GB PA0010115
User Manual
Viscoelastic foam mattress
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
VMS
VMA63
VMS
VMA64
VMA64S
VMA70
VMA80
VMA117XL/RC
VMA137XL/RC
VMA120BAR
VMA140BAR
VMA82-CIC
VMA/PEDIA/M
Sizes (cm)
196x87x14
196x87x14
196x87x14
195x85x14
196x70x14
196x80x14
195x117x17
195x137x17
196x117x17
196x137x17
170x82x14
160x80x14
Specification
Foam Sup
PU VE:
≥75kg/m³1.8
kPa
PU VE:
≥75kg/m³1.8
kPa
PU VE:
≥75kg/m³1.8
kPa
PU VE:
≥75kg/m³1.8
kPa
PU VE:
≥75kg/m³1.8
kPa
PU VE:
85 kg/m³1.7 kPa
PU VE :
95kg/m³ 4.5kPa
PU VE:
85 kg/m³1.7 kPa
PU VE:
85 kg/m³1.7 kPa
Specification
Foam Inf
PU :
≥18 kg/m³
3,0 kPa
PU :
≥25kg/m³ 3,4
kPa
PU :
≥34kg/m³3,4
kPa
PU :
≥34kg/m³3,4
kPa
PU :
≥34kg/m³3,4
kPa
PU :
≥25kg/m³ 3,4 kPa
PU :
40 kg/m³ 5,5
kPa
PU :
≥25kg/m³ 3,4
kPa
PU :
≥25kg/m³ 3,4
kPa
Patient
weight min
and max
30 à 120 kg
30 à 150 kg
30 à 180 kg
30 à 180 kg
30 à 135 kg
30 à 150 kg
135 à 270 kg
15 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
D
EVICE
P
ERFORMANCE
C
HARACTERISTICS
: 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.
E
XPECTED CLINICAL BENEFITS
: Maintenance of tissue oxygenation at the cutaneous and subcutaneous tissue level in contact with the support.
I
NFORMATION 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).
PREREQUISITES BEFORE USE AND INSTRUCTIONS FOR USE
T
RAINING AND QUALIFICATION OF THE DEVICE USER
:
user training must be carried out by individuals trained and approved by the economic operators
concerned, notably in terms of safety and non-compliance reporting.
D
EVICE
installation: The mattress is delivered with its removable zipped cover. The product is ready to be installed. The surface of the viscoelastic foam
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.
C
LEANING AND
D
ISINFECTION
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/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 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
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
Max weight User
Head
Buttocks
Heel
VMA Ma Promust PU/PUHD/CIC Cover
150 kg
89
60
75
BAR Ma Promust 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
S
TORAGE AND USAGE CONDITIONS
The supports must ideally be stored flat, away from direct light and excessive humidity.
Use
Storage
Temperature range
+15°C to + 45°C / +59°F to +113°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
R
OLLED
M
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
.
S
ERVICE 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).
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 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
