MacroMedics OmniBoard MR User manual

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
MacroMedics ®OmniBoardTM MR
MANUAL 175170
Instructions for use
English Instructions

Manual
Instructions for use OmniBoard MR
2
26042021V4IFU175170 MacroMedics ®
Table of Contents
1. Warnings 3
2. MRI Safety Information 3
3. Intended Use 3
4. Types of OmniBoards MR 4
5. Installation Instructions - OmniBoard MR 5
6. Cleaning, Storage and Disposal 6
7. Warranty 6
8. Notices 6
9. Glossary of Symbols 7

Manual
Instructions for use OmniBoard MR
3
26042021V4IFU175170 MacroMedics ®
1. Warnings
• Inspect the device toroughly 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.
• Take extra care when securing the baseplate to the couch to not damage the products.
• Secure the device properly before positioning the patient.
• Do not exceed an equally distributed load of 200 kg on the baseplate.
• Rulers used on the devices are only intended for reference of the device positioning of the
accessories. Rulers shall not replace patient position verication.
• In the USA, federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
2. MRI Safety Information
MR SAFE
The following devices are MR safe:
• 175080 OmniBoard S-Type M&N base GF
• 175090 OmniBoard MR Lower Extrimities
• 175170 OmniBoard S-Type Pediatric MR
• 175180 OmniBoard S-Type H&N Pediatric MR
3. Intended Use
Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated.

Manual
Instructions for use OmniBoard MR
4
26042021V4IFU175170 MacroMedics ®
4. Types of OmniBoards MR
175170 – OmniBoard S-Type Pediactric MR 175090 – OmniBoard MR Lower Extremities
175180 – OmniBoard S-Type H&N Pediactric MR 175080 - Omniboard S-Type M&N base GF

Manual
Instructions for use OmniBoard MR
5
26042021V4IFU175170 MacroMedics ®
5. Installation Instructions - OmniBoard MR
5.1 PLACE THE COUCHSTRIPS
Place indexing CouchStrip at the cranial end of the CouchTop.
Place a sliding CouchStrip on caudal end of the CouchTop.
Fasten properly without play.
For more information, refer to IFU147100 - CouchStrips and Sidepieces.
5.2 PLACE THE OMNIBOARD
Place the OmniBoard onto the CouchStrips. Make sure that no movement is possible
between the baseplate and the CouchTop.
5.3 PLACE THE ACCESSORIES
Place accessories when desired. Use the instructions for use for the individual devices
for a proper set-up of the patient.

Manual
Instructions for use OmniBoard MR
6
26042021V4IFU175170 MacroMedics ®
6. 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 man-
ufacturer 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.
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.

Manual
Instructions for use OmniBoard MR
7
26042021V4IFU175170 MacroMedics ®
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 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, nonmetallic, and
nonmagnetic.

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)