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Alaris® PK Syringe Pump - Frank`s Hospital Workshop

1. Predicted Plasma Concentration ng ml Ideal Plasma Concentration ng ml Predicted Plasma Concentration ng ml Ideal Plasma Concentration ng ml Time Interval mins Time Interval mins Sufentanil Gepts Model BD 50ml Syringe Drug Concentration 5 Oug ml Plasma Concentration Accuracy 43 1 0 40 o o p 8 Predicted Plasma Concentration ng ml Ideal Plasma Concentration ng ml Time Interval mins 1000DF00005 Iss 2 39 44 Products and Spare Parts Alaris Infusion System Range of products in the Alaris Infusion System product family are 80013UNO01 Alaris GS Syringe Pump 80023UNO01 Alaris GH Syringe Pump 5 80043UN01 Alaris TIVA Syringe Pump 80053UN01 Alaris PK Syringe Pump 80033UND1 Alaris CC Syringe Pump are also available without an RS232 option fitted contact local customer services representative to obtain part number details For Docking Stations and 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 cardinalhealth co uk alaris A username and password are required to access our manuals Please contact local customer services representative to obtain login
2. 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 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 ADV keys The pump status is shown as TITRATE and the pump continues to infuse at the original concentration target 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 M 1000DF00005 Iss 2 20 44 Operations During Use End of Operation This option will only appear in the options menu when the infusion has been stopped 1 Press the C2 button to access the options menu 2 Select the END OF OPERATION option using the amp DCV 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 amp amp YV keys select the TCI MODE 3 Press the OK softkey indicated on the screen A confirmation screen will be displayed Note When the
3. Clinical Trial Indicator TIVA Predictive Mode Only Default Target Concentration Enable Effect Site Targeting Enable Target Swapping Enable TIVA TCI Switching Target Soft Alert Max Default Decrement Concentration TIVA Induction Parameters Induction ON OFF Dosing Units Default Dose Default Induction Time Soft Alert Min Soft Alert Max Hard Limit Max Pause After Induction TIVA Maintenance Parameters Dose Rate Units Default Dose Rate Soft Alert Min Soft Alert Max Hard Alert Max TIVA Bolus Parameters Bolus Type Default 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 Occlusion Alarms Occlusion Alarm Pressure Desensitise Threshold Rate Concentration Limits Minimum Concentration Maximum Concentration 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 Only allows drugs with associated TCI model to be used in TIVA predictive mode The default target concentration offered when the drug is selected Enable effect site targeting if the model associated with the drug supports it Enab
4. b Press the OK softkey to confirm Concentration or press the MODIFY softkey to change drug amount and diluent volume 3 AGE adjust the patient age using the ADV keys press the OK softkey to confirm 4 The remaining patient parameters for the selected drug must be entered using the AS keys and press the OK softkey to confirm The required parameters may include the following depending on the model HEIGHT GENDER 5 WEIGHT adjust the patient weight using the AS keys press the OK softkey to confirm A permissable 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 6 If configuration allows select Plasma targeting or Effect Site targeting Prime the extension set 7 Load Syringe Load the syringe according to the procedure in this manual 8 Confirm Syringe 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 9 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
5. 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 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 Use The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use DFU including general wards critical and intensive care neonatal outpatients clinics operating rooms and accident and emerge
6. 34 GB Cardinal Health The Crescent Jays Close Basingstoke Hampshire RG22 4BS United Kingdom Tel 44 0800 917 8776 Fax 44 1256 330860 HU Cardinal Health D brentei t r 1 H 1013 Budapest Magyarorsz g Tel 36 14 88 0232 Tel 36 14 88 0233 Fax 36 12 01 5987 Date October 05 May 06 1000DF00005 Iss 2 IT Cardinal Health Via Ticino 4 50019 Sesto Fiorentino Firenze Italia T l 39 055 30 33 93 00 Fax 39 055 34 00 24 NL Cardinal Health Kantorenpand Hoefse Wing Printerweg 11 3821 AP Amersfoort Nederland Tel 31 33 455 51 00 Fax 31 33 455 51 01 NO Cardinal Health Solbr veien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 NZ Cardinal Health 14 George Bourke Drive Mt Wellington Auckland PO Box 14234 Panmure Auckland Tel 09 270 2420 Freephone 0508 422734 Fax 09 270 6285 SE Cardinal Health Hammarbacken 4B 191 46 Sollentuna Sverige Tel 46 8 544 43 200 Fax 46 8 544 43 225 41 44 US Cardinal Health 10221 Wateridge Circle San Diego CA 92121 USA Tel 1 800 854 7128 Fax 1 858 458 6179 ZA Cardinal Health 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 Cardinal Health Alaris Products Cardinal Health warrants that A Each new infusion instrument
7. 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 restarting the infusion whilst the patient contains a significant residual drug dose could result in an over infusion and therefo
8. N B MI f Uu 2205E Vial adaptor with SmartSite Needle Free Valve for 20mm vials 0 i EO G40720 Low sorbing PE lined extension set with clamp 200cm B pr b G40215 Extension set opaque PVC 150cm MFX 2293 Priming Volume 0 9ml Extension set with backcheck valve 14cm 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 MFX 2284 3 way tap blue with extension 100cm MFX 2280E 3 way tap with extension and SmartSite Needle Free Valve 10cm N Mi p N os MFX 2260 Extension set with anti syphon valve 200cm 2309E Bag spike with SmartSite Needle Free Valve and backcheck valve G40615 Low sorbing PE extension set 150cm GET 74 gt 30262E Extension set with 2 SmartSite Needle Free Valve ports 102cm pa m SCO oh pp 5 G40015 G40020B Standard PVC Syringe Extension Set 150cm Standard PVC Syringe Extension Set 200cm Priming Volume 2 6ml Priming Volume 1 5ml Ba E TR IE Bo i gt G40320 G40620 Opaque White PVC Syringe Extension Set 200cm Polyethylene Syringe Extension Set 200cm Priming Volume 3 6ml Priming Volume 1 6ml BC 7 t p CE ES E v p It is recommend
9. T Target 10 18 20 27 28 29 38 TCI 2 3 4 5 6 10 17 18 19 20 21 22 27 28 29 37 38 39 TCI Overview 3 Technical Service Manual 25 35 40 Test 32 Titration 20 TIVA 2 6 10 17 20 21 22 27 28 40 Trumpet Curves 36 V Volume Infused 29 Volume to be Infused See VTBI Ww Warnings 23 Warranty 42 Weight 29 Workstation 15 40 43 44 Page Intentionally Left Blank 1000DF00005 Iss 2 44 44 CardinalHealth Alaris Asena Guardrails and IVAC are registered trademarks of Cardinal Health Inc or one of its subsidiaries All other trademarks belong to their respective owners 2004 2006 Cardinal Health Inc or one of its subsidiaries All rights reserved 1000DF00005 Issue 2 This document contains proprietary information of Cardinal Health Inc 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 Cardinal Health Inc or one of its subsidiaries is strictly forbidden ud Cardinal Health 1180 Rolle Switzerland www cardinalhealth co uk alaris
10. 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 38 were measured in accordance with the protocol described 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
11. charged 5 0ml h amp 20 C under normal conditions Charging takes 2 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 more than 6 months when not powered up 1000DF00005 Iss 2 System Accuracy continuous mode ml h and TIVA Volumetric Mean 296 nominal Derating Temperature 0 5 5 40 C High Rates 4 2 0 rates syringe volume h eg gt 50ml h in a 50ml syringe Important System accuracy is 2 typical by volume as measured using the trumpet curve test method defined in IEC EN60601 2 24 at rates of 1 0ml h 23 C and above when the pump is used with the recommended syringes Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves See also trumpet curves section in this manual Fuse Type 2xT 1 25A 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 fluid ingress IPX1 Protected against vertically falling drops of water Alarm Conditions Drive Disengaged Occlusion Check Syringe Battery Low Battery Empty Near End Of Infusion End of Infusion AC Power Fail Internal Malfunction Attention Nurse Callback Titr
12. details 1000SP01122 Internal Battery Pack 1001FAOPT91 AC Power Lead UK 1001FAOPT92 AC Power Lead European 1000DF00005 Iss 2 40 44 Service Contacts For service contact your local Affiliate Office or Distributor AE Cardinal Health PO Box 5527 Dubai United Arab Emirates Tel 971 4 28 22 842 Fax 971 4 28 22 914 AU Cardinal Health 8 167 Prospect Highway Seven Hills NSW 2147 Australia Tel 61 2 9838 0255 Fax 61 2 9674 4444 Fax 61 2 9624 9030 BE Cardinal Health Otto De Mentockplein 19 1853 Strombeek Bever Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 CA Cardinal Health 235 Shields Court Markham Ontario L3R 8V2 Canada Tel 1 905 752 3333 Fax 1 905 752 3343 CN Cardinal Health Shanghai Representative Office Suite 9B Century Ba Shi Building 398 Huai Hai Rd M Shanghai 200020 China Tel 56 8621 63844603 Tel 56 8621 63844493 Fax 56 8621 6384 4025 Document History Revision CO Number 1 5933 2 6881 DE Cardinal Health Pascalstr 2 52499 Baesweiler Deutschland Tel 49 2401 6040 Fax 49 2401 604 121 ES Cardinal Health Avenida Valdeparra 27 28108 Alcobendas Madrid Espana Tel 34 91 657 20 31 Fax 34 91 657 20 42 FR Cardinal Health Immeuble Antares Technoparc 2 rue Charles Edouard Jeanneret 78300 POISSY France T l 33 1 30 06 74 60 Fax 33 1 39 11 48
13. exceeding the alarm limit Identify and remove the cause of the blockage in the drive syringe or administration system before restarting the infusion 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 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 The internal battery is exhausted Connect the pump to the AC power supply The pump is nearing the end of the infusion This value can be configured 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 The infusion rate has been changed but has not been confirmed and 2 minutes has expired without any operation Press the button to silence the alarm then press the CANCEL softkey to clear this message and silence the alarm Check infusion rate and confirm by pressing the button or press the button to revert to the previous rate Press the button to start infusion This alarm only occurs if rate titration is enabled AC Power has been disconnected and the pump is operating on battery power if this occurs when the pump
14. 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 38 over a one hour period the Alaris PK Syringe Pump has a mean volumetric accuracy in TCI Mode better than 5 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 39 showing the typical performance 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 flo
15. maximum patient weight in kg This is a Soft Alert and can be overridden The default patient age in years The minimum age in years This is a Soft Alert and can be overridden The maximum age in years This is a Soft Alert and can be overridden The approved Data Set contains configurable option values per profile The originator and approvers of the Data Set should be aware that unless a rationale for safety is provided it is not recommended to set the callback time to a value greater than the default setting of 2 minutes since doing so would not be in compliance with IEC EN60601 2 24 1998 standard 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 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 1000DF00005 Iss 2 26 44 Configured Options continued Alaris PK Editor Software Profile Drugs The following drug parameters are only configurable via the 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
16. pump controller or peripheral instrument is free from defects in material and workmanship under normal use and service for a period of two 2 years from the date of delivery by Cardinal Health to the original purchaser B Each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety 90 days from the date of delivery by Cardinal Health to the original purchaser C Each Mains Cable Battery Flow Sensor ECD and non disposable probe is free from defects in material and workmanship under normal use and service for a period of ninety 90 days from the date of delivery by Cardinal Health to the original purchaser D Each new Thermometer is free from defects in material and workmanship under normal use and service for a period of one 1 year from the date of delivery by Cardinal Health to the original purchaser If any product requires repair during the applicable warranty period the purchaser should communicate directly with its local Cardinal Health service centre to determine the appropriate service facility Except as provided otherwise in this warranty repair or replacement will be carried out at Cardinal Health s expense The product requiring service should be returned promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipment to Cardinal Health shall be at purchaser s risk In no event shall Cardinal Health be liable for any incidental indi
17. then this is called open loop effect site targeted TCI Input V2 V1 V3 Peripheral Central Peripheral Compartment Compartment Compartment ko Clearance CL 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 9596 of patients respectively For an example 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 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 correspondin
18. 0005 Iss 2 27 44 Configured Options Continued Default Drug Profile Library The following drug parameters are programmed in the pump Diprivan 1 Diprivan 2 Remifentanil Remifentanil TIVA 5s Sufentanil Gepts 0 2ug ml 10mg ml 20mg ml 20ug ml 20ug ml mE 2omgim sore sous 5 Oug ml 0 15ug kg 1 0mg kg 1 0mg kg 1 0ug kg 1 0ug kg 0 5ug kg smog 2smono Im Im 4 0mg kg 4 0mg kg 2 0ug kg 2 0ug kg 2 0ug kg UI e 0 1ug kg h 1ug kg h 2ug kg h 1200ml h nd This drug does not have an associated model and therefore cannot be run in TCI mode 0 15ug kg 1 00g kg 2 0ug kg 0 15ng ml 1 0ng ml 2 0ng ml 0 05ng ml TIT 1200ml h 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 1000DF00005 Iss 2 28 44 Infusion Specifications Maximum infusion rate can be set as part of the configuration 0 1ml h 150ml h 5ml syringes 0 1 ml 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 T
19. 0ml Syringe Patient Age 75 Yrs Patient Weight 65kg Patient Height 175cm Patient Gender Male Drug Concentration 50ug ml Volumetric Accuracy 1 696 Rate ml h 5 10 15 20 25 30 35 40 Time Interval mins 38 44 Target Plasma Concentration ng ml 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 Patient Weight 60kg Drug Concentration 10mg ml Drug Concentration 20mg ml Plasma Concentration Accuracy 40 2 Plasma Concentration Accuracy 0 3 2 S Predicted Plasma Concentration ng ml 80 o 8 0 gt 7 0 E 70 6 0 o 6 0 5 0 5 0 5 0 5 0 4 0 4 0 4 0 4 0 3 0 3 0 3 0 3 0 20 20 20 20 Ideal Plasma Concentration pg ml Predicted Plasma Concentration ng ml Ideal Plasma Concentration pg ml so 1 0 vol 1 0 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 Patient Weight 65kg Patient Weight 65kg Patient Height 175cm Patient Height 175cm Patient Gender Male Patient Gender Male Drug Concentration 50ug ml Drug Concentration 50ug ml Plasma Concentration Accuracy 0 2 Plasma Concentration Accuracy 0 5 2 E a fas 5 40 2 a 35 2 3 0 25
20. 1 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 1000DF00005 Iss 2 5 44 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 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 amp maximum limits and targets and occlusion level Configuration Instrument configuration settings and general options 3 Review Approve and Release Using Alaris PK Editor Software 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 be 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 To
21. 4 5 12 z aul A AA MEN are t z WOW NEW ji E os 5 g 8 c os a 04 15 0 2 0 0 20 o 10 20 30 40 50 60 70 80 90 100 110 120 0 5 10 15 20 25 30 35 Time mins Observation Window mins E Maximum Error Minimum Error amp Linear Mean 1 8 Start up Trend BD Plastipak 50ml 5 Oml h Ld 100 Trumpet Curve BD Plastipak 50ml 5 Oml h 90 10 80 5 70 60 of At E d EE 3 E Oow GE EED GE VEN SEN SENSE VEN VEN N ae E a z r Bos d 30 amp 20 10 10 00 45 0 10 20 30 40 50 60 70 80 90 100 110 120 0 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error Minimum Error k LinearMean 0 1 1000DF00005 Iss 2 36 44 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
22. Directions For Use English CardinalHealth Page e Introduction eek ed ed sed ee De GE ee N N DEd nd ka Ge ed eed 2 e About This EDI e 2 e TCI OVERVIEW 3 e Creating a Data Set qc C 6 e Features of the Alaris PK Syringe Pump ee ecee eere eere eene EG EG GE EG EG GE tease ense GE ense Ge ene 7 o Controls amp Indicators direi ordeo eset Ede F ese VE reo bee evo eo Lube oe eae epe To T epo LU eve ed N HER dee ed Ag eo ene isi 8 o Symbol Definitions e GE Ee ee Ge Ge 9 e Main Display Features M Ge Ge Ge Ge 10 e Operating Precautions seas sensseonsvoonveonsennseoonvennsennsennnveonvenssenssvennsennsennserenvennsennserenveonvenssennsenenvennven 12 e Getting Started ee M 14 e Basic Featufes SE e M 19 e Operations During Use 21 o Alarms and Warning ER 23 e Prompts EE Ee EE EE IE EE AE EE N EE 24 e Configured Options incre EE EE N EE AT 25 e SPECIFICATIONS ete I 29 e Compatible Syringes susse sissies tero gs GE ennen ERE N e eo eg ged Need ee Ed one SUP S eU ge oU ie se Gee V Ten re eode Eed 30 e Associated Product ees E 30 o Compatible Extension Sets ic sccccccseasecessossssssevensnssscescseseeseasa
23. I mode if the configuration permits 1 Press the C2 button to access the options menu 2 Select EFFECT SITE TCI using the amp DC 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 Pressthe C2 button to access the options menu 2 Select PLASMA TCI using the amp DCV keys 3 Press the OK softkey indicated on the screen A confirmation screen will be displayed 1000DF00005 Iss 2 22 44 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 Display DRIVE DISENGAGED OCCLUSION CHECK SYRINGE BATTERY LOW BATTERY EMPTY NEAR END OF INFUSION END OF INFUSION TITRATION NOT CONFIRMED AC POWER FAIL Error Code and Message ATTENTION with 3 Beeps Alarm Indicator Colour AMBER RED Description and Troubleshooting Guide The drive system has been disengaged during operation Check the finger grips and the position of the syringe Excessive pressure measured at the syringe plunger
24. RIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust rate above Soft Alert DOSE NOT PERMITTED The infusion rate has been set above a Hard Limit Check infusion setting and adjust rate to appropriate required rate TARGET WOULD EXCEED 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 BOLUS DOSE OVER 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 BOLUS DOSE UNDER 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 the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust dose above Soft Alert BOLUS DOSE NOT PERMITTED The bolus dose has been set above a Hard Limit Check bolus setting and adjust to appropriate required dose WEIGHT OUTSIDE LIMIT The patient weight has been set to a value which exceeds or is under a Soft Alert Check the weight setting to continue pres
25. T 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 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 Plasma current Plasma or Effect site Flow Rate and Effect Site Drug Name and Concentration Dose Rate Concentration Concentration Prediction 16 Stop Press the button to halt the operation ON HOLD will be displayed The amber stop light will replace the green start light The Ce value will not be displayed if there is no K K defined for the selected model Decrement Actual Time Effect Site Trend Time Prediction Time 1000DF00005 Iss 2 18 44 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 G button when the pump is not infusing Ensure that the extension set is not connected to the patient 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 When purging is complete release the PURGE softkey Press the QUIT softkey to exit back to the main display N w During PURGE the pressure limit alarms are te
26. al environment to control or receive data from the pump lies with the user of the equipment This software should include detection of the disconnection or other failure of the R 232 cable The protocol is detailed in the Technical Service Manual and is for general information only Anyconnectedanalogueanddigitalcomponents are required to meet IEC EN60950 for data processing and IEC EN60601 for medical devices Anyone connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard IEC EN60601 1 1 Baud Rate 38 4 kBaud Start Bits 1 Start Bit Data Bits 8 Data Bits Parity No Parity Stop Bits 1 stop bit 1000DF00005 Iss 2 RS232 Nurse Call Connection Data Nurse call Specification Connector TXD RXD TXD Output Voltage Range RXD Input Voltage Range RXD Input Thresholds RXD Input Resistance Enable Isolation Socket Pump Baud Rate Start Bits Data Bits Parity Stop Bits Nurse Call Relay Contacts Typical Connection Data D Type 9 Pin EIA RS232 C Standard Minimum 5V mark 4 5V space Typical 7V mark 7V space with 3kO load to ground 30V 30V max Low 0 6V minimum High 3 0V maximum 3kQ minimum Active Low 7V to 12V Active High 7V to 12V powers up the isolated RS232 circuitry Inactive Floating open circuit allows isolated RS232 circuitry to power down 1 5kV dc or ac pea
27. 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 Target Concentration Cpt or Cet Adjust the Target Concentration if necessary using the ASC keys Confirm the Target Concentration and Initial Infusion predicted parameters On confirmation if the Target Concentration exceeds any limits a warning will be displayed 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 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 To Patient Connect the extension set to the patient access device 14 Start 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 LIMI
28. andard disinfectant detergent solution Recommended cleaners are Brand Concentration Hibiscrub 20 v v Virkon 196 w v Do not use the following disinfectant types Disinfectants which are known to be corrosive to metals must not be used which include NaDcc such as Presept Hypochlorites such as Chlorasol Aldehydes such as Cidex 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 1 The syringe and extension sets are disposable single use items and should be discarded after use according to their manufacturers instructions If the pump is to 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 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 Disposal I
29. ation not confirmed Dose Would Exceed Dose not Permitted Target Would Exceed Dose Under Bolus Dose not Permitted Weight Outside Limit Bolus Dose Over Bolus Dose Under Concentration not Permitted Rate not Permitted Environmental Specifications 5 C 40 C 20 90 700hPa 1060hPa 30 C 50 C 10 95 500hPa 1060hPa Operating Temperature Operating Relative Humidity Operating Atmospheric Pressure Transport amp Storage Temperature Transport amp Storage Relative Humidity Transport amp Storage Atmospheric Pressure Electrical Mechanical Safety Complies with IEC EN60601 1 and IEC EN60601 2 24 EMC Complies with IEC EN60601 1 2 and IEC EN60601 2 24 29 44 Compatible 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 5ml leue ee eres eese Astrazeneca BBraunPerfusor o v BOPerfusor oo BDPreese Codan v Codan Perfusion Fresenius Injectomat_ v INpo Rapiject fT The Rapiject 50ml syringe is a specialised syringe with a large diameter barrel To provide protection against accidental dislodging always ensure the infusion line is secured using the infusion set hook see Loading a Syringe secti
30. 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 1000DF00005 Iss 2 8 44 Symbol Definitions Labelling Symbols Attention Consult accompanying documents Potential Equalisation PE Connector RS232 Nurse call Connector Optional Defibrillation proof type CF applied part Degree of protection against electrical shock Device complies with the requirements of the EC Directive 93 42 EEC Registered with the CE Mark Date of Manufacture Manufacturer Not for Municipal Waste Important information Fuse Rating 1000DF00005 Iss 2 9 44 Main Display Features TIVA Mode Drug Name and Pump Status Concentration Pressure Information EX usc 16 8ms h EE ID 0 20ug kg min 80 Ono th 59m 28s fF 4 ADJUST Cp Ce SI ED Ead ED Flow Rate and Dose and Operations Dose Rate Volume Infused During Use TCI Mode Drug Name and Induction Pause Before Pump Status Concentration Duration Maintenance 5 ON HOLD Remifentanil 50 0 y lt INDUCTION MAINTEPANCE Ca GO PK ye GP cet 3 Ong mi Pantin Wea AAT DDS ADJUST E CONFIRM AIME UR LE MERE ED EER ED N Plasma Plasma Target Initial Induction Initial Induction Initial Induction Time of Initial Maintenance Concentration Dose Rate Volume Induction Rate TCI Mode MORE
31. cking Station 15 40 Alaris Gateway Workstation 15 40 Alarms 23 Associated Products 30 Battery 23 29 40 See also Battery Operation Battery Operation 32 Bolus 7 8 19 24 29 C Cleaning 33 Clock Set 25 Concentration 3 5 10 17 18 20 21 27 28 29 33 37 38 39 Concentration Target Titration 20 Contrast 25 Controls CHEVRON 8 HOLD 7 8 MUTE 7 8 ON OFF 7 8 OPTION 7 8 PRESSURE 7 8 PURGE BOLUS 7 8 RUN 7 8 SOFTKEYS 8 D Data Set 6 22 26 Display 7 10 11 23 24 Disposal 33 Docking Station 15 40 Dose 24 Drug 3 5 6 10 17 18 26 27 28 38 39 Drug Name 21 Editor 6 25 26 27 EFFECT SITE TCI 22 End of Operation 21 Equipment Rail 15 Event Log 22 Extension Sets 12 31 F Fuses 32 G General Options 25 H Hands Free 19 Hands On 19 Indicators AC POWER 8 BATTERY 8 Installation 15 Introduction 2 IrDA 35 1000DF00005 Iss 2 L Labelling Symbols 9 Language 14 25 Loading a Syringe 16 M Maintenance 32 33 Mode TIVA 2 7 14 40 MORE 10 Mount 12 15 N Nurse Call 13 25 35 0 Occlusion 29 34 Operating Precautions 12 13 P Pharmacokinetic 2 3 5 PLASMATCI 22 Plunger 7 16 Pole Clamp 7 15 Pressure 29 34 Profile 6 19 27 28 Purge 7 8 19 29 R RS232 7 9 13 25 35 40 S Screen Icons 11 Service Contacts 41 Spare Parts 40 Specifications 29 Start up Curves 36 Starting the Pump 17 Storage 33 Syringes 30 See also Loading a Syringe
32. confirm 4 The remaining patient parameters for the selected drug 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 ADV 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 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 Prime the extension set 9 Load Syringe Load the syringe according to the procedure in this manual 10 Confirm Syringe 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 ex
33. ctive 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 1000DF00005 Iss 2 25 44 Configured Options Continued 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 AC Fail Warning Audio Volume Auto Night Mode Battery Icon Callback Time Event Log Drug Override Mode Pressure Default Pressure Display Purge Rate Purge Volume Max Purge Syringe Prompt Bolus Bolus Rate Default Bolus Volume Default KVO KVO Rate Near End of Infusion Time End of Infusion Weight Default Weight Minimum Weight Maximum Age Default Age Minimum Age Maximum i The AC Power Failure Alarm can be set to sound or be silent if the AC power is disconnected The audio alarm volume of the pump high medium or low Main Display Backlight dims between hours 21 00 and 06 00 Indicator displaying the remaining estimated battery capacity Adjusts the length of time before the pump sounds the Call Back alarm The Event Log can be set to be displayed on the main display Events are still recorded in the Event Log i
34. e rotating cam on the rear of the pump with the rectangular bar on the Docking Station Workstation or the equipment rail 2 Hold the pump horizontally push the pump firmly onto the rectangular bar or equipment rail Ensure that the pump clicks securely into position onto the bar 3 Torelease push the release lever and pull the pump forwards AlariS DS Docking Station Asena IDS Docking Station and Alaris Gateway Workstation 1000DF00005 Iss 2 15 44 Getting Started continued Loading a Syringe 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 and the performance of the pump When initially loading the syringe allow for the volume of fluid contained in the extension set and retained in the syringe at the end of infusion as this dead space will not be infused Place the pump on a stable horizontal surface or secure as described above Prepare load and prime the single use disposable syringe and extension set using standard aseptic techniques 1 Squeeze the finger grips together on the plunger holder and slide the mechanism to the right Pull the syringe clamp forward and down 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 Insert the syr
35. ector 1000DF00005 Iss 2 7 44 Controls amp Indicators Controls 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 MUTE button Press to silence alarm for 2 minutes configurable Press and hold until 3 beeps are heard for 15 minutes silence PURGE BOLUS button Press to access PURGE or BOLUS soft keys Press and hold down soft key to operate PURGE the extension set during set up Pump is on hold Extension set is not connected to the patient e Volume Infused VI is not added BOLUS fluid or drug delivered at an accelerated rate e Pumpis infusing Extension set is connected to the patient e Vlis added OPTION button Press to access optional features see Basic Features PRESSURE button Use this button to display the pumping pressure and alarm CHEVRON keys Double or single for faster slower increase or decrease of values shown on display BLANK SOFTKEYS Use in conjunction with the prompts shown on the display Indicators BATTERY indicator When illuminated the pump is running on the internal battery When flashing the
36. ed 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 1000DF00005 Iss 2 31 44 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 All servicing should only be performed by a qualified service engineer with reference to the Technical Service Manual TSM Circuit diagrams and components parts lists and all other servicing information which will assist the qualified service engineer in performing repair of the parts designated as repairable are available upon request from Cardinal Health If the pump is dropped damaged subjected to excessive moisture or high temperature immediately take it out of service for examination by a qualified service engineer All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied Cardinal Health will not be responsible should any of these actions be performed outside the instructions or information supplied by Cardinal Health Refer to the Technical Service Manual for the access code for technical service features Interval Routine Maintenance Procedure As per Hospital Policy Thoroughly clean ex
37. ell as pump delivery accuracy specification and accuracy of pump delivery are available in Profiles from TCI Mode 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 concentrations When Remifentanil and Sufentanil are used in TCI mode the Minto and Gepts models respectively are used to calculate the required infusion rates The Asena brand name has been recently changed to the Alaris brand name This change in brand name has no effect on the intended use or functionality of the product Recommended disposable products for use with this product may refer to either the Asena brand name or Alaris brand name and both types are suitable for use with this infusion pump 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 fo
38. extension set Time to alarm 1 0 ml h er Time to alarm 5 0 ml h typical 2 4 6 8 10 Occlusion Level Occlusion Level Bolus Volume typical 1 50 yp 1 00 E 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 1000DF00005 Iss 2 34 44 IrDA RS232 and Nurse Call Specification IrDA RS232 Nurse Call Feature The IrDA or RS232 Nurse Call optional feature is a feature on Alaris Syringe Pumps that allows the pump to be connected to a PC or other Alaris Syringe Pumps This allows data to be transferred between the Alaris Syringe Pump and a PC or another Alaris Syringe Pump The nurse call interface provides a remote backup to the internal audible alarm It should not be relied upon to replace monitoring of the internal alarm Refer to the Technical Service Manual for further information regarding the RS232 interface Since it is possible to control the syringe pump using the RS232 interface at some distance from the pump and hence remote from the patient responsibility for the control of the pump is vested in the software run on the computer control system Theassessmentforthesuitabilityofanysoftware used in the clinic
39. f disabled 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 The default occlusion pressure alarm level Sets whether the Pressure Information is available on the main display The rate used during purge operation The maximum permissible purge volume Feature which prompts the user to purge the extension set prior to the start of the infusion Bolus feature can be set to HANDS ON or HANDS FREE The default bolus rate The default bolus volume Allows the enabling or disabling of Keep Vein Open KVO at End of Infusion EOI Sets the KVO rate at which the pump will operate when EOI is reached Sets the Near End of Infusion warning time as time left to End of Infusion Sets the End of Infusion point as a percentage of syringe volume The patient default weight in kg The minimum patient weight in kg This is a Soft Alert and can be overridden The
40. ffect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effects as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered Short term fluctuations in rate accuracy may have clinical impact depending on the half life of the drug being infused therefore the clinical effect cannot be determined from the trumpet curves alone Start up and trumpet curves may not be indicative of operation under negative pressure Differences in factors such as size and plunger force in compatible syringes produced by other manufacturers can cause variations in accuracy and trumpet curves as compared to those represented Additional curves for compatible syringes are available upon written request For applications where flow uniformity is a concern rates of 1 0 ml h or above are recommended Trumpet Curve BD Plastipak 50ml 0 1ml h Start up Trend BD Plastipak 50ml 0 1ml h Ak LI A A 0 E E 8 w 20 30 40 0 02 50 0 10 20 30 40 50 60 70 80 90 100 110 120 o 5 10 15 20 25 30 35 Time mins Observation Window mins E Maximum Error Minimum Error 4 Linear Mean 4 5 Start up Trend BD Plastipak 50ml 1 0ml h Trumpet Curve BD Plastipak 50ml 1 0ml h 20 2 0 15 18 18 N 1
41. g any infusion pump in conjunction with other pumps or devices requiring vascular access extra care is advised Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the local vascular system by such pumps Typical examples of those pumps are used during dialysis bypass or cardiac assist applications This 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 Cardinal Health for further information This 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 P uum e Alarm Conditions Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms Users mu
42. g 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 V1 V3 Peripheral Central Peripheral Compartment Compartment Compartment Effect Compartment Fig 3 Schematic representation of the concentration effect relationship Clearance CL 1000DF00005 Iss 2 3 44 TCI Overview continued 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 pump has to work accurately The models used in the Alaris PK Syringe Pump are well validated and accepted Secondly the pha
43. he default bolus volume can be set as part of the configuration Minimum 0 1ml Maximum 100 0ml 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 1096 of syringe volume whichever is smaller End Of Infusion EOI Alarm 0 596 of syringe volume Electrical Classification Class product Continuous Mode Operation Transportable Maximum Pumping Pressure Limit Highest alarm level 1000mmHg nominal at L 10 Occlusion Accuracy of full scale L 0 L 3 L 5 L 10 approx approx approx approx 50 mmHg 300 mmHg 500 mmHg 1000 mmHg Temp 23 C Using most common 50ml syringes under normal conditions 9596 confidence 9596 of pumps Battery Specifications Rechargeable sealed NiMH Automatically charges when the pump is connected to AC power Battery life is typically 4h from fully
44. he syringe make specified on the pump or described in this manual Use of non specified syringes or extension sets may impair the operation of the pump and the accuracy of the infusion Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump or if it is removed from the pump before the extension set is properly isolated from the patient Isolation may include closing a tap in the patient line or activating a flow stop clamp 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 1 0m e Mounting the Pump The pump must be mounted within 1 0m above or below the patient s heart The most accurate pressure monitoring in the extension set is achieved when the pump is positioned close to the patients heart level Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe To protect against the introduction of air the user should regularly monitor the progress of the infusion syringe extension line and patient connections and follow the priming procedure specified herein Operating Environment When usin
45. information and press the QUIT softkey to exit SET BY DOSERATE SET BY ml h TIVA mode only Tosetdoseratetoflowratein preciseincrements it may benecessarytoswitch betweentherateadjustoptions SET BY DOSERATEandSET BY ml h An arrow to the left of the rate display shows the rate changed when the amp C Y 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 A SS 32 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 amp SS Y 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 TC
46. information screen Selecting the MORE softkey will display the following additional information Drug Name Volume and and Model Elapsed Time Dose Infused WEIGHT 70 0kg AGE 40yrs HEIGHT 180cm GENDER MALE LBM 57 6kg BMI 21 6 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 1000DF00005 Iss 2 10 44 Main Display Features continued Screen Icons TIME REMAINING DISPLAY icon Indicates time before syringe will require replacing mme 000 EIE BEN Maintenance Phase Dose Rate Displayed on protocol confirmation screen 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 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 VM DOWN MODE Infusion status indicating that the target concentration is below current concentration 1000DF00005 Iss 2 11 44 Operating Precautions Disposable Syringes and Extension Sets This Alaris PK Syringe 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 t
47. inge ensuring that the barrel flange is located in the slots on the syringe flange clamp Lift the syringe clamp until it locks against the syringe barrel Squeeze the finger grips on the plunger holder and slide the mechanism to the left until it reaches the plunger end Release the finger grips Ensure that the plunger grippers are securing the plunger in place and the finger grip returns to its original position EN R M Secure the extension set using the extensio n 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 Plunger Plunger Flange Grippers Plunger Plunger Holder Syringe Barrel Barrel Flange Syringe Clamp Syringe Flange Clamp 1000DF00005 Iss 2 16 44 Getting Started Continued Starting the Pump 1 Connect the pump to an AC power supply using the AC power cable Press the button The pump will run a short self test Ensure that two beeps are activated during this test Check the display test pattern and ensure that no coloured rows are missing e 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 cont
48. inue to power up as normal 2 CONFIRM PROFILE Answering NO will display SELECT PROFILE screen select profile and press the OK softkey YES will display the TCI MODE screen 3 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 amp SEP keys to select the required drug and press the OK softkey If the 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 WEIGHT adjust the patient weight using the AE keys press the OK softkey to
49. is infusing the message INFUSION CONTINUES will be displayed Reconnect AC power supply or press the QD button to silence the alarm and continue with battery operation The alarm will automatically cancel if the AC power supply is reconnected The alarm system has detected an internal malfunction Note the malfunction code Remove pump from service for examination by a qualified service engineer 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 15 minutes Alarms indicated AC POWER FAIL NEAR END OF INFUSION ATTENTION TITRATION NOT CONFIRMED BATTERY LOW All others Configurable option 1000DF00005 Iss 2 23 44 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 by pressing the YES softkey If OVERRIDE LIMIT is not required press the NO softkey and adjust rate below Soft Alert DOSE UNDER 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 OVER
50. k 38 4 kBaud 1 Start Bit 8 Data Bits No Parity 1 stop bit Pins 1 8 9 30V dc 1A rating 1 Nurse call Relay Normally Closed NC C 2 Transmit Data TXD Output 3 Received Data RXD Input 4 Power Input DSR 5 Ground GND 6 Not used 7 Power Input CTS 8 Nurse call Relay Normally open NC O 9 Nurse call Relay Common NC COM GND DSR RXD TXD NCC 5 4 9 7 6 NC NCO CTS COM 35 44 Trumpet Curves amp 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 IEC EN60601 2 24 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 e
51. le switching between plasma and effect site targeting if the model associated with the drug supports both modes Enable switching between TIVA and TCI modes Sets the target concentration soft alert maximum Sets the default decrement target concentration Enables Disables induction stage of TIVA protocol The induction dose units This can be based on patient weight The default induction dose offered Sets the default induction time 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 Enables Disables pause after induction 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 The maximum allowed maintenance dose rate Determines bolus operation when required The default bolus rate 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 override confirmation is required The maximum allowed bolus dose The default occlusion alarm level The infusion rate that when exceeded in TCI mode causes the occlusion detection to be desensitised The minimum drug concentration The maximum drug concentration 1000DF0
52. lease 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 soft key 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 button to display the Hands Free bolus selection screen 2 Use the AE keys to set the bolus volume dose required If necessary press the RATE softkey to adjust the bolus delivery rate 150 300 600 900 1200ml h Note Rate may be restricted by the syringe size and the CAP BOLUS RATE 3 Press the flashing BOLUS softkey once to begin the 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 If the bolus volume reaches the set bolus volume limit 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 Aler
53. lert the user by generating a combination of visual and audible alarms Should any encountered alarm condition persist even after user intervention it is recommended to replace that particular pump and quarantine the pump for the attention of appropriately trained technical personnel Consult Technical Service Manual for further information e 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 il 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 precautions are required when connecting RS232 Nurse Call Touching the pins of the AA connectors may result in ESD protection failure It is recommended that all actions must be taken by appropriately trained personnel e If this pump is dropped subjected to excessive moisture fluid spillage humidity or high temperature or MZ otherwise suspected to have been damaged remove it from service for inspection by a qualified se
54. ly 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 1000DF00005 Iss 2 14 44 Getting Started continued 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 fixing to vertical I V poles of a diameter between 15 and 40 mm 1 Pullthe folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole 2 Place pump around pole and tighten screw until the clamp is secured to the pole Ensure the pole clamp is folded away and stored 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 IV infusion stand becomes top heavy or unstable Docking Station Workstation or Equipment Rail Installation Rectangular bar Release lever push to release Rotating cam The rotating cam can be fitted to the rectangular bar on the Docking Station Workstation or the equipment rail measuring 10 by 25 mm 1 Align th
55. 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 AE 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 Press the button to access the options menu Using the amp amp keys select TREND SIZE Using the amp AE Y keys select the required TREND SIZE option 5 Mins 15 Mins 30 Mins or 60 Mins Press the SELECT softkey indicated on the screen na WN 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 TEXT GRAPH DISPLAY When in TCI mode the user is able to select a numerical or graphical display Press the button to access the options menu 2 Using the amp amp key
56. mporarily increased to their maximum level Bolus Infusion LY 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 i Hands On ii Hands Free BOLUS Disabled If configured to Disabled pressing the button will have no effect and the pump will continue to infuse at the set rate 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 soft key to deliver the required bolus The bolus rate can be adjusted The bolus volume is limited in the configuration 1 During infusion press the button once to display the bolus screen 2 Use the ASV 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 re
57. ncy rooms The Alaris PK Syringe Pump is compatible with a wide range of standard single use 3 piece Luer lock syringes It accepts syringe sizes from 5ml to 50ml Specifications are available in the relevant section 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 but 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 Cardinal Health has verified the accuracy of the mathematical model implementation as w
58. nformation on Disposal for Users of Waste Electrical amp Electronic Equipment This 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 Cardinal Health 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 by the local country regulations All other components can be safely disposed of as per local regulations 1000DF00005 Iss 2 33 44 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 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
59. ol Data Set transfers should only be performed by qualified technical personnel 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 Note Drug parameters have to be in accordance to local regulation and prescribed information See important note in Configured Options section 1000DF00005 Iss 2 6 44 Features of the Alaris PK Syringe Pump ON OFF Release lever for High visibility RUN Display MDI Alarm Indicator PURGE BOLUS MUTE PRESSURE OPTION Finger Grips Extension HOLD Shelf for chevron Syringe Clamp Positive Plunger set hook keys and softkeys Grippers Rating Plate see Symbol Definitions for an explanation of the symbols used Release lever for Rotating Cam Rotating Cam to lock on to horizontal rectangular bars IR Communications port Carrying Potential Folded Pole RS232 Extension set Handle Equalisation Clamp Connector hook PE conn
60. on TYCO Healthcare KENDALL MONOJECT Y v Ee Hel pu EE cui Es Associated Products The Alaris DS The Asena IDS The Alaris Gateway Workstation Docking Station Docking Station Wine aaa EL 1000DF00005 Iss 2 30 44 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 Cardinal Health Please check the availability of the sets listed below with your local Affiliate or Distributor 20038E 3 way extension set with 3 SmartSite Needle Free Valves low priming volume 13cm 20062E 3 way extension set with 3 SmartSite Needle Free Valves and one backcheck valve 16cm MFX 2290 3 way set with 2 anti syphon valves and backcheck valve low priming volume 209cm V MFX 2291 2 way set with anti syphon valve and backcheck valve low priming volume 209cm ena re Ami LH 20061E Y extension set with 2 SmartSite Needle Free Valves 18cm MFX 2233E 3 way extension set with 2 backcheck valves SmartSite Needle Free Valve and clamp low priming volume 10cm aoc
61. ote i IEC60601 2 24 Particular Requirements for the Safety of Infusion Devices 95 Confidence 95 Population 1000DF00005 Iss 2 37 44 Profiles from TCI mode Infusion Rate vs Target Concentration Diprivan 1 Marsh Model BD 50ml Syringe Diprivan 2 Marsh Model BD 50ml Syringe Patient Age 40 Yrs Patient Weight 60kg Drug Concentration 10mg ml Volumetric Accuracy 0 1 Rate ml h Remifentanil Minto Model BD 5ml Syringe 1200 1100 1000 Time Interval mins Patient Age 75 Yrs Patient Weight 65kg Patient Height 175cm Patient Gender Male Drug Concentration 50ug ml Volumetric Accuracy 0 2 Rate ml h Sufentanil Gepts Model BD 50ml Syringe Plasma Target 80 75 8 0 7 0 6 0 5 0 35 3 0 25 20 Time Interval mins Drug Concentration 5 Oug ml Volumetric Accuracy 43 0 Rate ml h 240 220 200 180 160 140 120 100 5 10 15 20 25 30 35 40 45 50 55 Time Interval mins 1000DF00005 Iss 2 a AA Target Plasma Concentration ug ml Target Plasma Concentration ng ml Target Plasma Concentration ng ml Patient Age 40 Yrs Patient Weight 60kg Drug Concentration 20mg ml Volumetric Accuracy 0 4 600 550 500 450 400 Rate ml h S 8 10 15 20 25 30 35 40 Time Interval mins Target Plasma Concentration pg ml Remifentanil Minto Model BD 5
62. r 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 Oml h The complete range of infusion rates settings and values are shown in the Specifications section 1000DF00005 Iss 2 2 44 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 A 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 bio phase the drug interacts with the receptor resulting in the pharmacological effect Until recently when intravenous anaesthetic agents we
63. re the pump should not be restarted in TCI mode 1000DF00005 Iss 2 A 44 TCI Overview continued Pharmacokinetic models in Alaris PK Syringe Pump and their parameters 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 kio 0 119 min k 0 112 min k 0 0419 min ky 20 055 min k 0 0033 min K 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 Ibm 55 V2 9 82 0 0811 x age 40 0 108 x Ibm 55 V3 5 42 CL 2 6 0 0162 x age 40 0 0191 x Ibm 55 CL 2 05 0 0301 x age 40 CL 0 076 0 00113 x age 40 ko CH Vc k CI2 Vc k CI3 Vc k CI2 V2 ky CI3 V3 k o 0 595 0 007 x age 40 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 Vc 14 3 ky 0 0645 min k 0 1086 min k 0 0229 min kj 0 0245 min k 0 0013 min Reference from the literature Gepts et al Anesthesiology 1995 83 1194 1204 1 1 1 1
64. re 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 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 k k and k 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 plasma compartment is targeted this is called open loop plasma targeted TCI When a certain concentration at the effect compartment is targeted
65. rect or consequential damages in connection with the purchase or use of any Cardinal Health product This warranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and Cardinal Health shall not be responsible for any loss or damage arising in connection with the purchase or use of any Cardinal Health product which has been A repaired by anyone other than an authorised Cardinal Health service representative B altered in any way so as to affect in Cardinal Health s judgement the stability or reliability of the product or has had the product s serial or lot number altered effaced or removed C subjected to misuse or negligence or accident or D improperly maintained or used in any manner other than in accordance with the written instructions furnished by Cardinal Health This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of Cardinal Health and Cardinal Health neither assumes nor authorises any representative or other person to assume for it any other liability in connection with the sale of Cardinal Health products CARDINAL HEALTH DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE 1000DF00005 Iss 2 42 44 Symbols 24 Hour Log 22 A About This Manual 2 Alaris DS Do
66. rmacokinetic 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 Theimer E Continuous intravenous infusion and multicompartment accumulation Eur J Pharmacol 1968 4 317 324 3 Schwilden
67. rvice engineer When transporting or storing the pump use original packaging where possible and adhere EE to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging Theembedded 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 Latex Content The Alaris PK Syringe Pump does not contain any Latex 1000DF00005 Iss 2 13 44 Getting Started Initial Set up Before operating the pump read this Directions For Use manual carefully 1 Check that the pump is complete undamaged and that the voltage rating specified on the label is compatible with your AC power supply 2 Items supplied are Alaris PK Syringe Pump UserSupport CD Directions For Use AC Power Cable as requested Protective Packaging 3 Connect the pump to the AC power supply for at least 2 hours to ensure that the internal battery is charged verify that the QE is lit Language Selection 1 Oninitial start up the pump will display the Select Language screen 2 Select the required language from the list displayed using the ASC keys 3 Press the OK softkey to confirm your selection The pump will automatical
68. s 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 amp amp keys and press the OK softkey 3 Press the QUIT softkey to exit the menu 1000DF00005 Iss 2 21 44 Operations During Use continued 24 Hour Log This option allows the 24 hour log of volume infused to be reviewed 1 Press the button to access the options menu 2 Select the 24H LOG option using the amp amp keys and press the OK softkey The display shows the hourly volume infused The volume infused shown in brackets is the total volume infused since the volume was last cleared See example below 07 48 08 00 4 34ml 4 34ml 08 00 09 00 2 10ml 6 44ml 09 00 10 00 2 10ml 8 54ml VOLUME CLEARED 3 Press the QUIT softkey to exit the log Event Log This option allows the event log to be reviewed It can be enabled disabled 1 Press the C2 button to access the options menu 2 Select the EVENT LOG option using the ASE keys and press the OK softkey 3 Scroll through the log using the amp amp Y keys Press the QUIT softkey to exit the log DATA SET DETAILS To review the currently selected Data Set information 1 Press the button to access the options menu 2 Select DATA SET DETAILS 3 Review the
69. s 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 RATE NOT PERMITTED The infusion rate has been set above a Hard Limit Check infusion setting and adjust to appropriate required rate 1000DF00005 Iss 2 24 44 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 Important 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 amp keys and press the OK softkey 2 Use the amp amp keys to adjust the date displayed pressing the NEXT softkey to access the next field 3 When the correct time and date are displayed press the OK softkey to return to the Configured Options menu Language This option is used to set the language of messages shown on the pump display 1 Select LANGUAGE from the Configured Options menu using the keys and press the OK softkey 2 Use the amp amp Y key
70. s 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 SEP 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 Alaris PK Syringe Pump General Options Select GENERAL OPTIONS from the Configured Options menu using the amp amp 3 keys and press the OK softkey Select the option you wish to enable disable or adjust and press the MODIFY softkey When all the desired modifications have been carried out press the QUIT softkey des N Either select the next configuration option from the menu or turn the pump OFF returning it to operation as reguired NURSE CALL FITTED Enables Nurse Call hardware option NURSE CALL INVERT When enabled the nurse call output is inverted R 232 SELECTED Sets the pump s communications to use RS232 hardware option Power Down Sequence Enter the access code on Alaris PK Syringe Pump for alternative Power Down Sequence see the Technical Service Manual for details Important Access codes should only be entered by qualified technical personnel ENABLED When running TCI or TIVA with predi
71. sesoonsseseaseseteoseosssevenssesacasescdeusonsuseeeossosesedes 31 e EIE TT suss sors b ssvrs sredu svedo sors vsa so stopte ss bsos v sosse o sss ossei 32 e Occlusion Pressure Limits snssonevsorenovenonrsenveonrensnenonrennrsnnnenenenonvensvensseronenoorensvenoneeonvnonvensnenonrenneen 34 e IrDA RS232 and Nurse Call Specification eere eere eee eere e eere enero esee ane EA GR GE Ge 35 e Trumpet Curves amp Start up Curves cerne ee eee eren eee GE GEE etas ese een EG tease se tensa esee siss 36 e Profiles From TCI Mode ses ee bee 37 e Products and Spare Parts 4 eee ee eee eese eee seen ette sten seen setas etse EG Ge eene sens stesse tasses sens Ge ess ee 40 e Service Ne cT CEPR 41 e Document History Gee 41 e ETE To N E E E E E 42 e INDER ra 43 1000DF00005 Iss 2 1 44 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
72. st perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating 1000DF00005 Iss 2 12 44 Operating Precautions continued Electromagnetic Compatibility amp Interference This 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 e ThispumpisaCISPR 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 pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation e 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 lt this external interference the pump will remain in a safe mode the pump will duly stop the infusion and ET En a
73. t must be confirmed before operation can be continued This is not applicable in TCI mode 1000DF00005 Iss 2 19 44 Basic Features Continued Pressure Level 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 Press the ASV keys to increase or decrease the alarm level The new level will be indicated on the display Press OK to exit the screen Hy 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 ASV keys The message lt START TO CONFIRM gt will flash on screen and pump continues to infuse at the original rate 2 Press the 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 Press the button to put the pump on hold 2 Select the new rate using the ASC 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 be cleared
74. tension set is complete Release the softkey The volume used during purging will be displayed 12 Connect To Patient Connect the extension set to the patient access device 13 Start 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 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 Stop Press the button to halt the operation ONHOLD will be displayed The AMBERSTOP light will replace the GREEN START light 1000DF00005 Iss 2 17 44 Getting Started Continued TCI Mode A list of available drugs and models will be displayed Use the ASY 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 2 CONCENTRATION a Select Concentration required and OK to confirm Only required if more than one concentration is available
75. ternal surfaces of the pump before and after prolonged period of storage At least once per year 1 Inspect AC power supply plug and cable for damage Refer to TSM for 2 Perform functional tests as outlined in the Technical Service Manual identification of parts 3 Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging 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 Replacing the AC Fuses If the pump continually illuminates the battery symbol and the AC power indicator light does not illuminate when the pump is connected to the AC power supply and switched ON either the power supply fuse in the AC plug if fitted or the internal fuses have blown First check the power supply fuse in the AC mains plug if fitted If the AC power indicator light does not illuminate remove the pump from service It is recommended that only a qualified service engineer replaces the AC fuses For further information regarding the replacement of internal AC fuses refer to the Technical Service Manual If the fuses continue to blow suspect an electrical fault and have the pump and power supply checked out by a qualified service engineer Battery Operation The internal rechargeable battery allows continued operation when the AC po
76. w 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 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 large 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 196 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 N
77. wer is unavailable for example during patient transfer or AC power failure A fully charged battery will provide over 4 hours of operation at typical infusion rates 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 intervals during storage Charge retention will eventually degrade Where retention is critical the internal battery should be replaced every 3 years It is recommended that only a qualified service engineer replaces the battery For further information regarding the replacement of batteries refer to the Technical Service Manual Test Routines The test routines are designed to allow confirmation of many of the pump functions defaults and calibrations without requiring internal inspection They do not represent a full calibration check See the Technical Service Manual for a complete list of the test procedures access codes and calibration procedures 1000DF00005 Iss 2 32 44 Maintenance continued 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 st

Alaris® PK Syringe Pump - Frank`s Hospital Workshop

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Alaris&reg; PK Syringe Pump - Frank`s Hospital Workshop

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Alaris® PK Syringe Pump - Frank`s Hospital Workshop