In the USA, federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. 2. MRI Safety Information MR UNSAFE The following devices are MR unsafe: • 161100 OmniCouch for Elekta, RE 3. Intended Use Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated. 26042021V4IFU161100 MacroMedics ®...
4. Installation Instructions The OmniCouch offers a wide range of treatment area with its integrated travel range system. The following instructions explain how range is achieved by moving the OmniCouch couchtop in two discrete positions, P1 or P2. 26042021V4IFU161100 MacroMedics ®...
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In position P1, an optimal travel range is offered towards the cranial section of the radio translucent part of the OmniCouch Couchtop. In position P2, an optimal travel range is provided towards the caudal section of the radio translucent part of the OmniCouch couchtop. 26042021V4IFU161100 MacroMedics ®...
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Please see the following images. The transfer of the OmniCouch couchtop to the desired discrete position can only be achieved with proper operation. PULL HANDLE 26042021V4IFU161100 MacroMedics ®...
Defects, malfunctions or failures caused by nature, misuse, abuse and unauthorized alteration or repair are not warranted. This warranty is limited to the repair and/or replacement at the sole discretion of MacroMedics. 7. Notices Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user or patient is established.
MR environment. An item that poses no known hazards resulting from MR Unsafe exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic. 26042021V4IFU161100 MacroMedics ®...
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Manual OmniCouch Instructions for use [ This page is intentionally left blank ] 26042021V4IFU161100 MacroMedics ®...
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Manual OmniCouch Instructions for use [ This page is intentionally left blank ] 26042021V4IFU161100 MacroMedics ®...
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MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands +31(0)182 389 777 info@macromedics.com www.macromedics.com (Visit www.macromedics.com for a digital copy of this manual)
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