Storage; Periodic Maintenance Schedule; Limited Warranty - Zimmer Biomet Tricera Handstuck Gebrauchsanweisung

14) Remove the handpiece from the cleaning bath and rinse it thoroughly, flushing the interior lumens and
cavities, for a minimum of 2 minutes under running lukewarm tap water 72° - 109°F (22° - 43°C).
Cleaning Verification
15) After cleaning, inspect the handpiece under normal lighting to ensure that all visible debris has been
removed.
16) If not visibly clean, repeat cleaning and re-inspect.
17) For difficult-to-view areas, 3% hydrogen peroxide may be applied (bubbling is evidence of the presence of
blood).
Note: Rinse the handpiece thoroughly under running lukewarm tap water 72° - 109°F (22° - 43°C)
following any hydrogen peroxide testing.
18) Shake the handpiece with the shaver blade cavity end pointing downward to remove any water.
19) Dry the handpiece with a lint-free towel.
Note: Compressed air or nitrogen may be used to remove any additional moisture from the handpiece.
Optional Automated Cleaning
Attach the soaking cap to the cable connector and place the handpiece into a basket in such a way that the
suction lumen points downwards or at an angle for drainage of fluids, the instruments in the basket do not contact
each other, and the basket is not overloaded. This helps ensure the instruments are cleaned and dried properly.
Then put the entire basket into the automated washer.
Note: The washer/disinfector manufacturer's instructions should be strictly adhered to. Use only cleaning
agents recommended for the specific type of automated washer/disinfector. A washer/disinfector with
approved efficacy (e.g. CE mark, FDA clearance, and validation according to ISO 15883) should be used.
Caution
To prevent corrosion, do not use a cleaning
Establish the following process parameters in the automated washer:
Step Phase
Step 1 PRE-WASH
Step 2 CLEANING
Step 3 NEUTRALIZING
Step 4 RINSE I
Step 5 FINAL RINSE
Step 6 DRY
10.2. STERILIZATION INSTRUCTIONS
Clean and sterilize the handpiece prior to the first use and every use thereafter.
Caution Never sterilize the handpiece that has not been cleaned. The success of the sterilization
process depends on the previous state of cleaning.
Caution Always install the soaking cap prior to cleaning or sterilization. If moisture reaches the
connection pins of the cable connector, it could damage the connector.
Caution The handpiece can be sterilized by using the following methods only.
Sterilizing the Handpiece:
1) Clean the handpiece according to the "Cleaning Instructions" section of this manual.
2) Attach the soaking cap to the cable connector if it is not already attached.
Caution Do not cross-sterilize the handpiece. Alternating between different methods of
sterilization may cause undue wear on the handpiece. Product longevity is extended by
the consistent use of a single sterilization method.
Caution Remove the handpiece from the sterilizer immediately after sterilization, or product
damage may result.
Caution Never immerse the handpiece in a liquid to help it cool after sterilization, or product
damage may result. If necessary, cool the handpiece by wrapping it in a sterilized damp
sponge or cloth.
3) Prepare the handpiece for sterilization by either:
a) Wrapping the handpiece in Kimberly-Clark Kimguard KC400 Sterilization Wrap or equivalent
b) Following the steps below if the optional Sterilization Tray is to be used.
4) Place the handpiece into the optional Sterilization Tray as shown in the figure below. Ensure that the
handpiece is snapped into the rubber holders.
DCO-1394
Effective Date: 12-JAN-2022
solution with a pH over 10.8.
Temperature Time
20 °C (68 °F) 2:00 minutes
55 °C (131 °F) 5:00 minutes
20 °C (68 °F) 2:00 minutes
20 °C (68 °F) 2:00 minutes
93 °C (200 °F) 5:00 minutes
99 °C (210 °F) 35:00 minutes
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.
AUTOCLAVE Method:
1) Clean the handpiece according to the "Cleaning Instructions" section of this manual.
2) Ensure the soaking cap is installed.
3) Run the Steam Pre-vacuum Cycle on the Autoclave per manufacturer's instructions.
Refer to the sterilization parameters below:
a. Temperature: 132-134 °C (270-273 °F)
b. Min. Steam Exposure Time: 4 minutes
c. Min. Dry Time: 20 minutes
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
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