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FLUOROSCOPY SYSTEM, mobile, digital (Cios Select VA21 II)

https://unicat.msf.org/cat/product/69494
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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.
Z11039009 - Fluoroscopy 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.
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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FLUOROSCOPY SYSTEM, mobile, digital (Cios Select VA21 II)

For technical guidance when ordering a fluoroscopic X-ray system (C-arm) contact the Diagnostic Imaging Working Group/DIWG (diagnostic-network@msf.org).

Definition

A digital mobile fluoroscopic x-ray system (C-arm) is an imaging device which uses X-rays to produce a live image which is displayed on a monitor. It is used inside an operating theatre when intraoperative fluoroscopic guidance is required, for example in orthopaedic internal fixation surgery.

Synonym

C-arm, image intensifier

Specifications

The C-arm should be clinically versatile, have excellent image quality with a low radiation dose and be cost-effective. It should be suitable for use with orthopaedic procedures in the operating theatre. All technical specifications to be discussed with the Diagnostic Imaging Working Group.

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Quality standards

  • EN 60601-2-43, 2022, edition 3, Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
  • IEC 60825-1, 2014, edition 3, Safety of laser products - Part 1: Equipment classification and requirements

Components

  • Cios Select VA21 II
  • 2x TFT monitor
  • Standard foot switch
  • RdM power cable
  • Fixed laser anti-glare grille
  • US cart keyboard
  • Sony Printer UP-971AD
  • Printer mounting kit

Technical specifications

C-arm with mechanical breaks:

  • Orbital movement 130 ° (- 40 ° to + 90 °)
  • Angulation ± 190 °
  • Horizontal movement 20 cm (7.9”)
  • Immersion depth 73 cm (28.7”)
  • Swivel range ± 12 °
  • Vertical travel 42 cm (16.5”), motorized
  • Source to image-receptor distance 100 cm (39.4”)
  • 7 m power cable

X-ray generator:

  • Nominal peak output power 2.5 kW
  • kV range 40 kV to 110 kV
  • Single Image 0.2 mA to 13 mA
  • Continuous fluoroscopy 0.2 mA to 13 mA
  • Pulsed fluoroscopy 3 mA to 24 mA

Monitor cart:

  • 19" (48 cm) diagonal sized twin monitors
  • 300 cd/m3 or greater brightness
  • DICOM image storage and export
  • DVD and USB image export
  • Paper printer
  • 8.5 m monitor cart cable

Power Supply:

  • Power requirements 100 V, 110 V, 120 V, 127 V, 200 V, 230 V, 240 V, (± 10 %), 50/60 Hz (± 1 Hz)
  • Maximum power consumption 4.6 kW
  • Standby power consumption (for 230 V) 713 W
  • Internal line impedance
    • Ri max. 0.3 ohms for 100 V to 127 V
    • Ri max. 0.8 ohms for 200 V to 240 V

Environmental operating conditions:

  • Temperature range + 10 °C to + 35 °C
  • Relative humidity 20% to 75%
  • Barometric pressure 700 hPa to 1060 hPa

Dimensions

Dimensions and weight:

  • Chassis: (l x w x h) 179.5 cm x 80 cm x 173.5 cm. 275 kg
  • Monitor cart: (l x w x h) 68.5 cm x 74 cm x 179 cm. 150 kg

Instructions for use

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Precautions for Use

Should only be used in a OT with suitable environmental radiation protection measures in place.

  • 1W RF 800MHz-2.5GHz TFX min distance of 2.5 meters away; IPX3 waterproof xray tube and c-arm;
  • floors should be made of wood, concrete or ceramic tiles and bear the 300kg weight on 4 wheels.
  • if the floor is covered with synthetic materials, the relative humidity must be at least 30%.
  • during transport floor inclination can not exceed 10 degrees

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

Full wrap around radiation safety gowns and thyroid protection, or a mobile radiation barrier must be used by all staff in the OT during operation of the C-arm.

Dedicated training on the equipment is required prior to use. Please contact the DIWG to arrange.

Maintenance

A service contract MUST be arranged with the manufacturer at the time of purchase. In addition there are specific maintenance requirements at project level. Please see MSF X-ray SharePoint - X-ray equipment maintenance folder, and the X-ray user maintenance SOPs document.

MSF requirements

Article for surgical programmes when intraoperative fluoroscopic guidance is required during surgical interventions.

Installation MUST be accompanied by an experienced radiographer training.

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