(Agfa CR10X) DIGITAL CASSETTE + PHOSPHOR SCREEN, 35x43cm

STD EDIMDISA335

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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.
Z11079006 - Cassettes with reinforcement screen for x–ray films
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
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)
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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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(DI scanner Agfa CR10X) CASSETTE+ SCREEN

Definition

Protective housing that contains a phosphor screen (sometimes called a plate) for taking radiographs that is processed by the digitizer to produce a digital image.

Specifications

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Quality standards

ISO 4090, 2001, edition 3, (confirmed 2021) Photography - Medical radiographic cassettes/screens/films and hard-copy imaging films - Dimensions and specifications

Technical specifications

Cassette:

  • aluminium alloy, lightweight and resistant
  • light-proof
  • x-ray transparent front side

Phosphor screen

Dimensions

  • 24 x 30 cm: requires an adaptor to use with CR10X
  • 35 x 43 cm

Instructions for use

Must only be used with Agfa CR10X digital image scanner.

Once exposed with x-rays the cassette is put into the CR10X. The phosphor storage screen is removed from the cassette, digitized, then erased and returned to the cassette ready for reuse. The digitized image is displayed on the computer screen.

24 x 30 cm sized cassettes need an adaptor (see related articles below).

Operating Temperature: recommended 20-25°C (allowed 15-30°C)

Precautions for Use

Agfa phosphor screens have a 5 year life span. A warning message will appear on the computer to alert the user.

Phosphor screens in the cassettes can be replaced independently to the cassette and can be ordered separately if required (see related articles below).

Maintenance

  • See the MSF X-ray User maintenance SOPs for detailed instructions.
  • Regularly check the wear and cleanliness condition of the cassettes. Any damaged cassette must be replaced.
  • The phosphor screens can be manually removed from the cassettes and cleaned using the specific cleaning solution and wipes (see 'consumables').

Storage

  • Do not store cassettes and phosphor screens inside the x-ray room as they are very sensitive to radiation.
  • Store horizontally on a flat surface, to avoid any deformation
  • Do not place excessive loads on the cassette
  • Store a maximum of 5 cassettes one on top of the other
  • Avoid UV-radiation or direct sunlight on the cassette
  • Storing temperature: allowed -25 to 55°C
  • Relative humidity: recommended 50-60% (allowed 15-80%)
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