Jay 247798 Manual Del Usuario página 5

E N G L I S H
24 MONTH LIMITED WARRANTY
Each Product is carefully inspected and tested to provide peak performance. Every Product 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 any removable
cover.
Removable covers are 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 authorised 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.
Product Name/
Type:
SKU Number
Lot
Date of
XXXX-XX-XX
Manufacture
CE Mark
UKCA Mark
Consult
instructions for
use
Record your serial number here:
JAY Pelvic Positioning Belts
Sunrise Medical Limited
Thorns Road, Brierley Hill
West Midlands, DY5 2LD
UNITED KINGDOM
This symbol means
Medical Device
Manufacturer's
address
European
Authorised
Representative
UK Responsible
Person
Swiss
Representative's
address
Importer's address
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 production. This
product complies with the standards set forth in EU and UK regulations.
Indications
The varieties of fi tting variants, as well as the modular design, mean that it can be
used by those who cannot walk or have limited mobility because of:
- Joint contractures - Muscle Distrophy
- Spasticity - Assymetric Postures
- Cerebral Palsy - MS
Contraindication
No contraindications are known or available.
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).
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 prod-
uct operates, and performs as intended by the manufacturer; all the user informa-
tion 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.
Record your Dealer address here:
5
WA R R A N T Y
- Neurogical disease pattern
- Hypo- Hyper tonic
- SCI
Rev.F