Relign R-10002 User manual

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.

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:

DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 3 of 8
1)
Concentration levels specified by the manufacturer of
the detergent must be strictly adhered to. Contact times
specified in these instructions for use must be strictly
adhered to. Use only freshly prepared solutions.
2)
Do not soak the handpiece in Isopropyl Alcohol or other
corrosive liquids that may not be compatible with the
instrument.
3)
Always use fresh volumes of water for rinsing. Do not
reuse rinsing water for rinsing or any other purpose.
10.1. CLEANING INSTRUCTIONS
Proper cleaning must be performed prior to sterilization. An effective
cleaning process is essential to ensure effective sterilization.
Clean the handpiece as soon as possible after use.
If it is not possible to clean/rinse the handpiece immediately following a
procedure, the instrument should be placed in a basin with clean
lukewarm tap water until proper cleaning can be commenced per the
instructions below.
Cleaning Agent:
Use ENZOL® or an equivalent neutral pH enzymatic detergent.
Enzymatic detergents aid in the removal of organic soil such as blood.
Cleaning the Handpiece:
1) Disassemble the handpiece from the other system components.
a. Remove the shaver blade/RF probe from the handpiece.
b. Dispose of all used shaver blades/RF probes according to
hospital regulations.
c. Disconnect the handpiece from the Relign Controller.
2) Attach the soaking cap to the cable connector.
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.
3) Gently and thoroughly rinse the handpiece under running
lukewarm tap water 72° - 109°F (22° - 43°C) for a minimum of 2
minutes, flushing water through all passages.
4) Lay the handpiece horizontally in a clean pan.
5) Prepare the cleaning solution, enzymatic neutral pH cleaner
(ENZOL® or equivalent), in accordance with the concentration
defined by the manufacturer of the detergent.
6) Add a sufficient amount of the prepared cleaning solution to the
pan to completely cover the handpiece.
Caution
Do not immerse the handpiece when it is hot. This may
damage the handpiece.
7) Soak the handpiece for a minimum of 10 minutes. Move the
handpiece back and forth 5 times to ensure that all surfaces are
exposed to cleaning solution. This will reduce blood, protein, and
mucus from the instrument.
8) Flush the cavity and lumens of the instrument 5 times with
minimum 25mL volume of cleaning solution using a disposable
syringe.

DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 4 of 8
9) Scrub the Shaver Blade/RF Probe Cavity using the Shaver Blade
Cavity cleaning brush for a minimum of 1 minute.
10) Scrub the Motor Shaft using the Motor Shaft cleaning brush for a
minimum of 1 minute.
11) Scrub the Fluid Channel using the Fluid Channel cleaning brush
for a minimum of 1 minute.
12) Ensure that all interior surfaces, crevices, lumens, cavities, and
holes of the handpiece are scrubbed thoroughly to remove any
visible debris.
13) Scrub the exterior surface of the handpiece with a gauze pad
soaked in the cleaning solution for a minimum of 1 minute.
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.
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-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 5 of 8
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.
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 consequential
loss, damage, or expense resulting, directly or indirectly, from the use
of its product regardless of whether Relign or its affiliates have been
advised of the possibility of such loss, damage or expense.
This warranty is made in lieu of all other warranties, expressed, implied
or statutory, including, but not limited to the implied warranties of
merchantability and fitness for a particular purpose and all other
obligations and liabilities on the part of Relign. Relign neither assumes
nor authorizes any other person to assume for it any other liability in
connection with the sale of the Tricera Handpiece. This warranty shall
not apply to the Tricera Handpiece or any other part thereof that has

DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 6 of 8
been subject to accident, negligence, alteration, abuse or misuse.
Relign makes no warranty whatsoever with regard to accessories or
parts used in conjunction with the Tricera Handpiece and not supplied
and manufactured by Relign.
No agent, employee, or representative of Relign or its affiliates has any
authority to change any of the foregoing or assume or bind Relign or
any of its affiliates to any additional liability or responsibility in
connection with this device. 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
purchaser shall be responsible for ongoing equipment support and
maintenance not covered by this warranty and after the warranty period
has expired.
The term “original purchaser,” as used in this warranty means that
person or organization and its employees, if applicable, to whom the
Tricera Handpiece was sold by Relign. This warranty may not be
assigned or transferred in any manner.
In order to make a warranty claim, the original customer must obtain a
Return Materials Authorization Number (“RMA Number”) and return
instructions from Relign’s Customer Service Department or authorized
representative. The allegedly defective Tricera Handpiece must be
returned, cleaned, repackaged, clearly marked with the RMA number
on all packaging, and adequately insured, to the following address:
Relign Corporation, 655 Campbell Technology Parkway, Suite 275,
Campbell, CA 95008.
14. CUSTOMER SERVICE/TECHNICAL SUPPORT
Contact Relign’s Customer Service for any customer or technical support.
Call 866-608-0131 or e-mail us at customer.servi[email protected]m.
Relign Corporation
655 Campbell Technology Parkway, Suite 275
Campbell, CA 95008, USA
866-608-0131
[e-mail]
www.religncorp.com
© 2018 Relign Corporation. All rights reserved.

DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 7 of 8
APPENDIX A: TRICERA HANDPIECE COMPONENTS
Figure A1: Relign Tricera Handpiece
1. Shaver Blade/RF Probe
Cavity
2. Motor Shaft
3. Fluid Channel
Figure A2: Tricera Handpiece
1. Shaver Blade/RF Probe
Cavity Brush (Gordon Brush
PN 721012 or equivalent)
2. Fluid Channel Brush (Key
Surgical PN AT-12-197 or
equivalent)
3. Motor Shaft Brush (Gordon
Brush PN 499NAD-ST or
equivalent)
Figure A3: Cleaning Brushes
1. Sterilization Tray
2. Sterilization Tray Lid
3. Rubber Holders
Figure A4: Optional Sterilization Tray (if available)
1
2
3
1. Shaver Blade
Cavity
2. Motor shaft
3. Fluid Channel
1
2
3

DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 8 of 8
APPENDIX B: TROUBLESHOOTING
Problem Possible Cause Recommended Action
Staining, discoloration - Inadequate cleaning (for example,
remaining protein residues)
- Clean in accordance with section 10.1
- Cleaning solutions are contaminated or
being reused
- Always use freshly prepared solutions
- Repeat cleaning in accordance with section 10.1
The shaver blade does not turn. The shaver blade is not inserted properly. Remove the blade and reinsert it according to the Relign Tricera
System instructions for directions on use of the Tricera Handpiece
as part of the Relign Tricera System.
The handpiece will not run. The handpiece is not properly connected to
the controller.
Remove and reconnect the handpiece cable to 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.