Idiomas disponibles
Idiomas disponibles
HR foam APLOT alveolar mattress
DEVICE INTENDED USE
This high resilience foam static mattress is intended to be used in combination with a medical bed for specific pressure ulcer prevention purposes due to
a loss of autonomy and/or deterioration of health resulting in reduced mobility and the risk of pressure ulcers.
INDICATIONS
Bedridden patients with reduced mobility and "Low to Medium" 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
Not documented.
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*
VA103MB14
VA103MB14RC
Sizes
195x85x14 cm
HR: 42.9 kg/m³
Lower specs
4.4 kPa
Patient weight min and max
40 to 120 kg
Foam material
Dermalon FR (Fire resistant)
The references mentioned can be completed with a suffix to constitute a commercial reference (example VA103MB14/TH)
CLINICAL BENEFIT, DEVICE PERFORMANCE, MECHANISM OF ACTION
D
P
C
: By immersion, this support relieves pressure on the body by improving blood circulation and thus reducing the
EVICE
ERFORMANCE
HARACTERISTICS
risk of pressure ulcers on the supporting areas of the body.
E
: Maintenance of tissue oxygenation at the cutaneous and subcutaneous tissue level in contact with the support.
XPECTED CLINICAL BENEFITS
I
: 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
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 mattress is delivered with its draw sheet or removable zipped cover. The product is ready to be installed. The surface of the
EVICE
foam composed of studs ("alveolar") must be positioned in contact with the patient's body. The protection must be dry.
Preventive maintenance: Carry out a regular visual inspection of the foam condition: visible sagging of material and a non-consistent and very slow return
of the foam shape are ageing criteria that compromise the properties of the support. 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
D
LEANING AND
ISINFECTION
Promust cover
PU and HDPU
Moderate washing up
Maximum chlorine
to 90°C
concentration of 5000ppm
Dermalon draw
sheet
I
NFORMATION ON APPROPRIATE PROCESSES TO ALLOW ITS REUSE
The product must exhibit physical and bacteriological cleanliness. "Promust" protection treated with a biocide substance at no risk to users. Avoid wet
contact with the foam. Prohibit all scouring, stripping products or solvents and "piercing-sharp" objects in direct contact with the cover.
GB
PA0010015
User manual
VA103MB14/HIP
VA103MB14/HIPH
195x85x14 cm
HR: 42.9 kg/m³
4.4 kPa
40 to 120 kg
100% coated polyurethane on PES weave
Dry with reduced
Use an approved surface
Do not iron
Do not dry clean
thermal restriction
disinfectant/detergent
WARNINGS, PRECAUTIONS FOR USE, MEASURES REQUIRED
P
RECAUTIONS FOR USE
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
Max weight User
UITABILITY FOR USE
APLOT mattress (mm of hg)
W
ARNING
(Re)assess the risk of patients being trapped in the non-moving parts of the medical bed associated with the "therapeutic mattress and accessories and
the articulated bed base positions". The use of segmented or full length side barriers must be required.
External cardiac massage not compatible without a board placed between the thorax and the top 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
Temperature range
+15°C to + 45°C / +59°F to +113°F
Humidity range
30% - 70%
Atmospheric pressure
R
M
OLLED
ATTRESSES
APLOT: 30 mn → 2h :
This time may be increased if the storage temperature is lower than 15°C and/or in line with the storage period (0 to 5 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
Highly resilient 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
APLOT mattresses have a 2-year guarantee. This guarantee starts from the date of purchase of the product from your distributor. This guarantee does
not cover normal wear and tear of the product and its protection. 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): ESC N° 16-005 of 10 June 2016
Contents of package
1 mattress
1 protective cover
1 user manual
Head
Buttocks
140 kg
54
46
Storage
-25°C to 70°C / +13°F to +158°F
30% - 95%
50kPa - 106 kPa // 7.25 Psi / 15.37 Psi
Heel
92
