Bionix TruGuard HNRT-3500 Instructions For Use

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:
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