MacroMedics ThoraxTilt Bedienungsanleitung
MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
+31(0)182 389 777
www.macromedics.com
MANUAL 115420
Instructions for use
English Instructions
MacroMedics ®ThoraxTilt
Manual
Instructions for use ThoraxTilt
2
26042021V4IFU115420 MacroMedics ®
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Manual
Instructions for use ThoraxTilt
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26042021V4IFU115420 MacroMedics ®
Table of Contents
1. Warnings
4
2. MRI Safety Information
4
3. Intended Use
4
4. Installation Instructions
5
5. Cleaning, Storage and Disposal
6
6. Warranty
6
7. Notices
6
8. Glossary of Symbols
7
Manual
Instructions for use ThoraxTilt
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26042021V4IFU115420 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.
• Place and x the device properly before positioning the patient.
• Do not exceed an equally distributed load of 75 kilograms.
• Ensure that the baseplate is correctly secured to the couch prior to use.
• 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
The following devices are MR safe:
• 115420 ThoraxTilt Set MB
3. Intended Use
Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated.
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Instructions for use ThoraxTilt
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26042021V4IFU115420 MacroMedics ®
4. Installation Instructions
The ThoraxTilt consists of three stackable layers and is compatible with the MultiBoard.
Place the Lowered part, at the bottom of the ThoraxTilt, into the cushion insert of the MultiBoard
so that the ThoraxTilt is secured to the MultiBoard.
Layer 3
Layer 2
Layer 1
Lowered Part
Cushion
Insert
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Instructions for use ThoraxTilt
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26042021V4IFU115420 MacroMedics ®
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
product 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.
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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Instructions for use ThoraxTilt
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26042021V4IFU115420 MacroMedics ®
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 identied.
GS1 Code: (10)
Batch Code
Indicates the manufacturer’s batch code so that the batch or
lot can be identied.
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.
Keep Dry
Indicates a medical device that needs to be protected from
moisture.
Keep Away from Sunlight
Indicates a medical device that needs protection from light
and heat sources.
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
+31(0)182 389 777
www.macromedics.com
(Visit www.macromedics.com for a digital copy of this manual)
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