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Alaris ® PK Syringe Pump - Directions for Use

1. Derating Temperature 0 5 5 40 C High Rates 2 0 rates gt syringe volume h eg 50ml h in a 50ml syringe curves section in this manual 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 Caution Infusion volume accuracy may be compromised at rates below 1 0ml h Differences in factors such as size and plunger force in recognised syringes can cause variations in accuracy and trumpet curves See also trumpet Electrical Classification Class product Continuous Mode Operation Transportable Battery Specifications Rechargeable sealed NiMH Automatically charges when the pump is connected to AC power Mean Time To Power Down from fully charged 5ml h and 23 C 2 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 In TCI mode a fully charged battery allows at least one full syringe to be infused Memory Retention The electronic memory of the pump will be retained for at least 6 months when not powered up Fuse Type 2 xT 1 254 slow blowing AC Power Supply 115 230VAC 50 60Hz 20VA nominal Dimensions 310 mm w x 121 mm h x 200 mm d Weight 2 7 kg excluding power cable Protection against fl
2. MFX 2233E 3 way extension set with 2 backcheck valves SmartSite Needle Free Valve and clamp low priming volume 10cm MFX 2293 Extension set with backcheck valve 14cm Priming Volume 0 9ml FO ae Low sorbing PE lined extension set with clamp 200cm ES G40215 Extension set opaque PVC 150cm G40015 Standard PVC Syringe Extension Set 150cm Priming Volume 2 6ml Alaris PK Syringe Pump Compatible Extension Sets MFX 2271 2 way set with anti syphon valve and backcheck valve 210cm MFX 2270 3 way set with 2 anti syphon valves and backcheck valve 210cm Bro e gt ne eel Br r a O MFX 2280E EI 3 way tap with extension and SmartSite Needle Free Valve 10cm d ES MFX 2284 3 way tap blue with extension 100cm DE ec z y A Ko y meso oe 2 MFX 2260 2309E Extension set with anti syphon valve Bag spike with SmartSite Needle Free 200cm Valve and backcheck valve pen Hon Y ae VA Ces AF sm S 3 G40615 Low sorbing PE extension set 150cm B O Hf gt 30262E Extension set with 2 SmartSite Needle Free Valve ports 102cm SE s G40020B Standard PVC Syringe Extension Set 200cm Priming Volume 1 5ml ao G TR gt I de TR gt G40320 G40620 Opaque White PVC Syringe Extension Set 200cm Polyethylene Syringe Ext
3. OCCLUSION Excessive pressure measured at the syringe plunger exceeding the alarm limit Identify and remove the cause of the blockage in the drive syringe or administration system before restarting the infusion CHECK SYRINGE 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 BATTERY LOW Battery charge low with 30 minutes operation remaining Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted Reconnect to the AC power supply to continue operation and charge the internal battery BATTERY EMPTY The internal battery is exhausted Connect the pump to the AC power supply NEAR END OF INFUSION The pump is nearing the end of the infusion This value can be configured END OF INFUSION The pump has reached the end of the infusion 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 TITRATION NOT The infusion rate has been changed but has not been confirmed and 2 minutes has expired without CONFIRMED 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 Press the button to start infusion This a
4. Connect the extension set to the patient access device 13 Press the button to commence operation INFUSING will be displayed The amber stop light will be replaced by the flashing green start light to indicate that the pump is in operation If the infusion rate exceeds the Soft Alerts then check infusion setting to continue with infusion at set target press the button and then confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust target concentration to be within the Soft Alerts 1 If a model has been selected the VOLUME softkey will be replaced by a Ce Cp softkey This will allow the user access to screens showing predicted target concentrations In this mode of operation the volume may never be cleared 14 Press the button to halt the operation ON HOLD will be displayed The AMBER STOP light will replace the GREEN START light 1000DF00331 Issue 4 18 46 Alaris PK Syringe Pump Starting the Pump TCI Mode le A list of available drugs and models will be displayed Use the ADV V keys to select the required drug and associated model and press the OK softkey Pressing the INFO key will show more information on the selection CONCENTRATION a Select Concentration required and OK to confirm Only required if more than one concentration is available b Press the OK softkey to confirm Concentration or press the MODIFY softkey to change drug amount and
5. 1000DF00331 Issue 4 41 46 Alaris PK Syringe Pump Profiles from TCI Mode Profiles from TCI Mode When targeting in TCI Mode the Alaris PK Syringe Pump will automatically calculate the flow rate profile from the specific pharmacokinetic pharmacodynamic model for the selected drug This section of the Directions For Use is intended to help users understand the profiled infusion and the performance accuracy attained from the TCI pump Induction Bolus and maintenance rates are displayed before starting the titration When initially starting the infusion or after increasing the target plasma or effect concentration by titration the pump will first deliver a bolus dose through a typically short high rate infusion On completion of this bolus the pump will immediately switch to a lower maintenance rate when plasma target mode is used or will pause for a period of time before switching to a lower maintenance rate when effect site targeting mode is used Once the maintenance phase is reached any reduction made to the target plasma or effect concentration will typically result in the infusion rate reducing to zero until the predicted plasma or effect concentration reduces the new target value The Alaris PK Syringe Pump updates the pharmacokinetic model driving the plasma or effect concentration prediction and the infusion rate every 10 seconds The infusion rate graph shown on page 43 were measured in accordance with the protocol describe
6. 36 1 488 0232 Tel 36 1 488 0233 Fax 36 1 201 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 0 30 2289 711 Fax 31 0 30 2289 713 NO CareFusion Solbr veien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 Alaris PK Syringe Pump 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 PL CareFusion ul Rzymowskiego 53 02 697 Warszawa Polska Tel 48 225480069 Fax 48 225480001 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 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 Rev B 1000DF00331 Issue 4 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 2000 2012 CareFusion Corporation or one
7. Alaris PK Editor Software PC based and are referenced when the Alaris PK Syringe Pump is being used with a drug name selected Refer to the Alaris PK Editor Software Directions for Use 1000CH00016 for details on how to configure the Profile Drug Library TCI these options are only displayed if the selected drug has an associated TCI model Clinical Trial Indicator Should be set to cause the Alaris PK Syringe Pump to identify that a selected drug model is used under the responsibility of the investigator of a clinical trial protocol Specifically for publication studies and when drug does not make reference to the selected TCI mode of administration in the prescribing information or when parameter selection deviates from it TIVA Predictive Mode Only Only allows drugs with associated TCI model to be used in TIVA predictive mode Default Target Concentration The default target concentration offered when the drug is selected Enable Effect Site Targeting Enable effect site targeting if the model associated with the drug supports it Enable Target Swapping Enable switching between plasma and effect site targeting if the model associated with the drug supports both modes Enable TIVA TCI Switching Enable switching between TIVA and TCI modes Target Soft Alert Max Sets the target concentration soft alert maximum Default Decrement Concentration Sets the default decrement target concentration TIVA Induc
8. Callback Time Adjusts the length of time before the pump sounds the Call Back alarm Event Log The Event Log can be set to be displayed on the main display Events are still recorded in the Event Log if disabled Drug Override Mode Always Any changes made to the dose rate or target concentration that are outside the editor Soft Alerts will require confirmation before starting infusion Smart Confirmation of setting will be required on the first dose rate or target concentration set outside the editor Soft Alerts Any subsequent changes will not require confirmation until after the dose rate or target concentration has been confirmed inside the editor Soft Alerts Additionally any changes in dose rate or target concentration from above a Soft Alert Max to below a Soft Alert Min or from below a Soft Alert Min to above a Soft Alert Max will also need to be confirmed Pressure Default The default occlusion pressure alarm level Pressure Display Sets whether the Pressure Information is available on the main display Purge Rate The rate used during purge operation Purge Volume Max The maximum permissible purge volume Purge Syringe Prompt Feature which prompts the user to purge the extension set prior to the start of the infusion Bolus Bolus Rate Default Bolus feature can be set to HANDS ON or HANDS FREE The default bolus rate Bolus Volume Default The default bolus volume KVO Al
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10. On initial start up the pump will display the Select Language screen 2 Select the required language from the list displayed using the GOC keys 3 Press the OK softkey to confirm your selection 1 e 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 possible and contact a qualified service engineer for investigation 1000DF00331 Issue 4 14 46 Alaris PK Syringe Pump 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 ils 2 Place pump around pole and tighten screw until the clamp is Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole secured to the pole Ensure the pole clamp is folded away and stored 1 within the recessed area at the rear of the pump before connecting to a Docking Station Workstation or when not in use Never mount the pump such that the 1 V infusion stand becomes top heavy or unsta
11. as part of the configuration Minimum 0 1ml Maximum 100 0ml e Increments of 0 1ml default 5 0ml During BOLUS the pressure limit alarms are temporarily increased to their maximum level Critical Volume The bolus which can occur in the event of a single internal fault condition with a 50 ml syringe is Maximum Overinfusion 0 5ml Purge Specifications The purge rate is limited to the 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 End Of Syringe Rate Stop KVO 0 1ml h to 2 5ml h or set rate if lower than KVO Near End Of Infusion Alarm 5min to end of infusion or 10 of syringe volume whichever is smaller End Of Infusion EOI Alarm 0 5 of syringe volume Maximum Pumping Pressure Limit Highest alarm level 1000mmHg nominal at L 10 Occlusion Accuracy without pressure set of full scale Pressure mmHg LO L 3 L 5 L 10 approx 50mmHg approx 300mmHg approx 500mmHg approx 1000mmHg Temp 23 C 18 21 23 28 Using most common 50ml syringes under normal conditions 95 confidence 95 of pumps 1000DF00331 Issue 4 31 46 System Accuracy continuous ml h and TIVA Alaris PK Syringe Pump Specifications Volumetric Mean 2 nominal
12. be cleared 1 Press the VOLUME softkey to display the CLEAR VOLUME option 2 Press the 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 Concentration Target Titration Note This only applies to TCI mode Concentration Target Titration allows the rate to be adjusted while infusing 1 Select the new target using the GOC D keys The pump status is shown as TITRATE and the pump continues to infuse at the original concentration target 2 Press the button to confirm the new concentration target and start infusing at the new rate If the new concentration target setting exceeds or is under a Soft Alert confirmation is required before infusion can resume 1000DF00331 Issue 4 22 46 Alaris PK Syringe Pump Operations During Use Operations During Use End of Operation This option will only appear in the options menu when the infusion has been stopped 1 Press the button to access the options menu 2 Select the END OF OPERATION option using the GOC D keys 3 Press the OK softkey indicated on the screen Note Selecting this option will reset parameters for a new patient TCI Mode When the pump is on hold in predictive TIVA mode the user is able to switch from TIVA to TCI mode 1 Press the button to access the options menu 2 Using the keys select the TCI MODE 3 Press the OK softkey indicated on the screen A co
13. bio phase the drug interacts with the receptor resulting in the pharmacological effect Until recently when intravenous anaesthetic agents were used for induction or maintenance of anaesthesia they were administered either manually by hand or by simple infusion pumps the anaesthetist calculated the infusion according to the body weight of the patient Inline measurement of concentrations is not possible and the polyexponential equations required to predict the concentrations requires vast computer processing power Based on the pioneering work of Kruger Thiemer and Schwilden et al 3 the TCI concept was developed during the 1980 s and early 1990 s as advances in computer technology made inline predictions of drug concentrations feasible The pharmacokinetic behaviour of most anaesthetic drugs can be described mathematically with a 3 compartment model usually a central compartment V1 a vessel rich compartment V2 and a vessel poor compartment V3 are described Transfer of drug between different compartments distribution is described by rate constants k ka ks and kis or clearances Drug metabolism is described by the rate constant k Fig 2 The aim of TCI techniques is to use pharmacokinetic modelling to calculate the infusion rates required to achieve a desired plasma concentration Thus instead of specifying an infusion rate the user specifies a target concentration based on clinical judgement When a concentration in the plas
14. 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 4 To terminate 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 5 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 Any Hands Free Bolus dose setting which exceeds or is under a Soft Alert must be confirmed before operation can be continued This is not applicable in TCI mode 1000DF00331 Issue 4 21 46 Alaris PK Syringe Pump Basic Features Purge The 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 t
15. display shows the trajectory of the estimated plasma and effect site drug concentration over time Effect Site target controlled infusion TCI In this mode the user sets the desired effect site target concentration and the pharmacodynamic model is used to calculate the infusion rates required to achieve that concentration A graphic display shows the trajectory of the estimated effect site and plasma concentration over time The Alaris PK Syringe Pump has a user friendly interface that displays the infusion rate the total drug dose delivered and the estimated plasma and effect site concentrations to enable the user to follow the drug prescription information from the relevant country Intended Purpose The Alaris PK Syringe Pump is intended for use by medical staff for purposes of controlling infusion rate and volume Conditions of Use The Alaris PK Syringe Pump should only be operated by a clinician competent in use of automated syringe pumps and post placement management of intravenous catheters Use of the Alaris PK Syringe Pump DOES NOT limit the responsibility of the anaesthetist for drugs administration It is important that users operating the Alaris PK Syringe Pump are fully aware of the available literature for any model used in association with a drug and that they refer to the prescribed information for rate and dosing limits Pharmacokinetic and Pharmacodynamic Interactions among anaesthetic drugs are known b
16. 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 CareFusion Switzerland 317 Sarl w A One Business Centre ZA Vers La Pi ce n 10 CH 1180 Rolle CareFusion UK 305 Ltd The Crescent Jays Close Basingstoke Hampshire RG22 4BS UK 1000DF00331 Issue 4 carefusion com
17. override confirmation is required The maximum allowed bolus dose Occlusion Alarms Occlusion Alarm Pressure The default occlusion alarm level Desensitise Threshold Rate The infusion rate that when exceeded in TCI mode causes the occlusion detection to be desensitised Concentration Limits Minimum Concentration The minimum drug concentration Maximum Concentration The maximum drug concentration 1000DF00331 Issue 4 29 46 Alaris PK Syringe Pump Configured Options Default Drug Profile Library The following drug parameters are programmed in the pump Diprivan 1 Diprivan 2 Remifentanil Remifentanil TIVA Sufentanil Model Marsh Marsh Minto n a Gepts Min Concentration 10mg ml 20mg ml 20ug ml 20ug ml 0 2ug ml Max Concentration 10mg ml 20mg ml 50ug ml 250ug ml 5 0ug ml Induction Default 1 0mg kg 1 0mg kg 1 0ug kg 1 0ug kg 0 15ug kg Induction Soft Max 2 5mg kg 2 5mg kg 1 5ug kg 1 5ug kg 0 5ug kg Induction Hard Max 4 0mg kg 4 0mg kg 2 0ug kg 2 0ug kg 2 0ug kg Induction Time 30s 30s 455 45s 45s Maintenance Default 8mg kg h 8mg kg h 0 2ug kg min 0 2ug kg min 0 1ug kg h Maintenance Soft Max 14mg kg h 14mg kg h 1ug kg min 1ug kg min 1ug kg h Maintenance Hard Max 20mg kg h 20mg kg h 2ug kg min 2ug kg min 2ug kg h Default Bolus Rate 1200ml h 600ml h 600ml h 600ml h 1200ml h Default Bolus 1 0mg kg 1 0mg kg 1 0ug kg 1 0ug kg 0 15ug k
18. permits 1 Press the button to access the options menu 2 Select EFFECT SITE TCI using the GOC Si keys 3 Press the OK softkey indicated on the screen A confirmation screen will be displayed PLASMA TCI When in EFFECT SITE TCI mode the user is able to switch to PLASMA TCI mode if the configuration permits 1 Press the button to access the options menu 2 Select PLASMA TCI using the ROC keys 3 Press the OK softkey indicated on the screen A confirmation screen will be displayed 1000DF00331 Issue 4 24 46 Alaris PK Syringe Pump 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 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 Ifthe infusion has stopped rectify the cause of the alarm then press the button to resume the infusion If the 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 Display Description and Troubleshooting Guide DRIVE DISENGAGED The drive system has been disengaged during operation Check the finger grips and the position of the syringe
19. representative in the European Community 1000DF00331 Issue 4 9 46 ima Prim Oe Math Display Features Main Display Features TIVA Mode Drug Name and j Concentration Pressure Information Pump Status TAS eed EE EE Oad 4 16 8mish DOE CHO BO 20ug kg min 80 D 1h 59m 28s mn ADJUST Cp Ce z Flow Rate and Dose and Operations Dose Rate During Use Volume Infused TCI Mode Drug Name and Induction Pause Before Concentration Duration Pump Status Maintenance O ON HOLD Remifentanil 50 0 Cp 0 Ong m INDUCTION MAINPZMANCE CY YS 0 24ug kg 10 0s 0 005 OS Cpt 3 0n9 m A 123mi h 0 3m1 16 7m h ADJUST T ER SS EIE SS ISS AS Plasma Plasma Target Initial Induction Initial Induction Initial Induction Time of Concentration Dose Rate A Initial Maintenance Volume Induction Rate TCI Mode MORE Information Screen Selecting the MORE softkey will display the following additional information Drug Name Volume and and Model Elapsed Time Dose Infused AGE 40yrs emifentanil HEIGHT 180cm 50 0 pg ml GENDER MALE Minto WEIGHT 70 0kg Fan LBM 57 6kg 1h 20m 45s BMI 21 6 Es gt A Patient Parameters Time to End of Infusion Decrement Decrement at Current Rate Time Concentration Press the BACK softkey to return to the TCI screen The display will automatically revert to the TCI screen after approximately 20 seconds 1000DF00331 Issu
20. set is connected to the patient Mille 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 Oo CHEVRON keys Double or single for faster slower increase or decrease of values shown on display gt d BLANK SOFTKEYS Use in conjunction with the prompts shown on the display O Indicators Symbol Description BATTERY indicator When illuminated the pump is running on the internal battery When flashing the O 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 1000DF00331 Issue 4 8 46 Alaris PK Syringe Pump Symbol Definitions Symbol Definitions Labelling Symbols Symbol Description ES Attention Consult accompanying documents Potential Egualisation PE Connector E f RS232 Nurse call Connector 19 Defibrillation proof type CF applied part Degree of protection against electrical shock Protected against vertically falling drops of water Alternating Current Device complies with the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC Date of Manufacture IPX1 dik pl Manufacturer S Not for Municipal Waste Fuse Rating EC REP Authorised
21. 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 Concentrated Isopropyl alcohol based cleaners will degrade plastic parts Recommended cleaners are Brand Concentration Hibiscrub 20 v v Virkon 1 w v The following products were tested and are acceptable for use on the Pump if used in accordance with the specified manufacturer s guidelines Warm soapy water Mild detergent in water e g Young s Hospec 70 Isopropyl Alcohol in water Chlor Clean e Clinell Sporicidal wipes Hibiscrub TriGene Advance e Tristel Fuse sachets Tristel Trio wipes system Tuffie 5 wipe Virkon Disinfectant Virusolve Ready To Use Virusolve Wipes 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 Ifthe 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 The syringe and extension sets are dispo
22. 086 min k 3 0 0229 min k 0 0245 min kz 0 0013 min Reference from the literature Gepts et al Anesthesiology 1995 83 1194 1204 Additional k calculated with time to peak effect 5 6 min k 0 17559 min reference Shafer et al Anesthesiology 1991 Jan 74 1 53 63 1000DF00331 Issue 4 5 46 Alaris PK Syringe Pump Creating a Data Set Creating a Data Set To fully utilise the Alaris PK Syringe Pump a Data Set will need to be developed reviewed approved released uploaded and verified according to the following process Refer to the Alaris PK Editor Software Directions for Use 1000CH00016 for further details and operating precautions 1 Create Master Lists Using Alaris PK Editor Software Master Drugs A list of drug names and standard concentrations These may be for TIVA use or may have an associated PK PD model for TCI use e Alaris PK Syringe Library Configure syringes enabled for use 2 Create Profile Using Alaris PK Editor Software Drug Library Drugs and concentrations for this profile with defaults minimum and maximum limits and targets and occlusion level e Configuration Pump configuration settings and general options 3 Review Approve and Release Using Alaris PK Editor Software e Review and Approve Entire Data Set Report to be printed reviewed and signed as proof of approval by an authorised person according to Hospital protocol Signed printout to b
23. 10mg ml Drug Concentration 20mg ml Plasma Concentration Accuracy 40 2 Plasma Concentration Accuracy 0 3 Predicted Plasma Concentration ng ml Ideal Plasma Concentration ug ml Predicted Plasma Concentration ng ml Ideal Plasma Concentration ug ml iod 10 Time Interval mins Time Interval mins Remifentanil Minto Model BD 5ml Syringe Remifentanil Minto Model BD 50ml Syringe Patient Age 75 Yrs Patient Age 75 Yrs e Patient Weight 65kg Patient Weight 65kg e Patient Height 175cm e Patient Height 175cm Patient Gender Male e Patient Gender Male Drug Concentration 50ug ml Drug Concentration 50ug ml Plasma Concentration Accuracy 40 2 Plasma Concentration Accuracy 40 5 deal Plasma Concentration ng ml deal Plasma Concentration ng ml Predicted Plasma Concentration ng ml Predicted Plasma Concentration ng ml Time Interval mins Time Interval mins Sufentanil Gepts Model BD 50ml Syringe Drug Concentration 5 0ug ml Plasma Concentration Accuracy 3 1 deal Plasma Concentration ng ml Predicted Plasma Concentration ng ml Time Interval mins 1000DF00331 Issue 4 44 46 Alaris PK Syringe Pump 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 8002MEDO1 Alaris GH
24. ADV keys select the display mode TEXT or GRAPH DISPLAY The options menu shows the available display mode option 3 Press the OK softkey indicated on the screen Dosing Summary 1 Press the button to access the options menu 2 Select the DOSING SUMMARY option using the keys and press the OK softkey 3 Press the QUIT softkey to exit the menu 1000DF00331 Issue 4 23 46 Alaris PK Syringe Pump Operations During Use 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 ANY 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 It can be enabled disabled 1 Press the button to access the options menu 2 Select the EVENT LOG option using the keys and press the OK softkey 3 Scroll through the log using the ANC 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 press the Q
25. Alaris PK Syringe Pump Directions For Use Alaris PK Syringe Pump Contents Page ad dee AE EA EA EE EE EE OE RE TE 2 AbotitThisManual i s stet ae ee RE E EE DE SE oe yea ne eyed Seed nd od EE Ee tendre er ER ed eww ad 3 die EE EE OE RE EE des 3 Creating a Data Set zer verster tsaren DE BR DE dE Ee of De Ee d d De Eg ed BE bored weer den 6 Features of the PUMPE eee 7 Controls and Indicators isi EERS ASE ERROR ed inte int Raede eetl aa 8 SymboeliDEfinitiONSs mess EER EEN RE Ee reede ae Ee es Cea edn he De EA laa Pe 9 Main Display Features iss ns ss ENS dE De as ae 10 Operating Precautions ie ER DEE Ee ach De ee PER tred OER DE ERGE EER DE EE RS end 12 Getting Started ses DE ED ee ee lane aca lebet nen dta 14 Loading and Confirming a Syringe onee venen eenen venen en eenen ennen eenen eenen eeen 16 Staring he PUMP DEET 18 Basic ss lS EE EE RE EO os dra 21 Operations During USB ss ese EER EE DEER EE RES nee A BE ee GER DEER DES d 23 Alafms and Warnings see Re EE EE EEN EA Pep Re vat EEN vab DER Re rad EER EG EE DEE EE DEE ER EIN 25 lende AE AR EE RE EO EE OE yee 26 Configured OPTIONS AE EL OE HA EE EE AE nente AE EE N 27 Specifications a e ege eat EE EE eben es 31 seer ek il GR EE EE OR enden weaver den wear erneer eee en 33 Associated Products sos sanat edn ad di bsten Ge DE ee a Ie 34 Compatible Extension SEtS aast SE SEER sean SE GE GR AD eend ED ER GEREG magda bard 35 MET ia RE ta ZEN RE OE N OE 36 Occlusion Pressure LIMES se vg
26. B Braun Omnifix B Braun Perfusor BD Perfusion BD Plastipak BD Precise Codan Codan Perfusion Fresenius Injectomat Monoject Nipro Pentaferte Rapiject Terumo 1 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 2 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 1 CareFusion has characterized a range of syringes as identified in the Recognised Syringes table CareFusion cannot guarantee the continued system accuracy of these recognised syringes as the manufacturer may change syringe specification significant to system accuracy without prior notification Subject to the above BD branded luer lock syringes can be confirmed as BD Plastipak syringes due to there being no significant variance in dimensions In no event shall CareFusion be liable for any damages of any kind or nature including without limitation direct or indirect special consequential or incidental damages arising from or in connection with the use of syringes not listed in the Recognised S
27. M 1000DF00331 Issue 4 40 46 Alaris PK Syringe Pump 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 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 fl
28. 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 Power Down Sequence Enter the access code on Alaris PK Syringe Pump for alternative Power Down Sequence see the Technical Service Manual for details 1 Access codes should only be entered by qualified technical personnel ENABLED When running TCI or TIVA with predictive TCI the pump may only be powered down by stopping the infusion selecting NEW OPERATION from the options menu confirming the selection and then power down the pump DISABLED In TCI or TIVA with predictive TCI the pump may be powered down after putting the pump on hold 1000DF00331 Issue 4 27 46 Alaris PK Syringe Pump Configured Options Alaris PK Editor Software Pump Configuration The following options are configurable via the Alaris PK Editor Software PC based see the Alaris PK Editor Software Directions for Use 1000CH00016 for details on how to alter the profile configurations General Pump Configurations AC Fail Warning The AC Power Failure Alarm can be set to sound or be silent if the AC power is disconnected Audio Volume Auto Night Mode The audio alarm volume of the pump high medium or low Main Display Backlight dims between hours 21 00 and 06 00 Battery Icon Indicator displaying the remaining estimated battery capacity
29. Syringe Pump with Plus Software 8003MEDO1 Alaris CC Syringe Pump with Plus Software 80043UNO1 Alaris TIVA Syringe Pump 80053UN01 Alaris PK Syringe Pump 8003MEDO1 G Alaris CC Guardrails Syringe Pump with Plus Software 8002MED01 G Alaris GH Guardrails Syringe Pump with Plus Software 9002MED01 Alaris GP Volumetric Pump with Plus Software 9002MED01 G Alaris GP Guardrails Volumetric Pump with Plus Software 80203UNSOx xx Alaris Gateway Workstation 1 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 co uk alaris technical 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 1000DF00331 Issue 4 45 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
30. UIT softkey to exit SET BY DOSERATE SET BY ml h TIVA mode only To set doserate to flowrate in precise increments it may be necessary to switch between the rate adjust options SET BY DOSERATE and SET BY ml h An arrow to the left of the rate display shows the rate changed when the amp OE keys are used to increase decrease the infusion rate To precisely set a doserate the arrow must be pointing to the doserate mg kg h the flowrate will be calculated from the doserate To precisely set a flowrate the arrow must be pointing to the flowrate ml h the doserate will be calculated from the flowrate Selecting the SET BY ml h option 1 Whilst the pump is infusing press the button to access the options menu 2 Select the SET BY ml h option using the keys and press the OK softkey indicated on the screen This will select the SET BY FLOWRATE option the arrow on the display will automatically select the flowrate the flowrate can be adjusted if required Selecting the SET BY DOSERATE option 1 Whilst the pump is infusing press the button to access the options menu 2 Select the SET BY DOSERATE option using the AY D keys and press the OK softkey indicated on the screen This will select the SET BY DOSERATE option the arrow on the display will automatically select the doserate the doserate can be adjusted if required EFFECT SITE TCI When in PLASMA TCI mode the user is able to switch to EFFECT SITE TCI mode if the configuration
31. als 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 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 1000DF00331 Issue 4 36 46 Alaris PK Syringe Pump 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 Do not use the following disinfectant types e Disinfectants which are known
32. arge volume syringes high syringe concentrations low patient weights and low target plasma or effect concentrations For applications where system accuracy is important maintenance rates less than 1 0 ml h are not recommended syringe sizes drug concentrations dilutions and target plasma or effect concentrations should be selected accordingly to ensure the maintenance rate exceeds this lower limit The performance graphs illustrated in this section are for a Diprivan 1 Concentration Diprivan 2 concentration Remifentenil 50ug ml concentration and Sufentanil 5ug ml concentration are given for comparison As an illustration of the effect the syringe size has on system performance Remifentenil 50ug ml concentration is shown with a 50ml and 5ml syringe respectively The target plasma or effect concentrations shown are for illustrative purposes only Note 1 1EC60601 2 24 Particular Requirements for the Safety of Infusion Devices 2 95 Confidence 95 Population 1000DF00331 Issue 4 42 46 Infusion Rate vs Target Concentration Alaris PK Syringe Pump Profiles from TCI Mode Diprivan 1 Marsh Model BD 50ml Syringe Patient Age 40 Yrs Patient Weight 60kg Drug Concentration 10mg ml Volumetric Accuracy 0 1 1200 80 1100 1000 900 60 800 f d 50 700 600 500 400 300 200 j al e Rate ml h Time Interval mins Remifentanil Min
33. arget Concentration Cpt or Cet Adjust the Target Concentration if necessary using the ROC keys Confirm the Target Concentration and Initial Infusion predicted parameters On confirmation ifthe Target Concentration exceeds any limits a warning will be displayed 1 Infusion can not be started until confirmation has been made Initial infusion parameters may fluctuate from the displayed predicted values as a result of real time recalculation If the induction time is greater than 10s the flow rate may decrease on the last 10s period to adjust the dose to be administered Maintenance flow rate will decrease over time for a fixed target 1000DF00331 Issue 4 19 46 Alaric OK Curinna Piimn Mal lS 2NIII IOC UTY S tarting the Pump 12 Purge if required Press the button and then press and hold the PURGE softkey until the fluid flows and the purging of the IV infusion set is complete Release the softkey The volume used during purging will be displayed 13 Connect the extension set to the patient access device 14 Press the button to commence operation INFUSING will be displayed The amber stop light will be replaced by the flashing green start light to indicate that the pump is in operation If the infusion rate exceeds the Soft Alerts then check infusion setting to continue with infusion at set target press the button and then confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not require
34. ble 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 T GR w 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 should 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 Release lever push to release Rotating cam Alaris Gateway Workstation and Alaris DS Docking Station 1000DF00331 Issue 4 15 46 Alaris PK Syringe Pump 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 extensio
35. by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust rate below Soft Alert DOSE UNDER DOSE NOT PERMITTED TARGET WOULD EXCEED BOLUS DOSE OVER BOLUS DOSE UNDER BOLUS DOSE NOT PERMITTED WEIGHT OUTSIDE LIMIT RATE NOT PERMITTED The infusion rate has been set to a value which is under a Soft Alert Check infusion setting to continue with infusion at set rate press the button and then confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust rate above Soft Alert The infusion rate has been set above a Hard Limit Check infusion setting and adjust rate to appropriate required rate The target has been set to a value which exceeds a Soft Alert Check infusion setting to continue with infusion at set target press the button and then confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust rate below Soft Alert The bolus dose has been set to a value which exceeds a Soft Alert Check the bolus setting to continue with the bolus press the button and then confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust dose below Soft Alert The bolus dose has been set to a value which is under a Soft Alert Check the bolus setting to continue with the bolus press the button and then confirm OVERRIDE LIMIT by pressing t
36. by the local country regulations All other components can be safely disposed of as per local regulations 1000DF00331 Issue 4 37 46 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 Alaris PK Syringe Pump Occlusion Pressure Limits 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 ml Time to alarm 1 0 ml h 21 typical 1 30 1 00 0 30 0 00 o N 4 6 8 10 Occlusion Level Bolus Volume ae typical 1 50 1 00 0 50 0 00 o N 4 6 8 10 Occlusion Level hr min Time to alarm 5 0 ml h 200 typical 1 30 1 00 0 30 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 1000DF00331 Issue 4 38 46 IrDA Alaris PK Syringe Pump 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 a
37. ce of the system against changes in the target plasma or effect concentration for a typical idealised profile For the same targeted profile the deviation of the predicted plasmatic or effect concentration back calculated from the volume collected from the expected Ideal plasma or effect concentration results from the volumetric inaccuracy of the system pump and syringe The Alaris PK Syringe Pump will track the predicted plasma or effect concentration to within 5 of that calculated by pharmacokinetic model over a one hour period Flow rate inaccuracies and start up delays may decrease the accuracy of the predicted plasma or effect concentration particularly where high syringe drug concentrations are used in conjunction with large sizes of syringes and low target plasma or effect concentrations as the syringe plunger motion over time proportional to the flow rate accuracy will be significantly reduced For a given drug concentration the volumetric error is proportional to the dose rate error Knowledge of the system 1 accuracy over different time intervals may be of interest when assessing the impact of administering short half life drugs In these circumstances short term fluctuation in the infusion rate could have a clinical impact that cannot be determined from the performance profiles shown in Figures below In general the volumetric error will increase with small induction and maintenance rates which may occur when with l
38. d in the IEC60601 2 24 Standard with the data sample period reduced from 30 to 10 seconds The pump solves the pharmacokinetic pharmacodynamic algorithms so that the target plasma or effect concentration is attained as rapidly and as accurately as possible However the User may need to take into consideration the limitations of the physical system in attaining the target plasma or effect concentration this includes The limit on the flow rate permitted by the infusion pump mechanism The limit on the flow rate permitted by the syringe size The patient drug dose limitation from the prescribing information to insure the safety of the administration The variation in individual patient response to reach the plasma or effect concentration The model specific cap rate A true assessment of the performance of the Alaris PK Syringe Pump can be made if the volumetric error that is the difference between the actual volume infused and the predicted volume infused is calculated For the performance graphs shown on page 43 over a one hour period the Alaris PK Syringe Pump has a mean volumetric accuracy in TCI Mode better than 5 2 By measuring the volume from the flow rate profile delivered from the Alaris PK Syringe Pump and then introducing this into a reverse pharmacokinetic model the predicted plasma or effect concentration can be calculated from the flow rate These are illustrated on page 44 showing the typical performan
39. d press the NO softkey and adjust target concentration to be within the Soft Alerts 1 If Target Concentration running exceeds the Soft Alerts then the display will cycle between Drug Name and Up arrows 15 Pressing the button during infusion will maintain the current Plasma or Effect site 16 Press the button to halt the operation ON HOLD will be displayed The amber stop light will replace the green start light Flow Rate and Effect Site Drug Name and Plasma Concentration Dose Rate Concentration Concentration Prediction _ fentanil 50 0 pg ml Decrement Time Actual Time Effect Site Trend Time Prediction The Ce value will not be displayed if there is no k Kas defined for the selected model 1000DF00331 Issue 4 20 46 Alaris PK Syringe Pump Basic Features Basic Features Bolus Infusion 1 BOLUS is disabled in TCI mode 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 e Hands On e Hands Free BOLUS Disabled If configured to Disabled pressing the G button will have no effect and the pump will continue to inf
40. der oi va ret vaan eet pe E iaa iaa 38 IrDA RS232 and Nurse call Specification venen eneen ee Ee AE ee RR neen en eneen en 39 Trumpet Curves and Start Up Curves anos sk enen de ge eke Rd eke de enen ereen eneen eneen eneen 41 Profiles fromiTGl MOd or ares sterven AR RE KERE ER OE ted ded 42 Products and Spare Parts suicida RE SE A A EE SEER GE a 45 le dee ed AR RE ER ER RE EE dede 46 1000DF00331 Issue 4 1 46 Alaris PK Syringe Pump Introduction Introduction The Alaris PK Syringe Pump herein after referred to as pump provides the user with an infusion tool for the administration of drugs for anaesthesia The embedded software within the pump is loaded with three compartment pharmacokinetic predictive models and has 4 modes of operation 1 Continuous infusion ml h 2 Total Intravenous Anaesthesia TIVA mode In this mode the user is able to select the infusion rate and administer bolus doses as required 3 Total Intravenous Anaesthesia TIVA with TCI predictions mode In this mode the user is able to select the infusion rate and administer bolus doses as required The pharmacokinetic model is used to estimate the plasma and effect site concentration 4 TCI Mode Plasma target controlled infusion TCI In this mode the user selects the desired target plasma drug concentration and the pharmacokinetic model is used to calculate the infusion rates required to achieve that concentration A graphic
41. diluent volume AGE adjust the patient age using the keys press the OK softkey to confirm The remaining patient parameters for the selected drug must be entered using the ASYM keys and press the OK softkey to confirm The required parameters may include the following depending on the model HEIGHT GENDER WEIGHT adjust the patient weight using the ADV 4 keys press the OK softkey to confirm A permissible weight range calculated using the models LBM limitations is displayed LBM and BMI Lean Body Mass and Body Mass Index This is for information only and is not an adjustable parameter If configuration allows select Plasma targeting or Effect Site targeting 1 Prime the extension set Load the syringe according to the procedure in this manual Check that the syringe type and size being used matches the display If required the syringe brand or type can be changed by pressing the TYPE softkey Press the CONFIRM softkey when the correct type and size are shown The CONFIRM induction screen shows the initial infusion parameters for the drug and model selected The screen will show blank data until the syringe has been loaded and confirmed 10 When a slower titration is required the induction time may be increased in Plasma Targeting Cpt only Press the TIME softkey and cap the maximum induction rate or doserate to increase the desired induction time The cap rate will be cleared when first titration occurs 11 T
42. display select profile screen Select profile Press OK to confirm b YES will display the TCI MODE screen 4 The TCI MODE selection is displayed Answering YES selects the TCI Mode NO will enter TIVA MODE The Alaris PK Syringe Pump allows the user to select a TCI or TIVA mode of operation The user may at any time switch mode by stopping the infusion and selecting the appropriate mode from the options menu When in TIVA mode if a drug with an associated model has been selected the current plasma and effect site concentration will be displayed This will demonstrate to the user unfamiliar with TCI the Pharmacokinetics and Pharmacodynamics of the drug while still using TIVA mode TIVA Mode with or without prediction 1 A list of available drugs and models will be displayed Use the GOED keys to select the required drug and press the OK softkey Ifthe drug has an associated model an INFO softkey will be displayed Pressing the INFO softkey will show more information on the selection The ml h option allows infusions without doserate calculation 2 CONCENTRATION a Select Concentration required and OK to confirm Only required if more than one concentration is available b Press the OK softkey to confirm Concentration or press the MODIFY softkey to change Drug amount and diluent volume 3 WEIGHT adjust the patient weight using the ASV keys press the OK softkey to confirm The remaining patient parameters for the selected d
43. e kept safe for use during verification procedure Release Data Set status to be promoted to Released password is required 4 Upload Data Set to Alaris PK Syringe Pump Using Alaris PK Editor Transfer Tool 5 Verify Data Set Upload First or Individual Instrument Verification On completion of upload record CRC Cyclic Redundancy Check number shown on the Alaris PK Syringe Pump Download the Data Set from the pump using the Alaris PK Verification Tool Compare Data Set downloaded with the approved signed Data Set printout Reviewer should sign the printout and also record the CRC number on the printout as record Subsequent Instruments Verification On subsequent uploads of the Data Set compare CRC number on the instrument with CRC number recorded on First Instrument Verification 6 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 See important note in Configured Options section 1000DF00331 Issue 4 6 46 Alaris PK Syringe Pump Features of the Pump Features of the Pump ON OFF Release lever High visibility Display for MDI Alarm Indicator PURGE BOLUS Finger Grips Extension set hook HOLD Shelf for chevron Syringe Clamp Posit
44. e 4 10 46 Screen Icons Alaris PK Syringe Pump Main Display Features Symbol Description CHO 00 00 TIME REMAINING DISPLAY icon Indicates time before syringe will require replacing BATTERY icon Indicates battery charge level to highlight when the battery will require recharging e Induction Phase Dose Displayed on protocol confirmation screen o Duration of Induction Phase Displayed on protocol confirmation screen O Duration of Hands Free Bolus Displayed in bolus set up screen Maintenance Phase Dose Rate Displayed on protocol confirmation screen TTTTT LLL SOFT ALERT Indicates the pump is running at a rate above pointing up or below pointing down a Soft Alert Number of arrows vary depending on drug name length yyy y LIMIT WARNING Indicates the setting entered is under or exceeds a Soft Alert or setting entered is not permitted as it exceeds a Hard Limit DOWN MODE Infusion status indicating that the target concentration is below current concentration 1000DF00331 Issue 4 11 46 Alaris PK Syringe Pump Operating Precautions Operating Precautions Luer Lock Y y Tom Tom 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 de
45. e 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 Configured Options menu using the keys and press the OK softkey 2 Usethe 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 Alarise PK Syringe Pump General Options Select GENERAL OPTIONS from the Configured Options menu using the keys and press the OK softkey Select the option required to enable disable or adjust and press the MODIFY softkey When all the required modifications have been carried out press the QUIT softkey Either select the next configuration option from the menu or turn the pump OFF returning it to operation as required ST ME NURSE CALL FITTED Enables Nurse Call hardware option NURSE CALL INVERT When enabled the nurse call output is inverted RS232
46. effect can be transferred to concentrations thereby resulting in a quantitative approach The concentration at the site of action is called the effect site concentration and the corresponding compartment see Fig 3 is called the effect site compartment Because the actual amount of drug entering the brain is very small the effect site compartment can be regarded as having no volume the rate constant k can be ignored and the rate constant k can be used to describe the rate of equilibration between the plasma and effect site compartments Knowledge of the k for various agents has made targeting of the effect site possible With effect site targeting the TCI system first calculates the necessary plasma concentration profile required to achieve the effect site target as rapidly as possible and then calculates the infusion rates required to achieve that plasma concentration profile Fig 3 Effect Site vs Plasma Concentration will generate a larger induction dose followed by a pause in the infusion to allow plasma to equilibrate with effect site concentration Input V2 Vi V3 Peripheral Central Peripheral Compartment Compartment Compartment Effect Compartment Fig 3 Schematic representation of the concentration effect relationship Clearance cl1 TCI infusion pumps can provide optimal control of anaesthesia when the three elements mentioned above have been accurately modelled and described Firstly the model that controls the p
47. eimer E Continuous intravenous infusion and multicompartment accumulation Eur J Pharmacol 1968 4 317 324 3 Schwilden H A general method for calculating the dosage scheme in linear pharmacokinetics Eur J Clin Pharmacol 1981 20 379 86 4 Shafer SL Towards optimal intravenous dosing strategies Seminars in Anesthesia 1993 12 222 234 5 Ausems ME Hug CC Jr Stanski DR Burm AG Plasma concentrations of alfentanil required to supplement nitrous oxide anesthesia for general surgery Anesthesiology 1986 65 362 73 6 Schnider TW Minto CF Stanski DR The effect compartment concept in pharmacodynamic modelling Anaesthetic Pharmacology Review 1994 2 204 213 7 Shafer SL Principles of pharmacokinetics and pharmacodynamics Principles and practice of anesthesiology 2nd Edition Edited by Longnecker DE Tinker JH Morgan GE New York Mosby Year Book 1998 pp 1159 1210 8 Shafer SL Gregg KM Algorithms to rapidly achieve and maintain stable drug concentrations at the site of drug effect with a computer controlled infusion pump J Pharmacokinet Biopharm 1992 20 147 69 TCI Precautions When first starting the infusion the pharmacokinetic pharmacodynamic models within the Alaris PK Syringe Pump are reset to zero Therefore for any reason if the pump is switched off during the surgical procedure all current pharmacokinetic pharmacodynamic model information will be lost Under such circumstances switching the pump off and on and re
48. ension Set 200cm Priming Volume 3 6ml Priming Volume 1 6ml o 7 gt P amp Saini H for availability e New sets are continuously being developed for our customers Please contact your local CareFusion representative e 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 1000DF00331 Issue 4 35 46 Alaris PK Syringe Pump Maintenance Maintenance Routine Maintenance Procedures 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 to a 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 fo
49. entrations When Remifentanil and Sufentanil are used in TCI mode the Minto and Gepts models respectively are used to calculate the required infusion rates CareFusion cannot guarantee the continued system accuracy with other manufacturer s syringes as identified in the Recognised Syringes table Manufacturers may change syringe specification significant to system accuracy without prior notification Indications The Alaris PK Syringe Pump is indicated for the administration of drugs for anaesthesia Contraindications The Alaris PK Syringe Pumps are contraindicated for e enteral therapies epidural infusion therapies 1000DF00331 Issue 4 2 46 Alaris PK Syringe Pump About This Manual About This Manual The user must be thoroughly familiar with the Alaris PK Syringe Pump described in this manual prior to use 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 exa
50. equired the make of syringe can be changed by pressing the TYPE softkey ON HOLD 3 2 04 mijn 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 number of configured syringe types and sizes available for selection on the pump 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 1000DF00331 Issue 4 17 46 Alaris PK Syringe Pump Starting the Pump Starting the Pump 1 Connect the pump to an AC power supply using the AC power cable 2 Press the 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 coloured rows are missing Finally check that the displayed time and date are correct 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 CONFIRM PROFILE a NO will
51. g Bolus Soft Max 2 5mg kg 2 5mg kg 1 5ug kg 1 5ug kg 1 0ug kg Bolus Hard Max 5 0mg kg 5 0mg kg 2 0ug kg 2 0ug kg 2 0ug kg Default Target Conc 4 0ug ml 4 0ug ml 3 0ng ml 0 15ng ml Target Conc Soft Max 10ug ml 10ug ml 8 Ong ml 1 0ng ml Target Conc Hard Max 15ug ml 15ug ml 20ng ml ET 2 0ng ml Decrement Conc 1ug ml 1ug ml 1ng ml 0 05ng ml Infusion Rate Limits 1200ml h 600ml h 1200ml h 1200ml h 1200ml h This drug does not have an associated model and therefore cannot be run in TCI mode 1 Default values are derived from publications and expert assessment and are given as reference only It is recommended that before starting the infusion or confirming a titrated value the values are checked to ensure that they conform to hospital protocol 1000DF00331 Issue 4 30 46 Alaris PK Syringe Pump Specifications Infusion Specifications Specifications Maximum infusion rate can be set as part 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 Selected maximum rates are shown below 150ml h 5ml syringes 300ml h 10ml syringes 600ml h 20ml syringes 900ml h 30ml syringes 1200ml h 50ml syringes The default bolus volume can be set
52. he PURGE softkey Press the QUIT softkey to exit back to the main display 1 During PURGE the pressure limit alarms are temporarily increased to their maximum level 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 Pressthe keys to increase or decrease the alarm level The new level will be indicated on the display 3 Press OK to exit the screen During PURGE BOLUS and INDUCTION the pressure limit alarms are temporarily increased to their maximum level For TCI operation a threshold rate may be set above which the pressure limit alarms are temporarily increased to their maximum level Rate Titration Note This is not applicable in TCI mode If Rate Titration is enabled the rate can be adjusted while infusing 1 Select the new rate using the keys 2 The message lt START TO CONFIRM 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 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 ROC keys 3 Press the button to start infusing at the new rate Clear Volume Note Clear Volume is not permitted in TCI mode or predictive TIVA mode This option enables the volume infused to
53. he YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust dose above Soft Alert The bolus dose has been set above a Hard Limit Check bolus setting and adjust to appropriate required dose The patient weight has been set to a value which exceeds or is under a Soft Alert Check the weight setting to continue press the button and then 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 adjust to appropriate required rate 1000DF00331 Issue 4 26 46 Alaris PK Syringe Pump 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 PK Editor Software Enter the access code on Alaris PK Syringe Pump for Configured Options see the Technical Service Manual for details 1 Access codes should only be entered by qualified technical personnel Use Alaris PK 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 keys and press the OK softkey 2 Use the amp ACV keys to adjust the date displayed pressing th
54. ive Plunger Rating Plate see Symbol Definitions for an keysand sottkeys Grippers explanation of the symbols used Release lever for Rotating X J HI Rotating Cam to lock on to horizontal rectangular bars IR Communications port Carrying Potential Folded Pole RS232 Extension set Handle Equalisation PE Clamp Connector hook connector 1000DF00331 Issue 4 7 46 Alaris PK Syringe Pump 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 Note Pump can only be switched off at specific stages of operation see Power Down Sequence section in Configured Options for further details 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 Press and hold until three beeps are heard for 60 minutes silence see e PURGE BOLUS button Press to access PURGE or BOLUS softkeys Press and hold down softkey to operate PURGE the extension set during set up Pump 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
55. larm only occurs if rate titration is enabled AC POWER FAIL AC Power has been disconnected and the pump is operating on battery power if this 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 will automatically cancel ifthe AC power supply is reconnected Error Code and Message The alarm system has detected an internal malfunction Note the malfunction code Remove pump from service for examination by a qualified service engineer ATTENTION with 3 Beeps Three beeps will sound if the pump has been left ON for more than 2 minutes referred to as CALLBACK in the log without starting the operation Press the button to silence the alarm for a further 2 minutes Alternatively press and hold down the button and wait for 3 beeps in succession this will put the warning alarm on standby for 60 minutes Alarm Indicator Colour Alarms indicated AMBER AC POWER FAIL NEAR END OF INFUSION ATTENTION TITRATION NOT CONFIRMED BATTERY LOW RED All others Configurable option 1000DF00331 Issue 4 25 46 Prompts Alaris PK Syringe Pump Prompts Display Description and Troubleshooting Guide DOSE WOULD EXCEED The infusion rate has been set to a value which exceeds a Soft Alert Check infusion setting to continue with infusion at set rate press the button and then confirm OVERRIDE LIMIT
56. llows 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 R 232 interface Since it is possible to control the syringe pump using the R 232 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 eguipment This software should include detection of the disconnection or other failure of the RS232 cable The protocol is detailed in the Alaris Syringe Pump Communications 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 re
57. lows the enabling or disabling of Keep Vein Open KVO at End of Infusion EOI KVO Rate Sets the KVO rate at which the pump will operate when EOI is reached Near End of Infusion Time 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 Weight Default The patient default weight in kg Weight Minimum The minimum patient weight in kg This is a Soft Alert and can be overridden Weight Maximum The maximum patient weight in kg This is a Soft Alert and can be overridden Age Default The default patient age in years Age Minimum The minimum age in years This is a Soft Alert and can be overridden Age Maximum The maximum age in years This is a Soft Alert and can be overridden 1 The approved data set contains configurable option values per profile 1 The bolus configurations are used only when the Alaris PK Syringe Pump is being used in ml h mode If a drug is selected then the drugs own configuration settings are used 2 Although a default and Soft Limits can be set for age and weight the actual selectable range may be limited by the drug and model chosen 1000DF00331 Issue 4 28 46 Alaris PK Syringe Pump Configured Options Alaris PK Editor Software Profile Drugs The following drug parameters are only configurable via the
58. ma compartment is targeted this is called open loop plasma targeted TCI When a certain concentration at the effect compartment is targeted then this is called open loop effect site targeted TCI Input V2 Vi V3 Peripheral Central Peripheral Compartment Compartment Compartment Clearance di Fig 2 Schematic representation of the three compartment model used for target controlled infusions For anaesthetic agents the effect site or bio phase is not the plasma but the brain where concentrations cannot be directly measured Until the early 1990 s it was considered that blood brain equilibration was virtually instantaneous Early TCI systems were thus all plasma targeted For many drugs the relationship between plasma concentration and clinical effect was described usually in terms of the Cp50 or Cp95 the concentrations required to elicit a specified clinical effect in 50 or 95 of patients respectively For an example 1000DF00331 Issue 4 3 46 Alaris PK Syringe Pump TCI Overview see Ausems et al During the 1990 s it was increasingly appreciated that after a change in plasma concentration there is a temporal delay in equilibration between the plasma and effect site concentrations The clinical effect changes in parallel with the effect site concentration and so for most drugs the rate of drug transfer into and from the site of action can be characterized by the time course of drug effect This means that the
59. mp use original packaging where possible and adhere ee to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging The embedded pump software incorporates limits and pump configuration parameters Qualified personnel must ensure the appropriateness of the 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 Electromagnetic Compatibility and Interference The pump is protected against the effects of external interference including high energy 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 a
60. mple 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 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 TCI Overview The dose response relationship can be divided into three parts the relationship between administered dose and plasma concentration the pharmacokinetic phase the relationship between effect organ concentration and clinical effect the pharmacodynamic phase and the coupling between pharmacokinetics and dynamics The ultimate goal when administering a particular dose of a drug is to obtain the desired clinical effect for which a specific therapeutic concentration of the drug at the site of action the receptor is necessary EN DOSE EXCRETION METABOLISM PLASMA CONCENTRATION BIOPHASE CONCENTRATION DRUG RECEPTOR INTERACTION EFFECT Fig 1 Schematic representation of the pharmacokinetic and dynamic processes determining the relationship between administered dose and resulting effect intensity of a drug Pharmacokinetic factors such as distribution metabolism and or excretion determine the relationship between drug dose and drug concentration in the plasma and bio phase effect site In the
61. n set and syringe at the end of infusion as this cannot be fully infused Plunger AN 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 aseptic technigues 1 Squeeze the finger grips together on the plunger holder and slide the mechanism to the right 2 Pull the syringe clamp forward and down 1000DF00331 Issue 4 16 46 3 Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange clamp Alaris PK Syringe Pump 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 r
62. nfirmation screen will be displayed Note When the mode is changed to TCI mode the initial target will be set to zero TIVA Mode When the pump is on hold in TCI mode the user is able to switch from TCI to predictive TIVA mode 1 Press the button to access the options menu 2 Using the keys select the TIVA MODE 3 Press the OK softkey indicated on the screen A confirmation screen will be displayed Note When the mode is changed to predictive TIVA mode the initial doserate will be set to zero DECREMENT CONC In TCI and predictive TIVA mode 1 Press the button to access the options menu 2 Select DECREMENT CONC 3 Select the required DECREMENT CONC and press the OK softkey to exit Trend Size The user is able to select the Trend Size of the Concentration Prediction graph 1 Press the button to access the options menu Using the keys select TREND SIZE Using the ADV keys select the required TREND SIZE option 5 Mins 15 Mins 30 Mins or 60 Mins Press the SELECT softkey indicated on the screen Press the RESIZE softkey to rescale the vertical axis of the graph The initial displays calculates the scale so the peak value fills graph If the trend is downward the graph only fills lower part and the RESIZE option forces it to rescale ti wh Text Graph Display When in TCI mode the user is able to select a numerical or graphical display 1 Press the button to access the options menu 2 Using the
63. 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 a 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 EE condition persist even after user intervention it is recommended to replace that particular pump and quarantine the pump for the attention of appropriately trained technical personnel Consult Technical Service Manual for further information 1000DF00331 Issue 4 13 46 Alaris PK Syringe Pump 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 e Alaris PK 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
64. quirements 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 1000DF00331 Issue 4 39 46 Alaris PK Syringe Pump 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 Data Transmit Data TXD Output Received Data RXD Input Power Input DSR Ground GND Not used Power Input CTS 1O go Oyn Ua B WN 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 CO
65. r 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 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 and 20 C under normal conditions is 6 hours From the battery low alarm it will take about 2 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 interv
66. ral 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 1000DF00331 Issue 4 12 46 Alaris PK Syringe Pump Operating Precautions Hazards An explosion hazard exists if the pump is used in the presence of flammable anaesthetics 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 Do not open the RS232 Nurse Call protective covering when not in use Electrostatic discharge ESD A precautions are required when connecting RS232 Nurse Call Touching the pins of the connectors may AA 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 LES otherwise suspected to have been damaged remove it from service for inspection by a qualified service engineer When transporting or storing the pu
67. re 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 Alternatively 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 IEC EN60601 1 2 and IEC EN60601 2 24 If the
68. rug must be entered using the keys and press the OK softkey to confirm The required parameters may include the following depending on the model AGE HEIGHT GENDER LBM and BMI Lean Body Mass and Body Mass Index This is for information only and is not an adjustable parameter 5 The CONFIRM drug setup screen shows the initial infusion parameters for the drug Press the OK softkey to accept or MODIFY to change the drug setup 6 INDUCTION Using the keys enter the induction dose amount per kg of patient weight if required for dosing Press the OK softkey to enter The Induction feature may be disabled reducing the dose to zero until OFF is displayed and press OK softkey to confirm 7 TIME Enter the induction time in seconds over which the induction dose will be delivered Press the OK softkey to enter 8 MAINTENANCE Set the maintenance dose rate in the drug protocol units Press the OK softkey to enter 1 Prime the extension set 9 Load the syringe according to the procedure in this manual 10 Check that the syringe type and size being used matches the display If required the make of syringe can be changed by pressing the TYPE button Press CONFIRM when the correct type and size are shown 11 Purge if required Press the button and then press and hold the PURGE softkey until the fluid flows and the purging of the extension set is complete Release the softkey The volume used during purging will be displayed 12
69. sable single use items and should be discarded after use according to their manufacturers instructions Ifthe pump is to 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 Disposal Information on Disposal for Users of Waste Electrical and Electronic Equipment This RA symbol on the product and or accompanying documents means that used electrical and electronic products should not be mixed with household waste If you 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 prevent 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
70. scribed 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 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 Always clamp or otherwise isolate the patient line before unclamping or removing a syringe from the pump Failure to do so may result in unintended administration 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 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 e
71. starting the infusion whilst the patient contains a significant residual drug dose could result in an over infusion and therefore the pump should not be restarted in TCI mode 1000DF00331 Issue 4 4 46 Pharmacokinetic models in Alaris PK Syringe Pump and their parameters Alaris PK Syringe Pump TCI Overview Drug Diprivan Model Marsh weight adjusted Age Limit 16 years upwards Unit of Plasma Concentration ug ml Max Plasma Concentration 15 ug ml Vc 0 228 x mass litres x kg ko 0 119 min ks 0 112 min k 3 0 0419 min k 0 055 min ks 0 0033 min keo 0 26 min Reference from the literature Marsh et al Brit J Anaesth 1991 67 41 48 Drug Remifentanil Model Minto Age Limit 12 years upwards Unit of Plasma Concentration ng ml Max Plasma concentration 20 ng ml Vc 5 1 0 0201 x age 40 0 072 x lbm 55 V2 9 82 0 0811 x age 40 0 108 x lbm 55 V3 5 42 cl1 2 6 0 0162 x age 40 0 0191 x Ibm 55 cl2 2 05 0 0301 x age 40 cl3 0 076 0 00113 x age 40 k y cl1 Vc k cl2 Vc k 3 cl3 Vc k cl2 V2 ka cl3 V3 k 0 595 0 007 x age 40 eo Reference from the literature Minto et al Anesthesiology 1997 86 10 33 Drug Sufentanil Model Gepts not weight adjusted Age Limit 12 years upwards Unit of Plasma Concentration ng ml Max Plasma concentration 2 ng ml Ve 14 3 kjo 0 0645 min k 0 1
72. tion Parameters Induction ON OFF Dosing Units Default Dose Enables Disables induction stage of TIVA protocol The induction dose units This can be based on patient weight The default induction dose offered Default Induction Time Sets the default induction time Soft Alert Min Soft Alert Max Hard Limit Max The induction value below which an override confirmation is required The induction value above which an override confirmation is required The maximum allowed induction dose Pause After Induction Enables Disables pause after induction TIVA Maintenance Parameters Dose Rate Units Default Dose Rate Soft Alert Min Soft Alert Max The maintenance rate units The default maintenance dose The maintenance dose rate below which an override confirmation is required The maintenance dose rate above which an override confirmation is required Hard Alert Max The maximum allowed maintenance dose rate TIVA Bolus Parameters Bolus Type Determines bolus operation when required Default Rate The default bolus rate Dosing Units Default Dose HANDS FREE only Soft Alert Min HANDS FREE only Soft Alert Max HANDS FREE only Hard Limit Max HANDS FREE only The bolus dose units This can be based on patient weight The default bolus offered The bolus dose value below which an override confirmation is required The bolus dose value above which an
73. to Model BD 5ml Syringe Patient Age 75 Yrs e Patient Weight 65kg e Patient Height 175cm e Patient Gender Male Drug Concentration 50ug ml Volumetric Accuracy 0 2 Rate ml h Time Interval mins Sufentanil Gepts Model BD 50ml Syringe Plasma Target Drug Concentration 5 0ug ml VTarget Plasma Concentration ng ml 220 0 35 200 180 0 30 160 Bad 0 25 140 E 120 5 0 20 U 100 0 15 80 ac 60 d 040 40 0 05 20 o 0 00 Time Interval mins Target Plasma Concentration ug ml Target Plasma Concentration ng ml Target Plasma Concentration ng ml Rate ml h Rate ml h Diprivan 2 Marsh Model BD 50ml Syringe Patient Age 40 Yrs Patient Weight 60kg Drug Concentration 20mg ml Volumetric Accuracy 0 4 Target Plasma Concentration ug ml Time Interval mins Remifentanil Minto Model BD 50ml Syringe Patient Age 75 Yrs Patient Weight 65kg Patient Height 175cm Patient Gender Male Drug Concentration 50ug ml Volumetric Accuracy 1 6 Target Plasma Concentration ng ml Time Interval mins 1000DF00331 Issue 4 43 46 Alaris PK Syringe Pump Profiles from TCI Mode Predicted vs Ideal Concentration Diprivan 1 Marsh Model BD 50ml Syringe Diprivan 2 Marsh Model BD 50ml Syringe Patient Age 40 Yrs Patient Age 40 Yrs Patient Weight 60kg e Patient Weight 60kg Drug Concentration
74. uctuations 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 recognised syringes produced by other manufacturers can cause variations in accuracy and trumpet curves as compared to those represented Additional curves for recognised syringes are available upon written request For applications where flow uniformity is a concern rates of 1 0ml h or above are recommended Start up Trend BD Plastipak 5ml 0 1ml h Trumpet Curve BD Plastipak 5ml 0 1ml h Es 20 Be 012 sant X r AA he hk A E o Soo 4 o 9 CS Le E Time mins Observation Window mins pn Maximum Error Minimum Error Linear Mean 44 5 Start up Trend BD Plastipak 50 ml 1 0 ml h Trumpet Curve BD Plastipak 50 ml 1 0 ml h AA AA A A A yl Rate ml h Error 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 Rate ml h Error o 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 0 1
75. uid ingress IPX1 Protected against vertically falling drops of water Alarm Conditions Drive Disengaged Occlusion Attention Nurse Callback Check Syringe Near End Of Infusion End of Infusion Battery Low Battery Empty AC Power Fail Titration not confirmed Internal Malfunction Concentration not Permitted Dose Would Exceed Target Would Exceed Dose Under Dose not Permitted Bolus Dose not Permitted Rate not Permitted Bolus Dose Under Bolus Dose Over Weight Outside Limit Environmental Specifications Operating Temperature 5 C 40 C Operating Relative Humidity 20 90 Operating Atmospheric Pressure 700hPa 1060hPa Transport and Storage Temperature 30 C 50 C Transport and Storage Relative Humidity 10 95 Transport and 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 1000DF00331 Issue 4 32 46 Alaris PK Syringe Pump Recognised Syringes Recognised Syringes The pump is calibrated and labelled for use with single use 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 IVAC AstraZeneca
76. ump has to work accurately The models used in the Alaris PK Syringe Pump are well validated and accepted Secondly the pharmacokinetic parameter set of a particular drug used by the computer model should match the pharmacokinetics of the patient it should be remembered that the models described in the literature are based on population data and apply to an average patient They do not take account of the inter patient pharmacokinetic variability Thirdly the pharmacodynamics of the administered drug should be well understood to enable the user to select the plasma or effect site concentration needed for the required effect with most anaesthetic agents there is broad inter patient pharmacodynamic variability and so the user needs to match knowledge of the general population pharmacodynamic data with careful observation of the individual patient to ascertain that individual s sensitivity to the drug to enable titration to effect if necessary Note Specific model parameters are available in the TCI Overview section or directly on the pump via the information key when selecting drugs Users should refer to the drug prescribing information to verify that TCI mode is authorised in their respective countries References 1 Danhof M Does variability explain all variability in drug effects Topics in pharmaceutical science Edited by Breimer DD Crommelin DJA Midha KK Noordwijk Amsterdam Med Press BV 1989 pp 573 586 2 Kruger Th
77. use at the set rate 1 A Hands On bolus and Hands Free bolus cannot be administered if the feature is disabled for the selected Profile or specific 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 G button once to display the bolus screen 2 Use the 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 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 G button to display the Hands Free bolus selection screen 2 Use the ROC V keys to set the bolus volume dose required If necessary use the RATE softkey and the ROC keys to adjust the bolus delivery rate Note Rate may be restricted by the syringe size and the CAP BOLUS RATE 3 Press the flashing BOLUS softkey once to begin the
78. ut are not taken into account in the calculation of the plasma and effect site concentrations The user should be appropriately trained in the use of the pump and should follow the recommendations of this Direction For Use DFU In particular the user must be aware that starting the pump in a TCI mode will result in the automatic infusion of a pre calculated bolus dose followed by an infusion to achieve the selected target concentration The initial parameter calculations are displayed on screen prior to starting the infusion It is thus essential that the user verifies that the patient characteristics and the selected infusion rate or target concentration conform with the drug prescribing information of the relevant country CareFusion has verified the accuracy of the mathematical model implementation as well as pump delivery accuracy specification and accuracy of pump delivery are available in Profiles from TCI Model section Different drugs are associated with dedicated models each model consists of a set of standard pharmacokinetic parameters which can be selected and used by the embedded 3 compartment model used in the Alaris PK Syringe Pump where use of that drug in TCI mode is authorised Diprivan from ASTRA ZENECA is the only recommended Propofol formulation to be used in TCI mode as per prescribing information This pump includes the Marsh model for the calculation of the Diprivan infusion rates and plasma and effect site conc
79. xtension line and patient connections and follow the priming procedure specified herein Operating Environment 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 oxide Operating Pressure 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 Seve
80. yringes table 1000DF00331 Issue 4 33 46 DY Con p K oyringe F Alaris Associated Products Associated Products The Alaris DS Docking Station The Alaris Gateway Workstation LE E Ig VEE EE EE EE EE 8 118811 087 T OST 681 87 1 68 LL DE lis A pt sll spl oll dd d lis 34 46 1000DF00331 Issue 4 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 20038E 3 way extension set with 3 SmartSite Needle Free Valves low priming volume 13cm a 20062E 3 way extension set with 3 SmartSite Needle Free Valves and one backcheck valve 16cm US Y H re MFX 2290 3 way set with 2 anti syphon valves and backcheck valve low priming volume 209cm Brod 8 df fp A Sr 20061E Y extension set with 2 SmartSite Needle Free Valves 18cm 2205E Vial adaptor with SmartSite Needle Free Valve for 20mm vials af G40720 o MFX 2291 2 way set with anti syphon valve and backcheck valve low priming volume 209cm

Alaris ® PK Syringe Pump - Directions for Use

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Alaris &reg; PK Syringe Pump - Directions for Use

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Alaris ® PK Syringe Pump - Directions for Use