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Askle Sante WINNCARE VMA64S Manuale d'uso

Viscoelastic foam mattress

DEVICE INTENDED USE

This viscoelastic foam static mattress, called "memory foam" is intended to be used in combination with a medical bed for specific medical purposes due

to a loss of autonomy and/or deterioration of health status resulting in reduced mobility and the risk of pressure ulcers.

INDICATIONS

For bedridden patients with mobility impairment with "Medium to High" risk of pressure ulcers (according to the Braden scale or any other validated

scale and on medical advice). Assists in the treatment of stage 1to 2 pressure sores according to EPUAP, up to stage 4 outside the support area.

CONTRAINDICATIONS

Patient weight level below or above the limits defined in the technical data table. For use on medical imaging table.

ADVERSE SIDE EFFECTS

Possible increase in certain sensory impairments in people with multiple sclerosis. Immobility syndrome in the elderly suffering from loss of

independence. Instability of seated transfers (excluding mattresses with VMABS stabilizing side borders).

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

References

Models and

VMA62

VMA63

VMA64

versions*

VSA6ST+ VMS

VSA7ST + VMS

Sizes

196x87x14 cm

Specification

PU VE:

Foam Sup

80kg/m³1.8 kPa

Specification

PU:18kg/m³

PU: 28kg/m³ 3.4

PU: ≥34 Kg/m³

Foam Inf

3.0 kPa

kPa

Patient weight

30 to 120 kg

30 to 150 kg

30 to 180 kg

min and max

Foam material

Cover material

PES mesh (except CIC with PE mesh) - PU induction

*The references mentioned can be completed with a suffix to constitute a commercial reference according to configuration (type of protective cover,

packaging) and/or distributor (examples: VMA62/TH; VMA63BOX-PHT; VMA64CIC; VMA63BOX-OXP...)

CLINICAL BENEFIT, DEVICE PERFORMANCE, MECHANISM OF ACTION D

enveloping, this support relieves pressure on the body by improving blood circulation and consequently reducing the risk of pressure ulcers in the

supporting areas of the body. Integrated heel support.

: Maintenance of tissue oxygenation at the cutaneous and subcutaneous tissue level in contact with the support.

XPECTED CLINICAL BENEFITS

: Monitor the condition of the patient's skin in contact with the support several times a day. Use pressure

NFORMATION FOR HEALTHCARE PROFESSIONALS

relief devices or positioning systems in patients with pressure ulcer(s).

PREREQUISITES BEFORE USE AND INSTRUCTIONS FOR USE

: 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.

installation: The mattress is delivered with its removable zipped cover. The product is ready to be installed. The surface of the viscoelastic foam

EVICE

must be positioned in contact with the patient's body.

Preventive maintenance: Carry out a regular visual check of the condition of the foam: visible sagging of the ALOVA material and a non-homogeneous

and very slow return of the foam are ageing criteria that compromise the properties of the support in helping to prevent pressure sores. Annual

inspection of the condition of the cover (surface aspect and zippers) by exposing the inner surface to a light source: no holes and/or tears. Replace the

cover if its surface appearance changes.

LEANING AND

ISINFECTION

Cover

Maximum chlorine

Moderate washing

concentration of

up to 90°C

5000ppm

PA0010115

User Manual

Products

VMA117XL or

VMA70

VMA117XL/RC

VMA64S

VMA80

VMA137XL or

VMA137XL/RC

196x70x14 cm

195x117x17 cm

195x85x14 cm

196x80x14 cm

195x137x17 cm

PU VE:

PU VE: 80kg/m³1.8

PU VE:

80kg/m³1.8 kPa

kPa

85 kg/m³1.7 kPa

PU: ≥34 Kg/m³

PU: 28 kg/m³3.6 kPa

30 to 180 kg

30 to 135 kg

30 to 150 kg

100% PU

EVICE

ERFORMANCE

HARACTERISTICS

Dry with reduced

Do not iron

Do not dry clean

thermal restriction

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 mattress without a cover. Item treated with a biocide substance at no risk to users. www.winncare.fr

Avoid extended wet contact with the foam. Always protect the mattresses with the supplied rigorously dry mattress protectors.

Prohibit all scouring, stripping products or solvents and "piercing-sharp" objects in direct contact with the cover.

WARNINGS, PRECAUTIONS FOR USE, MEASURES REQUIRED

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°)

UITABILITY FOR USE

VMA Mattress + Promust PU/PUHD/CIC Cover

BAR Mattress + Promust PU Cover

STORAGE, HANDLING, DISPOSAL

TORAGE AND USAGE CONDITIONS

The supports must ideally be stored flat, away from direct light and excessive humidity.

Temperature range

Humidity range

Atmospheric pressure

OLLED

ATTRESSES

ALOVA: 2 mn → 10 mn: This time may be increased if the storage temperature is lower than 15°C and/or in line with the

storage period (0 to 6 months). The return to a normal visual appearance of the mattress under normal usage temperature conditions may take up to 24 hours for

ALOVA, APLOT and MORFÉA mattresses but this does not present any risk for their use. Small creases may be visible on the lower surface of the CIC cover after

unrolling. They present no risk to the patient and do not affect the efficiency of the final product.

ERVICE LIFE

Viscoelastic foam (overlay) mattresses have an estimated service life of 6 years.

VMA120BAR

VMA140BAR

The rolled-compressed mattress life span is 6 months (see date on package label).

196x117x17 cm

RODUCT DISPOSAL

196x137x17 cm

Do not dispose of the product outside of the dedicated area. Respect the established recycling systems in your country.

PU VE: 95kg/m³

GUARANTEE

4.5kPa

The guarantee duration for ALOVA (overlay) mattresses is 3 years. This guarantee starts from the date of purchase of the product from your

distributor. In the case of single patient use, the guarantee relates to the support and its protective cover. In the case of multi-patient use, the duration of

PU: 40kg/m³

guarantee for the protective cover is 2 years. This guarantee does not cover normal wear and tear of the product and its protective cover and is not a

5.5 kPa

substitute for legal guarantees. Please contact your distributor about a defective product. They will carry out the necessary procedures with our

company to proceed with either repair or exchange.

135 to 270 kg

Class 1 medical device according to Regulation (EU) 2017/745.

Management systems: Quality: ISO 13485:2016 - Environmental: ISO 14001:2015

Technical compliance certificates (FCBA): N°ESC 14-018 / ESC 14016 / ESC 14-017/2

: By immersion and

1 mattress

1 protective cover

1 user manual

Use an approved

surface

disinfectant/detergent

Max weight User

Head

150 kg

270 kg

130

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

Contents of package

Buttocks

Heel

Storage

30% - 95%