ARJO HUNTLEIGH Alpha Active 3 Bedienungsanleitung

Alpha Active 3

Instructions for Use

...with people in mind

648934ML_06 • 08/2018

Instrucciones de uso • Manuel d’utilisation • Istruzioni per l’uso

Gebruiksaanwijzing

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(i)

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

Pump Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Mattress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Mattress Size Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Cleaning Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

(ii)

Cover Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

(iii)

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 ArjoHuntleigh should be

used. The correct function of the product cannot be guaranteed if incorrect pump

and mattress combinations are used.

(iv)

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 ArjoHuntleigh 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 ArjoHuntleigh 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 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

® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. 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 ArjoHuntleigh.

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