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Related Manuals for Cardinal Health Alaris PK
Summary of Contents for Cardinal Health Alaris PK
- Page 1 Alaris PK Syringe Pump ® Directions For Use - English...
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Page 2: Table Of Contents
Contents Page Introduction ............................About This Manual ..........................TCI Overview ............................Creating a Data Set ..........................Features of the Alaris® PK Syringe Pump .................... Controls & Indicators ..........................Symbol Definitions ..........................Main Display Features ........................... Operating Precautions .......................... Getting Started ............................Basic Features ............................ -
Page 3: Introduction
Cardinal Health 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' section). -
Page 4: Tci Overview
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. - Page 5 TCI Overview (continued) TCI infusion pumps can provide optimal control of anaesthesia when the three elements mentioned above have been accurately modelled and described. Firstly, the model that controls the pump has to work accurately (The models used in the Alaris® PK Syringe Pump are well- validated and accepted).
- Page 6 TCI Overview (continued) Pharmacokinetic models in Alaris® PK Syringe Pump and their parameters Drug: Diprivan Model: Marsh (weight adjusted) Age Limit: 16 years upwards Unit of Plasma Concentration: μg/ml Max. Plasma Concentration: 15 μg/ml Vc = 0.228 x mass (litres x kg = 0.119 min = 0.112 min = 0.0419 min...
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Page 7: Creating A Data Set
Creating a Data Set To fully utilise the Alaris® PK Syringe Pump a Data Set will need to be developed, reviewed, approved, released, uploaded and verified according to the following process. Refer to the Alaris® PK Editor Software Directions for Use (1000CH00016) for further details and operating precautions. -
Page 8: Features Of The Alaris® Pk Syringe Pump
Features of the Alaris® PK Syringe Pump ON/OFF Release lever for High visibility Display Alarm Indicator PURGE/ BOLUS MUTE PRESSURE OPTION Finger Grips Extension HOLD Shelf for chevron Syringe Clamp Positive Plunger set hook keys and softkeys Grippers Rating Plate (see Symbol Definitions for an explanation of the symbols used) Release lever for... -
Page 9: Controls & Indicators
Controls & Indicators Controls: Symbol Description ON/OFF button - Press once to switch the pump ON. Press and hold down for 3 seconds to switch the pump OFF. Note: Pump can only be switched OFF at specific stages of operation, see 'Power Down Sequence' section in Configured Options for further details. -
Page 10: Symbol Definitions
Symbol Definitions Labelling Symbols: Symbol Description Attention (Consult accompanying documents) Potential Equalisation (PE) Connector RS232/Nurse call Connector (Optional) Defibrillation-proof type CF applied part (Degree of protection against electrical shock) Protected against vertically falling drops of water Alternating Current Device complies with the requirements of the EC Directive 93/42/EEC. Registered with the CE Mark. -
Page 11: Main Display Features
Main Display Features TIVA Mode Drug Name and Pump Status Concentration Pressure Information Flow Rate and Dose and Operations Dose Rate Volume Infused During Use TCI Mode Drug Name and Induction Pause Before Pump Status Concentration Duration Maintenance CONFIRM TIME Initial Induction Plasma Plasma Target... - Page 12 Main Display Features (continued) Screen Icons: Symbol Description TIME REMAINING DISPLAY icon - Indicates time before syringe will require replacing. BATTERY icon - Indicates battery charge level to highlight when the battery will require recharging. Induction Phase Dose (Displayed on protocol confirmation screen) Duration of Induction Phase (Displayed on protocol confirmation screen) Duration of Hands Free Bolus (Displayed in bolus set-up screen) Maintenance Phase Dose Rate (Displayed on protocol confirmation screen)
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Page 13: Operating Precautions
AC mains power supply network that supplies buildings used for domestic purposes. However, it may be used in domestic establishments under the supervision of Medical professionals with additional necessary appropriate measures. (Consult Technical Service Manual, appropriately trained technical personnel or Cardinal Health for further information). •... - Page 14 Operating Precautions (continued) Electromagnetic Compatibility & Interference • This pump is protected against the effects of external interference, including high energy radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to remain safe when unreasonable levels of interference are encountered.
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Page 15: Getting Started
Getting Started Initial Set-up Before operating the pump read this Directions For Use manual carefully. 1. Check that the pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC power supply. 2. Items supplied are: Alaris®... - Page 16 Getting Started (continued) Do not mount the pump with the AC power inlet or the syringe pointing upwards. This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe. Pole Clamp Installation The pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I.V.
- Page 17 Getting Started (continued) Loading a Syringe Only use a syringe of the type stated on the pump or in this manual. Using an incorrect syringe could adversely affect the accuracy of the infusion and the performance of the pump. When initially loading the syringe, allow for the volume of fluid contained in the extension set and retained in the syringe at the end of infusion as this “dead-space”...
- Page 18 Getting Started (Continued) Starting the Pump 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. •...
- Page 19 Getting Started (Continued) TCI Mode A list of available drugs and models will be displayed. Use the keys to select the required drug and associated model and press the OK softkey. Pressing the INFO key will show more information on the selection. 2.
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Page 20: Basic Features
Basic Features Purge button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe. 1. Press the button when the pump is not infusing. Ensure that the extension set is not connected to the patient. 2. - Page 21 Basic Features (Continued) Pressure Level 1. To check and adjust the pressure level press the button. A bar graph will be displayed showing the pressure alarm level and the current pressure level. 2. Press the keys to increase or decrease the alarm level. The new level will be indicated on the display. 3.
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Page 22: Operations During Use
Operations During Use End of Operation This option will only appear in the options menu when the infusion has been stopped. 1. Press the button to access the options menu. 2. Select the END OF OPERATION option using the keys. 3. - Page 23 Operations During Use (continued) 24 Hour Log This option allows the 24 hour log of volume infused to be reviewed. 1. Press the button to access the options menu. 2. Select the 24H LOG option using the keys and press the OK softkey. The display shows the hourly volume infused.
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Page 24: Alarms And Warnings
Alarms and Warnings Alarms are indicated by a combination of an audible alarm, flashing alarm indicator and a descriptive message in the display. button to silence the alarm for a maximum of 2 minutes*, then check the display for an alarm message. Press CANCEL 1. -
Page 25: Prompts
Prompts Display Description and Troubleshooting Guide DOSE WOULD EXCEED The infusion rate has been set to a value which exceeds a Soft Alert. Check infusion setting, to button and then confi rm OVERRIDE LIMIT by continue with infusion at set rate press the pressing the YES softkey. -
Page 26: Configured Options
Configured Options This section comprises of a list of options which are configurable. Some can be entered via the pump configuration menu (available in Technician Mode) and others through the Alaris® PK Editor Software. Enter the access code on Alaris® PK Syringe Pump for Configured Options, see the Technical Service Manual for details. Important: Access codes should only be entered by qualified technical personnel. - Page 27 Configured Options (Continued) Alaris® PK Editor Software - Pump Configuration The following options are configurable via the Alaris® PK Editor Software (PC based), see the Alaris® PK Editor Software Directions for Use (1000CH00016) for details on how to alter the profile configurations. AC Fail Warning The AC Power Failure Alarm can be set to sound or be silent if the AC power is disconnected.
- Page 28 Configured Options (continued) Alaris® PK Editor Software - Profile Drugs The following drug parameters are only configurable via the Alaris® PK Editor Software (PC based), and are referenced when the Alaris® PK Syringe Pump is being used with a drug name selected. Refer to the Alaris® PK Editor Software Directions for Use (1000CH00016) for details on how to configure the Profile Drug Library.
- Page 29 Configured Options (Continued) Default Drug Profile Library The following drug parameters are programmed in the pump. Diprivan 1% Diprivan 2% Remifentanil Remifentanil TIVA* Sufentanil Model Marsh Marsh Minto Gepts Min Concentration 10mg/ml 20mg/ml 20μg/ml 20μg/ml 0.2μg/ml Max Concentration 10mg/ml 20mg/ml 50μg/ml 250μg/ml 5.0μg/ml...
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Page 30: Specifications
Specifications Infusion Specifications - System Accuracy (continuous mode ml/h and TIVA) - Maximum infusion rate can be set as part of the configuration. Volumetric Mean +/- 2% (nominal). 0.1ml/h - 150ml/h 5ml syringes Derating - 0.1ml/h - 300ml/h 10ml syringes Temperature +/- 0.5% (5 - 40ºC) 0.1ml/h - 600ml/h 20ml syringes... -
Page 31: Compatible Syringes
Compatible Syringes The pump is calibrated and labelled for use with single-use disposable Luer-lock syringes. Only use the size and type of syringe specified on the pump display. The full list of permitted syringe models is dependent on the software version of the pump. 10ml 20ml 30ml... -
Page 32: Compatible Extension Sets
The pump uses standard, single-use, disposable extension sets and syringes with Luer-lock connectors. The user is responsible for verifying the suitability of a product used, if it is not recommended by Cardinal Health. Please check the availability of the sets listed below with your local Affiliate or Distributor. -
Page 33: Maintenance
All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied. Cardinal Health will not be responsible should any of these actions be performed outside the instructions or information supplied by Cardinal Health. - Page 34 If you wish to discard electrical and electronic equipment, please contact your Cardinal Health affiliate office or distributor for further information.
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Page 35: Occlusion Pressure Limits
Occlusion Pressure Limits Time to alarm following occlusion is achieved in less than 30 minutes at rates of 1 ml/h and higher by the appropriate selection of occlusion levels. 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. -
Page 36: Irda, Rs232 And Nurse Call Specification
IrDA, RS232 and Nurse Call Specification IrDA / RS232 / Nurse Call Feature RS232 / Nurse Call Connection Data The IrDA (or RS232 / Nurse Call optional feature) is a feature on Nurse call Specification - Alaris® Syringe Pumps that allows the pump to be connected to a Connector D Type - 9 Pin PC or other Alaris®... -
Page 37: Trumpet Curves & Start-Up Curves
Trumpet Curves & Start-up Curves In this pump, as with all infusion systems, the action of the pumping mechanism and variations in individual syringes cause short-term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1) the delay in onset of fluid flow when infusion commences (start-up curves), and 2) the accuracy of fluid delivery over various time periods is measured (trumpet curves). -
Page 38: Profiles From Tci Mode
Profiles from TCI mode When targeting in TCI Mode the Alaris® PK Syringe Pump will automatically calculate the flow rate profile from the specific pharmacokinetic/ pharmacodynamic model for the selected drug. This section of the Directions For Use is intended to help users understand the profiled infusion and the performance accuracy attained from the TCI pump. - Page 39 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%...
- Page 40 Profiles from TCI mode - Predicted vs Ideal Concentration Diprivan 1% Marsh Model BD 50ml Syringe Diprivan 2% Marsh Model BD 50ml Syringe Patient Age: 40 Yrs Patient Age: 40 Yrs Patient Weight: 60kg Patient Weight: 60kg Drug Concentration: 10mg/ml Drug Concentration: 20mg/ml Plasma Concentration Accuracy: +0.2% Plasma Concentration Accuracy: -0.3%...
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Page 41: Products And Spare Parts
Products and Spare Parts Alaris® Infusion System Range of products in the Alaris® Infusion System product family are: Part Number Description 80013UN01 Alaris® GS Syringe Pump 80023UN01 Alaris® GH Syringe Pump 80033UND1 Alaris® CC Syringe Pump 80043UN01 Alaris® TIVA Syringe Pump 80053UN01 Alaris®... -
Page 42: Service Contacts
Service Contacts For service contact your local Affiliate Office or Distributor. Cardinal Health, Cardinal Health, Cardinal Health, Cardinal Health PO Box 5527, Pascalstr. 2, Via Ticino 4, 10221 Wateridge Circle, Dubai, United Arab Emirates. 52499 Baesweiler, 50019 Sesto Fiorentino, San Diego, CA 92121, Tel: (971) 4 28 22 842 Deutschland. -
Page 43: Warranty
(A) repaired by anyone other than an authorised Cardinal Health service representative; (B) altered in any way so as to affect, in Cardinal Health’s judgement the stability or reliability of the product or has had the product’s serial or lot number altered, effaced or removed;... -
Page 44: Index
Index Symbols Labelling Symbols 9 24 Hour Log 22 Language 14, 25 Loading a Syringe 16 About This Manual 2 Alaris® DS Docking Station 15, 40 Maintenance 32, 33 Alaris® Gateway Workstation 15, 40 Alarms 23 Mode TIVA 2, 7, 14, 40 Associated Products 30 MORE 10 Mount 12, 15... - Page 45 Page Intentionally Left Blank 1000DF00005 Iss. 2 44/44...
- Page 46 Alaris®, Asena®, Guardrails® and IVAC® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks belong to their respective owners. © 2004 - 2006 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 1000DF00005 Issue 2 This document contains proprietary information of Cardinal Health, Inc.