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Idiomas disponibles
Idiomas disponibles
Viscoelastic foam cushions
ALOVA CURVED – ALOVA ERGONOMIC
DEVICE INTENDED USE
Pressure sore prevention in prolonged sitting position.
INDICATIONS
A seated patient with reduced mobility, no support asymmetry and no risk of slipping forward, with a "Moderate to High" pressure ulcer risk (according
to the Braden or other approved scale and in accordance with medical opinion). Trunk and/or lower limb paralysis, history of ischial or sacrococcygeal
pressure ulcer, lower limb tenderness, spasticity, vascular amputation.
CONTRAINDICATIONS
Patient with sagittal or frontal stability disorders. Sacrococcygeal and/or ischial pressure ulcers. Patient weight levels above the limits set in the technical
data table.
ADVERSE SIDE EFFECTS
Trunk dynamic instability. Pelvic slippage in the saggital plane. Loss of efficiency in "sitting" transfers. Lateral trunk transfer instability.
Any serious incident occurring in connection with the device must be notified to the manufacturer and the competent authority of
the Member State in which the user and/or patient is established. Inform the competent authority if you consider or have reason to
believe that the device poses a serious risk or has been tampered with.
MEDICAL DEVICE COMPOSITION/TECHNICAL DATA
VCAG3636, CAG3841, VCAG4041,
VCAG5250,
VCAG4340, VCAG4341, VCAG4043,
VCAG5450,
Versions
VCAG4343, VCAG4347, VCAG4540,
VCAG5650,
VCAG4544, VCAG5044
VCAG6050
Dimensions
The Length and width dimensions are contained in the reference
Thickness
6 cm
Surface
Foam base
-
Protection
Removable cover in PU 30% / Polyester70% and non-slip lower side
Patient
120 to 200 kg
30 to 120 kg
weight min
according to
according to reference
and max
reference
CLINICAL BENEFIT, DEVICE PERFORMANCE, MECHANISM OF ACTION
D
P
C
: The viscoelastic foam material allows the pelvis to be immersed and the areas opposite bone protuberances
EVICE
ERFORMANCE
HARACTERISTICS
(ischium, coccyx, trochanter) to be enveloped.
E
: Maintenance of tissue oxygenation in the cutaneous and subcutaneous tissues in contact with the support.
XPECTED CLINICAL BENEFITS
I
H
P
: Monitor the condition of the patient's skin in contact with the cushion several times a day. Do not seat
NFORMATION FOR
EALTHCARE
ROFESSIONALS
patients with ischial and coccygeal pressure ulcers. Check that the seat of the chair is in good condition. In the case of a wheelchair, check the height
adjustment of the armrests, footrests, (...) and performance in terms of propulsion.
PREREQUISITES BEFORE USE AND INSTRUCTIONS FOR USE
T
: user training must be carried out by individuals trained and approved by the economic operators
RAINING AND QUALIFICATION OF THE DEVICE USER
concerned, notably in terms of safety and non-compliance reporting.
D
installation: The cushion is delivered with its cover fitted. The product is ready to be installed. The upper side of the cushion in contact with the
EVICE
patient is made up of viscoelastic foam, the ischial curves and coccygeal discharge towards the rear and external rotator towards the front.
Do not use the ALOVA CURVE and ERGONOMIC cushion without the protective cover.
Preventive maintenance: Carry out a regular visual check of the condition of the cover (surface appearance and zippers) by exposing the inner surface to
a light source: no holes and/or tears) and annually check the surface condition of the foam. Replace the protective cover if its surface appearance
changes. The non-slip surface is in contact with the seat of the chair. The handle (located underneath the product) must face the front of the cushion.
C
D
LEANING AND
ISINFECTION
Procedure
Cover
Maximum chlorine
Moderate washing
Promust PU
concentration of
up to 90°C
5000ppm
I
NFORMATION ON APPROPRIATE PROCESSES TO ALLOW ITS REUSE
Before re-using for another patient, the product must exhibit physical and bacteriological cleanliness after application of the above procedures. Item
treated with a biocide substance at no risk to users. www.winncare.fr
Avoid direct damp cushion contact with the skin. Always protect the cushions with the supplied protective cover. Prohibit all scouring, stripping
products or solvents and "piercing-sharp" objects in direct contact with the cover.
GB
User manual
VCAG
VCAG3841(BP), VCAG4041(BP),
VCAG4343XL,
VCAG4544(BP), VCAG4347(BP),
VCAG5044XL
VCAG5044BP, VCAG4341(BP),
VCAG4343(BP),
7 cm
9 cm
6 cm
Viscoelastic > 75 kg/m³
-
HR > 34 kg/m³
-
30 to 135 kg
30 to 135 kg
according to
according to reference
reference
Dry with reduced
Do not iron
Do not dry clean
thermal restriction
PA0010105
WARNINGS, PRECAUTIONS FOR USE, MEASURES REQUIRED
P
RECAUTIONS FOR USE
Patient with bone and/or muscle and/or skin trauma to the pelvic region and thigh in contact. Seating instability.
A bedsore is a lesion of varying depth on the skin, associated with excessive and prolonged compression of tissue between the body and a support
surface. This excessive pressure can prevent blood circulation and lead to pressure ulcers, a dangerous lesion because it develops from the inside of the
body to the outside, and is therefore initially invisible. A pressure sore can have several forms: a simple persistent rash for more than a day, hardening of
the skin, a wound of varying depth that can in severe cases affect muscles or underlying bone.
Pressure (max) in mmHg before ageing, at the maximum validated weight, measured flat (0°)
S
UITABILITY FOR USE
ALOVA CURVE cushion (mm of Hg)
ERGONOMIC cushion (mm of Hg)
STORAGE, HANDLING, DISPOSAL
S
TORAGE AND USAGE CONDITIONS
The supports must ideally be stored flat, away from direct light and excessive humidity.
Temperature range
Humidity range
S
ERVICE LIFE
The cushion has an estimated service life of 6 years.
P
RODUCT DISPOSAL
Do not dispose of the product outside of the dedicated area. Respect the established recycling systems in your country.
GUARANTEE
The guarantee duration for cushions is 3 years. This guarantee starts from the date of purchase of the product from your distributor. In the case of single
VCAE
patient use, the guarantee relates to the support and its protective cover.
This guarantee does not cover normal wear and tear of the product and its protective cover and is not a substitute for legal guarantees. Please contact
VCAE/M4343
your distributor about a defective product. They will carry out the necessary procedures with our company to proceed with either repair or exchange.
Technical compliance certificates
FCBA - ESC NO. 19-006
ALOVA Curved Standard Cushion
9 cm
ALOVA Curved Cushion Standard < 38 cm
ALOVA Cushion Curved Standard > 45 cm
-
Promust PU
Class 1 medical device according to Regulation (EU) 2017/745.
Management system: Quality: ISO 13485:2016 - Environmental: ISO 14001:2015
30 to 100 kg
1 cushion
2 covers. For the BP reference a cover with a housing for the pelvic end-piece.
1 user manual
Use an approved
surface
disinfectant/detergent
User weight
Head
100 kg
NA
100 kg
NA
Use
Storage
+15°C to + 45°C
-5°C – 60°C
+59°F to +113°F
+41°F to +140°F
30% - 70%
10% - 90%
FCBA - ESC NO. 19-008
FCBA - ESC NO. 13-007
ALOVA Cushion Curved Technical
ALOVA Cushion Curved BP
XL
Technique
Contents of package
Ischions
Heel
91.20
NA
85.32
NA
FCBA - ESC NO. 15-003
ALOVA Ergonomic Standard Cushion
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