Arjo Auralis Instructions For Use Manual
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Arjo Auralis Instructions For Use Manual

Arjo Auralis Instructions For Use Manual

Medical alternating pressure mattress system
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INSTRUCTIONS FOR USE
Auralis
Alternating pressure system
04.AI.00EN_03 • 10/2020

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  • Page 1 INSTRUCTIONS FOR USE Auralis Alternating pressure system 04.AI.00EN_03 • 10/2020...
  • Page 2 © Arjo 2020. 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 consent of Arjo.

  • Page 3: Table Of Contents

    Parts designation - Auralis 175 and 200 mattress replacement ....... .
  • Page 4 Auralis Plus mattress extensions (accessory only) ........

  • Page 5: Foreword

    Support Routine maintenance must be performed on the Auralis system before every use or every week (if for long term use) to maintain safety and reliability of the equipment. See section Care and preventive maintenance for more information. If you require further information, please contact Arjo for comprehensive support and maintenance to maximize the long-term safety, reliability and value of the product.

  • Page 6: Intended Use For Auralis

    For the Auralis Seat Cushion, the patient weight must not exceed 200 kg (440 lb). • For the Auralis Plus mattress, the patient is within the weight range of 100 kg (220 lb) to 454 kg (1000 lb). • For the Auralis Plus mattress, the patient Body Mass Index (BMI) is >30...

  • Page 7: Safety Instructions

    Safety instructions WARNING WARNING To avoid serious injur y or death, the To avoid severe burn injur y, do not use the Auralis pump in the presence of and accessible at all times. WARNING To avoid strangulation, always use WARNING...

  • Page 8: Home Care

    IFU. When the Auralis system is in use, make sure: • The Auralis system is kept away from sources of heat and moisture, and protected from dust, lint and dirt. • The Auralis system is not covered.

  • Page 9: Preparations

    The Auralis Plus mattress is designed to be used with the Arjo Citadel Plus bed frame. The Auralis mattress range (narrow, standard and Plus) may also be used with other bed frames (Arjo or non- Arjo). An assessment should be made by clinician or caregiver to determine which mattress and bed frame combination to use.

  • Page 10: After Each Patient

    Actions before every use (2 steps) 2. If any item is damaged - do NOT use the product. After each patient The position of the caregiver The caregiver should be positioned in front of the pump during operation. See Figure 1 Figure 1 HOME CARE...
  • Page 11 Intentionally left blank HOME CARE...

  • Page 12: Parts Designation - Auralis Pump

    Parts designation - Auralis pump 1. Control panel (with indicators) 4. Connector socket 2. Alarm indicators 5. Skin IQ port 3. Power cable 6. Hanging brackets Control panel - buttons and indicators 1. Run/Standby button and indicator 7. Low battery indicator 2.

  • Page 13: Parts Designation - Auralis 110 Mattress Overlay

    Parts designation - Auralis 110 mattress overlay 2. Detachable cover 3. Cover attachment zip 4. Cells (quantity) • Head cells (3) • Torso cells (12) • Heelguard™ cells (5) 5. Loop straps 6. Heelguard™ cell straps 7. Cell hooks 8. Overlay base cover (including micro air loss system) 9.

  • Page 14: Parts Designation - Auralis 175 And 200 Mattress Replacement

    8. Non-slip base with: Foam underlay (mattress 175) 9. Securing straps (four on each side) 10. Overlay base (including micro air loss system) 11. Overlay zip 12. Tube-set 13. Connector 14. Cable management PARTS DESIGNATION - AURALIS 175 AND 200 MATTRESS REPLACEMENT...

  • Page 15: Parts Designation - Auralis Plus Mattress Replacement

    Heelguard™ cells (6) 14. Bolster sleeve (x2) 15. Air channel 5. Loop straps 16. Foot extension sleeve 6. Heelguard™ cell straps 17. Bolster Valve (under valve symbol x2) 7. Cell hooks 18. CPR Tag mattress PARTS DESIGNATION - AURALIS PLUS MATTRESS REPLACEMENT...

  • Page 16: Parts Designation - Auralis Seat Cushion

    Parts designation - Auralis seat cushion 1. Detachable cover 2. Cover attachment zip 3. Alternating cells 4. Tube-set 5. Connector 7. Fixing straps 8. Non-slip base PARTS DESIGNATION - AURALIS SEAT CUSHION...

  • Page 17: Product Description - Auralis Pump

    Run mode - press the button once. The indicator Figure 2 Standby mode - press the button for two seconds.The NOTE To turn the Auralis pump off during power failure or battery operation, press the Run/Standby button for four seconds. Wait indicator...
  • Page 18 The Reactive CLP mode (see Figure 6) maintains a constant lower pressure in all the cells. When activated the indicator is shown. The Auralis seat cushion does not have Reactive CLP mode. Comfort control buttons and indicators The Comfort control buttons (see Figure 7) set the comfort level by adjusting the pressure within the support surface.
  • Page 19 1 hour battery life left. The alarm can be muted (see Mute alarm button). When there is less than 15 minutes of battery life left, the Auralis pump enters the Reactive CLP mode. At this point, the audible alarm cannot be muted.

  • Page 20: Alarm Indicators

    Alarm indicators The power and alarm indicators are located on the top (the control panel) and front of the Auralis pump. The alarm indicators shown on the front of the pump are green when the pump is operating normally and yellow when there is an alarm condition.

  • Page 21: Product Description - Auralis Mattresses

    The Heelguard™ cells help to keep the pressure in the heel area lower for longer. Figure 18 Cell hooks The cell hooks attach the cells to the Auralis mattress base. Tube-set The tube-set is anti-kink and not removable from the Auralis mattresses.

  • Page 22: Cable Management

    Figure 20 Auralis 110 mattress overlay The Auralis 110 mattress is an overlay and is placed on top of an existing bed mattress. Fixing straps (Auralis 110 mattress overlay) four corners of an existing bed mattress and prevent the Auralis 110 mattress overlay from sliding off.

  • Page 23: Securing Straps

    This allows the mattress replacements to be attached to different types of bed frames. In addition, Auralis to avoid mattress movement due to the increased patient weight.

  • Page 24: Product Description - Auralis Seat Cushion

    The detachable cover is attached by a zip. Alternating cells The seat cushion cells provide alternating support to the patient. The Auralis seat cushion can only be used with Alternating mode. Fixing straps from falling off a chair with an open construction or removable seat cushion.
  • Page 25 In the event of the patient suffering a cardiac activated: buttons simultaneously. See Figure 25 unit is open. See Figure 26 Figure 25 the main body of the mattress in 15 seconds. unit unit until it clicks into place. See Figure 27 Figure 26 Figure 27 CPR RAPID DEFLATION UNIT...

  • Page 26: Assemble The Auralis System

    Auralis mattress with the protective Figure 29 top cover. Place the detachable cover over the Auralis mattress overlay with the Arjo logo visible and located at the foot end of the Auralis mattress. Continue with steps on the next page. ASSEMBLE THE AURALIS SYSTEM...

  • Page 27: Auralis 175, 200 And Plus Mattress Replacement

    5. Zip the cover onto the Auralis mattress overlay, start from the head end. Do not trap any material in the zip. Make sure the zip is fully closed. closed position. (See Figure 30.) The CPR rapid Auralis 175, 200 and Plus mattress...

  • Page 28: Auralis Pump

    (Auralis Plus mattress only.) See Figure 34. Auralis pump (7 steps) Figure 34 1. Hang the Auralis pump at the foot end of the bed. See Figure 35 Make sure the pump is not: • near a heat source •...

  • Page 29: Auralis Plus Mattress Extensions (Accessory Only)

    5. Place the cable in the cable management. studs. See Figure 37 7. Connect the power cable to a power source. Auralis Plus mattress extensions (accessory only) (5 steps) The mattress extensions are intended to be used when the bed frame is operated in fully extended length mode.

  • Page 30: Auralis Seat Cushion

    Check that there are no sharp objects Figure 40 on the chair which may puncture the seat cushion. Place the Auralis seat cushion on top of the chair seat. From a position of standing and facing the front of the chair, make sure: •...
  • Page 31 Place the protective cover over the Auralis seat cushion. Make sure the Arjo logo is visible at the front part of the seat. 4. Zip the cover onto the Auralis seat cushion. Do not trap any material in the zip. Make sure the zip is fully closed.

  • Page 32: Start The Auralis System

    The Auralis Plus mattress takes approximately 17 2. When the Auralis head end of the bed. 3. Place the patient on the Auralis mattress with the head at the head end and the feet at the foot end. See Figure 46...
  • Page 33 360 kg (793 lb). (Auralis Plus only) If there is a power failure, the Auralis pump enters Battery mode. If the Auralis pump is fully charged the Auralis pump offers a minimum of 3 hours operational use.

  • Page 34: Select Mode

    Extend (1 step) • mode by 5 minutes. times. For further extension repeat step 1. If not extended, the Auralis pump goes back to the previous mode by default. Deactivate of the other modes. Alternating mode, default setting Activate (1 step) •...

  • Page 35: Reactive Clp Mode

    The Reactive CLP mode indicator is shown. Deactivate Figure 50 To deactivate Reactive CLP mode, select either therapy is required, remove patient from the surface and turn off the Auralis pump. Lock out mode Locking • Push and hold Comfort control Positive (+) and Comfort control Negative (–) buttons at the same...

  • Page 36: Transport Mode

    To avoid entanglement when the Auralis pump is in Transport mode, make sure that the tube-set connector is stowed appropriately. NOTE There is no Transport mode on the Auralis seat Figure 53 cushion. Deactivate To deactivate the Transport mode, connect the tube- set.
  • Page 37 through narrow openings. 1. Locate the valve symbol on the bottom of the mattress. See Figure 55 2. Turn the valve (under the valve symbol) on the bolster fully clockwise. See Figure 56 3. Repeat on the other bolster, if required. NOTE Figure 55 bed frame into its narrowest form.

  • Page 38: Turn Off And Store The Auralis System

    1. Press the Run/Standby button for 2 seconds. The Auralis pump enters Standby mode. 2. Disconnect the power cable from the power source. 3. To turn off the Auralis pump completely, press the Run/Standby button for 4 seconds until a double beep is heard. Figure 58...

  • Page 39: Store The Auralis Pump

    1. Clean and disinfect the Auralis pump according to page 40. 2. Wrap the power cable around the hanging brackets. See Figure 62 3. Store the Auralis pump in a designated area, in Figure 62 TURN OFF AND STORE THE AURALIS SYSTEM...

  • Page 40: Cleaning And Disinfection Instructions

    Cleaning and disinfection instructions The Auralis system should be routinely cleaned and disinfected after each patient and at regular intervals while in use, as local practice for all reusable medical devices. If there are any questions regarding cleaning and disinfecting the equipment contact Arjo Customer Service.

  • Page 41: Cleaning And Disinfection

    Auralis pump. 9. Remove any excess moisture by wiping over with a dry cloth. 10. Allow the Auralis pump to air dry before reuse. Clean the Auralis mattress / seat cushion 11. Spray all external areas of the Auralis mattress/...
  • Page 42 13. Use water and a new cloth to wipe off all traces of cleaning solution, followed by a dry cloth to remove any excess moisture. 14. If it is necessary to clean the inside of the Auralis mattress/ Auralis seat cushion, unzip the top cover to access the internal components.
  • Page 43 27. Allow the internal components to air dry before reattaching the top cover of the mattress. 28. If required, the straps and base of the Auralis mattress/seat cushion can also be cleaned using the same method as above. Unclip the straps before cleaning for ease of access.

  • Page 44: Care And Preventive Maintenance

    Expected service life The Auralis pump has an expected service life of 7 years. To maintain the condition of the Auralis pump, the Auralis pump must be serviced regularly according to the schedule recommended by Arjo. CARE AND PREVENTIVE MAINTENANCE...
  • Page 45 Visually check all cell hooks Auralis system Visually check all labels Perform a full functionality test on the Auralis system Auralis Plus mattress extension (accessory only) Visually check the top cover Visually check the foam core Visually check all labels...

  • Page 46: Clean And Disinfect

    See Figure 63 Perform a full functionality test on the Auralis system (6 steps) 1. Connect the tube-set to the Auralis pump. Make sure the tube-set clicks into place. 2. Connect the power cable to a power source. The Auralis pump sounds with a start-up tone and a self-diagnostic check runs for 10 seconds.

  • Page 47: Visually Check All Labels

    Visually check all labels Check that all labels are attached on the Auralis system according to section Labels on page 56 and Labels on Auralis mattresses, Auralis seat cushion and Auralis mattress extensions (accessory only) Labels on Auralis mattresses, Auralis seat cushion and Auralis mattress extensions on page 58.

  • Page 48: Troubleshooting And Alarms

    3. Check the valves on the mattress is not closed. seat cushion. WAIT 4. Check that the tube-set 3. The valves on the Auralis connector is correctly seat cushion are not connected to the Auralis closed. pump - an audible click 4.
  • Page 49 1. The Auralis seat cushion 1. Disconnect the Auralis seat Not applicable does not is in use. cushion. activate only applies to the Auralis 2. The Auralis mattress is in mattresses. use. button for 2 seconds. Continue on the next page. TROUBLESHOOTING AND ALARMS...
  • Page 50 The top and bottom Comfort simultaneously. Pump is now unlocked. OVER The Auralis pump is operating 1. Turn off the Auralis pump. 10 seconds TEMPERATURE outside its temperature range 2. Disconnect the power cable. and has entered the transport 3.
  • Page 51 Intentionally left blank TROUBLESHOOTING AND ALARMS...
  • Page 52 If the Auralis pump is stored in conditions outside the operating ranges, allow time for its temperature to stabilise to normal before use. Allow a minimum of 8 hours if the Auralis pump is stored at -20 °C or 60 °C.
  • Page 53 Temperature (Ambient) 0 °C to 40 °C (32 °F to 104 °F) Relative humidity range 0 % to 95 % (non-condensing) CAUTION To avoid damage to the Auralis system: • Do not store the Auralis system in direct sunlight. •...
  • Page 54 Chlorine concentrations may vary from 250 ppm to 10,000 ppm depending on local policy and contamination status. If an alternative disinfectant is selected from the wide variety available, Arjo recommend that suitability TECHNICAL SPECIFICATIONS...
  • Page 55 STANDARDS/CERTIFICATE DESCRIPTION IEC 60601-1 3.1 edition Medical Electrical Equipment – Part 1 : General requirements for basic safety and essential performance. IEC 60601-1-11:2015 Medical Electrical Equipment – Part 1-11 : General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-2:2014 (4th EMC Edition)

  • Page 56: Labels

    Labels Labels on the Auralis Pump LABEL EXPLANATION LABEL EXPLANATION Product label Product label States technical performance and requirements, e.g. input power and States technical performance and requirements, e.g. input power and input voltage. input voltage. Serial number label Serial number label...
  • Page 57 SYMBOL EXPLANATION Read the Instructions for use before use. CE marking indicating conformity with European Community harmonised Indicates the product is a Medical Device according to EU Medical Device Regulation 2017/745. accordance with CAN/CSA-C22.2 No.60601.1 (2008) + (2014) and ANSI/ AAMI ES60601-1 (2005)+AMD(2012).
  • Page 58 Labels on Auralis mattresses, Auralis seat cushion and Auralis mattress extensions LABEL EXPLANATION Serial number label Top cover label Care and cleaning label States the washing conditions Law tag (US and Canada only) Example of mattress Law tag, if applicable...
  • Page 59 (lb) Product weight (Auralis mattresses) = kg (lb) Product weight (Auralis seat cushion) Recommended wash temperature: 15 min at 60 °C (140 °F) Max wash temperature: 15 min at 95 °C (203 °F) Tumble dry at 80 °C (176 °F) Maximum drying temperature: 80 °C (176 °F)

  • Page 60: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) the user of the Auralis system should assure that it is used in such an environment. Electromagnetic Compatibility (EMC) This product complies with the requirements of applicable EMC Standards. Medical electrical equipment needs special precautions regarding EMC and needs to be installed in accordance with the following instructions: •...
  • Page 61 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS (EMI) of the Auralis pump should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Auralis pump uses RF energy only for its internal function.
  • Page 62 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY The Auralis the user of the Auralis pump should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance level Electromagentic environment - guidance level Conducted RF 3Vrms 6Vrms ISM,...
  • Page 63 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE PUMP The Auralis pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Auralis pump can help prevent electromagnetic interference...
  • Page 64 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY the user of the Auralis pump should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic ± 8 kV contact ±...

  • Page 65: Parts And Accessories

    Parts and accessories Auralis Plus Long mattress extension Accessory Auralis Plus Short mattress extension Accessory 636614 636615 Coiled Skin IQ power cable 636377 PARTS AND ACCESSORIES...
  • Page 66 Intentionally left blank PARTS AND ACCESSORIES...
  • Page 67 AUSTRALIA FRANCE POLSKA Arjo Australia Arjo SAS Arjo Polska Sp. z o.o. Building B, Level 3 2 Avenue Alcide de Gasperi ul. Ks Piotra Wawrzyniaka 2 11 Talavera Road CS 70133 PL-62-052 KOMORNIKI (Pozna ) Macquarie Park, NSW, 2113, FR-59436 RONCQ CEDEX...
  • Page 68 At Arjo, we are committed to improving the everyday lives of people affected by reduced mobility and age-related health challenges. With products and solutions that ensure ergonomic patient handling, personal hygiene, disinfection, diagnostics, and the effective prevention of pressure ulcers and venous thromboembolism, we help professionals across care environments to continually raise...

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