Arjo Auralis User manual

INSTRUCTIONS FOR USE
Auralis
04.AI.00EN_03 • 10/2020
Alternating pressure system

Design Policy and Copyright
® and ™ are trademarks belonging to the Arjo group of companies.
© Arjo 2020.
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 Arjo.
WARNING
To avoid injury, always read this Instructions For Use and accompanied documents before
using the product.
Mandatory to read the Instructions For Use.

3
Foreword....................................................................................5
IntendeduseforAuralis.......................................................................6
Safetyinstructions ...........................................................................7
Homecare...................................................................................8
UsetheAuralissystem.......................................................................8
Preparations.................................................................................9
Aftereachpatient..........................................................................10
Partsdesignation-Auralispump ..............................................................12
Partsdesignation-Auralis110mattressoverlay..................................................13
Partsdesignation-Auralis175and200mattressreplacement......................................14
Partsdesignation-AuralisPlusmattressreplacement............................................15
Partsdesignation-Auralisseatcushion........................................................16
Productdescription-Auralispump.............................................................17
Controlpanel..............................................................................17
Alarmindicators ...........................................................................20
Hangingbrackets ..........................................................................20
Powercable...............................................................................20
SkinIQport...............................................................................20
Productdescription-Auralismattresses .......................................................21
&35UDSLGGHÀDWLRQXQLW .....................................................................21
Detachablecover ..........................................................................21
Cells ....................................................................................21
Loopstraps...............................................................................21
Heelguard™cells..........................................................................21
Cell hooks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Tube-set .................................................................................21
Connector................................................................................21
Cable management.........................................................................22
Microairlosssystem .......................................................................22
Auralis110mattressoverlay .................................................................22
Fixingstraps(Auralis110mattressoverlay)......................................................22
Auralis175,200andPlusmattressreplacement..................................................22
Securingstraps............................................................................23
Overlayandoverlayzip .....................................................................23
Bolsters(AuralisPlusmattressonly)............................................................23
Footextension(AuralisPlusmattressonly)......................................................23
Mattressextensions(AuralisPlusmattressonly)..................................................23
Productdescription-Auralisseatcushion ......................................................24
Detachablecover ..........................................................................24
Alternatingcells............................................................................24
Fixingstraps..............................................................................24
Non-slipbase.............................................................................24
Contents

4
'HÀDWLRQYDOYHV............................................................................24
Tube-set .................................................................................24
Connector................................................................................24
&35UDSLGGHÀDWLRQXQLW ......................................................................25
$FWLYDWHWKH&35UDSLGGHÀDWLRQXQLW ...........................................................25
'HDFWLYDWHWKH&35UDSLGGHÀDWLRQXQLW .........................................................25
AssembletheAuralissystem..................................................................26
Auralis110mattressoverlay..................................................................26
Auralis175,200andPlusmattressreplacement..................................................27
Auralispump..............................................................................28
AuralisPlusmattressextensions(accessoryonly) ................................................29
Auralisseatcushion........................................................................30
StarttheAuralissystem......................................................................32
Auralissystemstart-up......................................................................32
Selectmode................................................................................34
$XWR¿UPPRGH.............................................................................34
Alternatingmode,defaultsetting ..............................................................34
ReactiveCLPmode ........................................................................35
Lockoutmode.............................................................................35
Transportmode............................................................................36
TurnoffandstoretheAuralissystem...........................................................38
TurnofftheAuralispump....................................................................38
'HÀDWHDQGVWRUHWKH$XUDOLVPDWWUHVV ..........................................................38
'HÀDWHDQGVWRUHWKH$XUDOLVVHDWFXVKLRQ .......................................................39
StoretheAuralispump......................................................................39
Cleaninganddisinfectioninstructions..........................................................40
Cleaninganddisinfection....................................................................41
Careandpreventivemaintenance..............................................................44
Expectedservicelife........................................................................44
Cleananddisinfect.........................................................................46
Visuallycheckalllabels .....................................................................47
Troubleshootingandalarms...................................................................48
7HFKQLFDOVSHFL¿FDWLRQV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
/LVWRIVWDQGDUGVDQGFHUWL¿FDWHV ..............................................................55
Labels.....................................................................................56
ElectromagneticCompatibility(EMC)...........................................................60
Partsandaccessories........................................................................65

FOREWORD 5
Foreword
Thank you for purchasing Arjo equipment.
Customer contact information
For questions regarding this product, supplies, maintenance, or additional information about Arjo products and
service, please contact Arjo or an Arjo authorized representative, or visit www.arjo.com.
Please read and fully understand the Instructions for Use (IFU) before using
the AuralisTM system
Information in this IFU is necessary to perform the proper operation and maintenance of the equipment. It will
help to protect your product and make sure that the equipment performs to your satisfaction. The information
in this IFU is important for your safety and must be read and understood to help prevent possible injury.
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products.
Support
Routine maintenance must be performed on the Auralis system before every use or every week (if for long term
use) to maintain safety and reliability of the equipment. See section Care and preventive maintenance for more
information. If you require further information, please contact Arjo for comprehensive support and maintenance
to maximize the long-term safety, reliability and value of the product. Contact your local Arjo representative for
spare parts. The telephone numbers appear on the last page of this IFU.
If a serious incident occurs in relation to this medical device, affecting the user, or the patient, then the user or
patient should report the serious incident to the medical device manufacturer or the distributor. In the European
Union, the user should also report the serious incident to the Competent Authority in the member state where
they are located.
Warning means: Safety warning. Failure to
understand and obey this warning may result in injury
to you or to others.
Caution means: Failure to follow these instructions
may cause damage to all or parts of the system or
equipment.
Note means: This is important information for the
correct use of this system or equipment.
WARNING
CAUTION
NOTE
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INTENDED USE FOR AURALIS6
Intended use for Auralis
The Auralis System is intended for use by caregivers in acute and post-acute care facilities including, long-term
care, home care facilities and private homes.
The system is indicated for the prevention and/or management of all categories of pressure injuries
(pressure ulcer) when combined with an individualised, comprehensive pressure ulcer protocol; for example,
repositioning, nutritional support, skin care.
The system represents one aspect of a pressure injury (pressure ulcer) management protocol, all other aspects
of care should be considered by the prescribing clinician. If existing wounds do not improve, or the patient’s
condition changes the overall therapy regimen should be reviewed by the prescribing clinician.
The above are guidelines only and should not replace clinical judgement. The system provides two modes of
therapy: ‘reactive pressure redistribution’ and ‘active (alternating) pressure redistribution’.
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Any other use is prohibited.
Patient assessment
• We recommend that facilities establish regular assessment routines. Caregivers should assess each patient
according to the following criteria prior to use:
• For the Auralis mattress, the patient weight must not exceed 250 kg (550 lb) for the standard and narrow
mattresses
• For the Auralis Seat Cushion, the patient weight must not exceed 200 kg (440 lb).
• For the Auralis Plus mattress, the patient is within the weight range of 100 kg (220 lb) to 454 kg (1000 lb).
• For the Auralis Plus mattress, the patient Body Mass Index (BMI) is >30
Contraindications
Do not use with patients with unstable cervical, thoracic and/or lumbar fracture, cervical traction, and skeletal
traction.
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 Standard and Narrow Auralis
mattress system has been designed to manage patients up to the weight limits indicated above, those
approaching this upper limit are likely to have additional care and mobility needs and may be better suited to a
system with a higher weight limit such as Auralis Plus mattress.
Expected service life
The expected service life of the Auralis pump is seven (7) years, subject to preventive maintenance being
carried out in accordance with the instructions for care and maintenance found in the Instructions for Use.

SAFETY INSTRUCTIONS 7
Safety instructions
WARNING
To avoid serious injury or death, the
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and accessible at all times.
WARNING
To avoid strangulation, always use
the cable management for the power
cable.
WARNING
To avoid injury, the mains power socket
and plug must be accessible at all times.
To disconnect the Auralis pump completely
from the electricity supply, remove the
plug from the mains power socket.
WARNING
To avoid entanglement hazard, never leave
children or vulnerable persons unattended
with the Auralis system at any time.
WARNING
To avoid pressure injury, make sure the
Auralis system is assembled correctly.
WARNING
To avoid bodily injury, never use the
Auralis mattress as a movement device.
WARNING
To avoid suffocation, always attach the
Auralis mattress cover and Auralis seat
cushion cover when in use.
WARNING
To avoid severe burn injury, do not
use the Auralis pump in the presence of
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WARNING
To avoid falling and injury, make sure that
cables and the tube-set are positioned
correctly and are clear of moving bed
mechanisms or other possible entrapment
areas.
WARNING
To avoid pressure injury the patient must
not wear clothing which may cause areas
of localised high pressure due to creases,
seams, etc. Placing objects in pockets
must be avoided for the same reason.
WARNING
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Auralis mattress, do not place extra
layers between the patient and the Auralis
mattress.
WARNING
To avoid injury to the patient, keep children
and pets away from the equipment.
WARNING
To avoid suffocation, keep the bags
supplied with this equipment away from
babies and small children.

HOME CARE8
Home care
Use the Auralis system
Before using the Auralis system in home environment make sure that all caregivers, including relatives, have
read and understood the instructions in this IFU.
When the Auralis system is in use, make sure:
• The Auralis system is kept away from sources of heat and moisture, and protected from dust, lint and dirt.
• The Auralis system is not covered.
• 7KHRSHUDWLRQDOHQYLURQPHQWIXO¿OVWKHUHTXLUHPHQWVVSHFL¿HGLQVHFWLRQ³2SHUDWLQJFRQGLWLRQV´RQSDJH
52.
When the Auralis system is not in use, make sure:
• No children can access the Auralis system.
• No pets can come in contact with the Auralis system.
• 7KHVWRUDJHHQYLURQPHQWIXO¿OVWKHUHTXLUHPHQWVVSHFL¿HGLQVHFWLRQ³7UDQVSRUWDQGVWRUDJHFRQGLWLRQV´RQ
page 53.
WARNING
To avoid choking, never leave children
unattended near the equipment. The
equipment includes small parts that may
present a choking hazard to small children,
vulnerable persons and pets if inhaled or
swallowed.
CAUTION
To avoid equipment damage, never use
the Auralis pump close to heat sources.
CAUTION
To avoid equipment damage, never use
sharp objects or electrically heated under
blankets on or under the Auralis system.
CAUTION
To avoid equipment damage, do not
expose the Auralis system, especially
WKHPDWWUHVVWRQDNHGÀDPHVVXFKDV
cigarettes. A leak in the Auralis mattress or
Auralis seat cushion could propagate the
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CAUTION
To avoid equipment damage, pets and
children must be supervised in the vicinity
of the Auralis system.
WARNING
Do not attempt to service or maintain the
Auralis pump while it is in use.
WARNING
Electrical equipment may be hazardous
if misused. Do not use unapproved
accessories or attempt to modify,
disassemble or otherwise misuse the
Auralis system
WARNING
To avoid discomfort or injury for the
patient, ALWAYS set the comfort level
at maximum for patients weighing over
360 kg (793 lb).

PREPARATIONS 9
Bed frame recommendation
The Auralis Plus mattress is designed to be used with the Arjo Citadel Plus bed frame.
The Auralis mattress range (narrow, standard and Plus) may also be used with other bed frames (Arjo or non-
Arjo). An assessment should be made by clinician or caregiver to determine which mattress and bed frame
combination to use. See respective bed frame IFU for compatible mattress sizes and page 53 (within this
IFU) for dimensions of all Auralis mattresses.
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(5 steps)
1. Check the package for damage. If the product looks damaged during transport, contact the transport
agency.
Do NOT use the product.
2. Check that the items are complete:
• Auralis pump with power cable and hanging brackets,
• Auralis 110 mattress overlay, Auralis 175, 200 or Plus mattress replacement or Auralis seat cushion,
all with integrated tube-sets, labels and covers.
3. Recycle the packaging according to local regulations.
4. Read this IFU.
5. Store the IFU in a designated area, where it is easily accessible at all times.
Preparations

HOME CARE10
Figure 1
Actions before every use
(2 steps)
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6FKHGXOH´RQSDJH
2. If any item is damaged - do NOT use the product.
After each patient
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GLVLQIHFWLRQLQVWUXFWLRQV´RQSDJH
The position of the caregiver
The caregiver should be positioned in front of the pump during operation. See Figure 1

HOME CARE 11
Intentionally left blank

PARTS DESIGNATION - AURALIS PUMP12
Auralis
Auralis
1. Control panel (with indicators)
2. Alarm indicators
3. Power cable
4. Connector socket
5. Skin IQ port
6. Hanging brackets
Parts designation - Auralis pump
1
6
5
2
1. Run/Standby button and indicator
2. Wait indicator
3. $XWR¿UPPRGHEXWWRQ
4. Alternating mode button
5. Reactive CLP mode button
6. Comfort control buttons/indicators
Lock out buttons/indicators
Control panel - buttons and indicators
7. Low battery indicator
8. Battery charge indicators
9. Mains power failure indicator
10. Low pressure indicator
11. Service indicator
12. Alarm mute button and indicator
1
2
3 54 687 9 10
11
12
4
3
2
2

PARTS DESIGNATION - AURALIS 110 MATTRESS OVERLAY 13
1. &35UDSLGGHÀDWLRQXQLW
2. Detachable cover
3. Cover attachment zip
4. Cells (quantity)
• Head cells (3)
• Torso cells (12)
• Heelguard™ cells (5)
5. Loop straps
6. Heelguard™ cell straps
7. Cell hooks
8. Overlay base cover (including micro air loss system)
9. Fixing straps
10. Tube-set
11. Connector
12. Cable management
2
4
3
1
5
8
10
12
Parts designation - Auralis 110 mattress overlay
11
7
6
9

1. &35UDSLGGHÀDWLRQXQLW
2. Detachable cover
3. Cover attachment zip
4. Cells (quantity)
• Head cells (3)
• Torso cells (12)
• Heelguard™ cells (5)
5. Loop straps
6. Heelguard™ cell straps
7. Cell hooks
8. Non-slip base with:
Foam underlay (mattress 175)
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9. Securing straps (four on each side)
10. Overlay base (including micro air loss system)
11. Overlay zip
12. Tube-set
13. Connector
14. Cable management
PARTS DESIGNATION - AURALIS 175 AND 200 MATTRESS REPLACEMENT14
2
3
12
14
Parts designation - Auralis 175 and 200 mattress
replacement
13
1
4
5
6
8 710 911

1. &35UDSLGGHÀDWLRQXQLW
2. Detachable cover
3. Cover attachment zip
4. Cells (quantity)
• Head cells (3)
• Torso cells (12)
• Heelguard™ cells (6)
5. Loop straps
6. Heelguard™ cell straps
7. Cell hooks
8. 1RQVOLSEDVHZLWKDLU¿OOHG]RQHGVXE
mattress
9. Securing straps (four on each side and
three at head end)
10. Tube-set
11. Connector
12. Cable management
13. Bolster (x2)
14. Bolster sleeve (x2)
15. Air channel
16. Foot extension sleeve
17. Bolster Valve (under valve symbol x2)
18. CPR Tag
PARTS DESIGNATION - AURALIS PLUS MATTRESS REPLACEMENT 15
2
3
1
4
5
6
79
Parts designation - Auralis Plus mattress
replacement
8
10
11
12
13
14
1516 17 18

1. Detachable cover
2. Cover attachment zip
3. Alternating cells
4. Tube-set
5. Connector
6. 'HÀDWLRQYDOYHV
7. Fixing straps
8. Non-slip base
PARTS DESIGNATION - AURALIS SEAT CUSHION16
1
2
4
7
8
6
3
5
Parts designation - Auralis seat cushion

Figure 3
Figure 4
Figure 2
Figure 5
PRODUCT DESCRIPTION - AURALIS PUMP 17
NOTE
There are three different indicator colours:
• Green indicators are functions
• Yellow indicators are information signals or alarms
• Blue indicators are battery charging
Control panel
Run/Standby button
The Run/Standby button (see Figure 2) switches the
Auralis pump between run mode and standby mode.
Run mode - press the button once. The indicator
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Standby mode - press the button for two seconds.The
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NOTE
To turn the Auralis pump off during power failure
or battery operation, press the Run/Standby
button for four seconds.
Wait indicator
The Wait indicator (see Figure 3) is shown when the
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indicator remains on for approximately 15 minutes
until the Auralis mattress or Auralis seat cushion
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mattress takes approximately 17 minutes to reach full
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$XWR¿UPPRGHEXWWRQ
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PDWWUHVVWRDWHPSRUDU\¿UPVXUIDFHDOORZLQJWKH
QXUVLQJSURFHGXUHVWREHSHUIRUPHG7KH$XWR¿UP
mode lasts for 15 minutes but may be increased in
5 minute steps to a maximum of 30 minutes. When
activated the indicator is shown. The Auralis seat
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Alternating mode button
The Alternating mode (see Figure 5) is set by default.
Product description - Auralis pump

Figure 7
Figure 8
Figure 9
Figure 10
Figure 6
PRODUCT DESCRIPTION - AURALIS PUMP18
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WRFUHDWHDÀXFWXDWLQJVXUIDFH:KHQDFWLYDWHGWKH
indicator is shown.
Reactive CLP (Constant Lower Pressure)
mode button
The Reactive CLP mode (see Figure 6) maintains
a constant lower pressure in all the cells. When
activated the indicator is shown. The Auralis seat
cushion does not have Reactive CLP mode.
Comfort control buttons and indicators
The Comfort control buttons (see Figure 7) set the
comfort level by adjusting the pressure within the
support surface. The Comfort control indicators
LQGLFDWHWKHFRPIRUWVHWWLQJ:KHQWKHV\VWHPLV¿UVW
switched on, the default is set to the middle comfort
setting.
• Press the + button to increase pressure in the cells
WRPDNHWKHPDWWUHVV¿UPHU
• Press the – button to reduce pressure in the cells
to make the mattress softer.
Lock out mode
The Lock out mode sets the pump in a locked state to
prevent unintentional changing of settings.
When the pump is in Lock out mode, pushing any
button will result in a negative tone and the top
DQGERWWRP&RPIRUWFRQWUROLQGLFDWRUVÀDVKLQJ
simultaneously to indicate the pump is in Lock out
mode. See Figure 8.
Mute alarm button
When the Mute alarm button (see Figure 9) is
activated the indicator is shown and the audible alarm
is silenced for 15 minutes.
The alarm is cancelled when the alarm condition has
been corrected.
Mains power failure indicator
The Mains power failure indicator (see Figure 10)
is activated when a mains power failure has been
Continue on the next page.

Figure 11
Figure 12
Figure 13
Figure 14
PRODUCT DESCRIPTION - AURALIS PUMP 19
detected. The indicator is shown for information only.
The pump continues to operate normally by using the
battery. There is no audible alarm.
Service indicator
The Service indicator (see Figure 11) indicates two
states:
• When the Auralis pump is ready for service,
the Service indicator shows yellow and the
front panel alarm indicators show green. This
is an information signal and not an alarm
condition.
• If the Auralis pump has an internal fault, the
Service indicator shows yellow, the front panel
alarm indicators show yellow and there is an
audible alarm. The Service indicator may take
up to 22 minutes to show. The alarm can be
muted (see Mute alarm button).
Low battery indicator
The single (top) indicator (see Figure 12) is shown
and an audible alarm sounds when there is a
minimum of 1 hour battery life left. The alarm can be
muted (see Mute alarm button). When there is less
than 15 minutes of battery life left, the Auralis pump
enters the Reactive CLP mode. At this point, the
audible alarm cannot be muted.
Battery charge indicators
The three indicators (blue) (see Figure 13) indicate
the charge level of the battery. When an indicator
LVÀDVKLQJLWLQGLFDWHVWKDWFKDUJLQJLVWDNLQJSODFH
When charged the indicator is constantly on. Each
indicator represents a 1/3 of the full charge of the
battery.
Low pressure indicator
The Low Pressure indicator (see Figure 14) is shown
within 30 minutes if the Auralis pump detects low
pressure within the Auralis mattress or Auralis seat
cushion. There is a single warning tone.
If the mattress or seat cushion is disconnected while
Continue on the next page.

Figure 15
Figure 16
Figure 17
PRODUCT DESCRIPTION - AURALIS PUMP20
in use, the Low Pressure indicator is shown after 30
seconds. When the indicator is shown, there is an
audible alarm. The alarm can be muted (see Mute
alarm button).
If the pump detects that a mattress is not connected
when the pump starts, the Low Pressure indicator is
shown and there is a single warning tone.
Alarm indicators
The power and alarm indicators are located on the
top (the control panel) and front of the Auralis pump.
The alarm indicators shown on the front of the pump
are green when the pump is operating normally and
yellow when there is an alarm condition. See Figure
15.
Hanging brackets
The hanging brackets are used to hang the Auralis
pump at the foot end of the bed. See Figure 16
Power cable
The power cable must be positioned in the cable
management on the left side of the Auralis mattress.
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Skin IQ port
This port is only to be used with Skin IQ.
See Figure 17
To power Skin IQ directly from the pump, a coiled
Skin IQ power cable is needed6HH³3DUWVDQG
DFFHVVRULHV´RQSDJH
For instructions how to use Skin IQ, see respective
Skin IQ IFU.