MacroMedics SBRT User manual

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
MacroMedics ® SBRTTM Systems
MANUAL 123100
Instructions for use
English Instructions

Manual
Instructions for use SBRT Systems
215112021V22IFU123100MacroMedics ®
Table of Contents
1. Warnings 3
2. MRI Safety Information 3
3. Intended Use 4
4. Installation Instructions - All baseplates, except HXP 5
5. Installation of Accessories 6
6. Installation Instructions - HXP Baseplates 8
7. Cleaning, Storage and Disposal 10
8. Warranty 10
9. Notices 10
10. Glossary of Symbols 11

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Instructions for use SBRT Systems
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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 in 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 T2/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

Manual
Instructions for use SBRT Systems
415112021V22IFU123100MacroMedics ®
2.2 MR UNSAFE
The following devices are labelled MR unsafe:
• 120360 Low Bridge Support
• 120370 High Bridge Support
• 123110 EAMIS Lite™
• 125110 VacuumCus.Pos.DSCP™
• 125130 MultiBoard™ baseplate
• 125160 MultiBoard™ base-O
• 125300 Rigid UAS set/2
• 125320 Adjust. UAS set/2
• 125410 MultiBoard™ base ExaFix HexaPod
• 125420 MultiBoard™ base Type-O HexaPod
• 125450 MB HXP Rail System, set/2
• 126110 OmniBoard™ HXP Base, EXF
• 126120 OmniBoard™ baseplate
• 126800 OmniBoard™ 2.0 base, EXF
• 126810 OmniBoard™ 2.0 HXP base, EXF
• 126250 OMB EXF HXP Rail System, set/2
• 126250R OMB HXP EXF Rail System right
• 126250L OMB HXP EXF Rail System left
2.3 MR SAFE
The following devices are MR safe:
• 123320 DSCP™ KS indexstrip
• 123400 SBRT Secure Arch, size L
• 123460 SBRT Secure Arch, size L HXP
• 123500 SBRT Secure Arch, size M
• 123530 Respiratory Suppr. Plate, S
• 123540 Respiratory Suppr. Plate, L
• 123550 PelvMidBlock EAMIS/UTB
• 123560 SBRT Secure Arch, size M HXP
• 123600 SBRT Secure Arch, size S
• 123660 SBRT Secure Arch, size S HXP
• 123700 SBRT Secure Arch, size XS
• 123760 SBRT Secure Arch, size XS HXP
• 123860 EAMIS Lite™ MR
3. Intended Use
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
• 173510 Low Bridge Support, RE
• 173520 VacuumCus.Pos.DSCP™RE
• 173530 HighBridgeSupport RE
• 174360 MultiBoard™ base I RE mouldroom
• 174460 MultiBoard™ base I RE
• 174510 OmniBoard™ HXP base, RE
• 174520 OmniBoard™ baseplate,RE
• 174900 OmniBoard™ 2.0 base,RE
• 174910 OmniBoard™ 2.0 HXP base, RE
• 175000 OmniBoard™ Base, S-Type
• 175130 OmniBoard™ HXP Base, S-Type
• 175140 OmniBoard™ Base,S-Type P.Thorax
• 175160 OMB HXP Rail System, set/2
• 175160L OMB HXP Rail System left
• 175160R OMB HXP Rail System right
• 175800 OmniBoard™ Base, S-Type 2.0
• 175810 OmniBoard™ Base HXP, S-Type 2.0
• 125190 PelvMidBlock UTB Type-O
• 125230 MultiBoard™ Mouldroom
• 125260 MultiBoard™ base-O, GF
• 126260 Handgrips for DSCP™ set/2
• 130100 KneeSupport™
• 130120 KneeSupport™ LiftBlock™
• 130130 KneeSupport™ low,plastic
• 130140 KneeSupport™, plastic
• 130160 KneeSupport™ PelvMidBlock
• 173540 Low Bridge Support, RE, MR
• 173720 VacuumCus.Pos.DSCP™ RE MR
• 174480 PelvMidBlock UTB RE
• 174430 MultiBoard™ base I RE MR

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4. Installation Instructions - ALL BASEPLATES, EXCEPT HXP.
I. PLACE THE COUCHSTRIPS
Place an indexing CouchStrip on the cranial end of the couchtop.
Place a sliding CouchStrip on the caudal end of the couchtop.
For more information, refer to IFU147100 - CouchStrips and Sidepieces.
For use in MR, use a glass fi ber, MR safe 3-Pin CouchStrip.
II. PLACE THE SBRT BASEPLATE
Align the SBRT baseplate with the Couchstrips and slot it into place. Make sure that no
movement is possible between the baseplate and the couch.
III. PLACE THE ACCESSORIES
Place the designated accessories on the baseplate. Make sure that no movement is possible between
the baseplate and the accessories.
IV. POSITION THE PATIENT
Place the patient on the SBRT baseplate.
Use the instructions for use for the individual devices for a proper patient set-up.
For more information, refer to IFU147100 - CouchStrips and Sidepieces.

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5. Installation of Accessories
5.1 PLACING THE SBRT SECURE ARCHES
I. Select the appropriate size of SBRT Secure Arch.
The SBRT Secure Arch is available in sizes; XS, S, M and L.
II. Place the brackets over the patient onto the SBRT baseplate sides.
To place the SBRT Secure Arch correctly, check the engravings on the SBRT Secure Arch for the
cranial/caudal direction.
III. Rotate the knobs on each side of the SBRT Secure Arch until the clamps properly fasten onto the
baseplate. Do not apply too much force as this may cause damage.
5.2 PLACING THE RESPIRATORY SUPPRESSION PLATE
I. Slot the white pins of the Respiratory Suppression Plate into the holes at the top of the SBRT Secure
Arch and slide the white sliding mechanism into the locked position. In the locked position, the
arrows on the Arch and on the sliding mechanism of the Arch will be in-line with each other.

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press/release
G5
G2
G1
G11
G12
G13
II. Lower the SBRT Secure Arch and hand-tighten it in the desired position by turning the knobs on
the sides of the arch. Do not apply too much force as this may cause damage.
III. To adjust the height of the Respiratory Suppression Plate,
press the yellow knob at the side. Move the Respiratory
Suppression Plate vertically into a desired indexed position.
Release the knob to lock the Plate into position.
5.3 PLACING THE ABDOMINAL VACUUM CUSHION
I. Slot the white pins of the cushion into the holes at the top of the SBRT Secure Arch and slide the
white sliding mechanism into the locked position. In the locked position, the arrows on the Arch
and on the sliding mechanism of the Arch will be in-line with each other.
II. Make sure that the arrows on the black attachment components of the cushion are in-line
with the arrows on the arch (pointing in the cranial direction).
III. Slide the two hooks of the Vacuum Cushion over the small white knobs of the Arch on the caudal
side of the Arch. Tighten the small knobs of the Arch to secure the Vacuum Cushion in place.

Manual
Instructions for use SBRT Systems
815112021V22IFU123100MacroMedics ®
IV. Lower the Secure Arch by turning the knobs on the side of the Arch until the Vacuum
Cushion is in tight contact with the patient.
V. Make a vacuum mould.
VI. Lower the bridge again and fasten it in the desired position.
VII. Make sure to keep the cushion valve out of the radiation treatment path.
6. Installation Instructions - HXP BASEPLATES.
6.1 SECURING THE OMNIBOARD HEXAPOD TO THE COUCH
I. Placing the CouchStrips
Place an indexing CouchStrip on the cranial end of the couchtop. Place a sliding CouchStrip on
the caudal end of the couchtop.
For more information, refer to IFU147100 - CouchStrips and Sidepieces.
II. Placing the OmniBoard
Align the Omniboard with the CouchStrips and slot it in place.
Make sure that no movement is possible between the baseplate and the couch.
6.2 ATTACHING AND DETACHING THE OMNIBOARD HXP RAIL SYSTEM
OMB HXP Rail System consists of a right and left rail that can be attached to either side of the
OmniBoard HXP baseplate.
To attach the rail:
Ensure that the locking mechanism on both sides of the OmniBoard HXP baseplate is in the
released position, as shown on the image below. Ensuring that the rulers are facing up, slide the
rails’ hooks onto the baseplate’s locking mechanism. Turn the knobs 90 degrees to secure the
rails in place.
To detach the rail:
Rotate all locking mechanisms 90 degrees to the released position. Pull on the rail to detach it
from the baseplate.
Released
Position Locked Position

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6.3 SECURING THE MULTIBOARD HEXAPOD TO THE COUCH
I. Placing the CouchStrips
Place an indexing CouchStrip on the cranial end of the couchtop.
Place a sliding CouchStrip on the caudal end of the couchtop.
For more information, refer to IFU147100 - CouchStrips and Sidepieces.
II. Placing the MultiBoard
Align the MultiBoard with the CouchStrips and slot it in place.
6.4 ATTACHING AND DETACHING THE MULTIBOARD HXP RAIL SYSTEM
The MultiBoard HXP Rail System can be attached to the MultiBoard HXP baseplate. Align
the bottom of the MultiBoard HXP baseplate with the rail system and slot it in place.
6.5 PLACING THE ACCESSORIES
Attach the required accessories following their instructions for use.
Check the latest MacroMedics’ catalogue or contact your distributor for further information
on available accessories. Note that the HXP baseplate secure arches differ from the secure
arches for regular baseplates.
6.6 PATIENT POSITIONING
Follow the department protocol and the Instructions for Use of the individual accessories for
patient set-up.

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7. 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 provided by the
manufacturer 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.
8. 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.
9. 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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10. 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.
GS1 Code: (21)
Serial Number
Indicates the manufacturer’s serial number so that a specifi c
medical device 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 Conditional
An item with demonstrated safety in the MR environment
within defi ned conditions.
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 Unsafe
An item which poses unacceptable risks to the patient,
medical staff or other persons within the MR environment.
Prevent Closed Loops
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.

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)