Arjo Alpha Active 4 User manual

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

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
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
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.

2
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

3
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.

4
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