Bionix TruGuard HNRT-3500 User manual

MKT-0104-00 R01 Page 1of 4
TruGuard™ Custom Tongue and Jaw Positioner Instructions for Use
Caution: Federal Law restricts this device to sale by or on the order of a licensed Physician or Radiation Therapist.
DEVICE DESCRIPTION
Bionix Radiation Therapy TruGuard Custom Tongue and Jaw Positioner (HNRT-3500 and HNRT-3501) is a
reusable, customizable device intended to be used for the positioning and re-positioning of patients
undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other
diseases.
INDICATIONS
The TruGuard Custom Tongue and Jaw Positioner is intended to be used for the positioning and
repositioning of patients undergoing or receiving a course of external beam radiation therapy for the
treatment of cancer and other diseases.
CONTRAINDICATIONS
No contraindications have been identified for the use of the TruGuard Custom Tongue and Jaw Positioner.
MR SAFE
This product is MR safe.
STORAGE
Store in a cool, dry environment.
ADVERSE REACTIONS
No adverse reactions have been identified for the use of the TruGuard Custom Tongue and Jaw Positioner.
WARNINGS
•
Do NOT use the TruGuard Custom Tongue and Jaw Positioner if the package is damaged or open.
•
Inspect the TruGuard Custom Tongue and Jaw Positioner before each use.
•
Do NOT attempt to sterilize TruGuard Custom Tongue and Jaw Positioner. Attempts to sterilize
the TruGuard Custom Tongue and Jaw Positioner may result in product damage and / or patient
injury.
CLEANING INSTRUCTIONS
Note: It is the user’s responsibility to clean products according to hospital protocol / local regulations. Do
not use alcohol-based cleaners on this product. Recommended cleaning procedures include:

MKT-0104-00 R01 Page 2of 4
Instructions for TruGuard when used with a water bath:
1.
Wipe thoroughly with water-based antiseptic cleaner or foam.
2.
Allow to dry before next patient use.
Note: Colors have been added to the illustration for clarity.
1.
If the Tongue Depressor (C) will be used, snap it on to the dental tray. Make sure it is securely
fastened at the three snap locations.

MKT-0104-00 R01 Page 3of 4
2.
Fold the Dental Tray (A)
3.
Place the tray in hot water for 90 seconds (165 degrees F). Heat the water using a
microwave, hot pot or equivalent.
4.
Place heated dental tray into patient’s mouth and instruct them to gently bite down
for approximately two minutes until cool.
5.
Once cooled, remove the patient’s mouth.
6.
Select the desired opening size and snap on the Indexing Tab (B) with the facing out.
Cut off excess if applicable. Make sure the Indexing Tab is securely fastened at the three
snap
locations.
7.
Place the Spacer (D) over the posts.
8.
Prepare a thermoplastic mask and form it onto the patient with the TruGuard in place. Place
the TruGuard by pushing the two posts through the mask and forming the mark around the
spacer (Figure 2).
9.
As the mask is cooling, fasten the two Thumb Fasteners (E) making sure the wide end is
facing down.
10.
Allow the mask to completely cool (Figure 3).
11.
After treatment, remove the mask from the patient; it may be necessary to remove the
mask from the patient; it may be necessary to remove the Thumb Fasteners from the posts
and then remove the mask from the patient.
Instructions for TruGuard when used with a Bionix Radiation Therapy Dry Oven:
1.
Turn on the power to the Dry Oven by using the main switch on the side.
2.
Using the touch screen display, set the Dry Oven to 160°F (71°C).
3.
Once the Dry Oven has been heated to the desired temperature, open the drawer and place
the TruGuard onto the non-stick tray.
4.
Close the drawer and use the touch screen display to set the timer to 6 minutes. Click
the ‘restart button’ to start the timer. Allow the TruGuard to heat inside the oven for 6
minutes.
5.
Retrieve the TruGuard, fold at the hinge and place in the subject’s mouth.
6.
Have the subject bite down gently, but with enough force to make an impression. Rinse
the TruGuard in running water and let dry.
Visit www.BionixRT.com for Warranty information

MKT-0104-00 R01 Page 4of 4
Label Symbol Glossary (Note: not all symbols may be applicable to this product)
Symbol
Title of Symbol
Description of Symbol
Symbol
Designation
Number
Title of Symbol
Standard
Development
Org. Standard
Manufacturer
Indicates the medical device manufacturer, as
defined in EU Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
5.1.1
ISO 15223-2012
Authorized
representative in the
European
Community
Indicates the authorized representative in the
European Community.
5.1.2
ISO 15223-2012
Date of
manufacture
Indicates the date when the medical device was
manufactured.
5.1.3
ISO 15223-2012
Use-By Date
Indicates the date after which the medical
device is not to be used.
5.1.4
ISO 15223-2012
Batch Code
Indicates the manufacturer’s batch
code so that the batch or lot can be identified.
5.1.5
ISO 15223-2012
Catalog Number
Indicates the manufacturer’s catalog number so
that the medical device can be identified.
5.1.6
ISO 15223-2012
Serial number
Indicates the manufacturer’s serial number so
that a specific medical device can be identified
5.1.7
ISO 15223-2012
Sterilized using
ethylene oxide
Indicates a medical device that has been
sterilized using ethylene oxide.
5.2.3
ISO 15223-2012
Sterilized using
irradiation
Indicates a medical device that has been
sterilized using irradiation.
5.2.4
ISO 15223-2012
Do Not Resterilize
Indicates a medical device that is not to be
resterilized.
5.2.6
ISO 15223-2012
Non-sterile
Indicates a medical device that has not been
subjected to a sterilization process.
5.2.7
ISO 15223-2012
Do Not Use if Package is
Damaged
Indicates a medical device that should not be
used if the package has been damaged or
opened.
5.2.8
ISO 15223-2012
Biological Risks
Indicates that there are potential biological
risks associated with the medical device.
5.4.1
ISO 15223-2012
Do Not Reuse
Indicates a medical device that is intended for
one use, or for use on a single patient during a
single procedure.
5.4.2
ISO 15223-2012
Consult Instructions For
Use
Indicates the need for the user to consult the
instructions for use.
5.4.3
ISO 15223-2012
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.
5.4.4
ISO 15223-2012
European Conformity
EC Declaration of Conformity by Notified Body
Annex XII
MDD 93/42/EEC:2007
European Conformity
EC Declaration of Conformity by Manufacturer
Annex XII
MDD 93/42/EEC:2007
℞Only
By Prescription Only
Federal (USA) law restricts this device to sale,
distribution, and use by or on the order of a
physician.
N/A
FDA 81 Federal Register
pg. 38911-38931
MR Safe
Indicates an item that poses no known hazards in
all MR environments.
7.4.3.1 or
7.4.4.1
F2503-13
Advena, Ltd.
Pure Offices, Plato Close
Warwick, CV34 6WE UK
Bionix Radiation Therapy, LLC.
5154 Enterprise Blvd.
Toledo, OH 43612
www.Bionixrt.com
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