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Electromagnetic Emissions 

This  equipment  is  intended  for  use  in  the  electromagnetic  environment  specified  below.  The  user  of  this 
equipment should assure that is used in such an environment. 

Emissions 

Compliance 
according to 

Electromagnetic environment 

RF emissions (CISPR 11) 

Group 2 

The Surgitron

®

 Dual/EMC must emit electromagnetic energy 

in order to perform its intended function. Nearby electronic 
equipment may be affected. 

CISPR Emissions Classification 

Class A

 

The emissions characteristics of this equipment make it 
suitable for use in industrial areas and hospitals (CISPR 11 
Class A). If it is used in a residential environment (for which 
CISPR 11 Class B is normally required) this equipment might 
not offer adequate protection to radiofrequency communication 
services. The user might need to take mitigation measures, 
such as relocating or re-orienting the equipment. 

Harmonic emissions  
(IEC 61000-3-2) 

Class A 
 

Voltage fluctuations / flicker (IEC 

61000-3-3) 

Compliant 
 

 

Electromagnetic Immunity 

This  equipment  is  intended  for  use  in  the  electromagnetic  environment  specified  below.  The  user  of  this 
equipment should assure that is used in such an environment. 

Immunity  
against 

IEC 60601-1-2 test 
level 

Compliance 
level (of this 
device) 

Electromagnetic environment 

electrostatic  
discharge, ESD  
(IEC 61000-4-2) 

contact discharge: ± 8 kV  
air discharge: ± 15 kV 

± 8 kV contact 
± 15 kV air 

Floors should be wood, concrete or 
ceramic tile. If floors are covered 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 lines:  
± 1 kV for longer input / output 
lines 

± 2 kV 

± 1 kV 

Mains power quality should be that of 
a typical commercial or hospital 
environment. 

surges on AC mains 
lines 
(IEC 61000-4-5) 

Common mode: ± 2 kV  
differential mode: ± 1 kV 

± 2 kV  
± 1 kV 

Mains power quality should be that of 
a typical commercial or hospital 
environment. 

power frequency 
magnetic field 
50/60 Hz 
(IEC 61000-4-8) 

30 A/m 

30 A/m 

Equipment which emits high levels of 
power line magnetic fields (in excess of 
30 A/m) should be kept at a distance 
to reduce the likelihood of interference. 

voltage dips and short 
interruptions on AC 
mains input lines 
(IEC  61000-4-11) 

0% UT

 (100% dip in UT) for 0.5 

cycle at 0°, 45°, 90°, 135°, 180°, 
225°, 270°, & 315°  

0% UT

 (100% dip in UT) for 1 cycle 

at 0° 

40% UT

 (60% dip in UT) for 5 

cycles 

70% UT

 (30% dip in UT) for 25/30 

cycles (50/60 Hz) at 0° 

0% UT

 (100% dip in UT) for 250 

cycles at 50 Hz and for 300 cycles 
at 60 Hz 

0% UT

 (100% dip in 

UT) for 0.5 cycle at 
0°, 45°, 90°, 135°, 
180°, 225°, 270°, & 
315°  

0% UT

 (100% dip in 

UT) for 1 cycle at 0° 

40% UT

 (60% dip 

in UT) for 5 cycles 

70% UT

 (30% dip 

in UT) for 25/30 
cycles (50/60 Hz) 
at 0° 

0% UT

 (100% dip in 

UT) for 250 cycles at 
50 Hz and for 300 
cycles at 60 Hz 

Mains power should be that of a typical 
commercial or hospital environment. If 
user requires continued operation during 
power mains interruptions insure that 
batteries are installed and charged. 
Insure that battery life exceeds longest 
anticipated power outages or provide and 
additional uninterruptible power source. 

 

 

 

 

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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