Sunrise Medical JAY LOWZONE Eco Manual Del Usuario página 4

ENGLISH
Medical device symbol glossary
This symbol means
Medical Device
Manufacturer's
address
Batch code
DANGER!
Warning messages
regarding possible
risks of serious
accident or death
Date of manufacture
xxxx-xx-xx
As the manufacturer, Helping Hand, declares that this
product conforms to the Medical Device Regulation
(2017/745).
As the manufacturer, Helping Hand, declares that
the product conforms to the UK Medical Devices
Regulation 2002 No.618.
We at Helping Hand have been awarded the ISO-13485
certificate, which affirms 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.
The varieties of cushions fitting variants, as well as the different
positioning components to deliver higher positioning and skin
protection benefits according to each user requirement and
indication, mean that it can be used by a range of users with
different positioning and skin protection needs and indications
as follows:
- Elderly
- Less Mobile (in the home)
- Wheelchair users
The cushion shall not be used in case of:
- if washed or tumble dried above 60 degrees
- User weight higher than allowed (Maximum User Load stated
on individual cushion).
JAY Lowzone ECO | JAY Lowzone Switch | JAY Lowzone+ | JAY Lowzone GEL Switch | JAY GelZone | JAY ClimaZone
UKCA Mark
European Authorised
Representative
Catalogue number
WARNING!
Warning messages
regarding possible
risks of injury
Load Maximum
Please refer to
XXX Kg individual cushion
CE Mark
Swiss Representative's
address
Unique device
identifier
CAUTION!
Warning messages
regarding possible
technical damage
Distributor's address
SAMPLE LABEL
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 the Member State in which the user and/or
patient is established.
Helping Hand Pressure Care strongly recommends that in order
to ensure that your cushion operates and performs as intended,
all information supplied within this operating manual is read,
understood and stored safely for future reference.
Medical Device Combinations
It may be possible to combine this Medical Device with one or
more Medical Devices, or other products. All combinations
have been validated to meet the General Safety and
Performance Requirements, Annex 1 No. 14.1 of the Medical
Device Regulation 2017/745.
Consult operator's
manual
Importer's address
Serial number
Do not use if package
is damaged and
consult the operator's
manual
Keep dry
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