Arjo Alpha Active 4 Instructions For Use Manual
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Arjo Alpha Active 4 Instructions For Use Manual

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INSTRUCTIONS FOR USE
Alpha Active 4
648936EN_11 • 02/2023

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  • Page 1 INSTRUCTIONS FOR USE Alpha Active 4 648936EN_11 • 02/2023...
  • Page 2 To avoid injury, always read this Instructions for Use and accompanied documents before using the product. Design Policy and Copyright ® and ™ are trademarks belonging to the Arjo group of companies. © Arjo 2023. 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

    Alpha Active 4 Mattress Replacement ........
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  • 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 To maintain the condition of the pump, have the pump serviced regularly according to the schedule recommended by Arjo. Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Alpha Active system.

  • 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 4 system, contact your local Arjo sales office, listed at the end of this manual.

  • Page 8: Alpha Active 4 Pump

    Alpha Active 4 Pump The Alpha Active 4 pump comprises of a moulded case with non slip feet on the base and integral hanging brackets. The controls are situated on the front of the pump and a sophisticated alarm system differentiates between normal operation and genuine system faults.

  • Page 9: Alpha Active 4 Mattress Replacement

    Alpha Active 4 Mattress Replacement The Alpha Active 4 mattress replacement comprises the following components: Detachable Cover The standard cover comprises of a 2-way stretch PU (polyurethane) coated knitted fabric zipped to a durable nylon base. The zips are protected by flaps to prevent ingress of contaminants and allow easy removal of the cover for cleaning.
  • Page 10 3 Static Head Cells Tubeset 16 Alternating Cells Serial No. (Inside cover) Base Cover A full technical description of the Alpha Active 4 system can be found in the Service Manual, part number SER0018, available from your Arjo sales office.

  • Page 11: Clinical Applications

    The Alpha Active 4 mattress is designed for patients weighting up to 200 kg (440lb). Contraindications Do not use Alpha Active 4 system for patients with unstable spinal fractures. Cautions If patients have other unstable fractures, or conditions which may be complicated by a soft or moving surface, advice should be sought from an appropriate clinician before use.

  • Page 12: Installation

    Preparing the system Remove the system from the packaging. You should have the for use following items: • Alpha Active 4 pump including mains power cord and hanging brackets. • Alpha Active 4 mattress replacement with integral tubeset. • Cover.
  • Page 13 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 14: Controls, Alarms And Indicators

    4. Controls, Alarms and Indicators Controls Cycle Time Alarm Mute Mode Select Auto-firm Mode Alpha Active 4 Patient Weight Selector Alarms On/Off Button Pressing the On/Off button will activate the pump.The pump will perform a self test during which all LEDs will illuminate, and audible beeps will sound.

  • Page 15: Alarms And Indicators

    Alarms and Indicators Low Pressure The Low Pressure indicator is illuminated whenever the pump Indicator detects low pressure within the mattress replacement. An audible alarm will sound, but the audible alarm can be muted by the mute button. The indicator will extinguish once normal pressure is reached. NOTE See “Troubleshooting and Alarm Conditions”...

  • Page 16: Mattress - Pump Operation

    Do not place the patient on the mattress until it is fully inflated. Quick Start Before using the Alpha Active 4 mattress replacement make sure it has been installed correctly in accordance with “Installing the Mattress” on page 6, and ensure that the CPR unit on the mattress is clicked into the closed position.

  • Page 17: Changes In Patient Position

    Changes in Patient When a patient is in the lying or supine position, their body weight Position is dispersed over a large area. When in the sitting position, their body weight is concentrated within a much smaller area and therefore will require more support than in the lying position. Therefore, when the patient changes position, it may be necessary, in order to maximise the benefit of the support surface, to make adjustments to the setting of the patient weight...

  • Page 18: To Deflate And Store The Alpha Active 4 Mattress

    Transport Mode To transport a patient using the Alpha Active 4 mattress replacement, disconnect the tubeset from the pump and place the attached cap over the end of the tubeset to put the mattress into transport mode. This will automatically switch the mattress into transport mode.

  • Page 19: 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 replacement (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 20: Decontamination

    Facility or the country of use. If you are uncertain, you should seek advice from your local Infection Control Specialist. The Alpha Active 4 system should be routinely decontaminated between patients and at regular intervals while in use; as is good practice for all reusable medical devices.

  • Page 21: Routine Maintenance

    Arjo trained personnel to repair the system. Service Period Arjo recommend that the Alpha Active 4 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 4 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 4 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: Pump Symbols

    Figures indicate UK Approved Body supervision. UK Responsible Person & UK Importer: Arjo (UK) Ltd, ArjoHuntleigh House, Houghton Regis. LU5 5XF Is the appointed UK Responsible Person as defined in UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended).

  • Page 25: Mattress

    648333W ALPHA ACTIVE 4 MR 80 648338W welded (31 1/2 " 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.

  • 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°,...
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  • Page 31 AUSTRALIA FRANCE Arjo Australia Arjo SAS Arjo Polska Sp. z o.o. Building B, Level 3 2 Avenue Alcide de Gasperi 11 Talavera Road CS 70133 Macquarie Park, NSW, 2113, FR-59436 RONCQ CEDEX Tel: +48 61 662 15 50 Australia Tél: +33 (0) 3 20 28 13 13...
  • Page 32 At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are 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.

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