Arjo Alpha Active 4 Manuale utente

Alpha Active 4

648936EN_11 • 02/2023

INSTRUCTIONS FOR USE

Design Policy and Copyright

® and ™ are trademarks belonging to the Arjo 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 Arjo.

WARNING

To avoid injury, always read this Instructions for Use and accompanied documents

before using the product.

(i)

Contents

General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

About Alpha Active 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Alpha Active 4 Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Alpha Active 4 Mattress Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Preparing the system for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Installing the Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Controls, Alarms and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Alarms and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Mattress - Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Support Setting Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Changes in Patient Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

To Deflate and Store the Alpha Active 4 Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

CPR Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

To activate CPR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

To reset CPR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Alpha Active 4 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Alpha Active 4 Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Alpha Active 4 Mattress Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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

Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

(ii)

Intentionally left blank

(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 IEC60601-1-8:2012

• ANSI/AAMI ES 60601-1(2005)+AMD(2012) and CAN/CSA C22.2 No.60601-1(2008)+(2014).

Safety Warnings

• It is the responsibility of the caregiver1to 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.

1. Caregiver may be a healthcare professional or a lay person who operates this medical device.

(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.

• 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®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 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.

1. Introduction

About this Manual This manual is your introduction to the

Alpha Active®4.

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 4

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 200 kg (440 lb).

The

Alpha Active 4

system should be used as part of a prescribed

plan of care (refer to “Indications” on page 5).

About Alpha Active 4 The

Alpha Active 4

systems comprise of a mattress replacement

and pump. The support system can be used on hospital and

domestic beds in acute care, long-term care and homecare

environments, including private homes.

WARNING

To avoid injury to the patient when operating the

Alpha Active 4 system as a caregiver and as a lay

person:

• Make sure the system is operating according to

section “Mattress - Pump Operation” on

page 10.

• If the system is not operating correctly, see

section “Troubleshooting and Alarm

Conditions” on page 16.

• If the system is still not operating correctly, or if

you have concerns, contact the patient’s doctor

or nursing staff for advice.

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. If an alarm situation is

detected an indicator will illuminate on the front of the pump and

an audible warning will sound.

Control Panel

Hanging

Mattress

Brackets

Connection

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.

Cells The mattress comprises of 19 PU cells, 16 providing support to

the user in either Alternating (Active) or Static (Reactive) mode

and 3 Static head cells.

CPR function A CPR (Cardio-Pulmonary Resuscitation) control is positioned at

the head end of the mattress to allow rapid deflation of the

mattress.

Tubeset The tubeset has a 3-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 tubeset, place the attached cover over

the end to place the mattress in transport mode.

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.

Mattress Replacement

Base Cover

The base cover for the mattress replacement is PU coated nylon

on the underside. There are six straps located on the underside

of the mattress replacement to secure the mattress to the

bedframe.

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.

Zipped Cover

3 Static Head Cells

16 Alternating Cells

Tubeset

Serial No.

Base Cover

(Inside cover)

CPR

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