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Manual

Instructions for use

  Thermoplastic Masks

4

26042021V21IFU117000

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.

•  Fix the Thermoplastic mask properly before treatment.

•  The Thermoplastic masks are for single patient use.

•  Ensure that the Thermoplastic mask is not too hot for skin contact before placing it on the patient.

•  Do not remove the Thermoplastic mask from the patient until the material has cooled completely. 

Removing the Thermoplastic mask before it has set may result in mask deformation.

•  Store the Plungers in the released position to prevent grommet deformation. 

•  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:

 

MacroMedics Thermoplastic masks with Carbon Fiber Profiles are MR unsafe.

2.2

      

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. 

Summary of Contents for Thermoplastic Masks

Page 1: ...oMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands 31 0 182 389 777 info macromedics com www macromedics com MANUAL 117000 Instructions for use English Instructions MacroMedics Thermoplastic Ma...

Page 2: ...Manual Instructions for use Thermoplastic Masks 2 26042021V21IFU117000 MacroMedics This page is intentionally left blank...

Page 3: ...6042021V21IFU117000 MacroMedics Table of Contents 1 Warnings 4 2 MRI Safety Information 4 3 Intended Use 4 4 Types of Mask Profiles 5 5 Installation Instructions 6 6 Cleaning Storage and Disposal 10 7...

Page 4: ...before placing it on the patient Do not remove the Thermoplastic mask from the patient until the material has cooled completely Removing the Thermoplastic mask before it has set may result in mask def...

Page 5: ...astic Masks 5 26042021V21IFU117000 MacroMedics 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 Profile...

Page 6: ...s 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...

Page 7: ...emperature of the mask is not too hot to touch the patients skin 3 Position the mask above the patients face Align the nose hole of the mask with the nose of the patient 4 Carefully pull the Profiles...

Page 8: ...oMedics 5 5 FASTENING THE PROFILES I Place the Profile perpendicular to the baseplate and align the Plungers with the holes in the baseplate II Place the Plungers in the holes III Press the Plungers t...

Page 9: ...rofile III Use your other hand to release all Plungers Do not pull too hard This will lock the Profile IV Set the plungers in released position during storage When removing the profiles becomes diffic...

Page 10: ...e 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 fo...

Page 11: ...scription 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 medi...

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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