To be used by a qualified medical professional
IFU Form: A101-06 8/19/20
*Patent Pending
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.
PARTS INCLUDED
Klarity
BiteLok®
RNB-100
Klarity BiteLok® Kit
Kit Includes
BiteLok® Mouthpiece
Two-Part Dental Putty (2 Packets)
QuickFit™ Tool
Long and Short Tongue Depressors
Right and Left Tongue Diverters
Tongue Device Removal Tool
Quick Instruction Card
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.
*The depressors and diverters are directional and are
marked to show which side goes “up” or “down”.
Mixing and Forming the Putty:
3.
Before mixing the putty, you have the option to remove the
tongue depressor or diverter from the BiteLok using the
included tongue device removal tool.
*This will allow a better impression of the teeth into the
putty. If you choose to leave the tongue accessory intact,
please be aware that the patient could cause the device
to wiggle with their tongue, which could affect the
impression in the putty made by the teeth.
4.
Tear or cut the putty pouch and squeeze out the contents
of both packets. Mix the two-part putty together thoroughly
for 15-20 seconds. Roll the putty into a two-inch long
cylinder. Pinch off a small amount of putty and set it aside
(about 0.5cm) (See step 3c).
5.
Wrap the entire cylinder of putty around the “BITE” area of
the BiteLok mouthpiece. Press the putty gently, but firmly,
around the “Bite” area to ensure it will fill the bite region
indentations.
Making the Impression:
6.
While the putty is still soft, have patient gently bite into the
putty until it hardens (about 2 minutes).
7.
Instruct the patient to bite down with a “natural” bite,
which will help relieve jaw fatigue during treatment.
Tongue depressor inserting
into the BiteLok
Putty wrapping around the BiteLok
Klarity Medical
& Equipment (GZ) Co., Ltd
www.klarity
-
medical.com
T:
86-20-8222 6380
F:
86-20-8208 8552
E:
sales
@klarity
-
medical.com
