WINNCARE PA0010115 Viscoelastic Foam Mattress User Manual

: June 12, 2024
: WINNCARE

Table of Contents

DEVICE INTENDED USE
INDICATIONS
CONTRAINDICATIONS
ADVERSE SIDE EFFECTS
MEDICAL DEVICE COMPOSITION/TECHNICAL DATA
WARNINGS, PRECAUTIONS FOR USE, MEASURES REQUIRED
STORAGE, HANDLING, DISPOSAL
GUARANTEE
References
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WINNCARE PA0010115 Viscoelastic Foam Mattress User Manual

DEVICE INTENDED USE

Viscoelastic foam static mattress, called “memory foam” is intended to be used in combination with a medical bed, for adults or children, 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 adults or children 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 versions*| Products for adult medical beds (height 146 cm)| For Junior children’s beds
---|---|---
VMA62
VSA6ST+
VMS| VMA63
VSA7ST +
VMS| VMA64| VMA64S| VMA70
VMA80| VMA I I 7XURC
VMA137XURC| VMA I 20BAR
VMA I 40BAR| VMA82-CIC| VMA/PEDIA/M
Sizes (cm)| I 96x87x I 4| 196x87x I 4| 196x87x14| I 95x85x I 4| I 96x70x I 4
I 96x80x I 4| 195x117x17
195x137x17| 196x117x17
196x137x17| I 70x82x I 4| I 60x80x I 4
Specification Foam Sup| PU VE: 75kg/m31.8kPa| PU VE: 75kg/m3 I .8kPa| PU VE: 75kg/m31.8kPa| PU VE:
fl5kg/m3 1.8
kPa| PU VE:
fl5kg/m3 1.8
kPa| PU VE:
85 kg/m31.7 kPa| PU VE :
80kg/m3 2.7kPa| PU VE:
85 kg/m31.7 kPa| PU VE:
85 kg/m31.7 kPa
Specification| PU:18 kg/m33,0 kPa| PU:
25kg/m3 3,4kPa| PU: 34kg/m33,4 kPa| Foam laPU:34kg/m33,4kPa| PU:
34kg/m33,4kPa| PU :

25kg/m3 3,4 kPa,| PU :
40 kg/m3 6 kPa| PU:n5kem3 3,4
kPa| PU:25kg/m3 3,4
kPa
Patientweight min and max| 30 1 120 kg| 30 a 150 kg| 30 1 180 kg| 30 a 180 kg| 30 1 135 kg| 30 1 150 kg| 135 I 270 kg| IS to 70 kg
Size: from 125
to 145 cm| 15 to 70 kg
Size: from 125
to 145 cm
Foam material| 100% PU
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 ; VMA64CIC; VMA63BOX-OXP…)

CLINICAL BENEFIT, DEVICE PERFORMANCE, MECHANISM OF ACTION DEVICE PERFORMANCE CHARACTERISTICS: By immersion and 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.
EXPECTED CLINICAL BENEFITS: Maintenance of tissue oxygenation at the cutaneous and subcutaneous tissue level in contact with the support.
INFORMATION FOR HEALTHCARE PROFESSIONALS: Monitor the condition of the patient’s skin in contact with the support several times a day. Use pressure relief devices or positioning systems in patients with pressure ulcer(s).

Cover| | | | | |
---|---|---|---|---|---|---
Moderate washing up to 90°C| Maximum chlorine concentration of 5000ppm| Do not iron| Do not dry clean| Dry with reduced thermal restriction| Use an approved surface disinfectant/detergentb

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 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

PRECAUTIONS 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.

SUITABILITY FOR USE	Max weight User	Head	Buttocks	Heel
VMA Mattress + Promust PU/PUHD/CIC Cover	150 kg	89	60	75
BAR Mattress + Pro must PU Cover	270 kg	130	85	93

WARNINGS
(Re) assess the risks of patient entrapment in the non-moving parts of the medical bed associated with “therapeutic mattresses and accessories and articulated positions of the bed base” according to standard EN 60601-2-52 in adults and EN 50637 in adults. child. The use of segmented or full-length side rails should be prescribed.
External cardiac massage not compatible without a board inserted between the thorax and the upper surface of the mattress

STORAGE, HANDLING, DISPOSAL

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

| Use| Storage
---|---|---
Temperature range| +15°C to + 40°C / +59°F to +104°F| -25°C to 70°C / +13°F to +158°F
Humidity range| 30% – 70%| 30% – 95%
Atmospheric pressure| 50kPa – 106 kPa // 7.25 Psi / 15.37 Psi

ROLLED MATTRESSES
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.

SERVICE LIFE
Viscoelastic foam (overlay) mattresses have an estimated service life of 6 years.
The rolled-compressed mattress life span is 6 months (see date on package label).

PRODUCT 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 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 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 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.
Class 1 medical device according to Regulation (EU) 2017/745.
Management systems: Quality: ISO 13485:2016 – Environmental: ISO 14001:2015
Technical compliance certificates (FCBA) : on request or downloadable from our website

Contents of package

1 mattress
1 protective cover
1 user manual

Création le 30/12/2012. Mise à jour le 14/03/2023 **Version numéro 22

**

WINNCARE FRANCE : – 4, Le Pas du Château – 85670 Saint-PaulMont-Penit – France
Tél. +33 (0)2 51 98 55 64 – Fax +33 (0)2 51 98 59 07
Site de production ASKLE SANTE 200 Rue Charles Tellier – 30034
Nîmes Tél. : +33 (0)4 66 02 15 15 –
Fax : +33 (0)4 66 02 15 00
www.winncare.com