Jay J3 Gebrauchsanweisung Seite 9

ENGLISH
JAY J3 Cushion Warranty
Each JAY fluid cushion is carefully inspected and tested to provide
peak performance. Every JAY fluid 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 are no warranties which extend beyond the
description on the face hereof. Remedies for breach of express
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 production. This
product meets the requirements in accordance with EU and UK regulations. Op-
tions 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
- 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!
JAY 3 FLUID
Type:
Date:
XXX mm
XXX mm
kg
XXX kg
- MS
- Joint contracture
- Tetraplegia
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.
Addendum To Warranty Use And Care Guide
Consult your health care professional for proper fitting and use, and
read the following statements carefully:
• The fluid in this cushion may lose volume over time.
• Volume loss in this cushion may result in bottoming-out of the
cushion.
• Monthly, during routine cleaning and inspection, check the
cushion for bottoming-out (see instructions under "checking for
bottoming-out" in the warranty use and care guide) and any fluid
inconsistencies. If the fluid is firmer in one area simply knead it
back to its original consistency.
• If bottoming-out occurs discontinue use of this cushion and
contact your health care professional. If further assistance is
necessary, contact Sunrise Medical Customer Services.
Product Name/
XXXX-XX-XX
SKU Number
LOT: defi ned by
Part Code
Julian Date
Seat width
Seat depth
Max user weight
CE Mark
UKCA Mark
Consult
instructions for
use
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.
9
JAY J3 CUSHION
Date of
Manufacture
Assembly Part
Number
This symbol means
Medical Device
Manufacturer's
address
European
Authorised
Representative
UK Responsible
Person
Swiss
Representative's
address
Importer's address
SAMPLE
255108 Rev.D