BD Alaris 80300MRI01-33 Directions For Use Manual
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BD Alaris 80300MRI01-33 Directions For Use Manual

Mri capsule
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BD Alaris
MRI Capsule
™
Model: 80300MRI01-33
en Directions For Use
s

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Summary of Contents for BD Alaris 80300MRI01-33

  • Page 1 BD Alaris MRI Capsule ™ Model: 80300MRI01-33 en Directions For Use...

  • Page 2: Table Of Contents

    BD Alaris™ MRI Capsule Contents Page Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Intended Use .
  • Page 3 BD Alaris™ MRI Capsule Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Spare Parts .

  • Page 4: Introduction

    Introduction MRI Scanners use strong magnetic fields that can cause partial or permanent damage to Infusion Pumps . The BD Alaris™ MRI Capsule (hereinafter referred to as MRI Capsule) has been designed to allow the hospital staff to use the Alaris™...

  • Page 5: Intended Positioning Of The Mri Capsule

    BD Alaris™ MRI Capsule Introduction Intended Positioning of the MRI Capsule The MRI Capsule incorporates a Magnetic Indicator that is used to safely position the MRI Capsule in relation to the MRI Scanner . The MRI Capsule should be positioned as near to the patient as possible, ensuring the Magnetic Indicator is illuminated Green which indicates a magnetic field density equal to or less than 20mT (millitesla) .

  • Page 6: About This Manual

    About This Manual About This Manual The user must be thoroughly familiar with the BD Alaris™ MRI Capsule described in this manual prior to use . Please refer to the relevant Directions For Use (DFU) for correct operation of the Pumps .

  • Page 7: Controls And Indicators

    BD Alaris™ MRI Capsule Controls and Indicators Controls and Indicators Controls Symbol Description ON/OFF Button - Press once to switch the MRI Capsule on . Press and hold for two seconds to switch the MRI Capsule off . In the event that the system needs to be reset, press and hold for at least four seconds, then press again to switch the MRI Capsule on .

  • Page 8: Magnetic Indicator

    BD Alaris™ MRI Capsule Controls and Indicators Magnetic Indicator The Magnetic Indicator is an integrated system to continuously measure the magnetic field strength in the MRI environment . The Magnetic Indicator is equipped with both visual and audio alarms . If the MRI Capsule is placed too close to the magnet bore, the Magnetic Indicator will alarm and data will be logged .

  • Page 9: Symbol Definitions

    BD Alaris™ MRI Capsule Symbol Definitions Symbol Definitions Labelling Symbols Symbol Description AC Power Inlet Fuse Rating Consult accompanying documents Potential Equalisation (PE) Connector Alternating Current MRI Capsule complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC .

  • Page 10: Features Of The Mri Capsule

    BD Alaris™ MRI Capsule Features of the MRI Capsule Features of the MRI Capsule Height adjustable Pump Alarm Location Beacon Pole with bag hanger hooks Keypad with Indicators Grooves for Infusion Sets to Volumetric Pumps Door handle with a lock...

  • Page 11: Trolley

    BD Alaris™ MRI Capsule Features of the MRI Capsule AC Power cable storage hooks AC Power Inlet Trolley When the MRI Capsule is not being transported or is positioned in place, the manual brakes should be engaged . Automatic Brakes The automatic brake lever is located with the MRI Capsule handle .

  • Page 12: Configurations

    BD Alaris™ MRI Capsule Features of the MRI Capsule Configurations 3 Volumetric and 3 Syringe Pumps 4 Volumetric Pumps 4 Syringe Pumps BDDF00171 Issue 4 11/39...

  • Page 13: Compatible Infusion Sets

    BD Alaris™ MRI Capsule Features of the MRI Capsule Compatible Infusion Sets The following list of Compatible infusion and extension sets are recommended for use in the MRI Capsule with the Alaris™ Infusion pumps: MRI Capsule Product Description Compatible product Reference Alaris™...
  • Page 14 BD Alaris™ MRI Capsule Features of the MRI Capsule Precautions while managing Infusion and Extension Sets from Alaris™ Infusion Pumps: • Ensure the sets are securely located in the grooves, when closing the MRI Capsule door and when installing the pumps .

  • Page 15: Height Adjustable Poles

    BD Alaris™ MRI Capsule Features of the MRI Capsule Height Adjustable Poles The height adjustable poles have been designed as a convenient means of securing the fluid bags onto the MRI Capsule . The height adjustable poles support a maximum load of 4 kg (i .e . 2 kg per height adjustable pole) . The height adjustable poles are held securely by a clamp and a slip catch .

  • Page 16: Power Input

    Power supply or the MRI Capsule internal battery . The battery indicator of the Magnetic Indicator will be flashing when the battery power is low and BD recommends replacing the battery every two years . Please contact Qualified Service Personnel to replace the battery .

  • Page 17: System Notifications

    BD Alaris™ MRI Capsule Features of the MRI Capsule System Notifications The MRI Capsule is equipped with both audio and visual notifications to promote user awareness . System Notifications have been segregated into three different categories: Status Notifications, System Fault Indications and Pump Alarms, based on their required response and method of user awareness .

  • Page 18: System Fault Indication

    BD Alaris™ MRI Capsule Features of the MRI Capsule System Fault Indication Continuous monitoring of the power distribution and communications system integrity is performed by the MRI Capsule . In the event that a system fault occurs whilst in use, the System Fault Indicator will be illuminated accompanied by an audible tone .

  • Page 19: Pump Alarm Location Beacon

    BD Alaris™ MRI Capsule Features of the MRI Capsule Pump Alarm Location Beacon The Pump Alarm Location Beacon is mounted at the top of the MRI Capsule to assist with identifying the presence of any alarms generated by the Pumps . When lit, the Pump Alarm Location Beacon colour matches that of the visual status indicator on the Pumps .

  • Page 20: Operating Precautions

    . Where appropriate, mitigations should be identified and implemented . • The MRI Capsule should only be used with compatible BD products and accessories . • While being used for patient therapy, each MRI Capsule should be dedicated to the care of a single patient .

  • Page 21: Hazards

    BD does not provide any warranty for or endorsement on any MRI Capsule that has been so modified or altered . BD product warranty shall not apply in the event the MRI Capsule has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of unauthorised modification or alteration of the MRI Capsule .
  • Page 22 BD Alaris™ MRI Capsule Operating Precautions • If the MRI Capsule is moved to an area where the Magnetic Indicator is flashing red, and the Pumps do not alarm, the user must move the MRI Capsule back to a position where the Magnetic Indicator flashes green .

  • Page 23: Operation Of The Mri Capsule

    BD Alaris™ MRI Capsule Operating Precautions Operation of the MRI Capsule Switching On Note: Magnetic Indicator is permanently on and is not affected by switching on/off the MRI Capsule . 1 . Connect the AC Power cord from the AC Power Supply to the AC Power inlet socket at the back of the MRI Capsule .

  • Page 24: The Mri Capsule In The Mri Environment

    BD Alaris™ MRI Capsule The MRI Capsule in the MRI Environment The MRI Capsule in the MRI Environment Control Room Only dock the compatible Pumps into the MRI Capsule, see 'Compatible Alaris™ Infusion Pumps for MRI Capsule' section. Perform the following steps in the control room before taking the patient and the MRI Capsule to the MRI Room .
  • Page 25 BD Alaris™ MRI Capsule The MRI Capsule in the MRI Environment Removing a Pump 1 . Unlock and open the MRI Capsule door . 2 . Holding the Pump with both hands, push the release lever on the right hand side of the Pump backwards .

  • Page 26: Getting Started In The Mri Room

    BD Alaris™ MRI Capsule The MRI Capsule in the MRI Environment Getting Started in the MRI Room Before entering the MRI Room, ensure that the MRI Capsule is switched on. Disconnect the MRI Capsule from AC Power before entering the MRI Room.
  • Page 27 BD Alaris™ MRI Capsule The MRI Capsule in the MRI Environment For exact positioning of the MRI Capsule please use the integrated Magnetic Indicator . Fringe Field of Typical values of approximate distances to opening of magnet bore Allowed position in...

  • Page 28: Product Specifications

    BD Alaris™ MRI Capsule Product Specifications Product Specifications Electrical Protection Against Electrical Shock: Class I Supply Voltage: 115–230V, ~50–60Hz Rating: 460VA (Maximum) Fuses: 2 × 4A/H Time-Lag T Consult Qualified Service Personnel for replacement of fuses . AC Power Outlets: MRI Capsule Tile: 115–230V, ~50–60Hz, 60VA...

  • Page 29: Regulatory Compliance

    BD Alaris™ MRI Capsule Product Specifications Regulatory Compliance Complies with IEC/EN60601-1, IEC/EN60601-1-2 . Potential Equalisation Conductor The function of the Potential Equalisation Connector (Conductor) is to provide a direct connection between the MRI Capsule and the potential equalisation busbar of the electrical installation . To use the Potential Equalisation Connector, connect the Potential Equalisation Connector on the MRI Capsule to the potential equalisation busbar of the electrical installation .

  • Page 30: Maintenance

    BD recommends replacing the Magnetic Indicator battery every two years . Any use of battery packs that are not manufactured by BD in the MRI Capsule is at your sole risk, and BD does not provide any warranty for or endorsement on any battery packs that are not manufactured by BD .

  • Page 31: Recommended Cleaning

    If the MRI Capsule has visible cracks or damage to the case do not clean and immediately take out of service for examination by Qualified Service Personnel. Do not clean the AC Power connector and socket. Please contact local BD Qualified Service Personnel for further guidance.
  • Page 32 BD Alaris™ MRI Capsule Maintenance BDDF00171 Issue 4 31/39...

  • Page 33: Disposal

    This U symbol on the product and/or accompanying documents means that used electrical and electronic products should not be mixed with household waste . If you wish to discard electrical and electronic equipment, please contact your BD affiliate office or distributor for further information .

  • Page 34: Spare Parts

    BD Alaris™ MRI Capsule Spare Parts Spare Parts Spare Parts A comprehensive list of spare parts for this MRI Capsule is included within the Technical Service Manual . The Technical Service Manual is now available in electronic format on the World Wide Web at: bd.com/int-Alaris-technical...

  • Page 35: Contact Us

    BD Alaris™ MRI Capsule Contact Us Contact Us For full contact information please refer to bd .com . Customer Service Information Country Telephone email Australia Freephone: 1 800 656 100 AUS_customerservice@bd .com België +32(0)53 720 556 info .benelux@bd .com Canada +1 800 387 8309 CanadaCapital@carefusion .com .

  • Page 36: Electromagnetic Emissions

    BD Alaris™ MRI Capsule Electromagnetic Emissions Electromagnetic Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The MRI Capsule is intended for use in the electromagnetic environment specified below . The customer or the user of the MRI Capsule should assure that it is used in such an environment .

  • Page 37: Electromagnetic Immunity

    Note 2 – Performed at the Minimum and Maximum Rated Input Voltage . Note 3 – BD recommends using signal cables of less than 3 metres in length and this requirement is applicable only if signal cables are 3 metres or more in length . (EN 60601-1-2:2002, Clause 36 .202 .4)
  • Page 38 BD Alaris™ MRI Capsule Electromagnetic Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – Life Support Equipment The MRI Capsule is intended for use in the electromagnetic environment specified below . The customer or the user of the MRI Capsule should ensure that it is used in such an environment .

  • Page 39: Recommended Separation Distances

    BD Alaris™ MRI Capsule Electromagnetic Emissions Recommended Separation Distances Recommended Separation Distances for Life Support Equipment between portable and mobile RF communications equipment and the MRI Capsule The MRI Capsule is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled .
  • Page 40 BD Alaris™ MRI Capsule Electromagnetic Emissions Recommended Separation Distances for between portable and mobile RF communications equipment and the MRI Capsule The MRI Capsule is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled .
  • Page 41 BD Switzerland Sàrl, Route de Crassier 17, Business Park Terre-Bonne, Batiment A4, 1262 Eysins, Switzerland bd.com BD, the BD Logo, Alaris and Guardrails are trademarks of Becton, Dickinson and Company or its affiliates. © 2019 BD. All rights reserved.

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