Arjo AtmosAir Velaris Instructions For Use Manual

Arjo AtmosAir Velaris Instructions For Use Manual

Hybrid mattress system
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INSTRUCTIONS FOR USE
AtmosAir Velaris
Hybrid mattress system
04.AAV.00EN_02 • 10/2021

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  • Page 1 INSTRUCTIONS FOR USE AtmosAir Velaris Hybrid mattress system 04.AAV.00EN_02 • 10/2021...
  • Page 2 © Arjo 2021. 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 .
  • Page 4 Assemble the hybrid mattress system ........... . . 24 Assemble the Standard, Plus and ST mattresses .
  • Page 5: Foreword

    The information in this IFU is important for your safety. You must read and understand the IFU to help prevent possible injury. Unauthorised modifi cations on any Arjo device can aff ect its safety and performance. Arjo cannot be held responsible for any accidents or incidents resulting from such modifi...
  • Page 6: Intended Use

    Intended use The AtmosAir Velaris hybrid mattress system is intended for use by caregivers in acute care, long-term care and home care facilities, including private homes. The hybrid mattress system is indicated for the prevention and management of pressure injuries. It should be used as part of an individualised, comprehensive pressure injury protocol.
  • Page 7 250 kg (550 lb) for the Seat cushion If the patient does not meet these criteria an alternative medical device/system shall be used. Expected service life The expected service life of the AtmosAir Velaris system elements is: • Mattress – 5 Years •...
  • Page 8: Safety Instructions

    Safety instructions WARNING WARNING To avoid risks of tripping or strangulation, To avoid falls and injury, make sure that always use the cable management for the cables and the tube-set are positioned power cable. correctly. Keep cables away from moving bed parts or other possible entrapment areas.
  • Page 9: Preparation

    Preparation Bed frame recommendation The mattress range is designed to be used on Arjo bed frames. See Technical specifi cations on page 38 of this IFU. The mattress range (Standard, Plus and ST) may also be used with other bed frames or trolleys (non-Arjo).
  • Page 10: Parts Designation

    2. Repeater light 5. Skin IQ port 3. Tube-set connector 6. Power cable Control panel AtmosAir Velaris Skin IQ 100 130 170 210 250 350 450 kg 1. Run/Standby button and light 7. Power fail light 2. Lock button and light 8.
  • Page 11 Standard and Plus mattress 2, 3 1. Detachable top cover 5. Detachable bottom cover 2. Mattress connector 6. Handles 3. Mattress connector cavity 7. Cover attachment zip with zip fl ap 4. Non-Slip strips 8. Cable management loops PARTS DESIGNATION...
  • Page 12 Stretcher (ST) mattress 1. Detachable top cover 4. Cover attachment zip with zip fl ap 2. Non-Slip strips 5. Handles 3. Detachable bottom cover PARTS DESIGNATION...
  • Page 13 Seat cushion 1. Detachable top cover 4. Detachable bottom cover 2. Cover attachment zip with zip fl ap 5. Handle 3. Non-Slip strip PARTS DESIGNATION...
  • Page 14: Control Panel

    Control panel Run/Standby button and light See Figure 1 The Run/Standby button switches the pump between Run mode and Standby mode. Figure 1 In Run mode the light is on. For Standby mode, press and hold the button for two seconds.
  • Page 15: Weight Select Buttons And Lights

    Weight select buttons and lights See Figure 4 100 130 170 210 250 350 450 The default weight is set and the light is on at 100 kg (220 lb). Figure 4 • Press the - button to reduce the patient weight. Minimum value is 40 kg (90 lb).
  • Page 16: Power Fail Light

    Power fail light See Figure 6 If a power failure is detected the power failure light turns on and an alarm sounds. Figure 6 Active (alternating) therapy is not possible during power failure conditions. NOTE To turn the pump off and cancel the alarm during a power outage, press and hold the run/standby button for two seconds.
  • Page 17: Product Description - Alternating Pressure Pump

    Product description - Alternating pressure pump Repeater light See Figure 10 During normal operation the repeater light is on and green. During a fault condition, the repeater light will turn yellow. Figure 10 Hanging brackets See Figure 11 Use the hanging brackets to mount the pump at the foot end of the bed.
  • Page 18: Skin Iq Port

    Skin IQ port See Figure 13 Only use the Skin IQ port with the Skin IQ power cable to provide power to the Skin IQ coverlet. See Allowed combinations on page 39. For instructions on how to use Skin IQ, see the Skin IQ IFU.
  • Page 19: Product Description - Standard And Plus Mattress

    Product description - Standard and Plus mattress Covers The mattress top and bottom welded covers are co-joined by a zip. Mattress connector The mattress connector is located at the foot end of the mattress. See Figure 15 The mattress connector is used to connect the mattress to the pump.
  • Page 20: Disconnect The Pump From The Mattress

    Disconnect the pump from the mattress 1. Locate the connector inside the connector cavity, near the foot end of the mattress. See Figure 19. Figure 19 2. Firmly squeeze the two buttons on the top and bottom of the pump connector and pull it away from the mattress connector.
  • Page 21: Handles

    Handles See Figure 22 WARNING To avoid bodily injury, never use the mattress or ST mattress as a patient movement device. To move the mattress use the four handles on the bottom mattress cover. Figure 22 Non-slip base See Figure 23 Non-slip strips integrated in the bottom cover prevent the mattress from slipping on the bed frame.
  • Page 22: Product Description - Stretcher (St) Mattress

    Product description - Stretcher (ST) mattress Covers The mattress top and bottom welded covers are co- joined by a zip. Handles See Figure 25 WARNING To avoid bodily injury, never use the mattress or ST mattress as a patient movement device. To move the mattress use the four handles on the Figure 25 bottom mattress cover.
  • Page 23: Product Description - Seat Cushion

    Product description - Seat cushion Covers The cushion top and bottom welded covers are co- joined by a zip. Handle See Figure 27 To move the seat cushion use the handle on the back. Figure 27 Non-slip base See Figure 28 The non-slip strip integrated in the bottom cover prevents the cushion from slipping on the chair.
  • Page 24: Assemble The Hybrid Mattress System

    Assemble the hybrid mattress system Assemble the Standard, Plus and ST mattresses 1. Remove any existing mattress from the bed/ trolley frame. 2. Check that there are no protruding sharp objects on the frame surface. WARNING To avoid death or serious injury by entrapment, always select the correct mattress size for the bed/trolley.
  • Page 25 Assemble the Pump 1. Unwrap the power cable and tube-set from the pump cable management. 2. Hang the pump at the foot end of the bed. See Figure 31. Make sure that the pump is not: • near a heat source •...
  • Page 26: Reactive Therapy

    Assemble Seat cushion CAUTION To avoid inadequate pressure redistribution, always use the seat cushion in the correct orientation. CAUTION To avoid puncturing the seat cushion, check that there are no sharp objects on the chair. Place the seat cushion on top of the chair seat. Position the cushion with the symbol located at the front of the chair and the carrying handle at the back.
  • Page 27: Active Therapy (Standard Or Plus Mattress)

    Active therapy (Standard or Plus mattress) Before active (alternating) therapy make sure that the hybrid mattress system is assembled correctly with the alternating pressure pump attached. See Assemble the hybrid mattress system on page 24. See Figure 36. Figure 36 Patient position Place the patient on the mattress.
  • Page 28: Turn-Off And Remove The Pump

    Turn-off and remove the pump 1. To stop therapy press and hold the Run/Standby button for 2 seconds. 2. Unplug the power cable from the power source. 3. Disconnect the pump tube-set connector from the mattress connector. Firmly squeeze the two buttons on the top and bottom of the pump connector and pull it away from the mattress connector.
  • Page 29: Homecare Use

    • If the device is still not operating correctly, or if you have concerns, contact the Before using the AtmosAir Velaris hybrid mattress patient’s doctor or nursing staff for advice. system in a home environment, make sure that all caregivers, including relatives, have read and understood the instructions in this IFU.
  • Page 30: Cleaning And Disinfection

    The hybrid mattress system should be cleaned and disinfected at regular intervals and between patients. Follow your local practices for all reusable medical devices. Contact Arjo Customer Service for any questions regarding the cleaning and disinfection of the device. Make sure that the Safety Data Sheet (SDS) is available for the disinfectant used.
  • Page 31 Allowed disinfectants HYBRID BOTTOM RECOMMENDATIONS FOR DISINFECTANT MATTRESS COVER COVER SYSTEM Alcohol solution ≤ 70% Coating may swell when wet hence care must be taken to avoid ● ● ● accidental scratches and fold only when dry before storage. Chlorine solution ≤ 1% Acceptable use at pH 7-9.
  • Page 32: Clean And Disinfect

    Accessories needed for cleaning/ disinfection • Protective glasses • Protective gloves • Spray bottle with cleaning solution • Spray bottle with disinfectant solution • Spray bottle with water • Cloths Clean and disinfect (26 steps) Always follow these steps for proper cleaning and disinfection after each patient. Prepare the pump 1.
  • Page 33 Clean the mattress / seat cushion covers NOTE The top cover should be assessed for the level of soiling. If this soiling is deemed excessive, the top cover should be washed. The bottom cover should always be cleaned and disinfected by wiping. 14.
  • Page 34: Care And Preventive Maintenance

    Care and preventive maintenance Under normal use the hybrid mattress system is subject to wear and tear. Perform the following actions when specifi ed to make sure that the product remains within its original manufacturing specifi cations. WARNING To avoid malfunction resulting in injury, inspection your device regularly. Always follow the recommended maintenance schedule.
  • Page 35 Caregiver obligations - before every use or every week NOTE If any part is damaged or missing DO NOT use the product. Perform a full functionality test on the hybrid mattress system 1. Connect the pump tube-set to the Standard or Plus mattress. Make sure that the tube-set clicks into place.
  • Page 36 Cleaning and disinfection on page 30. Visually check all labels Check that all labels are attached on the hybrid mattress system according to section Labels on page 42. If any label is missing, contact Arjo Customer Service. Visually check all zips •...
  • Page 37: Troubleshooting And Alarms

    Troubleshooting and alarms The LOW PRESSURE and HARDWARE FAIL alarms are low priority alarms. The POWER FAIL light is an information signal. ALARM LIGHT POSSIBLE CAUSE SOLUTION ACTIVATION DELAY • The mattress to pump 1. Check that the tube-set connector is Maximum 25 PRESSURE correctly connected to the pump - an...
  • Page 38: Technical Specifi Cations

    Technical specifi cations GENERAL - PUMP Model: AtmosAir Velaris Case material: PC ABS Part number: 633xxx (xxx is determined by the type of mains lead fi tted. Please refer to rear label for actual part number) Size: 337 x 107 x 200 mm (13.3 x 4.2 x 7.9 in) Weight: 4.1 kg (9 Ib)
  • Page 39 • Do not store in direct sunlight. • Store the pump and mattress in the protective bags supplied. • Clean and disinfect the pump and mattress before storage. EXPECTED SERVICE LIFE AtmosAir Velaris pump 7 years END OF LIFE DISPOSAL Package Corrugated cardboard, recyclable.
  • Page 40 MEASUREMENTS AND COMPATIBILITY Standard mattress Part no Size mm (in) Top cover material Weight kg (lb) Arjo bed frames 633048 Reliant 810 X 2000 X 180 15 (33) (32 x 79 x 7) 633049 Premium 633020 Reliant 860 x 1980 x 180 Contoura 460/480, Minuet 2, 15.5 (34)
  • Page 41 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 be confi rmed with the chemical supplier prior to use...
  • Page 42: Labels

    Labels Labels on the Pump LABEL EXPLANATION Product label States technical performance and requirements, e.g. input power and input voltage. Serial number label States the item identifi cation 1. Product label 2. Serial number label LABELS...
  • Page 43 SYMBOL EXPLANATION Read the Instructions for use before use. CE marking indicating conformity with European Community harmonised legislation. Figures indicate Notifi ed Body supervision. Indicates the product is a Medical Device according to EU Medical Device Regulation 2017/745. With respect to electric shock, fi re and mechanical hazards only in accordance with CAN/CSA-C22.2 No.60601.1 (2008) + (2014) and ANSI/ AAMI ES60601-1 (2005)+AMD(2012).
  • Page 44 Labels on the surfaces LABEL EXPLANATION Top cover label States the top cover identifi cation and maximum patient weight Surface ID Label States the product identifi cation and product weight Law tag States certifi cation of fl ammability test Example of mattress 3, 4, 5 3, 4, 5 1.
  • Page 45 SYMBOL EXPLANATION Read the Instructions for use before use. CE marking indicating conformity with European Community harmonized legislation. Indicates the product is a Medical Device according to EU Medical Device Regulation 2017/745. Lot number Serial number Reference number Name and address of the manufacturer Manufacturing date Safe working load defi...
  • Page 46: List Of Standards And Certifi Cates

    List of standards and certifi cates STANDARD / CERTIFICATE DESCRIPTION IEC 60601-1:2005 + AMD1:2012 Medical Electrical Equipment – Part 1: general requirements for basic safety and essential performance. + AMD2:2020 (Ed 3.2) IEC 60601-1-11:2015 + Medical Electrical Equipment – Part 1-11: general requirements for basic safety and essential performance –...
  • Page 47: Electromagnetic Compatibility

    If this equipment needs to be used adjacent to other electrical equipment, normal operation must be checked before use. For detailed EMC information contact Arjo service personnel. WARNING Stacking or placing other electrical equipment next to this device is not recommended, it can interfere with the equipment’s operation and safety.
  • Page 48 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY The pump is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the pump should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance...
  • Page 49 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION EQUIPMENT AND THE PUMP The pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the pump as recommended below, according to the maximum output power of the communications equipment.
  • Page 50 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY The pump is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the pump should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment –...
  • Page 51 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 52 At Arjo, we are committed to improving the everyday lives of people aff ected by reduced mobility and age-related health challenges. With products and solutions that ensure ergonomic patient handling, personal hygiene, disinfection, diagnostics, and the eff ective prevention of pressure ulcers and venous thromboembolism, we help professionals across care environments to continually raise the standard of safe and dignifi...

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