winncare GELTOP Manual Del Usuario página 2

Viscoelastic foam and/or gel cushion
DEVICE INTENDED USE
Pressure sore prevention in prolonged sitting position.
INDICATIONS
For bedridden patients with mobility impairment with "Low to Medium" risk of pressure ulcers (according to the Braden scale or any other approved
scale and in accordance with medical opinion).
CONTRAINDICATIONS
Patient with sagittal or frontal stability disorders. Paralysis of the trunk and/or lower limbs. Paralysis of the trunk and/or lower limbs, history of ischial or
sacrococcygeal pressure ulcer, lower limb tenderness, spasticity, vascular amputation. Patient weight level below or above the limits defined in the
technical data table.
ADVERSE SIDE EFFECTS
Trunk dynamic instability. Pelvic slippage in the saggital plane.
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
Models VAB (GELTOP)
Versions VAB4040/PUHD VAB4345/PUHD
Sizes 40x40x5,5 cm 43x45x5,5 cm
Viscofluid Coatex
Viscofluid Coatex DV1163
Specific gel DV1163
Thickness 1 cm
Thickness 1 cm
Specific PU HR PU HR
Lower Foam 34 kg/m³ 34 kg/m³
Removable cover
Removable cover
Protection PU51%/Polyester49%
PU51%/Polyester49%
Non-slip lower
Non-slip lower surface
surface
Patient
weight min 40 to 95 kg 40 to 95 kg
and max
CLINICAL BENEFIT, DEVICE PERFORMANCE, MECHANISM OF ACTION
D P C : The viscofluid gel principle as an interface with the seated patient reduces shear force in particular in a dynamic
EVICE ERFORMANCE HARACTERISTICS
position. The combination of viscofluid gel with a foam base allows relative immersion of the pelvis and the areas opposite bony protuberances (ischium,
coccyx, trochanter) to be enveloped.
P : Maintenance of tissue oxygenation in the cutaneous and subcutaneous tissues in contact with the support.
ROJECTED 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 and dry. The product is ready to be installed. The upper surface of the cushion in
EVICE
contact with the patient is made up of viscofluid gel. Attach the Gelscar cushion straps to the chair uprights.
Preventive maintenance: Carry out a regular visual check of the cover (surface appearance - absence of holes and/or tears - and zippers) or envelope
condition. The presence of a gel leak renders the product unfit for use. For the Geltop: Replace the protective cover if its surface appearance changes.
C D
LEANING AND ISINFECTION
Procedure
Cover Moderate washing
Maximum chlorine
GELTOP up to 90°C
concentration of
Gelscar Envelope
5000ppm
Surface detergent
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. Do not
use the Geltop cushion without a cover. Item treated with a biocide substance at no risk to users. www.winncare.fr
GB PA0010078
User Manual
GELTOP - GELSCAR
VGLS (GELSCAR)
VAB4040/CIC VAB4345/CIC VGLS01C
40x40x5,5 cm 43x45x5,5 cm 40x40x3,5 cm
Viscofluid Coatex Viscofluid Coatex
Viscofluid Coatex
DV1163 DV1163
DV1163
Thickness 1 cm Thickness 1 cm
PU HR PU HR
-
34 kg/m³ 34 kg/m³
Removable cover Removable cover
PU42%/Polyester58% PU42%/Polyester58% Fixed neoprene
Non-slip lower Non-slip lower cover
surface surface
40 to 95 kg 40 to 95 kg 50 to 110 kg
Dry with reduced
thermal restriction
Do not iron Do not dry clean
disinfectant/detergent
No
WARNINGS, PRECAUTIONS FOR USE, MEASURES REQUIRED
P
RECAUTIONS FOR USE
Non-stabilized bone and/or muscle injuries in contact with the support. COPD-type bronchopulmonary disorders with severe reduction in respiratory
muscle tone.
A bedsore is a lesion of varying depth in 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
Geltop cushion (mm of Hg)
Gelscar 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
Atmospheric pressure
S
ERVICE LIFE
The cushions have an estimated service life of 6 years.
(See date on package label).
P
RODUCT DISPOSAL
Do not dispose of the product outside of the dedicated area. Respect the established recycling systems in your country.
GUARANTEE
VGLS01C/4345
The guarantee duration for cushions is 2 years. This guarantee starts from the date of purchase of the product from your distributor. In the case of single
43x45x3,5 cm 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
Viscofluid Coatex
your distributor about a defective product. They will carry out the necessary procedures with our company to proceed with either repair or exchange.
DV1163
Technical compliance certificates
-
FCBA - N° ESC 17-004
Geltop Cushion
Fixed neoprene cover
Class 1 medical device according to Regulation (EU) 2017/745.
Management system: Quality: ISO 13485:2016 - Environmental: ISO 14001:2015
50 to 110 kg
1 cushion.
2 covers for the Geltop cushion. No cover required for the Gelscar cousin.
1 user manual
Use an approved
surface
Max weight User Head
95 kg NA
110 kg NA
Use
+15°C to + 45°C / +59°F to +113°F -25°C to 70°C / +13°F to +158°F
30% - 70%
50kPa - 106 kPa // 7.25 Psi / 15.37 Psi
FCBA - N° ESC 19-001
Gelscar cushion
Contents of package
Ischions Heel
88.5 NA
82 NA
Storage
30% - 95%