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.

5
3. Installation
Preparing the system
for use
Remove the system from the packaging. You should
have the following items:
•Alpha Active 3 pump including mains power cord
and hanging brackets.
•Alpha Active 3 mattress overlay with integral tube-
set.
• Cover.
Installing the Mattress
Mattress Overlay The Alpha Active 3 mattress overlay system should be
installed as follows:
1. Place the overlay on top of the base mattress, with
the tube-set located near the foot end of the bed and
the CPR at the head end. The cells of the mattress
must be uppermost.
2. Secure the overlay to the base mattress by placing
the four long straps under the corners of the base
mattress.
To Complete the
Mattress Installation Complete the installation of the mattress overlay 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.
Caution
• Do not use the mattress overlay directly on the bed frame.

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 tube-set is not "kinked" or
twisted and connect it to the pump until it clicks
into place. Ensure that the tube-set 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. Refer to
Page 9 “Mattress - Pump Operation” 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
pumpwillperformaselftestduringwhichallLEDswill
illuminate, and audible beeps will sound.
Alarm Mute During an alarm condition the sound of the alarm can be
muted by pressing this button. The muted state can also
be terminated manually by pressing this button again.
Mode Selector 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.
Pressure Control This is a rotary action control used to manually set the
pressure inside the mattress overlay and therefore the
amount of support the patient receives.

8
Alarms and Indicators
Low Pressure Indicator The Low Pressure indicator is illuminated whenever the
pump detects low pressure within the mattress overlay.
An audible alarm will sound unless cancelled by the
mute button.
The indicator will extinguish once normal pressure is
reached.
The Low Pressure alarm is inactive for the first 30 minutes of the pump being
switched on.
See Page 16 “Troubleshooting and Alarm Conditions” for possible causes
of Low Pressure.
Service Indicator/Pump Fault
The Service/pump fault indicator will illuminate, an
audible alarm will sound 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.
If the operation of the pump changes during use, refer to
Page 16 “Troubleshooting and Alarm Conditions” of this IFU before
calling a service engineer or contacting your local ArjoHuntleigh sales
office.

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 Page 7 “Controls, Alarms and Indicators” for a comprehensive
description of the controls and indicators on the pump.
Quick Start Before using the Alpha Active 3 mattress overlay make
sure it has been installed correctly in accordance with
Page 5 “Installation”andensurethattheCPRunitonthe
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
overlay to inflate fully.
4. Place a bed sheet over the mattress and tuck in
loosely. Ensure that the CPR unit is clearly visible
at the head end of the bed.
Support Setting
Procedure
It is important to follow the correct support setting
procedure to ensure the patient receives adequate
support while achieving maximum pressure
redistribution and comfort.
1. Lie or sit the patient on the mattress.
2. Set pressure dial on pump according to patient
weight. This should serve as an approximate guide
only. An independent clinical determination needs
to confirm that the patient is properly supported.
3. Wait 10 minutes while the pump adjusts the
pressures.
4. Ensure that the patient is not ‘bottoming out’ by
unfastening the cover and sliding a outstretched
hand (palm up) underneath the deflated cells below
the part of the body where the pressure ulcer exists,
or the area at risk for a pressure ulcer.
WARNING
Do not place the patient on the mattress until it is fully inflated.

10
5. If the caregiver feels less than an inch of support
material, the patient has bottomed out and the
support pressures should be adjusted accordingly.
6. Bottoming out should be checked at various
anatomical sites and while the patient assumes
various body positions.
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
sittingposition, their body weightisconcentrated 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 on
the pressure dial.
From Lying to Sitting - Increase pressure control.
From Sitting to Lying - Decrease pressure control.
This adjustment should be in conjunction with
independent clinical determination of appropriate
support.
Static Provides a stable, non-moving support surface for
instances where a active therapy surface is contra-
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 mattresss into transport mode.
Transportmode is non-therapeuticoffering support only
for up to 12 hours. It is recommended that when in
transportmodethepatientisfrequentlymonitored.Once
power is resumed, re-connect the tubeset to the pump to
continue therapy.

11
To Disconnect the
Tubeset To disconnect the tube-set at any time, depress the
buttons on the top and bottom of the tubeset connector
pull the tube-set connector away from the pump.
To deflate the mattress Refer to Page 11 “To Deflate
and Store the Alpha Active 3 Mattress”.
Transport Mode To transport a patient using the Alpha Active 3 mattress
overlay, disconnect the tube-set from the pump and
place the attached cap over the end of the tubeset to put
themattressintotransportmode.Thiswillautomatically
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 tube-
set and run the pump.
To Deflate and Store the Alpha Active 3 Mattress
To deflate the mattress: 1. Disconnect the tube-set 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 CPR
connector at 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 overlay (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.
TheAlphaActive 3 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.
Do not allow water or cleaning solutions to collect on
the surface of the pump.
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.
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 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
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.
DO NOT WRING/MANGLE, AUTOCLAVE OR USE
PHENOLIC BASED SOLUTIONS.
Thermal Disinfection For information for the mattress top cover, including
laundering guidelines, refer to Page 20 “Cover
Specification”.