Manual
Instructions for use
Vacuum Cushions
3
06052022V25IFU155100
MacroMedics ®
1. Warnings
• Inspect the device thoroughly before use. Do not use the device if damaged or if missing parts.
• Check individual components on MR-Safety when used together in a patient positioning system.
• Keep the Cushion valve out of the radiation treatment path.
•
Do not infl ate the Vacuum Cushion above 100 Mbar.
• Please be aware not to deform the cushion whilst the patient is being (re)positioned.
• In the USA, federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
2. MRI Safety Information
2.1
MR SAFE
•
155900 Quick infl ation connector
2.2
MR CONDITIONAL
• 155110 VacuumCushion 30x40
• 155140 VacuumCushion 25x50
• 155150 VacuumCushion 50x70 T
• 155210 VacuumCushion 50x70
• 155300 VacuumCushion 65x65
• 155400 VacuumCushion 100x70
• 155410 VacuumCushion 100x80
A patient with the above devices can be safely scanned in an MR system meeting the following the
following conditions:
•
Static magnetic fi eld of 1.5 Tesla and 3 Tesla, with
•
Maximum spatial fi eld gradient of 2,500 G/cm (25 T/m)
•
Maximum MR system reported, whole body averaged specifi c absorption rate (SAR) of 2 W/kg (Normal
Operating Mode)
Due to the size and location of the metallic parts, no clinically signifi cant RF heating is expected.
It is the responsibility of the user to ensure that these conditions are met.
3. Intended Use
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
4. Proton Use
Use of the VacuumCushions for patients receiving proton therapy has not been investigated.
• 155430 VacuumCushion 120x80
• 155450 VacuumCushion 100x150
• 155510 VacuumCushion 200x100
• 155520 VacuumCushion 120x120 T
• 155610 VacuumCushion EB-2
• 123450 VacuumCushion, abdom.S
• 123470 VacuumCushion, abdom.XL