CareFusion Alaris GP Directions For Use Manual

CareFusion Alaris GP Directions For Use Manual

Volumetric pump
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Alaris™ GP (Guardrails™)
Volumetric Pump
(with Plus Software)
s
Directions For Use
en

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Summary of Contents for CareFusion Alaris GP

  • Page 1 Alaris™ GP (Guardrails™) Directions For Use Volumetric Pump (with Plus Software)
  • Page 2: Table Of Contents

    Alaris™ GP (Guardrails™) Volumetric Pump Contents Page Introduction ....................2 About This Manual .
  • Page 3: Introduction

    The hospital defined data set is developed and approved through pharmacy and clinical input, and then transferred into the pump by qualified technical personnel. Intended Purpose The Alaris GP Volumetric Pump and Alaris GP Guardrails Volumetric Pump are intended for use by medical staff for the purpose of controlling infusion rate and volume. Conditions for Use The Alaris GP Volumetric Pump and Alaris GP Guardrails Volumetric Pump should only be operated by medical staff competent in the use of automated volumetric pumps and in the management of infusion therapy.
  • Page 4: Creating A Data Set

    4. Upload data set to the pump (Using Alaris Transfer Tool) Note: One profile selection will be required when uploading the data set to the Alaris GP Volumetric Pump. 5. Verify that the correct data set is loaded into the pump and accept it.
  • Page 5: Features Of The Volumetric Pump

    Alaris™ GP (Guardrails™) Volumetric Pump Features of the Volumetric Pump Features of the Volumetric Pump Alarm indicator Alaris® Guardrails ® Door Display Softkeys Chevrons Mute Bolus Pressure Hold Options Battery indicator AC power indicator On/Off Door Lever Handle Release lever for rotating Flow sensor connector RS232/Nursecall...
  • Page 6: Controls And Indicators

    Alaris™ GP (Guardrails™) Volumetric Pump Controls and Indicators Controls and Indicators Controls: Symbol Description ON/OFF button - Press once to switch the pump on. Press and hold down for approximately three seconds to switch the pump off. RUN button - Press to start the infusion. The green LED will flash during infusion. HOLD button - Press to put the infusion on hold.
  • Page 7: Symbol Definitions

    Alaris™ GP (Guardrails™) Volumetric Pump 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). IPX3 Protected against direct sprays up to 60° from the vertical. Alternating Current Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.
  • Page 8: Main Display Features

    Alaris™ GP (Guardrails™) Volumetric Pump Main Display Features Main Display Features Main Display - If VTBI has not been set (flow sensor must be used) Infusion Status / ON HOLD ON HOLD Drug Name / Profile Name / SET RATE WITH Primary or Secondary (Only if RATE secondary is enabled in the...
  • Page 9: Operating Precautions

    Uncontrolled flow may result if the infusion set is not properly isolated from the patient i.e. closing a tap in the set or activating an in-line clamp / roller clamp. • CareFusion infusion sets are fitted with an in-line clamp, which can be used to occlude tubing in case it is required to stop fluid flow. •...
  • Page 10 MRI compatible pump as such. If use of the pump within an MRI environment is unavoidable, then CareFusion highly recommends securing the pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the pump; or MRI image distortion.
  • Page 11 Alaris™ GP (Guardrails™) Volumetric Pump Operating Precautions Hazards • An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to locate the pump away from any such hazardous sources. • Dangerous Voltage: An electrical shock hazard exists if the pump’s casing is opened or removed. Refer all servicing to qualified service personnel.
  • Page 12: Getting Started

    • The default data set does not have drug related Guardrails limits. To set the limits use the Alaris Editor software. Care should be taken when specifying the Guardrails limits. * Only available on the Alaris GP Guardrails Volumetric Pump. 1000DF00546 Issue 5...
  • Page 13 Alaris™ GP (Guardrails™) Volumetric Pump Getting Started Pole Clamp Installation The pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I.V. poles of a diameter between 15 and 40 mm. 1. Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole. 2.
  • Page 14 Alaris™ GP (Guardrails™) Volumetric Pump Getting Started The Alaris Safety Clamp Alaris Safety Clamp*: Safety Clamp In Non Occluded Position: When a new infusion set is removed from packaging the Safety Clamp will be in this position**: Clamp in NON OCCLUDED POSITION Safety Clamp Frame Safety Clamp Tab...
  • Page 15 • 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 and Alaris GP Guardrails Volumetric Pump infusion sets, (Refer to 'Infusion Sets' section of the DFU) •...
  • Page 16 NOTE: The CONFIRM PROFILE screen is only shown if more than one profile (For Alaris GP Guardrails Volumetric Pump only) is available in the data set. If a profile has been filtered, then the option to select ALL will be displayed in the profile selection screen.
  • Page 17: Basic Features

    Alaris™ GP (Guardrails™) Volumetric Pump Basic Features Basic Features Drugs and Dosing The following options enable the pump to be set-up for use with a specific drug protocol. Drugs are pre-configured in the Alaris Editor to enable rapid selection of the drug protocol, dosing units and default rate. For increased security when using a configured drug, maximum and minimum safety limits can be set for concentrations and dose rates via the Alaris Editor.
  • Page 18 Alaris™ GP (Guardrails™) Volumetric Pump Basic Features Clear Volume Infused 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. This option enables the volume infused to be cleared.
  • Page 19 Alaris™ GP (Guardrails™) Volumetric Pump Basic Features Pressure To check and adjust the pressure level, press the button. The display will change to show the PRESSURE current pumping pressure level and the pressure alarm limit. The default pressure alarm limit can be set via the Alaris Editor.
  • Page 20 Rate may be restricted by the BOLUS RATE MAX which is configured in the Alaris Editor. NOTE: If the BOLUS exceeds the soft (Alaris GP Guardrails Volumetric Pump only) or hard limits, a prompt will display. NOTE: The bolus rate will be automatically set to the current infusion rate, when the default bolus rate is lower than the current infusion rate.
  • Page 21 Alaris™ GP (Guardrails™) Volumetric Pump Basic Features Rate Lock (If enabled) If Rate Lock is enabled, when the infusion rate has been set and the infusion started (or following a bolus infusion) the rate lock prompt will appear on the main display. To select the rate lock function press the YES softkey.
  • Page 22 2. Select PUMP DETAILS using the fkeys and press OK softkey to confirm. 3. Review the information and then press the QUIT softkey. Profile Filter (Only available on the Alaris GP Guardrails Volumetric Pump) This option allows selected profiles to be filtered from view. It can be enabled/disabled via the Alaris Editor.
  • Page 23 During use of Needle-Free Valve port, fluid may be observed between the housing and blue piston. This fluid does not enter the fluid path and requires no action. NOTE: For product questions or needle-free valve educational materials, contact your CareFusion representative. Consult facility protocols. Consult other organizations that publish guidelines useful in developing facility protocols. 1000DF00546 Issue 5...
  • Page 24: Secondary (Piggyback) Infusions

    Alaris™ GP (Guardrails™) Volumetric Pump Secondary (Piggyback) Infusions 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 25: Service Configuration Mode

    Alaris™ GP (Guardrails™) Volumetric Pump 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 menu (available in Technician Mode) and others through the Alaris Editor Software. Enter the access code on the pump for SERVICE mode, then select CONFIGURATION, see the Technical Service Manual for details.
  • Page 26: Pump Configuration Available Via The Alaris Editor Software

    WEIGHT DEFAULT The default patient weight. WEIGHT SOFT MIN (For Alaris GP Guardrails Volumetric Pump only) The minimum patient weight for weight-based drug dosing calculations before alerting the user. WEIGHT SOFT MAX (For Alaris GP Guardrails Volumetric Pump only) The maximum patient weight for weight-based drug dosing calculations before alerting the user.
  • Page 27 Alaris™ GP (Guardrails™) Volumetric Pump Pump Configuration available via the Alaris Editor Software Large Volume Pump Configuration Settings AIL LIMIT The single bubble Air-in-line alarm setting. BOLUS MODE Controls whether or not the pump allows bolus delivery method. BOLUS RATE DEFAULT The default value for bolus rates.
  • Page 28: Drug Library Available Via The Alaris Editor Software

    The default bolus dose for this drug. Applies to Hands-free bolus. BOLUS DOSE SOFT MIN (For Alaris GP Guardrails Volumetric Pump only) The minimum bolus dose that the pump allows before the user is required to confirm the selected bolus dose in response to a warning of the possibility of under-infusion.
  • Page 29: Alarms

    Alaris™ GP (Guardrails™) Volumetric Pump 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 30 Alaris™ GP (Guardrails™) Volumetric Pump Alarms Infusion Display Cause Action Status • Clamp infusion set using roller clamp. Gross difference • Check flow sensor. between detected drops FLOW ERROR Infusion stopped and expected amount of • Check fluid level in drip chamber. drops.
  • Page 31: Warnings

    Alaris™ GP (Guardrails™) Volumetric Pump Warnings Warnings Warnings 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. to silence the sound for 2 minutes, CANCEL to clear the message. 1.
  • Page 32: Prompts

    Alaris™ GP (Guardrails™) Volumetric Pump Prompts 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. to silence the sound for 2 minutes, CANCEL to clear the message. 1.
  • Page 33: Advisories

    Alaris™ GP (Guardrails™) Volumetric Pump Advisories Advisories Infusion Display Cause Action Status • Check infusion setting. Pump on hold (If titration is disabled) Infusion rate set exceeds a • To confirm CONFIRM DRUG? press DOSE WOULD EXCEED Guardrails soft limit. YES.
  • Page 34: Restarting An Infusion Following An Air-In-Line Alarm

    Alaris™ GP (Guardrails™) Volumetric Pump Restarting an Infusion following an Air-in-Line Alarm Restarting an Infusion following an Air-in-Line Alarm The pump may be restarted by opening the door, assessing and removing any air from the tubing guide area and in the infusion set on the patient side of the pump (if required) according to hospital policy.
  • Page 35: Flow Sensor Operation (Optional)

    Alaris™ GP (Guardrails™) Volumetric Pump 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 detect empty containers.
  • Page 36: Infusion Sets

    The pump uses standard, single-use, disposable infusion sets. The user is responsible for verifying the suitability of a product used, if it is not recommended by CareFusion. • New sets are continuously being developed for our customers. Please contact your local CareFusion representative for availability.
  • Page 37 Artwork Number: 1000AW03033 Change History: Issue Change Order Change description Drawn by Date Alaris GP light resistant infusion sets 7208 Introduction Angela Coles 12/10/06 60643 • 15 Micron Filter • Length: 250cm Please note these drawings are not to scale...
  • Page 38 Change Order Change description Drawn by Date 7208 Introduction Angela Coles 12/10/06 Alaris GP low sorbing infusion sets • 15 Micron Filter 60953 • Polyethylene lined PVC tubing • Length: 270cm • Polyethylene lined PVC tubing 63260NY • No Filter •...
  • Page 39: Associated Products

    Alaris™ GP (Guardrails™) Volumetric Pump Associated Products Associated Products • The Alaris DS Docking Station • The Alaris Gateway Workstation 1000DF00546 Issue 5 38/50...
  • Page 40: Maintenance

    Alaris Volumetric Pump, and in conjunction with Alaris Volumetric Pump software, controls battery use, charge and temperature. Any use of battery packs that are not manufactured by CareFusion in the Alaris Volumetric Pump is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any battery packs that are not manufactured by CareFusion.
  • Page 41: Cleaning And Storage

    Alaris™ GP (Guardrails™) Volumetric Pump Cleaning and Storage Cleaning and Storage Cleaning the pump 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.
  • Page 42 If you wish to discard electrical and electronic equipment, please contact your CareFusion affiliate office or distributor for further information.
  • Page 43: Specifications

    Alaris™ GP (Guardrails™) Volumetric Pump Specifications Specifications Electrical Protection Class I, Type CF (Defibrillation-proof ) Electrical/Mechanical Safety Complies with IEC/EN60601-1 and IEC/EN60601-2-24. Electro Magnetic Compatibility (EMC) Complies with IEC/EN60601-1-2 and IEC/EN60601-2-24. Electrical Safety Typical earth leakage current 78µA. Typical Enclosure Leakage Current (Normal Condition) = 0µA Typical Protective Earth Resistance = 32mOhms The above measurements are for guidance only, IEC/EN60601-1 limits are defined below: Earth Leakage Current (Normal Condition) <= 500µA...
  • Page 44 Alaris™ GP (Guardrails™) Volumetric Pump Specifications Alarm Conditions Alarms Warnings Prompts Advisories AIR IN LINE (SINGLE BUBBLE) AC POWER FAIL ATTENTION DOSE WOULD EXCEED AIR IN LINE (ACCUMULATED) VTBI DONE SET VTBI DOSE UNDER DOOR OPEN BATTERY LOW SET NOT FITTED DOSE NOT PERMITTED DOWNSTREAM OCCLUSION AIR-IN-LINE...
  • Page 45: Irda, Rs232 And Nursecall Specification

    Alaris™ GP (Guardrails™) Volumetric Pump IrDA, RS232 and Nursecall Specification IrDA, RS232 and Nursecall Specification IrDA / RS232 / Nursecall Feature The IrDA (or RS232 / Nursecall optional feature) is a feature that allows the pump to be connected to an external device for the purpose of data communication.
  • Page 46: Infusion Specifications

    Alaris™ GP (Guardrails™) Volumetric Pump Infusion Specifications Infusion Specifications System Accuracy: Rate Accuracy is ±5%, achieved under nominal conditions 1a,2 Rate Accuracy is ±10%, achieved under low flow conditions 1b,2 Occlusion Alarm Limits Achieved under nominal conditions 1a,4 Level Pressure (mmHg) approx.
  • Page 47 Alaris™ GP (Guardrails™) Volumetric Pump Infusion Specifications Air Sensor: Integral Ultrasonic Sensor. Air in line detection: Single Bubble (configurable): 50µl, 100µl, 250µl & 500µl. Bubble accumulation: 1ml over a 15 minute window. Critical Volume The maximum volume infused following a single fault condition is for rates < 10ml/h: +/- 0.25 ml, rates < 100ml/h: +/- 0.5ml, rates ≥100ml/h: +/- 2 ml The Alaris Safety Clamp Set based, pump activated Safety Clamp Device to prevent free flow...
  • Page 48: Trumpet And Flow Rate Curves

    Alaris™ GP (Guardrails™) Volumetric Pump Trumpet and Flow Rate Curves Trumpet and 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 49 Alaris™ GP (Guardrails™) Volumetric Pump Trumpet and Flow Rate Curves Trumpet Graph at 1.0ml/h (Initial Period) Trumpet Graph at 1.0ml/h (After 72 Hours) 30.0 20.0 10.0 Trumpet Graph at 25.0 ml/h (After 24 Hours) -10.0 -20.0 -30.0 Observation Window (minutes) Observation Window (minutes) Maximum Error Minimum Error...
  • Page 50: Products And Spare Parts

    A comprehensive list of spare parts for this pump is included within the Technical Service Manual. The Technical Service Manual (1000SM00013) is now available in electronic format on the World Wide Web at :- www.carefusion.co.uk/alaris-technical/ A username and password are required to access our manuals. Please contact a local customer services representative to obtain login details.
  • Page 51: Service Contacts

    Alaris™ GP (Guardrails™) Volumetric Pump Service Contacts Service Contacts For service contact your local Affiliate Office or Distributor: CareFusion, CareFusion, CareFusion, CareFusion, PO Box 5527, Tullastr. 8-12 Döbrentei tér 1, Avda. São Miguel, 296 Atelier 14 Dubai, United Arab Emirates.
  • Page 52 Alaris, Guardrails, IVAC and SmartSite are registered trademarks of CareFusion Corporation or one of its affiliates. All rights reserved. All other trademarks are property of their respective owners. ©2009-2016 CareFusion Corporation or one of its affiliates. All rights reserved. This document contains proprietary information...

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