Related Manuals for MacroMedics Thermoplastic Masks
Summary of Contents for MacroMedics Thermoplastic Masks
- Page 1 MANUAL 117000 Instructions for use English Instructions MacroMedics ® Thermoplastic Masks MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands +31(0)182 389 777 info@macromedics.com www.macromedics.com...
- Page 2 Manual Thermoplastic Masks Instructions for use [ This page is intentionally left blank ] 26042021V21IFU117000 MacroMedics ®...
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Page 3: Table Of Contents
Manual Thermoplastic Masks Instructions for use Table of Contents 1. Warnings 2. MRI Safety Information 3. Intended Use 4. Types of Mask Profiles 5. Installation Instructions 6. Cleaning, Storage and Disposal 7. Warranty 8. Notices 9. Glossary of Symbols 26042021V21IFU117000... -
Page 4: Warnings
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 UNSAFE: MacroMedics Thermoplastic masks with Carbon Fiber Profiles are MR unsafe. MR SAFE: All MacroMedics Thermoplastic masks with plastic Profiles are MR safe. 3. Intended Use Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated. -
Page 5: Types Of Mask Profiles
Manual Thermoplastic Masks Instructions for use 4. Types of Mask Profiles Mask with L-Profiles Mask with RealEase Profiles Mask with O-Profiles Mask with S-Type Profile Mask with Carbon Fiber (CF) Profiles U-frame mask standard perforation 26042021V21IFU117000 MacroMedics ®... -
Page 6: Installation Instructions
Position HOW TO MAKE THERMOPLASTIC MASKS FLEXIBLE Different types of Thermoplastic masks require different heating time in the water bath. The appropriate times and temperatures are presented in the table below. Keep the Carbon Fiber Profiles out of the water! Ensure that the material has turned completely from opaque to translucent before removing it from the water. - Page 7 Manual Thermoplastic Masks Instructions for use The above images portray the process of submerging a mask into a waterbath to make it flexible for use. USING THE EASYGRIP Attach the MacroCast mask with L-Profile to the EasyGrip device by pushing the pins through the profile holes.
- Page 8 Manual Thermoplastic Masks Instructions for use FASTENING THE PROFILES Place the Profile perpendicular to the baseplate and align the Plungers with the holes in the baseplate. Place the Plungers in the holes. III. Press the Plungers to lock. When resistance is noticed, remove the Profile and position it again.
- Page 9 Manual Thermoplastic Masks Instructions for use Removing the Profiles Always start with the head Profiles, then the shoulders. Press on the middle of the Profile. III. Use your other hand to release all Plungers. Do not pull too hard! This will lock the Profile.
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Page 10: Cleaning, Storage And Disposal
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. -
Page 11: Glossary Of Symbols
Manual Thermoplastic Masks Instructions for use 9. Glossary of Symbols Symbol Symbol Name Description of Symbol EC declaration of conformity by manufacturer. European Conformity Indicates the medical device manufacturer. Manufacturer Indicates the manufacturer’s catalogue number so that the Catalogue Number medical device can be identified. - Page 12 MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands +31(0)182 389 777 info@macromedics.com www.macromedics.com (Visit www.macromedics.com for a digital copy of this manual)
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