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The 

Fully Filtered Waveform 

is a pure continuous flow of high-frequency radiowaves. 

This filtration results in a continuous non-pulsating flow of radiowaves which provides a 
micro-smooth cutting flow. This wave produces the least amount of lateral heat and tissue 
destruction.

 

5.1.2 

BLEND - For cutting with coagulation:

 

Select BLEND by pushing SELECT button on the Cutting Mode to turn on the 
BLEND indicator. Push Power Up/Down Buttons on the Cutting Mode to select 
the desired power level. Depress the CUT Footswitch pedal or Fingerswitch 
BLEND button to activate the output power.

 

 

The 

Fully Rectified Modulated Waveform 

produces a mild pulsating effect which can, 

under certain conditions, slightly reduce the efficiency of the cutting effect. In additional to 
a smooth cut, the Fully Rectified Modulated Wave is accompanied by a thin layer of 
coagulation on the raw cut tissue surfaces.

 

 

5.1.3 

COAG -For pure Hemostasis-Coagulation to control most forms of bleeding:

 

Select COAG by pushing Select button of the Coagulation Mode to turn on the 
COAG indicator. Push Power Up/Down Buttons on the Coagulation Mode to select 
the desired power level. Depress the COAG Footswitch pedal or Fingerswitch 
HEMO button to activate the output power.

 

 

The 

Partially Rectified Modulated Waveform 

is an intermittent flow of the high- 

frequency radiowaves that produces hemostasis. The Partially Rectified Modulated Wave 
is also recommended for coagulating blood vessels via an indirect technique. To seal the 
walls of a vessel, grasp it with a hemostat and lift it free of surrounding tissues. Next 
contact the hemostat with the electrode, 1 to 2 inche

s from the hemostat’s tips.

 

 

5.1.4 

FULGURATION - For desiccation or fulgurate spark-gap:

 

Select FULGURATE by pushing SELECT button of the Coagulation Mode 
to turn on the FULGURATE indicator.

 

Push Power Up/Down Buttons on the Coagulation Mode to select the desired 
power level. Depress the COAG Footswitch controller to activate the output 
power. Note: Fulguration cannot be activated by use of the three button 
fingerswitch.

 

 

The 

Fulguration or Spark-Gap Wave 

is a waveform that has been modulated to 

simulate the effects of the Oudin current. The Fulguration wave produces a 
potent dehydration effect on tissues.

 

 

5.1.5 

BIPOLAR - For precise coagulation utilizing bipolar energy:

 

Select BIPOLAR by pushing SELECT button of the Coagulation Mode to 
turn on the BIPOLAR indicator.

 

Depress the COAG Footswitch controller to activate the output 
power.

 

 

5.2 

SMOKE HAZARD

 

By-products of high frequency surgical procedures are an occupational exposure 
hazard. Standards based policies and procedures must be developed in all 
practice settings to protect personnel from the causative factors of smoke plume 
and aerosols.

 

 

 

Summary of Contents for CYNOSURE ELLMAN SURGITRON 4.0 Dual RF/90 IEC

Page 1: ...4 0 Dual RF 90 IEC Instruction Manual English English...

Page 2: ...subjected to an accident tampering alteration misuse abuse negligence fire or water damage Warranty does not cover defects or damage caused directly or indirectly as a result of service by unauthoriz...

Page 3: ...FOR USE Page 12 5 0 Preparation for Use 5 1 Waveform Selection 5 2 Smoke Hazard VI SURGICAL DESCRIPTION AND USE Page 14 6 0 Learning to Use Radiosurgery 6 1 Pre Operative Cutting Practice 6 2 Pre Oper...

Page 4: ...stics 8 1 Preventive Inspection and Maintenance 8 2 Safety Features 8 3 Input Characteristics 8 4 Size and Weight 8 5 Operating Conditions 8 6 Transportation Storage Conditions 8 7 Error Codes Table I...

Page 5: ...arranty II SAFETY Improper use of this or any high frequency surgical instrument can result in a patient injury Read and become familiar with all directions before using this product 2 0 WARNINGS 2 0...

Page 6: ...with the patient or other leads is avoided Temporarily unused active electrodes should be stored segregated from the patient 2 1 1 10 The output power selected should be as low as possible for the int...

Page 7: ...as monitoring electrodes 2 1 3 Flammable Environment 2 1 3 1 Some materials for example cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in normal use of the equipmen...

Page 8: ...e of this device in the unsorted municipal waste stream 3 2 CLEANING DISINFECTING AND STERILIZING THE UNIT AND ACCESSORIES 3 2 1 Cleaning and disinfecting the unit Cleaning and disinfecting of the uni...

Page 9: ...available for use with the Surgitron Dual EMC A three button handpiece adds convenience by enabling the user to control CUT BLEND and COAG modes via fingerswitch The depressed button will control out...

Page 10: ...er cord supplied by the manufacturer Line Fuses The unit is protected with two line fuses If a fuse blows the unit should be checked for possible faults before the fuse is replaced and the unit is ope...

Page 11: ...the top of the line fuse door Remove two fuse holders Replace fuses with the same value size fuses ONLY The fuse holder arrows should be pointing towards the right Snap the compartment back with the f...

Page 12: ...If the neutral plate is not properly connected to the patient and or Surgitron Dual EMC the Neutral LED Indicator will turn red and the audio alarm will sound until the patient return neutral plate is...

Page 13: ...tch Handpiece Receptacle accepts any monopolar handpiece that is compatible with the Surgitron Dual EMC Yellow Footswitch Indicator The light indicator will be ON only when the CUT control footswitch...

Page 14: ...gures in Section 7 20 Power up Button for Coagulation Mode A single depression of the button switch increases the power setting by one Continuous depression gradually increases the power to maximum 10...

Page 15: ...ent s body as close as possible to the operating field as per the Safety Instructions specified in Section 2 1 4 5 0 5 Select the desired electrode and handpiece and connect them as instructed by thei...

Page 16: ...ated Waveform is an intermittent flow of the high frequency radiowaves that produces hemostasis The Partially Rectified Modulated Wave is also recommended for coagulating blood vessels via an indirect...

Page 17: ...point where excessive dehydration occurs Preventing the accumulation of such heat is a basic objective of radiosurgical technique The spread of lateral heat in tissue depends upon various factors as i...

Page 18: ...e to the electrode while cutting then increase the power gradually until a smooth cut occurs H If the setting is too high then you will notice sparking and discoloration along the electrode path Reduc...

Page 19: ...ed wave with different techniques Bleeding should be stopped by some form of direct manually applied pressure When bleeding has momentarily stopped final sealing of the vessels can be accomplished by...

Page 20: ...urgitron Dual EMC CUT MODE Figure 7 1 RESISTIVE LOAD OHMS POWER WATTS POWER WATTS Half Setting 50 Full Setting 100 Typical Nominal Plot CUT MODE Power Output vs Resistive Load Typical Nominal Plot 90w...

Page 21: ...ODE Figure 7 3 RESISTIVE LOAD OHMS RESISTIVE LOAD OHMS POWER WATTS POWER WATTS Half Setting 50 Full Setting 100 Typical Nominal Plot COAG MODE Power Output vs Resistive Load Half Setting 50 Full Setti...

Page 22: ...MODE Figure 7 5 RESISTIVE LOAD OHMS RESISTIVE LOAD OHMS POWER WATTS POWER WATTS Typical Nominal Plot BIPOLAR MODE Power Output vs Resistive Load Half Setting 50 Full Setting 100 Half Setting 50 Full S...

Page 23: ...20 Surgitron Dual EMC MONOPOLAR BIPOLAR MODES Figure 7 6 Typical Nominal Plot Voltage Output vs Digital Setting Open Circuit No Load CUT CUT COAG HEMO FULG BIPOLAR VOLTAGE PEAK PEAK DIGITAL SETTING...

Page 24: ...and method of circuit connection RF Power out is within 20 of nominal above when greater than 10 of maximum RF Power out is stable within 10 within 10 seconds after activation RF output frequency is w...

Page 25: ...s above 85 C the unit will declare an error message error code 12 8 2 7 Continuous power test monitor output power Error code 13 if power test failed 8 2 8 Error indication after self check Refer to l...

Page 26: ...had a warm reset 4 A D converter error 7 Foot Fingerswitch interface failed 8 Bond sensor interface failed 9 Keypad pressed during power up protection failed 10 Foot or Fingerswitch pressed during pow...

Page 27: ...f interference plug the unit in a separate outlet or plug the unit in another room 9 1 2 Medical electrical equipment requires special precautions regarding electromagnetic compatibility EMC and needs...

Page 28: ...overed with synthetic material the relative humidity should be kept at levels to reduce electrostatic charge to suitable levels electrical fast transients bursts IEC 61000 4 4 2 kV for power supply li...

Page 29: ...ce in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in t...

Page 30: ...ent Guidance 385 TETRA 400 380 390 MHz 27 V m 27 V m Unless otherwise specified the equipment was tested at a distance of 0 3m The equipment was tested using the IEC 61000 4 3 test method 450 GMRS 460...

Page 31: ...12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transm...

Page 32: ...Hologic BVBA Da Vincilaan 5 1930 Zaventem Belgium Tel 32 2 711 46 80 Cynosure LLC 5 Carlisle Road Westford MA USA Tel 888 523 2233 Fax 978 349 6152 DIM 50 65 Rev 002 04 2019...

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