Jay Zip, Manual

Page: 7 / 60

JAY Zip Cushion 122959 7 Rev.G
ENGLISH
J A Y Z I P
Sunrise Medical Limited
Thorns Road, Brierley Hill
West Midlands, DY5 2LD
UNITED KINGDOM
Type:
Product Name/
SKU Number
XXXX-XX-XX
Date of
Manufacture
Date:
LOT : defi ned by
Julian Date
Part Code
Assembly Part
Number
XXX mm
Seat width
This symbol means
Medical Device
XXX mm
Seat depth
Manufacturer’s
address
XXX kg
kg
Max user weight
European
Authorised
Representative
CE Mark
UK Responsible
Person
UKCA Mark
Swiss
Representative’s
address
Consult
instructions for
use
Importer’s address
SAMPLE
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 produc-
tion. 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
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!
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.
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.