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

Arjo Auralis Instructions For Use Manual

Alternating pressure system
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INSTRUCTIONS FOR USE
Auralis
Alternating pressure system
04.AI.00EN_08 • 2024-08

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Summary of Contents for Arjo Auralis

  • Page 1 INSTRUCTIONS FOR USE Auralis Alternating pressure system 04.AI.00EN_08 • 2024-08...
  • Page 2 © Arjo 2024. 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

    Contents Foreword...............................5 Intended use..............................6 Safety instructions............................7 Home care..............................8 Preparations..............................9 Parts designation - pump.......................... 10 Parts designation - 110 mattress overlay....................11 Parts designation - 175 and 200 mattress replacement................. 12 Parts designation - Plus mattress replacement..................13 Parts designation - seat cushion......................14 Product description - Pump........................
  • Page 4 Alternating cells............................22 Fixing straps.............................. 22 Non-slip base............................22 Deflation valves............................22 Tube-set..............................22 Connector..............................22 CPR rapid deflation unit..........................23 Activate the CPR rapid deflation....................... 23 Deactivate the CPR rapid deflation......................23 Assemble the system..........................24 Assemble the 110 mattress overlay......................24 Assemble the 175, 200 and Plus mattress replacement................
  • Page 5: Foreword

    Caution means: Failure to follow these For questions regarding this product or other instructions may cause damage to all or parts of Arjo products and services, contact Arjo, an Arjo the system or product. authorised representative or visit www.arjo.com. NOTE...
  • Page 6: Intended Use

    If existing wounds do not and mobility needs and may be better suited to a improve, or the patient’s condition changes, the system with a higher weight limit such as Auralis overall therapy regimen should be reviewed by Plus mattress.
  • Page 7: Safety Instructions

    Safety instructions WARNING WARNING To prevent injury, always read these To avoid reduced benefits from the Instructions for use and accompanied mattress, do not place extra layers documents before using the product. between the patient and the mattress. WARNING WARNING To prevent risks of injury, the power To prevent injury and/or unsafe source should always be accessible.
  • Page 8: Home Care

    Home care WARNING WARNING To prevent injury to the patient when To prevent choking, never leave operating the system as a caregiver and children unattended near the product. as a lay person: The product includes small parts that may present a choking hazard to small •...
  • Page 9: Preparations

    Arjo Citadel Plus bed frame. pump during operation. The 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: Parts Designation - Pump

    Parts designation - 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 11: Parts Designation - 110 Mattress Overlay

    Parts designation - 110 mattress overlay 1. CPR rapid deflation unit ® 6. Heelguard cell straps 2. Detachable cover 7. Cell hooks 3. Cover attachment zip 8. Overlay base cover (including micro air loss system) 4. Cells (quantity): 9. Fixing straps Head cells (3) 10.
  • Page 12: Parts Designation - 175 And 200 Mattress Replacement

    Parts designation - 175 and 200 mattress replacement 1. CPR rapid deflation unit 8. Non-slip base with foam underlay (mattress 175) or air filled zoned sub-mattress (mattress 2. Detachable cover 200) 3. Cover attachment zip 9. Securing straps (four on each side) 4.
  • Page 13: Parts Designation - Plus Mattress Replacement

    Parts designation - Plus mattress replacement 1. CPR rapid deflation unit 10. Bolster sleeve (x2) 2. Detachable cover 11. Non-slip base with air filled zoned sub- mattress 3. Cover attachment zip 12. Securing straps (four on each side and three 4.
  • Page 14: Parts Designation - Seat Cushion

    Parts designation - seat cushion 1. Detachable cover 5. Connector 2. Cover attachment zip 6. Deflation valves 3. Alternating cells 7. Fixing straps 4. Tube-set 8. Non-slip base PARTS DESIGNATION - SEAT CUSHION...
  • Page 15: Product Description - Pump

    Product description - Pump Autofirm mode button NOTE The Autofirm mode inflates the mattress to There are three different indicator a temporary firm surface allowing the nursing colours: procedures to be performed. • Green indicators are functions • Yellow indicators are information signals or alarms •...
  • Page 16 Comfort control buttons and indicators Mute alarm button The Comfort control buttons set the comfort level When the Mute alarm button is activated the by adjusting the pressure within the support indicator is shown and the audible alarm is surface. The Comfort control indicators indicate silenced for 15 minutes.
  • Page 17: Alarm Indicators

    Low battery indicator If the mattress or seat cushion is disconnected The single (top) indicator is shown and an audible while in use, the Low Pressure indicator is shown alarm sounds when there is a minimum of 1 hour after 30 seconds. When the indicator is shown, battery life left.
  • Page 18: Power Cable

    Power cable The power cable must be positioned in the cable management on the left side of the mattress. See section Cable management on page 19. Skin IQ port This port is only to be used with Skin IQ. To power Skin IQ directly from the pump, a coiled Skin IQ power cable is needed.
  • Page 19: Product Description - Mattresses

    ® • 6 foot cells with Heelguard , alternating/CLP To prevent tripping or strangulation, (Auralis Plus) always use the cable management for Loop straps the power cable. The loop straps keep the cells aligned and in 1. Open the cable management on the opposite place.
  • Page 20: Micro Air Loss System

    3. Close the flap around the cable with the press Securing straps studs. The 175, 200 and Plus mattress replacements have eight securing straps that can be moved to any of the ten anchor points on the base of the mattress.
  • Page 21: Mattress Extension (Plus Mattress Only)

    Mattress extension (Plus mattress only) Two sizes of mattress extensions are available as accessories, see section Parts and accessories on page 58. They can be placed at the foot of the bed. See section Assemble Plus mattress extensions (accessory only) on page 27. PRODUCT DESCRIPTION - MATTRESSES...
  • Page 22: Product Description - Seat Cushion

    Product description - Seat cushion Detachable cover Connector The detachable cover is attached by a zip. The connector is clicked in to place into the connector socket. Alternating cells The seat cushion cells provide alternating support to the patient. The seat cushion can only be used with Alternating mode.
  • Page 23: Cpr Rapid Deflation Unit

    CPR rapid deflation unit In the event of the patient suffering a cardiac Deactivate the CPR rapid deflation arrest, the CPR rapid deflation unit can be Press down the open part of the CPR rapid activated. deflation unit until it clicks into place. Activate the CPR rapid deflation Deflate the mattress to activate the CPR rapid deflation unit.
  • Page 24: Assemble The System

    Place the detachable cover over the mattress • The cells of the mattress are facing up. overlay with the Arjo logo visible and located at the foot end of the mattress. 5. Zip the cover onto the mattress overlay, start from the head end.
  • Page 25: Assemble The 175, 200 And Plus Mattress Replacement

    The CPR rapid deflation unit is located at the head end. Place the detachable cover over the mattress • The tube-set is positioned correctly. replacement with the Arjo logo visible at the foot end of the mattress. Continued on next page ASSEMBLE THE SYSTEM...
  • Page 26: Assemble The Pump

    8. Zip the cover onto the mattress replacement, Assemble the pump start from the head end. Do not trap any 1. Hang the pump at the foot end of the bed. material in the zip. Make sure the zip is fully closed.
  • Page 27: Assemble Plus Mattress Extensions (Accessory Only)

    6. Close the flap around the cable with the press 4. Place the mattress extension with the zip studs. nearest the bottom into the space between the mattress and the footboard. 7. Connect the power cable to a power source. Make sure that there are no sharp edges Assemble Plus mattress extensions which may rip the cover.
  • Page 28 If the chair is of the closed side type Place the protective cover over the seat with a non-removable seat cushion, cushion. Make sure the Arjo logo is visible at then security relies only on the the front part of the seat.
  • Page 29 WARNING To prevent falling, position the pump, the cable and the tube-set so that they do not create a trip hazard. Place the pump on the floor next to the chair. • The cable should be under the chair. • The tube-set should be placed along the side of the chair.
  • Page 30: Start The System

    Battery charge indicator • Green indicators on the front of the pump NOTE The pump automatically adjusts the Auralis pressure in the mattress to support the patient. 4. The Alternating mode is set by default. If needed, select another mode (see Select mode on page 32).
  • Page 31 WARNING To prevent discomfort or injury for the patient, ALWAYS set the comfort level at maximum for patients weighing over 360 kg (793 lb) for the Plus mattress only. For patient comfort, use the Comfort control buttons to adjust the pressure. The level of comfort is indicated by a light.
  • Page 32: Select Mode

    Select mode Autofirm mode Alternating mode (default setting) Activate Autofirm Activate Alternating mode Press the Alternating mode button, the The Autofirm mode only applies to the Alternating mode indicator is shown. mattresses. The mattress enters alternating mode. In this Press the Autofirm button for 2 seconds. The mode adjacent cells inflate and deflate on a 10 Autofirm mode and the Comfort control indicators minute cycle.
  • Page 33: Lock Out Mode

    Lock out mode CAUTION To prevent entanglement when the Lock pump is in Transport mode, make sure Push and hold Comfort control Positive (+) and that the tube-set connector is stowed Comfort control Negative (–) buttons at the appropriately. same time for at least 2 seconds. The top and bottom Comfort control indicators will flash NOTE simultaneously.
  • Page 34 Deactivate Transport mode NOTE To deactivate the Transport mode, connect the Bolsters should be deflated before tube-set. reducing the bed frame width. Inflate Bolster (Plus mattress only) WARNING To prevent discomfort or injury for the patient, deactivate transport mode before inflating the bolsters. Locate the valve symbol on the bottom of the The pump goes back to the previous mode by mattress.
  • Page 35: Turn-Off And Store The System

    Turn-off and store the system Turn off the pump 5. Place the mattress in the storage bag. 1. Press the Run/Standby button for 2 seconds. The pump enters Standby mode. 2. Disconnect the power cable from the power source. 3. To turn off the pump completely, press the Run/Standby button for 4 seconds until a The inside of the storage bag should be dry, double beep is heard.
  • Page 36: Store The Pump

    Store the pump 1. Clean and disinfect the pump according to section Cleaning and disinfection on page 2. Wrap the power cable around the hanging brackets. 3. Store the pump in a designated area, in line with storage requirements, see Transport and storage conditions on page 47.
  • Page 37: Cleaning And Disinfection

    Cleaning and disinfection The product should be cleaned and disinfected at Equipment needed regular intervals and between patients. Contact Arjo • Spray bottle with disinfectant solution (either Customer Service for any questions regarding the 70 % alcohol solution or chlorine solution up cleaning and disinfection of the product.
  • Page 38 8. After disinfecting the pump, use water and a 19. After disinfecting the top cover, use water new cloth to wipe off all traces of disinfectant and a new cloth to wipe off all traces of solution from the pump. disinfectant solution from the top cover.
  • Page 39: Care And Preventive Maintenance

    Care and preventive maintenance Under normal use the product is subject to wear and tear. Perform the following actions when specified to make sure that the product remains within its original manufacturing specifications. The actions should be performed when the product is not in use. WARNING To prevent electric shock, do not service or maintain the pump while it is in use.
  • Page 40 CAREGIVER OBLIGATION BEFORE EVERY USE OR AFTER EVERY 2 EVERY WEEK (IF FOR EACH YEARS LONG TERM USE) PATIENT Perform a full functionality test on the ● system Checks by qualified service personnel ● only. The Plus mattress extension (accessory only) Visually check the top cover ●...
  • Page 41: After Each Patient

    Before every use or every week if in 4. To check the alarm functionality, disconnect the tube-set from the pump while the system longterm use is switched on. After 30 seconds, two green alarm panel indicators on the front of the Visually check the pump for damage pump turn yellow, the Low pressure indicator •...
  • Page 42 Check that all labels are attached on the system according to section Labels on pump on page 50 and Labels on surfaces on page 52. If any label is missing, contact Arjo Customer Service. Checks by qualified service personnel only...
  • Page 43: Troubleshooting And Alarms

    Troubleshooting and alarms The following table provides a troubleshooting guide for alarms. The WAIT, POWER FAILURE and READY FOR SERVICE indicators are information signals. All other alarms are low priority alarms. INDICATOR POSSIBLE CAUSE SOLUTION WAIT Mattress is inflating. Wait for mattress to reach operating pressure (typically This does not indicate a fault 15 minutes for mattress and...
  • Page 44 INDICATOR POSSIBLE CAUSE SOLUTION LOW PRESSURE 1. The tube-set is not 1. Check that the tube-set connected properly. connector is correctly connected to the pump 2. The CPR rapid deflation - an audible click should unit on the mattress is not be heard when correctly closed.
  • Page 45 INDICATOR POSSIBLE CAUSE SOLUTION INTERNAL FAULT The pump has detected an Switch the pump off and restart internal fault. it. If alarm persists, contact qualified service personnel. Front panel alarms show yellow Alarm activation delay: Maximum 22 minutes AUTOFIRM does not activate 1.
  • Page 46 INDICATOR POSSIBLE CAUSE SOLUTION OVER TEMPERATURE The pump is operating outside 1. Turn off the pump. its temperature range and has 2. Disconnect the power cable. entered the transport mode. 3. Check the position of the There is an audible alarm and pump: the indicators turn yellow before •...
  • Page 47: Technical Specifications

    Technical specifications GENERAL DATA - PUMP Model Auralis Case material PC ABS Part number 636xxx (xxx is determined by the type of mains lead fitted. Please refer to rear label for actual part number) Size 385 x 290 x 170 mm (15.2 x 11.4 x 6.7 in)
  • Page 48 Cover material Premium fabric For the dimension and weight specifications in this IFU, there could be some tolerance, not explicitly listed. Arjo is entitled to have the final explanation on these specifications. Including transport bag of weight 0.46 kg ALLOWED COMBINATIONS Auralis ®...
  • Page 49 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 for use is confirmed with the chemical supplier prior to use.
  • Page 50: Labels On Pump

    Labels on pump 1. Product label - States technical performance 2. Serial number label - States the product and requirements, e.g. input power and input identification voltage. SYMBOL EXPLANATION Refer to instruction manual/ booklet - Instructions for use should be read CE marking indicating conformity with European Community harmonised legislation.
  • Page 51 UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) Figures indicate UK Approved Body supervision. UK Responsible Person & UK Importer: Arjo (UK) Ltd, ArjoHuntleigh House, Houghton Regis. LU5 5XF For Northern Ireland (NI) CE marking will still apply until further amendment to applicable regulations.
  • Page 52: Labels On Surfaces

    Labels on surfaces Example of mattress 1, 2, 3 1, 2, 3, 4 1. Serial number label - States the product 3. Care and cleaning label - States the washing identification and product weight conditions 2. Top cover label - States the product 4.
  • Page 53 UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) UK Responsible Person & UK Importer: Arjo (UK) Ltd, ArjoHuntleigh House, Houghton Regis. LU5 5XF For Northern Ireland (NI) CE marking will still apply until further amendment to applicable regulations.
  • Page 54: Electromagnetic Compatibility (Emc)

    Compliance Electromagnetic environment - guidance RF emissions Group 1 The Auralis pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions...
  • Page 55 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Auralis pump is used exceeds the applicable RF compliance level above, the Auralis pump should be observed to verify normal operation.
  • Page 56 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE PUMP Rated maximum output Separation distance according to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz d = 1.2√P d = 1.2√P d = 2.3√P...
  • Page 57 (60 % dip in U supply input lines hospital environment. for 5 cycle for 5 cycle IEC 61000-4-11 If the user of the Auralis 70 % U (30 % dip in U 70 % U (30 % dip in U pump requires continued...
  • Page 58: Parts And Accessories

    Parts and accessories Mattress extension Mattress extension long Coiled Skin IQ power cable 636615 636614 636377 PARTS AND ACCESSORIES...
  • Page 59 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 (Poznań) Macquarie Park, NSW, 2113, Australia FR-59436 RONCQ CEDEX...
  • Page 60 At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.