MacroMedics 155110 User manual

MacroMedics ®Vacuum Cushions
MANUAL 155100
Instructions for use
English Instructions
MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com

Manual
Instructions for use Vacuum Cushions
206052022V25IFU155100
MacroMedics ®
Table of Contents
1. Warnings 3
2. MRI Safety Information 3
3. Intended Use 3
4. Proton Use 3
5. Instructions for Use 4
6. Cleaning, Storage and Disposal 9
7. Warranty 9
8. Notices 9
9. Glossary of Symbols 10

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

Manual
Instructions for use Vacuum Cushions
406052022V25IFU155100
MacroMedics ®
5. Instructions for Use
5.1 INFLATION/DEFLATION OF THE VACUUM CUSHIONS AND PATIENT POSITIONING.
I. Flatten out the Vacuum Cushion and make sure that the fi lling is evenly distributed.
II. Position the patient on the Vacuum Cushion.
III. Connect the Vacuum Cushion to the pump. If necessary, use a Quick Infl ation Connector as shown
in the image below:
Quick infl ation connector, male part
Quick infl ation connector, female part
IV. Start the vacuum pump and generate a slight vacuum, then stop the pump.
V. Start molding the Vacuum Cushion around the patient’s body/region of interest. Build an adequate
rim around the body to ensure precise positioning for future use with that patient.
Quick infl ation connector, male part
Quick infl ation connector, female part

Manual
Instructions for use Vacuum Cushions
5
06052022V25IFU155100 MacroMedics ®
VI. Once the desired hardness has been achieved, stop the vacuum pump and detach it from the
Vacuum Cushion. If using the Quick Infl ation Connectors, press the blue buttons on either side of the
part to detach it from the Vacuum Cushions’ valve.
VII. Remember to keep the Vacuum Cushions’ valve out of the radiation treatment path.
5.2 ATTACHING THE VACUUM CUSHION TO THE SBRT SECURE ARCHES.
The instructions on this page and the next only apply to the following Vacuum Cushions:
• 123450 VacuumCushion, abdom.S
• 123470 VacuumCushion, abdom.XL
Dedicated plastic parts are required for attaching the Vacuum Cushions to the SBRT Secure Arch. These
plastic parts can be connected to the Vacuum Cushion by using Velcro pads, as shown in underneath
image.
I. Before attaching the Vacuum Cushion to the Secure Arch, check the orientation of the indication
arrows, as shown in the image below:
The orientation is correct when the arrows point in the same direction.