winncare PRIMA FORM Manuel D'utilisation page 4

1. INDICATIONS
Device Intended Use
› Prevention of pressure ulcers.
› Compensation for disability in the seated position
(cushions and back).
Indications
› Chair support for the prevention of pressure ulcers in
patients who are at moderate to high-risk of developing
pressure ulcers (as per clinical judgment and scales),
with no pressure asymmetry and who are not-at risk for
"forward-sliding" (KALLI VISCO, ISKIO VISCO, ISKIO BM,
PRIMA FORM)
› Chair support for the prevention of pressure ulcers in
patients who are at moderate to high-risk of developing
pressure ulcers (as per clinical judgment and scales), with
no pressure asymmetry, and who have a "forward-sliding"
type of postural deficit (psychomotor regression, stroke,
hypertonia of the hamstrings, hypertonia of the extensors
of the spine) (PRIMA PLOT)
› Wheelchair seating support for patients with no risk of
pressure ulcers (KALLI HR, back)
› Localised excessive pressure due to changes to the
curvature of the spine. Lateral inclination of the trunk due
to a mild postural deficit (back).
Contra-indications
› Patients with frontal or sagittal stability difficulties.
› Established sacrococcygeal and/or ischial pressure
ulcers.
› Patients whose weight is higher than that which the
mattress can support.
› Risk of "forward sliding" (except for PRIMA PLOT).
Target patient and user group
› Seated patients with reduced mobility with no pressure
asymmetry and with no risk of sliding forward, who have
a "moderate to high" risk for pressure ulcers (KALLI VISCO,
ISKIO VISCO, ISKIO BM, PRIMA FORM).
› Seated patients with reduced mobility with no pressure
asymmetry, presenting with a forward-sliding type postural
deficit in the seated position, and who have a "moderate to
high" risk for pressure ulcers (PRIMA PLOT).
› Seated patients with reduced mobility, with no risk of
pressure ulcers (KALLI HR, back)
Report undesirable side-effects
All serious incidents which are related to the device must be
notified to the manufacturer and the competent authority of
the member state in which the user and/or patient resides.
Inform the competent authority if you consider or have
reason to believe that the device presents a serious risk or
that it is a fake product.
2. COMPOSITION OF THE MEDICAL DEVICE
PRIMA PLOT
Viscoelastic polyurethane foam (80 kg/m
High resiliency abduction pad (40 kg/m
PHARMATEX cover, with anti-slide underside and transport
handle.
Operating instructions (paper or electronic).
KALLI VISCO, KALLI HR & PRIMA FORM
Viscoelastic polyurethane foam (80 kg/m3). (80 kg/m
KALLI VISCO and PRIMA FORM, or highly resilient mousse (37
kg/m ) for KALLI HR.
3
PHARMATEX cover, with anti-slide underside and transport
handle. A JERSEY cover is also available for the KALLI HR.
Operating instructions (paper or electronic).
ISKIO BM & ISKIO VISCO
Viscoelastic polyurethane foam (80 kg/m
Highly resistant foam insert (37 kg/m
viscoelastic foam insert, with greater load-bearing capacity for
ISKIO VISCO.
MAILLE 3D complete cover; or PHARMATEX cover, with anti-
slide underside and transport handle.
Operating instructions (paper or electronic).
BACK
Viscoelastic polyurethane foam (80 kg/m3). (80 kg/m
DOS VISCO, or highly resilient mousse (37 kg/m
HR.
PHARMATEX cover (KALLI DOS VISCO). JERSEY cover and
edges in PHARMATEX (KALLI DOS HR).
Operating instructions (paper or electronic).
3. CLINICAL BENEFIT, PERFORMANCE,
MECHANISM OF ACTION
Performance characteristics of the device
› Cushion for the prevention of pressure ulcers: The viscoelastic
foam material allows for immersion of the pelvis, enveloping the
areas in which bones stick out (ischium, coccyx, trochanter).
› Non-specific comfort cushions and back: Improved comfort in
the seated position, that allows basic daily living tasks (bodily
hygiene, transfers etc) to be performed.
Expected clinical benefits
Maintains tissue oxygenation at the cutaneous and subcutaneous
tissues that are in contact with the support, and/or contributes to
the activities required for life support.
Information for health professionals
Observe the condition of the patient's skin which is in contact with
the cushion several times a day. Do not sit the patient down if they
have a pressure ulcer at the ischial or coccygeal regions. Verify that
the seat of the chair is in good condition. For wheelchairs, verify the
height of the arm rests, the footrests etc. as well as its performance
in terms of propulsion.
GB
).
3
).
3
) for
3
).
3
) for ISKIO BM, or
3
) for KALLI
3
) for KALLI DOS
3