DCO-1318
Effective Date: 01-SEP-2021
LBL 6028 Rev. G
Page 4 of 23
•
DO NOT re-use or re-sterilize the shaver blades/burrs and RF
probes and Fluid Management Accessories. Use of re-
processed, single-use device(s) may result in patient or physician
injury.
•
Handle all equipment carefully. If any equipment is dropped or
damaged in any way, return it immediately for service.
•
Prior to each use, perform the following:
o
Inspect all equipment for proper operation.
o
Ensure all attachments and accessories are correctly and
completely attached to the Tricera Handpiece.
o
Perform the required Performance Tests for each associated
handpiece (See LBL 6025/LBL 6043 Handpiece IFU).
•
DO NOT excessively bend or kink the instrument handpiece cord
or power cord. Always inspect cords for signs of excessive wear
or damage, or bent, broken or missing pins within the
connector(s).
If any wear or damage is found, discontinue use
and replace immediately
.
•
DO NOT handle the controller, handpieces or footswitch by the
cord. DO NOT pull on the cord to remove it from the handpiece or
controller.
•
Running the shaver blades/burrs and RF probes without fluid flow
(dry) may cause damage to the device.
•
DO NOT stall handpieces, damage can occur.
•
Always inspect for bent, dull or damaged blades/burrs and RF
probes before each use. DO NOT attempt to straighten or
sharpen. DO NOT use if damaged. After use, dispose of
properly.
•
Direct contact of the rotating cutting edge of shaver blades/burrs
with metallic surfaces and/or other hard surfaces such as
arthroscopes, cannulas, or other instruments can cause damage
to the devices. If contact does occur, shaver blades/burrs can
break, seize, or shed particles. Shaver blades/burrs should be
examined for damage and replaced if necessary.
•
DO NOT apply excessive loading on the shaver blade/burr or RF
probe. Performance is not increased with force. Excessive force
or using devices as a lever can cause damage to the device
including permanent deformation, wear and seizure.
•
Use Tricera System with caution in the presence of any active
implantable or body worn medical devices such as internal or
external pacemakers or neurostimulators. Interference produced
by the use of electrosurgical devices can cause a pacemaker to
enter an asynchronous mode or can block the pacemaker effect
entirely. The output of the Tricera device might also affect other
types of active devices such as implanted neurostimulator devices.
Consult the active implantable device manufacturer (for implanted
pacemakers and ICDs the hospital cardiology department might
also be helpful) for further information when use of electrosurgical
devices is planned in patients with active implantable devices such
as cardiac pacemakers.
•
If the patient has an implantable cardioverter defibrillator (ICD),
contact the ICD manufacturer for instructions before performing
ablation, coagulation, or other electrosurgery. Electrosurgery or
tissue coagulation may cause multiple activations of ICDs.
Tricera Controller Precautions
•
Verify the Tricera Controller passes the controller self-test prior to
starting the clinical procedure. Failure of the Tricera Controller
could result in an unintended increase of output power.
•
Interference produced by the operation of high-frequency
equipment may adversely affect the operation of other electronic
medical equipment such as monitors and imaging systems.
•
DO NOT operate the Tricera Controller in a moist environment, as
a shock hazard may exist. If liquids have entered the unit, the
Controller must be returned to the manufacturer for testing prior to
use.
•
Use of accessories and cables other than those specified may
result in increased emissions or decreased immunity of the
system.
•
Return the Tricera Controller to manufacturer for servicing in the
event of failure.
•
In case of Controller failure, remove the Tricera device from the
body cavity immediately. Remove the tubing from the pump
heads; switch off/ unplug the power cord to stop Controller
operation.
•
Removing screws and/or opening the Controller will invalidate the
warranty.
•
To ensure proper grounding reliability, a Hospital Grade Power
Cord must be used with a receptacle marked “Hospital Grade”.
•
DO NOT sterilize the Tricera Controller. Sterilization may damage
the unit.
•
Reconditioning, refurbishing, repair, or modification of the
Controller is expressly prohibited as it may result in loss of function
and/or patient injury.
•
DO NOT obstruct openings on the bottom and back of the
Controller, as they provide required airflow for cooling.
•
The Tricera Controller needs special precautions regarding EMC
and needs to be placed and put into service according to the EMC
information provided in LBL 6028 (this document). Note that
portable and mobile RF communication equipment can affect the
performance of the Controller (See
Appendix G
).
•
If electromagnetic interference with other equipment is suspected,
re-orient the device and/or remove possible sources of
interference (e.g., cellular phones, radios, etc.) from the room.
•
Needle monitoring electrodes are not recommended.
•
Patient should not come into contact with grounded metal parts;
the use of antistatic sheeting is recommended.
•
Cables to the Tricera Handpiece are recommended to be
positioned such that contact with patient or other leads is avoided.
The lightning flash with arrowhead symbol, within an
equilateral triangle, is intended to alert the user to the presence of
un-insulated "dangerous voltage" within the product’s enclosure
that may be of sufficient magnitude to constitute a risk of electric
shock to persons.
