Getinge Arjohuntleigh ALPHA RESPONSE Instructions For Use Manual
ALPHA RESPONSE
INSTRUCTIONS FOR USE
0086
...with people in mind
Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About Alpha Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Mattress: Overlay and Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Seat Cushion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Care of the patient when sitting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Preparing the Systems for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Installing the Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Installing the Seat Cushion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Installing the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Controls, Alarms and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mattress - Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Installing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Initial Inflation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Mattress Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Stopping Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
To Deflate the Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
To Store the Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Transport Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
CPR Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Seat Cushion - Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Seat Cushion Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
To Deflate the Seat Cushion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Alpha Response System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Mattress Replacement, Overlay and Seat Cushion . . . . . . . . . . . . . . . . . . . . . . . . 25
Serial Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
(i)
Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
(ii)
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:
• EN60601-1:1990/A13:1996 and IEC 60601-1:1988/A2:1995.
• UL60601-1, UL2601-1 and CAN/CSA C22.2 No. 601.1-M90.
• EN60601-1:2006, EN60601-1-11:2010 and IEC 60601-1:2005.
• AAMI/ANSI ES60601-1:2006 and CAN/CSA C22.2 No.60601.1(2008).
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, the decision to use safety sides should be 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. The mains power cable of this pump is designed
to allow movement of the bed, and should be fitted into the cable management
flaps along the sides of the mattress, as described in this manual.
• When using a seat cushion, the tubeset may be a trip hazard; position the tubeset
so that it does not create a trip hazard, and always supervise babies and small
children when the product is in use.
• 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.
• Do not use the mattress without a cover, it provides a protective barrier.
• Bags supplied with this equipment may present a suffocation risk; to avoid the risk
of suffocation keep the bags away from babies and small children.
• There is no transport mode on the seat cushion.
• Only the pump and mattress or seat combination as indicated by ArjoHuntleigh
should be used. The correct function of the product cannot be guaranteed if
incorrect pump and mattress or seat combinations are used.
(iii)
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 use or 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.
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 Response™ 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
extreme cases, death.
Response system. Failure to observe this caution could result in injury, or in
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 2013
(iv)
1. Introduction
About this Manual This manual is your introduction to the Alpha
Response™ system. Use it to initially set up the system
and keep it as a reference for day-to-day routines and as
a guide to maintenance. You must read and fully
understand this manual before using the system.
If you have any difficulties in setting-up or using the
Alpha Response system, contact your 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 160 kg
(352 lb).
About Alpha
Response
The Alpha Response
system should be used as part of a
prescribed plan of care (refer to “Indications” on
page 4).
The Alpha Response system is a pressure redistributing
mattress replacement, mattress overlay or seat cushion
system designed to complement pressure ulcer
treatment and prevention protocols. The product offers
two therapeutic modes:
• Active
1
(Alternating) mode which periodically
redistributes pressure away from vulnerable areas by
inflating and deflating the cells beneath the body
every 10 minutes.
• Reactive
1
(Constant Lower Pressure or CLP) mode
where the cell pressure is reduced and held constant
across the surface in order to lower the pressure
exerted on the body.
The product also offers an additional option, Transport
Mode, where therapy is interrupted and the mattress
cells become static in order to assist with patient
transport.
The mattresses can be used on standard hospital and
normal domestic beds. Beds with divided sections for
independent elevation of a patient's head and/or knees
can be adjusted with these mattresses in position. The
seat cushion can be used on standard hospital and
normal domestic chairs.
1. International Pressure Ulcer Prevention and Treatment Guideline (2009). www.epuap.org
1
The pump has three settings for the patient weight range:
• Light: 40-70 kg
• Normal: 70-120 kg
• Heavy: 120-160 kg
The pump will automatically detect whether a mattress
or seat cushion is connected.
If the backrest on the bed is raised (the patient is in a
semi-recumbent position), the system detects the new
position and automatically increases the pressure in the
mattress cells to provide optimal pressure redistribution
to the patient.
Pump
LCD Screen, Controls
and LED Indicator
A full technical description of the Alpha Response
system can be found in the Service Manual, part number
SER0021, available from your ArjoHuntleigh sales
office.
Carry
Handle
Tubeset
Connector Bed-Hooks
Swing-out
2
Mattress: Overlay and Replacement
Detachable Cover3 Static Head Cells
14 Standard Cells
FOOT END
Tubeset
HEAD END
CPR
Control
Securing Straps
Cable Management Flap
Transportation Loop
Seat Cushion
Active (Alternating) Cells
Fixing Straps
Base Cover
Detachable Cover
Deflation Valves
(on underside for
packing and storage)
Tubeset
3
2. Clinical Applications
Indications The Alpha Response systems are indicated for the
prevention and/or management of all categories
1
of
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.
These 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 Response mattress and cushion are designed for
patients weighing up to
Contraindications Do not use Alpha Response systems for patients with
unstable spinal fractures.
160 kg (352 lb).
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 Response systems have 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.
Active therapy (alternating) cushions may be unsuitable
for patients with poor sitting posture or pelvic deformity;
advice from a seating specialist should be sought.
Care of the patient
when sitting
Seated patients are at increased risk of pressure ulcers
particularly if they are immobile or have wounds over the
seating area. For optimal outcome, provide a pressure
redistributing seat cushion in a chair which promotes a
good sitting posture and has a level base seat to support the
cushion, in addition to an individualised repositioning
programme.
Mattress and cushion combinations may have different upper weight limits.
Cushions should be used in combination with pressure-redistributing
mattresses to provide 24-hour therapy.
1. NPUAP/EPUAP International Pressure Ulcer Guideline, 2009.
4
3. Installation
WARNING
Bags supplied with this equipment may present a suffocation risk;
to avoid the risk of suffocation keep the bags away from babies and
small children.
Preparing the
Systems for Use
Remove the system from the packaging. You should
have the following items:
• Alpha Response pump including mains power cable.
• Alpha Response mattress overlay, Alpha Response
mattress replacement or Alpha Response seat
cushion, which all have integral tubesets and top
covers.
Do not use the mattress or seat cushion without a
cover.
Installing the Mattress
Caution
Do not use the mattress overlay directly on the bed frame.
Mattress Overlay 1. Place the overlay on top of the base mattress, with
the tubeset located near the foot end of the bed and
the CPR at the head end. The mattress cover must
be uppermost.
2. Attach the mattress to the bed frame using the four
strap assemblies on the underside of the mattress
replacement:
• The strap assemblies are attached to four of the
five pairs of anchor points, their position
depending on the type of bed frame. One strap
assembly must be at the head end of the mattress
and a second must be at the foot end. The
remaining two can be attached to any of the three
pairs of anchor points in the middle of the
mattress.
• Pass each half of the strap assembly under the
base mattress, connect them together and pull the
strap assembly tight.
5
Top View View on Underside of Mattress
Head
End
Base Mattress
Mattress Replacement 1. Remove the existing mattress from the bed frame
Strap Strap AssembliesTypical Strap Anchor Points
Foot
End
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 at the foot end of the bed
and the CPR at the head end.
3. Attach the mattress to the bed frame using the eight
fastener straps. The eight fastener straps can be
moved to any of the ten anchor points on the
bottom of the mattress replacement. This allows for
attaching the mattress to different types of bed
frame.
If the bed has divided sections for independent
elevation of a patient's head and/or knees, attach the
mattress to the movable parts of the bed frame only.
One strap assembly must be at the head end of the
mattress and a second must be at the foot end.
WARNING
The CPR control and CPR indicator tag must be visible and
accessible at all times.
Closing the CPR
Control
On the mattress overlay or mattress replacement, make
sure the CPR control is closed:
• The CPR control consists of a connector in the side
of the mattress with a removable plug fitted.
• Make sure the CPR plug is fully pushed into the
connector on the mattress.
6
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