Manual
Instructions for use
SBRT Systems
3
15112021V22IFU123100
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.
• Do not use MR unsafe items in an MR environment.
• Ensure that the baseplate is correctly secured to the couch prior to use.
• Do not lean on the OmniBoard HXP Rail System.
• If the cranial end of the board is extended past the couch, do not exceed a load of 15 kg in this
area.
• Do not exceed an equally distributed load of 200 kg on the baseplate.
• Take extra care when securing the baseplate to the couch to not damage the products.
• Prevent the surface from damage and scratching.
• Rulers used on the devices are only intended for reference of the device positioning of accessories.
Rulers shall not replace patient position verifi cation.
• Keep the vacuum 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.
• Place the patient carefully on the device and make sure that they lie down calmly. Instruct the
patient not to reposition themself after set-up.
• Prevent the formation of closed-loops as they can lead to MRI burns.
Use an isolator between the patient’s arms to avoid skin-to-skin contact.
• 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 CONDITIONAL
Non-clinical testing has demonstrated the following devices are MR conditional:
• 123450 Vacuum Cushion, abdom. S
• 123470 Vacuum Cushion, abdom. XL
• 125310 Rigid UAS MR set/2
• 125350 Adjust. UAS MR set/2
•
130250 FeetSupport™, fi xed
• 130260 FeetSupport™, rotatable
• 130460 FeetSupport
TM
, rotatable 2.0
• 130450 FeetSupport
TM
, fi xed 2.0
The devices labelled as MR Conditional can be safely used in a MR system meeting the following condi-
tions:
•
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 force product of 50,000,000 G²/cm (50 T
2
/m)
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.
• 126890 OmniBoard™ 2.0 base, EXF MRC
• 174550 OmniBoard™ base MRC
• 174990 OmniBoard™ 2.0 S-Type MRC
• 175050 OmniBoard™ Base, S-Type MRC
• 175150 OmniBoard™ Base short S-Type MRC
• 175890 OmniBoard™ 2.0 S-Type Base MRC
