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

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Instructions for use Vacuum Cushions
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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
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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

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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.

Manual
Instructions for use Vacuum Cushions
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II. Attach the Vacuum Cushion, one side at a time, to the Secure Arch. Once the fi rst side is in position
lock it by turning the white star shaped knob clockwise, as shown in the image below:
III. Continue with the plastic part in the middle and stick the two white pins through the holes. Slide the
white locking plate to the right side to secure the Vacuum Cushion, as shown in the images below.
Note: If the white locking plate moves with too
much resistance, release the black ribbed knobs
until the resistance reaches an acceptable level.
Be careful not to unscrew them too much.
much resistance, release the black ribbed knobs
until the resistance reaches an acceptable level.
Be careful not to unscrew them too much.
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IV. Repeat step two for attaching the last side.
V. After treatment, detach the Vacuum Cushion from the Secure Arch by slide the white locking plate
to the left and turn the aforementioned star shaped locking knobs counterclockwise.
5.3 PLACING THE U-SHAPED VACUUM CUSHION ON THE EAGLEBOARD-2.
I. Position the U-shaped Vacuum Cushion on the EagleBoard-2 with the two ends of the Vacuum
Cushion facing upwards, as shown below:
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Manual
Instructions for use Vacuum Cushions
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II. Flatten out the Vacuum Cushion and distribute the fi lling roughly as desired.
Mould the cushion around the Vacuum Cushion positioning knobs on the wings of the
EagleBoard-2 to hold the Vacuum Cushion in place.
III. Position the patient.
IV. Start defl ating the Vacuum Cushion as described in chapter 4.1 - ‘Infl ation/defl ation of the
Vacuum Cushion’.

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Instructions for use Vacuum Cushions
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6. Cleaning, Storage and Disposal
• Clean the device before and after every use with mild soap and luke-warm water or
alchohol-based disinfectant applied with a soft cloth. Rinse with water and dry properly. Avoid
aeorosol sprays, bleach, solvents or abrasive detergents.
• The devices are not suitable for sterilization or thermal disinfection.
• Store the device in a clean, ventilated environment.
• Dispose of the device in accordance with the local laws and regulations applicable to your
country.
7. Warranty
The MacroMedics products are warranted to be free from defects in manufacturing, material and
construction. The warranty is for 1 year starting from the date of delivery.
Product warranties remain valid provided the product was installed and/or used according to the
instructions. Defects, malfunctions or failures caused by nature, misuse, abuse and unauthorised
alteration or repair are not warranted.
This warranty is limited to the repair and/or replacement at the sole discretion of MacroMedics.
8. 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.

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9. Glossary of Symbols
Symbol Symbol Name Description of Symbol
European Conformity
EC declaration of conformity by manufacturer.
Manufacturer
Indicates the medical device manufacturer.
Catalogue Number
Indicates the manufacturer’s catalogue number so that the
medical device can be identifi ed.
GS1 Code: (10)
Batch Code
Indicates the manufacturer’s batch code so that the batch
or lot can be identifi ed.
Consult Instruction for Use
Indicates the need for the user to consult the instructions for
use.
Caution
Indicates the need for the user to consult the instructions for
use for important cautionary information such as warnings
and precautions that cannot, for a variety of reasons, be
presented on the medical device itself.
Prescription Only
Devices for sale to physicians or trained healthcare
providers only.
MR Safe
An item that poses no known hazards resulting from
exposure to any MR environment. MR Safe items are
composed of materials that are electrically nonconductive,
nonmetallic, and nonmagnetic.
MR Conditional
An item with demonstrated safety in the MR environment
within defi ned conditions.

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MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
(Visit www.macromedics.com for a digital copy of this manual)