drug name using the KW keys press OK to confirm Select concentration using the keys press OK to confirm if applicable Select patient weight using the keys press OK to confirm if applicable Confirm drug overriding Guardrails soft limits as appropriate Seley Adjust Alarm Volume zl OOV UY de poe c To change the alarm volume if enabled 1 Press the button to access the options menu 2 Select ADJUST ALARM VOLUME Note The pump will beep at the selected alarm volume setti
16. the cause of the blockage in the drive syringe or administration system before restarting the infusion ES Red Excessive pressure measured in the extension set at the pressure sensing disc exceeding LINE OCCLUSION the alarm limit Identify and remove the cause of the blockage in the drive syringe patient access site or administration system before restarting the infusion CHECK SYRINGE Red Incorrect size of syringe has been fitted the syringe has not been positioned correctly or has been disturbed during operation Check the syringe location and the position ES Red The pressure disc has been removed from the pressure transducer during the infusion PRESSURE DISC OUT Replace the pressure disc then restart the infusion BATTERY LOW Amber Battery charge low with 30 minutes operation remaining Reconnect to the AC power supply to charge the internal battery and continue operation If action is not taken the battery indicator will flash for 30 minutes followed by a continuous audible alarm red alarm indicator and message BATTERY EMPTY displayed indicating that the battery is too low to operate the pump BATTERY EMPTY Red The internal battery is too low to operate the pump Immediately connect the pump to the AC power supply and cycle the power to resume operation NEAR END OF INFUSION Amber The pump is nearing the end of the infusion This value can be configured END OF INFUSION Red The pump has reached the end of the infusion and the pump h
17. to Technical Service Manual for calibration procedures The units of measurement used in the calibration procedure are standard SI The International System of Units units Battery Operation The internal rechargeable battery allows continued operation when the AC power is unavailable for example during patient transfer or AC power failure Mean Time To Battery Empty from fully charged 5ml h amp 20 C under normal conditions is 6 hours From the battery low alarm it will take about 22 hours to 90 charge when reconnected to the AC power supply whether the pump is in use or not The battery is maintenance free sealed Nickel Metal Hydride and requires no routine servicing However to achieve optimum operation ensure that the battery is fully recharged after full discharge before storage and at regular 3 month intervals during storage It is recommended that only a qualified service engineer replaces the battery only use CareFusion recommended battery For further information regarding the replacement of batteries refer to the Technical Service Manual The battery pack used in this Alaris Syringe Pump is manufactured by CareFusion and includes a proprietary PCB printed circuit board designed specifically for the Alaris Syringe Pump and in conjunction with Alaris Syringe Pump software controls battery use charge and temperature Any use of battery packs that are not manufactured by CareFusion in the Alaris Syringe Pump
18. 0DF00545 Issue 1 3 46 Alaris Syringe Pumps Features of the Pump Features of the Pump ON OFF Q Pressure transducer for MDI Release lever High visibility Alarm Indicator PURGE BOLUS Finger Grips Positive Plunger Syringe Clamp Grippers HOLD Shelf for chevron keys and softkeys Rating Plate see Symbol Definitions for an explanation of the symbols used cc Pressure transducer Release lever for Rotating Cam Rotating Cam to lock on to horizontal rectangular bars IR Communications port Folded Pole RS232 Extension set Carrying Potential Handle Equalisation PE Clamp Connector connector 4 46 1000DF00545 Issue 1 Alaris Syringe Pumps Controls and Indicators Controls and Indicators Controls Symbol Description ON OFF button Press once to switch the pump ON Press and hold down for 3 seconds to switch the pump OFF RUN button Press to start the infusion The green LED will flash during infusion HOLD button Press to put the infusion on hold The amber LED will be lit while on hold MUTE button Press to silence alarm for two minutes configurable When not in alarm press and hold until three audible beeps are sounded for 15 minutes silence PURGE BOLUS button Press to access PURGE or BOLUS soft keys Press and hold down soft key to operate PURGE primes the extension set with fluid or drug during initial set up Pu
19. 1c 1 Directions For Use Alaris Syringe Pump with Plus Software Alaris Syringe Pumps Contents Page troduction ii AA A A 2 About This Manual iicet di dd a deeded 2 Creating a Data Stunt kee a oped Pak 3 Features of the Pump ee codecs cohen dred aden eae oa ad RENE RENE gure Mase bored gave dieu bera ene dears 4 Controls and Indicators 238 SES Cede A Ee pe SR sue eee hes 5 Symbol Definitions rrr tpe ERENNERT REENEN 6 Main Display Features s icc rte eta rue inta vtae dua otha cea eth eI E I UN eI EE UEM QE 7 Operating le LI CEET 8 Elle Ein 11 Loading and Confirming a Syringe 6 cece cece ene n en mH hh hene 13 Starting the PUMP sees p per e per p aie RU o EEN o op p t ag Ro USER RI RU RU SU ARA 15 Ee PH 17 Pressure Feat res aisoexesvas a e sera ALA RE CHER TPES sed ERATE E QOO PED FER S CR GERE 21 Alatrms and VE d Ur nior as 22 Config red Options eise escort n EE au Re PX IU Yr uy ERI ad Ehe Eh rag 24 Specification a ER EPOR REE IF IR A NPEF FERA AR a 29 Compatible Sytihiges E iii ee KEE d KEE d Nee EE dd Wee d Cie ds ER Associated Proc 29 REENERT EEN REENEN PT OU EA E P UII OR A Ie ts 33 Compatible Extension Sets Ae NENNEN ec REENEN A eee ee EN hoe ei eei NEEN 34 MAMA ET 36 Occl sion Pressure LIMITS venian anciana eee Ceres p PRI P IER EEG E 38 IrDA RS232 and Nurse call Specification coo ctr gis eure t Gee ERR eI ERR TRA CUI SA AG C n 40 Trumpet Curves and Start up CUlWes nassib ii ENEE E
20. 7128 Fax 1 858 458 6179 ZA CareFusion Unit 2 Oude Molen Business Park Oude Molen Road Ndabeni Cape Town 7405 South Africa Tel 27 0 860 597 572 Tel 27 21 510 7562 Fax 27 21 5107567 1000DF00545 Issue 1 45 46 Alaris Syringe Pumps Page Intentionally Left Blank 1000DF00545 Issue 1 46 46 Alaris Guardrails IVAC and SmartSite are registered trademarks of CareFusion Corporation or one of its subsidiaries All rights reserved All other trademarks are property of their respective owners 2009 2010 CareFusion Corporation or one of its subsidiaries All rights reserved This document contains proprietary information of CareFusion Corporation or one of its subsidiaries and its receipt or possession does not convey any rights to reproduce its contents or to manufacture or sell any product described Reproduction disclosure or use other than for the intended purpose without specific written authorization of CareFusion Corporation or one of its subsidiaries is strictly forbidden m CareFusion Switzerland 317 S rl CH 1180 Rolle CareFusion U K 305 Ltd RG22 4BS UK 1000DF00545 Issue 1 carefusion com
21. Data Transmit Data TXD Output Received Data RXD Input Power Input DSR Ground GND Not used Power Input CTS SO Qo c Ov Ur d amp tU M c GND DSR RXD TXD NCC 5 9 7 6 NC NCO CTS com Nurse call Relay Normally Closed NC C Nurse call Relay Normally open NC O Nurse call Relay Common NC COM 1000DF00545 Issue 1 41 46 Alaris Syringe Pumps Trumpet Curves and Start up Curves Trumpet Curves and Start up Curves In this pump as with all infusion systems the action of the pumping mechanism and variations in individual syringes cause short term fluctuations in rate accuracy The following curves show typical performance of the system in two ways 1 the delay in onset of fluid flow when infusion commences start up curves and 2 the accuracy of fluid delivery over various time periods is measured trumpet curves The start up curves represent continuous flow versus operating time 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 Tests performed per EN IEC60601 2 24 1998 standard Trumpet curves are named for their characteristic shape They display discrete 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
22. NEE OR Ed A ERR 42 Products and Spare Pats s AR E OUR IUS Ie ade ween deo TU ween telo T n o 44 Service COM cc 45 Document SEO Eeer ULT 45 1000DF00545 Issue 1 1 46 Alaris Syringe Pumps Introduction Introduction This Directions for use can be used with the following pumps Alaris CC Guardrails Syringe Pump Alaris CC Syringe Pump Alaris GH Guardrails Syringe Pump Alaris GH Syringe Pump Note All the above products are hereinafter referred to as pump except where different features are applicable then the specific pump will be stated or symbol used see Conventions used in this Manual section All the pumps above mentioned function with a wide range of standard single use disposable Luer lock syringes together with extension sets The pump accepts syringe sizes from 5ml to 50ml A full list of compatible syringes can be found in the Compatible Syringes section A list of recommended extension sets can be found in the Compatible Extension Sets section The Alaris Editor software for the pump allows the hospital to develop a best practice data set of intravenous IV medication dosing guidelines for patient specific care areas referred to as profiles Each profile contains a specific library of drugs as well as pump configurations appropriate for the care area A profile also contains Hard Limits that cannot be overridden during infusion programming The Alaris CC Guardrails Syringe Pump amp
23. NFIRM gt will flash on screen and pump continues to infuse at the original rate 3 Pressthe button to confirm the new infusion rate and start infusing at the new rate Note Press the QUIT softkey to exit titration and return to original rate Note If the new infusion rate setting exceeds or is under a Guardrails Soft Alert confirmation is required before infusion can start infusing at the new rate If Rate Titration is disabled the rate can only be adjusted whilst on hold 1 Pressthe button to put the pump on hold 2 Select the new rate using the ADV keys 3 Pressthe button to start infusing at the new rate A Guardrails 1000DF00545 Issue 1 18 46 Alaris Syringe Pumps Basic Features Dosing Summary To review currently selected dosing information 1 Press the button to first access the options menu 2 Select DOSING SUMMARY 3 Review the information and then press the QUIT softkey Set VTBI over Time This option allows a VTBI and delivery time to be specified The rate necessary to deliver the required volume within the specified time is calculated and displayed 1 Stop the infusion Press the 2 button to access the options menu 2 Select the SET VTBI OVER TIME option using the amp amp keys and press the OK softkey 3 Adjust the volume to be infused using the amp SY keys When the desired volume has been reached press the OK softkey 4 Enterthe time over which the volume is to be infused The i
24. The Alaris GH Guardrails Syringe Pump profiles also contain Guardrails Soft Alerts that can be overridden based on clinical requirements The hospital defined data set is developed and approved through pharmacy and clinical input and then configured into the pump by qualified technical personnel The Alaris CC Guardrails Syringe Pump and the Alaris GH Guardrails Syringe Pump with a data set loaded provides automatic alerts when a dosing limit bolus limit concentration limit or weight limit has been exceeded These safety alerts are provided without the need for the pump to be connected to a PC or network The Alaris CC Guardrails Syringe Pump and the Alaris CC Syringe Pump feature an in line pressure sensor technology capable of highly accurate real time pressure monitoring Improving the early detection of occlusions by reducing time to alarm and preventing the potential risk of post occlusion bolus Intended Use The intended use of the Alaris Syringe Pumps includes the following Intravenous fluid and drug therapy Intravenous blood and blood product therapy Epidural therapy Alaris CC Syringe Pump and Alaris CC Guardrails Syringe Pump only The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use DFU including general wards critical and intensive care neonatal operating rooms accident and emergency rooms and in ambulances The pu
25. YES If OVERRIDE LIMIT is not required press NO and adjust rate to be within the Guardrails Soft Alerts 1 If infusion rate running exceeds or is under the Guardrails Soft Alerts then the display will show INFUSING with either Up or Down arrows on both sides 15 Press to halt the operation ON HOLD will be displayed The amber stop light will replace the green start light tug Fully Dedicated to start an infusion a pressure disc must be fitted Semi Dedicated to start an infusion with DRUG NAME or DOSING ONLY selected a pressure disc must be fitted 1000DF00545 Issue 1 16 46 Alaris Syringe Pumps Basic Features Basic Features Bolus Infusion Bolus Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic purposes The pump should always be infusing and always attached to the patient Drugs given by an IV bolus could achieve immediate and high drug concentration levels Bolus can be used at the start of an infusion or during an infusion The bolus feature can be configured to a BOLUS Disabled b BOLUS Enabled Hands On only Hands Free and Hands On BOLUS Disabled If configured to Disabled pressing the Go button will have no effect and the pump will continue to infuse at the set rate u A Hands On bolus and Hands Free bolus cannot be administered if the rate lock is active or if the feature is disabled for the selected Profile or speci
26. and size leading to significant under or over infusion Secure the extension set to the pump using the extension set hook at the rear of the pump This provides protection against accidental dislodging of the syringe from the pump When combining several apparatus and or instruments with extension sets and other tubing for example via a 3 way tap the performance of the pump may be impacted and should be monitored closely Mounting the Pump The most accurate pressure monitoring in the extension set is achieved when the pump is positioned close to the patients heart level The pump must be mounted within 1 0m above or below the patient s heart e Raising a pump whilst infusing may result in a bolus of the infusate whereas lowering a pump whilst infusing may result in a delay in the infusion an underinfusion Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe To protect against the introduction of air the user should regularly monitor the progress of the infusion syringe extension line and patient connections and follow the priming procedure specified herein Operating Environment Intended environments include general wards critical and intensive care operating rooms accident and emergency rooms The pump may be used in an ambulance environment Ensure that the pump is appropriately attached using the provided pole clamp The
27. as stopped infusing A pre set volume will remain in the syringe to minimise the risk of the infusion of air bubbles into the set This value can be configured END OF INFUSION Amber The pump has reached the end of the infusion and the pump continues to infuse at KVO or set rate if lower TITRATION NOT Amber The infusion rate has been changed but has not been confirmed and 2 minutes has expired CONFIRMED without any operation Press the button to silence the alarm then press the CANCEL softkey to clear this message and silence the alarm Check infusion rate and confirm by pressing the button or press the button to revert to the previous rate This alarm only occurs if rate titration is enabled Pressing QUIT will cancel the titration and keep the original rate VTBI DONE Red The pre set Volume To Be Infused is complete and the pump has stopped infusing VTBI DONE Amber The pre set Volume To Be Infused is complete and the pump continues to infuse at set rate or at KVO rate 1000DF00545 Issue 1 22 46 Alaris Syringe Pumps Alarms and Warnings Display Alarm Description and Troubleshooting Guide Indicator AC POWER FAIL Amber AC Power has been disconnected and the pump is operating on battery power if this Error Code and Message Red occurs when the pump is infusing the message INFUSION CONTINUES will be displayed Reconnect AC power supply or press the button to silence the alarm and continue with battery operation The alarm
28. bolus volumes to be achieved Bolus volumes can be minimised as described in the Alarms and Warnings Occlusion or by enabling the back off general option Pressure Occlusion level on Alaris GH Syringe Pump or other pumps with occlusion levels L2 approx 200 mmHg 300 L Auto pressure setting on Alaris CC Syringe Pump e g 55 mmHg T1 T2 x C E Alarm Alaris GH Syringe Pump Auto Setting L1 1004 Alaris CC Syringe Pump 777v Alarm Alaris CC Syringe Pump Typical running m i pressure 25mmHg Occlusion ri Time T2 With a Pressure Extension Set fitted G30402M Standard disposable extension set Q The following graphs show the typical values for time to alarm and bolus volume that can be expected in the event of an occlusion when the BD Plastipak 50 ml syringe is selected with a G30402M extension set with occlusion sensing disc Time to alarm 1 0 ml h Time to alarm 5 0 ml h 2 00 02 typical 2 00 02 typical 1 30 02 1 30 02 VW VW 9 9 c 1 00 01 E 1 00 01 lt lt 0 30 01 0 30 01 0 00 00 0 00 00 css 0 200 400 600 800 1000 0 200 400 600 800 1000 mmHg mmHg Bolus Volume without back off Bolus Volume with back off 2 00 typical 2 00 typical 1 50 1 50 1 00 100 E E 0 50 0 50 0 00 0 00 0 200 400 600 800 1000 O 200 400 600 800 1000 mmHg mmHg 1000DF00545 Issue 1 38 46 Alaris Syringe Pumps Occlusion Pressure Limits Without a Pressure Extension Set fitted
29. disposable Luer lock syringes Only use the size and type of syringe specified on the pump display The full list of permitted syringe models is dependent on the software version of the pump 5ml 10ml 20ml 30ml 50ml IVAC Y AstraZeneca Y B Braun Omnifix Y Y Y Y Y B Braun Perfusor Y Y BD Perfusion Y BD Plastipak Y Y Y Y Y BD Precise Y Y Codan Y Y Y Y Codan Perfusion Y Fresenius Injectomat Y Y Monoject Y Y Y Y Y Nipro Y Y Y Y Pentaferte Y YA Y Y Rapiject Y Terumo Y va Y Y Y The Rapiject 50ml syringe is a specialised syringe with a large diameter barrel To provide protection against accidental dislodging always ensure the extension set is secured using the extension set hook see Loading and Confirming a Syringe section TYCO Healthcare KENDALL MONOJECT 1 To minimise the risk of incorrect confirmation of the syringe type it is recommended that only syringe types available in the hospital are configured on the pump 1000DF00545 Issue 1 32 46 Syringe Pumps Associated Products IS a A Associated Products The Alaris DS Docking Station The Alaris Gateway Workstation jm in b IST i ee DA li AE AA AE AE AC UL e KS 33 46 1000DF00545 Issue 1 Ala
30. djust to appropriate required rate 1000DF00545 Issue 1 23 46 Alaris Syringe Pumps Configured Options Configured Options This section comprises of a list of options which are configurable Some can be entered via the pump configuration menu available in Technician Mode and others through the Alaris Editor Software Enter the access code on the pump for Configured Options see the Technical Service Manual for details 1 Access codes should only be entered by qualified technical personnel Use Alaris Editor to configure general options drug library and units enabled for each profile and to configure Syringe Brands and Models to be enabled Clock Set 1 Select CLOCK SET from the Configured Options menu using the amp ACV keys and press the OK softkey 2 Use the amp ACV keys to adjust the date displayed pressing the NEXT softkey to access the next field 3 When the correct time and date are displayed press the OK softkey to return to the Configured Options menu Language This option is used to set the language of messages shown on the pump display 1 Select LANGUAGE from the Configured Options menu using the keys and press the OK softkey 2 Usethe ADY keys to select the language 3 When the desired language has been selected press SELECT softkey to return to the Configured Options menu Contrast This option is used to set the contrast on the pump display 1 Select CONTRAST from the
31. en the battery will require recharging or re connection to mains power supply mE BH C TINFUSINGT Guardrails Soft Alert icons Indicates the pump is running at a rate or dose above pointing up or below pointing down a Guardrails Soft Alert 1INFUSINGI D Hard limit Warning icon Indicates the setting entered is not permitted as it is under or exceeds a Hard Limit 1000DF00545 Issue 1 7 46 Alaris Syringe Pumps Operating Precautions Operating Precautions Luer Lock y In Disposable Syringes and Extension Sets The pump has been calibrated for use with single use disposable syringes To ensure correct and accurate operation only use 3 piece Luer lock versions of the syringe make specified on the pump or described in this manual Use of non specified syringes or extension sets may impair the operation of the pump and the accuracy of the infusion Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump or if it is removed from the pump before the extension set is properly isolated from the patient Isolation may include closing a tap in the patient line or activating a flow stop clamp The user must be thoroughly familiar with instructions in this Directions For Use and understand how to load and confirm the syringe on the pump Incorrect syringe loading may result in misidentification of the syringe type
32. ent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling Information on Disposal in Countries outside the European Union This symbol is only valid in the European Union The product should be disposed of taking environmental factors into consideration To ensure no risk or hazard remove the internal rechargeable battery and the Nickel Metal Hydride battery from the control board and dispose of as outlined by the local country regulations All other components can be safely disposed of as per local regulations 1000DF00545 Issue 1 37 46 Alaris Syringe Pumps Occlusion Pressure Limits Occlusion Pressure Limits Time to alarm following occlusion is achieved in less than 30 minutes at rates of 1 ml h and higher by the appropriate selection of occlusion levels Use of the dedicated pressure set is recommended for the Alaris CC Syringe Pump and the Alaris CC Guardrails Syringe Pump Its use permits the occlusion alarm pressure mmHg to be set accurately with a small operating margin between the alarm and normal infusion pressures When using infusion pumps without a pressure set line pressures are estimated from pumping force For this reason the occlusion alarm needs to be set with an operating margin of at least one level between the alarm and normal infusion levels The ability to set a small operating margin permits short time to alarm and small potential
33. eptic techniques 1 Squeeze the finger grips together on the plunger holder and slide the mechanism to the right 2 Pullthe syringe clamp forward and down 1000DF00545 Issue 1 13 46 3 Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange clamp Alaris Syringe Pumps Loading and Confirming a Syringe H To ensure the syringe is loaded correctly place the barrel flange in the space between the syringe clamp and the syringe flange clamp This is correct if the syringe remains in position before the syringe clamp is closed 4 Lift the syringe clamp until it locks against the syringe barrel 5 Squeeze the finger grips on the plunger holder and slide the mechanism to the left until it reaches the plunger end 6 Release the finger grips Ensure that the plunger grippers are securing the plunger in place and the finger grip returns to its original position 7 Ensure that the syringe type and size match those displayed on the pump then press CONFIRM If required the make of syringe can be changed by pressing the TYPE softkey ON HOLD 3 o4un gt 3 00 mg kg h ADJUST Note If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the extension set can be purged as required however ensure that the extension set is not connected to the patient during this process H CareFusion recommends to limit the numbe
34. ernatively contact your local CareFusion representative for further guidance Accessories Do not use any non recommended accessory with the pump The pump is tested and compliant with the relevant EMC claims only with the recommended accessories Use of any accessory transducer or cable other than those specified by CareFusion may result in increased emissions or decreased pump immunity This pump is a CISPR 11 Group 1 Class A device and uses RF energy only for its internal function in the normal product offering Therefore its RF emissions are very low and are not likely to cause any interference with the nearby electronic equipment However this pump emits a certain level of electromagnetic radiation which is within the levels specified by EC EN60601 1 2 and IEC EN60601 2 24 If the pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation In some circumstances the pump may be affected by an electrostatic discharge through air at levels close to or above 15kv or by radio frequency radiation close to or above 10v m If the pump is affected by this external interference the pump will remain in a safe mode the pump will duly stop the infusion and alert the user by generating a combination of visual and audible alarms Should any encountered alarm condition persist even after user intervention it is recommended to replace that particular pump and quarantine the pump for t
35. ert Min to above a Soft Alert Max will also need to be confirmed Event Log The event log can be set to be displayed or not on main display Events are still recorded in the log Pressure Display Sets whether the Pressure Information is available on the display Quiet Mode Mode to silence key press tones and power down sequence Rate Titration Feature to adjust the infusion rate while the pump is infusing without putting the pump on hold Rate Lock Anti tamper feature which prevents rate changes bolus operations and powering pump down Standby Mode Sets whether the Standby Mode is available on the pump VTBI Clear Rate Infusion rate will be set to zero when VTBI has been completed Weight Default The default patient weight in kg Weight Soft Minimum Guardrails The minimum patient weight in kg This is a Guardrails Soft Alert and can be overridden Weight Soft Maximum Guardrails The maximum patient weight in kg This is a Guardrails Soft Alert and can be overridden 1000DF00545 Issue 1 25 46 Alaris Syringe Pumps Configured Options General Syringe Pump Configurations Back Off An automatic feature which is activated following an occlusion The pump action reverses and pumps backwards to release the pressure which has built up in the infusion system this minimises the post occlusion bolus Display Syringe Brand Sets whether the syringe brand and size is sho
36. fic drug During BOLUS the pressure limit alarm is temporarily increased to the maximum level BOLUS Enabled Hands On In Hands On Bolus press and hold the flashing BOLUS softkey to deliver the required bolus The bolus rate can be adjusted The bolus volume is limited in the configuration 1 During infusion press the C button once to display the bolus screen 2 Usethe amp amp keys to adjust the bolus rate if required 3 To deliver the bolus press and hold the BOLUS softkey During the bolus the volume being infused is displayed When the desired bolus volume has been delivered or the bolus volume limit is reached release the softkey The bolus volume is added to the total volume infused BOLUS Enabled Hands Free and Hands On The Hands Free Bolus is delivered with a single press of the flashing BOLUS softkey The bolus rate and bolus volume are set by drug profile in the data set and can be changed within limits set by the data set 1 During infusion press the Ga button to display the Hands Free bolus selection screen 2 Pressthe YES softkey to go to Hands Free selection bolus screen press the HANDS ON softkey for Hands On bolus see section above 3 Usethe keys to set the bolus volume dose required If necessary use the RATE softkey and the ASV keys to adjust the bolus delivery rate Note Rate may be restricted by the syringe size and the CAP BOLUS RATE 4 Pressthe flashing BOLUS softkey once to begin the
37. fused reaches 0 0ml or a VTBI reaches the value at which it was set 1000DF00545 Issue 1 39 46 IrDA Alaris Syringe Pumps IrDA RS232 and Nurse call Specification RS232 and Nurse call Specification IrDA RS232 Nurse call Feature The IrDA or RS232 Nurse call is a feature on the pump that allows connection to a PC or another Alaris Syringe Pump This allows data to be transferred between the pump and a PC or another Alaris Syringe Pump e g data sets to be uploaded to the pump Event Reports to be downloaded from the pump and the pump to be monitored remotely via a suitable central monitoring or computer system H The nurse call interface provides a remote backup to the internal audible alarm It should not be relied upon to replace monitoring of the internal alarm Refer to the Technical Service Manual for further information regarding the RS232 interface Since it is possible to control the syringe pump using the RS232 interface at some distance from the pump and hence remote from the patient responsibility for the control of the pump is vested in the software run on the computer control system The assessment for the suitability of any software used in the clinical environment to control or receive data from the pump lies with the user of the equipment This software should include detection of the disconnection or other failure of the RS232 cable The protocol is detailed in the Alaris Syringe Pump Comm
38. hanged by pressing the TYPE softkey Note If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the extension set can be purged as required however ensure that the extension set is not connected to the patient during this process 11 Purge if required Press the button and then press and hold the PURGE softkey until fluid flows and the purging of the extension set is complete Release the softkey The volume used during purging will be displayed u Gi Purge extension set massaging pressure disc to prevent ballooning and ensuring all air removal 12 Check the rate shown if set and change the rate if necessary using the ADP keys 13 Connect the extension set to the patient access device 14 Press to commence operation The amber stop light will be replaced by the flashing green start light to indicate that the pump is in operation INFUSING will be displayed Note If infusion rate exceeds the Hard Limit then the pump will not start and the display will Show DOSE NOT PERMITTED Guardrails e Ifthe infusion settings are within the Guardrails Soft Alerts then the amber stop light will be replaced by the flashing green start light to indicate that the pump is in operation INFUSING will be displayed Note If infusion rate exceeds or is under the Guardrails Soft Alerts then check infusion setting to continue with infusion at set rate press and then confirm OVERRIDE LIMIT by pressing
39. he attention of appropriately trained technical personnel Consult Technical Service Manual for further information 1000DF00545 Issue 1 10 46 Alaris Syringe Pumps Getting Started Getting Started Initial Set up 1 Before operating the pump read this Directions For Use manual carefully 1 Check that the pump is complete undamaged and that the voltage rating specified on the label is compatible with your AC power supply 2 Items supplied are Alaris Syringe Pump User Support CD Directions For Use AC Power Cable as requested Protective Packaging 3 Connect the pump to the AC power supply for at least 2 2 hours to ensure that the internal battery is charged verify that the AOE is lit Language Selection 1 Oninitial start up the pump will display the Select Language screen 2 Select the required language from the list displayed using the amp DCV keys 3 Pressthe OK softkey to confirm your selection 1 e The pump may be used safely with the pre installed default data set Any data set created for installation must be approved by an appropriately qualified person with clinical authority in accordance with hospital protocol prior to upload and activation The pump will automatically operate from its internal battery if the pump is switched on without being connected to the AC power supply Should the pump fail to perform correctly replace in its original protective packaging where p
40. he drug is selected Soft Max The continuous dose rate value above which override confirmation is required Hard Max The maximum allowed continuous dose rate Bolus Mode Bolus feature can be set to one of the following options e Disabled Hands On only e Hands Free and Hands On Bolus Dose Units The bolus dose units Can be based on patient weight Soft Min The bolus dose value below which override confirmation is required Hands Free only Default The default bolus dose offered Hands Free only Soft Max The bolus dose value above which override confirmation is required Hands Free only Hard Max The maximum allowed bolus dose Bolus Rate Default The default value for bolus rate in ml h GH The default occlusion alarm pressure Occlusion Alarm Pressure Occlusion Alarm Pressure Q The default occlusion alarm pressure A Guardrails Profile Syringe Library The Profile Syringe Library is created from the predefined Master Syringe Library Check the boxes of the syringes to be included in the profile Checking the All Syringes checkbox under Operations selects all the syringes For Syringe brands and sizes available see Compatible Syringes section Note It is recommended that only syringe types and sizes used in the care area are selected 1000DF00545 Issue 1 28 46 Alaris Syringe Pumps Specifications Specifications Infusion Specifications Maximum infusion rate can be set as pa
41. he maximum rate for the syringe and can be set as part of the configuration 100ml h 500ml h The purge volume range is 0 5ml 5ml During PURGE the pressure limit alarms are temporarily increased to their maximum level Keep Vein Open KVO Rate 0 1 ml h 2 5ml h End Of Syringe Rate Stop KVO 0 1ml h to 2 5ml h or set rate if lower than KVO Volume To Be Infused VTBI 0 10ml 1000ml 1min 24h VTBI Complete Rate Stop KVO 0 1ml h to 2 5ml h set rate if lower than KVO or continue at set rate Near End Of Infusion Alarm 1min 15min to end of infusion or 1096 of syringe volume whichever is smaller 1000DF00545 Issue 1 29 46 Alaris Syringe Pumps Specifications End Of Infusion EOI Alarm 0 1 5 of syringe volume Maximum Pumping Pressure Limit Highest alarm level 1000mmHg nominal at L 10 Occlusion Accuracy without pressure set 96 of full scale Pressure mmHg L 0 L 3 L 5 L 10 approx 50mmHg approx 300mmHg approx 500mmHg approx 1000mmHg Temp 23 C 18 21 23 28 Occlusion Accuracy with pressure set of full scale 9 Pressure mmHg 0 25 500 1000 Temp 23 C 2 4 5 6 Temp 5 C 40 C 4 7 7 10 Using most common 50ml syringes under normal conditions 95 confidence 95 of pumps System Accuracy Volumetric Mean 2 for rates 1ml h nominal Derat
42. hould click into position when fitted to the bar Ensure that the pump is positioned securely To release push the release lever and pull the pump forwards St des DO NA Rectangular bar Release lever push to release Rotating cam E A Alaris Gateway Workstation and Alaris DS Docking Station 1000DF00545 Issue 1 12 46 Alaris Syringe Pumps Loading and Confirming a Syringe Loading and Confirming a Syringe 1 Warning To securely load and confirm a syringe carefully follow the steps below An incorrect loading of a syringe may result in misidentification of the syringe type and size If then confirmed this may lead to significant inaccuracy of the infusion rate and may also affect pump performance Only use a syringe of the type stated on the pump or in this manual Using an incorrect syringe could adversely affect the accuracy of the infusion rate and may also affect pump performance When drawing fluid into the syringe draw enough to compensate for any dead space volume in the extension set and syringe at the end of infusion as this cannot be fully infused Plunger et Plunger Flange Grippers Plunger Plunger Holder Syringe Barrel Barrel Flange Syringe Clamp Syringe Flange Clamp Place the pump on a stable horizontal surface or secure as described previously Prepare load and prime the single use disposable syringe and extension set using standard as
43. icio Veganova Avenida de La Vega n 1 Bloque 1 Planta 1 28108 Alcobendas Madrid Espana Tel 34 902 555 660 Fax 34 902 555 661 FR CareFusion Parc d affaire le Val Saint Quentin 2 rue Ren Caudron 78960 Voisins le Bretonneux France T l 33 1 30 05 34 00 Fax 33 1 30 05 34 43 Document History Revision 1 9683 CO Number Date October 2009 GB CareFusion The Crescent Jays Close Basingstoke Hampshire RG22 4BS United Kingdom Tel 44 0800 917 8776 Fax 44 1256 330860 HU CareFusion D brentei t r 1 H 1013 Budapest Magyarorsz g Tel 36 14 88 0232 Tel 36 14 88 0233 Fax 36 12 01 5987 IT CareFusion Via Ticino 4 50019 Sesto Fiorentino Firenze Italia T l 39 055 30 33 93 00 Fax 39 055 34 00 24 NL CareFusion De Molen 8 10 3994 DB Houten Nederland Tel 31 30 228 97 11 Fax 31 30 225 86 58 NO CareFusion Solbr veien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 Alaris Syringe Pumps Service Contacts NZ CareFusion 14B George Bourke Drive Mt Wellington 1060 PO Box 14 518 Panmure 1741 Auckland New Zealand Tel 09 270 2420 Freephone 0508 422734 Fax 09 270 6285 SE CareFusion Hammarbacken 4B 191 46 Sollentuna Sverige Tel 46 8 544 43 200 Fax 46 8 544 43 225 US CareFusion 10020 Pacific Mesa Blvd San Diego CA 92121 USA Tel 1 800 854
44. ight and OK to confirm if required e Press OK to confirm dosing information Go to step 8 7 DRUG NAME a Select Concentration required press OK to confirm Concentration or MODIFY to change Drug amount and total volume to be used If the dose amount and total volume are not defined in the data set then they will need to be set as follows Adjust dose amount and OK to confirm Use UNITS softkey to change concentration unit if required Adjust Total Volume and OK to confirm b Adjust Weight and OK to confirm if required c Press OK to confirm setup Go to step 8 1 Steps for Drug Name setup may vary dependant on how the profile is configured in the Alaris Editor 8 Load the syringe according to the procedure in this manual 1000DF00545 Issue 1 15 46 Alaris Syringe Pumps Starting the Pump 9 Insert the pressure disc into the pressure transducer Q 1 Gi Pressure Transducer Detects if an extension set with a pressure disc is fitted The pressure transducer will measure positive pressures within the extension set Warning To remove or insert pressure disc from or into pressure transducer assembly insert finger into the recess in the pressure disc and pull forward or push back with care Do not pull the extension set to remove or to insert the pressure disc 10 Ensure that the syringe type and size match those displayed on the pump then press CONFIRM If required the make of syringe can be c
45. ilter Controls whether the user is able to filter which profiles will be available on the pump Guardrails ees Microgram The text used to display microgram either mcg or ug Unit Display Unit The text used to display Units either mU U and kU or mUnit Unit and kUnit General Pump Configuration S AC Fail Audio Volume The AC Power Failure Alarm can be set to sound or be silent if the AC power is removed The audio alarm volume of the pump high medium or low Audio Volume Adjustable Sets whether the user is able to adjust the audio volume setting Auto Night Mode Main Display Backlight dims between hours 21 00 and 06 00 Auto Save Feature to retain previous settings when pump is switched on Battery Icon Indicator displaying the remaining estimated battery capacity Callback Time Adjusts the length of time before the pump sounds the call back alarm Drug Override Mode Guardrails Always Confirmation of setting will be required for any changes made to the dose rate that are outside of the Guardrails Soft Alerts Smart Confirmation of setting will be required on first dose rate set outside of the Guardrails Soft Alert Any subsequent changes will not require confirmation until after the dose rate has been confirmed inside the Guardrails Soft Alert limits Additionally any changes in dose rate from above a Soft Alert Max to below a Soft Alert Min or from below a Soft Al
46. ing Temperature 0 5 5 40 C High Rates 2 0 rates gt syringe volume h eg gt 50ml h in a 50ml syringe System accuracy is 2 typical by volume as measured using the trumpet curve test method defined in 1 EN IEC60601 2 24 at rates of 1 0ml h 23 C and above when the pump is used with the recommended syringes Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves See also trumpet curves section in this manual Electrical Classification Class product Continuous Mode Operation Transportable Data set Specification A maximum of 30 profiles can be set with a maximum of 100 drugs per profile with only one profile permitted to be uploaded to a Non Guardrails pump at a time See Alaris Editor Software DFU for more details Battery Specifications Rechargeable sealed NiMH Automatically charges when the pump is connected to AC power Mean Time To Battery Empty from fully charged 5ml h amp 20 C under normal conditions is 6 hours 95 lower confidence interval of 5 hours 50 minutes Charging takes 2 hours from discharge to 90 charge Memory Retention The electronic memory of the pump will be retained for more than 6 months when not powered up Fuse Type 2 xT 1 254 slow blowing AC Power Supply 115 230VAC 50 60Hz 20VA nominal Dimensions 335 mm w x 121 mm h x 200 mm d 9 310 mm w x
47. ing Volume 1 5ml Patient Controlled Analgesia PCA Sets 30822 30832 30842E 30852 30862 04102215162 04100010162 PVC Syringe Extension Set with clamp 152 cm Priming Volume 0 5ml PVC Syringe Extension Set with back check valve and 2 clamps 178 cm Priming Volume 1 5ml ec E gt ss 18 c3 PVC Syringe Extension Set with back check valve SmartSite Needle Free Valve Port and clamp 30 cm Priming Volume 1 4ml SB CE YH PVC Y Syringe Extension Set with anti siphon valve back check valve and 2 clamps 183 cm Priming Volume 1 8ml Sr Bs As ves ER PVC Syringe Extension Set with anti siphon valve and clamp 156 cm Priming Volume 0 6ml PVC Syringe Extension Set with rotating luer 150 cm Priming Volume 2 9ml ELE PVC Syringe Extension Set 105 cm Priming Volume 7 2ml SEI 1 New sets are continuously being developed for our customers Please contact your local CareFusion representative for availability It is recommended that extension sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale 1000DF00545 Issue 1 35 46 Alaris Syringe Pumps Maintenance Maintenance Routine Maintenance Procedures
48. irm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust rate above Guardrails Soft Alert The dose rate has been set above a Hard Limit Check infusion setting and adjust rate to appropriate required rate The bolus dose has been set to a value which exceeds a Guardrails Soft Alert Check the bolus setting to continue with the bolus confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust dose below Guardrails Soft Alert The bolus dose has been set to a value which is under a Guardrails Soft Alert Check the bolus setting to continue with the bolus confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust dose above Guardrails Soft Alert The bolus dose has been set above a Hard Limit Check bolus setting and adjust to appropriate required dose The drug concentration has been set above or below a Hard Limit Check the amount and total volume and adjust to give the appropriate required concentration The patient weight has been set to a value which exceeds or is under a Guardrails Soft Alert Check the weight setting to continue confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust the value within the limits The infusion rate has been set above a Hard Limit Check infusion setting and a
49. is at your sole risk and CareFusion does not provide any warranty for or endorsement on any battery packs that are not manufactured by CareFusion CareFusion s product warranty shall not apply in the event the Alaris Syringe Pump has suffered damage or premature wear or malfunctions or otherwise operates incorrectly as a result of use with a battery pack that is not manufactured by CareFusion 95 lower confidence interval of 5 hours 50 minutes 1000DF00545 Issue 1 36 46 Alaris Syringe Pumps Maintenance Cleaning and Storage Before the transfer of the pump to a new patient and periodically during the use clean the pump by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Recommended cleaners are Brand Concentration Hibiscrub 20 v v Virkon 1 w v Do not use the following disinfectant types Disinfectants which are known to be corrosive to metals must not be used these include e NaDcc such as Presept e Hypochlorites such as Chlorasol e Aldehydes such as Cidex e Cationic Surfactants such as Benzalkonium Chloride Use of lodine such as Betadine will cause surface discoloration e Concentrated Isopropyl alcohol based cleaners will degrade plastic parts The syringe and extension sets are disposable single use items and should be discarded after use according to their manufacturers instructions If the pump is to
50. mp is on hold Extension set must not be connected to the patient Volume Infused VI is not added BOLUS fluid or drug delivered at an accelerated rate Pump is infusing Extension set should be connected to the patient Vlis added OPTION button Press to access optional features see Basic Features section PRESSURE button Use this button to display the pumping pressure and alarm level Q This button will also display the pressure trend display CHEVRON keys Double or single for faster slower increase or decrease of values shown on display odes sees BLANK SOFTKEYS Use in conjunction with the prompts shown on the display Indicators Symbol Description BATTERY indicator When illuminated the pump is running on the internal battery When flashing the vd A battery power is low with less than 30 minutes of use remaining AC POWER indicator When illuminated the pump is connected to an AC power supply and the battery is being charged 1000DF00545 Issue 1 5 46 Alaris Syringe Pumps Symbol Definitions Symbol Definitions Labelling Symbols Symbol Description Attention Consult accompanying documents Potential Equalisation PE Connector RS232 Nurse call Connector Defibrillation proof type CF applied part Degree of protection against electrical shock Protected against vertically falling drops of water Alternating Curren
51. mp may also be used outside the ambulance as long as the temperature is within the specified range as stated in the Specifications section and on the pump label About This Manual Users are advised to read to understand this manual and to be thoroughly familiar with the pumps prior to operating All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump These settings and values are for illustrative use only Where stated a minimum infusion rate refers to a nominal rate of 1 0ml h and an intermediate infusion rate refers to a nominal rate of 5 0ml h The complete range of infusion rates settings and values are shown in the Specifications section Conventions used in this manual BOLD Used for Display names software commands controls and indicators referenced in this manual for example Battery Indicator PURGE ON OFF button Single quotes Used to indicate cross references made to another section of this manual Italics Used to refer to other documents or manuals and also used for emphasis This symbol indicates that the option is relevant for the Alaris CC Syringe Pump and the Alaris CC Guardrails Syringe Pump only GH This symbol indicates that the option is relevant for the Alaris GH Syringe Pump and the Alaris GH Guardrails Syringe Pump only Guardrailse This symbol indicates that the option is relevant for the Alaris CC Gua
52. nergy radio frequency emissions magnetic fields and electrostatic discharge for example as generated by electrosurgical and cauterising equipment large motors portable radios cellular telephones etc and is designed to remain safe when unreasonable levels of interference are encountered Therapeutic Radiation Equipment Do not use the pump in the vicinity of any Therapeutic Radiation Equipment Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator may severely affect functioning of the pump Please consult manufacturer s recommendations for safe distance and other precautionary requirements For further information please contact your local CareFusion representative Magnetic Resonance Imaging MRI The pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices Therefore the pump is not considered an MRI compatible pump as such If use of the pump within an MRI environment is unavoidable then CareFusion highly recommends securing the pump at a safe distance from the magnetic field outside the identified Controlled Access Area in order to evade any magnetic interference to the pump or MRI image distortion This safe distance should be established in accordance with the manufacturers recommendations regarding electromagnetic interference EMI For further information please refer to the product Technical Service Manual TSM Alt
53. nfusion rate will automatically be calculated Press the OK softkey to enter the value 5 Select the rate at VTBI end from the list using the keys and press the OK softkey The default is STOP 24 Hour Log This option allows the 24 hour log of volume infused to be reviewed 1 Press the button to access the options menu 2 Select the 24H LOG option using the amp X amp keys and press the OK softkey The display shows the hourly volume infused The volume infused shown in brackets is the total volume infused since the volume was last cleared See example below 07 48 08 00 4 34ml 4 34ml 08 00 09 00 2 10ml 6 44ml 09 00 10 00 2 10ml 8 54ml VOLUME CLEARED 3 Press the QUIT softkey to exit the log Event Log This option allows the event log to be reviewed if enabled 1 Press the button to access the options menu 2 Select the EVENT LOG option using the 42 keys and press the OK softkey 3 Scroll through the log using the ASYM keys Press the QUIT softkey to exit the log Data Set Details To review currently selected data set information 1 Press the button to access the options menu 2 Select DATA SET DETAILS 3 Review the information and then press the QUIT softkey Infusion Setup MEM To change Infusion Setup 1 Stop the infusion Press the 2 button to access the options menu 2 Select INFUSION SETUP 3 Select Infusion Setup required and press the OK softkey Pump Details To
54. ng The user must assess whether the alarm volume setting is loud enough for the intended operating environment and adjust appropriately 3 Select alarm volume required and press the OK softkey Profile Filter Guardrails Configure the profiles to be enabled or disabled in the list of selectable profiles if enabled 1 Stop the infusion Press the button to access the options menu 2 Select PROFILE FILTER 3 Select Profile s required to change and press the MODIFY softkey 4 Press the OK softkey to confirm Standby This option allows the pump to be placed on standby mode if enabled 1 Stop the infusion Press the 2 button to access the options menu 2 Select STANDBY using the keys press the OK softkey to confirm 3 Select CANCEL to return to main display 1000DF00545 Issue 1 20 46 Alaris Syringe Pumps Pressure Features Pressure Features Auto Set Pressure If enabled Gi If the Auto Set Pressure Option is enabled then the pump automatically adjusts the pressure occlusion limit After 15 minutes of infusion the pump automatically adjusts the occlusion pressure limit to X mmHg above the average infusion pressure taken from the average of the last five minutes of infusion The pressure adjusted X which takes the AUTO OFFSET value configured and scales it dependent on the average infusion pressure At pressures up to 100mmHg the AUTO OFFSET value is added From this pressure to above the alarm le
55. ossible and contact a qualified service engineer for investigation 1000DF00545 Issue 1 11 46 Alaris Syringe Pumps Getting Started 1 Do not mount the pump with the AC power inlet or the syringe pointing upwards This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe Pole Clamp Installation The pole clamp is fitted to the rear of the pump and will provide secure Recessed area fixing to vertical I V poles of a diameter between 15 and 40 mm 1 Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole 2 Place pump around pole and tighten screw until the clamp is secured to the pole within the recessed area at the rear of the pump before connecting to a Docking Station Workstation or when not in use 1 Ensure the pole clamp is folded away and stored Never mount the pump such that the 1 V infusion stand becomes top heavy or unstable Docking Station Workstation or Equipment Rail Installation The rotating cam can be fitted to the rectangular bar on the Docking Station Workstation or the equipment rail measuring 10 by 25mm 1 Align the rotating cam on the rear of the pump with the rectangular bar on the Docking Station Workstation or the equipment rail Hold the pump horizontally push the pump firmly onto the rectangular bar or equipment rail The pump s
56. pump is designed to withstand possible bumps and vibrations whilst being used in an ambulance complying with the standard EN 1789 If the pump is dropped or experiences any severe physical disturbances arrange a thorough inspection by appropriately trained technical personnel as soon as is practically possible The pump may also be used outside the ambulance as long as the temperature is within the specified range as stated in the Specifications section and on the pump label e When using any infusion pump in conjunction with other pumps or devices requiring vascular access extra care is necessary Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the infusion system by such pumps Typical examples of those pumps are used during dialysis bypass or cardiac assist applications The pump is suitable for use in Hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC mains power supply network that supplies buildings used for domestic purposes However it may be used in domestic establishments under the supervision of Medical professionals with additional necessary appropriate measures Consult Technical Service Manual appropriately trained technical personnel or CareFusion for further information The pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous
57. r of configured syringe types and sizes available for selection on the pump using the Alaris Editor Secure the extension set using the extension set hook at the rear of the pump This provides protection against accidental dislodging of the syringe from the pump Ensure that both plunger grippers are fully locked onto the plunger flange and the upper finger grip has returned to its original position 1000DF00545 Issue 1 14 46 Alaris Syringe Pumps Starting the Pump Starting the Pump Connect the pump to an AC power supply using the AC power cable 2 Press the 9 button The pump will run a short self test Ensure that two beeps are activated during this test e Check the display test pattern and ensure that no rows are missing e Check that the displayed time and date are correct Finally check display shows the data set name version number and released date and time Note A warning REPAIRING LOGS may be displayed if event log information was not completely stored at the previous power down This is for information only the pump will continue to power up as normal 3 CLEAR SETUP Selecting NO will keep previous setup and go to step 8 Selecting YES will clear previous setup and will go to step 4 1 Clear setup screen will only be displayed if a previous setup was used 4 CONFIRM PROFILE Note The CONFIRM PROFILE screen will not be displayed for the Alaris GH Syringe Pump the Alaris CC Sy
58. railse 1000DF00545 Issue 1 17 46 Alaris Syringe Pumps Basic Features Purge The E9 button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe 1 Press the button when the pump is not infusing Ensure that the extension set is not connected to the patient 2 Press and hold the PURGE softkey until fluid flows and the purging of the extension set is complete The volume used during purging will be displayed but it is not added to the volume infused 3 When purging is complete release the PURGE softkey Press the QUIT softkey to exit back to the main display The pump will not purge if the RATE LOCK has been enabled During PURGE the pressure limit alarms are temporarily increased to their maximum level Volume to be Infused VTBI This option allows a specific volume to be infused to be set Rate at the end of this VTBI can also be set selecting from stop KVO or continuous infusion at the set rate 1 Press the VTBI softkey to select the volume to be infused option 2 Enter the volume to be infused using the amp SY Y keys and press the OK softkey 3 Selectthe rate at the end of the VTBI using the keys to scroll through the on screen choices The default is stop 4 Pressthe OK softkey to confirm and exit the VTBI menu Note When current VTBI has finished no other infusion will be allowed unless a new VTBI
59. rdrails Syringe Pump and the Alaris GH Guardrails Syringe Pump only Important Information Wherever this symbol is shown an Important note is found These notes highlight an aspect of use that is important for the user to be aware of when operating the pump 1000DF00545 Issue 1 2 46 Creating a Data Set Alaris Syringe Pumps Creating a Data Set To create a data set for the pump first the hospital will need to develop review approve and upload a data set according to the following process Refer to the Alaris Editor help file for further details and operating precautions 1 Create a new Data Set Using the Alaris Editor Select new data set type 2 Master Lists Using the Alaris Editor Master Drugs Master Syringe Library 3 Create Care Area Profiles Using the Alaris Editor Drug Library Configuration a Plus Data Set to create a new data set for the Alaris GH Syringe Pump or the Alaris CC Syringe Pump b Plus Guardrails Data Set to create a new data set for the Alaris GH Guardrails Syringe Pump or the Alaris CC Guardrails Syringe Pump A predefined list of drug names and concentrations This list as well as alternate names and concentrations defined in the Master Drug List will be accessible when creating a Profile Drug Library A predefined list of the currently supported syringes available for selection within the profile Drugs and concentrations for a
60. ringe Pump or there is only one profile available in the data set a NOwill display select profile screen Select profile from list if required press ALL to update the list displayed to include all the profiles within the data set Press OK to confirm status is disabled 1 ALL softkey will only be displayed if there are some profiles in the data set not being displayed since their selectable b YES will display drug select screen or clear setup screen 5 DRUG SELECT Select one of the following Note The DRUG SELECT screen will not be displayed if there are no drugs setup in the profile ml h allows infusions to be given in ml h only after selecting OK to confirm Go to step 8 DOSING ONLY enables the pump to be set up with a dosing protocol after selecting OK to confirm Go to step 6 1 No concentration or dose rate limits are used when ml h or DOSING ONLY modes are selected DRUG NAME select a drug name from profile s drug library after selecting OK to confirm Go to step 7 Note Drugs are listed in alphabetical groups as follows A E F J K O P T and U Z Select group containing the drug name required and then the required drug and all other drugs can be seen 6 DOSING ONLY a Select Dosing unit and OK to confirm b Select Concentration Amount and OK to confirm Use UNITS softkey to change concentration unit if required c Select Total Volume to be used and OK to confirm d Adjust We
61. ris Syringe Pumps Compatible Extension Sets Compatible Extension Sets The pump uses standard single use disposable extension sets and syringes with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by CareFusion Standard Sets G40015 Standard PVC Syringe Extension Set 150 cm Priming Volume 2 6ml ETE AAA IUUUU gt G40020B Standard PVC Syringe Extension Set 200 cm Priming Volume 1 5ml ETE EM me G402EP Extension set Luer lock connectors Kink resistant DEHP free PVC yellow striped tubing Bore 1mm 200cm G30402M Gi G302EP cc Priming volume 1 6ml EF Yer EECH Standard PVC Syringe Extension Set with occlusion sensing disc 200 cm gt Priming Volume 1 5ml Se SES dengt P Extension set with pressure sensing disc Luer lock connectors Kink resistant DEHP free PVC yellow striped tubing Bore 0 9mm Length 200cm Priming volume 1 5ml Bh L S ERR ELLE Low Sorbing Sets G40615 G40620 G30303M cc G30453M cc G30302M 9 G40720 04105010509 Polyethylene Syringe Extension Set 150 cm Priming Volume 1 5ml BCDE OCH p Polyethylene Syringe Extension Set 200 cm Priming Volume 2ml Cot LL s9m p Polyethylene Syringe Extension Set with occlusion sensing disc 200 cm Priming Volume 1 5ml D IE S OE b Opaque White PVC low sorbing Syringe Extension Se
62. rt of the configuration 0 1ml h 150ml h 5ml syringes 0 1ml h 300ml h 10ml syringes 0 1ml h 600ml h 20ml syringes 0 1ml h 900ml h 30ml syringes 0 1ml h 1200ml h 50ml syringes The Volume Infused range is 0 0ml 9990ml Bolus Specifications Maximum Bolus rates can be set as part of the configuration Bolus rates are user adjustable in increments of 10ml h 10 ml h 150ml h 5ml syringes 10 ml h 300ml h 10ml syringes 10 ml h 600ml h 20ml syringes 10 ml h 900ml h 30ml syringes 10 ml h 1200ml h 50ml syringes The bolus volume limit can be set as part of the configuration Minimum 0 1ml maximum 25 0ml Increments of 0 1ml default 5 0ml During BOLUS the pressure limit alarms are temporarily increased to their maximum level Bolus Volume Accuracy ES Bolus Volume Typical Typical Maximum Typical Minimum Pump Specification 0 1ml 1 796 5 196 2 5 10 25ml 0 196 0 596 0 696 i 5906 GH Bolus Volume Typical Typical Maximum Typical Minimum Pump Specification 0 1ml 1 9 6 2 7 3 1096 25ml 0 2 0 5 0 1 5 Using BD Plastipak 50ml syringe at 5ml h under normal conditions 95 confidence 95 of pumps Critical Volume The bolus which can occur in the event of a single internal fault condition with a 50 ml syringeis Maximum Overinfusion 0 5ml Purge Specifications The purge rate is limited to t
63. selected during an infusion Auto Pressure Cc Feature to set the occlusion pressure alarm level to an amount mmHg above the current in line pressure using a single key press Auto Set Pressure Gi Auto Offset cc Automatic feature to set the occlusion pressure alarm level to an amount mmHg above the current in line pressure 15 minutes after starting the infusion The automatic offset value in mmHg used by auto pressure and auto set pressure Pressure Maximum 9 The maximum occlusion pressure alarm level that can be selected during an infusion Occlusion Alarm Pressure D The default occlusion pressure alarm level that can be selected during an infusion 1 The approved data set contains configurable option values per profile 1000DF00545 Issue 1 26 46 Alaris Syringe Pumps Configured Options Dosing Only Units The following dose rate units can be configured for use in Dosing Only mode Checking the All checkbox will select all of the listed units Type Unit rid Unit pieni Unit GE Unit pind ng min Disabled ng kg min Enabled ng h Disabled ng kg h Disabled ng 24h Disabled ng kg 24h Disabled Hg min Enabled ug kg min Enabled Ce ug h Enabled ug kg h Enabled ug 24h Disabled ug kg 24h Disabled mg min Disabled mg kg min Enabled mg h Enabled mg kg h Enabled mg 24h Disabled mg kg 24h Disabled g min Disabled g kg min Disabled g h Enabled g kg h Disabled
64. t Device complies with the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC Date of Manufacture Manufacturer Not for Municipal Waste Fuse Rating 40 C Operating Temperature Range Pump can be used between 0 and 40 degrees centigrade 0 C EC REP Authorised representative in the European Community 1000DF00545 Issue 1 6 46 Alaris Syringe Pumps Main Display Features Main Display Features Alaris CC Syringe Pump and Alaris CC Guardrails Syringe Pump Display Q9 Syringe type fitted Profile Drug name Pressure Information Pump Status RE M Pe DOPAMINE E se L VOLUME lt H PRESSURE E gt 3 00 mg kg h Y 1 mi Tnm Tos A 20048 JE TEE VOLUME VTBI CLR ER Infusion Rate Volume Volume Infused VTBI Infused Option Option Alaris GH Syringe Pump and Alaris GH Guardrails Syringe Pump Display D Syringe type fitted Profile Drug name DOPAMINE 21 f VOLUME C778 5 ron E 04 mih Sal gt 3 00 mg kg h l 1 49 mil 15h 34m 10s 5 93mg ee Pressure Information Pump Status VOLUME isis Volume Volume Infused VTBI Rate Infused Option Option Screen Icons Symbol Description CHO Time remaining display icon Indicates time before syringe will require replacement BATTERY icon Indicates battery charge level to highlight wh
65. t with occlusion sensing disc 200 cm Priming Volume 1 5ml N O Y ex gt Polyethylene Lined Syringe Extension Set with occlusion sensing disc and clamp 200 cm Priming Volume 1 6ml ES M 0 i Polyethylene Lined Syringe Extension Set with clamp 200 cm Priming Volume 1 5ml ES ip ex p Polyethylene Syringe Extension Set 100 cm Priming Volume 1ml B 15H p e New sets are continuously being developed for our customers Please contact your local CareFusion representative for availability It is recommended that extension sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale 1000DF00545 Issue 1 34 46 Alaris Syringe Pumps Compatible Extension Sets The pump uses standard single use disposable extension sets and syringes with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by CareFusion Light Protected Sets G40215 G40320 G30653M cc Amber PE Syringe Extension Set 150 cm Priming Volume 1 2ml EH rp White PVC Syringe Extension Set 200 cm Priming Volume 3 6ml ETE M E M M M M em p Opaque White PVC Syringe Extension Set with occlusion sensing disc 200 cm Prim
66. tics Exercise care to locate the pump away from any such hazardous sources Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or removed Refer all servicing to qualified service personnel When connected to an external power source a three wire Live Neutral Earth supply must be used If the integrity of the external protective conductor in the installation or its arrangement is in doubt the pump should be operated from the battery Donotopen the RS232 Nurse Call protective covering when not in use Electrostatic discharge ESD precautions are required when connecting RS232 Nurse Call Touching the pins of the connectors may Az result in ESD protection failure It is recommended that all actions must be taken by appropriately trained personnel Ifthe pump is dropped subjected to excessive moisture fluid spillage humidity or high temperature or otherwise suspected to have been damaged remove it from service for inspection by a qualified service D e engineer When transporting or storing the pump use original packaging where possible and adhere a e to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging 1000DF00545 Issue 1 9 46 Alaris Syringe Pumps Operating Precautions Electromagnetic Compatibility amp Interference The pump is protected against the effects of external interference including high e
67. ty of the clinician and should include the clinical context in which the pump is being used Gi without pressure set fitted not applicable when Fully Dedicated 1000DF00545 Issue 1 21 46 Alaris Syringe Pumps Alarms and Warnings Alarms and Warnings Alarms are indicated by a combination of an audible alarm flashing alarm indicator and a descriptive message in the display except prompts which only have an audible alarm and message The infusion will stop for all alarms that show a red alarm indicator 1 First press the button to silence the alarm for a maximum of 2 minutes then check the display for an alarm message Press CANCEL to cancel the alarm message 2 If the infusion has stopped rectify the cause of the alarm then press the button to resume the infusion Ifthe pump initiates a safety processor alarm condition an audible high pitched continuous shrill accompanied with a red alarm indicator and there is no error message displayed on the pump remove the pump from service for examination by a qualified service engineer 1 Infusion will stop for all alarms that have a Red alarm indicator Display Alarm Description and Troubleshooting Guide Indicator DRIVE DISENGAGED Red The drive system has been disengaged during operation Check the finger grips and the position of the syringe OCCLUSION Red Excessive pressure measured at the syringe plunger exceeding the alarm limit Identify and remove
68. unications Protocol and is for general information only Any connected analogue and digital components are required to meet IEC EN60950 for data processing and IEC EN60601 for medical devices Anyone connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard IEC EN60601 1 1 IrDA Baud Rate 38 4 kBaud Start Bits 1 Start Bit Data Bits 8 Data Bits Parity No Parity Stop Bits 1 stop bit 1000DF00545 Issue 1 40 46 Alaris Syringe Pumps IrDA RS232 and Nurse call Specification RS232 Nurse call Connection Data Nurse call Specification Connector D Type 9 Pin TXD RXD EIA RS232 C Standard TXD Output Voltage Range Minimum 5V mark 5V space Typical 7V mark 7V space with 3kO load to ground RXD Input Voltage Range RXD Input Thresholds 30V 30V max Low 0 6V minimum High 3 0V maximum RXD Input Resistance 3kQ minimum Enable Active Low 7V to 12V powers up the isolated RS232 circuitry Active High 7V to 12V Inactive Floating open circuit allows isolated RS232 circuitry to power down Isolation Socket Pump 1 5kV dc or ac peak Baud Rate 38 4 kBaud Start Bits 1 Start Bit Data Bits 8 Data Bits Parity No Parity Stop Bits 1 stop bit Nurse Call Relay Contacts Pins 1 8 9 30V dc 1A rating Typical Connection
69. vel is set to whatever the AUTO OFFSET value is as a percentage above the average infusion pressure up to the maximum pressure of 1000mmHg Pressure Level with pressure set fitted 9 1 To check and adjust the pressure level press the button The display will change to show a 20 minute pressure trend graph displaying the pressure alarm level and the current pressure level LINE PRESSURE ADJUST 2 Press the amp DCV keys to increase or decrease the pressure alarm level The new level will be indicated on the display 3 The AUTO Pressure feature may be used when a stable pressure has been achieved over a short period of infusion If AUTO Pressure has been enabled the automatic pressure alarm level is calculated and set by pressing the AUTO softkey 4 Pressthe TREND softkey to view the pressure trend of the previous 12 hours The pressure trend can be viewed at 15 minute intervals by using the softkeys The pressure trend graph displays the pressure at a given time 5 Pressthe OK softkey to exit the pressure screen Pressure Level 1 To check and adjust the pressure level press the button A bar graph will be displayed showing the pressure alarm level and the current pressure level 2 Press the ADV keys to increase or decrease the alarm level The new level will be indicated on the display 3 Press OK to exit the screen 1 The interpretation of the pressure readings and occlusion alarms are the responsibili
70. will automatically cancel if the AC power supply is reconnected The alarm system has detected an internal malfunction Note the malfunction code Remove pump from service for examination by a qualified service engineer ADD DRUG NOT COMPLETE Amber The ADD DRUG operation has not been completed Press CANCEL softkey and complete ADD DRUG option ATTENTION with 3 Amber Three beeps will sound if the pump has been left ON for more than 2 minutes referred to Beeps Configurable option Prompts as CALLBACK in the log without starting the operation Press the button to silence the alarm for a further 2 minutes For extended callback press and hold down the button and wait for 3 beeps in succession this will put the pump on standby for 15 minutes Display Description and Troubleshooting Guide DOSE WOULD EXCEED The dose rate has been set to a value which exceeds a Guardrails Soft Alert Check infusion setting to continue with infusion at set rate confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust rate below Guardrails Soft Alert DOSE UNDER The dose rate has been set to a value which is under a Guardrails Soft Alert Check infusion DOSE NOT PERMITTED BOLUS DOSE OVER BOLUS DOSE UNDER BOLUS DOSE NOT PERMITTED CONCENTRATION NOT PERMITTED WEIGHT OUTSIDE LIMIT RATE NOT PERMITTED A Guardrails setting to continue with infusion at set rate conf
71. wn while pump is infusing Manual Bolus Bolus delivered by manually moving the plunger mechanism during an infusion or while on hold Volume infused displayed will be increased accordingly Bolus Mode Bolus feature can be set to one of the following options Disabled Hands On only Hands Free and Hands On Bolus Rate Default The default value for bolus rates Bolus Rate Max The maximum value for bolus rate Bolus Volume Max The maximum permissible bolus volume Infusion Rate Max Near End of Infusion Point The maximum value for infusion rate Sets the Near End Of Infusion warning time as time left to End Of Infusion End of Infusion Sets the End Of Infusion point as a percentage of syringe volume KVO at EOI Sets whether the Keep Vein Open KVO at End Of Infusion EOI is available KVO Rate Sets the Keep Vein Open KVO rate at which the pump will operate when End of Infusion EOI is reached Purge Syringe Feature which prompts the user to purge the extension set prior to the start of the infusion Purge Rate The rate used during purge operation Purge Volume Max The maximum permissible purge volume VTBI Max The maximum value for Volume To Be Infused VTBI Pressure Maximum Cc The maximum occlusion pressure alarm value that can be selected during an infusion Occlusion Alarm Pressure Cc The default occlusion pressure alarm value that can be

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