ARJO HUNTLEIGH Alpha Active 3 User manual

Alpha Active 3
Instructions for Use
...with people in mind
648934EN_04 • 11/2017

(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
Pump Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Mattress Size Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

(ii)
Cleaning Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
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®3pump 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.
© ArjoHuntleigh 2017.

1
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
AlphaActive3 system,contact yourlocal ArjoHuntleigh
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 and domestic beds.
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 Panel
Control Knob
Hanging
Mattress
Brackets
Connection

2
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.
Alpha Active 3
Mattress Overlay
The Alpha Active 3 mattress overlay comprises the
following components:
Detachable Cover 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.
Cells 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.
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.
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.
Cover
3 Static Head Cells
13 Alternating (Active) Cells
Tubeset
Serial No.
Base Cover

3
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 PVC coated
nylon (a PU version is also available) on the underside.
Four corner retention straps are incorporated, which
slide under the corners of the base mattress.
A full technical description of theAlphaActive 3 system
can be found in the Service Manual, part number
SER0017, available from your ArjoHuntleigh sales
office.

4
2. Clinical Applications
Indications The Alpha Active 3 system is indicated for the
prevention and/or management of all categories1of
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
managementprotocol;all otheraspectsof careshouldbe
considered by the prescribing clinician.
If existing wounds do not improve or the patient's
conditionchanges theoveralltherapy regimenshouldbe
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 Do not use Alpha Active 3 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.
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.
The above are guidelines only and should not replace clinical judgement or
experience.
1. NPUAP/EPUAP International Pressure Ulcer Guideline, 2009.