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Manual

Instructions for use

DSPS-Prominent

SOLUTIONS IN RADIOTHERAPY

11

06042023V4IFU113000

MacroMedics ® 

®

9.  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 identifi ed.

        GS1 Code: (10)

Batch Code

Indicates the manufacturer’s batch code so that the batch or 

lot can be identifi ed.

        GS1 Code: (21)

Serial Number

Indicates the manufacturer’s serial number so that a specifi c 
medical device can be identifi 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.

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 
sources.

        GS1 Code: (17)

Use-by Date

Indicates the date after which the medical device is not 
to be used. When the graphical symbol is used, the date is 
expressed in the format: YYYY-MM-DD. On the other hand, 
when expressed next to the GS1 Code (17), the date is in the 
format: YYMMDD.

MR Safe

An item that poses no known hazards resulting from 
exposure to any MR environment.  MR Safe items are 
composedof materials that are electrically nonconductive, 

non-metallic, and nonmagnetic. 

MR Unsafe

An item which poses unacceptable risks to the patient, 

medical staff  or other persons within the MR environment.

Single patient multiple use To indicate that the emdical device may be used multiple 

times (multiple procedures) on a single patient. 

Содержание DSPS-Prominent MR SAFE

Страница 1: ...ADIOTHERAPY MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands 31 0 182 389 777 info macromedics com www macromedics com MANUAL 113000 Instructions for use English Instructions MacroMedics...

Страница 2: ...Manual Instructions for use DSPS Prominent SOLUTIONS IN RADIOTHERAPY 2 06042023V4IFU113000 MacroMedics This page is intentionally left blank...

Страница 3: ...PY 3 06042023V4IFU113000 MacroMedics Table of Contents 1 Warnings 4 2 MRI Safety Information 4 3 Intended Use Indications for Use 4 4 Baseplate and cradle set up 5 5 Mask set up 5 6 Cleaning Storage a...

Страница 4: ...ct before placing it on the patient Do not remove the mask from the patient until the material cools completely Removing the thermoplastic mask before it has set may result in the mask s deformation H...

Страница 5: ...e baseplate by means of the supplied quickfacteners 5 Mask set up Follow your department s patient positioning protocol For DSPS treatments there should be approximately one nger width in between the...

Страница 6: ...ck frame fall into the designated holes of the cradle 6 Bend both the ends of the frame at shoulder height along the slope of the cradle lock the frame s ends with the rotatable lock pawl that is posi...

Страница 7: ...MacroMedics MacroBath 4 or a bath with min internal dimensions in mm 665w x 575d x 80h to heat the mask set the water temperature between 68 C and 70 C 154 4 F and 158 F Leave the mask in the water fo...

Страница 8: ...uldroom Tool above the patient s head again to check if the chin still ts underneath it 12 Use both hands to mould the structures of the face like the nose bone orbitae chin and forehead 13 After moul...

Страница 9: ...nd shoulder masks 2 Unlock the black sliding lock pawls Place your thumb on top and your index nger at the bottom of the black lock pawl With care gently push a little upwards with your index nger to...

Страница 10: ...lvents or abrasive detergents Store the thermoplastic masks in a dry place away from direct sunlight Store the products with the black sliding lock pawls in locked position Dispose of the device in ac...

Страница 11: ...ecautions 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 medi...

Страница 12: ...UTIONS IN RADIOTHERAPY MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands 31 0 182 38 97 77 info macromedics com www macromedics com Visit www macromedics com for a digital copy of this man...

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