Arjohuntleigh Alpha Active 3 Instructions For Use Manual

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Alpha Active 3
Instructions for Use
...with people in mind
648934EN_04 • 11/2017

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Summary of Contents for Arjohuntleigh Alpha Active 3

  • Page 1 Alpha Active 3 Instructions for Use ...with people in mind 648934EN_04 • 11/2017...
  • Page 3: Table Of Contents

    Alpha Active 3 Mattress Overlay ........
  • Page 4 Cleaning Symbols ..........19 Cover Specification .
  • Page 5: General Safety

    • The cover of this product is vapour permeable but not air permeable and may present a suffocation risk. • Only the pump and mattress combination as indicated by ArjoHuntleigh should be used. The correct function of the product cannot be guaranteed if incorrect pump and mattress combinations are used.
  • Page 6 ArjoHuntleigh. Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Alpha Active 3 system. Failure to observe this caution could result in injury, or in extreme cases, death. Design Policy and Copyright ®...
  • Page 7: Introduction

    If you have any difficulties in setting-up or using the Alpha Active 3 system, contact your local ArjoHuntleigh sales office, listed at the end of this manual. Intended Use The intended use of this product is to prevent and/or manage pressure ulcers for patients up to 135 kg (297 lb).
  • Page 8: Alpha Active 3 Mattress Overlay

    If an alarm situation is detected an indicator will illuminate on the front of the pump and an audible warning will sound. Alpha Active 3 Alpha Active 3 mattress overlay comprises the Mattress Overlay...
  • Page 9 Four corner retention straps are incorporated, which slide under the corners of the base mattress. Alpha Active 3 A full technical description of the system can be found in the Service Manual, part number SER0017, available from your ArjoHuntleigh sales office.
  • Page 10: Clinical Applications

    Clinical Applications Indications The Alpha Active 3 system is indicated for the prevention and/or management of all categories pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care. Selection should be based upon a holistic assessment of the patient’s individual care needs.
  • Page 11: Installation

    3. Installation Preparing the system Remove the system from the packaging. You should for use have the following items: Alpha Active 3 • pump including mains power cord and hanging brackets. Alpha Active 3 • mattress overlay with integral tube- set.
  • Page 12 WARNING Make sure that the mains power cable is positioned to avoid causing a hazard and is clear of moving bed mechanisms or other possible entrapment areas. The pump should be installed as follows: Installing the Pump 1. Position the pump, feet down, on any convenient horizontal surface or alternatively suspend from the bed foot rail by means of the integral hanging brackets.
  • Page 13: Controls, Alarms And Indicators

    4. Controls, Alarms and Indicators Controls On/Off Pressing the button will activate the pump.The On/Off Button pump will perform a self test during which all LEDs will illuminate, and audible beeps will sound. During an alarm condition the sound of the alarm can be Alarm Mute muted by pressing this button.
  • Page 14: Alarms And Indicators

     If the operation of the pump changes during use, refer to Page 16 “Troubleshooting and Alarm Conditions” of this IFU before calling a service engineer or contacting your local ArjoHuntleigh sales office.
  • Page 15: Mattress - Pump Operation

    WARNING Do not place the patient on the mattress until it is fully inflated. Quick Start Before using the Alpha Active 3 mattress overlay make sure it has been installed correctly in accordance with Page 5 “Installation” and ensure that the CPR unit on the mattress is clicked into the closed position.
  • Page 16: Changes In Patient Position

    5. If the caregiver feels less than an inch of support material, the patient has bottomed out and the support pressures should be adjusted accordingly. 6. Bottoming out should be checked at various anatomical sites and while the patient assumes various body positions.
  • Page 17: To Deflate And Store The Alpha Active 3 Mattress

    Transport mode is non-therapeutic offering support only for up to 12 hours. It is recommended that when in transport mode the patient is frequently monitored. To Deflate and Store the Alpha Active 3 Mattress 1. Disconnect the tube-set from the pump. To deflate the mattress: 2.
  • Page 18: Cpr Control

    CPR Control IMPORTANT IN THE EVENT OF CARDIAC ARREST In the event of a patient suffering cardiac arrest and CPR needing to be administered: To activate CPR Located at the head end of the mattress overlay (on the same side as the tubeset) is a red strap labelled CPR. In the event of a cardiac arrest pull this from the mattress to deflate.
  • Page 19: Decontamination

    Healthcare Facility or the country of use. If you are uncertain, you should seek advice from your local Infection Control Specialist. Alpha Active 3 system should be routinely decontaminated between patients and at regular intervals while in use; as is good practice for all reusable medical devices.
  • Page 20 If an alternative disinfectant is selected from the wide variety available we recommend that suitability for use is confirmed with the chemical supplier prior to use. DO NOT WRING/MANGLE, AUTOCLAVE OR USE PHENOLIC BASED SOLUTIONS. For information for the mattress top cover, including Thermal Disinfection laundering guidelines, refer to Page 20 “Cover Specification”.
  • Page 21: Routine Maintenance

    The serial number for the pump is on the label on the Pump back of the pump case. The mattress serial label can be found just inside the Mattress base cover above the tubeset, refer to the illustration on page Page 2 “Alpha Active 3 Mattress Overlay”.
  • Page 22: Troubleshooting And Alarm Conditions

    8. Troubleshooting and Alarm Conditions The following table provides a troubleshooting and alarm condition guide for the Alpha Active 3 system in the event of malfunction. These alarms do not cause any delay or interruption in therapy. Indicator Possible Cause...
  • Page 23: Technical Description

    9. Technical Description PUMP Model: Alpha Active 3 Part Numbers: 648301UK UK (Note: pre 2015 this part number was 648301) 648309AU AUSTRALIA Supply Voltage: 230V Supply Frequency: 50Hz Power Input: 0.1A Size: (L)280mm x (W)205mm x (H)112mm Weight: 2.5kg Case Material:...
  • Page 24: Pump Symbols

    PUMP SYMBOLS The operator must read Power this document Power Disconnects (Instructions for Use) O (Off) I (On) Connects to the from the mains before use. mains supply supply Note: This symbol is blue on the product label. With respect to electric shock, fire and mechanical hazards only in accordance with...
  • Page 25: Mattress

    ALPHA ACTIVE 3 OVERLAY 90 Polyurethane PVC Nylon Coated ALPHA ACTIVE 3 OVERLAY 85 Polyurethane PVC Nylon Coated ALPHA ACTIVE 3 OVERLAY 85 PU Polyurethane PU Nylon Coated ALPHA ACTIVE 3 OVERLAY 80 PU Polyurethane PU Nylon Coated ALPHA ACTIVE 3 OVERLAY 90 PU...
  • Page 26 Chlorine concentrations may vary from 250ppm to 10,000ppm depending on local policy and contamination status. If an alternative disinfectant is selected from the wide variety available, ArjoHuntleigh recommend that suitability for use is confirmed with the chemical supplier prior to use.
  • Page 27 Guidance and manufacturer’s declaration - electromagnetic emissions The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance RF emissions Group 1...
  • Page 28 Guidance and manufacturer’s declaration - electromagnetic immunity The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should assure that it is used in such an environment. Immunity IEC 60601 Test Compliance Electromagnetic environment - guidance Test...
  • Page 29 Guidance and manufacturer’s declaration - electromagnetic immunity The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic environment - Level...
  • Page 31 AUSTRALIA FRANCE POLSKA ArjoHuntleigh Pty Ltd ArjoHuntleigh SAS ArjoHuntleigh Polska Sp. z o.o. 78, Forsyth Street 2 Avenue Alcide de Gasperi ul. Ks Piotra Wawrzyniaka 2 O’Connor CS 70133 PL-62-052 KOMORNIKI (Pozna ) AU-6163 Western Australia FR-59436 RONCQ CEDEX Tel: +48 61 662 15 50 Tel: +61 89337 4111 Tél: +33 (0) 3 20 28 13 13...
  • Page 32 Getinge Group is a leading global provider of products and systems that contribute to quality the three brands of ArjoHuntleigh, Getinge and Maquet Getinge provides solutions for Maquet specializes in solutions, therapies and products for surgical interventions, interventional ArjoHuntleigh focuses on patient handling and hygiene, disinfection, DVT prevention,...

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