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X-RAY UNIT, FIXED, ANALOGUE, SEDECAL Multi-RAD, 32kW

https://unicat.msf.org/cat/product/79875
STD EDIMXRUE6B-

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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.
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 MULTI-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 MULTI-RAD is a floor and wall mounted fixed x-ray unit and is ideal for all 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 equpiment selection for the project/ context.

Specifications

The MULTI-RAD is similar to the WHIS-RAD model (uses the same generator) but has a more advanced table and X-ray bucky configuration that may be preferred in higher volume / trauma settings. However it is more complex, has greater maintenance requirements and requires well-trained X-ray staff. It provides

  • greater movement / flexibility (than the WHIS-RAD)
  • excellent image quality
  • 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

Quality Standards Comment

  • IEC 60601-2-54:2009+AMD1: 2015+AMD2: 2018 : 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

  • Floor mounted tube stand
  • Rotating arm allowing for vertical, horizontal and oblique diagnostic
  • Variable focus-film distance (FFD)
  • 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

  • 4 way ‘floating table top' with electromagnetic locks
  • 200 cm x 72.5 cm
  • Supports up to 200 kg

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
  • Internal capacitors 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 (4 boxes)

(Cf Introduction: Packaging and labelling)

To be Ordered Separately

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

Instructions for use

  • 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 (MSF X-ray engineer or local company).
  • The apparatus must be used in a room that meets radiation safety requirements
  • Training of radiographer (positioning of patients, calculation of doses, radiation protection, etc) is mandatory
  • Assessment / training on appropriate indications & X-ray interpretation strongly recommended
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Precautions for Use

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

Must be used in a dust free / temperature controlled 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.

Any questions regarding purchase or maintenance may be sent to the Diagnostic Imaging Working Group (diagnostic-network@msf.org).

MSF requirements

MULTI-RAD equipment

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