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

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Z11039009 - Fluoroscopy devices
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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%

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.

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.

environmental conditions:

  • 700 hPa to 1060 hPa barometric pressure;
  • 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


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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