Arjo Alpha Active 3 Instructions For Use Manual
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Arjo Alpha Active 3 Instructions For Use Manual

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INSTRUCTIONS FOR USE
Alpha Active 3
648934EN_07 • 05/2019

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Summary of Contents for Arjo Alpha Active 3

  • Page 1 INSTRUCTIONS FOR USE Alpha Active 3 648934EN_07 • 05/2019...
  • Page 2 Mandatory to read the Instructions for Use Design Policy and Copyright ® and ™ are trademarks belonging to the Arjo group of companies. © Arjo 2019. 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

    Changes in Patient Position ..........10 To Deflate and Store the Alpha Active 3 Mattress ......11 CPR Control .
  • Page 4 Intentionally left blank (ii)

  • 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 Arjo should be used. The correct function of the product cannot be guaranteed if incorrect pump and mattress combinations are used.
  • Page 6 Arjo. 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.

  • Page 7: Introduction

    Use this manual to initially set up the system, and keep it as a reference for day-to-day routines and as a guide to maintenance. If you have any difficulties in setting-up or using the Alpha Active 3 system, contact your local Arjo 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

    Alpha Active 3 The Alpha Active 3 mattress overlay comprises the following Mattress Overlay components: Cover 3 Static Head Cells Tubeset 13 Alternating (Active) Cells Serial No. Base Cover Detachable Cover The standard cover comprises of a 2-way stretch polyurethane (PU) coated knitted fabric zipped to a durable nylon base.
  • Page 9 Four corner retention straps are incorporated, which slide under the corners of the base mattress. A full technical description of the Alpha Active 3 system can be found in the Service Manual, part number SER0017, available from your Arjo sales office.

  • Page 10: Clinical Applications

    2. Clinical Applications Indications The Alpha Active 3 system is indicated for the prevention and/or management of all categories of 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

    Preparing the system Remove the system from the packaging. You should have the for use following items: • Alpha Active 3 pump including mains power cord and hanging brackets. • Alpha Active 3 mattress overlay with integral tube-set. • Cover.
  • 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. Installing the Pump The pump should be installed as follows: 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 Alpha Active 3 Pressing the On/Off button will activate the pump.The pump will On/Off Button perform a self test during which all LEDs will illuminate, and audible beeps will sound. Alarm Mute During an alarm condition the sound of the alarm can be muted by pressing this button.

  • Page 14: Alarms And Indicators

    NOTE 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 Arjo sales office.

  • Page 15: Mattress - Pump Operation

    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

    If the caregiver feels less than an inch of support material, the patient has bottomed out and the support pressures should be adjusted accordingly. Bottoming out should be checked at various anatomical sites and while the patient assumes various body positions. Changes in Patient When a patient is in the lying or supine position, their body weight Position...

  • Page 17: To Deflate And Store The Alpha Active 3 Mattress

    Alpha Active 3 Mattress”. Transport Mode To transport a patient using the Alpha Active 3 mattress overlay, disconnect the tube-set from the pump and place the attached cap over the end of the tubeset to put the mattress into transport mode.

  • 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

    Facility or the country of use. If you are uncertain, you should seek advice from your local Infection Control Specialist. The 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. Thermal Disinfection For information for the mattress top cover, including laundering guidelines, refer to Page 20 “Cover Specification”.

  • Page 21: Routine Maintenance

    Arjo trained personnel to repair the system. Service Period Arjo recommend that the Alpha Active 3 system should be serviced by an Arjo authorised service agent, after 12 months running time has elapsed.

  • 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 Supply Voltage: 230V Supply Frequency: 50Hz Power Input: 0.1A Size: (L)280mm x (W)205mm x (H)112mm Weight: 2.5kg Case Material: ABS Plastic Plug Fuse Rating: 5A to BS1362 (UK ONLY) Pump Fuse Rating:...

  • Page 24: Symbols

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

  • Page 25: Mattress

    (74 3/4") (5") 648321W ALPHA ACTIVE 3 MR 90 welded 648430W (33 3/4") 648343W ALPHA ACTIVE 3 MR 90 PU welded 648323W ALPHA ACTIVE 3 MR 85 welded 648460W (31 1/4") 648325W ALPHA ACTIVE 3 MR 85 PU welded 648342W...

  • Page 26: Cleaning Symbols

    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, Arjo recommend that suitability for use is confirmed with the chemical supplier prior to use.

  • Page 27: Electromagnetic Compatibility (Emc)

    EMI (electromagnetic interference) from external sources. Some procedures can help reduce electromagnetic interferences: • Use only Arjo 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 28 Guidance and manufacturer’s declaration - electromagnetic immunity Immunity Test IEC 60601-1-2 Compliance Electromagnetic environment - test level Level guidance Electrostatic ±2kV, ±4kV, ±8kV, ±2kV, ±4kV, ±8kV, Floors should be wood, concrete or discharge (ESD) ±15kV air ±15kV air ceramic tile. If floors are covered with synthetic material the relative EN 61000-4-2 ±8kV contact...
  • Page 29 Guidance and manufacturer’s declaration - electromagnetic immunity Voltage dips, short 0 % UT; 0,5 cycle 0 % UT; 0,5 cycle Mains power quality should be that of interruptions and At 0°, 45°, 90°, At 0°, 45°, 90°, a typical commercial or hospital voltage variations 135°, 180°, 225°, 135°, 180°, 225°,...
  • Page 30 Intentionally left blank...
  • Page 31 AUSTRALIA FRANCE POLSKA Arjo Australia Pty Ltd Arjo SAS Arjo 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...
  • Page 32 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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