ARJO HUNTLEIGH alpha active 4 User manual

Alpha Active 4
Instructions for Use
...with people in mind
648936EN_04 • 10/2017
Kg
Min

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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 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 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.

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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.
• 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®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 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.

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Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About Alpha Active 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Alpha Active 4 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Alpha Active 4 Mattress Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 4 Mattress. . . . . . . . . . . . . . . . . . . . . . 11
CPR Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
To activate CPR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
To reset CPR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
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
Pump Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Mattress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Mattress Size Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

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Cleaning Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Cover Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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 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 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 4).
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.
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

2
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.
Mattress Replacement
Base Cover
The base cover for the mattress replacement is PVC
(Polyvinyl Chloride) coated nylon on the underside.
There are six straps located on the underside of the
mattress replacement to secure the mattress to the
bedframe.
Zipped Cover
3 Static Head Cells
16 Alternating Cells
Tubeset
Serial No.
Base Cover
(Inside cover)
CPR

3
A full technical description of the Alpha Active 4 system
can be found in the Service Manual, part number
SER0018, available from your ArjoHuntleigh sales
office.

4
2. Clinical Applications
Indications The Alpha Active 4 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
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 4 mattress is designed for patients
weighting up to 200 kg (440lb).
Contraindications Do not use Alpha Active 4 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 4 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.

5
3. Installation
Preparing the system
for use
Remove the system from the packaging. You should
have the following items:
•Alpha Active 4 pump including mains power cord
and hanging brackets.
•Alpha Active 4 mattress replacement with integral
tubeset.
• Cover.
Installing the
Mattress
The Alpha Active 4 mattress replacement system should
be installed as follows:
1. Remove the existing mattress from the bed frame
and check that there are no protruding bed springs
or sharp objects on the bed frame surface.
2. Unroll the mattress onto the bed frame and ensure
that the tubeset is located near the foot end of the
bed and the CPR at the head end. The cells of the
mattress must be uppermost.
3. Secure the mattress to the bed frame using the 6
fastener straps.
If the bed can be profiled to any position (i.e. raised or lowered), attach the
mattress to the movable parts of the bed only.
To Complete the
Mattress Installation
Complete the installation of the mattress replacement 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.
The CPR must be accessible at all times.

6
Installing the Pump 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 tubeset is not “kinked” or
twisted and connect it to the pump until it clicks
into place. Ensure that the tubeset is securely
connected to the pump.
3. Insert the mains power plug into a suitable mains
power socket.
System Operation The system is now ready for use. See “Mattress - Pump
Operation” on page 9 for day-to-day operating
instructions.
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.

7
4. Controls, Alarms and Indicators
Controls
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, and the audible alarm will
be silenced for 15 minutes. The mute state can also be
terminated manually by pressing this button again.
Mode Select The mode selector allows the mode of operation to be
selected.
Two modes of operation are available, Alternating or
Static (non-alternating). The indicator next to the
respective icon indicates the currently selected mode.
Auto-firm Mode Selects the Auto-firm, non-alternating mode. The orange
indicator will illuminate when the pump is in this mode.
Auto-firm lasts 30 minutes, after which the pump will
default back to the previous setting.
Patient Weight Selector Two buttons (+ and -) are used to select the patient
weight. This sets the pressure inside the mattress
replacement and therefore the amount of support the
patient receives. The patient weight setting may be
affected by a power fail event. See Power Fail on
page 8.
The pressure setting is indicated by the green indicator
above the selected setting.
Cycle Time A single button allows the cycle time to be selected for
patient and/or clinician preference. The cycle time
setting is indicated by the green indicator above the
selected setting.
Kg
Min
AlarmsPatient Weight Selector
Cycle Time Alarm Mute Mode Select Auto-firm Mode
Kg
Min

8
Alarms and Indicators
Low Pressure Indicator The Low Pressure indicator is illuminated whenever the
pump detects low pressure within the mattress
replacement. An audible alarm will sound, but the
audible alarm can be muted by the mute button.
The indicator will extinguish once normal pressure is
reached.
See “Troubleshooting and Alarm Conditions” on page 16 for possible
causes of Low Pressure.
Service Indicator/Pump Fault
The Service/pump fault indicator will illuminate and
remain on if the pump has detected an internal fault. A
Service Engineer should be called.
Power Fail Indicator 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.
Weight settings are affected due to power fail. There are two variants of
pump in the market as follows:
1. The pump will revert to a default patient weight setting of 125 kg
(275 pounds) once power is restored after a power outage or generator test.
2. The pump will revert to the last setting set by the caregiver once power is
restored after a power outage or generator test.
To determine which pump is being used once the pump is operating, set the
pump to 20 kg (44 pounds) and disconnect from the power supply. Reconnect
power and if the pump reverts to 125 kg (275 pounds), you have pump 1, and
if it reverts to 20 kg (44 pounds), you have pump 2.

9
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.
Refer to “Controls, Alarms and Indicators” on page 7 for a comprehensive
description of the controls and indicators on the pump.
Quick Start Before using the Alpha Active 4 mattress replacement
make sure it has been installed correctly in accordance
with “Installing the Mattress” on page 5, 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
replacement to inflate fully.
4. Place a bed sheet loosely over the mattress without
tucking, to gain maximum pressure redistribution.
Support Setting
Procedure
It is important to follow the correct support setting
procedure to ensure the patient receives adequate
support (lift) while achieving maximum pressure
redistribution and comfort.
1. Lie or sit the patient on the mattress.
2. Select appropriate cycle time.
3. Select patient weight on pump. This should serve as
an approximate guide only. An independent clinical
determination needs to confirm that the patient is
properly supported.
4. Wait 10/20 minutes while the pump adjusts the
pressures.
WARNING
Do not place the patient on the mattress until it is fully inflated.

10
5. Ensure that the patient is not ‘bottoming out’. To do
this, unfasten the cover and slide a hand beneath the
patients sacral area to ensure at least 2.5cm
clearance between the sacrum and bed base.
6. If the caregiver feels less than 2.5cm of support
material, the patient has bottomed out and the
support pressures should be adjusted accordingly.
Changes in Patient
Position
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 of the
patient weight selector.
From Lying to Sitting - Increase weight selector setting.
From Sitting to Lying - Decrease weight selector setting.
This adjustment should be in conjunction with
independent clinical determination of appropriate
support.
Static Provides a stable, non-moving support surface for
instances where active therapy is not 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.
Once power is resumed, re-connect the tubeset to the
pump and carry out the “Support Setting Procedure” on
page 9 to continue therapy.
To Disconnect the
Tubeset
To disconnect the tubeset at any time, depress the
buttons on the top and bottom of the tubeset connector
pull the tubeset connector away from the pump.
To deflate the mattress Refer to “To Deflate and Store the
Alpha Active 4 Mattress” on page 11.

11
Transport Mode To transport a patient using the Alpha Active 4 mattress
replacement, disconnect the tubeset 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
tubeset and run the pump.
To Deflate and Store the Alpha Active 4 Mattress
To deflate the mattress: 1. Disconnect the tubeset from the pump.
2. Activate the CPR control to deflate the mattress.
To store 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 head
end of the mattress.
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.

12
CPR Control
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 replacement (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.
IMPORTANT
IN THE EVENT OF CARDIAC ARREST

13
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 4 system should be routinely decontaminated between patients and
at regular intervals while in use; as is good practice for all reusable medical devices.
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.
Chemical Disinfection To protect the integrity of the cover we recommend a
chlorine-releasing 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.
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.
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 wring/mangle, boil or autoclave the cover.
Avoid immersing electrical parts in water during the cleaning
process. Do not spray cleaning solutions directly onto the pump.

14
Thermal Disinfection For information for the mattress top cover, including
laundering guidelines, refer to “Cover Specification” on
page 20.