MacroMedics ThoraxSupport User manual

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
MacroMedics ®BreastBoards & ThoraxSupports
MANUAL 122500
Instructions for use
English Instructions

Manual
Instructions for use BreastBoards & ThoraxSupports
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02082021V11IFU122500 MacroMedics ®
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Manual
Instructions for use BreastBoards & ThoraxSupports
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02082021V11IFU122500 MacroMedics ®
Table of Contents
1. Warnings 4
2. MRI Safety Information 4
3. Intended Use 5
4. Installation Instructions 6
5. Cleaning, Storage and Disposal 13
6. Warranty 13
7. Notices 13
8. Glossary of Symbols 14

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Instructions for use BreastBoards & ThoraxSupports
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02082021V11IFU122500 MacroMedics ®
1. Warnings
• Inspect the device thoroughly before use. Do not use the device if damaged or incomplete.
• Check individual components on MR-safety when used together in a patient positioning system.
• Do not use MR unsafe items in an MR environment.
• Prevent the surface from damage and scratching.
• Secure the device properly before positioning the patient.
• The device shall not extend from the cranial side of the couch.
• Do not exceed an equally distributed load of 75 kilograms on the BreastBoard module.
• Rulers on the devices are only intended for reference of the device positioning of accessories. Rulers
shall not replace patient position verication.
• Instruct the patient to lay down calmly and not to reposition themself after set-up.
• 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 UNSAFE
The following devices are MR unsafe:
• 122100 ThoraxSupport™
• 122300 Upper AS TS/MBLX, set/2
• 122330 Cranial AS for BBLX/TS, set/2
• 122380 Proles LB1, set/10
• 122390 Proles LB1, set/2
• 122520 WedgeThoraxSupport™
• 122540 HighBridgeSupp. TS/MBLX
• 122610 ThoraxSupport™ complete
• 122650 ThoraxSupport™ short
• 122670 90D ArmSupports TS
• 122730 Handpoles MBLX-LB1
• 122760 Handpoles with armcup
• 122500 BreastBoardLX™
• 122590 BottomStop Adaption
• 122350 Proles BreastBoardLX™ set/10
• 122360 Proles BreastBoardLX™, set/2
• 126140 OmniBoard™ BTM
• 172400 BreastBoardSX™, RAS
• 172410 BreastBoard SX™
• 172420 Proles BreastBoardSX™
• 172450 BreastBoardSX™, HAS
• 172110 FlexBoard™ base
• 172120 BreastBoard™ EX module
• 172130 OmniBoard BreastBoard EX Module
• 173600 Breast Treatment Module LX
• 173660 FlexBoard BTM LX RealEase
• 174540 OmniBoard™ BTM, RE
• 174630 FlexBoard BB-SX RealEase
• 175010 OmniBoard™ BTM, S-Type

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2.2 MR CONDITIONAL
The following devices are MR conditional:
• 122750 BreastBoard LX™ MRC
• 122150 ThoraxSupport™, MRC
• 122660 ThoraxSupport™short MRC
• 122740 Wrist support for handpoles set/2
• 174590 OmniBoard™ BTM RE MRC
• 175060 OmniBoard™ BTM, S-Type MRC
The devices labelled as MR Conditional can be safely used in a MR system meeting the following condi-
tions:
• Static magnetic eld of 1.5 Tesla and 3 Tesla, with
• Maximum spatial eld gradient of 2,500 G/cm(25 T/m)
• Maximum force product of 50,000,000 G²/cm (50 T2/m)
Due to size and location of the metallic parts, no clinically signicant RF heating is expected.
It is the responsibility of the user to ensure that these conditions are met.
2.3 MR SAFE
The following devices are MR safe:
• 122530 WedgeThoraxSupport™, MR
3. Intended Use
Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated.

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OmniBoard
4. Installation Instructions
I. Instructions for placing the BreastBoard SX Module, BreastBoard LX Module & BreastBoard EX Module
on an OmniBoard or FleXBoard:
Lift the BreastBoard Module and position it vertically above the predestined board. Align the
hinge plates at the caudal end of the BreastBoard Module with the slots in the predestined
board and slide the BreastBoard in the slots. Carefully lower the Cranial end of the BreastBoard
towards the OmniBoard/FlexBoard and the BreastBoard will lock itself. Fix the BreastBoard at an
angle using the Angled plates.
The images above show the attachment of the BreastBoard EX to the FleXBoard. The procedure is the same
for attaching the BreastBoard Modules to the OmniBoard.
BreastBoard SX Module BreastBoard LX Module
BreastBoard EX Module
OR
FleXBoard

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II. Instructions for placing the FleXBoard with BreastBoard Module SX, LX & EX, the BreastBoard SX &
LX and the ThoraxSupport on a CouchTop:
Place the correct Couchstrips on the Couch in indexed positions. Fasten the CouchStrip and
make sure that no movement is possible between the CouchStrip and the couch. For more
information, refer to IFU147100 - CouchStrips and Sidepieces. The CouchStrips can be screwed
onto the baseplate for convenience. (For the usage in a MR environment, use the glass ber,
MR-Safe 3-Pin CouchStrip).
Position the BreastBoard or ThoraxSupport above the Couchtop, align the slots at the bottom of
the module with the CouchStrips and carefully place it on the Couchtop.
BreastBoard EX on FleXBoard BreastBoard SX
BreastBoard LX ThoraxSupport

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III. Adjusting the components of the BreastBoards & ThoraxSupports
Adjust the components of the BreastBoards and ThoraxSupports for accurate patient positioning
and record the positions in the corresponding Set-Up sheet.
The Armsupports
The armsupports can be adjusted in one direction.
The Upper Armsupports
The upper arm supports can be adjusted in
three directions with pushpins.
The Cranial Armsupports
The Cranial Arm Supports can be adjusted in
two directions.

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The BottomStop
Lift the bottomstop on the grip aperture, slide into
the desired position and lower into the middle strip.
Carbon Fiber L-Proles
Place the carbon ber proles for the
Breast Mask in the desired position on
the sides of the BreastBoard and lock
them with Quickfasteners. Refer to the
Thermoplastic Masks IFU117000 for
instructions on prole assembly and
Mask heating.
IV. Installation of the EagleBoard 2 on the BreastBoard EX
Position the EagleBoard 2 above the BreastBoard EX, align its holes at the bottom with the knobs
on the BreastBoard EX and place it carefully on the BreastBoard.

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Slide the EagleBoard 2 towards the caudal side and lock it by turning the lock knobs
counterclockwise. Turn the lock knobs back in clockwise direction to loosen.
For adjustment of the EagleBoard 2 in longitudinal direction, loosen both of the grip knobs at the
dorsal side of the BreastBoard EX.

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Turn the grip knobs clockwise to lock the EagleBoard 2 on the desired indexed position.
Align the M-Grip with the rails on the EagleBoard 2. Push the white lock knobs on the M-Grip and
slide it onto the rails.

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Place the M-Grip on the desired indexed position and release the lock knobs to x the M-Grip
to the rails of the OmniBoard EX.
Place the HeadSupport in the HeadSupport adaptor.

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5. Cleaning, Storage and Disposal
• Clean the device before and after every use with 70% Isopropanol or soapy water, applied with a
soft cloth. Rinse with water and dry properly. Follow the cleaning precautions detailed on the
bottle of the cleaning agent.
• If unsure about the cleaning uid, do not use it. Never use Ethanol (Ethyl alcohol), aerosol sprays,
corrosive cleaning agents, solvents or abrasive detergents.
• Make sure that there is no residue of the cleaning agent left on the device prior to use.
• 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.
6. 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.
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.

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8. 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 identied.
GS1 Code: (10)
Batch Code
Indicates the manufacturer’s batch code so that the batch or
lot can be identied.
GS1 Code: (21)
Serial Number
Indicates the manufacturer’s serial number so that a specic
medical device can be identi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, non-metallic,
and nonmagnetic.
MR Conditional
An item with demonstrated safety in the MR environment
within dened conditions.
MR Unsafe
An item which poses unacceptable risks to the patient,
medical staff or other persons within the MR environment.

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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)