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8.2 

SAFETY FEATURES

 

8.2.1

 

Standard Compliance

 

IEC60601-1

 

IEC60601-1-2 
IEC60601-2-2

 

UL 2601  (USA Version) 
CSA 22.2601

 

8.2.2

 

Electrical Safety 
Electric Shock: 
Defibrillator Protection:

 

 

Class I 
Type BF

 

8.2.3

 

Neutral Plate

 

earthed at HF

 

8.2.4

 

Neutral Plate monitor

 

resistance between the 2 contact 
areas of a split neutral electrode

 

MAX 1000 ohms

 

8.2.5

 

Alarm when resistance between 
the contact areas of a split neutral 
electrode is 1000 ohms or greater

 

Red signal indicator and audio alarm

 

8.2.6

 

Continuous internal unit 
temperature monitor during 
operations

 

If temperature rises 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 listing of error codes in section 8.7

 

8.2.9

 

Defined duty cycle protection

 

10 sec. ON / 30 sec. OFF

 

8.2.10

 

Ingress of water

 

Ordinary equipment.

 

 

 

 

8.3 

INPUT CHARACTERISTICS

 

8.3.1

 

Nominal line voltage

 

100 / 120 / 220 / 240 V ~ + 10%

 

8.3.2

 

Line frequency

 

50/60 Hz.

 

8.3.3

 

Input current at max output power

 

100 / 120 V: 3.3A 
220 / 240 V: 1.5A

 

8.3.4

 

Rating of fuses in the main 
supply power

 

T 2.0AL, 250V, Two for 220 / 240 V 
T 4.0AL, 250V, Two for 100 /120 V

 

 

8.4 

SIZE AND WEIGHT

 

8.4.1

 

W x H x D

 

9x5x13

"

 

8.4.2

 

Weight

 

18 lbs.

 

 

8.5 

OPERATING CONDITIONS

 

8.5.1 

Ambient Temperature: +10° C - +40° C

 

8.5.2 

Relative Humidity: 30% - 75%

 

 

 

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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