Cardinal Health Alaris GP Directions For Use Manual

Volumetric pump

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Technical & service manual (84 pages)

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Alaris

GP Volumetric Pump

Directions For Use - English

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Summary of Contents for Cardinal Health Alaris GP

Page 1 Alaris GP Volumetric Pump ® Directions For Use - English...
Page 2: Table Of Contents
Contents Page Introduction ..................2 About this Manual .
Page 3: Introduction
Introduction The Alaris® GP Volumetric Pump (hereinafter referred to as 'Pump') is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a range of rates. The Alaris® GP Editor Software is a medical device accessory, which allows the hospital to develop a best-practice data set of IV medication dosing guidelines for patient-specific care areas.
Page 4: Creating A Data Set
Creating a Data Set To create a data set for the Alaris® GP Volumetric Pump, first the hospital will need to develop, review, approve, upload according to the following process. Refer to the Alaris® GP Editor help file for further details and operating precautions. 1.
Page 5: Features Of The Alaris® Gp Volumetric Pump
Features of the Alaris® GP Volumetric Pump Alarm indicator Door Display Softkeys Chevrons Mute Bolus Hold Pressure Options Battery indicator AC power indicator On/Off Door Lever Handle Release lever for rotating cam Flow sensor connector RS232/ Nursecall connector (cover removed for clarity) Rotating cam to lock onto Folded pole clamp horizontal rectangular bars.
Page 6: Controls And Indicators
Controls and Indicators Controls: Symbol Description ON/OFF button - Press once to switch the pump ON. Press and hold down for approximately 3 seconds to switch the pump OFF. RUN button - Press to start the infusion. The green LED will flash during infusion.
Page 7: Symbol Definitions
Symbol Definitions Labelling Symbols: Symbol Description Attention (Consult accompanying document) Potential Equalisation (PE) Connector RS232/ Nursecall Connector.  Defibrillation-proof type CF applied part. (Degree of protection against electrical shock) IPX1 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 8: Main Display Features
Main Display Features Main Display - If VTBI has not been set (ﬂ ow sensor must be used): Infusion Status/ ON HOLD ON HOLD Drug Name/Primary or SET RATE WITH Secondary RATE (Only if secondary is enabled in the data set) RATE If the rate has not been set 25.0...
Page 9: Operating Precautions
Operating Precautions Infusion Sets To ensure correct and accurate operation, only use Cardinal Health single use infusion sets described in this Directions For Use. It is recommended that infusion sets are changed according to the instructions in the 'Changing the Infusion Set' section.
Page 10 Operating Precautions (Continued) Alarm Conditions Several alarm conditions detected by this pump will stop the infusion and generate visual and audible Alaris® alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating. Electromagnetic Compatibility and 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...
Page 11: Getting Started
Getting Started Before operating the pump read this Directions For Use (DFU) manual carefully. Initial Set Up Check that the pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC power supply. Items supplied are : Alaris®...
Page 12 Getting Started (Continued) Pole Clamp Installation A pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I.V. poles of a diameter between 15 and 40 mm. Recessed area Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole.
Page 13: The Alaris® Safety Clamp
Getting Started (Continued) - The Alaris® Safety Clamp ALARIS® ALARIS® SAFETY CLAMP**: SAFETY CLAMP**: SAFETY CLAMP IN NON OCCLUDED POSITION: When a new infusion set is removed from packaging the When a new infusion set is removed from packaging the Safety Safety Clamp will be in this position*: Clamp will be in this position*:...
Page 14: Loading An Infusion Set
Getting Started (Continued) - Loading an Infusion Set Ensure the appropriate infusion set for the fluid/drug to be infused has been selected. Follow the instructions supplied with the individual infusion set. Only use Alaris ® GP Volumetric Pump infusion sets, (Refer to 'Infusion Sets' section of the DFU) Position the fluid container to avoid spillage onto the pump.
Page 15: Starting The Infusion
Getting Started (Continued) - Starting the Infusion PRIME AND LOAD THE SET (Refer to 'Loading an Infusion Set') Ensure the pump is connected to an AC power supply (also operates from battery). Connect flow sensor, if required. (See 'Flow Sensor Operation') Press the key.
Page 16: Basic Features
Basic Features - Drugs and Dosing The following options enable the pump to be set-up for use with a specific drug name and/or drug protocol. Drugs are pre-configured in the Alaris® GP Editor to enable rapid selection of the drug name, dosing units and default rate. For increased security using a configured drug, maximum and minimum safety limits are programmable for concentration and dose rates.
Page 17 Basic Features VOLUME Clear Volume Infused VOLUME INFUSED This option enables the volume infused to be cleared. 1. Press the VOLUME softkey on main display to show the clear VOLUME INFUSED option. 2. Press the CLEAR softkey to clear the volume infused. Press the QUIT softkey to retain the volume. When a new drug or a new concentration has been setup and the previous volume infused has not been cleared, then the message DOSE INFUSED HAS BEEN CLEARED will be displayed.
Page 18 Basic Features BOLUS Bolus Infusions RATE Bolus - Administering a controlled volume of ﬂ uid or drug at an increased rate for diagnostic or therapeutic SET WITH purposes. The pump should always be infusing and always attached to the patient. (Drugs given by an IV bolus could achieve immediate and high drug concentration levels.) ml/h The bolus feature can be conﬁ...
Page 19: Options
Basic Features - Options button Adjusting Existing Dosing or Protocol Infusions - Set By ml/h / Set By Doserate To set doserate or flowrate in precise increments it may be necessary to switch between the rate adjust options SET BY DOSERATE and SET BY ml/h.
Page 20: Secondary (Piggyback) Infusions
Basic Features - Secondary (Piggyback) Infusions Secondary (or piggyback) Infusion mode is only available if it has been configured. The application of secondary infusions should be limited to the intermittent therapy of medications which are not sensitive to the total time required to complete an infusion.
Page 21 Basic Features Changing the Infusion Set Press to put the pump ON HOLD. Close in-line clamp and ensure the access to the patient is isolated. Disconnect the infusion set from the patient. Open pump door and remove infusion set from the pump and discard the set and fluid container according to hospital protocol. Prepare the new infusion set, load infusion set into pump and close the door, see "Loading the Infusion Set".
Page 22: Service Configuration Mode
Service Configuration Mode This section comprises of a list of options which can be configured. Some can be entered via the pump SERVICE CONFIGURATION menu (available in Technician Mode) and others through the Alaris® GP Editor Software. Enter the access code on Alaris® GP Volumetric Pump for SERVICE mode, then select SERVICE CONFIGURATION, see the Technical Service Manual for details.
Page 23: Pump Configuration
Pump Configuration available via the Alaris® GP Editor Software The following options are only configurable via the Alaris® GP Editor Software (PC based), see Alaris® GP Editor help files for further details. GENERAL SETTINGS: AC Fail Warning Warning to indicate that the AC Power has been disconnected and the pump is operating on battery power.
Page 24: Drug List
Drug List available via the Alaris® GP Editor Software The following drug parameters are only configurable via the Alaris® GP Editor Software (PC based), see Alaris® GP Editor help files for further details. CONCENTRATION SETTINGS: Concentration Specifies the drug concentration. Concentration Min The weakest permissible concentration for this drug (amount of drug per ml).
Page 25: Alarms
Alarms Alarms stop the infusion and are indicated by a combination of an audible sound, flashing red alarm indicator and a message on the display. 1. Check the display for an alarm message and review table below for cause and action. Press to silence the sound for 2 minutes, CANCEL to clear the message.
Page 26: Warnings
Alarms (Continued) Display Infusion Status Cause Action WRONG SET Pump on hold Safety clamp not detected. • Clamp infusion set using roller clamp. • Check set and close door. • Replace infusion set. (If necessary) Pump on hold Safety clamp in non-occluded •...
Page 27: Prompts And Restarting An Infusion Following An Air-In-Line Alarm
Prompts Prompts alert the user but may not stop the infusion and are indicated by an audible sound, a flashing amber warning indicator and a message on the display or both. 1. Check the display for a prompt message. Press to silence the sound for 2 minutes, CANCEL to clear the message.
Page 28: Flow Sensor Operation (Optional)
Flow Sensor Operation (Optional) The flow sensor automatically monitors the infusion flow rate through the drip chamber. The flow sensor will cause the pump to alarm if a significant deviation from the infusion rate occurs. The flow sensor will also be able to For this reason we recommend use of a flow sensor wherever possible detect empty containers.
Page 29: Infusion Sets
For availability please contact your local Cardinal Health, infusion sets. The user is responsible for verifying the suitability of a Alaris® Product representative. product used, if it is not recommended by Cardinal Health. Alaris® GP standard infusion sets 60073 • 2 Injection Ports • No Filter • Length: 260cm ®...
Page 30 For availability please contact your local Cardinal infusion sets. The user is responsible for verifying the suitability of a Health, Alaris® Product representative. product used, if it is not recommended by Cardinal Health. Alaris® GP standard infusion sets 63200NY • No Filter • Length: 260cm 63110V •...
Page 31 For availability please contact your local Cardinal infusion sets. The user is responsible for verifying the suitability of a Health, Alaris® Product representative. product used, if it is not recommended by Cardinal Health. Alaris® GP light resistant infusion sets 60643 •...
Page 32: Associated Products
Associated Products ® ® The Alaris DS Docking Station The Asena IDS Docking Station ® The Alaris Gateway Workstation 1000DF00152 Issue 1 31/42...
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, Alaris® Products will not be responsible should any of these actions be performed outside the instructions or information supplied by Cardinal Health.
Page 34: Cleaning And Storage
If you wish to discard electrical and electronic equipment, please contact your Cardinal Health affiliate office or distributor for further information.
Page 35: Specifications
Specifications Electrical Protection BATTERY SPECIFICATIONS - Rechargeable NiMH (Nickel Metal Hydride). Automatically charges Class I, Type CF (Defibrillation-proof ) when the pump is connected to AC power. Electrical/Mechanical Safety Battery Life - 4 hours @ 125ml/h Complies with IEC/EN60601-1 and IEC/EN60601-2-24. Battery Charging - 2.5 hours to 95%.
Page 36: Irda, Rs232 And Nursecall Specification
IrDA, RS232 and Nursecall Specification IrDA / RS232 / Nursecall Feature RS232 / Nursecall Connection Data The IrDA (or RS232 / Nursecall optional feature) is a feature on Nursecall Specification - Alaris® GP Volumetric Pump that allows the pump to be connected Connector D Type - 9 Pin to an external device for the purpose of data communication...
Page 37: Infusion Specifications
Infusion Specifications System Accuracy: Critical Volume Rate Accuracy is ±5.0% [95% Conﬁ dence Interval / 80% Population], The maximum volume infused following a single fault condition achieved under nominal conditions is for rates < 10ml/h: +/- 0.25 ml, rates < 100ml/h: +/- 0.5ml, rates ≥100ml/h: +/- 2 ml Occlusion Alarm Limits Set based, pump activated Safety Clamp Device to prevent free...
Page 38: Trumpet And Flow Rate Curves
Trumpet & Flow Rate Curves In this pump, as with all infusion systems, the action of the pumping mechanism and variations cause short-term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1) the accuracy of fluid delivery over various time periods is measured (trumpet curves), and 2) the delay in onset of fluid flow when infusion commences (start-up curves).
Page 39: 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 Alaris® GS Syringe Pump 80013UN01 Alaris® GH Syringe Pump 80023UN01 Alaris® CC Syringe Pump 80033UND1 Alaris® TIVA Syringe Pump 80043UN01 Alaris®...
Page 40: 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 41: Warranty
(D) improperly maintained or used in any manner other than in accordance with the written instructions furnished by Cardinal Health. This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of Cardinal Health, and Cardinal Health neither assumes nor authorises any representative or other person to assume for it any other liability in connection with the sale of Cardinal Health products.
Page 42: Index
Index Introduction 2 A/C power indicator 4 IR communications port 4 Air-in-line 13 IrDA 35 Accumulated air 24 single bubble 24 KVO 16 air vent 8 Alaris® DS Docking Station 38 Language 21 Alarm 4, 5, 24, 35 Latex Content 9 Associated Products 31 Light resistant infusion sets.
Page 43 Page Intentionally Left Blank 1000DF00152 Issue 1 42/42...
Page 44 Cardinal Health, Inc. or one of its subsidiaries. All other trademarks belong to their respective owners. © 2005 - 2006 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 1000DF00152 Issue 1 This document contains proprietary information of Cardinal Health, Inc.

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