Getinge ARJOHUNTLEIGH AURA User manual

AURA
Instructions for Use
...with people in mind
0086

(i)
Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About Aura . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Care of the patient when sitting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Preparing the Aura Cushion and Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Controls, Indicators and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Installing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Inflating the Seat Cushion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Pressure Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Deflating the Seat Cushion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Seat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Cover Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Cleaning Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

(ii)

(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, UL2601-1 and CAN/CSA C22.2 No. 601.1-M90
• EN60601-1:2006 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.
• Make sure that the mains power cable and tubeset or air hoses are positioned to
avoid causing a trip or other hazard or other possible entrapment areas.
• Electrical equipment may be hazardous if misused. There are no user-serviceable
parts inside the pump. The pump 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.
• 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 Aura seat cushion.
• Only the pump and seat 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 seat potentially reduces the benefits
provided by the seat 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 seat, 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 seat in the protective bags supplied.

(iv)
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 Aura 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 Aura 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.
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 2012

1
1. Introduction
About this Manual This manual is your introduction to the Aura®system.
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
Aura 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 120 kg
(264 lb).
The Aura system should be used as part of a prescribed
plan of care (refer to “Indications” on page 3).
About Aura The Aura system consists of a pump and a seat cushion
and can be used on standard hospital chairs.
A full technical description of the Aura system can be
found in the Service Manual, part numbers SER0004
(pump) and SER0005 (seat cushion), available from
your ArjoHuntleigh sales office.
Aura Pump
Pressure Control
Low pressure
Tubeset connection
s
Fuse Holder
Run/Standby
Switch
Suspension hooks
on rear
Knob
indicator
Power Fail Indicator
Power Indicator
Setting up instructions on rear

2
Aura Seat Cushion
Cover
Straps
Cells

3
2. Clinical Applications
Indications The Aura systems are 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.
These systems represent one aspect of a pressure ulcer
managementprotocol;allotheraspectsofcareshouldbe
considered by the prescribing clinician.
If existing wounds do not improve or the patient's
conditionchangesthe overalltherapyregimenshould be
reviewed by the prescribing clinician.
The above are guidelines only and should not replace
clinical judgement.
The Aura cushion is designed for patients weighing up
to 120 kg (264 lb).
Contraindications Do not use Aura 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 Aura systems have been designed to manage
patients up to the weight limits indicated above, those
approachingthisupper limitarelikely tohaveadditional
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
The system is simple to set up and the following
guidelines may assist you.
Preparing the Aura
Cushion and Pump 1. Remove the contents of the packaging. You should
have the following items:
•Aura pump with integral mains power cord and
hanging bracket.
•Aura seat cushion, with cover
2. Plug the pump power cable into wall socket.
Do NOT switch the pump on.
3. The pump should be placed feet down on any
convenient horizontal surface or alternatively
suspended from the chair frame by means of the
spring loaded hanging hooks.
4. Check that there are no sharp objects on the chair
surface which may puncture the seat cushion.
5. Place the Aura cushion on top of the chair surface.
From a standing position in front of the chair and
facing it, ensure that:
• the air feed tubes appear from the front right
corner of the cushion
• the cells are uppermost
• the cells are in a horizontal position across the
chair, NOT from front to back.
6. Secure the Aura cushion to the chair by using the
fixing straps as shown in the following illustrations.
Cautions
• Do not use the Aura seat cushion without a foam cushion
beneath it.
• Always use the Aura seat cushion with the protective top cover.
• Always use the Aura seat cushion in the correct orientation.
• Avoid trailing cables - ensure that cables and tubing are
positioned beneath the chair to avoid causing a hazard.

5
7. If the chair is of the open sided construction, then
fix the cushion as shown below.
8. If the chair is of the closed side type with a
removable seat cushion, fix the Aura cushion as
shown below.
9. If the chair is of the closed side type with a non-
removable seat cushion, then security will rely on
the anti-slip pads on the base of the Aura cushion.
10. Place the protective cover over the cushion and zip
up all round, taking care not to trap any material in
the zip.
11. Connect the air feed tube connectors to the air
outlet connectors on the pump unit, ensuring that
the tubes are not “kinked” or twisted. Push the
connectors in until they click.

6
4. Controls, Indicators and Alarms
Controls
Run/Standby Switch This is situated on the side panel of the pump and is used
to activate the unit and reset the alarm. Mains isolation
should be performed by switching the pump to standby
( ) and then removing the mains plug from the socket.
Pressure Control This is situated on the front panel and is adjusted by the
user to provide extra comfort.
Indicators
Run/Standby A light on the front panel indicates that the pump is
running.
Low Pressure In the event of low pressure in the seat cushion, the red
Low Pressure alarm indicator starts flashing and an
audible alarm sounds. The pitch of the alarm will
increase at 60 second intervals.
Power Fail In the event of mains failure, the red alarm indicator
starts flashing and an audible alarm sounds. The pitch of
the alarm will increase in time. If the power supply is
returned the audible alarm stops, but the alarm light
remains illuminated until the system is reset.
Alarms
Alarm Reset When the cause of the alarm has been resolved, the
pump must be reset. This can be achieved by switching
the pump to Standby and back to Run using the Run/
Standby switch on the side panel.
Self Test Every time the pump is switched on all indicator lights
illuminate for approximately two seconds. During this
period, the system self tests its circuits.
(Run)
(Standby)

7
5. 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 Section 4, Page 6 “Controls, Indicators and Alarms” for a
comprehensive description of the controls and indicators on the pump.
If the operation of the pump changes during use, refer to Troubleshooting
procedures on page 11 of this manual before calling a service engineer or
contacting your local ArjoHuntleigh sales office.
Installing the System Before using theAura system make sure that it has been
installed correctly in accordance with
Section 3, Page 4 “Installation”.
Inflating the
Seat Cushion 1. Connect the pump to the mains power supply using
the supplied cable and set the pump power switch
to its run ( ) position.
It may take up to two minutes to inflate the cushion.
2. When the seat cushion is inflated, the patient can sit
on the seat cushion.
Pressure Control Adjust the Pressure Control to the patient’s
requirements.
There is no transport mode on the Aura seat cushion.
Shut Down Power the pump off by switching the pump power
switch to the standby ( ) position. If the pump needs to
be completely isolated from the mains power supply,
remove the plug from the mains power socket.
WARNING
Do not place the patient on the seat cushion until it is fully inflated

8
Deflating the
Seat Cushion To deflate and store the seat cushion, do the following:
1. Switch off the pump, and disconnect the pump from
the mains power supply.
2. Remove the tubeset from the pump.
3. Deflate the seat cushion.
Make sure the seat cushion is dry before rolling it
up.

9
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.
TheAura systemshouldberoutinelydecontaminatedbetweenpatientsandatregular
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, 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.
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.

10
DO NOT WRING/MANGLE, AUTOCLAVE OR USE
PHENOLIC BASED SOLUTIONS.
Thermal Disinfection For information for the seat top cover, including
laundering guidelines, refer to “Cleaning Symbols” on
page 14.
Re-use with multiple
patients Professional hygiene maintenance is required before
re-use of the system with a different patient.

11
7. Troubleshooting Guide
Ensure pump alarms are reset by operating the Run/Standby switch after the fault has been
corrected.
If the operation or performance of the pump is not restored by performing the
troubleshooting procedures, stop using the system immediately and call the service
engineer.
Problem Possible Cause Action
Seat cushion not inflating. 1. Tubes kinked.
2. Pump not switched on.
3. No pump output.
4. Punctured cell or leakage
from T-connector
5. Tubes not correctly fitted.
Check
Check
Check
Check. See Pump not
operating below
Check
Consistent Low Pressure
Alarm.
1. Tubes not correctly fitted.
2. Leakage.
Check
Check
The Power Fail indicators
(audible and visual) are active.
1. A mains power failure has
occurred.
2. The power cord has been
removed from the wall
socket.
Check
Check
The Power Fail indicator
remains constantly illuminated
but there is no audible alarm.
There has been a mains power
failure but power has been
restored.
Check if electrical plug is
correctly fitted, and if pump is
running correctly.
Pump makes a lot of noise
and/or is causing a lot of
vibration.
System damaged or dirty. Call Service Engineer for
maintenance.
Pump not operating. 1. Pump Run switch not on.
2. Plug not inserted correctly.
3. Fuse blown.
4. Technical failure.
Switch on
Check
Call Service Engineer for
maintenance.
Call Service Engineer for
maintenance.
All indicators remain illuminated
on initial switch-on.
Internal fault. Call Service Engineer for
maintenance.

12
8. Technical Description
PUMP
Model: Aura
UK USA
Part Numbers: ALS01 ALS03
Supply Voltage: 230 V 120 V
Supply Frequency: 50 Hz 60 Hz
Power Input: 14 VA 14 VA
Size: 248 x 160 x 116 mm (9.8 x 6.3 x 4.6 in.)
Weight: 2.75 kg (6 lb)
Case Material: ABS Plastic
Plug Fuse Rating: 5A to BS1362 (UK ONLY)
Pump Fuse Rating: F500 mA H 250 V
Degree of protection
against electric shock:
Class II, Double Insulated with Functional Earth
Type BF
Degree of protection
against liquid ingress:
IPX0 - No protection
Mode of operation: 10 minute Operating Cycle
Pressure Range: 70 - 100 mmHg ± 5%
ENVIRONMENTAL INFORMATION
Condition Temperature Range Relative Humidity Atmospheric Pressure
Operating +10°C to +40°C
(+50°F to +104°F)
30% to 75%
(non-condensing)
700hPa to 1060 hPa
Storage (Long Term) +10°C to +40°C
(+50°F to +104°F)
20% to 95%
(non-condensing)
700 hPa to 1060 hPa
Storage (Short Term) -20°C to +50°C
(-4°F to +122°F)
20% to 95%
(non-condensing)
500 hPa to 1060 hPa
If the pump is stored in conditions outside the “Operating” ranges, allow time for its
temperature to stabilise to normal, before use.

13
PUMP SYMBOLS
The operator must read
this document
(Instructions for Use)
before use.
Note: This symbol is blue
on the product label.
Standby Do not dispose of in
domestic refuse
With respect to electric
shock, fire and
mechanical hazards only
in accordance with CAN/
CSA-C22.2 No. 60601.1
(2008).
MEDICAL EQUIPMENT
Run Type BF
Refer to this document
(Instructions for Use) for
a description of the
product classification (3rd
Edition).
SN: Serial Number Ref: Model number
Refer to this document
(Instructions for Use) for
a description of the
product classification
(2nd Edition).
Double Insulated
Manufacturer: This
symbol is
accompanied by the
name and the
address of the
manufacturer.
i
SEAT
Aura Seat Cushion 403001
Length: 455 mm (17.9 in.)
Width: 470 mm (18.5 in.)
Height: 50 mm (2.0 in.) minimum
Cell Material: Polyurethane
Top Cover Material: Polyurethane Knitted Fabric
Weight: 0.7 kg (1.5 lb)

14
COVER SPECIFICATION
Feature Standard Cover
(Dartex®)
Removable Cover Yes
Moisture Vapour Permeable Yes
Air Permeable No
Low Friction Yes
Water Resistant / Repellent Yes
Infection Control Material coating is bacteriostatic, fungistatic, antimicrobial
Fire Retardant BS 7175: 0,1 & 5
2-Way Stretch Yes
Washing ConditionsaMAX 95°C (203°F) for 15 mins
Drying ConditionsbTumble Dry up to 130°C (266°F) or Air Dry
Life Span 50 Wash Cycles (minimum)
Application Area Acute and Homecare
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.
CLEANING SYMBOLS
Wash at 95°C (203°F) MAX Tumble dry at 130°C
Do not iron Wipe surface with damp cloth
Do Not Use Phenol-based cleaning
Solutions
Use solution diluted to 1000 ppm of Available
Chlorine
95
130