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.
About this ManualThis 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 UseThe 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
ConnectorBed-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
IndicationsThe Alpha Responsesystems 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.
TheAlpha Response mattress and cushion are designed for
patients weighing up to
ContraindicationsDo not use Alpha Response systems for patients with
unstable spinal fractures.
160 kg (352 lb).
CautionsIf 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 Overlay1.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 ViewView on Underside of Mattress
Head
End
Base Mattress
Mattress Replacement1.Remove the existing mattress from the bed frame
StrapStrap 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
12
Installing the Seat Cushion
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.
• Position the tubeset so it does not create a trip hazard and
always supervise babies and small children when the product
is in use.
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.
7
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:
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 nonremovable 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.
8
Installing the Pump1.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
Mains Power Plug
Cable Management
in Mattresses
Swing-Out Hook
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.
9
“Click”
12
Disconnecting the
Tubeset
Release
Button
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.
12
System OperationThe 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.
10
4.Controls, Alarms and Indicators
Control Panel
Weight Range IconsActivity Indicator
Weight/Mode
Select Buttons
LCD ScreenThis displays the operating mode and status of the pump,
LCD Screen
Mattress/Seat Mode Icon
Select Button
as follows:
• Mattress/Seat Status.
• Weight Range (or Mattress Mode, if selected by the
Mode Selection).
LED Indicator
Run/Standby
Button
Mode
Selection
Icon
• Mode Selection.
• Activity Indicator.
Run/Standby ButtonPress the Run/Standby button to put the pump into the
Run mode; the LED indicator changes to green.
LED Indicator
To put the pump into Standby, press the Run/Standby
button for approximately three seconds; this prevents
accidental operation. The LCD screen goes blank and
the LED indicator changes to amber.
After you put the pump in Standby, if you press the Run/
Standby button within approximately 15 seconds the
Run/Standby Button
pump goes straight to the Run mode and continues the
previous therapy; if you wait more than 15 seconds the
pump re-initialises and restarts the initial mattress/seat
cushion inflation sequence.
If the mains power is disconnected from the pump while
the pump is operating, the pump enters the Power Fail
Alarm mode (refer to “Alarms” on page 15). Press and
hold the Run/Standby button; the alarm stops and the
pump switches off completely.
11
LED IndicatorThe multicolour LED adjacent to the Run/Standby
button indicates the status of the pump, as follows:
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/Seat StatusThere are five mattress/seat mode icons which can be
displayed, as follows:
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
Select ButtonThe function of the Select button depends on the pump
control change being carried out and the icon that is
displayed on the LCD screen directly above the button.
Mode Selection IconThis “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.
When the Weight Range or Mode is being changed, the
Mode Selection icon changes to a “tick” and flash.
Pressing the Select button under the “tick” confirms the
new selection.
If the Select button is not pressed for five seconds
when the flashing “tick” is displayed, the requested
pump status change is ignored, the “tick” reverts
back to the Mode Selection icon and the pump
continues in its current state.
12
Weight RangeThere 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.
Light Weight
Weight Range: 40-70 kg
Normal Weight
Weight Range: 70-120 kg
Heavy Weight
Weight Range: 120-160 kg
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 is solid
and flashing.
2.The Mode Selection icon changes:
3.Press the Select button to confirm the new Weight
Range setting.
13
ModeIf 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:
Active (Alternating) Mode
Backrest Horizontal
Reactive (CLP) Mode
Backrest Horizontal
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 is solid
with a square border.
4.The new Mode icon and square flashes and the
Mode Selection icon changes:
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 IndicatorAfter 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 stops rotating and starts
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 stops flashing and starts rotating again.
14
Alarms1.When the pump detects an alarm condition:
• The corresponding visual alarm is displayed on
the LCD screen, as detailed below.
• The LED indicator on the control panel flashes
alternately red and green.
• An audible alarm is sounded, which increases in
pitch if the alarm is ignored.
2.Press the Run/Standby button to stop the alarm.
3.Refer to Section 9, Page 26 “Troubleshooting” for
the alarms, their possible causes and their remedies.
If the operation of the pump changes during use,
refer to Troubleshooting procedures on page 26 of
this IFU before calling a service engineer or
contacting your local ArjoHuntleigh sales office
.
15
5.Mattress - Pump Operation
These instructions cover the 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 Section 4, Page 11 “Controls, Alarms and Indicators” for a
comprehensive description of the controls and indicators on the pump.
WARNING
Do not place the patient on the mattress until it is fully inflated
Installing the SystemBefore using the Alpha Response system make sure the
system has been installed correctly in accordance with
Section 3, Page 5 “Installation”.
Initial Inflation1.Connect the pump to the mains power supply using
the supplied cable and switch on the pump.
2.When mains power is first connected to the pump:
• The LED indicator is illuminated amber to
indicate that external power is applied to the
pump but the pump is still in Standby.
• The LCD screen is blank.
3.Press the Run/Standby button to put the pump into
the Run mode:
• The LED indicator changes to green.
• The LCD screen displays the ArjoHuntleigh logo
for 5 seconds, followed by the Alpha Response
animated logo for five seconds.
• The pump carries out a self-test routine and
initialises itself.
4.At the end of this start-up sequence, the pump starts
to inflate the mattress system.
If no tubeset is connected to the pump, or the tubeset
is not connected securely, the LCD screen displays
a No Connection alarm, which alternates the No
Mattress and No Seat screens, and an audible alarm
is sounded. To clear the alarm, connect a mattress
or seat tubeset to the pump.
16
Mattress Operation1.Make sure the CPR control on the mattress is
closed.
2.At the start of the inflation sequence, the default
mattress-inflation screen is displayed.
• The default patient weight range setting is
Normal, as indicated by the three Weight Range
icons.
• The default cell inflation mode is Active
(Alternating) and the default setting for the bed
frame is with the backrest horizontal, as
indicated by the Mattress/Seat Mode icon.
• For the duration of the inflation sequence, the
patient body is replaced by an “egg timer” icon.
3.The pump may take up to 40 minutes to inflate a
mattress to operating pressure.
Failure to fully inflate the mattress will result in a
low pressure alarm.
4.When the mattress inflation is complete, the default
mattress-operating screen is displayed:
• The “egg timer” is replaced by the patient body
icon.
• The Activity Indicator is displayed and starts
rotating to indicate that the pump is in the Run
mode.
5.The patient can now be put onto the mattress.
6.To change the Weight Range setting or put the
mattress into Reactive (CLP) mode, refer to
Section 4, Page 11 “Controls, Alarms and
Indicators”.
These settings can also be changed while the
mattress is being inflated.
17
When changing between operating modes, patient’s
monitoring and repositioning program should be
reviewed.
If the operation or performance of the pump
changes during use, stop using the system and refer
to Section 9, Page 26 “Troubleshooting”.
Raising the Backrest
on the Bed Frame
1.If the backrest on the bed is raised (the patient is in
a semi-recumbent position), the system detects the
new position and automatically does the following:
• Increases the air pressure in the mattress cells to
provide optimal pressure redistribution to the
patient.
• Changes the mattress icon from a “backrest
horizontal” icon to a “backrest raised” icon.
The screen below shows the mattress in Active
(Alternating) mode when the backrest is raised.
2.When the bed frame is put back to the “backrest
horizontal” position, the system detects this and
automatically does the following:
• Decreases the air pressure in the mattress cells to
the value before the backrest was raised.
• Changes the mattress icon back to the “backrest
horizontal” icon.
Stopping TherapyTo stop the therapy, press and hold the Run/Standby
button for three seconds to put the pump into Standby.
• The LED indicator changes to amber.
• the LCD screen goes blank.
• If the pump is to be completely isolated from the
mains, remove the plug from the mains power
socket.
To Deflate the
Mattress
To deflate the mattress:
1.Stop the therapy and put the pump into Standby.
2.Disconnect the tubeset from the pump (refer to
“Disconnecting the Tubeset” on page 10).
3.Activate the CPR control at the head end of the
mattress to deflate it (refer to “To Activate the
CPR Control” on page 20)
18
To Store the MattressFollowing deflation:
1.Start rolling the mattress from the foot end towards
the head end; stop after ONE turn of the mattress.
2.Bring the tubeset connector over the mattress and
secure.
3.Continue to roll the mattress from the foot end
towards the head end.
Make sure the mattress is dry before rolling it up.
3
1
2
Transport ModeTo transport a patient who is lying on the Alpha
Response mattress:
1.Stop the therapy and put the pump into Standby.
2.Disconnect the tubeset from the pump (refer to
“Disconnecting the Tubeset” on page 10). This will
automatically put the mattress into transport mode.
3.Put the tubeset connector through the transportation
loop to prevent any damage to the tubeset while the
bed is being moved.
The patient will remain supported for up to eight
hours on the mattress.
4.To resume normal operation, reconnect the tubeset
to the pump and restart the therapy.
Tubeset Connector
Transportation Loop
19
IMPORTANT
IN THE EVENT OF CARDIAC ARREST
CPR ControlIn the event of a patient suffering cardiac arrest and CPR
(Cardio-Pulmonary Resuscitation) needing to be
administered, activate the CPR control to rapidly deflate
the mattress:
To Activate the
CPR Control
Use a quick, firm pull on the CPR tag to remove the CPR
plug. The air is rapidly evacuated from the mattress.
The plug is fastened to the mattress by a strap.
If the pump is operating when the CPR is activated,
the Low Pressure alarm may be activated.
12
WARNING
The CPR control and CPR indicator tag must be visible and
accessible at all times.
To Close the
CPR Control
Push the CPR plug into the connector on the mattress.
Make sure the plug is securely fitted.
12
20
6.Seat Cushion - Pump Operation
GeneralRefer to the "Initial Inflation" section in
Section 5, Page 16 “Mattress - Pump Operation”.
WARNING
Do not place the patient on the seat cushion until it is fully inflated
Seat Cushion
Operation
1.At the start of the inflation sequence, the default
seat-inflation screen is displayed.
• The default patient weight range setting is
Normal, as indicated by the three Weight Range
icons.
• The only cell inflation mode is Active
(Alternating), as indicated by the Mattress/Seat
Mode icon.
• For the duration of the inflation sequence, the
patient body is replaced by an “egg timer” icon.
2.The pump may take up to 5 minutes to inflate a seat
cushion to operating pressure.
Failure to fully inflate the seat cushion will result in
a low pressure alarm.
3.When the seat cushion inflation is complete, the
default seat-operating screen is displayed; the “egg
timer” is replaced by the patient body icon.
4.The patient can now sit on the seat cushion.
5.To change the Weight Range setting, refer to
Section 4, Page 11 “Controls, Alarms and
Indicators”.
This setting can also be changed while the seat
cushion is being inflated.
21
To Deflate the Seat
Cushion
To deflate the seat cushion, do the following:
1.Press and hold the Run/Standby button for three
seconds to put the pump into Standby.
• The LED indicator changes to red.
• The LCD screen goes blank.
• If the pump is to be completely isolated from the
mains, remove the plug from the mains power
socket.
2.Disconnect the tubeset from the pump (refer to
“Disconnecting the Tubeset” on page 10).
3.Depress the two valves on the underside of the seat
cushion to release the remaining air from it.
There is no transport mode on the Alpha Response
seat cushion.
22
7.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 Response system should be routinely decontaminated between patients
and at regular intervals while in use; as is good practice for all reusable medical
devices.
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.
To CleanClean 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 DisinfectionTo 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, then wipe
with a cloth moistened in water 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.
DO NOT WRING/MANGLE, AUTOCLAVE OR USE
PHENOLIC BASED SOLUTIONS TO LAUNDER
THE TOP COVER.
23
For information on the mattress top cover, including
laundering guidelines, refer to “COVER
SPECIFICATION” on page 29.
Re-use with multiple
patients
Professional hygiene maintenance is required before
re-use of the system with a different patient.
24
8.Routine Maintenance
Alpha Response System
MaintenanceThe equipment has been designed to be virtually
maintenance-free between service periods.
ServicingArjoHuntleigh will make available on request service
manuals, component parts lists and other information
necessary for ArjoHuntleigh trained personnel to repair
the system.
Service PeriodArjoHuntleigh recommend that the Alpha Response
system should be serviced by an ArjoHuntleigh
authorised service agent, after 12 months running time
has elapsed.
The Service symbol illuminates to indicate that the
pump is ready for a service (refer to “Alarms” on
page 15).
Pump
General Care,
Maintenance and
Inspection
Check all electrical connections and power cable for
signs of excessive wear or damage.
If the pump has been subjected to abnormal treatment,
e.g. immersed in water or dropped, the unit must be
returned to an authorised service centre.
BiofilterThe internal biofilter can be run continuously for 12
months before it requires autoclaving or replacement.
The biofilter can only be replaced by a service engineer.
Mattress Replacement, Overlay and Seat Cushion
General CareRemove the top cover and inspect for signs of wear or
any tears.
Check all zips are secure.
Check integrity of all connectors, including cell to
manifold connections.
Ensure all cell fasteners are correctly connected to the
mattress base sheet and are not loose or damaged.
Serial Labels
PumpThe serial number for the pump is on the label on the
back of the pump case.
MattressThe mattress serial label can be found just inside the
base cover above the tubeset.
Seat CushionThe seat cushion serial label can be found just inside the
front of the base cover.
Quote these serial numbers when requesting service.
25
9.Troubleshooting
The following table provides a troubleshooting guide for the Alpha Response
systems in the event of malfunction.
LCD ScreenPossible CauseRemedy
Pump is inflating the mattress
replacement or mattress overlay.
Mattress Inflating
Pump is inflating the seat cushion.The “egg timer” is replaced by the patient
Seat Inflating
1. No tubeset connected to pump.
2. Tubeset fitted but not
connected securely.
The “egg timer” is replaced by the patient
body icon when mattress inflation is
complete.
body icon when seat cushion inflation is
complete.
1. Connect a mattress or seat tubeset to the
pump.
2. Remove and reconnect tubeset, making
sure it is securely pushed onto the pump
until a “click” is heard.
No Mattress/Seat
(graphics alternate)
Low Pressure
High Pressure
Power Fail
Hardware Fail
Service Indicator
(top right of LCD
screen)
1. The tubeset is not connected
properly.
2. CPR control not fully closed
3. There is a leak in the system.
1. Tubeset is “kinked” or blocked.
2. Pump has detected an internal
fault.
External mains power supply has
been removed while the pump is
operating.
Pump has detected an internal
fault.
Pump needs a service:
After 12 months run time, the
spanner icon is illuminated.
After a further 3 months run time,
the spanner icon starts flashing.
1. Remove and reconnect tubeset, making
sure it is securely pushed onto the pump
until a “click” is heard.
2. Make sure the CPR plug is fully pushed
into the CPR grommet.
3. Call service engineer.
1. Check and remove any “kinks” or
blockages in the tubeset.
2. Disconnect the pump from the electrical
supply and call service engineer.
Reconnect the mains power supply to the
pump.
Disconnect the pump from the electrical
supply and call service engineer.
Call the service engineer.
If correct operation or performance of the pump is not restored by troubleshooting
procedures, stop using the system immediately and call the service engineer.
26
10. Technical Specification
PUMP
Model:Alpha Response
Part Numbers:464001 - UK
464009AU - AUS
Supply Voltage:100 - 230 V
Supply Frequency:50 - 60 Hz
Power Input:24 - 36 VA
Size:240 (L) x 210 (H) x 135 mm (D) [9.49 x 8.27 x 5.3”]
Weight:3.2 kg (7.05 lb)
Case Material:ABS Plastic
Plug Fuse Rating:5A to BS1362 (UK ONLY)
Degree of protection
against electric shock:
Degree of protection
against liquid ingress:
Mode of operation:Continuous
Mains Connected: Class II, Double Insulated with Functional Earth
Type BF
IP21 - Protection against ingress of solid objects more than 12.5mm
diameter and water droplets falling vertically.
PUMP SYMBOLS
The operator must read
this document
(Instructions for Use)
before use.
Note: This symbol is blue
on the product label.
With respect to electric
shock, fire and
mechanical hazards only
in accordance with CAN/
CSA-C22.2 No. 60601.1
(2008).
MEDICAL EQUIPMENT
Refer to this document
(Instructions for Use) for
i
a description of the
product classification (3rd
Edition).
SN:
Run/Standby
Button
Double InsulatedType BF
Serial Number
Ref:
Do not dispose of in
domestic refuse
Model number
Refer to this document
(Instructions for Use) for
a description of the
product classification
(2nd Edition).
Manufacturer: This
symbol is
accompanied by the
name and the
address of the
manufacturer.
If the pump is stored in conditions outside the “Operating” ranges, allow time for its temperature
to stabilise to normal before use.
One of the effects of prolonged exposure to high temperatures is to increase the self-discharge of
the internal battery; this will reduce the duration of power fail alarms. The pump will fully charge
the battery over a 24-hour period when the pump is connected to a mains power supply.
MATTRESS
DescriptionSize (Height x Length)Cell Material
Mattress Replacement (MR)205mm (H) x 2090mm (L)PolyurethanePU Laminate
Mattress Overlay (OL)115mm (H) x 2090mm (L)PolyurethanePU Laminate
Use solution diluted to 1000 ppm of
Available Chlorine
Wash at 95°C (203°F) MAX
130
Tumble dry at 130°C (266°F)
Wipe surface with damp cloth
COVER SPECIFICATION
Feature
Removable CoverYe sYes
Moisture Vapour PermeableYesYes
Standard Cover (Dartex)
®
Advantex
®
Air PermeableNoNo
Low FrictionYes18% lower
Water Resistant / RepellentYe sYes
Infection ControlMaterial coating is
Antimicrobial
Fire RetardantBS 7175: 0,1 & 5BS 7175: 0,1 & 5
2-Way StretchYesSome
Washing Conditions
Drying ConditionsTumble Dry up to 130°C (266°F) or
Life Span50 Wash Cycles (minimum)50 Wash Cycles (minimum)
Application AreaAcute and HomecareAcute and Homecare
(a)
MAX 95°C (203°F)MAX 95°C (203°F)
(b)
Air Dry
Material coating is
Antimicrobial
Tumble Dry ONLY
at 80-85°C (176°F-185°F)
a. The top cover may be washed. The temperature in the washing cycle may be up to 95°C (203°F);
however it is recommended that you check your local policy to determine the time/
temperature ratio required to achieve thermal disinfection.
b. The top cover may be tumble dried or air dried. The temperature in the drying cycle may be up
to 130°C (266°F); however it is recommended that you check your local policy to determine the
time/temperature ratio required.
c. The top cover should be tumble dried only at a temperature of 80-85°C (176-185°F); however it
is recommended that you check your local policy to determine the time/temperature ratio
required.
(c)
29
Guidance and manufacturer’s declaration - electromagnetic emissions
The pump is intended for use in the electromagnetic environment specified below. The customer or
the user of the pump should assure that it is used in such an environment.
Group 1The pump uses RF energy only for its internal
function. therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
Class BThe pump is suitable for use in all
establishments including domestic
establishments and those directly connected to
Class A
Complies
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Recommended separation distances between portable
and mobile RF communications equipment and the pump
The pump is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the pump can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the pump as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
Rated maximum
output power of
transmitter
W
0.010.120.120.23
0.10.380.380.73
11.21.22.3
102.83.87.3
100121223
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
m
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
30
Guidance and manufacturer’s declaration - electromagnetic immunity
The pump is intended for use in the electromagnetic environment specified below. The customer or
the user of the pump should assure that it is used in such an environment.
Immunity
Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601 Test
Level
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5GHz
Compliance
Level
3 V
3 V/m
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the pump, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey a, should be less than the compliance
level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the pump is used exceeds the applicable RF compliance level
above, the pump should be observed to verify normal operation. If abnormal operation is observed,
additional measures may be necessary, such as reorientating or relocating the pump.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
31
32
AUSTRALIA
ArjoHuntleigh Pty Ltd
78, Forsyth Street
O’Connor
AU-6163 Western Australia
Tel: +61 89337 4111
Free: +1 800 072 040
Fax: + 61 89337 9077
BRASIL
Maquet do Brasil
Equipamentos Médicos Ltda
Rua Tenente Alberto Spicciati, 200
Barra Funda, 01140-130
SÃO PAULO, SP - BRASIL
Fone: +55 (11) 2608-7400
Fax: +55 (11) 2608-7410
CANADA
ArjoHuntleigh
90 Matheson Boulevard West
Suite 300
CA-MISSISSAUGA, ON, L5R 3R3
Tel/Tél: +1 905 238 7880
Free: +1 800 665 4831 Institutional
Free: +1 800 868 0441 Home Care
Fax: +1 905 238 7881
E-mail: info.canada@arjohuntleigh.com
ČESKÁ REPUBLIKA
ArjoHuntleigh s.r.o.
Hlinky 118
CZ-603 00 BRNO
Tel: +420 549 254 252
Fax: +420 541 213 550
HONG KONG
ArjoHuntleigh (Hong Kong) Ltd
1510-17, 15/F, Tower 2
Kowloon Commerce Centre
51 Kwai Cheong Road
Kwai Chung
HONG KONG
Tel: +852 2207 6363
Fax: +852 2207 6368
INTERNATIONAL
ArjoHuntleigh International Ltd
ArjoHuntleigh House
Houghton Hall Park
Houghton Regis
UK-DUNSTABLE LU5 5XF
Tel: +44 (0) 1582 745 800
Fax: +44 (0) 1582 745 866
E-mail:
international@arjohuntleigh.com
ITALIA
ArjoHuntleigh S.p.A.
Via di Tor Vergata 432
IT-00133 ROMA
Tel: +39 (0) 6 87426211
Fax: +39 (0) 6 87426222
E-mail: Italy.promo@arjohuntleigh.com
NEDERLAND
ArjoHuntleigh Nederland BV
Biezenwei 21
4004 MB TIEL
Postbus 6116
4000 HC TIEL
Tel: +31 (0) 344 64 08 00
Fax: +31 (0) 344 64 08 85
E-mail: info.nl@arjohuntleigh.com
SUOMI
Oy Vestek AB
Martinkuja 4
FI-02270 ESPOO
Puh: +358 9 8870 120
E-mail: info@vestek.fi
SVERIGE
ARJO Scandinavia AB
Hans Michelsensgatan 10
SE-211 20 MALMÖ
Tel: +46 (0) 10 494 7760
Fax: +46 (0) 10 494 7761
E-mail: kundservice@arjohuntleigh.com
UNITED KINGDOM
ArjoHuntleigh UK
ArjoHuntleigh House
Houghton Hall Park
Houghton Regis
UK-DUNSTABLE LU5 5XF
Tel: +44 (0) 1582 745 700
Fax: +44 (0) 1582 745 745
E-mail: sales.admin@arjohuntleigh.com
USA
ArjoHuntleigh Inc.
2349 W Lake Street Suite 250
US-Addison, IL 60101
Tel: +1 630 307 2756
Free: +1 800 323 1245 Institutional
Free: +1 800 868 0441 Home Care
Fax: +1 630 307 6195
E-mail: us.info@arjohuntleigh.com
REV 14: 07/2014
www.arjohuntleigh.com
www.arjohuntleigh.com
ArjoHuntleigh AB
Hans Michelsensgatan 10
211 20 Malmö, Sweden
GETINGE GROUP is a leading global provider of products and
systems that contribute to quality enhancement and cost efficiency
within healthcare and life sciences. We operate under the three
brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh
focuses on patient mobility and wound management solutions.
GETINGE provides solutions for infection control within healthcare
and contamination prevention within life sciences. MAQUET
specializes in solutions, therapies and products for surgical
interventions and intensive care.
464933EN_02: 07/2014
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