Publicidad
Idiomas disponibles
Idiomas disponibles
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 Annexe 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.
•
Use only normal saline (sodium chloride 0.9% w/v; 150mmol/l) or Ringer's lactate irrigation solution. The
performance of the system can be adversely affected by use of any other solution.
•
DO NOT pinch, step on, kink or otherwise occlude the tubing set. Tubing restrictions can result in high
pressure or poor device performance.
•
Continuous, extended RF energy output may cause the Tricera Controller to overheat. If this occurs, the
Controller must be allowed to cool down before further use.
Shaver Blade/Burr and RF Probe Precautions
•
Excessive force on the shaver blade/burr and RF probe tip does not improve the device's performance and
may increase the risk of tissue and/or device damage.
•
DO NOT allow the tip of the shaver blades/burrs and RF probes to touch any hard object. If such contact
does occur, inspect the tip. If there are cracks, fractures, or if there is any other reason to suspect the tip is
damaged, replace the device immediately.
•
Any monitoring electrodes are recommended to be placed as far as possible from the Tricera devices when
high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the
same patient. Monitoring systems incorporating high frequency current-limiting devices are recommended
for use.
•
Excessive force applied during insertion or removal of the shaver blades/burrs and RF probes may result in
device damage or tissue injury.
DCO-1394
Effective Date: 12-JAN-2022
•
Insertion and removal of the shaver blades/burrs and RF probes should always be under direct
visualization.
•
DO NOT activate the shaver blades/burrs and RF probes unless the tip is immersed in a saline
environment. Electrodes may arc if activated in air, damaging the device.
•
DO NOT use the shaver blades/burrs and RF probes as a tool for mechanical displacement of tissue or
bone or use the devices as a prying or scrubbing tool, as this may result in damage to the tip of the devices.
7.
ENVIRONMENTAL PROTECTION
•
Observe all national waste management regulations.
•
DO NOT dispose of Waste Electrical and Electronic Equipment (WEEE) as unsorted municipal waste.
•
Follow local governing ordinances and hospital practice regarding the disposal of the Probe/Tricera Devices
and Fluid Management Accessories – Disposable Devices.
•
The Controller contains an electronic printed circuit assembly. At the end of the useful life of the equipment,
it should be disposed of in accordance with any applicable national or institutional policy relating to obsolete
electronic equipment.
8.
HOW SUPPLIED
8.1.
Controller with Integrated Fluid Management
The Controller is supplied non-sterile and is intended for reuse as a capital equipment in an orthopaedic or
arthroscopic surgical environment.
The shipping box contains:
•
One (1) Controller
•
One (1) Footswitch
•
One (1) Detachable 10 ft. Hospital Grade Power Cord
•
One (1) Tricera System Instructions Manual
8.2.
Fluid Management Accessories (All Models)
The Fluid Management Accessories are supplied sterile and are intended for single-patient use only.
DO NOT re-sterilize or reuse. After each patient use, dispose of properly.
The shelf box contains:
•
One (1) Fluid Management Accessories
•
One (1) Tricera System Package Insert
8.3.
Shaver Blade/Burr and RF Probe (All Models)
The shaver blades/burrs and RF probes are supplied sterile and are intended for single patient use
only. DO NOT re-sterilize or reuse. After each patient use, dispose of properly.
The shelf box contains:
•
Four (4) Shaver Blade/Burr or RF Probe
•
One (1) Tricera System Package Insert
8.4.
Tricera Handpieces (All Models)
The Tricera Handpiece is supplied non-sterile and is intended for reuse. 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:
•
One (1) Tricera Handpiece
•
One (1) Tricera Handpiece Instructions for Use (including cleaning and sterilization
instructions)
•
Three (3) Cleaning Brushes
One (1) Tricera Device Cavity Brush
o
One (1) Motor Shaft Brush
o
One (1) Fluid Channel Brush
o
LBL 6028 Rev. K
Page 5 of 306
Publicidad
