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®

CONTENTS

I. Introduction Page 2

1.1 Symbol Definitions


1.2 Installation
1.3 Cleaning and Disinfecting
1.4 Duty Cycle

II. Description of Control Elements Page 4

2.1 Special feature - Mode and Power Output Level Memory


Dual Footswitch and 3-Button Fingerswitch Handpiece
2.2 Rear Panel
2.3 Front Panel

III. Technical Specifications Page 11

3.1 Output Characteristics


3.2 Safety Features
3.3 Input Characteristics
3.4 Size and Weight
3.5 Error Codes Table

IV. Test Procedure Page 13

4.1 Supplier’s Information


4.2 Inspection Check List
4.3 Power Output Figures (Diagrams)
4.3.1 Power Output vs. Digital Setting
4.3.2 Cut Mode Power Output vs. Resistive Load
4.3.3 Coag Mode Power Output vs. Resistive Load
4.3.4 Hemo Mode Power Output vs. Resistive Load
4.3.5 Fulgurate Mode Power Output vs. Resistive Load
4.3.6 Bipolar Mode Power Output vs. Resistive Load

V. Structure of Surgitron® Unit Page 26

VI. Parts List Page 27

3
INTRODUCTION

This Service Manual consists of the general technical information, specification, test procedures, troubleshooting
guide, hardware structure, and circuit diagram of the ellman Dual High Radio Frequency Surgical generator
(ellman Surgitron® 4.0 Dual RF/120 IEC). Instruction for use and cautions and warnings concerning ellman
Surgitron® 4.0 Dual RF/120 IEC are given in the Instruction Manual supplied with the ellman Surgitron® 4.0 Dual
RF/120 IEC.

The ellman Surgitron® 4.0 Dual RF/120 IEC is a enhanced capability Radiosurgical Generator. It is a compact
source of high power RF energy to be employed for a variety of Radiosurgery™ procedures. This action is
achieved by front panel selection of waveforms and power levels. All selections are effected through push
buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front
panel digital displays which also show the status of self-test and monitoring. This display is interlocked with
controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or
hand switches. An internal memory provides a special feature for the storage of all the front settings, mode and
power output level. Both Monopolar and Bipolar electrodes are provided. It is designed to comply with
international safety standards.

The ellman Surgitron® 4.0 Dual RF/120 IEC High-Frequency Radiosurgical Generator must be inspected for
technical safety at least once a year. These technical safety inspections consist of:

* Inspection of electrical safety in compliance with IEC 60601-1 and 60601-2-2

* Inspection for damage to the unit and its accessories

* Inspection of proper function of the unit

* Inspection of high-frequency output power in the variety of modes

These technical safety inspections should be entrusted only to ellman trained personnel. The manufacturer
assumes no responsibility for improper changes or repairs carried out on the unit or its accessories by unautho-
rized persons, and the warranty of the unit expires immediately.

ellman reserves the right to make any changes in construction of the ellman Surgitron® 4.0 Dual RF/120 IEC
without incurring any obligation at any time.

1.1. SYMBOL DEFINITIONS

The following symbols are used on the equipment

1.1.1 Classification = Class 1 1.1.6 Neutral Electrode


Referenced to Ground
1.1.2 Supply Input Power = 240V, 220V, 120V, 100V ~ 50/60 Hz
Option = 240V, 230V, 120V, 100V ~ 50/60 Hz 1.1.7 Finger Switch Control

1.1.3 Type BF defibrillator protection 1.1.8 Foot Switch Control

1.1.4 ! Refer to Manual 1.1.9 Neutral plate

1.1.5 Protective Earth Connection 1.1.10 Non-Ionization radiation

4
1.2 INSTALLATION

The ellman Surgitron® 4.0 Dual RF/120 IEC is a portable unit and can be installed in a variety of ways. It
may be placed on any convenient and sturdy table or on the mounting cart (ellman IEC cart
P/N#IEC-C100). The power amplifier within the unit generates heat. The metal enclosure of the unit is
utilized to transfer and radiate the heat to the surrounding air, therefore, the ellman Surgitron® 4.0 Dual
RF/120 IEC unit should be placed in the open space for the free circulation of air. It is normal for the
cover of the enclosure to feel warm after an extended continuous operation.

Input characteristics of the Surgitron® 4.0 Dual RF/120 IEC unit are listed as following:
1.2.1 Nominal line voltage 240 Volt/120 Volt +/-10%
1.2.2 Nominal line voltage 60 Hz/ 50 Hz
1.2.3 Nominal line voltage 330 VA
1.2.4 Nominal line voltage 1.3 A/ 2.90 A
1.2.5 Nominal line voltage T2A (250V)/ T4A(250V)

An approved hospital grade three-prong plug power cord, or standard European power cord, is supplied
with the unit. The power cord meets all requirements for safe grounding.

1.3 CLEANING AND DISINFECTION

Cleaning and disinfection of the unit should only be done with nonflammable and nonexplosive agents.
Make sure that no moisture or detergents enter the unit. If cleaning or disinfecting of the unit with flamma-
ble or explosive agents is unavoidable, these must be completely evaporated from the unit before it is
switched on. The dual footswitch pedal is a waterproof unit, it can be cleaned with regular detergent.

ATTENTION: Alcohol must never be used to clean and disinfect the front panel. We recommend
that the panel be disinfected by spraying or wiping. However, it is essential to follow
the manufacturer’s directions regarding cleaning, disinfection and sterilization of the
accessories.

1.4 DUTY CYCLE

The operational duty cycle is suggested to be 10 seconds ON and 30 seconds OFF. The yellow indicator
will be ON when CUT MODE is activated. The blue indicator will be ON when HEMO MODE is activated.
The unit will sound a continuous tone when ON. After 55 seconds, the tone will change to alert the user
the RF power will shut off automatically in 5 seconds to protect the unit from over heating.

1.5 THE PERMISSIBLE OPERATIONAL ENVIRONMENT CONDITIONS:


o o
ambient temperature range +10 C ~ +40 C (50˚ F ~ 104˚ F)
relative humidity range 30 ~ 75%

For transport and storage:


o o
ambient temperature range - 10 C ~ +50 C (14˚ F ~ 122˚ F)
relative humidity range 10 ~ 95%
atmospheric pressure range 500 hPa ~ 1060 hPa

This unit has been checked for proper and safe operation prior to shipment. However, all equipment should be
rechecked for proper and safe operation prior to initial operation, and before each subsequent use.

5
I. DESCRIPTION OF CONTROL ELEMENTS

2.1 SPECIAL FEATURE


ellman Surgitron® 4.0 Dual RF/120 IEC has some unique special accessories which includes retractable
mode and power output level settings, waterproof dual footswitch for CUT and COAG modes, and a
Three-Button Fingerswitch Handpiece for CUT, CUT/COAG, and HEMO modes. The following are the
descriptions:

2.1.1 MODE AND POWER OUTPUT LEVEL MEMORY

2.1.1.1 Mode and power output levels are stored in a non-volatile memory and recalled at the
unit turn-on.
2.1.1.2 The memory is set to default values when shipped. To set default value, press and hold
both the Cutting Mode and Coagulation Mode Select buttons simultaneously and turn on
the unit. When “CLR” is displayed release the buttons.

2.1.2 DUAL FOOTSWITCH PEDAL AND 3-BUTTON FINGERSWITCH CONTROLS

2.1.2.1 Dual Footswitch Pedal: CUT COAG

The unit is equipped with a heavy duty waterproof dual footswitch pedal for CUT/COAG modes.
The footswitch mode selector and light indicators described in the section 2.2.7, 2.2.8 and 2.2.9
will respond accordingly to the activated mode, i.e., the yellow light indicator will be "ON" when
the Cut footswitch pedal is depressed. The blue light indicator will be "ON" when the COAG
footswitch pedal is depressed. The light indicators are normally OFF in this footswitch controlled
mode since the mode selection CUT or COAG is activated by the footswitch. i.e. the Footswitch
mode switch will not be in effect. All modes, CUT, CUT/COAG, HEMO, FULGURATE, and
BIPOLAR shall be selected by depressing the selector buttons on the front panel as well as
adjusting the output power settings. The power output is activated by the footswitch pedal. The
Footpedal will activate the mode that is lit up on the front panel.

2.1.2.2 3-Button Fingerswitch Handpiece Control:

This patented, unique fingerswitch handpiece is implemented to control CUT, CUT / COAG, and
HEMO. To activate this special function handpiece, depress the middle button on the finger-
switch handpiece and hold down for three seconds. As the button is held down the following
sequence should be observed:

a. "HOLD" should be displayed on the power display of the CUT mode.


b. The power display of COAG mode starts to count down from "03","02","01" and then "0"
c. Release this middle button on the 3-Button Fingerswitch Handpiece and the functions are
successfully activated. Then all power displays return to previous power settings.
d. Yellow light CUT and CUT / COAG indicators will alternate "ON" and "OFF" as well as
blue light HEMO and BIPOLAR indicators. They are in standby, ready for action in
CUT,CUT/ COAG, or HEMO mode by the fingerswitch handpiece control.
e. Once the yellow and the blue lights are flashing set all appropriate power settings.
The first yellow button activates the CUT mode.
The middle yellow button activates the CUT/COAG mode.
The blue button activates the HEMO mode.
f. ONLY THE FOOTPEDAL CONTROL CAN ACTIVATE THE BIPOLAR FUNCTION

The FULGURATE mode is not accessible.

6
To adjust the power output level if it is desired, the procedure is:
a. Depress any push button in the front panel to temporarily stop and exit the flashing, no
power levels or modes can be changed while the LED indicators are flashing.
b. Press “SELECT” button to select the desired mode, then adjust the power output by depressing
the up or down button to the desired power level for either CUT, CUT/COAG, BIPOLAR or
HEMO mode. The user may continue to change modes and power levels.
c. The unit will re-enter the flashing, 3-Button Fingerswitch mode, if no push buttons are
depressed in three seconds. Repeat step (b) if further readjustment of power is desired.
d. The fingerswitch and footswitch are disabled and no power can be output during the output
power adjustment.

Regression:
The 3-button fingerswitch handpiece may be used as a conventional two-button fingerswitch
handpiece if the BLEND mode is not activated by depressing it for more than three seconds. Or, the
Surgitron® 4.0 Dual RF/120 IEC may be operated as an IEC unit to adopt an IEC 2-button Fingerswitch
Handpiece, if a 3-Button Fingerswitch Handpiece is not available.

2.2 THE REAR PANEL CONTROL ELEMENTS


see Figure 2.2 Rear Panel

2.2.1 POWER PLUG:


The Surgitron® Unit is shipped with an approved hospital grade power connector. To ensure
patient safety, the Surgitron® unit must be properly grounded.

2.2.2 POWER SOCKET:


The Surgitron® unit must be connected to correctly installed sockets with a grounded earth
conductor using the power cord supplied by the manufacturer.

2.2.3 LINE FUSES:


The unit is protected with two line fuses. If fuse blows, the unit should be checked for possible
faults before the fuse is replaced and the unit is operated again. Always replace with a fuse of
the same rating.

2.2.4 AUDIO VOLUME CONTROL:


The volume of the acoustic signal should be set to a volume that can easily be heard by
the user.

2.2.5 FOOTSWITCH RECEPTACLE:


This 9-pin receptacle accepts a Hypersonics Footswitch connector.

2.2.6 FOOTSWITCH: CUT COAG

The unit is shipped with a waterproof Dual Footswitch

7
Figure 2.2
Rear Panel

8
Figure 2.3
Front Panel Control Elements

9 10 11 22 23 12 13 14

CUTTING
CUTTING MODE
MODE ENERGIZED
7 SELECT
SELECT CUT
CUT
POWER
ellman
llman
FOOTSWITCH CUT/C OAG
CUT/COAG
FOOTSWITCH
4.0 Dual RF
20
INDICATOR COAGULATION
COAGULATION MODE
MODE ENERGIZED
MODE POWER
8 SELECT
SELECT HEMO
HEMO 2
FAULT
FAULT
FULGURATE
FULGURATE
BIPOLAR
BIPOLAR 21
15 NEUTRAL
NEUTRAL
120 IEC
120 IEC
4
16
17 FINGERSWITCH / HANDPIECE BIPOLAR HANDPIECE ON/OFF ! 19
NEUTRAL

18

6 5 3
1

FINGERSWITCH
HANDPIECE BIPOLAR NEUTRAL
HANDPIECE

2.3 FRONT PANEL CONTROL ELEMENTS


see Figure 2.3 for Description of the Front Panel Control Elements

1 1 = ON
2.3.1 POWER SWITCH:
0
0 = OFF
When the power switch is turned on, the unit always automatically performs the following function:

• The audio signal is activated after turning on the power switch.


• All start up sequence of tones on the front panel are activated automatically during the
functional test. All front panel LEDS are activated.
• The patient return neutral plate is tested automatically. If the manufacturer provided neutral
plate is not in place and not properly connected to the patient, the neutral optical signal will turn
red and the audio alarm will sound until the patient return neutral plate is properly applied. The
test is bypassed when the bipolar function is selected.

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* All power digital indicators shall be at initial state — “zero” shall be shown on both digital power
indicators. If any error code is shown, the error must be cleared prior to using the equipment.
For error codes information, see 3.6 - Error Codes Table

2.3.2 FAULT LED INDICATOR :


It will be red if any error is detected, otherwise, it should be green.

2.3.3 NEUTRAL PLATE RECEPTACLE:


The neutral plate must be applied to the patient and connected to the equipment for monopolar
techniques. This unit is equipped with a neutral plate safety monitor which monitors the
electrical connection between a split-neutral plates and the unit, as well as between the
split-neutral plates and the patient.

2.3.4 NEUTRAL LED INDICATOR:


The indicator lights up Red and triggers an audible alarm if the neutral plate is not properly
applied. The LED indicator will turn to Green when the neutral plate is correctly applied. This
function is automatically bypassed if Bipolar mode is selected.

2.3.5 BIPOLAR CORD RECEPTACLE:


Bipolar function can be activated by footswitch controller only.

2.3.6 FINGERSWITCH/HANDPIECE RECEPTACLE:


Fingerswitch function may be applied on “CUT/COAG” (blend) and “HEMO” modes. The regular
Handpiece may be used for both Cutting Mode and Coagulation Mode with the footswitch only.

2.3.7 YELLOW LIGHT INDICATOR:


The light indicator will be “ON” only when the “CUT” control footswitch is depressed in Surgitron®
4.0 Dual RF/120 IEC model.

2.3.8 BLUE LIGHT INDICATOR:


The light indicator will be “ON” only when the “COAG” control footswitch is depressed in
Surgitron® 4.0 Dual RF/120 IEC model.

2.3.9 CUTTING MODE FUNCTION SELECTOR: (SELECT)


It is for selecting CUT or CUT/COAG functions. See section 2.1.2. for 3 Button-Fingerswitch
Handpiece application.

2.3.10 YELLOW LIGHT (CUT) INDICATOR:


The indicator illuminates when CUT function has been selected. See section 2.1.2. for
3 Button-Fingerswitch handpiece application.

2.3.11 YELLOW LIGHT (CUT/COAG) INDICATOR:


The indicator illuminates when CUT/COAG function has been selected. See section 2.1.2. for
3 Button-Fingerswitch Handpiece application.

2.3.12 OUTPUT POWER INTENSITY INDICATOR:


When the power switch is turned on, the settings that were last used will appear on the display.
For true output power, see figure output power Intensity vs. Power Setting. The number
displayed indicates the relative power, which will be delivered to the patient when the mode is
activated. See section 2.1.2.2 for 3 Button-Fingerswitch Handpiece application.

10
2.3.13 POWER-UP PUSH BUTTON FOR CUTTING MODE:
A single depression of the button switch increases the power setting by one. Continuous
depression gradually increases the power to maximum - 100. See section 2.1.2. for
3-Button Fingerswitch Handpiece application.

2.3.14 POWER-DOWN PUSH BUTTON FOR CUTTING MODE:


A single depression lowers the power setting by one. Continuous depression gradually
decreases the power to minimum - “0”. See section 2.1.2. for 3-Button Fingerswitch Handpiece
application.

2.3.15 COAGULATION MODE FUNCTION SELECTOR: (SELECT)


It is for selecting Hemo, Fulgurate, or Bipolar function.

2.3.16 BLUE LIGHT INDICATOR: (HEMO)


The indicator illuminates when Hemo function has been selected.

2.3.17 BLUE LIGHT INDICATOR: (FULGURATE)


The indicator illuminates when Fulgurate function has been selected.

2.3.18 BLUE LIGHT INDICATOR: (BIPOLAR)


The indicator illuminates when Bipolar function has been selected.

2.3.19 OUTPUT POWER INTENSITY INDICATOR FOR COAGULATION MODE:


The initial state is zero when the power switch is turned on. See section 2.1.1 for the special
features of the power storage. The output power will remain at the selected level unless it is
changed. The number displayed indicates the relative power, which will be delivered to the
patient when the mode is activated. For true output power, see Figure Output Power Intensity vs.
Power Setting.

2.3.20 POWER-UP PUSH BUTTON SWITCH FOR COAGULATION MODE:

2.3.21 POWER-DOWN PUSH BUTTON FOR COAGULATION MODE:

2.3.22 YELLOW LIGHT INDICATOR:


The yellow indicator will be ON when CUTTING MODE circuit is energized.

2.3.23 BLUE LIGHT INDICATOR:


The blue indicator will be ON when COAGULATION MODE circuit is energized.

.
NOTE: To guarantee against cross-contamination, ellman international highly recommends the use
of disposable electrodes and accessories.

11
III. TECHNICAL SPECIFICATIONS

3.1 OUTPUT CHARACTERISTICS

Mode/ Output M a x i m u m Power Output Power Output Activation


Character Waveform Output Power vs. Setting vs. Load
Resistance
Cut 4.0 MHz CW 120W See Figure 4.1 See Figure 4.2 via foot pedal or
sinusoid fingerswitch
Cut/Coag 4.0 MHz with 80W See Figure 4.1 See Figure 4.3 via foot pedal or
rectified full-wave fingerswitch
envelope
Hemo 4.0 MHz with 60W See Figure 4.1 See Figure 4.4 via foot pedal or
square wave fingerswitch
rectified envelope
Fulgurate 4.0 MHz with 40W See Figure 4.1 See Figure 4.5 via foot pedal and
modulated handpiece
Bipolar 1.7 MHz with 120W See Figure 4.1 See Figure 4.6 via foot pedal

NOTE: The open-circuit Output peak-to-peak Voltage for all modes is approximately 1,000 Volts.

3.2 SAFETY FEATURES


All waveforms are interrupted at a 37 Hz. rate to allow sampling with the power off.

3.2.1 Standard Compliance IEC60601-1


IEC60601-2-2

3.2.2 Neutral Plate Electrode earthed at HF

3.2.3 Neutral Electrode monitor MAX 1000 ohms


resistance between the 2 contact
area of a split neutral electrode

3.2.4 Alarm when resistance between Red signal indicator and audio alarm
the contact areas of a split neutral
electrode is 1000 ohms or greater

3.2.5 Continuous temperature monitor If temperature rises above 85° C


during operations the unit will declare an error message
- error code 12

3.2.6 Continuous power test/monitor Error codes 13 if power test failed


output power

3.2.7 Error indication after self check Refer to listing of error codes

3.2.8 Defined duty cycle protection 10 sec. on active time/30 sec. off

12
3.3 CLASSIFICATION:

3.3.1 According to the type of protection against electrical shock:


the equipment is energized from an external electrical power source and is
Class I equipment.

3.3.2 According to the degree of protection against electric shock:


Type BF equipment.

3.3.3 According to the degree of protection against harmful ingress of water:


ordinary equipment.

3.4 INPUT CHARACTERISTIC


3.4.1 Nominal line voltage 240V, 220V, 120V, 100V ~ + 10%
Option 240V, 230V, 120V, 100V ~ + 10%
3.4.2 Line frequency 60 Hz./50 Hz.

3.4.3 Input current at max output power 1.5A (operation at 220V, 230V, and 240V)
3.3A (operation at 100V, and 120V)

3.4.4 Rating of fuses in the main supply power T 2.0A, 250V, Two for 240V, 220V
T 4.0A, 250V, Two for 120V, 100V

3.5 SIZE AND WEIGHT


3.5.1 WxHxD 9” x 5” x 13”

3.5.2 Weight 18 lbs.

3.6 ERROR CODES TABLE

DESCRIPTION ERROR CODE


Interface to displays failed 1
Interface to LEDS failed 2
Interface to keypad failed 3
Processor 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 power up protection failed 11
Temperature out of limits 12
Output power test failed 13
Linear Table in Error 15
EEPROM Read 16
EEPROM Write 17

NOTE: All error messages will be reset by turning the unit off and correcting the condition.

13
IV. INSPECTION AND TEST PROCEDURE

The Surgitron® 4.0 Dual RF/120 IEC unit has been thoroughly inspected and tested for proper and safe operation
prior to shipment. However, all equipment should be rechecked for proper and safe operation prior to initial use.

The purpose of this section is to give a guide line to check the Surgitron® 4.0 Dual RF/120 IEC unit by giving a
list of the test equipment and a defined methods to perform these test.

4.1 TEST EQUIPMENT LIST

4.1.1 HARDWARE TEST EQUIPMENT

4.1.1.1 Digital Calipers


4.1.1.2 Resistive Load 50 ohm/100W
4.1.1.3 Resistive Load 100 ohm/100W
4.1.1.4 Resistive Load 500 ohm/100W
4.1.1.5 Resistive Load 1,000 ohm/100W
4.1.1.6 Resistive Load 2,000 ohm/100W
4.1.1.7 Low Power Resistor 330 ohm/0.25 W
4.1.1.8 Low Power Resistor 1,000 ohm/0.25 W
4.1.1.7 Low Power Resistor 100 ohm/0.25W
4.1.1.8 Low Power Resistor 75 ohm/0.25W
4.1.1.9 Low Power Resistor 10 ohm/0.25W
4.1.1.10 Test Leads with Terminals

4.1.2 ELECTRONICS TEST EQUIPMENT

4.1.2.1 Digital AC True RMS Multimeter


4.1.2.2 Oscilloscope
4.1.2.3 Function Generator
4.1.2.4 Current Sampling Transformer
4.1.2.5 Digital Multimeter
4.1.2.6 Digital Thermometer
4.1.2.7 Variable Transformer
4.1.2.8 RCL Meter
4.1.2.9 High Voltage Probe
4.1.2.10 Hypot Tester
4.1.2.11 Electrosurgical Analyzer

14
4.2 TEST CHECKLIST
4.2.A EXTERNAL CONTROLS AND INDICATORS TEST AND INSPECTION:

No. Test Function Data Note


A1 Turn on the unit and verify the initial tone

A2 Without any cable connection, verify the Neutral fault light is RED
and the intermittent tone continues.

A3 Short the Neutral terminals with 1K ohm resistor and verify that
the Neutral fault light is RED and the intermittent tone continues.

A4 Replace 1K ohm with 330 ohm and verify that the Neutral fault
light is GREEN and the intermittent tone ceases. (leave the
330 ohm resistor on until instructed to remove it).

A5 Verify that both numerical displays read 0 (leave at 0). Depress


FOOTSWITCH MODE selector switch repeatedly. No Footswitch
Mode light indicator will be activated, they are normal OFF.

A6 Insert the footswitch connector to the rear receptacle on the rear


panel. The Footswitch Mode light indicators will be activated when
the footswitch is depressed.

A7 Depress CUT Footswitch to verify CUTTING MODE (YELLOW


light), and verify that the lower COAGULATION MODE display
shows ----- and a continuous tone sounds.
The upper CUTTING MODE display should continue to display 0.

A8 Depress COAG Footswitch to verify COAGULATION MODE


(BLUE light) and verify that the upper CUTTING MODE display
shows ----- and a continuous tone sounds. The lower
COAGULATION MODE display should continue to display 0.

A9 With any one of the footswitches, CUT/COAG, depressed, turn


the unit OFF and then back on (1).

A10 Verify that the FAULT light is RED, a tone sounds and that Er11
is displayed.

A11 Release the footswitch and verify that the alarm tone and error
message remain.

A12 With the footswitch released, turn the unit OFF and then back
ON and verify that the alarm tone FAULT light and error message
are all cleared.

A13 With the footswitch depressed, verify that there is no change


on the front panel display. Release and repeat procedure.

A14 On the top CUTTING MODE, push SELECT button to select CUT
(upper yellow light). Using the up arrow push button to the right of
the display, verify that the displayed number increases in value.
(Set it to "5".)

15
No. Test Function Data Note
A15 On the top CUTTING MODE, push SELECT button to select CUT
/COAG (upper yellow light). Using the up arrow push button to the
right of the display, verify that the displayed number increases in
value. (Set it to "7".)

A16 Repeatedly depress the SELECT push button, and Verify that the
displayed value toggles between the two values previously set,
i.e., 5-7-5-7......

A17 In the COAGULATION MODE - push SELECT button to select


HEMO (upper blue light). Using the up arrow push button to the
right of the lower display, verify that the displayed number, initially
zero, increases in value. (Set it to "5".)

A18 By the same token, select FULGURATE (middle blue light) and set
it to "6".

A19 By the same token, select BIPOLAR (lower blue light) and set it to "7".

A20 Repeatedly depress the SELECT push button, and Verify that the
displayed previously set values are corresponding to the selected
mode, i.e., HEMO-5, FULGURATE-6, & BIPOLAR-7.

A21 Connect the fingerswitch connector to the unit from the front panel for
testing its function.

A22 To initialize the 3-Button Fingerswitch function depress and hold the
BLEND button on the fingerswitch. Verify that the upper display shows
HOLD and the lower display counts down from 3,2,1,then 0.Release
the button. Both power displays return to the previous power setting.

A23 Set to the BIPOLAR mode and remove 330 ohm resistor from the
NEUTRAL terminals. Verify that the alarm does not activate when the
footswitch is pressed but the NEUTRAL light turns to RED.
A24 Depress the CUT button on the fingerswitch to verify that
COAGULATION MODE display shows ----- and that a tone sounds.
Release the button.

A25 Depress the HEMO button on the fingerswitch. Verify that the
CUTTING MODE display shows ----- and that a tone sounds.
Release the button.

A26 To test memory, Mode and Power output level settings that are stored
and recalled as the unit is turned OFF and back ON, verify the memory
with steps A16 and A20.

A27 To test for setting default values, turn the unit OFF. Press and hold
both Cutting Mode and Coagulation Mode "Select" buttons
simultaneously and turn the unit back ON. Verify "Clr" is seen,
and all displays are zero for all modes upon release the hold.

A28 To initialize the 3-bButton Fingerswitch function, depress and hold


the BLEND button on the fingerswitch. Verify that the upper display
shows HOLD and the lower display counts down from 3, 2, 1, then 0.
Release the button. Both power displays return to the previous
power setting

16
No. Test Function Data Note
A29 Note that the light indicators of CUT and CUT/COAG are
alternated back forth in the standby mode waiting for the action
from the fingerswtich.

A30 On FOOTSWITCH MODE, the blue light indicator is "ON" now,


which sets BIPOLAR mode in standby if it is selected. The COAG
footswitch control this mode.
Note: The light indicators of HEMO and BIPOLAR alternate back and
forth in the standby mode.

A31 To test the adjustment of the power output setting:

A32 On the top CUTTING MODE, push SELECT button to select CUT
(upper yellow light), the alternation paused. Using the up arrow
push button to the right of the display, verify that the displayed
number increases in value. (Set it to "5".)

A33 Push SELECT button again to select CUT/COAG (upper yellow


light). Using the up arrow push button to the right of the display,
verify that the displayed number increases in value. (Set it to "7".)

A34 Depress the SELECT push button again to return the 3-Button
Fingerswitch mode, the indicators alternated again. Verify that the
displayed value toggles between the two values previously set,
i.e., 5-7-5-7......

A35 With the COAGULATION MODE - push SELECT button to select


HEMO (upper blue light). Using the up arrow push button to the right
of the lower display, verify that the displayed number, initially zero,
increases in value. (Set it to "6".)

A36 Note that FULGURATE will be skipped, because there is no


FULGERATION on the 3-Button Fingerswitch handpiece.

A37 By the same token, select BIPOLAR (lower blue light) and set it to "9".

A38 Repeatedly depress the SELECT push button, and Verify that the
displayed previously set values are corresponding to the selected
mode, i.e., HEMO-6 & BIPOLAR-9.

A39 Depress CUT, CUT/COAG, and HEMO buttons to verify that the
previously set values correspond with displayed numbers,
i.e., CUT-5, CUT/COAG-7, and HEMO-6 .

A40 Turn the unit OFF and back ON to verify that all displays remain the
same.

A41 To test for setting default value, Repeat step A27.

A42 To test operational duty cycle for and audio tone, activate the unit
to verify the power output with the first tone for 55 seconds then
another 5 seconds for the second tone before OFF.

- NOT USED -

- NOT USED -

17
4.2.B OUTPUT POWER AND WAVEFORM TEST AND INSPECTION:
(The following test is carried out with 500 ohm resistive load.)

No. Test Function Data Note

B1 CUT MODE

B1.1 Advance the CUT mode power indication to 50. Depress the
footswitch and verify that the supplied power reads 88 W +/- 20%.
Release the footswitch.

B1.2. Advance the CUT mode power indication to 100. Depress the
footswitch and verify that the supplied power reads 120 W +/- 20%.
Release the footswitch.

B1.3. Check the waveform of the CUT mode. It should be a continue-wave


with no sign of breakup.

B1.4. Check the waveform of the CUT/COAG mode. The envelope should
look like that of a full-wave rectifier and show no sign of breakup.

B2. COAGULATION MODE

B2.1. Advance the HEMO mode power indicator to 50. Depress the
footswitch and verify that the supplied power reads 44 W +/- 20%.
Release the footswitch.

B2.2. Advance the HEMO mode power indicator to 100. Depress the
footswitch and verify that the supplied power reads 60 W +/- 20%.
Release the footswitch.

B2.3. Check the waveform of the HEMO mode. The envelope should look
like that of a half-wave rectifier.

B2.4. Check the waveform of the FULGURATE mode. It should be a series


of square bursts.

C3 BIPOLAR MODE The following test is carried out with 200 Ohm resistive load

C3.1. Advance the BIPOLAR mode power indicator to 50. Depress


the footswitch and verify that the supplied power reads 87 W +/- 20%.
Release the footswitch.

C3.2 Advance the BIPOLAR mode power indicator to 100. Depress the
footswitch and verify that the supplied power reads 120 W +/- 20%.
Release the footswitch.

- NOT USED -

- NOT USED -

18
4.3 POWER OUTPUT FIGURES

4.3.1 Power Output vs. Digital Setting (500 Ohm Resistive Load)

4.3.2 Cut Mode Power Output vs. Resistive Load

4.3.3 Coag Mode Power Output vs. Resistive Load

4.3.4 Hemo Mode Power Output vs. Resistive Load

4.3.5 Fulgurate Mode Power Output vs. Resistive Load

4.3.6 Bipolar Mode Power Output vs. Resistive Load

4.3.7 Monopolar Bipolar Modes Voltage Output vs. Digital Setting

19
SURGITRON® 4.0 DUAL RF/120 IEC
MONOPOLAR AND BIPOLAR MODES

Figure 4.3.1 - Power Output vs Digital Setting


Monopolar 500 Ohms (Bipolar 200 Ohms) Resistive Load

NOTE:
The above power chart is a typical output characteristic of the ellman Surgitron®
4.0 RF/120 IEC unit. Actual output power measurements may vary with type of
test equipment used and method of circuit connection. The actual power as a
function of load resistance and output control setting shall not deviate by more
than +/-20%.

20
SURGITRON® 4.0 DUAL RF/120 IEC CUT MODE

Figure 4.3.2 - Power Output vs Resistive Load

NOTE:
The above power chart is a typical output characteristic of the ellman Surgitron®
4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type
of test equipment used and method of circuit connection. The actual power as a
function of load resistance and output control setting shall not deviate by more
than +/-20%.

FILE:IEC:FIG:PIEC2-02

21
SURGITRON® 4.0 DUAL RF/120 IEC COAG MODE

Figure 4.3.3 - Power Output vs Resistive Load

NOTE:
The above power chart is a typical output characteristic of the ellman Surgitron®
4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type
of test equipment used and method of circuit connection. The actual power as a
function of load resistance and output control setting shall not deviate by more
than +/-20%.

FILE:IEC:FIG:PIEC2-02

22
SURGITRON® 4.0 DUAL RF/120 IEC HEMO MODE

Figure 4.3.4 - Power Output vs Resistive Load

NOTE:
The above power chart is a typical output characteristic of the ellman Surgitron®
4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type
of test equipment used and method of circuit connection. The actual power as a
function of load resistance and output control setting shall not deviate by more
than +/-20%.

FILE:IEC:FIG:PIEC2-24

23
SURGITRON® 4.0 DUAL RF/120 IEC FULGURATE MODE

Figure 4.3.5 - Power Output vs Resistive Load

NOTE:
The above power chart is a typical output characteristic of the ellman Surgitron®
4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type
of test equipment used and method of circuit connection. The actual power as a
function of load resistance and output control setting shall not deviate by more
than +/-20%.

FILE:IEC:FIG:PIEC2-25

24
SURGITRON® 4.0 DUAL RF/120 IEC BIPOLAR MODE

Figure 4.3.6 - Power Output vs Resistive Load

NOTE:
The above power chart is a typical output characteristic of the ellman Surgitron®
4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type
of test equipment used and method of circuit connection. The actual power as a
function of load resistance and output control setting shall not deviate by more
than +/-20%.

FILE:IEC:FIG:PIEC2-26

25
SURGITRON® 4.0 DUAL RF/120 IEC BIPOLAR MODE

Figure 4.3.7 - Voltage Output vs Digital Setting


Open Circuit (No Load)

NOTE:
The above voltage chart is a typical output characteristic of the ellman Surgitron®
4.0 Dual RF/120 IEC unit. Actual output voltage measurements may vary with
type of test equipment used and method of circuit connection. The actual voltage
as a function of output control setting shall not deviate by more than +/-20%.

26
V. STRUCTURE OF SURGITRON® UNIT

Item Description Drawing No. Revision Note

1 IEC -3 Enclosure 080-901 10-01 1/12


2 IEC -3 Display Board 080-901 10-01 5/12
3 IEC -3 Mounting Speaker 080-901 10-01 2/12
4 IEC -3 Top Enclosure 080-901 10-01 3/12
5 IEC -3 Assembly Matching Board 080-901 10-01 4/12
6 IEC -3 Assembly Main Board 080-901 10-01 6/12
7 IEC -3 Assembly Bottom Enclosure 080-901 10-01 7/12
8 IEC -3 Cable Assembly 080-901 10-01 8/12
9 IEC -3 Power Assembly 080-901 10-01 9/12
10 IEC -3 Assembly Drawing 080-901 10-01 10/12
11 IEC -3 Assembly Drawing 080-901 10-01 11/12
12 IEC -3 Overlay Drawing 080-901 10-01 12/12
- NOT USED -
- NOT USED -
- NOT USED -

27
VI. PARTS LIST

Item Description Parts Number Quantity Note


1 Bottom Cover IEC3-ENB-001 1
2 Top Cover IEC3-ENT-002 1
3 Rear Case Panel IEC3-ENR-003 1
4 Assemble Main Board IEC3-MPC-004 1
5 Assemble Matching Board IEC3-CPC-005 1
6 Assemble Display Board IEC3-DPC-006 1
7 Speaker IEC3-SPK-007 1
8 Power Transformer IEC3-XFM-008 2
9 Power Supply System IEC3-PSS-009 1
10 Input Power Modular IEC3-IPM-010 1
11 Power Switch IEC3-PSH-011 1
12 3-p Footswitch Cable IEC3-FSC-012 1
13 3-p Audio Cable IEC3-AUC-013 1
14 5-p Power Cable IEC3-PWC-014 1
15 10-p Audio & Sensor Cable IEC3-ASC-015 1
16 10-p Display Cable IEC3-DSC-016 1
17 4-p RF Cable IEC3-RFC-017 1
18 2-p Neutral Cable IEC3-NTR-018 1
19 Rubber Mount IEC3--RBF-019 4
20 Mounting Screw IEC3-MTS-020 8
21 Volume Control Knob IEC3-VCK-021 1
22 Footswitch Receptacle IEC3-FSR-022 1
23 Overlay IEC3-OVL-023 1
- NOT USED -

28
Part 1
Bottom Cover

Part 3
Rear Panel

29
Part 2
Top Cover
Bottom View
Title
120-IEC Enclosure
Drawing No.
3-080901
Rev. Scale: Sheet:
1001 1:1 1 of 12
Drawn by
3/5/01 Myriatha St-fleur
Part 4
Speaker

30
Title
120-IEC Mounting Speaker
Drawing No.
3-080901
Rev. Scale: Sheet:
1001 1:1 2 of 12
Drawn by
3/5/01 Myriatha St-fleur
31
Part 2
Top Cover

Title
120-IEC Top Enclosure
Drawing No.
3-080901
Rev. Scale: Sheet:
1001 1:1 3 of 12
Drawn by
3/5/01 Myriatha St-fleur
Part 18
2 Pin Neutral Cable

Part 5
Matching Board

32
Title
120-IEC Assembly Matching Board
Drawing No.
3-080901
Rev. Scale: Sheet:
1001 1:1 4 of 12
Drawn by
3/5/01 Myriatha St-fleur
Part 16
10 Pin
Display Cable

33
Title
120-IEC Display Board
Drawing No.
3-080901
Rev. Scale: Sheet:
Part 6 1001 1:1 5 of 12
Display Board Drawn by
3/5/01 Myriatha St-fleur

Part 6
Display Board
Part 17
Part 16 4 Pin
10 Pin RF Cable
Display Cable

34
Connected
to
Part 14
Part 15
5 Pin
10 Pin
Power Cable
Audio And
Sensor Cable

RV301
Title
TP301
120-IEC Assembly Main Board
Part 4 Connected to Drawing No.
Main Board Part 12 3-080901
Connected to Rev. Scale: Sheet:
3 Pin
1001 1:1 6 of 12
Part 13 Foot Switch Cable Drawn by
Audio Cable 3/5/01 Myriatha St-fleur
Bottom Cover

Matching Board

35
E2
TP4 E1
RV1
TP2
Title
120-IEC Cable Assembly
Speaker Drawing No.
RV2 3-080901
Rev. Scale: Sheet:
TP3 1001 1:1 7 of 12
TP1 Drawn by
3/5/01 Myriatha St-fleur
Part 8
Power
Transformer
Part 12
3 Pin
Foot Switch Cable
Part 7
3 Pin
Audio Cable

36
Title
120-IEC Cable Assembly
Part 14 Drawing No.
5Pin Power 3-080901
Cable Rev. Scale: Sheet:
1001 1:1 8 of 12
Drawn by
3/5/01 Myriatha St-fleur
Part 9 Display Board
Power Supply
System

37
Title
120-IEC Power Assembly
Drawing No.
3-080901
Rev. Scale: Sheet:
1001 1:1 9 of 12
Drawn by
3/5/01 Myriatha St-fleur
Main Board
Part 10
Input Power
Modular

Display Board

38
Title
120-IEC Assembly Drawing
Drawing No.
3-080901
Rev. Scale: Sheet:
Part 11 1001 1:1 10 of 12
Power Switch Drawn by
3/5/01 Myriatha St-fleur
Part 9
Rubber Mount
(4 Pls)

Part 20
Screw
(11Pls)

Display PC Board

39
Title
120-IEC Assembly Drawing
Drawing No.
3-080901
Rev. Scale: Sheet:
Top Cover
1001 1:1 11 of 12
Drawn by
3/5/01 Myriatha St-fleur
CUTTING
CUTTING MODE
MODE ENERGIZED
POWER
SELECT
SELECT CUT
CUT ellman
llman
FOOTSWITCH CUT/C OAG
CUT/COAG
FOOTSWITCH

INDICATOR COAGULATION MODE


COAGULATION MODE ENERGIZED 4.0 Dual RF
MODE POWER
SELECT
SELECT HEMO
HEMO
FAULT
FAULT
FULGURATE
FULGURATE
BIPOLAR
BIPOLAR
NEUTRAL
NEUTRAL
120 IEC
120 IEC

40
FINGERSWITCH / HANDPIECE BIPOLAR HANDPIECE ON/OFF
NEUTRAL !

Title
120-IEC Front Panel
Drawing No.
3-080901
Rev. Scale: Sheet:
1001 1:1 12 of 12
ERROR CODES TROUBLESHOOTING TABLE
ERROR CODE DESCRIPTION CORRECTIVE ACTION
1 Interface to displays failed Replace Display Board
2 Interface to LEDS failed
3 Interface to Keypads failed Replace Overlay Keypad. If this does not correct error
then replace Display Board
4 Processor had warm reset Re-Seat Processor. If this does not correct error then
replace MAIN BOARD and the MATCHING AND
SENSING BOARD *
5 N/A
6 N/A
7 A/D converter error Re-Seat Processor. If this does not correct error then
replace MAIN BOARD and the MATCHING AND
SENSING BOARD *
8 Footswitch/ Fingerswitch Perform calibration of Footswitch and Fingerswitch If
interface failed this does not correct error then replace MAIN BOARD
and the MATCHING AND SENSING BOARD *
9 Bond sensor interface failed Perform Calibration of Bond Sense If this does not
correct error then replace MAIN BOARD and the
MATCHING AND SENSING BOARD *
10 Keypad pressed during Replace Membrane Board. If this does
power up protection failed not correct error then replace Display Board
11 Footswitch/ Fingerswitch pressed Replace Footswitch or Fingerswitch and cables
during power up protection failed
12 Temperature out of limits Turn off unit and allow to cool down
13 Output power test failed Replace MAIN BOARD and the MATCHING AND
SENSING BOARD *
14 N/A
Re-Seat Processor and EEPROM. If this does not
15 Linear Table in Error
correct error then replace MAIN BOARD and the
16 EEPROM Read
MATCHING AND SENSING BOARD *
17 EEPROM Write

*The MAIN BOARD and the MATCHING AND SENSING BOARD is a Matched Set and must be replaced
together.

41
ALIGNMENT PROCEDURES FOR THE
SURGITRON® 4.0 DUAL RF/120

REQUIRED EQUIPMENT NEEDED

The following Equipment is required in the testing and alignment of the SURGITRON® 4.0 DUAL RF/120

ITEM Description Qty Manufacturer Manufacturer P/N Vendor Vendor P/N


1 8-inch Neutral jumper 1
2 8- inch Handpiece jumper 1
3 Digital Multimeter 1 Fluke
4 Digital Oscilloscope 1 Tektronix
5 High Voltage Scope 1 Tektronix P5100
Probe X100
6 330 Ohm _ watt Resistor 1
7 1k Ohm _ watt Resistor 1
8 Viskay Power Resistor, 1 Viskay/Dale NH250500R0FJ01 Mouser 71-NH250-500
500 Ohm, 250 watt
9 Electrical Safety Analyzer 1 Fluke Biomedical EIC601
10 Electrosurgery 1 Fluke Biomedical RF303RS
Performance Analyzer

DC VOLTAGES

1. Disconnect the connector on J601.


2. Confirm with a DVM the DC voltage between Pins 1 to 2 of the connector is 28 Volts.
3. Confirm with a DVM the DC voltage between Pins 3 to 6 of the connector is 36 Volts.
4. Confirm with a DVM the DC voltage between Pins 4 to 6 of the connector is 18 Volts.
5. Confirm with a DVM the DC voltage between Pins 1 to 6 of the connector is 56 Volts.
6. Reconnect the J601 Connector

BOND SENSE CALIBRATION

1. Place a 330W Resistor across into the Ground Plate (neutral) connector J2-1 and J2-2 on front panel of Unit.
2. Monitor the voltage between TP2 and TP4 (Ground) of the Matching and Sensing Board with a DVM.
3. Adjust RV1 to 3.2 Volts.
4. Replace the 330W Resistor with a 1KW Resistor.
5. Monitor the voltage between TP2 and TP4 (Ground) with a DVM and confirm that the voltage
present is 3.7 Volts.

42
FOOTSWITCH CALIBRATION

1. Set the Power Levels for Cutting Mode and Coagulation Mode to Zero.
2. Monitor the voltage between TP301 and Q201 E2 (Ground) of Main Board with a DVM.
3. Press the CUT Footswitch.
4. Adjust RV301 to 2.9 Volts.
5. Press the COAG Footswitch and confirm that the voltage is 1.6 Volts.
6. Confirm that the voltage is 4.5 Volts with Neither the CUT or COAG Footswitches Pressed.

FINGERSWITCH CALIBRATION

1. Set the Power Levels for Cutting Mode and Coagulation Mode to Zero.
2. Connect the Fingerswitch Probe Pin 1 to E1 and Pin 2 to E2 of the Matching and Sensing Board using 2
(two) Alligator clip jumpers.
3. Monitor the voltage between TP1 and TP3 (Ground) of the Matching and Sensing Board with a DVM.
4. Press the CUT Fingerswitch.
5. Adjust RV2 to 3.1 Volts.
6. Press the COAG Fingerswitch and confirm that the voltage is 3.8 Volts.
7. Press the HEMO Fingerswitch and confirm that the voltage is 1.6 Volts.
8. Confirm that the voltage is 4.5 Volts with Neither the CUT, COAG or HEMO Fingerswitches Pressed.

ALTERNATE PERFORMANCE PROCEDURES FOR THE


SURGITRON® 4.0 DUAL RF/120

Using an RF303RF Electrosurgery Performance Analyzer or equivalent check out the Bipolar output of the SUR-
GITRON® 4.0 DUAL RF/120 conforms Figure 4.3.1

Since Electrosurgery Performance Analyzers are not calibrated for measurements at


4 MHz, Monopolar performance must use the following procedure:

1. Connect a 500-ohm load to the IEC using the 8-inch Jumpers and connect the P5100 High Voltage Scope
Probes across the 500-ohm load.

**Caution: do not use a normal scope probe as it could result in damage to the oscilloscope.
2. Measure the Peak Volts across the 500 ohm load and confirm using the table below that the unit is within
limits.

Percent Power Output Power (Watts) Peak Volts Limits


0 0 0 0 0
5 15 122 110 331
10 26 161 144 380
15 36 190 170 412
20 45 212 190 436
25 53 230 206 454
30 60 245 219 468
40 73 270 242 492
50 85 291 261 511
60 95 308 276 525
70 103 321 287 536
80 109 330 295 544
90 115 339 303 551
100 120 346 310 557

Using an EIC601 Electrical Safety Analyzer or equivalent check that the SURGITRON® 4.0 DUAL RF/120 is
within limits for Electrical Safety as per IEC60601

Rules to Prevent damage to the IEC3a Unit


1. Never run unit for long periods of time over 30∞ C. When the transistor reaches 40∞ C damage will occur
2. Check Mono-polar and Bi-polar at 5% power to check for output.
3. When using the 500W load on Mono-Polar Mode, Start at 5% power. Then slowly increase Power
4. Never let the load resistor become too hot, it will cause them to fail

44
45
49
50
NOTES
0413

BM-543-f

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