winncare Epsus Notice D'utilisation page 2

page de 9

/ 9
Signets

Les langues disponibles

Removable module EPSUS 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

For bedridden patients with reduced mobility and "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

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

VE208MB

and versions*

Sizes

196x87x17 cm

Lower specs

HR: 39.3 kg/m³

Base and edges

4.1 kPa

HR: 37.9 kg/m³

Foam insert specs.

3.5 kPa

Patient weight min

40 to 120 kg

and max

Foam material

Dermalon FR (Fire resistant)

*The indicated references may be completed with a suffix to constitute a commercial reference depending on the configuration (type of protective cover,

packaging) and/or medical equipment dealer

CLINICAL BENEFIT, DEVICE PERFORMANCE, MECHANISM OF ACTION

: By immersion, this support relieves pressure on the body by improving blood circulation and thus reducing the

EVICE PERFORMANCE CHARACTERISTICS

risk of pressure ulcers on the supporting areas of the body. Stabilising side edges. Removable modules to place inserts (foam, static air) to strengthen the

pressure ulcer prevention level.

: 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 draw sheet or removable zipped cover. The product is ready to be installed. The module surface

EVICE

composed of studs ("alveolar" type) or inserts 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.

LEANING AND

ISINFECTION

Promust PU cover

Promust HDPU

cover

Moderate washing up

Maximum chlorine

to 90°C

concentration of 5000ppm

Dermalon draw

sheet

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.

WARNINGS, PRECAUTIONS FOR USE, MEASURES REQUIRED

RECAUTIONS FOR USE

PA00101018

User manual

VE208MB/HIPH

196x87x17 cm

HR: 39.3 kg/m³

4.1 kPa

HR: 37.9 kg/m³

3.5 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

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°)

Max weight User

UITABILITY FOR USE

EPSUS mattress (mm of hg)

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

IRCUMSTANCES IN WHICH USERS SHOULD CONSULT WITH A HEALTHCARE PROFESSIONAL

Immediately notify your doctor or nurse of all abnormal events such as fever, pain or redness or whitening of pressure points (head, shoulder, back, hip,

shoulder blade, pelvis, heel, etc.).

INFORMATION ON ALL KNOWN RESTRICTIONS ON THE COMBINATION WITH SYSTEMS AND EQUIPMENT

The use of accessories other than those provided and specified by WINNCARE may result in the system malfunctioning and/or render it incompatible

with safe use and the preservation of its performances.

STORAGE, HANDLING, DISPOSAL

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