Alpha Active 3 Pressure Redistributing Mattress Overlay Instructions for Use Rev 24 April 2019

WARNING To avoid injury, always read this Instructions for Use and accompanied documents before using the product. 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 consent of Arjo.

Contents General Safety... iii Introduction... 1 About this Manual... 1 Intended Use... 1 About Alpha Active 3... 1 Alpha Active 3 Pump... 1 Alpha Active 3 Mattress Overlay... 2 Clinical Applications... 4 Indications... 4 Contraindications... 4 Cautions... 4 Installation... 5 Preparing the system for use... 5 Installing the Mattress... 5 Controls, Alarms and Indicators... 7 Controls... 7 Alarms and Indicators... 8 Mattress - Pump Operation... 9 Quick Start... 9 Support Setting Procedure... 9 Changes in Patient Position... 10 To Deflate and Store the Alpha Active 3 Mattress... 11 CPR Control... 12 To activate CPR... 12 To reset CPR... 12 Decontamination... 13 Routine Maintenance... 15 Alpha Active 3 System... 15 Alpha Active 3 Pump... 15 Alpha Active 3 Mattress Overlay... 15 Serial Labels... 15 Troubleshooting and Alarm Conditions... 16 Technical Description... 17 Pump... 17 Symbols... 18 Mattress... 19 Mattress Size Information... 19 Cleaning Symbols... 20 Cover Specification... 20 Electromagnetic Compatibility (EMC)... 21

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General Safety Before you connect the system pump to a mains socket, read carefully all the installation instructions contained within this manual. The system has been designed to comply with regulatory safety standards including: • EN60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012 • EN60601-1-11:2010; IEC 60601-1-11:2010 and IEC 60601-1-8:2012 • ANSI/AAMI ES60601-1(2005)+AMD(2012) and CAN/CSA-C22.2 No.60601-1(2008)+(2014)

Safety Warnings • It is the responsibility of the care giver to ensure that the user can use this product safely. • Whilst the patient is unattended, safety sides should be used based on clinical assessment and in line with local policy. • Alignment of the bed frame, safety sides and the mattress should leave no gap wide enough to entrap a patient's head or body, or to allow egress to occur in a hazardous manner where entanglement with the mains power cable and tubeset or air hoses may result. Care should be exercised to prevent occurrence of gaps by compression or movement of the mattress. Death or serious injury may occur. • Make sure that the mains power cable and tubeset or air hoses are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas. Where cable management flaps are provided along the sides of the mattress, these should be used to cover the mains power cable. • Electrical equipment may be hazardous if misused. There are no user-serviceable parts inside the pump. The pump's case must only be removed by authorised technical personnel. No modification of this equipment is allowed. • The mains power socket/plug must be accessible at all times. To disconnect the pump completely from the electricity supply, remove the plug from the mains power socket. • The CPR control and/or the CPR indicator tag must be visible and accessible at all times. • Disconnect the pump from the mains power socket before cleaning and inspecting. • Keep the pump away from sources of liquids and do not immerse in water. • Do not use the pump in the presence of uncontained flammable liquids or gasses. • 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. • If a serious incident occurs in relation to this medical device, affecting the user, or the patient then the user or patient should report the serious incident to the medical device manufacturer or the distributor. In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located.

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Precautions For your own safety and the safety of the equipment, always take the following precautions: • Placing extra layers between the patient and the mattress potentially reduces the benefits provided by the mattress and should be avoided or kept to a minimum. As part of sensible pressure area care, it is advisable to avoid wearing clothing which may cause areas of localised high pressure due to creases, seams, etc. Placing objects in pockets should be avoided for the same reason. • Do not expose the system, especially the mattress, to naked flames, such as cigarettes, etc. • In the event of a fire, a leak in the seat or mattress could propagate the fire. • Do not store the system in direct sunlight. • Do not use phenol-based solutions to clean the system. • Make sure the system is clean and dry prior to use or storage. • Never use sharp objects or electrically heated under blankets on or under the system. • Store the pump and mattress in the protective bags supplied. • Pets and children must be supervised in the vicinity of the system. • When the pump is in use the operator should remain in area in case the system alarms.

Electromagnetic Compatibility (EMC) This product complies with the requirements of applicable EMC Standards. Medical electrical equipment needs special precautions regarding EMC and needs to be installed in accordance with the following instructions: • The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance. • Portable and mobile radio frequency (RF) communications equipment (e.g. mobile/cell phones) can affect medical electrical equipment. • 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.

Environmental Protection Incorrect disposal of this equipment and its component parts, particularly batteries or other electrical components, may produce substances that are hazardous to the environment. To minimise these hazards, contact Arjo for information on correct disposal.

Expected Service Life The Alpha Active® 3 pump has an expected service life of seven years. 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 3 system. Failure to observe this caution could result in injury, or in extreme cases, death.

End of Life Disposal • Fabric material used on the mattresses or any other textiles, polymers or plastic materials etc. should be sorted as combustible waste. • Mattresses at the end of life should be disposed of as waste according to the national or local requirements which may be landfill or combustion. • Pump units have electrical and electronic components should be disassembled and recycled per Waste of Electrical and Electronic Equipment (WEEE) or in accordance with local or national regulation.

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1. Introduction About this Manual

This manual is your introduction to the Alpha Active 3. You must read and fully understand this manual before using the system. 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). The Alpha Active 3 system should be used as part of a prescribed plan of care (refer to Page 4 “Indications”).

About Alpha Active 3

The Alpha Active 3 systems comprise of a mattress overlay and pump. The support system can be used on hospital beds and domestic beds in acute care, long-term care and homecare environments, including private homes.

Alpha Active 3 Pump

The Alpha Active 3 pump comprises of a moulded case with non slip feet on the base and integral hanging brackets.

Control Knob Control Panel

Hanging Brackets

Mattress Connection

The controls are situated on the front of the pump. An alarm system differentiates between normal operation and genuine system faults. If an alarm situation is detected an indicator will illuminate on the front of the pump and an audible warning will sound.

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Alpha Active 3 Mattress Overlay

The Alpha Active 3 mattress overlay comprises the following components:

Cover

3 Static Head Cells

Tubeset

13 Alternating (Active) Cells Serial No. Base Cover

Detachable Cover

Cells

The standard cover comprises of a 2-way stretch polyurethane (PU) 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. The mattress comprises of 16 polyurethane (PU) cells, 13 providing support to the user in either Alternating (Active) or Static (Reactive) mode and 3 Static head cells. NOTE The head cells are not involved for alternating, so these cells don't provide pressure ulcer management function.Check patient head area on a regular basis and be vigilant to skin issue are necessary to patient care.

CPR function

A CPR (Cardio-Pulmonary Resuscitation) control is positioned at the head end of the mattress to allow rapid deflation of the mattress overlay.

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Tube-set

The tube-set has a 2-way pneumatic connection which incorporates a flexible, compact anti-kink tube that is resistant to crushing and any subsequent obstruction of air flow. When disconnecting the tube-set, place the attached cover over the end to place the mattress in transport mode.

Overlay Base Cover

The base cover for the mattress overlay is PU coated nylon on the underside. 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.

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2. Clinical Applications Indications

The Alpha Active 3 system is indicated for the prevention and/or management of all categories1 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. The systems represent one aspect of a pressure ulcer management protocol; all other aspects of care should be considered by the prescribing clinician. If existing wounds do not improve or the patient's condition changes the overall therapy regimen should be reviewed by the prescribing clinician. The above are guidelines only and should not replace clinical judgement. The Alpha Active 3 mattress is designed for patients weighing up to 135 kg (297 lb).

Contraindications Cautions

Do not use Alpha Active 3 system for patients with unstable spinal fractures. 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. While the Alpha Active 3 system has been designed to manage patients up to the weight limits indicated above, those approaching this upper limit are likely to have additional care and mobility needs and may be better suited to a specialist bariatric system. NOTE The above are guidelines only and should not replace clinical judgement or experience.

1. NPUAP/EPUAP International Pressure Ulcer Guideline, 2014.

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3. Installation Preparing the system for use

Remove the system from the packaging. You should have the following items: • Alpha Active 3 pump including mains power cord and hanging brackets. • Alpha Active 3 mattress overlay with integral tube-set. • Cover.

Installing the Mattress

Caution Do not use the mattress overlay directly on the bed frame.

Mattress Overlay

To Complete the Mattress Installation

The Alpha Active 3 mattress overlay system should be installed as follows: 1.

Place the overlay on top of the base mattress, with the tube-set located near the foot end of the bed and the CPR at the head end. The cells of the mattress must be uppermost.

2.

Secure the overlay to the base mattress by placing the four long straps under the corners of the base mattress.

Complete the installation of the mattress overlay as follows: 1.

If not already fitted, place the protective cover over the mattress. Ensure that the logo is uppermost and at the foot end of the mattress.

2.

Zip the cover onto the mattress starting from the head end and taking care not to trap any material in the zip.

3.

Ensure that the CPR unit is secured in it’s closed position.

NOTE The CPR must be accessible at all times.

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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

System Operation

The pump should be installed as follows: 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.

2.

Ensure that the mattress tube-set is not "kinked" or twisted and connect it to the pump until it clicks into place. Ensure that the tube-set is securely connected to the pump.

3.

Insert the mains power plug into a suitable mains power socket.

4.

Put the mains cable under the mattress using the three mattress cable ties. The magic cable tie can be used to manage the surplus cable by the bed foot rail.

The system is now ready for use. Refer to Page 9 “Mattress Pump Operation” for day-to-day operating instructions.

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4. Controls, Alarms and Indicators Controls

Alpha Active 3 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.

Alarm Mute

During an alarm condition the sound of the alarm can be muted by pressing this button. The muted state can also be terminated manually by pressing this button again.

Mode Selector

The mode selector allows the mode of operation to be selected. Two modes of operation are available, Alternating or Static (nonalternating). The indicator next to the respective icon indicates the currently selected mode.

Pressure Control

This is a rotary action control used to manually set the pressure inside the mattress overlay and therefore the amount of support the patient receives.

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Alarms and Indicators Low Pressure Indicator

The Low Pressure indicator is illuminated whenever the pump detects low pressure within the mattress overlay. An audible alarm will sound unless cancelled by the mute button. The indicator will extinguish once normal pressure is reached.

NOTE The Low Pressure alarm is inactive for the first 30 minutes of the pump being switched on.

NOTE The Low Pressure alarm is inactive for the first 30 minutes of the pump being switched on.

Service Indicator/ Pump Fault

Power Fail Indicator

The Service/pump fault indicator will illuminate, an audible alarm will sound and remain on if the pump has detected an internal fault. A Service Engineer should be called.

The Power Fail indicator will illuminate when a mains power failure has been detected. An audible alarm will sound until power is resumed or the pump is switched off using the on/off button.

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.

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5. Mattress - Pump Operation These instructions cover day-to-day operation of the system. Other operations, such as maintenance and repair, should only be carried out by suitably qualified personnel.

NOTE Refer to Page 7 “Controls, Alarms and Indicators” for a comprehensive description of the controls and indicators on the pump. .

WARNING Do not place the patient on the mattress until it is fully inflated.

Quick Start

Support Setting Procedure

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. 1.

Connect the pump to the mains power supply using the supplied cable and switch on the pump.

2.

Press the On/Off button on the side of the pump.

3.

Allow approximately 30 minutes for the mattress overlay to inflate fully.

4.

Place a bed sheet over the mattress and tuck in loosely. Ensure that the CPR unit is clearly visible at the head end of the bed.

It is important to follow the correct support setting procedure to ensure the patient receives adequate support while achieving maximum pressure redistribution and comfort. 1.

Lie or sit the patient on the mattress.

2.

Set pressure dial on pump according to patient weight. This should serve as an approximate guide only. An independent clinical determination needs to confirm that the patient is properly supported.

3.

Wait 10 minutes while the pump adjusts the pressures.

4.

Ensure that the patient is not ‘bottoming out’ by unfastening the cover and sliding a outstretched hand (palm up) underneath the deflated cells below the part of the body where the pressure ulcer exists, or the area at risk for a pressure ulcer.

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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.

When a patient is in the lying or supine position, their body weight 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 on the pressure dial. From Lying to Sitting - Increase pressure control. From Sitting to Lying - Decrease pressure control. This adjustment should be in conjunction with independent clinical determination of appropriate support.

Static

Provides a stable, non-moving support surface for instances where a active therapy surface is contra-indicated e.g. to carry out nursing procedures or for patients unable to tolerate a moving surface. In Static mode the support surface remains constant (all cells are equally inflated). Additional nursing assessment must be undertaken in order to direct an individualised repositioning programme. When operating the system in Static mode it may be necessary, where possible, to reduce the pressure setting to increase patient comfort and safety.

Power Fail Condition

If a Power Fail condition arises disconnect the tubeset from the pump and place the attached cap over the end of the tubeset to put the mattress into transport mode. Transport mode is nontherapeutic offering support only for up to 12 hours. It is recommended that when in transport mode the patient is frequently monitored. Once power is resumed, re-connect the tubeset to the pump to continue therapy.

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To Disconnect the Tubeset

To disconnect the tube-set at any time, depress the buttons on the top and bottom of the tubeset connector pull the tube-set connector away from the pump. To deflate the mattress Refer to Page 11 “To Deflate and Store the 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. This will automatically switch the mattress into transport mode. The patient will remain supported by the mattress for up to 12 hours. To resume normal operation, simply reconnect the tube-set and run the pump.

Caution 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 To deflate the mattress To store the mattress

1.

Disconnect the tube-set from the pump.

2.

Activate the CPR control to deflate the mattress.

Following deflation: 1.

Bring the tubeset over the mattress to lie parallel to the foot end of the mattress.

2.

Roll the mattress from the foot end toward the CPR connector at the head end of the mattress.

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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.

To reset CPR

To re-inflate the mattress simply replace the stopper securely into the manifold.

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6. Decontamination The following processes are recommended, but should be adapted to comply with the local or national guidelines (Decontamination of Medical Devices) which may apply within the Healthcare 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.

WARNING Remove the electrical supply to the pump by disconnecting the mains power cord from the mains power supply before cleaning. Protective clothing should always be worn when carrying out decontamination procedures.

Caution Do not use Phenol-based solutions or abrasive compounds or pads during the decontamination process as these will damage the surface coating. Do not boil or autoclave the cover. Avoid immersing electrical parts in water during the cleaning process. Do not spray cleaning solutions directly onto the pump.

To clean

Clean all exposed surfaces and remove any organic debris by wiping with a cloth moistened with a simple (neutral) detergent and water. Dry thoroughly. Do not allow water or cleaning solutions to collect on the surface of the pump.

Chemical Disinfection

To protect the integrity of the cover we recommend a chlorinereleasing agent, such as sodium hypochlorite, at a strength of 1,000ppm available chlorine (this may vary from 250ppm to 10,000ppm depending on local policy and contamination status). Wipe all cleaned surfaces with the solution, rinse and dry thoroughly. Alcohol based disinfectants (strength 70%) may be used as an alternative. Ensure the product is dry before storage.

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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”.

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