Sunrise Medical JAY ZIP BACK Manual Del Usuario página 5

ENGLISH
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 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 backrest fi tting variants, as well as the diff erent positioning
components to deliver postural support, pressure distribution, increase seating
tolerance are benefi ts according to each user requirement and indication,
mean that it can be used by a range of users with diff erent positioning needs
and indications as follows:
- Spinal Cord Injury - Amputation
- MS - Tetraplegia
- Neurological disease pattern (hemiplegia, M. Parkinson)
- Muscle Dystrophy - Extremity defect deformity
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!
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.
JAY Zip Back 122962
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
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
- Joint contracture
information is not discarded after reading it, but it is kept safely stored for
- Cerebral Palsy
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.
5
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.
INTRODUCTION
SAMPLE
Part Code:
Date:
kg
cm cm
Sunrise Medical (US) LLC
2842 Business Park Avenue
Fresno, California, 93727 USA
Sunrise Medical GmbH
Kahlbachring 2-4
EC REP
69254 Malsch / HD
Germany
Sunrise Medical Ltd.
Thorns Road, Brierley Hill
UK RP
West Midlands DY5 2LD
United Kingdom
Assembled in Mexico
60°C
106132 Rev. J
REV.H