RADIATION SHIELDING SKIRT+ VEST, 0.5/0.25mm Pb equivalent,XL

STD EDIMAPRO2XL

Valid Article

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.
T0304 - Radiotherapy protection devices
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.
The order of this product needs to be justified and is only acceptable under certain conditions.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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RADIATION SHIELDING SKIRT + VEST

Definition

A two piece apron, made with light-lead material or lead-equivalent material, is worn to protect the front and back of the body against ionising radiation during x-ray exposure. This apron consists of two parts which must be worn together, a wrap around skirt, and vest.

The two piece apron is recommended for use with a fluoroscopic x-ray system (C-arm) in an operating theatre, where lead aprons are often worn for longer periods of time. The lighter weight and all round protection of the skirt and vest are more suited for these situations.

In addition, a lead thyroid shield should also be worn for complete protection.

Specifications

Quality standards

  • EN 61331-1, 2014, Protective devices against diagnostic medical x-radiation - Part 1 : Determination of attenuation properties of materials
  • EN 61331-3, 2014, Protective devices against diagnostic medical X-radiation - Part 3 : Protective clothing, eyewear and protective patient shields
  • ISO 8194, 1987, edition 1, (confirmed 2019) Radiation protection - Clothing for protection against radioactive contamination - Design, selection, testing and use

Material

  • Polymer made from lead-free composite materials or
  • Light-lead composite material made with partial lead content
  • Inside lining: woven nylon
  • Outer lining:

Technical specifications

  • Two piece lead apron consisting of a wrap around skirt and vest. (front and back protection)
  • Protection: equivalent to 0.25 mm of lead (NB When the skirt and vest are worn, the wrap around design allows a double layer of protection on the front of the body. Effectively, protection is therefore 0.25 mm Pb equivalent at the back, and 0.5mm Pb equivalent at the front.)

Dimensions

Small, medium, large and extra large sizes available

Instructions for use

Do not fold, put on a hanger after use in order to avoid tears or cracks (local purchase or manufacture).

Once a month, visually check for possible damage (tears/ cracks). Once a year, take a radiograph of the apron. If there are small black lines or marks on the film, it is likely that radiation is leaking through cracks in the composite materials. Small amounts of leakage are acceptable, but when damage becomes too extensive, the apron must be replaced.

Maintenance

  • See the MSF X-ray User maintenance SOPs for detailed instructions
  • Clean regularly with soapy water (neutral soap) with a damp cloth, rinse and dry away from sunlight.
  • Disinfect if needed with a 0.25 % detergent-disinfectant solution for surfaces (i.e. 20 ml = 1 sachet = 1 stroke of dosing pump for 8 l water). Do not rinse (contact time must be 15 minutes minimum and the product is not corrosive).
  • Do not machine wash, do not dry-clean, do not iron, do not sterilize by steam autoclave.

Storage

  • Temperature < 35ºC, Protect from sunlight
  • Do not fold, store on a hanger (can be rolled up)

MSF requirements

Ensures optimal protection during all x-ray examinations, including fluoroscopic examinations.

Light weight, lead-free or light-lead two piece protective apron.

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