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Manual

Instructions for use

  Thermoplastic Masks

10

26042021V21IFU117000

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 

       manufacturer of the cleaning agent.

•  Store the thermoplastic masks in a dry place away from direct sunlight.

•  Store the products with the Quickfasteners in the released position to prevent grommet deformation.

       (See the Plunger image on page 9).

•  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.

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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