DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 2 of 8
5)
The Tricera Handpiece is supplied non-sterile. It must
be cleaned and sterilized before the first use. Prior to
each subsequent use, it must be cleaned and sterilized.
Caution
To avoid potential damage to this device, please note
the following cautions:
1)
Test this instrument for functionality prior to a surgical
procedure. This unit was fully tested at the factory
before shipment.
2)
Attempt no internal repairs or adjustments not
specifically detailed in this manual. Doing so may
cause damage to the device.
3)
Pay close attention to the care and cleaning instructions
in this manual. Any deviations may cause damage.
4)
Avoid exposing the handpiece to sudden temperature
changes. Do not immerse hot handpiece into cold water
or liquid. Allow the handpiece to properly cool after
sterilization cycles.
5)
Between uses, the device must be stored in accordance
with these instructions. Storing in another manner may
results in damage or loss of function.
6)
Read the entire instruction manual before using or
connecting the unit.
The warranty is void if any of these warnings or cautions is
disregarded.
Relign Corporation accepts full responsibility for the effects on safety,
reliability, and performance of the instrument only if:
•
Readjustments, modifications, and/or repairs are carried out
exclusively by Relign Corporation.
•
The electrical installation of the relevant operating room
complies with the applicable IEC, CEC, and NEC requirements.
Relign Corporation is not responsible for damage caused by misuse of
the Tricera Handpiece. Misuse of the Tricera Handpiece shall void the
warranty.
Relign Corporation reserves the right to make improvements in the
product(s) described herein. Product(s), therefore, may not agree in
detail to the published design or specifications. All specifications are
subject to change without notice. Please contact the local Relign
Corporation sales representative or agent for information on changes
and new products.
6.
COMPATIBILITY
Tricera Handpiece is for use in conjunction with the Relign Tricera
System. Refer to Relign Tricera System instructions for directions on
use of the Tricera Handpiece as part of the Relign Tricera System.
Before using the Tricera Handpiece with any other accessory or device,
be sure to follow the instructions provided with the accessory or device.
7.
HOW SUPPLIED
Warning
The Tricera Handpiece is supplied non-sterile. It must
be cleaned and sterilized before the first use. Prior to
each subsequent use, it must be cleaned and sterilized.
The shipping box contains:
1 ea Relign Tricera Handpiece
1 ea Shaver Blade/RF Probe Cavity Brush (Gordon Brush PN
721012 or equivalent)
1 ea Motor Shaft Brush (Key Surgical PN AT-12-197 or
equivalent)
1 ea Fluid Channel Brush (Gordon Brush PN 499NAD-ST or
equivalent)
8.
REQUIRED MATERIALS
8.1.
MATERIALS USED EACH TIME THE TRICERA HANDPIECE
IS BEING REPROCESSED
Cleaning
Enzymatic neutral pH cleaner (ENZOL® or equivalent)
25mL volume disposable syringe (2 each)
Shaver Blade/RF Probe Cavity brush (
Appendix A
)
Motor Shaft brush (
Appendix A
)
Fluid Channel brush (
Appendix A
)
Gauze pads
Lukewarm running tap water 72° - 109°F (22°- 43°C)
Optional Sterilization Tray (ASP PN 13836), which can be
purchased directly from the manufacturer (
Appendix A
)
Sterilization
STERRAD 100S
STERRAD 100NX
STERRAD NX
STERIS V-PRO
8.2.
MATERIALS MAY BE USED FOR CLEANING
VERIFICATION
3% hydrogen peroxide
9.
INSPECTION, MAINTENANCE AND TESTING
Warning
The handpiece is supplied non-sterile. It must be
cleaned and sterilized before the first use. Prior to each
subsequent use, it must be cleaned and sterilized.
9.1.
INSPECTION PRIOR TO USE
Prior to each use, inspect the outer surface of the handpiece and the
inner surface of the shaver blade/RF probe cavity and fluid channel to
ensure there are no unintended rough surfaces, sharp edges, or
protrusions.
9.2.
MAINTENANCE AND TESTING
Relign recommends careful inspection of the handpiece and any
accessories before and after each procedure for possible signs of
damage. This will allow early detection of minor damage, which if
repaired immediately will increase the life of the handpiece.
Caution
To avoid potential use of damaged device that could
lead to injury to the user and/or the patient, please note
the following cautions:
1)
If deposits are not removable by cleaning, the handpiece
should be sent to the manufacturer or an authorized
service specialist to be checked.
2)
A handpiece with damaged LCD screen and/or cable
should be sent to the manufacturer or an authorized
service specialist to be checked.
10. REPROCESSING INSTRUCTIONS
Warning
To minimize the risk of infection, clean and sterilize the
handpiece prior to the first use and every use thereafter.
Please note the following warnings:
