Drive DeVilbiss Healthcare Theia Instructions For Use Manual

Drive DeVilbiss Healthcare Theia Instructions For Use Manual

Dynamic system

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Dynamic System
Instructions for use

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Summary of Contents for Drive DeVilbiss Healthcare Theia

  • Page 1 Dynamic System Instructions for use...
  • Page 2 THEIA Pump with mattress options and cushion QUICK REFERENCE GUIDE P1 of 2 TO BE USED IN CONJUNCTION WITH THE FULL INSTRUCTIONS FOR USE FOR THIS PRODUCT. THIS QUICK GUIDE DOES NOT REPLACE THE FULL DOCUMENT. Overlay Mattress Air on Foam Mattress Dynamic Cushion The mattress is intended to support a The mattress is intended to support a...
  • Page 3 THEIA Pump with mattress options and cushion QUICK REFERENCE GUIDE P2 of 2 TO BE USED IN CONJUNCTION WITH THE FULL INSTRUCTIONS FOR USE FOR THIS PRODUCT. THIS QUICK GUIDE DOES NOT REPLACE THE FULL DOCUMENT. Transport Mode You can achieve 8 hours transport time by FIG 5.
  • Page 4: Table Of Contents

    CONTENTS 1. INTRODUCTION ................... 2. CONTACT INFORMATION ..............3. PRODUCT DESCRIPTION ..............3.1 Environment ..................... 3.2 Intended User Group................3.3 Intended Use................... 3.4 Product Overview .................. 3.5 Indications ....................3.6 Features ....................4. SAFETY ....................4.1 Warnings and Cautions ................ . 4.2 Risk Assessment ...................
  • Page 5: Introduction

    For assistance in setting up, using, maintaining your system, to report unexpected operation or for any service, warranty, sales or customer service information regarding this product please contact your provider or if in doubt contact Drive DeVilbiss Healthcare Ltd. at the following address: Drive DeVilbiss Healthcare Ltd.
  • Page 6: Product Description

    3. PRODUCT DESCRIPTION 3.1 Environment Your dynamic system is intended for use in the following environments: • A hospital where intensive/acute care is provided and medical supervision is required and monitoring provided. • A long term care area where medical supervision is required and monitoring is provided if necessary (e.g.
  • Page 7: Indications

    3.5 Indications To assist as part of an overall programme of care when active load distribution through mechanical means is required. 3.6 Features Control Unit Mattress • Bed platform securing straps • Provides an air supply to the mattress or cushion •...
  • Page 8: Contraindications

    • Product combinations (bed frame, mattress, side rails etc.). • Extent of tissue damage (if any). • Entrapment. • Patient falls. • Small adults (and children). • Patients who have reduced capacity and are agitated and/or restless. • Patients with burns. •...
  • Page 9: General Warnings

    • Modification of the mattress or control box is not allowed without the permission of Drive DeVilbiss Healthcare Ltd. – A hazard could be introduced. • Occupants and users of this equipment must never smoke in close proximity to the control unit, mattress, cushion or bedding being used with it - Risk of fire.
  • Page 10: Transport And Storage

    5. TRANSPORT AND STORAGE 5.1 Storage • Detach the control unit from the support surface. • Release CPR or rotate the CPR dial until it is open. • Lay the mattress or cushion out flat and position upside down. • Ensure there is no air trapped in the cells.
  • Page 11: Symbol Definition

    The user/occupant is protected by at least two layers of insulation between the current carrying parts (e.g. control box and mains cable) and the metal accessible parts – If damage is noticed to any electrical component, turn off at the mains and contact your provider or Drive DeVilbiss Healthcare Ltd. immediately. CE certification...
  • Page 12 Type BF applied part Applied Part: The parts of the bed that come into physical contact with the user/occupant in order for the bed to carry out its intended function (refer to section 16.2 for a list of applied parts). Type BF: Applied parts which are electrically isolated from earth and other parts of the medical equipment - Complying with specific requirements for protection against electric shock to EN 60601-1.
  • Page 13: Installation

    A CE marked extension cable must only be used when it is not Warning possible to reach a wall socket with the equipment mains cable – Contact Drive DeVilbiss Healthcare Ltd. for detail in regards to safe use of extension cables. •...
  • Page 14 Open all packaging with care. • Once removed from the packaging check the product for any signs of damage. If damaged do not put into use and contact your provider or Drive DeVilbiss Healthcare Ltd. (See Section 2). • Remove all covers, sheets and the existing mattress/cushion from the bed/ chair.
  • Page 15: Operation

    • Attach the male air connector to the control unit, ensuring the air hose does not kink or become trapped between parts of the bed frame. • Plug the mains cable into a suitable mains supply and switch on the control unit.
  • Page 16: Control Interface

    8.2 Control Interface MUTE STATIC WEIGHT RANGE LOW PRESSURE POWER FAILURE Power Button - Press to turn system ON/OFF, green light will indicate pump is ON. Comfort Control - Press to UP arrow to increase pressure and the MUTE STATIC DOWN arrow to decrease pressure, comfort setting shown in the ANGE digital display.
  • Page 17: Cpr Function

    8.3 CPR Function When there is an emergency requirement to perform CPR on the patient, pull the CPR strap at the foot end of the mattress to this will release the air quickly from the mattress. The CPR strap is located at the left-hand side of the mattress. 8.4 Low Pressure Warning When abnormal low pressure occurs, the low pressure indicator will illuminate and the audible alert will be activated to alert of a low pressure condition.
  • Page 18: Decontamination/Cleaning

    9. DECONTAMINATION/CLEANING Infection control and routine cleaning must be carried out in accordance with your local infection control policy or regulatory body. • Always disconnect the support surface and bed frame from the main power supply prior to cleaning. • The control unit is rated to IP21 and provides protection from condensation only, do not immerse or soak the control unit –...
  • Page 19: Mattress And Cushion

    Mattress and Cushion Before attempting to clean, the top cover is to be checked for physical signs of damage that may lead to strike-through (ingress of fluid through cover). This is achieved by unzipping the top cover and looking for signs of staining to the white underside.
  • Page 20: Maintenance

    • Only Drive DeVilbiss Healthcare Ltd. approved components specified for the Theia dynamic system are to be used - if in doubt contact Drive DeVilbiss Healthcare Ltd. or your local distributor. Only authorised service personnel or Drive DeVilbiss Healthcare Ltd. service engineers should carry out repairs or service activities.
  • Page 21: Disposal

    For more detailed service information, spare parts, circuit diagrams etc. please refer to the service manual. Copies are available from Drive DeVilbiss Healthcare Ltd. Contact details can be found in section 2.
  • Page 22: Specification

    12.1 18” CUSHION SPECIFICATION Classification: Electrical shock protection: Class II, Type Applied Part: Cushion Ingress protection: IP21*** Not AP or APG equipment* Supply Rating: 230V, 50 Hz, 12W Fuse Rating: Mains Plug - 5A Control Unit - T1A, 230VAC Mains plug: Type G/BS1363 Cushion Dimensions: (L) 500mm x (W) 450mm x (D) 100mm...
  • Page 23: Air On Foam Mattress Specification

    12.2 AIR ON FOAM (FULL/MAT) SPECIFICATION Classification: Electrical shock protection: Class II, Type Applied Part: Mattress Ingress protection: IP21*** Not AP or APG equipment* Supply Rating: 230V, 50 Hz, 12W Fuse Rating: Mains Plug - 5A Control Unit - T1A, 230VAC Mains plug: Type G/BS1363 Mattress Dimensions:...
  • Page 24: Overlay Mattress Specification

    12.3 OVERLAY (OVERLAY/MAT) SPECIFICATION Classification: Electrical shock protection: Class II, Type Applied Part: Mattress Ingress protection: IP21*** Not AP or APG equipment* Supply Rating: 230V, 50 Hz, 12W Fuse Rating: Mains Plug - 5A Control Unit - T1A, 230VAC Mains plug: Type G/BS1363 Mattress Dimensions: (L) 2030mm x (W) 900mm x (D) 127mm...
  • Page 25: Air On Air Mattress Specification

    13. ELECTROMAGNETIC COMPATIBILITY (EMC) The Theia is intended for use in the electromagnetic environment specified below. The customer or the user of the Theia should ensure that it is used in such an environment. The Theia control unit should not be used adjacent to or stacked with other medical electrical equipment, where viable.
  • Page 26: Hybrid Mattress Specification

    Guidance and manufacture’s declaration – electromagnetic immunity IEC 60601 test and Immunity test Electromagnetic environment - guidance compliance level Power frequency (50/60 Hz) Power frequency magnetic fields should be at magnetic field 30 A/m levels characteristic of a typical location in a typical commercial or hospital environment.
  • Page 27 Guidance and manufacture’s declaration – electromagnetic immunity IEC 60601 test level Compliance Immunity test Electromagnetic environment – guidance level Portable and mobile RF communications equipment should be used no closer to any part of the Theia control unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 28: Warranty

    (d) used in conjunction with a third party product or products not approved in advance by Drive DeVilbiss Healthcare Ltd., (e) damaged or failed by or attributes to acts of God, (f) damaged, caused by failure to follow instructions,or (g) otherwise used in a manner inconsistent with any instructions provided by Drive DeVilbiss Healthcare Ltd.
  • Page 30 1F, 3F, 4F, No. 6, East Haijing Road, Haicang Xiamen, Fujian, China Y. Sung Handelsvertretung Duesselihaler Str. 24, 40211 Duesseldorf Germany Drive DeVilbiss Healthcare Ltd. IMPORTER: Sidhil Business Park, Holmfield, Halifax, HX2 9TN, UK ORIGINAL INSTRUCTIONS INSTRUC/THEIA, 2021/02 - Rev3...

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