MacroMedics ThoraxSupport Bedienungsanleitung

MacroMedics BV

Oostbaan 670

2841ML Moordrecht

The Netherlands

+31(0)182-389777

[email protected]

www.macromedics.com

MacroMedics ®BreastBoards & ThoraxSupports

MANUAL 122500

Instructions for use

English Instructions

Manual

Instructions for use BreastBoards & ThoraxSupports

02082021V11IFU122500 MacroMedics ®

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Manual

Instructions for use BreastBoards & ThoraxSupports

02082021V11IFU122500 MacroMedics ®

Table of Contents

1. Warnings

2. MRI Safety Information

3. Intended Use

4. Installation Instructions

5. Cleaning, Storage and Disposal

6. Warranty

7. Notices

8. Glossary of Symbols

Manual

Instructions for use BreastBoards & ThoraxSupports

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

Manual

Instructions for use BreastBoards & ThoraxSupports

02082021V11IFU122500 MacroMedics ®

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.

Manual

Instructions for use BreastBoards & ThoraxSupports

02082021V11IFU122500 MacroMedics ®

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

FleXBoard

Manual

Instructions for use BreastBoards & ThoraxSupports

02082021V11IFU122500 MacroMedics ®

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

Manual

Instructions for use BreastBoards & ThoraxSupports

02082021V11IFU122500 MacroMedics ®

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.

Manual

Instructions for use BreastBoards & ThoraxSupports

02082021V11IFU122500 MacroMedics ®

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.

Manual

Instructions for use BreastBoards & ThoraxSupports

02082021V11IFU122500 MacroMedics ®

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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