DCO-1318
Effective Date: 01-SEP-2021
LBL 6028 Rev. G
Page 3 of 23
WARNING:
DO NOT use sterile devices after the stated expiration date.
WARNING:
Continually check all handpieces and
attachments for overheating. If overheating is sensed,
immediately discontinue use and return equipment for service.
Overheating can lead to patient injury (burn). Refer to Tricera Handpiece
Instructions for Use LBL 6025/LBL 6043 for additional warnings and
precautions for the Tricera Handpieces (All Models).
WARNING:
The service intervals are required to keep the handpieces
at their optimum operating performance. Failure to follow the
recommended PM schedule can cause devices to overheat which may
lead to patient injury (burn). Refer to Tricera Handpiece Instructions for
Use LBL 6025/LBL 6043 for additional warnings and precautions for the
use of the Tricera Handpieces (All Models).
WARNING:
DANGER: DO NOT operate the Tricera System in close
proximity to volatile solvents such as methanol or alcohol, or in the
presence of flammable anesthetics, as explosion may occur.
WARNING:
DO NOT connect the Tricera FMA to another fluid
management system, shaver handpiece, or controller. Use with another
fluid management system, shaver handpiece or controller may result in
failure of the device to operate or lead to patient or physician injury.
WARNING:
Equipment grounding is vital to ensure safe operation. Plug
the power cord into a properly earthed mains supply outlet whose
voltage and frequency characteristics are compatible with those listed
on the unit or in this manual. DO NOT use plug adapters or extension
cords; such devices defeat the safety ground and could cause injury.
Fluid Management Warnings
WARNING:
Place the pump at the same height or lower than the joint to
ensure accurate pressure readings.
WARNING:
Perform the endoscope calibration at the same height as
the joint to ensure accurate pressure readings. Ensure that the
endoscope stopcock connected to the inflow tubing is completely open
during the calibration procedure and that any other stopcock is closed.
WARNING:
Using fluid to distend the joint carries the possibility of fluid
extravasation into the surrounding tissue. Select the optimal pressure
based on the patient profile, including but not limited to: blood pressure,
height, weight, age, and tissue quality. Recommended pressure
settings are included in this manual; however, these are only
suggestions, and each surgery and each patient may require different
parameters.
WARNING:
The fluid pump is only intended for use with flexible
containers for the inflow fluid. Do not use glass containers as they
might implode due to the vacuum being generated inside of the
container.
WARNING:
For Veriflow inflow only, DO NOT partially open or close the
stopcocks on the inflow sheath as this may lead to overpressure or
underpressure within the joint. The inflow stopcock should be
completely open or completely closed.
WARNING:
Keep the pump dry. If liquid has accidentally leaked into the
pump from the Fluid Management Accessories cassette, change the
cassette.
WARNING:
Failure of the system may result in an unintended increase
or decrease in flow and/or pressure. Carefully monitor the joint when
using the system.
Known Risks Associated with use of Electrosurgical Devices:
1.
EMC issues – interference causes device failure,
interference causes other devices to fail, RF interferes with
pacemaker, defibrillator
2.
Electrical safety issues – shock, burn – device/controller
overheats, incorrect power source used, fluid enters the
controller, use of incorrect power source, arcing.
3.
Explosion/fire if operated near volatile solvents
4.
Tissue damaged during coagulation/resection
Shaver Blade/Burr and RF Probe Warnings
WARNING:
DO NOT operate the Tricera Devices without clear
visualization. The device should be in the field of view while it is
operating. If visualization is lost at any point during the procedure, the
device’s function must be stopped immediately.
WARNING:
Do NOT touch the device tip at any time during the
application of motor or RF power.
WARNING:
Do NOT insert or withdraw the device during application of
power.
WARNING:
Do NOT activate the device while in contact with metal
objects and/or instruments as unintended tissue or device damage can
occur.
WARNING:
During extended periods of activation the shaft of the
device may become hot. Pause occasionally to keep the shaft cool.
WARNING:
Ensure that adequate inflow and outflow of conductive
irrigant is maintained at all times during RF probe use or else irrigant
may overheat and damage surrounding tissue.
6.
PRECAUTIONS
A precaution contains instructions for any special care to be exercised
by the practitioner for the safe and effective use of the equipment.
Failure to observe the information or procedures presented in a
Precaution may result in damage to the equipment.
Tricera System General Precautions
•
Federal (US) law restricts this device to sale by or on the order of
a physician.
•
DO NOT expose the Tricera Controller to moisture, operate in wet
areas, or place liquids on or above the controller.
•
Tricera handpieces are factory sealed. DO NOT disassemble or
lubricate, as this may void the warranty. There are no user-
serviceable parts inside.
•
Use only associated Tricera attachments and accessories as
defined within the descriptions of each attachment.
•
After each use, thoroughly clean the controller, footswitch, and
handpieces.
•
DO NOT use the shaver blades/burrs and RF probes or the Fluid
Management Accessories if the sterile barrier or sterility is
compromised prior to or during the procedure. Failure to maintain
sterile technique in the operating room could result in the transfer
of microorganisms into the body tissues.
•
The shaver blades/burrs and RF probes and Fluid Management
Accessories are intended for single patient use only. Discard
these disposable devices after each patient use.
