WHEELCHAIR CUSHION, memory foam, anatomical, 42x42x8cm
STD
EPHYWHEC001
Valid Article
Account code:
60100
HS Code:
901890
Last Updated on:
11/12/2024, 20:59:32
Former
Code(s):
EHOEZFR0626
Y122406 - Belts, seats and armrests for wheelchairs
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
WHEELCHAIR CUSHION, memory foam
Definition
A cushion specifically designed to provide comfort and protection against injury for wheelchair users. It also helps in properly positioning the user in the correct posture.
The material (memory foam) and the shape (anatomically pre-formed) reduce the risk of pressure sores.
Specifications
Quality standards
- ISO 16840-1, 2006, edition 1, (confirmed 2019) Wheelchair seating - Part 1: Vocabulary, reference axis convention and measures for body segments, posture and postural support surfaces
- ISO 16840-2, 2018, edition 2, Wheelchair seating - Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity
- ISO 16840-3, 2014, edition 2, (confirmed 2019) Wheelchair seating - Part 3: Determination of static, impact and repetitive load strengths for postural support devices
- ISO 16840-6, 2015, edition 1, Wheelchair seating - Part 6: Simulated use and determination of the changes in properties of seat cushions
- ISO/TR 16840-9, 2015, Wheelchair seating - Part 9: Clinical interface pressure mapping guidelines for seating
- ISO 16840-10, 2021, edition 2, Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
- ISO 16840-11, 2022, edition 1, Wheelchair seating - Part 11: Determination of dissipation characteristics of sensible perspiration into seat cushions
- ISO 16840-12, 2021, edition 1, Wheelchair seating - Part 12: Envelopment and immersion characterization of seat cushions using a dual semispherical indenter
Technical specifications
CUSHION
- Anatomically shaped: a curve ensures a good positioning of the patient with abduction pad and lateral support.
- Bottom plate: anti slip, high density poly foam 40 kg/m³ (= +/- 2.5 PCF)
- Core of cushion: high density memory foam of 80 kg / m³ (= +/- 5 PCF)
(PCF = Pound per cubic foot)
COVER
- waterproof and water repellent
- machine washable 95°C
- equipped with a grip strap
Check that the cushion is compatible with the wheelchair for which it is intended: the width of the cushion must be equal to or a little smaller than the width of the seat of the chair.
- width x depth = 42 x 42 cm, +/- 3 cm
- height: 8 – 10 cm
Instructions for use
Maintenance
Cushion cleaning:
- product or soapy water. Allow to air dry in an open area before putting the cover back on.
Cover cleaning:
- clean daily with a sponge and soapy water,
- rinse with clean water
- machine wash 95°C
MSF requirements
Anti-bedsore cushion for the adult wheelchair
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