Relign R-10002, Инструкция по эксплуатации

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DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 1 of 8
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 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.
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.