WINNCARE Pressure Relief Cushions: Product Guide and Instructions

Product Overview

This document provides instructions and information for WINNCARE's range of pressure relief cushions, designed to prevent pressure ulcers and compensate for postural deficits in seated individuals.

Product Range

The WINNCARE range includes several models, each with specific features:

• PRIMA FORM: Basic pressure relief cushion.
• PRIMA PLOT: Features an abduction pad for specific postural support.
• KALLI HR: High-resiliency foam cushion.
• KALLI VISCO: Viscoelastic foam cushion.
• ISKIO BM: Bi-material cushion.
• ISKIO VISCO: Viscoelastic foam cushion with higher load-bearing capacity.
• KALLI DOS HR: Back support with high-resiliency foam.
• KALLI DOS VISCO: Back support with viscoelastic foam.

Visual descriptions of the cushion shapes and approximate heights are provided in the original document.

Indications and Contraindications

Intended Use

Prevention of pressure ulcers in prolonged seated positions and compensation for disability in seated positions.

Indications

• Chair support for pressure ulcer prevention in patients at moderate to high risk, with no pressure asymmetry and no risk of "forward-sliding" (KALLI VISCO, ISKIO VISCO, ISKIO BM, PRIMA FORM).
• Chair support for pressure ulcer prevention in patients at moderate to high risk, with no pressure asymmetry and a "forward-sliding" postural deficit (e.g., psychomotor regression, stroke, hypertonia) (PRIMA PLOT).
• Wheelchair seating support for patients with no risk of pressure ulcers (KALLI HR, back support).
• Management of localised excessive pressure or lateral trunk inclination due to mild postural deficit (back support).

Contra-indications

• Patients with frontal or sagittal stability difficulties.
• Established sacrococcygeal and/or ischial pressure ulcers.
• Patient weight exceeding the cushion's support capacity.
• Risk of "forward sliding" (except for PRIMA PLOT).

Target Patient and User Group

Seated patients with reduced mobility, with or without specific postural deficits, and varying levels of pressure ulcer risk.

Composition of the Medical Device

Each cushion model is primarily composed of viscoelastic or high-resiliency polyurethane foam, covered with a PHARMATEX or MAILLE 3D cover. Some models include specific inserts or abduction pads. All models are supplied with operating instructions.

Clinical Benefit and Performance

Performance Characteristics

• Pressure ulcer prevention cushions: Viscoelastic foam allows immersion and envelopment of bony prominences (ischium, coccyx, trochanter) to distribute pressure.
• Comfort cushions and back supports: Improve comfort in seated positions, facilitating daily living activities like hygiene and transfers.

Expected Clinical Benefits

Maintenance of tissue oxygenation and contribution to life support activities.

Information for Health Professionals

Regularly observe patient skin condition. Do not seat patients with existing ischial or coccygeal ulcers. Verify chair and wheelchair condition and adjustments.

Usage Instructions

User Training

Training must be conducted by qualified personnel focusing on safety and non-conformity reporting.

Device Installation

Cushions are ready for installation with the cover fitted. Ensure the anti-slide underside is in contact with the seat and the handle faces forward. Seat the patient.

Preventive Maintenance

Perform annual visual checks of foam condition and cover integrity (check for holes/tears using light).

Cleaning and Disinfection

• Clean between patients.
• Cover washing: Up to 90°C (PHARMATEX), or 40°C (MAILLE 3D).
• Do not iron covers.
• Bleach compatibility: Up to 5000 ppm for PHARMATEX; not compatible for MAILLE 3D.

Information for Re-use

Ensure physical and bacteriological cleanliness according to the technical manual. Replace cover if its appearance changes.

Warnings and Precautions

Required Measures

• Install cushion on a well-maintained wheelchair seat.
• Ensure cushion dimensions are compatible with the wheelchair seat.
• Verify patient's seated position (pelvis, spine, head, armrests, leg/footrests).
• Cushions are part of a broader pressure ulcer prevention strategy, which includes regular position changes, skin hygiene, avoiding maceration, not using interfaces between the patient and the cushion, daily skin checks, regular protective cover changes for incontinence, and adequate fluid intake.
• Minimize thickness between body and support (e.g., sheets, nappies).
• Wear loose cotton clothing, preferably without seams in the support area.
• Ensure no foreign bodies are present.
• Consult prescriber within one month of purchase.
• Enhanced monitoring for patients at risk of falls.

Circumstances for Consulting a Healthcare Professional

Inform your doctor or nurse if any measures cannot be followed or if abnormal events occur (fever, pain, skin changes at pressure points).

Precautions for Use

• Avoid direct contact with unstable or painful bone, muscular, or skin trauma in the pelvic, thigh, or spinal regions.
• Use with caution for patients with instability in the seated position.
• Use with caution in the first days following surgery for pressure ulcers/wounds.
• Check exposed skin condition during care.

Warnings

Re-evaluate the risk of patient entrapment in non-moving wheelchair parts.

Lifetime Information

The device may be reused as long as its initial performance is maintained. Estimated lifetime is 4 years.

Accessories

Only manufacturer-supplied protective accessories ensure product safety and performance.

Storage, Handling, and Disposal

Storage Conditions

Store away from light, heat, and humidity.

Disposal

Dispose of the product responsibly according to local recycling regulations.

Technical Specifications

Pressure Ratings

Note: Pressure values are before ageing.

Care Symbols

The following care symbols are indicated:

• Washing: Moderate wash up to 90°C (PHARMATEX), Moderate wash up to 40°C (MAILLE 3D).
• Bleaching: Maximum allowable chlorine concentration of 5000 ppm (PHARMATEX); not permitted for MAILLE 3D.
• Drying: Tumble dry on low heat possible.
• Ironing: Do not iron.
• Dry Cleaning: Do not dry clean.

Manufacturer Information

WINNCARE France

Site de Miniac-Morvan, ZONE ACTIPOLE, 2 RUE DE SAINT-COULBAN, 35540 MINIAC-MORVAN, FRANCE

WINNCARE FRANCE

4, Le Pas du Château, 85670 SAINT-PAUL-MONT-PENIT, FRANCE

Contact: Tél.: +33 (0)4 66 02 15 15, Fax.: +33 (0)4 66 02 15 00, Email: contact@winncare.fr

Website: www.winncare.com