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d. TECHNICAL SPECIFICATIONS

Manufacturer

TENEX HEALTH

Model

Classification (IEC 60601)

CLASS I

PARAMETER

SPECIFICATION

Electrical

INPUT VOLTAGE

100 to 240 VAC @ 50/60 Hz

MAXIMUM CURRENT

1.2 Amps

LINE FUSES

5A T (Slow-blow)

MAX. OUTPUT VOLTAGE (CUTTING)

250 Volts

MAX. OUTPUT VOLTAGE (COAGULATION)

15 Volts at 75 ohm load (Fixed output)

MAX. OUTPUT VOLTAGE (FOOT PEDAL)

5 Volts

Irrigation

FLUID DELIVERY

Pressure fed: regulated compressor

OPERATING PRESSURE

4 PSI nominal

VALVE TYPE

Solenoid-actuated Pinch Valve

CONTROL

Foot Pedal

Cutting

TX MicroTip TYPE

Sterile, Disposable Ultrasonic

OPERATING FREQUENCY

25–28 kHz

CONTROL

Foot Pedal

SYSTEM PRIMING

Automated Prime Cycle

Available Power Delivery

LOW

100% delivered at 50 ms ON and 50 ms OFF

MEDIUM

100% delivered at 75 ms ON and 25 ms OFF

HIGH

100% delivered Continuously

DUTY CYCLE (USER-CONTROLLED)

15s/45s (15 seconds ON, 45 seconds OFF at maximum

power)

Aspiration

ASPIRATION PUMP

Peristaltic, Low Pulsation

AVAILABLE MAX. VACUUM LEVEL

User selectable: Low/Medium/High (100/300/500 mmHg)

AVAILABLE FLOW RATE

User selectable: Low/Medium/High (10/20/30 cc/min)

CONTROL

Foot Pedal

Coagulation

TYPE

Biploar Generator

OPERATING FREQUENCY

315kHz

MAXIMUM POWER

3.4 Watts at 75 ohm load (Fixed output)

ACCESSORY TYPE

Bipolar Forceps or Pencil

(user-provided accessory)

CONTROL

Foot Pedal

Содержание MicroTip TX1

Страница 1: ...TX Console Operator s Manual For Software Versions 0 1 4 and 1 0 0...

Страница 2: ......

Страница 3: ...chnique practiced Pay close attention to warnings and cautions in this manual Warnings are intended to protect individuals from serious bodily harm Cautions are intended to protect the individuals fro...

Страница 4: ...9 Chapter 5 System Setup 10 a INTRODUCTION 10 b SETUP 10 Figure 4 Correct Aspiration Tube Alignment 11 Figure 5 Correct Insertion 11 Figure 6 Incorrect Aspiration Tube Alignment 11 Figure 7 Incorrect...

Страница 5: ...E COMMANDS 37 h OPTIONS MODE FUNCTIONS 38 Chapter 12 Troubleshooting Guide with coagulation function 39 Chapter 13 Run Time Alerts with coagulation function 40 a USER FUNCTION PARAMETER SETTINGS 40 b...

Страница 6: ......

Страница 7: ...cation and aspiration of uterine fibroids The Tenex Health TX System with the TXB MicroTip is also contraindicated for Active Infections Weakness of the posterior muscle group with a calcaneal gait di...

Страница 8: ...sed in the presence of flammable anesthetics oxidizing gases i e nitrous oxide and oxygen endogenous gases disinfecting agents cleaning agents or aerosol sprays WARNING Console Rear Panel Network and...

Страница 9: ...it components if present are sterile if the package is unopened and undamaged CAUTION DO NOT laterally load the MicroTip during use Failure to follow appropriate technique could result in potential ha...

Страница 10: ...lling Tenex Health at 949 454 7500 Any shipping charges incurred shall be paid by the purchaser user of the equipment This warranty does not apply to abnormal use or to defects malfunctions or failure...

Страница 11: ...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 protec...

Страница 12: ...CONNECTOR Connection for system foot pedal 7 AC POWER INPUT Provides power connection and overload protection to the system 8 SERIAL NUMBER Unique code assigned for identification of the unit 9 CARTR...

Страница 13: ...7 Figure 2 Side View Figure 3 Front View 10 11 12 13 15 16 17 18 9 14 CAUTION Pinch point hazard exists Keep hands and fingers clear when lowering the display...

Страница 14: ...PRIMING Automated Prime Cycle Available Power Delivery LOW 100 delivered at 50 ms ON and 50 ms OFF MEDIUM 100 delivered at 75 ms ON and 25 ms OFF HIGH 100 delivered Continuously DUTY CYCLE USER CONTR...

Страница 15: ...ing up and operating the TX Console Table 2 Symbols found on the TX Console and Packaging No Symbol Definition 1 Date of Manufacture Waste Electrical and Electronic Equipment Degree of protection agai...

Страница 16: ...f an alternate volume irrigation bag in the inflation cuff may result in possible contamination of the surgical environment lack of irrigation flow during use or electrical hazard CAUTION For TXB Micr...

Страница 17: ...MicroTip electrical connector with the Red Dot on the console side panel CUT receptacle and then insert straight into the receptacle CAUTION Failure to align the Red Dot on the MicroTip connector wit...

Страница 18: ...limit the ability to detect device malfunction or damage to the MicroTip related to use NOTE Identify the target pathology via ultrasound imaging direct visualization and or by palpation as appropria...

Страница 19: ...eedle and irrigation sheath upon completion of treatment Failure to do so may result in device remnants left in the patient in the event of device damage 18 Upon completion of the procedure prepare th...

Страница 20: ...momentarily display the Tenex Health logo followed by the Main Mode screen The three 3 user functions are Irrigation Aspiration and Cutting Power The parameter settings for each function are only avai...

Страница 21: ...selected ON the irrigation pinch valve will open when the Foot Pedal is depressed allowing fluid to flow When the Foot Pedal is released the pinch valve will close and the fluid will stop flowing If I...

Страница 22: ...Pedal is depressed and continue until the vacuum limit is reached When vacuum drops below the limit the pump will restart When LOW is selected the vacuum limit is 100 mmHg When MEDIUM is selected the...

Страница 23: ...NG POWER is delivered at 75 milliseconds ON and 25 milliseconds OFF For the HIGH CUTTING POWER setting cutting power is delivered continuously therefore a user controlled duty cycle is required to ens...

Страница 24: ...ng successful and an audible tone followed by the IRRIGATION panel being highlighted indicating that the system is ready for parameter settings A failed priming cycle will be indicated by the message...

Страница 25: ...bar or pressing anywhere on the bar 2 BRIGHTNESS The BRIGHTNESS function allows the brightness of the screen to be adjusted by depressing the HIGH Soft key to raise the brightness or depressing the LO...

Страница 26: ...No Irrigation Check Irrigation parameter setting is selected ON Depress foot pedal and listen for irrigation pinch valve operation click Check tubing is properly connected Check the Inflation Cuff Ai...

Страница 27: ...ot pedal until the Inflation Cuff is tight around the irrigation bag and the needle cap is filled with irrigation fluid 4 Select cutting power LOW MEDIUM or HIGH and depress the Foot Pedal to test ult...

Страница 28: ...ressed Three beeps Pause When occlusion occurs Will continue until occlusion clears Occlusion or blockage of aspiration line in microtip Adjust aspiration setting to provide more fluid To help dislodg...

Страница 29: ...g the cord provided and a foot pedal connection 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 splas...

Страница 30: ...POWER INPUT Provides power connection and overload protection to the system 8 SERIAL NUMBER Unique code assigned for identification of the unit 9 CARTRIDGE LOCK Locking mechanism for tube set cartridg...

Страница 31: ...25 CAUTION Pinch point hazard exists Keep hands and fingers clear when lowering the display Figure 11 Front View 18 19 Figure 10 Side View...

Страница 32: ...Disposable Ultrasonic OPERATING FREQUENCY 25 28 kHz CONTROL Foot Pedal SYSTEM PRIMING Automated Prime Cycle Available Power Delivery LOW 100 delivered at 50 ms ON and 50 ms OFF MEDIUM 100 delivered at...

Страница 33: ...ements are as follows f SYMBOL DESCRIPTIONS The Table on the following page provides the symbols that are found on the TX Console and their definitions These symbols are used to provide quick informat...

Страница 34: ...al Ground Stud USB Connection Network Connection ON power connection to the mains OFF power disconnection from the mains Attention Refer to Chapter 1 Warnings and Precautions 2 3 13 10 11 12 4 16 5 17...

Страница 35: ...n Mode screen to appear 3 Insert saline irrigation bag into inflation cuff CAUTION Only use 500cc saline irrigation bag Use of an alternate volume irrigation bag in the inflation cuff may result in po...

Страница 36: ...g upward and press the PRIME key on the TX Console 13 After successful priming leave the tip cap on Select IRRIGATION to ON ASPIRATION to MEDIUM or HIGH CUTTING POWER to MEDIUM or HIGH and COAGULATION...

Страница 37: ...riate technique is necessary for thermal management at the treatment site and will minimize the potential for tissue burns CAUTION DO NOT use the TX1 or TX2 Microtip for a total cutting time exceeding...

Страница 38: ...erformance cross infection and other safety hazards WARNING Surgical waste presents a biological hazard and must be handled and disposed of properly The MicroTip must be disposed of according to local...

Страница 39: ...oft key in the panel labeled with the name of that function This will be indicated by the function being highlighted When the TX Console is first powered ON the initialization screen will momentarily...

Страница 40: ...Pedal is depressed and continue until the vacuum limit is reached When vacuum drops below the limit the pump will restart When LOW is selected the vacuum limit is 100 mmHg When MEDIUM is selected the...

Страница 41: ...nd MEDIUM CUTTING POWER settings the console provides power delivery according to a software controlled duty cycle When LOW is selected the CUTTING POWER is delivered in cycles at 50 milliseconds ON a...

Страница 42: ...ends an isolated 315 kHz power signal to a user provided bipolar cautery accessory to cauterize small blood vessels When COAGULATION is selected all other functions are automatically set to OFF Depres...

Страница 43: ...ng successful and an audible tone followed by the IRRIGATION panel being highlighted indicating that the system is ready for parameter settings A failed priming cycle will be indicated by the message...

Страница 44: ...bar or pressing anywhere on the bar 2 BRIGHTNESS The BRIGHTNESS function allows the brightness of the screen to be adjusted by depressing the HIGH Soft key to raise the brightness or depressing the LO...

Страница 45: ...pinch valve operation click Check tubing is properly connected Check the Inflation Cuff Air Tubing is properly connected to the Console receptacle Check tubing is not kinked or damaged Depress Foot P...

Страница 46: ...tion Cuff is tight around the irrigation bag and the needle cap is filled with irrigation fluid 5 Select cutting power LOW MEDIUM or HIGH and depress the Foot Pedal to test ultrasonic power Fluid Path...

Страница 47: ...inue until occlusion clears Occlusion or blockage of aspiration line in microtip Adjust aspiration setting to provide more fluid To help dislodge the blockage depress foot pedal for 3 5 seconds and re...

Страница 48: ...the Console Never submerge the Console into any cleaning solution c FOOT PEDAL Even though the Foot Pedal is waterproof always wipe away any fluids that come into contact with the Foot Pedal during th...

Страница 49: ...e arrow on the top of the holders and pull them up 4 Remove the old fuses and replace with Part No 430 2215 002 fuse type 5 x 20 250 V T 5 0A 5 Push the fuse holders back into place toward the arrow o...

Страница 50: ...OMER SERVICE AND TECHNICAL SUPPORT For customer service or technical support call Tel 949 454 7500 Toll free 855 2TENDON In USA only 855 283 6366 Fax 949 580 1270 E mail orders tenexhealth com Website...

Страница 51: ...creased IMMUNITY of the Tenex Health TX System Table 5 Guidance and Manufacturer s Declaration Electromagnetic Emissions for the Tenex Health TX System The Tenex Health TX System is intended for use i...

Страница 52: ...2 kV line to ground 1 kV line to line 2 kV line to ground 1 kV line to line Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and volt...

Страница 53: ...s from the fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipmen...

Страница 54: ...of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 mHz d 1 2 P 80 mHz to 800 mHz d 1 2 P 800 mHz to 2 5 gHz d 1 2 P 0 01 0 12 0 12 0 12 0 1 0 38 0 38 0 38 1 1 2...

Страница 55: ......

Страница 56: ...283 6366 Customer Service 949 454 7500 Email orders tenexhealth com Internet www tenexhealth com Tenex Health TX and the Tenex Health logo are trademarks owned by Tenex Health Inc 2019 Tenex Health In...

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