Cushion,wheelchair,pressure,mod no layer

GENERAL DESCRIPTION
Wheelchair seat cushion: Pressure-redistribution cushion with moderate/partial offloading or immersion/envelopment features: Contoured cushion without top layer.

IMPORTANT INFORMATION
Minimum order quantities apply.
Inappropriate prescription and fitting of wheelchairs, cushions and accessories may harm the user’s health and/or function. Therefore, this product should only be purchased after consultation with the Medical Devices Unit in Supply Division.

INTENDED USE
Pressure-redistribution cushion with moderate/partial offloading or immersion/envelopment features: Contoured cushion without top layer.
For CHILD or ADULT wheelchair users who are at risk of pressure injuries and who need good support to maintain stability and an aligned posture. Cushion and cover function to reduce heat and moisture generated when the user is sitting on the cushion.

TECHNICAL SPECIFICATIONS
Characteristics:
Depending on model selected: Firm, non-deforming, pre-contoured base, with pre-shaped seat bone well area OR firm base with deforming properties in the seat bone well area so that the well area appears flat. Variations in foam support create a functonal well area with moderate or partial offloading or immersion
Depending on model selected: Thigh area: sloping down OR level
Depending on model selected: Thigh area: integrated inside thigh support OR inside- and outside thigh support

Height and offloading OR immersion
Overall cushion height 98 mm OR 70 mm depending on model selected
Allows limited offloading OR immersion and envelopment of 40 mm

Design of bottom of base:
Bottom of base: curved OR flat depending on model selected

Size and dimensions:
Seat width range: Depending on model selected, either:
4 sizes between 350 and 500 mm in 50 mm increments
Seat depth: Adjustable
OR
6 sizes between 250 and 500 mm in 50 mm increments
Seat depth: Adjustable and/or different seat depth options

Cushion cover
Removable cover
Cover allows contouring with user weight and compression of cushion without restricting/changing posture support and pressure redistribution properties and function
Moisture-resistant breathable cover

Cushion weight
Weight of cushion with cover: 1.3 kg OR 0.35-1.00 kg depending on model and size selected

Desirable user weight capacity
User weight capacity: CHILD: N/A OR 60 kg depending on model selected
User weight capacity: ADULT: 114 kg OR 120 kg depending on model selected

Use and orientation:
The cushion is 'ready to use', and requires no specific setup or assembly prior to use (excluding customizations)
Bottom, front and back of cushion clearly marked
Cover front and back clearly marked if specific front/back

WARRANTY
Limited warranty to cover defects in material and workmanship only. Warranty excludes normal wear or damage following inappropriate use or lack of maintenance.
Cushion: 1-2 years depending on model selected
Cover: 1 year

SUPPLIED WITH
Cushion cover
Detailed illustrated instructions for safe use

MINIMUM ORDER QUANTITIES
Minimum order quantities apply

PACKAGING / LABELLING
Minimum order quantities apply
One (1) unit per box
Dimensions:
- Unit Weight in Kg (including its packaging): 2 kg
- Unit Volume in M3 (including its packaging): 0.025 m³
Labelling: Compliance with EAN 128 bar code requirements

ESTIMATED LEAD TIME
60 days

ITEMS REQUIRED, BUT NOT SUPPLIED
N/A

ESTIMATED LIFE SPAN
1-2 years depending on model selected

ENVIRONMENTAL CONDITIONS
Storage conditions: -10 to 65 degrees Celsius; 10 to 90% RH
Operating conditions: 0 to 40 degrees Celsius; 20 to 60% RH

USER FITTING AND TRAINING REQUIREMENTS
Users to be fitted and trained by trained wheelchair service personnel

MAINTENANCE REQUIREMENTS
Product maintenance as per manufacturer’s instructions

RELATED PRODUCTS
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S0004007 Wheelchair, active urban, rigid
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S0004009 Wheelchair, active dual terrain, rigid
S0004010 Wheelchair, active rough terrain
S0004011 Wheelchair, postural support
S0004020, Strap pelviship, wheelchair
S0004021, Strap lower legcalf, wheelchair
S0004022, Strap anklefoot, wheelchair


ALTERNATIVE PRODUCTS
S0002012 Cushion,wheelchair, posture, layered
S0002014 Cushion,wheelchair,pressure, mod layered
S0002018 Cushion,wheelchair,pressure,deep,section

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class I device.

SAFETY AND PRODUCT STANDARDS
ISO 16840-2:2018 (modified loaded contour depth and overload tests)

NOMENCLATURE
GMDN Code:
11100