Orthofix GALAXY UNYCO SYSTEM, Instruction Leaflet

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MRI SAFETY INFORMATION
Galaxy UNYCO Diaphyseal Tibia Kit is labeled MR CONDITIONAL
MR
according to the terminology specified in ASTM F2503 Standard Practice for Marking Medical Devices and
Other Items in the Magnetic Resonance Enviroment.
Non-clinical testing has demonstrated that the Galaxy UNYCO Diaphyseal Tibia Kit components are MR Conditional. It can be safely scanned under the following conditions:
• Static magnetic field of 1.5 Tesla and 3.0 Tesla
• Maximum spatial magnetic field gradient of 900-Gauss/cm (90 mT/cm)
• Maximum whole-body-averaged specific absorption rate (SAR) of ≤4.0 W/kg (First Level Controlled Operating Mode).
• No local transmit/receive coils can must be used on the device.
• The Galaxy UNYCO Diaphyseal Tibia Kit components must be entirely outside the MR scanner bore.
• No part of the Galaxy UNYCO Diaphyseal Tibia Kit components must extend into the MR bore. Therefore MR scanning of body parts where the Galaxy UNYCO Diaphyseal Tibia Kit
components are located is contraindicated.
DISPLACEMENT INFORMATION
The system will not present an additional risk or hazard to a patient in the 1.5 and 3.0 Tesla MR environment with regard to translational attraction or migration and torque.
HEATING INFORMATION
Under the scan conditions defined above, the Galaxy UNYCO Diaphyseal Tibia Kit is expected to produce a maximum temperature rise of 2ºC after 15 minutes of continuous
scanning.
MR PATIENT SAFETY
MRI in patients with Galaxy UNYCO Diaphyseal Tibia Kit components can only be performed under these parameters. It is not allowed to scan the Galaxy UNYCO Diaphyseal Tibia
Kit components directly. Using other parameters, MRI could result in serious injury to the patient. When the Galaxy UNYCO Diaphyseal Tibia Kit components are used in conjunction
with other External Fixation Systems, please be advised that this combination has not been tested in the MR environment and therefore higher heating and serious injury to the
patient may occur. Because higher in vivo heating cannot be excluded, close patient monitoring and communication with the patient during the scan is required. Immediately
abort the scan if the patient reports burning sensation or pain.
Galaxy UNYCO Diaphyseal Tibia Kit can only be guaranteed for MRI when using the following components to build a frame:
Description
2 x Large Multiscrew Clamps for UNYCO Screws
1 x Rod Ø 12 mm L 350 mm
Up to 8 within these screws available in the kit:
8 x UNYCO Screw QC Shaft Ø 6 mm
4 x UNYCO Cancellous Screw QC Shaft Ø 6 mm