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X-RAY UNIT, FIXED, ANALOGUE, SEDECAL WHIS-RAD, basic 32kW

https://unicat.msf.org/cat/product/12657
STD EDIMXRUE6--

Valid Article

Former Code(s): -X EDIMXRAY6--
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.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PME
The order of this product needs to be justified and is only acceptable under certain conditions.
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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X-RAY UNIT, FIXED, ANALOGUE WHIS-RAD

The most appropriate X-ray equipment will depend on the specific project requirements. The WHIS-RAD or MULTI-RAD x-ray unit is generally preferred as the primary option for MSF hospital based projects, but may not be suitable in all scenarios. Before ordering an x-ray unit, please contact the Diagnostic Imaging Working Group (diagnostic-network@msf.org) for advice, and to discuss radiation safety requirements, human resources requirements, servicing and necessary accessory equipment.

Definition

The WHIS-RAD (World Health Imaging System for Radiology) is a fixed installation x-ray unit suitable for most routine radiography examinations and is used in combination with the AgfaCR10X.

The WHIS-RAD or the MULTI-RAD is often preferred as the primary X-ray machine for general hospital settings depending the context, but please discuss with the DIWG the most appropriate equipment selection for the project/context.

Specifications

The WHIS-RAD was developed by the WHO and is produced by several manufacturers meeting the following requirements:

  • excellent image quality
  • highest possible safety
  • easy to use and to maintain
  • reliable under difficult conditions
  • cheaper than conventional equipment

Quality standards

  • IEC 60601-1-3, 2008, edition 2.2, +A1 2013, A2 2021 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
  • EN 60601-2-54, 2009, +A2 2019 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Technical specifications

EXAMINATION STAND

  • Fixed to floor and wall
  • Rotating arm allowing for vertical, horizontal and oblique diagnostics
  • Fixed focus-film distance (FFD): 140 cm
  • Cassette tray for cassettes sizes up to 35 x 43 cm
  • Anti-scatter static grid to increase image contrast on certain exams
  • Manual collimator with lamp

EXAMINATION TABLE

  • On castors
  • Dimensions (LxWxH): 200 x 65 x 70 cm

X-RAY GENERATOR

  • 110/220/240V ± 10%, 50/60Hz
  • Power requirement: 2-5 kW depending on configuration
  • Can be delivered with capacitor to reduce power demand
  • Exposure time limited to 0.005s
  • Output:
    • power: 32 kW
    • tension: 40-125 kV
    • current: 10-320 mA
    • exposure time: 1ms-10s

Remark

Possibilities for local support and service contract are important and should be verified before order is made.

Packaging & Labelling

Unit packaging (2 boxes)

(Cf Introduction: Packaging and labelling)

To be Ordered Separately

  • EDIMXRAY6IT: (X-ray unit, fixed, Whis-Rad) INSTALLATION AND TRAINING
  • EDIMXRUS618: (X-ray unit WHIS-RAD) SET of SPARE PARTS

Instructions for use

  • X-ray equipment must only be used by a trained/qualified radiographer/X-ray technician
  • The apparatus can be used with a CR reader (e.g. Agfa CR10X) or x-ray films to be developed in a darkroom.
  • Installation must be done by a specialised technician.
  • The apparatus must be used in a room that meets radiation safety requirements
  • Training of radiographer (positioning of patients, exposure factors, radiation safety etc) is mandatory
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Precautions for Use

Radiation emitting device. To be used only by trained staff.

Must be used in a dust free environment.

It is mandatory to protect the device with a double conversion UPS (see related articles below).

Maintenance

There are specific manufacturer and MSF maintenance tasks that MUST be followed. Manuals, schedules and MSF SOP documents are available on the MSF X-ray SharePoint page. Contact DIWG for more information.

MSF requirements

WHIS-RAD equipment

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