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Jay Lite Manuel De L'utilisateur page 6

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  • FRANÇAIS, page 11
E N G L I S H
JAY LITE CUSHION WARRANTY
Every Jay Lite cushion is guaranteed to be free from defects in materials and workmanship for a period of 24 months from the date of
purchase provided normal use. Should a defect in materials or workmanship occur within 24 months from the original date of purchase,
Sunrise Medical will, at its option, repair or replace it without charge. This warranty does not apply to punctures, tears or burns, nor to the
cushion's removable cover. The removable cover is guaranteed to be free from defects in materials and workmanship for a period of six (6)
months from the date of purchase, provided normal use. Should a defect in materials or workmanship occur within six (6) months from the
original date of purchase, Sunrise Medical will, at its option, repair or replace it without charge. Claims and repairs should be processed
through the nearest authorized supplier. Except for express warranties made herein, all other warranties, including implied warranties of
merchantability and warranties of fitness for a particular purpose are excluded. There is no implied warranty beyond what is contained
herein. Remedies for breach of express warranties herein are limited to repair or replacement of the goods. In no event shall damages
for breach of any warranty include any consequential damages or exceed the cost of non-conforming goods sold.
This does not affect your statutory rights.
Sunrise Medical Limited
Thorns Road, Brierley Hill
West Midlands, DY5 2LD
UNITED KINGDOM
The management system of SUNRISE MEDICAL is certifi ed to EN ISO 13485
and ISO 14001.
We at SUNRISE MEDICAL have been awarded the ISO-13485 certifi cate,
which affi rms the quality of our products at every stage, from R & D to pro-
duction. This product meets the requirements in accordance with EU and UK
regulations. Options or accessories shown are available at extra cost.
The varieties of cushions fi tting variants, as well as the diff erent positioning com-
ponents to deliver higher positioning and skin protection benefi ts according to each
user requirement and indication, mean that it can be used by a range of users with
diff erent positioning and skin protection needs and indications as folows[R7-R14] :
- Spinal Cord Injury
- Neurological disease pattern (hemiplegia, M. Parkinson)
- Extremity defect deformity
- Amputation
The cushion for a wheelchair shall not be used in case of [R3, R4]:
- Redness developed in the skin contact area
- Bottoming out present in the JAY Fluid Insert
- Decubitus
NOTE: General user advice. Not following these instructions may result in
physical injury, damage to the product or damage to the environment!
Notice to the user and/or patient: any serious incident that has occurred
in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is
established.
112803
Product Name/
Type:
SKU Number
LOT: defi ned by
Date:
Julian Date
Seat width
XXX mm
Seat depth
XXX mm
kg
Max user weight
XXX kg
CE Mark
UKCA Mark
Consult
instructions for
use
- MS
- Joint contracture
- Tetraplegia
Date of
XXXX-XX-XX
Manufacture
Assembly Part
Part Code
Number
This symbol means
Medical Device
Manufacturer's
address
European
Authorised
Representative
UK Responsible
Person
Swiss
Representative's
address
Importer's address
As the manufacturer, SUNRISE MEDICAL, declares that this
product conforms to the Medical Device Regulation (2017/745).
As the manufacturer, SUNRISE MEDICAL, declares that the
product conforms to the UK Medical Devices Regulation 2002 No.
618.
B4Me special adaptations
Sunrise Medical strongly recommends that in order to ensure that your B4Me
product operates, and performs as intended by the manufacturer; all the user
information supplied with your B4Me product is read and understood, before
the product is first used. Sunrise Medical also recommends that the user
information is not discarded after reading it, but it is kept safely stored for
future reference.
Medical Device Combinations
It may be possible to combine this Medical device with one or more other
Medical Device or other product. Information on which combinations are
possible can be found at www.Sunrisemedical.co.uk. All combinations
listed have been validated to meet the General Safety and Performance
Requirements, section 14.1 of the Medical Device Regulation 2017/745.
Guidance on the combination, such as mounting, can be found at www.
SunriseMedical.co.uk.
6
WA R R A N T Y
SAMPLE
JAY Lite
Rev.J

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