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CUSHION for OT table, set of 4 pieces STERIS GEL024B

https://unicat.msf.org/cat/product/12956
STD EHOECUSG001

Valid Article

Former Code(s): -X
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
V080302 - Patient positioning medical cushions
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.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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GEL CUSHION, for OT table

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Definition

A gel-filled cushion intended to be placed between an operating table mattress and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts. This is a reusable device.

Specifications

  • radiolucent
  • silicone gel filler
  • cover: waterproof, wear-resistant and resistant to disinfectants (PUR or other)

The STERIS standard set is composed of 4 cushions:

  • 1 closed ring head support for adults
  • 1 half-cylinder cushion
  • 1 mattress cover with uro cut-out
  • 1 arm & leg plate

The following cushions are accessories of the Medifa operating table

  • EHOECUSG007 GEL CUSHION HEAD prone position, adult
  • EHOECUSG008 GEL CUSHION, flat bottom chest roll, M
  • EHOECUSG009 GEL HEEL PADS, pair, silicone

Technical specifications

EHOECUSG002

closed ring head support, adult

external Ø= 20 – 22 cm

internal Ø= 6 – 8 cm

thickness = 4 – 5 cm

EHOECUSG003

closed ring head support, child

Ødiam = 13 - 15 cm,

Ødiam = 6 cm,

thickness = 3 - 4 cm

EHOECUSG004

half cylinder

length = 25 - 35 cm

width = 10 – 15 cm

thickness = 5 - 6 cm

EHOECUSG005

overlay with uro cut-out

length = 52 cm

width = 52 cm

thickness = 1 cm

EHOECUSG006

arm/leg plate

length = 60 cm

width = 20 cm

thickness = 1 cm

EHOECUSG007head prone position for adult

length = 28 cm

width = 24 cm

thickness = 15 cm

EHOECUSG008flat bottom chest roll, Mediumlength = 40.5 cm

width = 10 cm

thickness = 7.5 cm

EHOECUSG009pair of heel pads, for patient in supine positionlength = 19 cm

width = 10 cm

thickness = 7 cm

Instructions for use

Using these cushions allows distributing the pressure, keeping the temperature, maintaining the positioning and and optimising the surgical comfort.

Maintenance

Cushions must be cleaned and disinfected with a detergent/disinfectant solution for surfaces / non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products. Make sure to wet the surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

MSF requirements

Part of the operation table accessories.

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