winncare PRIMA FORM Manuel D'utilisation page 5

4. USAGE INSTRUCTIONS
User training
User training must be carried out by persons who have been trained
and approved by the relevant economic operators, especially in
terms of safety and reporting of non-conformities.
Device installation
The cushion is provided with the cover on (and with a spare cover
in some cases) The product is ready to be installed. The anti-slide
underside of the cushion must be in contact with the wheelchair,
and the handle must be facing the front of the cushion. Sit the
patient down.
Preventive maintenance
› Perform an annual visual check of the condition of the foam.
› Perform an annual check of the external surface of the cover, by
using a light source from inside in order to check for holes and/
or tears.
Cleaning and disinfection
› Between each patient.
› Wash the cover in a machine at a temperature of up to 90°C
(PHARMATEX), or up to 40ºC (MAILLE 3D).
› Do not iron the cover.
› Can be used with a bleach solution of up to 5,000 ppm
(PHARMATEX). Cannot be used with a bleach solution (MAILLE 3D).
Information regarding suitable procedures for
re-use
› Each time that it is re-used, the product must be physically and
bacteriologically cleaned by performing the procedures given in the
technical manual (which can be downloaded at www.winncare.com).
› Replace the cover if the appearance of its surface changes.
5. WARNINGS AND PRECAUTIONS
Required measures
› A cushion must be placed on a wheelchair in good condition.
› Ensure that the dimensions of the cushion are compatible with
the seat of the wheelchair. The equipment must be used with its
original protection.
› Check the position of the pelvis, the vertebral spine, the head, the
armrests and the length of the leg rests and footrests after the
patient has been seated on the cushion.
› A cushion by itself is not enough to prevent pressure ulcers/
pressure wounds; other preventative measures are also required:
Change positions at least once every 2 hours.
Maintain skin hygiene and avoid maceration; do not put any other
surface (sheet, towel etc.) between any part of the chair (back
and seat) which would cause surface tension to appear, in order
to maintain the efficacy of the cushion.
Once a day, observe, or ask someone else to observe, the condition
of the skin.
In case of incontinence, regularly change the protective cover,
Regularly drink enough fluids.
› To ensure that the support is effective, it is important that limit
excessive thicknesses between the body and the support (sheets,
adult nappies etc). Mainly wear clothes that have a lot of cotton, if
possible, without seams in the support region.
› Ensure that no foreign bodies are present, such as tubing, crumbs,
fatty substances etc.
› Important: please talk with your prescriber in the month following
the purchase of the cushion.
› Enhanced monitoring for patients who are at risk of falls (patient
profile: disabled, agitated, not lucid).
Circumstances under which the user must talk
with a healthcare professional
› If one of these measures cannot be implemented, you must
inform your doctor or nurse as soon as possible.
› Inform your doctor or nurse as soon as possible of any abnormal
events such as fever, pain, reddening or whitening of the weight-
bearing areas (ischium, coccyx, trochanter, hip, shoulder blade).
Precautions for use
› Bone and/or muscular and/or skin trauma in the pelvic and thigh
or spinal regions, that is not stabilised and/or painful, and that is
in direct contact with the support device.
› Instability in the seated position.
› The first few days following surgery for a pressure ulcer/wound
(skin graft or flap).
› Please also verify the condition of the exposed part of the skin
each time that care is provided.
Warnings
(Re)evaluate the patient's risk of entrapment in the non-moving
parts of the wheelchair equipped with the therapeutic cushion.
Lifetime information
The device may be reused within the initial performance
maintenance limits for the duration of its life cycle. Its estimated
lifetime is of 4 years.
Accessories
Only protective accessories for the cushion supplied by the
manufacturer can ensure the safety and performance of the
complete product.
6. STORAGE/ HANDLING/DISPOSAL
Specific conditions for storage and/or handling
Store away from light, heat, and humidity.
Disposal of the product
Do not throw the product out into non-dedicated locations in nature.
Follow the recycling channels that are in place in your country.
Pressures (max) in mmHg
before ageing, using the
maximum validated weight
Max. user
weight
PRIMA FORM
100 kg
PRIMA PLOT
KALLI VISCO 130 kg
ISKIO BM 160 kg
ISKIO VISCO 150 kg
GB
mmHg
Max. user pressure
Buttocks
126
169
104
104