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).
ENGLISH
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.
SAMPLE LABEL
Medical device symbol glossary
This symbol means
Medical Device
UKCA Mark
CE Mark
Consult operator’s
manual
Manufacturer’s
address
European Authorised
Representative
Swiss Representative’s
address
Importer’s address
Batch code
Catalogue number
Unique device
identifier
Serial number
DANGER!
Warning messages
regarding possible
risks of serious
accident or death
WARNING!
Warning messages
regarding possible
risks of injury
CAUTION!
Warning messages
regarding possible
technical damage
Do not use if package
is damaged and
consult the operator’s
manual
Date of manufacture
Load Maximum
Please refer to
individual cushion
Distributor’s address
Keep dry
XXX Kg
xxxx-xx-xx
Approved Cleaning Procedures for JAY Helping Hand Pressure Care Cushions
Product
Lowzone
ECO
Lowzone
Switch
Lowzone GEL
Switch
GelZone
ClimaZone
1. Cushion OUTER COVER - CoolOver / Spacer fabric / Wipedown PU* / Wipedown PU non-slip* / Toweling
Wipe clean with a soft
cloth moistened with
water & a neutral
detergent.
Machine wash with
detergent up to 60°C
or dry clean. Chlorine
based cleaning
solutions (i.e. bleach)
can be diluted to
1%.
DO NOT
use
biological cleaner
60
60
60
60
60
60
HANG COVERS TO AIR DRY BEFORE RE-USE | DO NOT TUMBLE DRY | DO NOT IRON
2. Cushion INNER COVER - polyurethane film
Gently clean with a
soft cloth moistened
with water & a neutral
detergent
3. Cushion CORE BASE - DO NOT SUBMERGE IN WATER
Steam autoclave
up to 105 °C
Gently clean with a
soft cloth moistened
with water & a neutral
detergent
Immersion isinfection
60°C is the maximum recommended temperature for ALL covers.
* Possible wrinkling may occur with PU if washed at 60°C but the functional aspect of the cover is not diminished
ENGLISH
5
4
JAY Lowzone ECO | JAY Lowzone Switch | JAY | JAY Lowzone GEL Switch | JAY GelZone | JAY ClimaZone
JAY Lowzone ECO | JAY Lowzone Switch | JAY | JAY Lowzone GEL Switch | JAY GelZone | JAY ClimaZone