Tenex MicroTip TX1, Руководство оператора

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Chapter 4 General Information
a. SYSTEM DESCRIPTION
The Tenex Health TX System is an ultrasonic surgical aspirator that cuts and removes soft and
hard tissue. The TX System includes the TX MicroTip, a sterile, single-use, disposable ultrasonic
handpiece with integrated tube set, and the TX Console, an ultrasonic and fluidics driver.
The TX MicroTip (the Applied Part) is supplied in a Procedure Pack, which includes the
Microtip, and a convenience kit with individually sterile items for use during the procedure. The
MicroTip has three models with varying needle lengths and diameters which are to be selected
based upon the target tissue type and depth from the surface of the skin. The TX-Bone (TXB)
MicroTip is indicated for both soft and hard tissue applications. TX1 and TX2 MicroTips are
indicated for use in soft tissue applications only.
The TX Console provides control over the three modes of operation including irrigation, aspiration,
and cutting. The console has a large, color LCD and employs a touchscreen for selection of
required settings. The console provides audible tones for confirmation of selections. The console
houses irrigation and aspiration pumps, thereby eliminating the need for a dedicated service cart
or suction/waste source. Irrigation fluid is delivered to the target site under pressure by operation
of an air pump housed in the console. The regulated output of the air pump pressurizes a cuff that
is fitted around an irrigating fluid bag, thus providing irrigation at a fixed pressure regardless of the
height of the fluid bag. Connections for the TX MicroTip and irrigation cuff are located on one side
of the console. On the back of the console are an equipotential grounding stud, the power inlet
module to connect the console to a power source using the cord provided, and a foot pedal con-
nection. The supplied foot pedal is used by the clinician to control each of the three user functions.
Simple in design, it offers on/off functionality. It is splash-proof for protection against liquids.
The pathology for treatment with the TX System is to be identified by ultrasound imaging, direct
visualization and/or palpation as appropriate. When ultrasound is used, the ultrasound probe is
placed directly over the TX MicroTip with the MicroTip at the edge and midline of the transducer
to provide for visualization of the target tissue. The ultrasound imaging device is not manufactured
or provided by Tenex Health, Inc.
b. UNPACKING
Your Tenex Health TX System was thoroughly inspected and tested prior to shipment. Carefully
unpack and visually inspect all items for any apparent damage that may have occurred during
shipment. If any physical damage is found or if the system is not within specification when
received, immediately notify the shipping company and Tenex Health Customer Service. All
claims for damage should be filed promptly.
NOTE: All packing material should be saved for reuse in case the system is returned for service.
The contents of the case should always be checked against the packing slip to ensure all items
have been shipped. If the system is incomplete, notify Tenex Health Customer Service immediately.
*1000cc Inflation Cuffs are to be used with TXB. 500cc Inflation Cuffs are to be used with TX1 and TX2.
MicroTip Model No. and Desc. Procedure Pack Needle Needle Diameter Tissue Application
Model No. Length
557-1002-001, TX-Bone (TXB) MicroTip 554-3003-001, 554-3003-002 1.3” .074” (non-standard gauge) Soft and Hard Tissue
554-2002-001, TX2 MicroTip 554-2003-001, 554-2003-002 1.7” .050” (18 gauge) Soft Tissue Only
554-1002-001, TX1 MicroTip 554-1003-001, 554-1003-002 1.0” .042” (19 gauge) Soft Tissue Only
QTY ITEM QTY ITEM
1 Console
1
Foot Pedal
1 Power Cord 120 VAC
2 Inflation Cuff, 500cc*
2 Inflation Cuff, 1000cc*
1 Extra Fuse Set
1 Operator’s Manual
1 Travel Case