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14

 

 

 

 

VI.

 

SURGICAL DESCRIPTION AND USE

 

6.0 

LEARNING TO USE RADIOSURGERY

®

 

Before making contact with the tissue, the power intensity must be selected and the foot 
pedal or fingerswitch must be activated. During the actual cutting, it is important to use a 
smooth uninterrupted motion with even and light manually applied pressure. The 
movement should not be too slow. If it is, the build-up of lateral heat in the tissue may 
cause charring, followed by necrosis and sloughing (see Preoperative Cutting Practice 
Section 6.1). When performing a second or third cut in the same surgical site, allow 
approximately ten seconds for the tissue to cool between applications of the electrode to 
the site. Radiosurgery

®

 

should be regarded as a new technique that will require learning 

of new skills. All rules of good surgical technique and clinical judgment still apply.

 

 

The biggest difference to be learned is that, unlike a steel scalpel or standard 
electrosurgery, radiosurgery does not use manually applied pressure to cut. Therefore, 
a light, smooth, continuous, and brush-like stroke should be developed. Only then will 
the surgeon appreciate the tremendous advantages inherent in Radiosurgery

®

.

 

 

Defining Good Technique: Tissue damage will occur if heat is allowed to accumulate to 
the 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 indicated in the following formula:

 

Time x Power

 

Lateral Heat 

 

–––––––––––––––––

 

Frequency

 

 

Additionally the electrode type and selected waveform impact the thermal build up.

 

 

This formula may be broken down in the following manner:

 

A. 

Time 

of Electrode Contact

 

a. The slower the passage of the electrode, the greater the lateral 

heat.

 

b. The more rapid the passage of the electrode, the less the 

lateral heat.

 

B. 

Power 

Level

 

a. If power is too high there is a high accumulation of heat.

 

b. If power is set correctly, lateral heat reduced to the minimum necessary to volatize 

tissue cells. Smooth flow through tissue with no sparking and no resistance through 
tissue.

 

c. If power is set too low, drag is observed causing excessive contact time and 

bleeding due to tissue being pulled and torn from its base.

 

C. 

Frequency 

– Tissue provides lower resistance to higher frequencies, reducing thermal 

build up.

 

D. 

Electrode 

Type

 

a. A broader electrode tip requires more power and creates greater 

thermal spread.

 

b. A narrower electrode tip requires less power and creates less thermal 

spread.

 

E. 

Nature 

of the Waveform - See Section 5.1 for details

 

a. Fully Filtered (Continuous Wave - CW) - Least lateral heat.

 

b. Fully Rectified - Low lateral heat.

 

c. Partially Rectified - High lateral heat.

 

d. Fulgurate - Highest lateral heat.

 

Содержание CYNOSURE ELLMAN SURGITRON 4.0 Dual RF/90 IEC

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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