Arjohuntleigh Malibu Instructions For Use Manual
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Arjohuntleigh Malibu Instructions For Use Manual

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Malibu / Sovereign
Instructions for Use
04.AZ.00_14GB • 12/2018
...with people in mind

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Summary of Contents for Arjohuntleigh Malibu

  • Page 1 Malibu / Sovereign Instructions for Use 04.AZ.00_14GB • 12/2018 ...with people in mind...
  • Page 2 Mandatory to read the Instructions for Use Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. © ArjoHuntleigh 2014. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.The content of this publication may not be copied either whole or in part without the...

  • Page 3: Table Of Contents

    Cleaning and Disinfection Instructions ........30 Care and Preventive Maintenance .......... 37 Troubleshooting ..............42 Technical Specifications ............44 Labels ..................48 List of Standards and Certificates ........... 50 Electromagnetic Compatibility ..........52 Parts and Accessories ............55 ArjoHuntleigh Addresses ..........Last page...

  • Page 4: Foreword

    Thank You for Purchasing Service and Support ArjoHuntleigh Equipment A service routine has to be done on the Malibu/Sovereign Your Malibu/Sovereign® bath is part of a bathing system to make sure the safety and operating series of quality products designed especially procedures of your product.

  • Page 5: Intended Use

    (optional) is intended for indoor use only. position. • The resident’s length must be in the range of 140 Malibu/Sovereign must be used by appropriately and 200 cm (4’ 7” - 6’ 6”). trained caregivers with adequate knowledge of the care environment, its common practices and...

  • Page 6: Safety Instructions

    Safety Instructions WARNING WARNING To avoid falling, make sure that the patient To prevent cross-contamination, always is positioned in accordance with this IFU. follow the disinfection instructions in this Instructions for Use. WARNING WARNING To avoid entrapment, make sure the path of the movement is free from obstacles.

  • Page 7: Preparations

    Actions Before the First Use this Instructions for Use. (9 steps) Before every use, make sure the Malibu/ 1 Make sure that the bath has been installed Sovereign bath is cleaned and disinfected according to the Assembly and Installation according to section Cleaning and Disinfection Instructions.

  • Page 8: Parts Designation

    Parts Designation 1 Bathtub Malibu/Sovereign bath 19 Water level sensors 2 Control panel (Basic and Assisted) 20 Hand control holder A) Mains power indicator 21 Transfer chair with commode seat and wheel chassis (optional) B) Battery level 22 Transfer chair with comfort seat and wheel...
  • Page 9 • 1 1 1 Basic Assisted 1 1 1 1 Malibu bath Sovereign bath...

  • Page 10: Product Description/Functions

    Product Description/Functions Control Panel Fig. 1 Lower/Raise bathtub WARNING To avoid the device in use from tipping, do not raise or lower other equipment close to it and be aware of stationary object when lowering. Push and hold Lower bathtub (A) to lower the bathtub. Push and hold Raise bathtub (B) to raise the bathtub.

  • Page 11: Battery Back-Up

    If the battery fails to work during a power failure contact your ArjoHuntleigh technician. The battery must be checked and replaces according to section Care and Preventive Maintenance on page 37. The battery must be replaced by ArjoHuntleigh technician only. Battery Charge Level Fig. 1...

  • Page 12: Auto Flush Function

    Auto Flush Function The bath is equipped with an auto flush function that prevents stagnating water in the shower system. The auto flush function will start 30 hours after the last use of the bathtub and then every 24 hours if the bathtub is not used. NOTE Do not leave the bathtub with the emergency stop pressed down since it will disable the auto flush...

  • Page 13: Attach And Remove The Seat

    Attach and Remove the Seat Attach (4 steps) (See Fig. 1) 1 With both hands start pushing the front end of the seat against the front frame. 2 Push down the bent part of the seat. 3 Push one side around the arm rest and make sure it snaps into place.

  • Page 14: Auto Fill Function

    Auto Fill Function The Malibu/Sovereign bath is equipped with an auto fill function, which is preset to one water level (approximately 230 mm (9”) depth). • Activate it by pushing the auto fill button. • Once the filling level is reached it stops by itself.

  • Page 15: Safety Belt

    Safety Belt WARNING To prevent the patient from falling, make sure the Fig. 1 safety belts are undamaged. If damaged, do NOT use the safety belts, replace with new ones before use. WARNING To avoid falling, make sure that the patient is positioned correctly and that the safety belt is being used, properly fastened and tightened.
  • Page 16 2 Loosen the safety belt by pulling the inner strap (A) at the Fig. 6 side and at the same time lifting the larger fastening clip (B). (See Fig. 6) 3 Tighten the safety belt by pulling the outer strap (A) at the Fig.

  • Page 17: Disinfection Unit

    Disinfection Unit Fig. 1 • WARNING To prevent cross-contamination, always follow the disinfection instructions in this Instructions for Use. The disinfection unit is located behind the cover of the front panel. The disinfectant bottle is located behind a key lock inside the disinfection compartment.

  • Page 18: Transfer Chair

    Transfer Chair WARNING To avoid entrapment, make sure to keep the patients hair, arms and feet close to the body and Fig. 1 use designated grab supports during any movement. WARNING To avoid the patient from falling out of the device, make sure that all catches are in a locked position.

  • Page 19: Air Spa System Operation (Option)

    15 minutes. • The Air Spa system has two different intensity settings. Air Spa system outlets on the Malibu/Sovereign bath bathtub Fig. 2 Air Spa system outlets on the Sovereign bath bathtub How to use the Air Spa System (3 steps) 1 Push the Air Spa system ON/OFF button on the control panel and the air blower will start at minimum speed.

  • Page 20: Connect/Disconnect The Transfer Chair

    Connect/Disconnect the Transfer Chair Connect Detachable Transfer Chair to the Lift Fig. 1 Arm (7 steps) 1 Set the bathtub in its lowest position by pushing Lower bathtub on the control panel. 2 Push the Lift out button on the hand control to have the lift arm positioned outside the bathtub.
  • Page 21 Disconnect Detachable Transfer Chair from Fig. 1 the Lift Arm (12 steps) 1 Set the bathtub in its lowest position by pushing Lower bathtub on the control panel. 2 Push the Lift out button on the hand control to have the lift arm position the transfer chair outside the bathtub.
  • Page 22 7 Wiggle to wheel chassis back and forth to make sure it is Fig. 4 securely attached. (See Fig. 4) 8 Continue lowering the chair. WARNING To avoid falling, the wheeled chassis castors must be unlocked when detaching the transfer chair from the lift arm. 10 Lower the chair by pushing the Lift out button and stop lowering once castors on the wheel chassis touches the floor.

  • Page 23: Assisted Bathing With Transfer Chair

    (See Fig. 3) 4 Apply the brakes on the wheel chassis. Position the patient Fig.4 on the Malibu/Sovereign bath transfer chair either by a standing and raising aid or by wheelchair. (See Fig. 4) Continue with the steps on the next page.
  • Page 24 5 Unlock the castors on the wheel chassis. 6 Position the seated patient on the transfer chair with the Fig. 5 wheel chassis next to the lift arm. (See Fig. 5) WARNING To avoid entrapment of the patients or caregivers legs or feet, make sure that they are kept clear of all obstacles.
  • Page 25 13 Pull out the spring loaded catch to release the wheel chassis Fig. 7 from the transfer chair and at the same time slide out the wheel chassis sideways from the chair. (See Fig. 7 and 8) WARNING To avoid entrapment or pinching of genitals, make sure there is enough clearance during movement over the tub edge, toilet, bedpan or other furniture.
  • Page 26 From Bath (16 steps) WARNING To avoid falling, make sure that the patient is positioned correctly and that the safety belt is being used, properly fastened and tightened. WARNING To avoid falling during transfer, always make sure that the brakes are applied on all equipment being used.
  • Page 27 8 Make sure the spring load catch in the back of the chair Fig. 3 clicks into place. Listen for the click sound when inserting the wheel chassis. (See Fig. 3) 9 Wiggle to wheel chassis back and forth to make sure it is Fig.

  • Page 28: Home Care Use

    Home Care Use For Distributors and Renters Use the Malibu/Sovereign bath When transporting the Malibu/Sovereign bath to Before using the Malibu/Sovereign bath in home the customer with a van: environment make sure that: • Make sure the bath is properly secured during •...
  • Page 29 Space Requirements around the Bath The Malibu/Sovereign bath must always be installed according to recommended space requirements, this to provide optimal working conditions for personnel and patient. • NOTE Fig. 1 Fig. 2...

  • Page 30: Cleaning And Disinfection Instructions

    Accessories for Disinfecting the Thorough disinfection routines are necessary to stop the build-up of bacteria on the equipment. Malibu/Sovereign bath This is particularly vital in cases where the Malibu/ • Protective glasses Sovereign bath is in a shared facility. Effective disinfection as outlined below reduces the •...
  • Page 31 Clean and disinfect the bathtub according to the IFU before the first bath of the day and after the bath of each patient. Do not forget to contact ArjoHuntleigh for the annual Preventive Maintenance visit. 7 Make sure to close the disinfection cover after use, to prevent the patient getting their feet hurt during lowering of the chair.
  • Page 32 Clean and Disinfect with Spray Bottle (30 Steps) Remove visual residue (Step 1-7 of 30) 1 Raise bathtub to convenient working position. 2 Make sure all functions are turned off. 3 Open drain to empty any left over water. 4 Detach and place the loose parts such as armrests, seat of the Fig.
  • Page 33 16 Soak a cloth in disinfectant. 17 Wipe all other contact areas such as the outside of the bathtub (particularly behind the head), metal sensory knobs, the hand control and the wheel chassis (optional) with the cloth. 18 Wet a new cloth with water and remove all traces of disinfectant on contact areas.
  • Page 34 Clean and Disinfect with Disinfection Unit – with or without Air Spa System (40 Steps) Remove visual residue (Step 1-7 of 40) 1 Raise bathtub to convenient working position. 2 Make sure all functions are turned off. 3 Open drain to empty any left over water. 4 Detach and place the loose parts such as arm rests, seat of Fig.
  • Page 35 14 Make sure the flow meter shows the right mix ratio as stated Fig. 5 in the IFU, adjust if needed. Lower the water temperature to approximately 20 °C (68 °F). (See Fig. 5) 15 Spray/shower disinfectant in drain. Use a long handled brush to scrub drain.
  • Page 36 Disinfect (Step 25-40 of 40) 25 Direct the disinfection spray handle towards the drain and spray disinfectant in the drain. 26 Close the drain. 27 Disinfect by spraying disinfectant on all internal bathtub surfaces, lift arm, transfer chair and the loose parts and accessories at the bottom of the bathtub.

  • Page 37: Care And Preventive Maintenance

    Care and Preventive Maintenance The Malibu/Sovereign bath is subject to wear and tear, and the following actions must be per- formed when specified to make sure that the product remains within its original manufacturing specification. WARNING To avoid malfunction resulting in injury, make sure to conduct regular inspections and follow the recommended maintenance schedule.

  • Page 38: Clean And Disinfect

    Malibu/Sovereign bath knowledge following the instructions in this IFU. Between Patients • Clean and disinfect: Before every use, make sure the Malibu/Sovereign bath is cleaned and disinfected according to section Cleaning and Disinfection Instructions on page 30. Every Week •...

  • Page 39: Check Hand Control And Cable

    • Check hand control and cable: Fig. 4 Visually check the condition of the hand control and its cable. If found cut or damaged, replace it. (See Fig. 4) • Check castors on wheel chassis: Fig. 5 Check that the castors are properly fixed and are rolling and swivelling freely, (the function can be affected by soap, hair, dust and chemicals from floor cleaning).

  • Page 40: Check/Clean Filters, Incoming Water

    Every Month • Test the thermostatic mixer Fig. 1 Turn the temperature control back and forth over the entire temperature range with water on. This is particularly important in areas with hard water. (See Fig. 1) • Check/clean filters for incoming water: WARNING Pressurised system and risk of scalding.

  • Page 41: Yearly Checks By Qualified Personnel Only

    Yearly Checks by Qualified Personnel Only The Malibu/Sovereign bath must be serviced once a year in accordance with the Maintenance and Repair Manual. Contact your local ArjoHuntleigh service representative to sign for a service agreement. WARNING To avoid injury and/or unsafe product, the...

  • Page 42: Troubleshooting

    NOTE Before starting the troubleshooting check: Power supply, Water supply and the LEDs on control panel. If the problem can not be solved with the problem solving actions below, please contact an ArjoHuntleigh authorized technician. PROBLEM ACTION Nothing happens when pushing a button. Check that the emergency stop button is not pushed down, reset until it pops-up.
  • Page 43 ALARM ACTION The LED on button flashes green when Disinfectant bottle is empty, replace. pushing the disinfection button. The battery level LED is showing a steady This means that mains is off and battery is low. yellow light and beeping sound is heard 1 Continue bath if started.

  • Page 44: Technical Specifications

    Technical Specifications A full technical description of the Malibu can be found in the service documentation, please contact ArjoHuntleigh for a copy. Contact information appears on the last page of this IFU. General SWL (Safety working Load) (patient + water)
  • Page 45 Bathtub lowering time (full load) 25 ± 5 s Lifting stroke (lift arm) 530 mm (20 7/8”) / 580 mm (23”) Malibu/Sovereign bath Cyclic time for lift arm movement 65 ± 5 s (up-turn-down, full load) Maximum duty cycle: Lift actuator...
  • Page 46 This requirement applies in the European Union. Do not dispose these products as unsorted municipal waste. You can return your device and accessories to ArjoHuntleigh or you can contact your local authorities for advice on disposal.
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  • Page 48: Labels

    Labels Label explanation Expiration date for the seat: year and month. Applied Part Type B, Applied part: protection against electrical shock in Safe working load accordance with IEC 60601-1. Max Patient Maximum weight of the patient. Attention Important user information for Weight Label correct use.
  • Page 49 Data Label for Arm Rest Data Label for Seat Data Label for Attention Label Wheel Chassis Attention Label Equipotential Bonding Data Label for Applied Part Approval Label Wheel Chassis Data Label for Data Label Bathtub/Lift (EU) Bathtub/Lift (US) Identification Label...

  • Page 50: List Of Standards And Certificates

    List of Standards and Certificates STANDARDS/CERTIFICATES DESCRIPTION EN/IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance AMD1:2012 ANSI/AAMI ES60601-1 (2005) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance AMD 1 (2012) CAN/CSA-C22.2 No.
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  • Page 52: Electromagnetic Compatibility

    (electromagnetic interference) from external sources. Some procedures can help reduce electromagnetic interferences: • Use only ArjoHuntleigh cables and spare parts to avoid increased emissions or decreased immunity which can compromise the correct functioning of the equipment. • Ensure that other devices in patient-monitoring and/or life-support areas comply to accepted emissions standards.
  • Page 53 Guidance and manufacturer’s declaration – electromagnetic immunity Electromagnetic Immunity test IEC 60601-1-2 test level Compliance level environment – guidance Electrostatic ±2kV, ±4kV, ±8kV, ±15kV air ±2kV, ±4kV, ±8kV, ±15kV air Floors should be wood, discharge (ESD) concrete or ceramic tile. ±8kV contact ±8kV contact EN 61000-4-2...
  • Page 54 Guidance and manufacturer’s declaration – electromagnetic immunity Electromagnetic Immunity test IEC 60601-1-2 test level Compliance level environment – guidance Voltage dips, 0% UT; 0,5 cycle 0% UT; 0,5 cycle short At 0°, 45°, 90°, 135°, 180°, At 0°, 45°, 90°, 135°, 180°, interruptions and 225°, 270°...

  • Page 55: Parts And Accessories

    Parts and Accessories ArjoHuntleigh Arjo Clean For disinfectant contact local Chair seat (commode and comfort) ArjoHuntleigh representative Safety belt Neck support 8664559...
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  • Page 59 Fax: + 61 89337 9077 E-mail: info.france@arjo.com PORTUGAL BELGIQUE / BELGIË HONG KONG Arjo em Portugal Arjo NV/SA ArjoHuntleigh (Hong Kong) Limited MAQUET Portugal, Lda. Evenbroekveld 16 Room 411-414, 4/F, Manhattan Centre, (Distribudor Exclusivo) BE-9420 ERPE-MERE 8 Kwai Cheong Road, Kwai Chung, N.T., Rua Poeta Bocage n.º...
  • Page 60 Hans Michelsensgatan 10 211 20 Malmö, Sweden www.arjohuntleigh.com ArjoHuntleigh is a world-leading provider of integrated products and solutions that improve the lives of patients and residents with reduced mobility. We help healthcare facilities deliver wellness and effective everyday care, early mobilisation, safe patient handling, venous thromboembolism prevention, pressure injury prevention, hygiene routines, bariatric care and diagnostics.

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