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Alaris Asena PK - User manual

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1. 209cm 209cm C x CJ A de B E Ei C j i d 7 Ne ez an 20061E MFX 2233E MFX 2260 2309E Y extension set with 2 SmartSite Needle 3 way extension set with 2 backcheck Extension set with anti syphon valve Bag spike with SmartSite Needle Free Free Valves 18cm valves SmartSite Needle Free Valve and 200cm Valve and backcheck valve clamp low priming volume 10cm med ULB Oe J Bes a Mes AB C73 Ee amp 2205E MFX 2293 Vial adaptor with SmartSite Needle Free Extension set with backcheck valve 14cm Valve for 20mm vials Priming Volume 0 9ml t t1 G40720 G40615 Low sorbing PE lined extension set with clamp 200cm Low sorbing PE extension set 150cm E S 1 B E oo 74 E G40215 30262E Extension set opaque PVC 150cm Extension set with 2 SmartSite Needle Free Valve ports 102cm gt C3 G40015 G40020B Standard PVC Syringe Extension Set 150cm Standard PVC Syringe Extension Set 200cm Priming Volume 2 6ml Priming Volume 1 5ml B LE 7 1i p LI afb P G40320 G40620 Opaque White PVC Syringe Extension Set 200cm Polyethylene Syringe Extension Set 200cm Priming Volume 3 6ml Priming Volume 1 6ml B3 v P e Ss j Y P It is recommended that the extension sets are changed according to hospital protocol or as per the extension set Directions For Use Carefully read the Directions For Use supplied with the extension set prior to use Please n
2. Asena PK Syringe Pump ALARIS MEDICAL SYSTEMS Asena PK Syringe Pump Directions for Use ENGLISH Page Introduction 9 TCI Overview 3 Creating a Data Set 5 Features of the Asena PK Syringe Pump 6 Controls and Indicators 7 Operating Precautions 8 Getting Started 9 Basic Features 12 Operations During Use 13 Alarms and Warnings 15 Configured Options 16 Specifications 20 Compatible Accessories 21 Maintenance 23 Occlusion Pressure Limits 24 IrDA RS232 Nursecall Specification 25 Trumpet amp Start up Curves 26 Profiles from TCI Mode 27 Service Contacts 30 Warranty 31 Patent Copyright and Trademarks 32 Introduction The Asena PK Syringe 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 The pharmacokinetic model is used to estimate the plasma and effect site concentration 3 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 sh
3. 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 1000PB01489 Iss 4 18 32 Configured Options continued Default Drug Profile Library The following drug parameters are programmed in the pump Diprivan 2 Sufentanil Marsh n a 4 0mg kg 2 0ug kg Diprivan 196 This drug does not have an associated model and therefore cannot be run in TCI mode 8mg kg h 0 1ug kg h soomi h 200m zover sonom ons ESE Important 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 1000PB01489 Iss 4 19 32 Infusion Specifications Maximum infusion rates are syringe dependant 0 1ml h 150ml h 5ml syringes 0 1ml h 300ml h 10ml syringes 0 1ml h 600ml h 20ml syringes 0 1ml h 900ml h 30ml syringes
4. 0 1ml h 1200ml h 50ml syringes The Volume Infused range is 0 0ml 9990ml Bolus Specifications Bolus rates are syringe dependant 10 ml h 150ml h 10 ml h 300ml h 10 ml h 600ml h 10 ml h 900ml h 10 ml h 1200ml h 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 50ml syringe is 5ml syringes 10ml syringes 20ml syringes 30ml syringes 50ml syringes Maximum Overinfusion 0 25ml Purge Specifications Purge rate 100 500ml h Purge volume 0 5 5ml During PURGE the pressure limit alarms are temporarily increased to their maximum level 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 Factory Default L 5 adjustable via Asena PK Editor Software Occlusion Accuracy of full scale Pressure mmHg 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 95 confidence 95 of pumps System Accuracy continuous mode ml h and TIVA Volumetric Mean 296 nominal Tempera
5. Manufacturer s Address ALARIS Medical UK Ltd The Crescent Jays Close Basingstoke Hampshire RG22 4BS United Kingdom Tel 44 0800 389 6972 Fax 44 1256 388 411 HU ALARIS Medical Hungary D brentei t r 1 H 1013 Budapest Magyar Tel 36 14 88 0232 Tel 36 14 88 0233 Fax 36 12 01 5987 Date 01 06 04 16 06 04 07 07 04 21 09 04 IT ALARIS Medical Italia S P A Via Ticino 4 50019 Sesto Fiorentino Firenze Italia T l 39 055 34 00 23 Fax 39 055 34 00 24 NL ALARIS Medical Holland B V Kantorenpand Hoefse Wing Printerweg 11 3821 AP Amersfoort Nederland Tel 31 33 455 51 00 Fax 31 33 455 51 01 NO ALARIS Medical Norway A S Solbr veien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 NZ ALARIS Medical NZ Ltd Unit 14 13 Highbrook Drive East Tamaki Auckland New Zealand Tel 64 9 273 3901 Fax 64 9 273 3098 SE ALARIS Medical Nordic AB Hammarbacken 4B 191 46 Sollentuna Sverige Tel 46 8 544 43 200 Fax 46 8 544 43 225 Description of Change Changed by Initial release Martin Burnett Amendment to graph data values MPB Minor amendments to text SED Update to include Asena PK Editor Software MPB 1000PB01489 Iss 4 30 32 US ALARIS Medical Systems Inc 10221 Wateridge Circle San Diego CA 92121 USA Tel 1 800 854 7128 Fax 1 858 458 6179 ZA ALARIS Medical S A Pty Ltd Un
6. 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 IEC60601 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 effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effects as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered Short term 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 Important 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
7. Beeps Three beeps will sound if the pump has been left ON for more than 2 minutes referred to as CALLBACK in the log without starting the operation Press the button to silence the alarm for a further 2 minutes Alternatively press and hold down the button and wait for 3 beeps in succession this will put the warning alarm on standby for 60 minutes 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 the rate below Soft Alert DOSE UNDER The infusion rate has been set to a value that is under a Soft Alert Check infusion setting to continue with infusion at set rate press the button and then confirm OVERRIDE LIMIT by pressing the YES softkey If OVERRIDE LIMIT is not required then press the NO softkey and adjust the rate above Soft Alert DOSE NOT PERMITTED The infusion rate has been set or has attempted to be 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 the target below So
8. 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 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 EN60601 2 24 1998 standard The bolus configurations are used only when the Asena 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
9. Malfunction Titration not confirmed Dose not Permitted Target Would Exceed Environmental Specifications Operating Temperature 5 C 40 C 20 90 700mbar 1060mbar 30 C 50 C 10 95 500mbar 1060mbar Operating Relative Humidity Operating Atmospheric Pressure Transport Temperature Transport Relative Humidity Transport Atmospheric Pressure Electrical Mechanical Safety Complies with IEC60601 1 EN60601 1 and IEC60601 2 24 EN60601 2 24 EMC Complies with IEC60601 1 2 2002 and IEC60601 2 24 1000PB01489 Iss 4 20 32 Syringes Compatible Accessories 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 EZ AstraZeneca BBraunPerfusor J CY ESTE BoPrecise coan v v v Codan Perfusion M So Freseniusinjectomat inl el A Oo NEN v 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 section TYCO Healthcare KENDALL MONOJECT Recommended Accessory Asena Docking Station Recommended accessory to use in conjunction with the Ase
10. Systems neither assumes nor authorises any representative or other person to assume for it any other liability in connection with the sale of ALARIS Medical Systems products ALARIS MEDICAL SYSTEMS DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE 1000PB01391 Iss 2 1000PB01489 Iss 4 31 32 Patent Copyright and Trademarks Manufacturers Patent Notice This pump is designed and manufactured in the U K by ALARIS Medical UK Ltd ALARIS Medical UK Ltd reserves the right to alter product specifications without notice AU Patent No 723 884 144 125 144 122 144 123 CA Patented Brevet 90 906 91 584 FR Brevete No 997 137 DE D B P No 49910883 3 29920378 6 GB Patent No 2 083 563 2 083 560 2 083 561 IE Patent No D13001 D13003 D13007 JP Patent No x 1 117 996 5 X amp x 281 117 9975 ER 281 117 999 5 U S Patent No 6 407 335 6 428 509 Other patents pending ALARIS ALARIS Medical Systems Asena and IVAC are registered trademarks of ALARIS Medical Systems Inc All other trademarks belong to their respective owners O 2003 2004 ALARIS Medical UK Ltd All rights reserved This document contains proprietary information of ALARIS Medical Systems 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 inte
11. amp 250 y 400 200 w S S 300 20 150 20 a ji 10 E T 10 E 100 q E 50 en fel o ipai 0 0 o i pap 0 0 0 5 10 15 20 25 30 35 40 45 50 55 60 o 5 10 15 20 25 30 35 40 45 50 55 60 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 50pg ml Volumetric Accuracy 0 296 Volumetric Accuracy 1 696 Rate ml h e Rate ml h Target Plasma Concentration ng ml Target Plasma Concentration ng ml o 5 10 15 20 25 30 35 40 45 50 55 60 0 5 10 15 20 25 30 35 40 45 50 55 60 Time Interval mins Time Interval mins Sufentanil Gepts Model BD 50ml Syringe Plasma Target Drug Concentration 5 0ug ml Volumetric Accuracy 43 096 240 0 40 220 0 35 E 200 180 0 30 H 160 3 oz 140 E T 124 o2 Y E 5 amp 104 v 0415 80 4 E 60 oo a pr 40 v oo 8 20 0 i e 0 00 Time Interval mins 1000PB01489 Iss 4 28 32 Profiles from TCI mode Predicted vs Ideal Conc 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
12. 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 as per local regulations 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 Important See the Technical Service Manual for a complete list of the test procedures access codes and calibration procedures 1000PB01489 Iss 4 23 32 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 extension set 00 4 2 00 200 Time to alarm 1 0 ml h Time to alarm 5 0 ml h 1 30 4 E 400 E C E de 0 30 4 0 00 0 2 4 6 8 10 Occlusion Level Occlusion Level 2m Bolus Volume typical 4 50 ypica 1 00 ml 0 00 o N 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
13. change drug amount and diluent volume AGE adjust the patient age using the ADV keys press the OK softkey to confirm The remaining patient parameters for the selected drug must be entered using the GOC Y keys and press the OK softkey to confirm The required parameters may include the following depending on the model HEIGHT GENDER WEIGHT adjust the patient weight using the ADV 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 If configuration allows select Plasma targeting or Effect Site targeting Important Prime IV infusion set 7 10 11 Load Syringe Load the syringe according to the procedure in this manual 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 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 When a slower titration is required the induction time may be increased in Plasma Targeting Cpt only Press the TIME softkey and cap the maximum induction rate or doserate to increase t
14. represented Additional curves for compatible syringes are available upon written request For applications where flow uniformity is a concern rates of 1 0ml hr or above or concentrations resulting in a rate above 1ml h are recommended Trumpet Curve BD Plastipak 50ml 0 1ml h Start up Trend BD Plastipak 50ml 0 1ml h Initial Period ki he Ar he D g ES g s 3 Ge 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 LinearMean 4 5 Start up Trend BD Plastipak 50ml e 1 0ml h Trumpet Curve BD Plastipak 50ml 1 0ml h E Initial Period 20 15 18 18 10 14 5 12 0 5 a A A AA M rans E 5 Wo v uere wey ww we E El 08 5 5 1 c os Gio 04 15 02 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 Maximum Error Minimum Error k LinearMean 1 8 Start up Trend BD Plastipak 50ml 5 0ml h m 100 Trumpet Curve BD Plastipak 50ml 5 0ml h 20 D Initial Period 80 5 70 60 0l Ak re d 3 E SO a Te m d T Ei E 40 x p e d 30 5 20 10 10 00 45 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 Maximum Error Minimum Error k LinearMean 0 1 1000PB01489 Iss 4
15. 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 Drug Name and Pump Status Concentration Pressure Information eo EE 8m n 80 On CHO E 20ug kg min 1 63m 1 1h 59m 28s ADJUST C C M EL Flow Rate and Dose and Time Remaining Battery Icon Operations Dose Rate Volume Infused During Use 1 Alist of available drugs and models will be displayed Use the 8 MAINTENANCE Set the maintenance dose rate in the drug RNC keys to select the required drug and press the OK protocol units Press the OK softkey to enter softkey If the drug has an associated model an INFO softkey Important Prime IV infusion set will be displayed Pressing the INFO softkey will show more information on the selection The ml h option allows infusions 9 Load Syringe Load the syringe according to the procedure in without doserate calculation this manual 2 CONCENTRATION 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 a Select Concentration required and OK to confirm Only required if more than one concentration is available b Press the OK softkey to confirm Conc
16. the actual selectable range may be limited by the drug and model chosen 1000PB01489 Iss 4 17 32 Configured Options continued Asena PK Editor Software Profile Drugs The following drug parameters are only configurable via the Asena PK Editor Software PC based and are referenced when the Asena PK Syringe Pump is being used with a drug name selected Refer to the Asena PK Editor Software Directions for Use 1000CH00016 for details on how to configure the Profile Drug Library TCI these options are only displayed if the selected drug has an associated TCI model Clinical Trial Indicator 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 Shou
17. to the low forces will be less than the nominal quoted occlusion pressure 1000PB01489 Iss 4 24 32 IrDA RS232 and Nurse Call Specification The IrDA or RS232 Nurse Call optional feature is a feature on Asena Syringe Pumps that allows the pump to be connected to a PC or other Asena Syringe Pumps This allows data to be transferred between the Asena Syringe Pump and a PC or another Asena Syringe Pump Important 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 The assessment for the suitability of any software used in the clinical environment to receive data from the pump lies with the user of the equipment This software should include detection of the disconnection or other failure of the RS232 cable The protocol is detailed in the Technical Service Manual and is for general information only Any connected analogue and digital components are required to meet EN60950 for data processing and 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 EN60601 1 1 Baud Rate 38 4 kBaud Nurse Call Specification Connector TXD RXD TXD Output Voltage Range RXD Input Voltage Range RXD Input
18. your local ALARIS Medical Systems Affiliate Office or Distributor ALARIS Medical Systems Service Centre Addresses AE ALARIS Medical Systems Middle East Office PO Box 5527 Dubai United Arab Emirates Tel 971 428 22 842 Fax 971 428 22 914 AU ALARIS Medical Australia Pty Ltd 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 ALARIS Medical Belgium B V Otto De Mentockplein 19 1853 Strombeek Bever Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 CA ALARIS Medical Canada Ltd 235 Shields Court Markham Ontario L3R 8V2 Canada Tel 1 905 752 3333 Fax 1 905 752 3343 CN ALARIS Medical Systems Shanghai Representative Office Suite 9B Century Ba Shi Building 398 Huai Hai Rd M Shanghai 200020 China Tel 56 8621 6384 4603 Tel 56 8621 6384 4493 Fax 56 8621 6384 4025 Document History Revision CO Number 1 5080 2 5248 3 5296 4 5446 DE ALARIS Medical Deutschland GmbH Pascalstr 2 52499 Baesweiler Deutschland Tel 49 2401 604 0 Fax 49 2401 604 121 ES ALARIS Medical Espana S L Avenida Valdeparra 27 Edificio Alcor 28108 Alcobendas Madrid Espana Tel 34 91 657 20 31 Fax 34 91 657 20 42 FR ALARIS Medical France S A 95 rue P reire 78105 St Germain en Laye Cedex France T l 33 0 820 821 123 Fax 33 1 30 61 22 23 GB
19. 26 32 Profiles from TCI mode When targeting in TCI Mode the Asena PK Syringe Pump will automatically calculate the flow rate profile from the specific pharmacokinetic pharmacodynamic model for the selected drug This section of the Directions For Use is intended to help users understand the profiled infusion and the performance accuracy attained from the TCI pump Induction Bolus and maintenance rates are displayed before starting the titration When initially starting the infusion or after increasing the target plasma or effect concentration by titration the pump will first deliver a bolus dose through a typically short high rate infusion On completion of this bolus the pump will immediately switch to a lower maintenance rate when plasma target mode is used or will pause for a period of time before switching to a lower maintenance rate when effect site targeting mode is used Once the maintenance phase is reached any reduction made to the target plasma or effect concentration will typically result in the infusion rate reducing to zero until the predicted plasma or effect concentration reduces the new target value The Asena 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 28 were measured in accordance with the protocol described in the IEC60601 2 24 Standard with the data sample period reduced from
20. 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 Asena PK Syringe Pump can be made if the volumetric error that is the difference between the actual volume infused and the predicted volume infused is calculated For the performance graphs shown on page 28 over a one hour period the Asena 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 Asena 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 29 showing the typical performance of the system against changes in the target plasma or effect concentration for a typic
21. ALARIS Asena PK Syringe Pump User Support CD AC Power Cable as requested Protective Packaging Connect the pump to the AC power supply for 2 2 hours to ensure that the internal battery is fully charged prior to use Should the pump fail to perform correctly replace in its original protective packaging and contact a qualified service engineer for investigation On initial start up the pump will display the Select Language screen Select the required language from the list displayed using the C m keys Press the OK softkey to confirm your selection A pole clamp is fitted to the rear of the pump and will provide secure fixing to standard vertical IV poles of a diameter of between 15 and 40 mm It should be folded away when not in use There is a Medical Device Interface MDI at the rear of the pump used for mounting the pump onto horizontal rectangular bars for instance the ALARIS Asena Docking Station Holding the pump horizontally push the pump firmly on to the bar Ensure that the pump clicks securely into position on the bar To release push the release lever and pull the pump forward Important 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 The pump will automatically operate from its internal battery if the pump is switched on without being c
22. Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted Reconnect to the AC power supply to continue operation and charge the internal battery BATTERY EMPTY The internal battery is exhausted Connect the pump to the AC power supply NEAR END OF INFUSION The pump is nearing the end of the infusion END OF INFUSION The pump has reached the end of the infusion A preset volume will remain in the syringe to minimise the risk of the infusion of air bubbles into the extension set TITRATION NOT CONFIRMED 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 CANCEL 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 FAIL AC Power has been disconnected and the pump is operating on battery power Infusion continues Reconnect AC power supply or press the button to silence the alarm and continue with battery operation The alarm will automatically cancel if the AC power supply is reconnected Error Code and Message The alarm system has detected an internal malfunction Note the malfunction code Remove pump from service for examination by a qualified service engineer ATTENTION with 3
23. Concentration 10mg ml Drug Concentration 20mg ml Plasma Concentration Accuracy 0 2 Plasma Concentration Accuracy 0 3 2 o 80 o 80 2 a 70 a 70 6 0 6 0 6 0 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 ul 0 0 0 0 0 0 0 0 20 20 Predicted Plasma Concentration ng ml Ideal Plasma Concentration pg ml Predicted Plasma Concentration ng ml Ideal Plasma Concentration pg ml 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 50pg ml Drug Concentration 50pg ml Plasma Concentration Accuracy 40 296 Plasma Concentration Accuracy 40 596 30 3 0 1 3 4 ZA 30 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 0pg ml Plasma Concentration Accuracy 43 196 0 40 0 40 0 35 0 35 Predicted Plasma Concentration ng ml Ideal Plasma Concentration ng ml Time Interval mins 1000PB01489 Iss 4 29 32 Service Contacts For service contact
24. E from the Configured Options menu using the ROC keys and press the OK softkey Use the GOC V keys to select the language When the desired language has been selected press OK to return to the Configured Options menu N Asena PK Syringe Pump General Options Select GENERAL OPTIONS from the Configured Options menu using the AY 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 OK softkey je eS Either select the next configuration option from the menu or turn the pump OFF returning it to operation as required NURSE CALL FITTED Enables Nurse Call hardware option NURSE CALL INVERT When enabled the Nurse Call output is inverted RS232 SELECTED Sets the pumps communications to use RS232 hardware option 1000PB01489 Iss 4 16 32 Configured Options continued Asena PK Editor Software Pump Configuration The following options are configurable via the Asena PK Editor Software PC based see the Asena 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 I
25. Select the SET BY DOSERATE option using the ASV 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 N 1000PB01489 Iss 4 14 32 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 If the infusion has stopped rectify the cause of the alarm then press the button to resume the infusion Display Description and Troubleshooting Guide DRIVE DISENGAGED The drive system has been disengaged during operation Check the finger grips and the position of the syringe OCCLUSION Pumping pressure has reached the alarm limit Squeeze the finger grips on the plunger holder to release the drive mechanism and relieve any excessive pressure in the syringe and extension set Identify and remove the cause of the blockage in the drive syringe or administration system before restarting the infusion CHECK SYRINGE Incorrect size of syringe has been fitted the syringe has not been positioned correctly or has been disturbed during operation Check the syringe location and the position BATTERY LOW Battery charge low with 30 minutes operation remaining
26. TITRATE and the pump continues to infuse at the original concentration target 2 Press the button to confirm the new concentration target and resume infusion If the new concentration target setting exceeds or is undera Soft Alert confirmation is required before infusion can resume 1000PB01489 Iss 4 Bolus Infusion If the bolus volume reaches the set limit the bolus will stop and the pump will revert to infuse at the set infusion rate 1 During infusion press the C button once to display the Hands Free bolus selection screen 2 Use the ADV keys to set the bolus dose volume required If necessary press the RATE softkey to adjust the bolus delivery rate 150 300 600 900 1200ml h 3 Pressthe BOLUS softkey once to begin the delivery of the preset bolus The display will show the bolus being delivered the bolus counts down on the screen and will count down to zero upon completion of the bolus On completion of the bolus the pump will automatically revert to the set infusion rate and continue infusing 4 To terminate a bolus being delivered press STOP softkey This will stop the bolus and continue infusing at the set rate Important Any Hands Free Bolus dose setting which exceeds or is under a Soft Alert must be confirmed before operation can be continued This is not applicable in TCI mode Pressure Level 1 To check and adjust the pressure level press the button A bar graph will be displayed showing the pressure al
27. Thresholds RXD Input Resistance Enable Isolation Socket Pump Baud Rate Start Bits Data Bits Parity Stop Bits Nurse Call Relay Contacts Typical Connection Data IrDA RS232 Nurse Call Feature RS232 Nurse Call Connection Data D Type 9 Pin EIA RS232 C Standard Minimum 5V mark 5V space Typical 7V mark 7V space with 3K load to ground 30V 30V max Low 0 6V minimum High 3 0V maximum 3K 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 peak 38 4 kBaud 1 Start Bit 8 Data Bits Odd Parity No Parity 1 stop bit Pins 1 8 9 30V dc 1A rating 1 Nurse Call Relay Normally Closed 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 9 Nurse Call Relay Common GND DSR RXD TXD NCC 5 NC COM 1000PB01489 Iss 4 25 32 4 3 2 1 8 7 6 NCO CTS 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
28. air or replacement will be carried out at ALARIS Medical Systems expense The product requiring service should be returned promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipment to ALARIS Medical Systems shall be at purchaser s risk In no event shall ALARIS Medical Systems be liable for any incidental indirect or consequential damages in connection with the purchase or use of any ALARIS Medical Systems 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 ALARIS Medical Systems shall not be responsible for any loss or damage arising in connection with the purchase or use of any ALARIS Medical Systems product which has been A repaired by anyone other than an authorised ALARIS Medical Systems service representative B altered in any way so as to affect in ALARIS Medical Systems 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 ALARIS Medical Systems This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of ALARIS Medical Systems and ALARIS Medical
29. al 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 Asena PK Syringe Pump will track the predicted plasma or effect concentration to within 5 of that calculated by pharmacokinetic model over a one hour period Flow rate inaccuracies and start up delays may decrease the accuracy of the predicted plasma or effect concentration particularly where high syringe drug concentrations are used in conjunction with large sizes of syringes and low target plasma or effect concentrations as the syringe plunger motion over time proportional to the flow rate accuracy will be significantly reduced Note Fora 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 o
30. arm level and the current pressure level 2 Press the ASY keys to increase or decrease the alarm level The new level will be indicated on the display 3 Press the OK softkey to exit the screen Important 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 Clear Volume Note Clear Volume is not permitted in TCI mode or predictive TIVA mode This option enables the volume infused to be cleared 1 Press the VOLUME softkey to display the CLEAR VOLUME option 2 Press the YES softkey to clear the volume Press the NO softkey to retain the volume 12 32 Operations During Use END OF OPERATION The END OF OPERATION option is only available in the options menu when the infusion has been stopped 1 Press the button to access the options menu 2 Select the END OF OPERATION option using the ANC keys A confirmation screen will be displayed 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 Press the button to access the options menu Using the amp DC keys select the TCI MODE Press the OK softkey indicated on the screen A confirmation screen will be displayed Note When the mode
31. ata Set will need to be developed reviewed approved released uploaded and verified according to the following process Refer to the Asena PK Editor Software Directions for Use 1000CH00016 for further details and operating precautions 1 Create Master Lists Using Asena 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 Asena PK Syringe Library Configure syringes enabled for use 2 Create Profile Using Asena 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 Asena 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 Asena PK Syringe Pump Using Asena PK Editor Transfer Tool 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 number shown on the Asena PK Syringe Pump Download the Data Set
32. earance 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 95 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 corresponding compartment see Fig 3 is called the effect site compartment Because the actual amount of drug entering the brain is very small the effect site compartment can be regarded as havin
33. either remove the source of the interference or regulate the infusion by another appropriate means This pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC60601 2 24 and IEC60601 1 2 2002 If however the pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation If this pump is dropped subjected to excessive moisture fluid spillage humidity or high temperature or otherwise suspected to have been damaged remove it from service for inspection by a qualified service engineer When transporting or storing the pump use original packaging where possible and adhere to temperature humidity and pressure ranges stated on page 16 and on the outer packaging 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 An electrical shock hazard exists if the units 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 equipment should be operated from the battery A comprehensive Technical Service Manual is available for this pump The part number is 1000SM00001 All illustrations used in th
34. entration or press the MODIFY softkey to change Drug amount and diluent volume 11 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 3 WEIGHT adjust the patient weight using the keys used during purging will be displayed press the OK softkey to confirm i 12 Connect To Patient Connect the extension set to the patient 4 The remaining patient parameters for the selected drug must access device be entered using the AY keys and press the OK softkey to confirm The required parameters may include the following depending on the model 13 Start Press the button to commence operation INFUSING will be displayed The amber stoplight will be replaced by the flashing green start light to indicate that the AGE pump is in operation If the infusion rate exceeds the Soft Alerts HEIGHT then check infusion setting to continue with infusion at set GENDER target press the button and then confirm OVERRIDE LIMIT gt LBM and BMI Lean Body Mass and Body Mass Index This is by pressing the YES softkey If OVERRIDE LIMIT is not required for information only and is not an adjustable parameter press the NO softkey and adjust target concentration to be 5 The CONFIRM drug setup screen shows the initial infusion within the Soft Alerts parameters for the drug Press the OK softkey to accept or N
35. enzalkonium Chloride Use of lodine such as Betadine will cause surface discoloration Concentrated Isopropyl alcohol based cleaners will degrade plastic parts Recommended cleaners are Brand Concentration Hibiscrub 20 v v Virkon 1 w v The syringe and extension lines 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 Important 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 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 suspect that either the power supply fuse in the AC plug if fitted or the internal fuses have blown First chec
36. from the pump using the Asena 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 1000PB01489 Iss 4 5 32 Features of the Asena PK Syringe Pump Front View ON OFF Release lever for High visibility Display MDI Alarm Indicator PURGE BOLUS MUTE PRESSURE OPTION Finger Grips Extension HOLD Shelf for Syringe Clamp Positive Plunger set hook chevron keys Grippers and softkeys Features of the Asena PK Syringe Pump Rear View Rating Plate see Medical Device Symbol Definitions for Interface MDI an explanation of the rotating cam to symbols used lock on to horizontal Release LL rectangular bars IR Comms port Carrying Functional Folded Pole Extension set Handle Earth Clamp RS232 hook Connector optional 1000PB01489 Iss 4 6 32 Controls and Indicators 6996 6 ON OFF Press once to switch the pump ON Press and hold down for 3 seconds to switch the pump OFF RUN button Press to start the infusion The green LED wil
37. ft Alert Alarm Indicator Colour Alarms indicated AMBER AC POWER FAIL NEAR END OF INFUSION ATTENTION TITRATION NOT CONFIRMED BATTERY LOW DOSE WOULD EXCEED DOSE UNDER TARGET WOULD EXCEED RED All others 1000PB01489 Iss 4 15 32 Configured Options This section comprises of a list of configurable options which are entered via the pump configuration menu available in Technician Mode Enter the access code on Asena PK Syringe Pump for Configured Options see the Technical Service Manual for details Important Access codes should only be entered by qualified technical personnel CLOCK SET CONTRAST 1 Select CLOCK SET from the Configured Options menu using This option is used to set the contrast on the pump display the ADY keys and press the OK softkey 1 Select CONTRAST from the Configured Options menu using 2 Use the amp amp Y keys to adjust the date displayed pressing the ADD keys and press the OK softkey the NEXT softkey to access the next field f 2 Use the ADV keys to select a contrast ratio value The 3 When the correct time and date are displayed press the OK contrast of the display will change when scrolling through the softkey to return to the Configured Options menu numbers 3 When the desired value has been reached 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 LANGUAG
38. g no volume the rate constant kie can be ignored and the rate constant keo can be used to describe the rate of equilibration between the plasma and effect site compartments Knowledge of the keo 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 CL CL k V2 2 V1 V3 Peripheral Central Peripheral Compartment Ki Compartment Compartment Effect Compartment Fig 3 Schematic representation of the concentration effect relationship Clearance CL 1000PB01489 Iss 4 3 32 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 Asena PK Syringe Pump are well validated and accepted Secondly the pharmacokinetic parameter set of a particular drug used by the computer model should match the pharmacokinetics of the patient it Should be remembered that the models descr
39. he desired induction time The cap rate will be cleared when first titration occurs Target Concentration Cpt or Cet Adjust the Target Concentration if necessary using the amp amp Y keys Confirm the Target Concentration and Initial Infusion predicted parameters On confirmation if the Target Concentration exceeds any limits a warning will be displayed 1000PB01489 Iss 4 Pause Before Maintenance Induction Duration Drug Name and Concentration Initial Induction Time of Initial Maintenance Rate Induction Rate Note Infusion can not be started until confirmation has been 12 13 14 Note 15 Flow Rateand Effect Site 16 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 Purge if required Press the C9 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 Connect To Patient Connect the extension set to the patient access device Start Press the button to commence operation INFUSING will be displayed The amberstoplight will be replaced by the flashing green start lig
40. ht 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 Target Concentration running exceeds the Soft Alerts then the display will cycle between Drug Name and Up arrows Pressing the button during infusion will maintain the current Plasma or Effect site Plasma Drug Name and Concentration Prediction Dose Rate Concentration Concentration Trend Time Effect Site Prediction Actual Time Decrement Time Stop Press the button to halt the operation ON HOLD will be displayed The amberstop light will replace the green start light 11 32 Getting Started continued MORE Information Screen Selecting the MORE softkey will display the following additional information Drug Name and Model WEIGHT 70 0kg AGE 40yrs HEIGHT 180cm GENDER MALE 57 6kg 21 6 Minto LBM BMI En A S c Time to End of Infusion at Current Rate Patient Parameters Time lt THO 1h 20m 45s Decrement Volume and Elapsed Time Dose Infused emi fentanil 50 0 pg ml Decrement Concentration Battery Icon Press the BACK softkey to return to the TCI screen The display will automatically revert to the TCI screen af
41. ibed 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 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 strategie
42. imit 16 years upwards Unit of Plasma Concentration ug ml Max Plasma Concentration 15 ug ml Vc 0 228xmass litres x kg kio 0 119 min k 0 112 min k 0 0419 min kz 0 055 min k3 0 0033 min Keo 0 26 min Reference from the literature Marsh et al Brit J Anaesth 1991 67 41 48 Drug Remifentanil Model Minto Age Limit 12 years upwards Unit of Plasma Concentration ng ml Max Plasma concentration 20 ng ml Vc 5 1 0 0201 x age 40 0 072 x 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 koo CH Vc k2 CI2 Vc k z CI3 Vc ky CI2 V2 ka CI3 V3 Keo 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 31 kyo 0 0645 min k2 0 1086 min k 0 0229 min kz 0 0245 min ks 0 0013 min Reference from the literature Gepts et al Anesthesiology 1995 83 1194 1204 Additional ke calculated with time to peak effect 5 6 min keo 0 17559 min reference Shafer et al Anesthesiology 1991 Jan 74 1 53 63 1000PB01489 Iss 4 4 32 Creating a Data Set To fully utilise the Asena PK Syringe Pump a D
43. is changed to TCI mode the initial target will be set to zero N 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 ROC 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 C DECREMENT CONC In TCI and predictive TIVA mode Press the button to access the options menu Select DECREMENT CONC Select the required DECREMENT CONC and press the OK softkey to exit w P TREND SIZE The user is able to select the Trend Size of the Concentration Prediction graph 1 Press the button to access the options menu 2 Using the ROC keys select TREND SIZE Using the ASY keys select the required TREND SIZE option 5 Mins 15 Mins 30 Mins or 60 Mins Press the SELECT softkey indicated on the screen 5 1000PB01489 Iss 4 TEXT GRAPH DISPLAY When in TCI mode the user is able to select a numerical or graphical display 1 Press the button to access the options menu 2 Using the amp amp V keys select the display mode TEXT or GRAPH DISPLAY The options menu shows the available display mode option 3 Press the OK softkey indicated on the screen DOSING SUMMARY To review currently selected dosing i
44. is manual show typical settings and values which may be used in setting up the functions of the pump These settings and values are for illustrative use only The complete range of settings and values are specified on page 16 Where stated a minimum infusion rate refers to a nominal rate of 1 0ml h and an intermediate infusion rate refers to a nominal rate of 5 0ml h The complete range of infusion rates are shown on page 16 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 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 connectors may result in ESD protection failure In order to prevent any potential failure generated by ESD close to or above 15kV it is recommended that all actions must be taken by appropriately trained personnel and the pump should not be attached to the patient when connecting RS232 Nurse Call Getting Started Installation Check that the pump is complete undamaged and that the voltage rating specified on the base plate is compatible with your AC power supply Items supplied are
45. it 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 ALARIS Medical Systems Inc herein after referred to as ALARIS Medical Systems warrants that A Each new infusion instrument 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 ALARIS Medical Systems 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 ALARIS Medical Systems 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 ALARIS Medical Systems 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 ALARIS Medical Systems to the original purchaser If any product requires repair during the applicable warranty period the purchaser should communicate directly with its local ALARIS Medical Systems service centre to determine the appropriate service facility Except as provided otherwise in this warranty rep
46. k 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 Battery Operation The internal rechargeable battery allows continued operation when the AC power 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 fully recharge 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 Disposal The pump should be disposed of taking environmental factors into consideration To ensure no risk or hazard remove the internal rechargeable
47. l flash during infusion HOLD button Press to put the infusion on hold The amber LED will be lit while on hold MUTE Press to silence alarm for 2 minutes Press and hold until 3 beeps are heard for 15 minutes silence PURGE BOLUS Press to access PURGE or BOLUS soft keys Press and hold down soft key to operate PURGE the extension set during set up Pump on hold extension set not connected to patient Volume Infused VI not added BOLUS delivered at an accelerated rate Pump infusing extension set connected to patient VI added ED C2 OPTION button Press to access optional features see page 12 PRESSURE Use this button to display the pumping pressure trend display and alarm level CHEVRONS 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 EE ONSE Symbol Definitions lt AE TTTTT 11111 Sos BATTERY When illuminated the pump is running on the internal battery When flashing the battery power is low with less than 30 minutes of use remaining AC POWER When illuminated the pump is connected to an AC power supply and the battery is being charged TIME REMAINING DISPLAY Indicates time before syringe will require replacing BATTERY ICON Indicates battery charge level to highlight when the battery will require recharging SOFT ALERT Indicates the pump is running a
48. ld be set to cause the Asena 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 Enable 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
49. ministration 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 administration sets and other tubing for example via a 3 way tap the performance of the pump may be impacted and should be monitored closely 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 set and patient connections and follow the priming procedure specified herein This is a positive pressure pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the inf
50. na PK Syringe Pump is The Asena DS Docking Station 1000PB01489 Iss 4 21 32 Extension Sets Compatible Accessories continued 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 ALARIS recommended Please check the availability of the sets listed below with your local ALARIS Medical Systems 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 MEX 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 LS 1 MFX 2290 3 way set with 2 anti syphon valves and backcheck valve low priming volume MFX 2291 2 way set with anti syphon valve and backcheck valve low priming volume MFX 2284 3 way tap blue with extension 100cm MFX 2280E 3 way tap with extension and SmartSite Needle Free Valve 10cm
51. nded purpose without specific written authorization of ALARIS Medical Systems is strictly forbidden 1000PB01489 Iss 4 32 32
52. nformation 1 Press the button to first access the options menu 2 Select DOSING SUMMARY 3 Review the information and then press QUIT CD 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 C V 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 C EVENT LOG This option allows the event log to be reviewed 1 Press the button to access the options menu 2 Select the EVENT LOG option using the ASY keys and press the OK softkey 3 Scroll through the log using the ANY keys Press the QUIT softkey to exit the log 13 32 Operations During Use continued DATA SET DETAILS EFFECT SITE TCI To review the currently selected Data Set information When in PLASMA TCI mode the user is able to switch to EFFECT SITE TCI mode if the configuration permits 1 Press the button to access the options menu de Select DATA SET DETAILS 1 Press the button to access the options menu Select EFFECT SITE TCI using the amp DCV keys Press the OK softkey indicated on the screen A confirmati
53. nfusion Time End of Infusion 96 Weight Default Weight Minimum Weight Maximum Age Default Age Minimum Age Maximum Important Information 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 if 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
54. o calculate the required infusion rates 1000PB01489 Iss 4 2 32 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 DISTRIBUTION 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 were used for induction or maintenance of anaesthesia they were administered either manually by hand or by simple infusion pumps the anaesthetist calculated the infusion according to the body weigh
55. on screen will be displayed SET BY DOSERATE SET BY ml h TIVA mode only PLASMA TCI To set doserate to flowrate in precise increments it may be When in EFFECT SITE TCI mode the user is able to switch to necessary to switch between the rate adjust options PLASMA TCI mode if the configuration permits SET BY DOSERATE and SET BY ml h An arrow to A 1 the rate display shows the rate changed when the G keys are we to Tout Pid the infusion rate 2 Select PLASMA TCI using the ASC keys To precisely set a doserate the arrow must be pointing to the 3 Press the OK softkey indicated on the screen A confirmation doserate mg kg h the flowrate will be calculated from the screen will be displayed doserate To precisely set a flowrate the arrow must be pointing to the flowrate ml h the doserate will be calculated from the flowrate 3 Review the information and press the QUIT softkey to exit Press the C2 button to access the options menu Selecting the SET BY ml h option 1 Whilst the pump is infusing press the button to access the options menu Select the SET BY ml h option using the AS 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 N 1 Whilst the pump is infusing press the button to access the options menu
56. onnected to the AC power supply Loading a Syringe 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 Important 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 1 Squeeze the finger grips together on the plunger holder and slide the mechanism to the right Pull the syringe clamp forward and down 2 Insertthe syringe ensuring that the finger flanges are located in the slots on the syringe holder Lift the syringe clamp until it locks against the syringe barrel 4 Squeeze the finger grips on the plunger holder and slide the mechanism to the left until it reaches the plunger end 5 Release the finger grips Ensure that the plunger grippers are securing the plunger in place and the finger grip returns to its original position Important Secure the extension set using the extension set hook at the rear of the pump This provides protection against accidental dislodging of the syringe from the pump Important Ensure that both plunger grippers are fully locked onto the pl
57. ote If a model has been selected the VOLUME softkey MODIFY to change the drug setup 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 6 INDUCTION Using the amp DCV 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 J disabled reducing the dose to zero until OFF is displayed and 14 Stop Press the button to halt the operation ON HOLD press OK softkey to confirm will be displayed The AMBERSTOP light will replace the GREEN START light 7 TIME Enter the induction time in seconds over which the induction dose will be delivered Press the OK softkey to enter 1000PB01489 Iss 4 10 32 Plasma Concentration ile Getting Started continued TCI Mode Pump Status n ON HOLD 0 Ong m1 Cpt 3 Ong mi ADJUST ED c Initial Induction Dose Plasma Target A list of available drugs and models will be displayed Use the amp S amp keys to select the required drug and associated model and press the OK softkey Pressing the INFO key will show more information on the selection CONCENTRATION a Select Concentration required and OK to confirm Only required if more than one concentration is available b Press the OK softkey to confirm Concentration or press the MODIFY softkey to
58. ote these drawings are not to scale 1000PB01489 Iss 4 22 32 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 for this product TSM reference 1000SM00001 Refer to the Technical Service Manual for the access code for technical service features Interval Routine Maintenance Procedure As required Thoroughly clean external surfaces of the pump before and after prolonged period of storage At least once T per year Inspect AC power supply plug and cable for damage 2 Perform functional tests as outlined in the Technical Service Manual 3 Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging Cleaning and Storage Before the transfer of the pump to a new patient and periodically during the use clean the pump by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Disinfectants which are known to be corrosive to metals must not be used These include the following disinfectant types NaDcc such as Presept Hypochlorites such as Chlorasol Aldehydes such as Cidex Cationic Surfactants such as B
59. ows the trajectory of the estimated plasma and effect site drug concentration over time 4 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 Asena 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 The Asena 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 Asena PK Syringe Pump DOES NOT limit the responsibility of the anaesthetist for drugs administration It is important that users operating the Asena 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
60. r effect concentrations For applications where system accuracy is important maintenance rates less than 1 0 ml h are not recommended syringe sizes drug concentrations dilutions and target plasma or effect concentrations should be selected accordingly to ensure the maintenance rate exceeds this lower limit The performance graphs illustrated in this section are for a Diprivan 1 Concentration Diprivan 2 concentration Remifentenil 5Oug ml concentration and Sufentanil 5ug ml concentration are given for comparison As an illustration of the effect the syringe size has on system performance Remifentenil 50ug ml concentration is shown with a 50ml and 5ml syringe respectively The target plasma or effect concentrations shown are for illustrative purposes only Note 1 1EC60601 2 24 Particular Requirements for the Safety of Infusion Devices 9596 Confidence 9596 Population 1000PB01489 Iss 4 27 32 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 Age 40 Yrs Patient Weight 60kg Patient Weight 60kg Drug Concentration 10mg ml Drug Concentration 20mg ml Volumetric Accuracy 0 1 Volumetric Accuracy 0 4 1200 8 0 600 8 0 11004 B 550 4 E t 1000 a 500 a E z 900 60 ge 450 60 g 7 50 s 50 s E mw E i7 E 9 soo so g PS 40 E m o o GE 500 d
61. s 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 Asena 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 therefore the pump should not be restarted in TCI mode Pharmacokinetic models in Asena PK Syringe Pump and their parameters Drug Diprivan Model Marsh weight adjusted Age L
62. t 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 DOWN MODE Infusion status indicating that the target concentration is below current concentration PEN MAX 30V 1A o 0 0 1000PB01489 Iss 4 7 32 Attention Consult accompanying documents Functional Earth RS232 Nurse Call Connector Optional Type CF Equipment Degree of protection against electrical shock Protected against vertically falling drops of water Alternating Current Pump complies with the requirements of the EC Directive 93 42 EEC Registered with the CE Mark Date of Manufacture Important Information Induction Phase Dose Displayed on protocol confirmation screen Duration of Induction Phase Displayed on protocol confirmation screen Maintenance Phase Dose Displayed on protocol confirmation screen Duration of Hands Free Bolus Displayed on bolus set up screen Operating Precautions Luer Lock y lt is gt 3 JER This ALARIS 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 the syringe make specified on the pump or described in this manual Use of non specified syringes or ad
63. t 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 Kz ks and k 3 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 then this is called open loop effect site targeted TCI Input CL Gs V2 V1 V3 Peripheral Central Peripheral Compartment Compartment Compartment V Cl
64. ter approximately 20 seconds Basic Features 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 Stop the pump and press the button Ensure that the extension set is not connected to the patient 2 Press and hold the PURGE softkey until fluid flows and the purging of the syringe extension set is complete The volume used during purging will be displayed but it is not added to the volume infused 3 When purging is complete release the PURGE softkey Press the QUIT softkey to exit back to the main display Important During PURGE the pressure limit alarms are temporarily increased to their maximum level Rate Titration Note This is not applicable in TCI mode Rate Titration allows the rate to be adjusted while infusing 1 Select the new rate using the ANY keys The message lt START TO CONFIRM gt will flash on the screen and the pump continues to infuse at the original rate Press the button to confirm the new infusion rate and resume infusion If the new infusion rate setting exceeds or is under a Soft Alert confirmation is required before infusion can resume Concentration Target Titration Note This only applies to TCI mode Concentration Target Titration allows the rate to be adjusted while infusing N 1 Select the new target using the amp DC keys The pump status is shown as
65. 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 ALARIS Medical Systems has verified the accuracy of the mathematical model implementation as well as pump delivery accuracy specification and accuracy of pump delivery are available in Profiles from TCI Mode pages 27 29 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 Asena 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 t
66. ture 0 596 5 409C High Rates 2 096 rates gt 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 IEC60601 2 24 at rates of 1 0ml h 23 C and above when the pump is used with the recommended syringes Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves See also trumpet curves section in this manual Battery Specifications Rechargeable sealed NiMH Automatically charges when the pump is connected to AC power Battery life is typically 4h from fully charged 5 0ml h amp 20 C under normal conditions Charging takes 2 hours from discharge to 90 charge In TCI mode a fully charged battery allows at least one full syringe to be infused Memory Retention The electronic memory of the pump will be retained for more than 6 months when not powered up Fuse Type 2xT 1 25A slow blowing AC Power Supply 115 230VAC 50 60Hz 20VA nominal Case Material GE Cycolac S157 fire retardant to UL94V 2 Dimensions 335 mm w x 121 mm h x 200 mm d Weight 2 5 kg excluding power cable Alarm Conditions Drive Disengaged Occlusion Check Syringe Near End Of Infusion AC Power Failure Attention Nurse Callback Dose Would Exceed Dose Under Battery Low Battery Empty End of Infusion Internal
67. unger flange and the upper finger grip has returned to its original position Important 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 Syringe Flange Clamp 1000PB01489 Iss 4 9 32 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 continue 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 Asena 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
68. usion system The pumping pressure alarm system is not designed to provide protection against or detection of infiltration conditions which can occur at low pressures Several alarm conditions detected by this pump will stop the infusion and generate audible alarms and lights Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating This pump is protected against the effects of external interference including high energy radio frequency emissions magneticfieldsandelectrostaticdischarge for example as generated by electrosurgical and cauterising equipment large motors portable radios cellular telephones etc When using any infusion pump in conjunction with other instruments 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 instruments Typical examples of those instruments are used during dialysis bypass or cardiac assist applications o 1000PB01489 Iss 4 8 32 In some circumstances the pump may be affected by an electrostatic discharge through air at levels close to or above 15kv or by radio frequency radiation close to or above 10v m If the pump is affected by this external interference the pump will fail safe or reset after which a call back alarm will occur Should false alarm conditions be encountered

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