DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 5 of 8
5)
Coil the cable up adjacent to the handpiece. Ensure that the
soaking cap is placed on the cable connector
6)
Place the lid onto the sterilization tray.
7)
Wrap the sterilization tray in Kimberly-Clark Kimguard KC400
Sterilization Wrap or equivalent.
8)
Sterilize the handpiece according to the parameters listed for one
of the following methods:
STERRAD 100S Method:
1)
Clean the handpiece according to the “Cleaning Instructions”
section of this manual.
2)
Ensure the soaking cap is installed.
3)
Run STERRAD 100S Short Cycle Sterilization System per the
manufacturer’s instructions.
STERRAD 100NX Method:
1)
Clean the handpiece according to the “Cleaning Instructions”
section of this manual.
2)
Ensure the soaking cap is installed.
3)
Run STERRAD 100NX STANDARD Cycle Sterilization System
per the manufacturer’s instructions.
STERRAD NX Method:
1)
Clean the handpiece according to the “Cleaning Instructions”
section of this manual.
2)
Ensure the soaking cap is installed.
3)
Run STERRAD NX Standard Cycle Sterilization System per the
manufacturer’s instructions.
STERIS V-PRO Method:
1)
Clean the handpiece according to the “Cleaning Instructions”
section of this manual.
2)
Ensure the soaking cap is installed.
3)
Run the Lumen Cycle on any of the following STERIS V-PRO
Sterilization Systems per the manufacturer’s instructions:
V-PRO 1, V-PRO PLUS, V-PRO MAX, V-PRO MAX 2.
11. STORAGE
The handpiece and accessories should be stored either in their
shipping box or in a sterilization tray. In either case, ensure that the
Tricera Handpiece is immobile to prevent any damage.
12. PERIODIC MAINTENANCE SCHEDULE
To ensure the safety and longevity of your handpiece, observe the
following maintenance procedures.
Before every surgical procedure:
1)
Assemble the entire system, including the controller, footswitch,
handpiece, and shaver blade/RF probe.
Caution
To ensure proper heat dissipation and keep the joints
clear, do not run the handpiece without proper suction or
irrigation. Immerse the blade in a sterile irrigant and
activate suction while testing the handpiece.
2)
Run the handpiece through its various functions, modes, and
settings to ensure it responds properly to commands. Ensure that
all parts move freely and that there are no loose or missing
components. Note any unusual sounds or vibrations, and note
operating speeds.
3)
Refer any calibration or operating difficulties to your Relign sales
representative or Relign Customer Service.
Every 12 Months:
Check the leakage current using a true RMS digital multimeter and
safety analyzer. Consult the analyzer’s instructions for details.
13. LIMITED WARRANTY
Relign warrants to the original purchaser of Tricera Handpiece that the
Tricera Handpiece will be free of defects in material and workmanship
for a period of one year after the date of purchase when used as
intended under normal operating conditions and in conformance with its
instructions for use and maintenance instructions. Any warranty
concerning software and/or hardware upgrades shall expire in the
original one-year warranty. The sole obligation of Relign and its
affiliates under this warranty shall be limited to the replacement of the
Tricera Handpiece or equivalent models, at no charge to the original
purchaser and at the option of Relign, during the warranty period but
only if examination reveals to the satisfaction of Relign that the Tricera
Handpiece contains a defect in material or workmanship.
Relign and its
affiliates will not be liable for any incidental, special or consequential
loss, damage, or expense resulting, directly or indirectly, from the use
of its product regardless of whether Relign or its affiliates have been
advised of the possibility of such loss, damage or expense.
This warranty is made in lieu of all other warranties, expressed, implied
or statutory, including, but not limited to the implied warranties of
merchantability and fitness for a particular purpose and all other
obligations and liabilities on the part of Relign. Relign neither assumes
nor authorizes any other person to assume for it any other liability in
connection with the sale of the Tricera Handpiece. This warranty shall
not apply to the Tricera Handpiece or any other part thereof that has
