MacroMedics Thermoplastic Masks User manual

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
MANUAL 117000
Instructions for use
English Instructions
MacroMedics ® Thermoplastic Masks

Manual
Instructions for use Thermoplastic Masks
2
26042021V21IFU117000 MacroMedics ®
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Manual
Instructions for use Thermoplastic Masks
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26042021V21IFU117000 MacroMedics ®
Table of Contents
1. Warnings 4
2. MRI Safety Information 4
3. Intended Use 4
4. Types of Mask Proles 5
5. Installation Instructions 6
6. Cleaning, Storage and Disposal 10
7. Warranty 10
8. Notices 10
9. Glossary of Symbols 11

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Instructions for use Thermoplastic Masks
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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 Proles are MR unsafe.
2.2 MR SAFE:
All MacroMedics Thermoplastic masks with plastic Proles are MR safe.
3. Intended Use
Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated.

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Instructions for use Thermoplastic Masks
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4. Types of Mask Proles
Mask with L-Proles Mask with RealEase Proles
Mask with O-Proles Mask with S-Type Prole
Mask with Carbon Fiber (CF) Proles U-frame mask standard perforation

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26042021V21IFU117000 MacroMedics ®
5. Installation Instructions
5.1 ASSEMBLY OF THE CARBON FIBER PROFILES
Attach the Thermoplastic Mask to the Carbon Fiber Proles by screwing the bolts and nuts into
each other as shown below.
Make sure that the Quickfasteners in the Proles are set to their released position when the mask
is stored.
5.2 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 Proles out of the water!
Ensure that the material has turned completely from opaque to translucent before removing it
from the water.
Perforated MacroCast
Thermoplastics
Non-perforated MacroCast
Thermoplastics
Selective perforated
Thermoplastics
(S-Type & U-Frame)
Time of immersion
in the waterbath 45 - 60 s 2 - 4 min 2.3 mm = 2 min
3.0 mm = 4 min
Temperature of
the waterbath 68°C - 70°C / 158°F 68°C - 70°C / 158°F 68°C - 70°C / 158°F
Released
Position
Locked
Position
Incorrect
Position (locked)

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Instructions for use Thermoplastic Masks
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The above images portray the process of submerging a mask into a waterbath to make it exible for use.
5.3 USING THE EASYGRIP
Attach the MacroCast mask with L-Prole to the EasyGrip
device by pushing the pins through the prole holes.
Submerge the mask and EasyGrip in the water bath.
Remove the EasyGrip from the mask before you will
start moulding the mask on the patient.
5.4 MOULDING THE MASK
1. Dry the mask with a towel.
2. Check if the temperature 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 Proles towards the baseplate so
that the mask forms around the patients’ face.
5. First secure the proles which are located on both sides
of the head to the baseplate. Then lock the most Cranial
Prole. Lastly, secure the Shoulder Proles if applicable.
6. Mould the mask precisely around the nose bridge, chin
and eye sockets of the patient.
7. When the facial features have been precisely moulded
into the mask, start cooling down the mask. Cold-packs
can be used to speed up the cooling process.
8. When completely cooled, remove the mask.

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5.5 FASTENING THE PROFILES
I. Place the Prole 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 to lock.
When resistance is noticed, remove the Prole and position it again.

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Instructions for use Thermoplastic Masks
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5.6 Removing the Proles
I. Always start with the head Proles, then the shoulders.
II. Press on the middle of the Prole.
III. Use your other hand to release all Plungers.
Do not pull too hard! This will lock the Prole.
IV. Set the plungers in released position during storage.
When removing the proles becomes difcult:
• Clean the baseplate holes with a cotton bud.
• Spray Teon spray in the hole.
• Remove residual teon spray from the hole.
PUSH
PULL
PULL
Released
Position
Locked
Position
Incorrect
Position (locked)

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Instructions for use Thermoplastic Masks
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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.

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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: (10)
Batch Code
Indicates the manufacturer’s batch code so that the batch or
lot 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.
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 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.
Single patient multiple use
To indicate that the medical device may be used multiple
times (multiple procedures) on a single patient.
9. Glossary of Symbols

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)