Jay Xtreme Active Manuel De L'utilisateur page 13

E N G L I S H
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 production. This product meets the requirements in accordance with EU regulations. Options or accessories shown are
available at extra cost.
The varieties of cushions fi tting variants, as well as the diff erent positioning components 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
- MS
- Neurological disease pattern (hemiplegia, M. Parkinson)
- Extremity defect deformity
- Joint contracture
- Amputation
- Tetraplegia
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!
A notice to the user and/or patient that 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.
As the manufacturer, SUNRISE MEDICAL, declares that this product conforms to the Medical Device Regulation
(2017/745).
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 fi rst 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.
JAY Xtreme Active Rev.F
1 Type: Product Name
LOT: defi ned
Date:
2
by Julian Date
Seat width
XXX mm
Seat depth
XXX mm
kg
Max user
weight
XXX kg
CE Mark
Date of
XXXX-XX-XX
Manufacture
Assembly Part
Part Code
Number
This symbol
means Medical
Device
Manufacturer
European
Authorised
Representative
127348
13