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.
8QDXWKRUL]HGPRGL¿FDWLRQVRQDQ\$UMRHTXLSPHQWFDQDIIHFWVDIHW\$UMRZLOOQRWEHKHOGUHVSRQVLEOHIRU
DQ\DFFLGHQWVLQFLGHQWVRUODFNRISHUIRUPDQFHWKDWRFFXUDVDUHVXOWRIDQ\XQDXWKRUL]HGPRGL¿FDWLRQWRLWV
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
'H¿QLWLRQVLQWKLV,)8

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’.
7KHV\VWHPVKRXOGRQO\EHXVHGIRUWKHSXUSRVHVSHFL¿HGLQWKHVH,QVWUXFWLRQVIRU8VH
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
&35UDSLGGHÀDWLRQXQLWPXVWEHYLVLEOH
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
XQFRQWDLQHGÀDPPDEOHOLTXLGVRUJDVHV
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
7RDYRLGUHGXFHGEHQH¿WVIURPWKH
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
¿UH
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.
$FWLRQVEHIRUH¿UVWXVH
(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)
1. ,QVSHFWWKH$XUDOLVV\VWHPDFFRUGLQJWRVHFWLRQ³&DUHDQGSUHYHQWLYHPDLQWHQDQFH
6FKHGXOH´RQSDJH
2. If any item is damaged - do NOT use the product.
After each patient
&OHDQDQGGLVLQIHFWWKHSURGXFWDIWHUHDFKSDWLHQWDFFRUGLQJWRVHFWLRQ³&OHDQLQJDQG
GLVLQIHFWLRQLQVWUXFWLRQV´RQSDJH
The position of the caregiver
The caregiver should be positioned in front of the pump during operation. See Figure 1