DCO-1394
Effective Date: 12-JAN-2022
LBL-6059 Rev D
Page 3 of 116
ENGLISH
Tricera Handpiece, Autoclavable (R-10023)
Instructions for Use
PREFACE
This manual provides the information to operate and maintain the Tricera Handpiece. It is essential to read and
understand all the information in this manual before using or maintaining this device. Refer to
for the latest revision of this document.
CONTENTS
Preface ................................................................................................................................................................. 3
Contents ............................................................................................................................................................... 3
1.
Symbols Used on Labeling ................................................................................................................ 3
2.
Device Description .............................................................................................................................. 3
3.
Indications for Use .............................................................................................................................. 3
4.
Contraindications ................................................................................................................................ 3
5.
Warnings and Cautions ...................................................................................................................... 3
6.
CompatIbility ....................................................................................................................................... 3
7.
How Supplied ...................................................................................................................................... 3
8.
Required Materials.............................................................................................................................. 3
9.
Inspection, Maintenance and Testing ................................................................................................ 3
10.
Reprocessing Instructions .................................................................................................................. 3
11.
Storage ................................................................................................................................................ 5
12.
Periodic Maintenance Schedule ........................................................................................................ 5
13.
Limited Warranty ................................................................................................................................. 5
14.
Customer Service/Technical Support ................................................................................................ 6
Appendix A: TRICERA HANDPIECE, Autoclavable COMPONENTS .............................................................. 7
Appendix B: Troubleshooting .............................................................................................................................. 8
1.
SYMBOLS USED ON LABELING
Catalog Number
Consult Instructions for Use
Serial Number
Non-Sterile
Store in a cool dry
place
MRI unsafe
Date of Manufacture
Manufacturer
Type BF Applied Part
Waste Electrical and Electronic
Equipment. Must follow local
law for equipment disposal.
European Authorized
Representative
2.
DEVICE DESCRIPTION
The Tricera Handpiece is a reusable, electrically powered, hand-held surgical instrument that uses
interchangeable shaver blades/RF probes to abrade and remove bone and accomplish the debridement of soft
tissue. The handpiece features a quick-locking mechanism for easy blade insertion and removal, and a suction
irrigation port for removing irrigant from the operating site.
The Tricera Handpiece is for use with the RELIGN Tricera System.
3.
INDICATIONS FOR USE
The RELIGN Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid
Management System of the RELIGN Arthroscopic System provides fluid distension and irrigation of the knee,
shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures.
The Shaver Blade/RF Probe of the RELIGN Arthroscopic System provides abrasion, resection, debridement, and
removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis
of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn
knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
Contraindications:
The electrosurgical probe should not be used in procedures where a nonconductive irrigant is
used or with patients having cardiac pacemakers or other electronic implants.
4.
CONTRAINDICATIONS
The RELIGN Arthroscopic System contains a large amount of metal components. Therefore, it is MRI unsafe. DO
NOT use the RELIGN Arthroscopic System in conjunction with MRI, CT or RFID.
5.
WARNINGS AND CAUTIONS
Please read this manual and follow its instructions carefully. The words
warning
,
caution
, and
note
carry special
meanings and should be carefully reviewed:
Warning
The personal safety of the patient or physician may be involved. Disregarding the information
could result in injury to the patient or physician.
Caution
Special service procedures or precautions must be followed to avoid damaging the instrument.
Note
Special information to make maintenance easier or important information more clear.
An exclamation mark within a triangle is intended to alert the user to the presence of
important operating and maintenance instructions in the literature accompanying the
product.
Warning
To avoid potential serious injury to the user and the patient and/or damage to this device,
please note the following warnings:
1)
Federal law (United States of America) restricts this device to use by, or on order of, a
physician.
2)
To avoid potential serious injury to the user and patient and/or damage to this device,
read this operating manual thoroughly and be familiar with its contents prior to using this
equipment.
3)
The Tricera Handpiece is designed to be used by a qualified physician familiar with
arthroscopic procedures. It is the responsibility of the user to be familiar with indications,
contraindications, potential complications and risks associated with the arthroscopic
procedures being performed. Misusing the Tricera Handpiece may cause damage to
both the patient and system components.
4)
Carefully unpack the unit and check if any damage occurred during shipment. DO NOT
use the instrument if damage is detected. Please refer to the Customer Service/
Technical Support section in this manual.
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, Autoclavable
▪
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
)
▪
Materials for Optional Automated Washer Process:
o
Detergent with pH not exceeding 10.8 (for optional automated washer cleaning)
o
Rinse Aid.
Sterilization
▪
STERRAD 100S
▪
STERRAD 100NX
▪
STERRAD NX
▪
STERIS V-PRO
▪
AUTOCLAVE
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 a damaged 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:
