ARJO HUNTLEIGH Alpha Response User manual

Instructions For Use
ALPHA RESPONSE™

(i)
Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Safety Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Environmental Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Design Policy and Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About Alpha RESPONSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Mattress: Overlay and Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
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 Alpha RESPONSE Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Installing the Alpha RESPONSE Seat cushion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Installing the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Controls, Alarms and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mattress - Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

(ii)
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Maintenance and Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Alpha RESPONSE System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Alpha RESPONSE Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Alpha RESPONSE Mattress Replacement, Overlay and Seat Cushion . . . . . . . . . 24
Serial Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

(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:
• EN60601-1:1990/A13:1996 and IEC 60601-1:1988/A2:1995
• UL60601-1 and CAN/CSA C22.2 No. 601.1-M90
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.
• There is no transport mode on the Alpha RESPONSE seat cushion.
• 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.
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.

(iv)
• 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.
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.
Service Information
ArjoHuntleigh recommend that this system should be serviced every 12 calendar months or,
where applicable, when the service indicator is illuminated.
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.
© ArjoHuntleigh 2009.

1
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.
About Alpha
RESPONSE 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:
•Active1(Alternating) mode which periodically
redistributes pressure away from vulnerable areas by
inflating and deflating the cells beneath the body
every 10 minutes.
•Reactive1(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.
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.
1. International Pressure Ulcer Prevention and Treatment Guideline (2009). www.epuap.org

2
Pump
Mattress: Overlay and Replacement
LCD Screen, Controls
Swing-out
Tubeset
Connector Bed-Hooks
Carry
Handle
and LED Indicator
Detachable Cover3 Static Head Cells
CPR
14 Standard Cells
Tubeset
Control
Transportation Loop Cable Management Flap
Securing Straps
HEAD END
FOOT END

3
Seat Cushion
Detachable Cover
Active (Alternating) Cells
Base Cover
Fixing Straps
Tubeset
Deflation Valves
(on underside for
packing and storage)

4
2. Clinical Applications
Indications The Alpha RESPONSE systems are indicated for the
prevention and management of all categories1of pressure
ulcer when combined with an individualised monitoring,
repositioning and wound care programme.
The Alpha RESPONSE mattress is designed for patients
weighing up to 160 kg (352 lb).
The Alpha RESPONSE cushion is designed for patients
weighing up to 160 kg (352 lb).
Contraindications Do not use Alpha RESPONSE systems 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 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 levelbaseseat to support the
cushion, in addition to an individualised repositioning
programme.
The above are guidelines only and should not replace clinical judgement.
The Alpha RESPONSE systems represent one aspect of a pressure ulcer
management strategy; if existing wounds do not improve or the patients
condition changes the overall therapy regimen should be reviewed by the
prescribing clinician.
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.

5
3. Installation
Preparing the
Systems for Use 1. Remove the system from the packaging. You
should have the following items:
•Alpha RESPONSE pump including mains
power cable.
• Either the Alpha RESPONSE mattress overlay,
Alpha RESPONSE mattress replacement or
Alpha RESPONSE seat cushion, which all have
integral tubesets.
Installing the Alpha RESPONSE Mattress
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 4
strap assemblies on the underside of the mattress
replacement:
• The strap assemblies are attached to 4 of the 5
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.
Caution
Do not use the mattress overlay directly on the bed frame.
Strap Strap AssembliesTypical Strap Anchor Points
Top View View on Underside of Mattress
Base Mattress
Head
End Foot End

6
Mattress Replacement 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 at the foot end of the bed
and the CPR at the head end.
3. Attach the mattress to the bed frame using the 8
fastener straps. The 8 fastener straps can be moved
to any of the 10 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
elevationofapatient'sheadand/orknees,attachthe
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.
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.
WARNING
The CPR control and CPR indicator tag must be visible and
accessible at all times.
12

7
Installing the Alpha RESPONSE Seat cushion
1. Check that there are no sharp objects on the chair
which may puncture the cushion.
2. Place the cushion on top of the chair surface.
Stand in front of the chair and look towards it.
Make sure that:
• The cells are uppermost.
• The tubeset appears from the front right corner of
the cushion.
• The cells in the seat cushion are in a horizontal
position across the chair, with the “V” shape
pointing towards the front.
3. Secure the seat cushion to the chair by using the
fixing straps as shown in the following illustrations.
4. If the chair is of the open sided construction, then
fix the cushion as shown below:
Cautions
• Do not use the seat cushion without a foam cushion beneath it.
• Always use the seat cushion with the protective top cover.
• Always use the seat cushion in the correct orientation.
• Avoid trailing cables - make sure that cables and tubes are
positioned beneath the chair to avoid causing a hazard.

8
5. If the chair is of the closed side type with a
removable seat cushion, fix the seat cushion as
shown below:
6. If the chair is of the closed side type with a non-
removable seat cushion, then security will rely on
the anti-slip base material of the seat cushion.
7. Place the protective cover over the seat cushion and
ensure that the logo and the orientation icon,
printed on the cover, are uppermost and at the front
of the seat.
8. Zip the cover onto the seat cushion, taking care not
to trap any material in the zip.
Installing the Pump 1. Position the pump, feet down, on any convenient
horizontal surface or alternatively suspend from the
bed foot-rail by means of the swing-out hooks.
2. Insert the mains power plug into a suitable mains
power socket.
Bed Foot-Rail Swing-Out Hook
Mains Power Plug

9
Cable Management
in Mattresses The mains power cable should be put through one of the
cable management flaps which are on each side of the
mattress, as follows:
1. Locate one of the cable management flaps.
2. If necessary, open the press studs along the flap.
3. Run the mains power cable along the side of the
mattress securing the flap round the cable using the
press studs.
Connecting the
Tubeset Make sure the mattress/seat tubeset is not “kinked” or
twisted, and push the tubeset connector firmly onto the
pump until it clicks into place.
Make sure that the tubeset is securely connected to
the pump.
“Click”
12

10
Disconnecting the
Tubeset To disconnect the tubeset at any time, push down the
release button on the top of the tubeset connector and
pull the tubeset connector away from the pump.
This will put the mattress into Transport Mode and will
not deflate the mattress. To deflate the mattress,
refer to “To Deflate the Mattress” on page 18.
There is no transport mode on the Alpha
RESPONSE seat cushion.
System Operation The system is now ready for use. Refer to “Controls,
Alarms and Indicators” on page 11 and “Mattress -
Pump Operation” on page 16 for day-to-day operating
instructions.
12
Release
Button

11
4. Controls, Alarms and Indicators
Control Panel
LCD Screen Thisdisplaystheoperatingmodeandstatusofthepump,
as follows:
• Mattress/Seat Status.
• Weight Range (or Mattress Mode, if selected by the
Mode Selection).
• Mode Selection.
• Activity Indicator.
Run/Standby Button Press the Run/Standby button to put the pump into the
Run mode; the LED indicator will change to green.
To put the pump into Standby, press the Run/Standby
button for approximately 3 seconds; this prevents
accidental operation. The LCD screen will go blank and
the LED indicator will change to amber.
After you put the pump in Standby, if you press the
Run/Standby button within approximately 15 seconds
the pump will go straight to the Run mode and continue
the previous therapy; if you wait more than 15 seconds
the pump will re-initialise and restart the initial mattress/
seat cushion inflation sequence.
If the mains power is disconnected from the pump while
the pump is operating, the pump will enter the Power
Fail Alarm mode (refer to “Alarms” on page 15). Press
and hold the Run/Standby button; the alarm will stop
and the pump will switch off completely.
LED Indicator
Select Button
Run/Standby
Weight/Mode
LCD Screen
Mattress/Seat Mode Icon
Weight Range Icons Activity Indicator
Button
Select Buttons
Mode
Selection
Icon
LED Indicator
Run/Standby Button

12
LED Indicator The multicolour LED adjacent to the Run/Standby
button indicates the status of the pump, as follows:
Mattress/Seat Status There are 5 mattress/seat mode icons which can be
displayed, as follows:
Select Button The function of the Select button depends on the pump
changebeingcarriedoutandthe icon being displayed on
the LCD screen directly above the button.
Mode Selection Icon This “double-arrow” icon indicates that the pump is in
normal therapy mode, and pressing the Select button
below it will select either the Weight Range icons or
the Mode icons.
Whenthe Weight Range or Modeis being changed, the
Mode Selection icon will change to a “tick” and flash.
Pressing the Select button under the “tick” will confirm
the new selection.
If the Select button is not pressed for 5 seconds
when the flashing “tick” is displayed, the requested
pump status change will be ignored, the “tick” will
revert back to the Mode Selection icon and the
pump will continue in its current state.
Amber (Constant) External power is applied to the
pump, but the pump is in Standby.
Green (Constant) The pump is in Run mode and
operating.
Red (Flashing) The pump has detected an alarm
condition.
Mattress
Backrest Horizontal
Active (Alternating) Mode
Mattress
Backrest Horizontal
Reactive (CLP) Mode
Mattress
Backrest Raised
Active (Alternating) Mode
Mattress
Backrest Raised
Reactive (CLP) Mode
Seat
Active (Alternating) Mode

13
Weight Range There are three Weight Range icons displayed on the
LCD screen, the relative size of each “person” icon
corresponding to the patient weight range. The selected
weight range is indicated by the corresponding icon
being solid and the other two icons as outlines.
Patient comfort and clinical judgement should be
used to select the correct weight range setting.
To change the Weight Range, do the following:
1. Press the Weight/Mode Select buttons to highlight
the new Weight Range icon; the new icon will be
solid and flashing.
2. The Mode Selection icon will change:
3. Press the Select button to confirm the new Weight
Range setting.
Light Weight
Weight Range: 40-70 kg
Normal Weight
Weight Range: 70-120 kg
Heavy Weight
Weight Range: 120-160 kg

14
Mode If the Select button is pressed during therapy when the
Mode Selection icon is displayed, then the Weight
Range icons are replaced by two Mode icons. The
selected Mode is indicated by the corresponding icon
being solid and surrounded by a square and the
remaining icon as an outline:
To change the Mode, do the following:
1. Make sure the Mode Selection icon is displayed.
2. Press the Select button, and the two Mode icons
are then displayed.
3. Press the Weight/Mode Select buttons to highlight
the new Mode icon. The new Mode icon will be
solid with a square border.
4. The new Mode icon and square will flash and the
Mode Selection icon will change:
5. Press the Select button to confirm the new Mode.
6. Press the Select button again and the two Mode
icons are replaced by the Weight Range icons.
Activity Indicator After the mattress has inflated and the system is in the
normal operating mode, an Activity Indicator icon is
displayed in the top right corner of the LCD screen:
•The
Activity Indicator rotates in a clockwise
direction to show that the pump is operating
normally.
•The
Activity Indicator will stop rotating and start
flashing if the pressure changes dramatically e.g. if
the patient moves heavily on the mattress or if the
Weight Range is changed. Once the pump pressure
has stabilised around its target pressure the Activity
Indicator will stop flashing and start rotating again.
Active (Alternating) Mode
Backrest Horizontal
Reactive (CLP) Mode
Backrest Horizontal