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Tricera Handpiece (R-10002)
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
www.religncorp.com
for the latest revision of this document.
CONTENTS
Preface ................................................................................................... 1
Contents ................................................................................................. 1
1.
Symbols Used on Labeling ......................................................... 1
2.
Device Description ...................................................................... 1
3.
Indications for Use ...................................................................... 1
4.
Contraindications ........................................................................ 1
5.
Warnings and Cautions .............................................................. 1
6.
CompatIbility ............................................................................... 2
7.
How Supplied .............................................................................. 2
8.
Required Materials ...................................................................... 2
9.
Inspection, Maintenance and Testing ......................................... 2
10.
Reprocessing Instructions .......................................................... 2
11.
Storage ....................................................................................... 5
12.
Limited Warranty ......................................................................... 5
13.
Customer Service/Technical Support ......................................... 6
Appendix A: Tricera Handpiece Components ....................................... 7
Appendix B: Troubleshooting ................................................................. 8
1.
SYMBOLS USED ON LABELING
Catalog Number
Serial Number
Store in a cool dry
place
Date of Manufacture
Type BF Applied
Part
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.
DCO-0599
Effective Date: 14-DEC-2018
Consult Instructions for Use
Non-Sterile
MRI unsafe
Manufacturer
Waste Electrical and
Electronic Equipment. Must
follow local law for
equipment disposal.
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.
LBL-6025 Rev B
Page 1 of 8
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Summary of Contents for Relign R-10002
- Page 1 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, Tricera Handpiece (R-10002) shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures.
-
Page 2: Compatibility
System. Refer to Relign Tricera System instructions for directions on the following cautions: use of the Tricera Handpiece as part of the Relign Tricera System. If deposits are not removable by cleaning, the handpiece Before using the Tricera Handpiece with any other accessory or device, should be sent to the manufacturer or an authorized be sure to follow the instructions provided with the accessory or device. - Page 3 5 times to ensure that all surfaces are exposed to cleaning solution. This will reduce blood, protein, and Disconnect the handpiece from the Relign Controller. mucus from the instrument. Flush the cavity and lumens of the instrument 5 times with minimum 25mL volume of cleaning solution using a disposable syringe.
- Page 4 Cleaning Verification Scrub the Shaver Blade/RF Probe Cavity using the Shaver Blade Cavity cleaning brush for a minimum of 1 minute. 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).
-
Page 5: Storage
Tricera Handpiece or equivalent models, at no charge to the original STERRAD 100NX Method: purchaser and at the option of Relign, during the warranty period but Clean the handpiece according to the “Cleaning Instructions” only if examination reveals to the satisfaction of Relign that the Tricera section of this manual. -
Page 6: Customer Service/Technical Support
The essential purpose of this provision is to limit the potential liability of Relign and its affiliates arising out of this agreement and/or any purchase and sale hereunder. Original... -
Page 7: Appendix A: Tricera Handpiece Components
APPENDIX A: TRICERA HANDPIECE COMPONENTS Figure A1: Relign Tricera Handpiece 1. Shaver Blade/RF Probe Cavity 2. Motor Shaft 3. Fluid Channel 2. Motor shaft 1. Shaver Blade 3. Fluid Channel Cavity Figure A2: Tricera Handpiece 1. Shaver Blade/RF Probe Cavity Brush (Gordon Brush PN 721012 or equivalent) 2. -
Page 8: Appendix B: Troubleshooting
Remove and reconnect the handpiece cable to the controller the controller. according to the Relign Tricera System instructions for directions on use of the Tricera Handpiece as part of the Relign Tricera System. The cord is malfunctioning. Send the handpiece in to Relign for repair.
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