MacroMedics UniqFix User manual

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
MANUAL 135100
Instructions for use
English Instructions
MacroMedics ®UniqFix

Manual
Instructions for use UniqFix
2
26042021V11IFU135100 MacroMedics ®
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Instructions for use UniqFix
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26042021V11IFU135100 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

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Instructions for use UniqFix
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26042021V11IFU135100 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.
• Secure the device properly before positioning the patient.
• 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:
• 135100 UniqFix
2.2 MR SAFE
The following devices are MR safe:
• 135150 UniqFix MR
3. Intended Use
Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated.

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26042021V11IFU135100 MacroMedics ®
4. Installation Instructions
I. PLACE THE COUCHSTRIPS
Place the couchstrips onto the couchtop.
II. PLACE THE UNIQFIX
Place the UniqFix onto the couchstrips. Make sure that there is no movement between the
baseplate and the couch.
III. POSITIONING THE PATIENT
Place the affected body part onto the UniqFix.
Lift the body part with a cushion if necessary.
Mould a Mask around the body part, referring to IFU117000 - Thermoplastic Masks.
Record the position of the Mask Proles on the UniqFix Set-Up sheet.

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26042021V11IFU135100 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.
• 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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26042021V11IFU135100 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 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.
MR Unsafe
An item which poses unacceptable risks to the patient,
medical staff or other persons within the MR environment.

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)