Askle Sante Winncare one plus User manual

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User manual
*PA0010136*
MAJ 19.06.2017 FR

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TABLE OF CONTENTS
INTRODUCTION..............................................................................................................................................................................- 4 -
Necessary information for patients and their families ...........................................................- 4 -
Instructions for use...........................................................................................................................- 4 -
Indications.........................................................................................................................................- 5 -
Contraindications ...........................................................................................................................- 5 -
Precautions .......................................................................................................................................- 5 -
Warning..............................................................................................................................................- 5 -
USE....................................................................................................................................................................................................... - 7 -
Content of packaging for mattress topper and mattress type aids.................................- 7 -
Operating principle ........................................................................................................................- 7 -
Installation of supports ...................................................................................................................- 7 -
Use:......................................................................................................................................................- 9 -
Emergency cardio-pulmonary resuscitation: CPR (Supports)...........................................- 10 -
Un-installing the support..............................................................................................................- 10 -
Storage and transport..................................................................................................................- 11 -
MAINTENANCE/DISINFECTION..............................................................................................................................................- 11 -
ONE PLUS compressor:.................................................................................................................- 12 -
Macro-particle filter:.....................................................................................................................- 12 -
Supports:..........................................................................................................................................- 12 -
Maintenance diagram and recommended disinfection..................................................- 13 -
ALARMS and REPAIR.................................................................................................................................................................- 14 -
MAINTENANCE - REVISION .....................................................................................................................................................- 15 -
Frequency of revisions: ................................................................................................................- 15 -
DISPOSAL OF MEDICAL DEVICE...........................................................................................................................................- 15 -
Protection of the environment ..................................................................................................- 15 -
GUARANTEE...................................................................................................................................................................................- 16 -
TRACEABILITY ................................................................................................................................................................................- 16 -
TECHNICAL CHARACTERISTICS.............................................................................................................................................- 17 -
ELECTROMAGNETIC COMPATIBILITY..................................................................................................................................- 18 -

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INTRODUCTION
NECESSARY INFORMATION FOR PATIENTS AND THEIR FAMILIES
This product helps to prevent and treat pressure ulcers
Why have you been prescribed this support?
Your health condition reduces your mobility and exposes you to the risk of pressure
ulcers.
What is a pressure ulcer?
A pressure ulcer is a lesion of varying depth on the skin, associated with excessive and
prolonged compression of tissue between the body and a support surface. This
excessive pressure can prevent blood circulation and cause pressure ulcers.
A pressure ulcer can have several forms: a simple persistent rash for more than a day,
hardening of the skin, a wound of varying depth that can in several cases affect
muscles or under-lying bone.
A pressure ulcer can be related to a lack of mobility and/or a chronic disease.
How does the support work?
The support reduces pressure and enables better blood circulation in skin with the aim
of helping to prevent pressure ulcers.
INSTRUCTIONS FOR USE
A support in itself is not enough to prevent pressure ulcers; other preventive
measures are also essential:
- change position frequently (at least every 2 to 3 hours)
- maintain skin hygiene and avoid maceration
- in the event of incontinence, change protection regularly
- check (or have checked) skin condition daily
- ensure a sufficient and appropriate diet
- drink regularly and in sufficient quantities.
If any of these measures cannot be followed, your doctor or nurse must be informed as
quickly as possible.
Tell your doctor or nurse about any abnormal event such as fever, pain or even a rash
or whitening of support points (head, shoulder, back, hip, shoulder blade, pelvis, heel,
etc.).
It is important to limit over-thickness between the body and the support as much as
possible, with the exception of a cover for a bed support, clothing and a potential
complete change. Preferably loose cotton clothing and if possible without stitching in
the support zone. Do not insert: folded towel or sheet, additional cushion, etc.
Ensure there are no foreign objects such as: tubes, crumbs, fat, etc.
For hygiene reasons, each pressure ulcer prevention support must be restricted to a
single person.

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INDICATIONS
According to the National Commission for the Evaluation of Medical Devices and
Health Technologies (CNEDiMTS) dated 22 December 2009 and in accordance with
the expert opinions of clinicians:
Prevention and treatment support for stage 1 to 2 pressure ulcers (above this
according to medical advice) for patients who are up during the day, confined to
bed for over 15 hours and with a “moderate” to “high” risk of pressure ulcer evaluated
according to a validated scale and clinical judgement.
CONTRAINDICATIONS
Patients who are not up during the day, in poor general health and/or with
arteriopathy and/or recent neurological disorder. Stage 3 or 4 pressure ulcers in
support area.
Patients with several pressure ulcers at stage strictly over 2 in support area.
Post-surgery pressure ulcer for 3 months following the procedure.
Patients weighing over 150 kg. Use in decompression chamber. Use on a stretcher.
PRECAUTIONS
Non-stabilized bone and/or muscle injuries in contact with the support.
Initial days for post-surgery pressure ulcer (skin transplant or flap)
[Use the low pressure static mode].
Patients treated at home with no possibility for auxiliary medical intervention .
For a patients confined to bed in semi-seated position at 45° at least: To make sure
that there is no risk of injury, check that there is a sufficient volume of air by placing
the palm of the hand towards the top between the buttock area and the support.
The “comfort” setting can be used to add air, if applicable.
Also check the condition of exposed skin at each treatment and change of position.
WARNING
In accordance with appendix 1 of the 93/42/CEE directive regarding essential
requirements applicable to medical devices, only the compatibility between
systems assembled by the manufacturer ASKLÉSANTÉ, ensures a safe combination
with the use of AXTAIR ONE PLUS motorized air support.
The characteristics and performance of the motorized air support will be maintained
exclusively through the use of a compressor [see references on page 18], combined
with mattress type supports [see references on page 17] with no modification and
optionally, with a rapid inflation/deflation kit [see references on page 17]
The national authority responsible for the safety of health products can at any time
check marketing conditions for products and take the necessary steps in the event
of danger or breach of regulations. Should the conditions for use outlined above not
be followed, the user’s responsibility is likely to be implicated in the event of an
accident.
Products in the AXTAIR motorized air range are therapeutic supports for medical
beds in the context of the CEI standard 60601-2-52 regarding the evaluation of
protection against mechanical hazards from Electro-Mechanical devices (EM) and
EM systems; in this context, they are excluded from the scope of tests according to

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figures 201.107, 201.108 and table 201.101 for the measurement of the “D”
dimension.
To satisfy the risk analysis according to the ISO 14971 standard, the evaluation was
conducted on “medical bed-therapeutic support (AXTAIR) units - accessories”. The
risk assessment demonstrates that there could be a risk of bodily entrapment in the
case of a person confined to bed with a confusion and/or anxiety disorder.
The use of the device was approved for improved service provided in terms of
therapeutic support and/or pressure ulcer prevention.
We approved this product for the improved service that it provides in the prevention
and treatment of pressure ulcers versus the exceptional risk of entrapment of a
person confined to bed.
Keep the packaging, transport bag and the support out of reach of children to
avoid the risk of suffocation.
In order to avoid any risk, any modification to this product, or use of non-specified
accessories is forbidden.
Meaning of symbols
Note, see user manual and (or) instruction leaflet
Category II device (Dual insulation)
BF type electrical device (applied to aids)
Complies with essential requirements of European directive
93/42/CEE applicable to medical devices (amended
2007/47/CEE)
Note, electrical and electronic equipment subject to selective
waste collection
Manufacturer
Serial number
Batch number
Patient weight range
Warning

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USE
CONTENT OF PACKAGING FOR MATTRESS TOPPER AND MATTRESS TYPE AIDS
1 rolled mattress topper in a transport bag
1 dirty/clean label
1 identification label
1 integrated compressor in a rolled support
1 electrical power supply cable with 2 attachment systems to long sides of a
medical bed
1 user manual
OPERATING PRINCIPLE
The inflation pressure calculation is automatic and continuous according to a
patient’s morphology. No external intervention is needed.
The seated position function adjusts the pressure when the chest relief is over 30°.
The comfort setting adjusts the pressure irrespective of position.
NOTES:
Contact the shop or service provider where the product was purchased for any
assistance with assembly, use or repair of the product.
INSTALLATION OF SUPPORTS
1. Unroll the support.
2. Position it on the bed base in accordance with the location of the “head” and
“foot” symbols for the cover.
3. Hang the compressor on the bed panel (foot side) using the hooks.
4. Guide the power supply cable for the compressor along the bed to the closest
socket, attach it to long side of bed using 2 connectors on the cable and connect
the socket: The indicator lights flash for a few seconds and a BEEP is heard.
5. If you have a rapid inflation kit, follow these steps, otherwise go to step 9.
6. Open the CPR valve by positioning the index finger on OPEN, .
7. Connect the rapid inflation kit to the CPR.

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Keep the CPR and pump in the same axis in order to avoid arching the CPR by the
weight of the pump. Incorrect use could cause a water tightness defect for the
CPR.
8. Press the button to switch on the rapid inflation kit until the support is inflated
(approx. 1 minute) - Note: The level of inflation has no significance because it will
be adjusted automatically by the compressor.
9. Close the CPR valve by positioning the index finger on CLOSED, .
10. Connect the support to the compressor:
11. After the hourglass indicator light has gone off, the patient can be installed on the
support.
NOTES:
The information needed to use the compressor is placed on the side of it: simplified
leaflet.
After 5 minutes without a selection, the brightness of the indicators is lessened to
avoid disturbing the user at night. Pressing any key reactivates maximum brightness
for 5 minutes.
The pneumatic connector has a stopper to re-equilibrate pressure of the support
when it is disconnected from the compressor.
WARNINGS:
The electrical cable must be kept away from any severing with the articulated parts,
the wheels of the bed and walking area. Risk of physical injury and equipment
damage. Use the removable attachment systems provided.
The power supply cable is the severing system for the machine.
The compressor keyboard, the power supply cable, the pneumatic connector and
the CPR valve must be permanently visible and accessible.

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USE:
Shows that the compressor is switched on
Flashes to indicate inflation of the support
After it goes off, the patient can be installed
The on indicator shows that the keyboard is locked: it is not
possible to change mode.
Continuously pressing for 4 seconds unlocks the keyboard.
Automatically closed after 5 minutes by continuously pressing for 4
seconds.
Enables comfort to be adjusted for the patient regardless of
position.
By default, the LED is in the central position, which is the
calculated nominal position.
The seated position function can be selected when the chest
relief is over 30°.
When the function is set, the dynamic cycle is accelerated for
greater comfort and restricts the risk of injury.
NOTE: It is preferable to press this function before tilting the chest
relief rather than the other way around.
NOTE: Don’t forget exit the function if the patient returns to the
lying down position.
FIXED LED: Compressor revision recommended
(17500 hours of operation)
Fixed LED: Low priority alarm. (See alarms chapter)
Flashing LED: Medium priority alarm.
(See alarms chapter)
Button press: stop sound alarm
In the event of a medium priority alarm, the sound alarm is
reactivated after 3 minutes.
The following conditions of use must be followed:
Temperature: between +15°C and + 40°C
Hygrometry level: between 30% and 95%
Altitude: Less than 2000 m

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EMERGENCY CARDIO-PULMONARY RESUSCITATION:CPR (SUPPORTS)
In the event of a cardiac arrest:
1. Turn the nozzle of the CPR valve to position the index finger on the “OPEN”
position.
2. The support deflates and the back part of the thorax is on the firm surface of the
bed base in less than 20 seconds to enable External Cardiac Massage to be
performed.
UN-INSTALLING THE SUPPORT
1. Disconnect the compressor from the mains
2. Open the CPR valve to deflate the support. Complete removal of air from the
support can be facilitated by using the inflation/deflation kit connected to the
CPR.
3. Position the compressor in the middle of the support.
4. Roll the support starting from the foot end.
5. Insert the support in the transport bag supplied with the product.
6. Position the dirty/clean label in order to make the yellow side visible.
Blue label: the support is clean
Yellow label: the support is dirty (risk
of contamination)
WARNING:
Accidental deflation of the mattress (power cut or accidental cut of the air circuit):
Should the patient have to be kept in the continuous seated position and/or the
patient is unable to get up alone or assisted and/or the patient lives alone and/or
the patient is hard of hearing, the patient must be lifted to replace the mattress of
the medical bed as soon as possible. Should the patient be able to get up alone
and intervention is possible within less than 8 hours, he/she must lower the chest relief
at least.

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STORAGE AND TRANSPORT
There is a label on the transport bag to enable rapid identification of the device from
the AXTAIR range contained in the bag. This label must be visible when the product is
stored.
The following storage and transport conditions must be followed:
Temperature: between -25°C and + 70°C
Hygrometry level: between 30% and 95%
Atmospheric pressure: between 50 kPa and 106 kPa
WARNING:
Keep the device away from humidity, direct sunlight, and continuous heat source.
Prevent the risk of shock or alteration from sharp objects.
NOTE:
The MANUFACTURER will provide, upon request, the circuit schemas, list of
components, descriptions, calibration instructions or any other relevant information
to MAINTENANCE STAFF to perform authorized repairs in accordance with the
contract that binds the requester to the manufacturer ASKLÉ SANTÉ.
MAINTENANCE/DISINFECTION
The method used depends on the required level of disinfection: Techniques and
products will be applied according to validated good practice recommendations.
The compressor and supports are compatible with SANIVAP type steam processes
(Contact us for further information)
See the diagram at the end of the section.
- Daily upkeep of the compressor is done in operation with the connector for the
support to the connector.
- For all other maintenance, it is essential to disconnect the mains socket from the
electrical cable attached to the compressor and ensure that the transport stopper is
placed on the over-mattress. The “mains present” indicator light must be off.
- Do not project drops of water on the Axtair ONE PLUS compressor as this could have
harmful effects related to safety and its use NF EN 60529).
- Do not use a high-pressure jet to clean an Axtair ONE PLUS compressor.
- Do not put the compressor on the ground. Hang it at a distance ≥ 60 cm from a
water point.

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Do not allow abrasive cleaning products such as commercial detergents,
acetone type solvents, ether and colouring products (iodized alcohol, potassium
permanganate, silver nitrate etc.). Do not use abrasive materials such as steel wool or
“scotch brite”.
ONE PLUS COMPRESSOR:
Use a cloth soaked in a detergent product solution or CE* labelled surface
detergent/disinfectant at the usage concentrations recommended by the
manufacturer. Adhere to the remanence times.
MACRO-PARTICLE FILTER:
The filter must be replaced once a year or more frequently depending on
environmental conditions (dust, smoke, etc.).
This macro particle filter is on the back of the compressor, protected by a transparent
cover.
SUPPORTS:
On the support, two zippers inside the cover at the head and foot end of the support
are used to separate the elements quickly.
All the cells and the maintenance sheet remain together and must be manually
disinfected: use a cloth soaked in a detergent solution or CE* labelled surface
detergent/disinfectant at usage concentrations recommended by the manufacturer.
Adhere to the remanence times.
* CE labelling obligatory in the context of directive 93/42/CEE for products claiming
use on surfaces for Medical Devices.
For the cover and base, the following maintenance recommendations must be
respected:
Wash in water, maximum temperature 90°C, reduced mechanical
action, rinsing at decreasing temperature, reduced spinning.
Bleaching possible, chlorination at 5000 ppm authorized.
Ironing excluded.
Dry cleaning excluded, use of solvent-based stain remover
excluded.
Drum drying authorized, moderate temperatures (60°C)
Item treated with biocide substance at no risk to users. www.winncare.fr

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MAINTENANCE DIAGRAM AND RECOMMENDED DISINFECTION
* Broad spectrum, alcohol-based Disinfectant Detergent, standardized: bactericide
EN1040, EN13727, Fungicide EN1275, EN13624, NF T72-190, Sporicide EN13697, EN14561,
Polyvirus EN14476, HBV, HCV, EN 14347 (clostridium difficile)
Restrict spraying to mattress topper. Damp wiping of compressor.
** Detergent-Disinfectant for maintenance of floors and surfaces (Positive list of
Disinfectants)
*** Neutral detergent (domestic washing product)
NO
YES
NO
YES
YES
Receipt
Complete Device
Pre-treatment of surface (Decontamination)
Surface distribution by µfibres
Alcohol based solution* (PPE: Hygiene mask, gloves,
apron)
Physical
cleanliness
Unacceptable
Bio cleaning surface maintenance
Method: 3 Operations
Product: Detergent-Disinfectant**
(PPE: gloves, apron)
Cover washing in machine at 90°C
(Detergent ***)
Identical replacement cover
to original protection
Support and Compressor
Conformity
Assemble
Record
Surface spray
Detergent-Disinfectant**
(PPE: hygiene mask)
Product release
Packaging
NO
Product
expertise
Cover altered?
Disposal by waste network
Surface maintenance
1 Operation
Detergent-Disinfectant

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ALARMS AND REPAIR
The following table shows all the alarms for the device, their triggering conditions, their
priority as well as possible repair.
Description
Priority
Trigger
Possible repair
Condition
Time
frame
Alarm indicator
flashing
and mains present
indicator off
+
+ sound signal
Medium
Electrical fault:
the compressor is
not powered by
the mains
0 min
1 - Re-connect the compressor
2 - Check the status of the
electrical network
3 - Replace the fuse
4 - Disconnect the support from
the compressor (put the
transport stopper)
5 - Contact your maintenance
department
Alarm indicator
flashing
and mains present
indicator on
+ sound signal
Medium
Compressor
system problem
0 to 1
min
1 - Check that the support is
properly connected to the
compressor
2 - Check that the CPR is well
sealed
3 - Remove the patient from
the support
4 - Contact your maintenance
department
The compressor
measures a nil
pressure whereas
it pumps
1 min
The compressor
measures an
over-pressure
1 min
Inflation
impossible
40
min
The compressor
detects a
pneumatic
problem
1 min
Fixed alarm
indicator
+ sound signal
Low
Initial inflation
impossible
40
min
1 - Check that the support is
properly connected to the
compressor
2 - Check that the CPR is well
sealed
3 - Contact your maintenance
department
NOTES:
When the compressor is disconnected, even voluntarily, there is systematically an
electrical fault alarm to prevent involuntary action.
The triggering conditions in the table above are classified according to their
priority.
The sound and visual alarms are designed to be noticed 2 metres from the
compressor.

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WARNING:
After accidental deflation of the support due to an extended power cut, at re-
inflation, ensure that the patient has no limbs stuck between the support and the bed
barriers.
MAINTENANCE -REVISION
FREQUENCY OF REVISIONS:
it is recommended revising the ONE PLUS compressor at least every 2 years of use.
To facilitate the management and scheduling of these revisions running time counters
give information about the compressor usage times. To view this information, specific
equipment is necessary, contact your retailer for more information.
WARNING:
Revisions can only be made by authorized individuals, contact your retailer.
need for revision
Meaning
FIXED LED
Product revision is required
(17500 hours of operation).
DISPOSAL OF MEDICAL DEVICE
PROTECTION OF THE ENVIRONMENT
This device contains multiple recyclable materials.
This symbol shows you that this equipment is recyclable and that used
devices must not be mixed with other waste.
The recycling of devices will therefore be done under the best safety
conditions to limit effects on the environment and human health in the event of the
existence of hazardous substances, in accordance with European directive
2002/96/CE for obsolete electrical and electronic equipment.
You can return your obsolete compressor to your closest waste reception
centre. The device should be placed in the container for mixed small
devices.
You can contact the shop or service provider from whom the product was
purchased to find out the details of used device collection points closest to your
home.
The DEEE collection applies to the complete medical device: compressor + associated
mattress or associated cushion. Log on to www.eco-systemes.fr and search for your
closest collection point.
Your DEEE waste can be dropped off there free of charge. For further information log
on to www.winncare.fr where you will find information about this in each of the
product sections.
Prior to any disposal, the device should be cleaned according to the instructions in the
MAINTENANCE-DISINFECTION chapter to avoid any risk of contamination.
Thank you for your public citizen contribution to protecting the environment.

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GUARANTEE
The compressor and its supports are guaranteed for 2 years against any
manufacturing defect from the date of purchase and under the recommended
usage conditions outlined in the usage leaflet. This guarantee cannot substitute legal
guarantees.
To avail of this, the purchase invoice for the product must be retained.
In the event of a manufacturing defect and if the product is still under guarantee,
please contact your service provider showing them the relevant product. They will start
the necessary steps with our company to proceed with repair.
Read the general sales conditions for the current year for the product and
replacement parts.
WARNING:
A guarantee seal is placed under the simplified leaflet stuck on the side of the
compressor. This seal ensures that the compressor has passed all the control tests
successfully as well as its tamper resistance.
In the event of removal of this label by the user or an unauthorized third person, the
integrity of the compressor is no longer guaranteed: ASKLÉ SANTÉ could refuse to cover
the repair under guarantee, and authorize the right to end this.
TRACEABILITY
Traceability by serial number or batch number according to product types enables
ASKLÉSANTÉ to ensure traceability of raw materials and assembly operations for these
products.
In the Axtair range, compressors are managed by serial number. The serial number is
on the product and its packaging.
SN: AASSTXXX
AA: Year of Manufacture
SS: Week of Manufacture
T: Type
XXX: Incremental number
In the Axtair range, mattress toppers are managed by batch number except for
Axensor mattresses which are managed by serial number. The batch number is on the
product and its packaging.
BATCH: AASS
AA: Year of Manufacture
SS: Week of Manufacture

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TECHNICAL CHARACTERISTICS
CHARACTERISTICS OF:
MATTRESS TOPPER SUPPORTS
References
Supports from KITS
VAXT2/ONE-P
VAXT2/ONE/CIC-P
Validated patient weight
30 – 150 kg
Support weight
5.7 Kg
Support size
195 x 87 x 17 cm
Therapeutic air cells (AT)
Number: 18
Height: 12 cm
Material: Polyurethane ether
Rapid deflation (CPR valve)
less than 20 seconds.
Foam mattress
Polyether foam (removable) - Height + 5 cm
Upper cover part
- Material impermeable to liquids and permeable to
water vapour.
Promust CIC: Polyurethane/Polycarbonate on a
mesh enriched with silver ions and assembled by
soldering.
Lower cover part
- Material: non-slip PU/PVC
Support standby disconnected
> 8 hours
Fire standards
EN 597-1&2 and GPEM D1-89bis and D1-90 Class D
Guarantee
2 years against manufacturing defects
Service life
5 years
Rapid deflation kit
Compatibility (ref. VKIT/AXT and VAXT/PGR)

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CHARACTERISTICS OF:
COMPRESSOR
Reference:
Compressor from KITS
VAXT2/ONE-P
VAXT2/ONE/CIC-P
Mode of operation
Alternative: 1 cell out of 2
Compressor weight
2.7 Kg
Compressor size
22 x 25 x 11.5 cm
Pressure setting
Automatic
Complete cycle time
Between 10 and 11 min
Pump speed (indicative value)
> 7 litres / min
Support inflation time
Approx. 20 minutes
Less than 1 minute with a rapid inflation pump
Acoustic pressure
As per NF EN3744
< 35 dBA
Alarms
Visual and sound
Electricity supply
220-240 volts – 50 Hertz
Power supply cable length
4,5 m
Fuse
T 0,63A H 250 V
Max consumed visible power
13 VA
Average consumption seen
5 Wh
Electric shock protection
Class II.
BF type insulation applied to compressor
Box material
Fire-retardant plastic material
Guarantee
2 years against manufacturing defects
Service life
6 years
Standards
IEC 60601-1; IEC 60601-1-2
ELECTROMAGNETIC COMPATIBILITY
The Axtair ONE PLUS complies with applicable electromagnetic compatibility
standards (CEM).
The Axtair ONE PLUS requires special precautions with respect to CEM and it must be
installed and serviced according to CEM information provided upon request from
ASKLE SANTE and available on their website.
The use of accessories, and cables other than those supplied and specified by ASKLE
SANTE can result in increased emissions from the Axtair ONE PLUS or reduced immunity,
affecting its operation, as well as its performance.

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ASKLÉSANTÉ Groupe Winncare – 200, rue Charles Tellier – Actiparc de Grézan – 30 034 Nîmes Cedex 1
(France)
Tel.: [phone] – Fax. : [phone] – Email: [e-mail]
www.winncare.fr
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