KLARITY BiteLok Instructions For Use

Removing the BiteLok from the Mask:

16. The BiteLok can be removed from the mask for easy
cleaning. Once the mask is fully cured, hold onto the
BiteLok with one hand. With your other hand, press on the
outside of the mask at the corner of the BiteLok and push
the BiteLok in on one side. This will allow the BiteLok to
release from the mask. *Take care not to hold it by the
putty or tongue depressor/diverter.

Cleaning the BiteLok:

17. Once removed from the mask, the BiteLok can be rinsed
with water and cleaned with an antiseptic product such as
mouthwash. Once clean, press the BiteLok back into the
mask.
Extra Strong Thermoplastics and the Klarity BiteLok:
18. Form the upper mask according to the manufacturer's
instructions, placing the mask over the BiteLok.
19. When using a strong thermoplastic mask, there are 2
options for using the QuickFit tool.
a. Option 1 - While the mask is still warm, pinch the
two QuickFit tool handles together, place the
QuickFit tool over the BiteLok and release. Allow
mask to fully cool.
with stronger thermoplastic masks, take extra care when
removing the mask. You may not be able to remove the
BiteLok from the mask
b. Option 2 – While the mask is still warm, pinch the
two handles together and align the QuickFit tool
with the lower part of the BiteLok mouthpiece,
toward the chin. You will only lock in the bottom
half of the Bitelok. This
will still allow you to re-
index the BiteLok to
the mask, while still
being able to remove it
for cleaning.
To be used by a qualified medical professional
IFU.A.001.08 9/20/21
Removing BiteLok
from mask
Please note: When using the BiteLok
.
Keep in a 35˚C
cool and dry
Store below
environment
35˚C (95˚F)
Klarity BiteLok
INSTRUCTIONS FOR USE
GENERAL INFORMATION
The Klarity BiteLok is a one-per-patient medical device used with a
®
thermoplastic mask as an aid for positioning the teeth and tongue for
radiation therapy treatment.
PRODUCT DESCRIPTION
The Klarity BiteLok is an innovative design for simple positioning of the
teeth and tongue. The BiteLok and its optional attachments can be
easily removed from the mask for cleaning. The general size of the
BiteLok allows it to fit various mouth sizes and offers an open airway for
optimal patient comfort. The BiteLok is custom molded to the patient's
dental anatomy as well as the thermoplastic mask, allowing for accurate
reproducibility.
MAINTENANCE AND DISPOSAL
The Klarity BiteLok must be stored in a dry, clean place at temperatures
between 50°F (10°C) and 95°F (35°C) and can be disposed of with
normal facility waste.
Components may vary depending on item number
Two-Part Dental Putty (2 Packets)
Klarity BiteLok®
Long and Short Tongue Depressors
Right and Left Tongue Diverters
Tongue Device Removal Tool
INSTRUCTIONS FOR USE

Determine Placement of the BiteLok:

1. Place the BiteLok mouthpiece in the patient's mouth. *The
mouthpiece alone is not directional until putty has been
formed by the patient's dental impression.
2. If using one of the optional tongue depressors or diverters,
insert the device into the BiteLok and test for desired
length and placement.
EC REP
AJW Technology Consulting GmbH
Konigsallee 106
40215 Dusseldorf, Germany
T: +49 211 30132232
www.ajwtech.com
®*

Components

BiteLok® Mouthpiece
QuickFit™ Tool
Quick Instruction Card
*Patent Pending
Klarity Medical Products, LLC
600 Industrial Parkway
Heath, OH 43056
T: 740.788.8107 F: 740-788-8109
info@klaritymedical.com
www.klaritymedical.com