Patient Safety - Orthofix Galaxy Unyco System Anleitungsfaltblatt

Risks due to the re-use of "single use" device
Any device which is labelled "single use only" must never be reused. Orthofix is only responsible for safety and effectiveness for the first patient
use of single use devices. The institution or practitioner bears full responsibility for any subsequent use of these devices.
Implantable device*
The "SINGLE USE" implantable device* of Orthofix is identified through symbol reported on the product label.
After the removal from the patient, the implantable device* has to be dismantled.
The re-use of implantable device* introduces contamination risks for users and patients.
The re-use of implantable device* can not guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health
risks for the patients.
(*): Implantable device: any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for
at least 30 days is considered an implantable device.
Non implantable device
The "SINGLE USE" non implantable device of Orthofix is identified through symbol reported on the label or are indicated in the "Instructions For Use" supplied with the products.
The re-use of "SINGLE USE" non implantable device can not guarantee the original mechanical and functional performances, compromising the effectiveness of the products and
introducing health risks for the patients.
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
MRI SAFETY INFORMATION
Galaxy UNYCO System is labeled MR CONDITIONAL according to the terminology specified in "ASTM F2503 Standard Practice for Marking Medical Devices and Other Items
MR
in the Magnetic Resonance Enviroment".
Non-clinical testing has demonstrated that the Galaxy UNYCO System 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 System components must be entirely outside the MR scanner bore.
• No part of the Galaxy UNYCO System components must extend into the MR bore. Therefore MR scanning of body parts where the Galaxy UNYCO System 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 System is expected to produce a maximum temperature rise of 2°C after 15 minutes of continuous scanning.

PATIENT SAFETY

MRI in patients with Galaxy UNYCO System components can only be performed under these parameters. It is not allowed to scan the Galaxy UNYCO System components directly.
Using other parameters, MRI could result in serious injury to the patient. When the Galaxy UNYCO System components are used in conjunction with other External Fixation
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