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Table of Contents

  

Introduction 

        

1

 

 

 

Description and Application    

 

 

  1

 

 

 

Electrosurgical Generator 

 

 

 

  1

 

 

 

Smoke Evacuation System 

 

 

 

  2

 

 

 

Electrosurgical Procedure Guidelines     

  

  2

 

 

 

Operational Safety Notes and Warnings 

 

  4

 

 

Principles 

of 

Electrosurgery 

 

    9

 

 

 

Cutting  

 

 

 

 

 

  9

 

 

 

Coagulation    

 

 

 

 

  9

 

 

 

Complications   

 

 

 

 

10

 

 

 

Smoke Evacuation and Filtration  

 

 

10 

 

 

Installation 

 

       11

 

 

 

Initial Setup   

  

 

 

   

11

 

 

 

Functional Check 

 

 

 

  

11

 

 

 

Maintenance   

 

 

 

 

12

 

 

Device 

Description 

      15

 

 

 

Front Panel Indicators and Connectors  

 

15

 

 

 

Rear Panel Controls and Connectors    

 

19

 

 

Technical 

Data 

 

      21

 

 

 

Physical Specifications  

 

 

 

21

 

 

 

Supply Voltage and Current Considerations   

21

 

 

 

Output Characteristics  

 

 

 

22

 

 

 

Smoke Evacuator System  

 

 

 

25

 

 

 

Environmental Specifications   

 

 

26

 

 

Circuit 

Descriptions 

     27

 

 

Test 

Procedures 

      31

 

 

Symbology 

       35

 

 

List 

of 

Drawings 

 

      37

 

 

Warranty 

and 

Service 

     47

Содержание FINESSE +

Страница 1: ...Service Manual Electrosurgical Generator and Smoke Evacuation System Utah Medical Products Inc 7043 South 300 West Midvale Utah USA www utahmed com ...

Страница 2: ... Products Inc Midvale Utah This manual may not be reproduced in full or in part without express written consent of Utah Medical Products Inc The information contained in the manual was correct when printed Changes may occur that ren der portions of this manual inaccurate Please contact Utah Medical Products Inc for updated information if errors or changes in the contents of this manual are suspect...

Страница 3: ...e Evacuation and Filtration 10 Installation 11 Initial Setup 11 Functional Check 11 Maintenance 12 Device Description 15 Front Panel Indicators and Connectors 15 Rear Panel Controls and Connectors 19 Technical Data 21 Physical Specifications 21 Supply Voltage and Current Considerations 21 Output Characteristics 22 Smoke Evacuator System 25 Environmental Specifications 26 Circuit Descriptions 27 Te...

Страница 4: ... FINESSE rear panel connectors and controls 19 Table 1 Output Characteristics 22 Figure 5 Typical output power vs load resistance for cut and blend modes 23 Figure 6 Typical output power vs load resistance for coag mode 23 Figure 7 Maximum Output Voltage vs displayed settings 23 Figure 8 Typical output power vs display settings 24 Table 2 Symbols used in conjunction with the FINESSE System 35 ...

Страница 5: ...e shallower and less extensive cuts that are performed in office based electrosurgical procedures The output waveforms and load characteristics in the pure cut and blended cut modes are opti mized for excisions in which the cut starts with only a small area of the cutting electrode in con tact with tissue and proceeds to a maximum depth where the cutting line may be more than two centimeters long ...

Страница 6: ...nes The surgical techniques using low power generators are described in several medical journal papers and are being taught in current medical seminars You are encouraged to learn the surgi cal methods from the established experts then to read this manual carefully before using the FINESSE system and instruments to perform these procedures A bibliography of papers on the subject is found later in ...

Страница 7: ...necessary to practice these procedures on patients using electrodes of different sizes and configu rations for various procedures Practitioners who prefer a slow cut using a small electrode or excising a small amount of tissue should use settings at the lower end of the output range Those who prefer a faster cut using a large electrode or excising a large amount of tissue should use settings at th...

Страница 8: ...om 40 to 70 have been found to be effective with a setting of 65 typically used Coagulation mode output settings ranging from 40 to 75 have been found to be effective in providing hemostasis for bleeding vessels with a setting of 60 typically used Operational Safety Notes and Warnings The FINESSE system has been designed to implement the best principles of electrical safety The remaining burden fo...

Страница 9: ... patient shock or burn Jewelry should be removed or isolated by dry gauze as much as possible Leads Unshielded active and return leads should be positioned so that they cannot come into contact with the patient or with other leads connected to the patient They should also not be allowed to run closely parallel to other leads Monitoring Leads Electrodes and probes connected to monitoring stimulatin...

Страница 10: ...r coagulation may indicate faulty application of the dispersive electrode or failure of a patient lead It may also result from attempting to push the electrode through the tissue faster than the natural speed of the electrode for the output level set inside the generator If a slower cut does not produce the desired results then the patient circuit including the active and disper sive electrodes sh...

Страница 11: ...milarly certified electronic equipment used near the FINESSE system should not be affected by it However users should take special pre cautions regarding EMC and need to install the FINESSE system according to the EMC informa tion provided in the Electromagnetic Compatibility section of this manual Users should also note that portable and mobile RF communications equipment can affect medical elect...

Страница 12: ...8 FINESSE Service Manual ...

Страница 13: ...heating a tool with a small cross section such as the thin wire loop is driven with an electrical source having a continuous unmodulated wave form This kind of power source is referred to as a pure cut source Modulating or periodically interrupting the voltage from the cutting source creates a current that will cause shallow surface coagulation as well as cutting This kind of source is called a bl...

Страница 14: ... the dispersive electrode s connections are broken and patient contact possibly compromised There remains the possibility that the isolation may be destroyed by inadvertent direct or capaci tive grounding in the patient connections outside the generator The warnings and precautions given in the Operational Safety Notes and Warnings section of this manual must be strictly heeded Smoke Evacuation an...

Страница 15: ... the front panel Replace the internal filter retaining ring lining up the position pointer on the ring with the unlocked icon inserting the ring until it is flush against the front panel and rotating until the position pointer is aligned with the locked icon Do not operate the FINESSE system without the internal filter installed 6 Plug the FINESSE system into any standard power outlet correspondin...

Страница 16: ...witch If the vacuum motor does not come on check the position of the vacuum control switch and the vacuum fuses on the back panel 5 Repeat step 4 above with the coag switch rather than the cut switch All operation should be the same except that the blue coag lamp illuminates rather than the yellow cut lamp 6 If a footswitch is connected to the FINESSE s rear panel repeat steps 4 and 5 above using ...

Страница 17: ...rnal Filter inside the smoke evacuator port until it is nearly flush against the front panel 3 Replace the internal filter retaining ring lining up the position pointer on the ring with the unlocked icon inserting the ring until it is flush against the front panel and rotating until the position pointer is aligned with the locked icon For the care and performance of your FINESSE electrosurgical sy...

Страница 18: ...14 FINESSE Service Manual ...

Страница 19: ... in the Annual Maintenance section of this manual 2 Vacuum Level Switch This two position rocker switch controls the smoke evacuation system flow rate The left or normal position runs the vacuum motor at a level that is sufficient to draw the smoke plume away from the surgical site during the LETZ procedure The right or high position of the switch runs the vacuum motor at a higher speed creating a...

Страница 20: ...dispersive electrode is still properly applied 5 Cut Blend Mode Select Switch This switch allows the selection of the appropriate mix of cut and coagulation activity for the performed procedure One pure cut and three blended cut modes are available In the pure cut mode denoted by an illuminated C when selected a continuous sinusoidal voltage is applied to the surgical tool in use If the electrode ...

Страница 21: ...s Manual As mentioned in the safety warnings of this manual this knob should not be turned up to correct an apparent power output deficiency without first verifying that all connections are in good order and the patient dispersive electrode is still properly applied Error Indicators The FINESSE system incorporates several important safety features to minimize the risks of using electrosurgical equ...

Страница 22: ...hat are available This receptacle is a Type BF Applied Part per IEC 60601 1 The left most of the three sockets marked with the active port icon the A icon shown beside the prior paragraph accommodates a non switching pen for monopolar cutting loops balls and other surgical tools When these pens are used the FINESSE system must be activated by a footswitch connected to the rear panel see next secti...

Страница 23: ...ost This connection does not have any clinical relevance as it is used only for testing purposes or to satisfy local electrical code requirements 4 Fuse Sockets These two pairs of sockets house the fuses that provide overcurrent protection for the electrosurgical and smoke evacuation modules of the FINESSE system They are labeled with the appropriate fuse specifications for these circuits Use only...

Страница 24: ...20 FINESSE Service Manual ...

Страница 25: ... Manual Supply Voltage and Current Considerations The FINESSE system can be obtained in 115 VAC item no FIN 110 or 230 VAC item no FIN 220 configurations Supply Voltages voltages are AC rms FIN 110 FIN 220 Nominal Voltage 115 volts 230 volts Regulated Range 103 5 126 5 volts 207 253 volts Frequency 50 60 Hz 50 60 Hz Output Power vs Supply Voltage Within the Regulated Range listed above output powe...

Страница 26: ...420 2 5 Blend 3 99 37 5 1500 2 8 Coag 75 c 2400 5 8 a Output Setting specified is power in watts plus or minus 15 delivered into a 500Ω patient load b Duty Cycle is ratio of burst duration to burst plus rest duration c Coag pulse consists of two high voltage cycles followed by lower amplitude ringout for about 10 µsec repeated at 28 1 kHz d Maximum Output Voltage voltage is zero to peak open circu...

Страница 27: ... 50 0 20 40 60 80 100 120 0 500 1000 1500 2000 Power Watts Load Resistance Ohms Blend 3 Mode display 99 display 50 0 20 40 60 80 100 120 0 500 1000 1500 2000 Power Watts Load Resistance Ohms Cut Mode display 99 display 50 Figure 5 Typical output power vs load resistance for cut and blend modes 0 20 40 60 80 0 500 1000 1500 2000 Power Watts Load Resistance Ohms Coag Mode display 75 display 37 0 500...

Страница 28: ...s all system functions when the output exceeds the expected nominal output The error indication can only be reset by turning off the main power switch The output error safety system will activate if the output power exceeds the displayed output as defined in standard IEC 60601 2 2 Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High F...

Страница 29: ...M split precorded ES 1180 Dispersive Pad CQM split non corded requires reusable cable WARNING To ensure safe contact of the dispersive pad to the patient use only pads listed as compatible with the FINESSE S CQM system The use of contact monitoring pads that are not on this list may not properly signal an error condition and result in patient injury CQM circuit frequency 39 5 kHz CQM pad contact r...

Страница 30: ...SSE 500 is a pleated ULPA filter element Annual replacement is recommended Particle Removal Efficiency Spherical particles with a mean diameter of 0 1 microns were removed with a minimum efficiency of 99 999 as determined by laboratory tests via a latex particle challenge Vacuum Motor Exhaust Filter The FINESSE smoke evacuation motor is equipped with a HEPA grade particulate filter This filter pro...

Страница 31: ...former provide AC power to the Power Supply Board for rectification to unregulated 200VDC and 50VDC The 50VDC is then regulated to 15VDC and 5VDC voltages for use on the RF Power Amplifier Logic and Display boards The Power Supply Board contains a solid state relay K201 that controls the smoke evacuator motor The smoke evacuation motor timing is controlled by the microprocessor on the Logic Board ...

Страница 32: ...ply This provides the microprocessor with output voltage and current data for monitoring the output power The microprocessor continuously monitors these two signals and compares their product to values in a lookup table which have been calculated according to the requirements of electromedical safety standard IEC 60601 2 2 2009 sec 12 4 for protection against hazardous output COC s second tier pro...

Страница 33: ...icroprocessor assesses this DC voltage and the status of the mechanical pad detect switch located in the pad receptacle and determines whether the signal is at a level appropriate for a standard or CQM pad If a CQM pad is detected the microprocessor considers the DC voltage a CQM status signal and calculates an error threshold level from this DC voltage that corresponds to roughly 25 30 pad surfac...

Страница 34: ...30 FINESSE Service Manual ...

Страница 35: ...ged Pass Verify switchpen receptacles firmly hold switchpen Pass Knobs and color coded knob caps are securely attached Pass Verify power cord and its rear panel receptacle are not damaged Pass Verify footswitch cord if present and its rear panel receptacle are not damaged Done Replace FINESSE Internal Smoke Evacuation Filter Performance Inspection Pass Green LED in main power switch lights when sw...

Страница 36: ... allow at least 20 seconds between readings Individual output calibration is not adjustable Pass Cut 30 _____ 25 35W 60 _____ 51 69W 90 _____ 77 103W Pass Blend 1 30 _____ 25 35W 60 _____ 51 69W 90 _____ 77 103W Pass Blend 2 30 _____ 25 35W 60 _____ 51 69W 90 _____ 77 103W Pass Blend 3 30 _____ 25 35W 60 _____ 51 69W 90 _____ 77 103W Pass Coag 30 _____ 25 35W 60 _____ 51 69W 75 _____ 64 86W HF Lea...

Страница 37: ...sts Do not activate the FINESSE system during these tests as most ES analyzers are not designed to withstand activation during CQM testing Following the instructions for the ES analyzer perform the following measurements IN THE ORDER LISTED without disconnecting the CQM dispersive pad lead between steps Set CQM tester or resistor substitution box if analyzer does not have CQM test capability to 15...

Страница 38: ...34 FINESSE Service Manual Notes Performed by FINESSE Serial No Signature Date Test Equipment Make Model Serial Reference Calibration Expiry ES Analyzer Safety Analyzer ...

Страница 39: ...wer on Symbol Definition Description Reference model number Serial Number Date of Manufacture Manufacturer Representative in the European Union Input connector alternating current AC power Equipotential connector Continuously adjustable control Footswitch connector Do not use in presence of flammable anesthetics and air Symbols defined for the FINESSE System Audible tone volume control Locked pert...

Страница 40: ...dicators Output activity indicator Pure Cut waveform Blend 1 waveform Blend 2 waveform Blend 3 waveform Symbol Definition Description Coag Mode control and indicator Cross key error indicator Dispersive pad not inserted or single pad cable continuity error indicator CQM error indicator Output error indicator Output terminals Active port Split CQM dispersive pad indicator Solid dispersive pad indic...

Страница 41: ...ram 38 System Functional Diagram 40 RF Power Amplifier PCB Drawing 41 Logic Board PCB Drawing 42 Display Board PCB Drawing 43 Power Supply PCB Drawing 44 Assembly Diagram Internal View 45 Parts List 46 Schematics will be made available on request to qualified technical personnel ...

Страница 42: ...38 FINESSE Service Manual Mains Power and System Wiring Diagram ...

Страница 43: ...FINESSE Service Manual 39 ...

Страница 44: ...lse Waveform Driver Power Monitor Buck Supply Current Limit Circuit CPLD Microprocessor Footswitch Logic and Isolation Pad Logic Isolation and Filtering Vacuum Motor Display and Indicators Logic Audio Amplifier and Speaker Vacuum Motor Control VOLUME SWITCHPEN FOOTSWITCH DISPERSIVE VAC SWITCH OUTPUT CONTROLS MODE SELECT ...

Страница 45: ...FINESSE Service Manual 41 RF Power Amplifier PCB Drawing ...

Страница 46: ...42 FINESSE Service Manual Logic PCB Drawing 90738 B ...

Страница 47: ...FINESSE Service Manual 43 Display PCB Drawing 90737 B ...

Страница 48: ...44 FINESSE Service Manual Power Supply PCB Drawing 90740 ...

Страница 49: ...FINESSE Service Manual 45 Assembly Diagram Internal View 3 4 6 7 8 9 11 12 17 16 18 5 10 13 14 15 21 19 20 2 1 24 25 23 22 ...

Страница 50: ...cles 3 required 9 0013 222 Cut Blend Mode Selector Knob 0013 225 Cut Blend Mode Selector Cap yellow 10 0012 004 Cut Blend Mode Selector Switch 11 0013 221 Control Knob Coag Mode 0013 223 Control Knob Cap blue Coag Mode 12 1850 184 Dispersive Pad Receptacle shell only 0049 231 Dispersive Pad Pins 2 required 0012 003 Pad Type Detection Switch 13 90737 Display PCB Assembly 14 0044 800 Power Control P...

Страница 51: ... be void and of no force and effect with respect to any product which is damaged as a result of A neglect alteration electric current fluctuation or accident B improper use including failure to follow proper operating and maintenance instructions and to provide proper environmental conditions prescribed in UTMD s product instruction manual C repair by other than UTMD or authorized service agents a...

Страница 52: ...48 FINESSE Service Manual Notes ...

Страница 53: ...FINESSE Service Manual 49 ...

Страница 54: ... 84047 800 533 4984 1 801 566 1200 Ireland Utah Medical Products Ltd Athlone Business Technology Park Garrycastle Athlone Co Westmeath Ireland N37 XK74 353 090 64 73932 United Kingdom Femcare Ltd 32 Premier Way Romsey Hampshire SO51 9DQ 44 01794 525 100 p n 58393 rev 100218 ...

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