Upper Jaw Support And Reference Plates - Brainlab RT/RS Hardware User's Manual

CLEANING, DISINFECTION, AND STERILIZATION
7.2.4

Upper Jaw Support and Reference Plates

Silicone Disposables
The silicone disposables are manufactured in a cleanroom. They are intended for single patient
use only and must be disposed after every use. They cannot be disinfected or sterilized.
Additional protection (e.g., disposable finger coats) can be used to cover the silicone disposables
on the reference plate, making sterilization unnecessary.
Upper Jaw Support: Cleaning and Disinfection
The Upper Jaw Support can be cleaned with a damp and lint-free cloth. The device can also be
cleaned and disinfected using automatic cleaning and disinfection. See page 95
Upper Jaw Support: Sterilization
The Upper Jaw Support may be sterilized using neutral steam sterilization. See page 97
Reference Plates: Cleaning and Disinfection
The reference plates are delivered non-sterile and therefore should be cleaned, disinfected, and
sterilized before the first use.
The reference plates should be cleaned and disinfected using automatic cleaning and disinfection.
See page 95
Reference Plates: Sterilization
The reference plates must be cleaned, disinfected, and dried effectively prior to sterilization.
The reference plates must be transferred to the Sterilization Tray prior to sterilization. Wrap the
Sterilization Tray in suitable single-use sterilization packaging in accordance with EN 868 and
AAMI/ISO 11607 (e.g., paper/foil sterilization bags).
Sterilize the reference plates using neutral steam sterilization (Page 97).
The reference plates must be sterilized according to AAMI TIR 12.
If the reference plate is used for more then one patient without any additional protection,
sterilization becomes necessary.
The user is fully responsible for any deviations from the recommended cleaning,
disinfection, and sterilization processes. If the processes are altered, the desired effect
may not be achieved. Brainlab excludes any liability in such cases.
Following sterilization, wait until instruments are cooled down to room temperature before
use. The use of hot instruments could injure the patient or damage non-heat resistant
instruments.
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 103