BC Biomedical ESU-2300 User Manual

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Electrosurgical

Unit Analyzer

ESU-2300

USER MANUAL

Page 2

Page 3

BC BIOMEDICAL

ESU-2300

TABLE OF CONTENTS

WARNINGS, CAUTIONS, NOTICES ........................................................................... 2

DESCRIPTION............................................................................................................. 7

OVERVIEW.................................................................................................................. 9

SCREENS.................................................................................................................... 17

POWER UP SETTINGS............................................................................................... 24

TEST SETUPS............................................................................................................. 26

ERROR MESSAGES ................................................................................................... 48

DFA

TECHNOLOGY .................................................................................................. 50

MANUAL REVISIONS.................................................................................................. 51

WARRANTY................................................................................................................. 51

SPECIFICATIONS ....................................................................................................... 52

NOTES......................................................................................................................... 54

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WARNING - USERS

The ESU-2300 Analyzers are for use by

skilled technical personnel only.

WARNING - USE

The ESU-2300 Analyzers are intended for testing

only and they should never be used in

diagnostics, treatment or any other capacity

where they would come in contact with a patient.

WARNING - MODIFICATIONS

The ESU-2300 Analyzers are intended for use

within the published specifications. Any

application beyond these specifications or any

unauthorized user modifications may result in

hazards or improper operation.

WARNING - CONNECTIONS

All connections to patients must be removed

before connecting the Device Under Test (DUT)

to the Analyzer. A serious hazard may occur

if the patient is connected when

testing with the Analyzer.

Do not connect any leads from the patient

directly to the Analyzer or DUT.

WARNING - TEST LEADS

There are retractable ends on the test leads for

use with the ESU to avoid possible electric

shock, skin burns or personal injury.

Do not touch any metal on the

banana plugs or probes.

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WARNING - POWER SUPPLY

Unplug the Power Supply before

cleaning the surface of the Analyzer.

WARNING - LIQUIDS

Do not submerge or spill liquids on the Analyzer.

Do not operate the Analyzer if internal

components not intended for use with fluids may

have been exposed to fluid, as the internal

leakage may have caused corrosion and be a

potential hazard.

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CAUTION - SERVICE

The ESU-2300 Analyzers are intended to be

serviced only by authorized service personnel.

Troubleshooting and service procedures

should only be performed by

qualified technical personnel.

CAUTION - ENVIRONMENT

The ESU-2300 Analyzers are intended to

function between 15 and 30 °C.

Exposure to temperatures outside this range can

adversely affect the performance of the Analyzer.

CAUTION - VENTILATION

The ESU-2300 Analyzers include ventilation grills

on either side of the units to help prevent

overheating during operation. These grills and

internal fan should not be blocked.

Continuing to apply a high-level ESU signal

after an Error Message,

can result in damage to the unit.

CAUTION - CLEANING

Do not immerse. The Analyzer should be

cleaned by wiping gently with a damp, lint-free

cloth.

CAUTION - INSPECTION

The ESU-2300 Analyzers should be

inspected before each use for wear and

the Analyzer should be serviced

if any parts are in question.

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NOTICE – SYMBOLS

Symbol Description

Caution

(Consult Manual for Further Information)

RF Current Transformer

2002/95/EC, do not dispose of this product as unsorted municipal waste.

Per European Council Directive

NOTICE – ABBREVIATIONS

A/D

c centi- (10

CF Crest Factor

DFA Digital Fast Acquisition

DUT Device Under Test

ESU Electrosurgical Unit

Ext External

Hz hertz

Int Internal

k kilo- (10 kg kilograms kHz kilohertz VDC Direct Current Voltage

lbs pounds

Max Maximum

M Mega- (10

MHz Megahertz

µ micro- (10

µA microampere

m Milli- (10

mA milliampere

mHz millihertz

mm millimeter

ms millisecond

mV millivolts

Min Minimum

-2

)

-6

)

-3

)

# Number

Ω Ohm

PC Personal Computer

Pk Peak

% Percentage

RF Radio Frequency

RMS Root Mean Square

sec seconds

sec. section

US United States V Volt

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USER ASSUMES FULL RESPONSIBILITY FOR UNAUTHORIZED EQUIPMENT MODIFICATIONS OR APPLICATION OF EQUIPMENT OUTSIDE OF THE PUBLISHED INTENDED USE AND SPECIFICATIONS. SUCH MODIFICATIONS OR APPLICATIONS MAY RESULT IN EQUIPMENT DAMAGE OR PERSONAL INJURY.

BC GROUP INTERNATIONAL, INC. RESERVES THE RIGHT TO MAKE CHANGES TO ITS PRODUCTS OR SPECIFICATIONS AT ANY TIME, WITHOUT NOTICE, IN ORDER TO IMPROVE THE DESIGN OR PERFORMANCE AND TO SUPPLY THE BEST POSSIBLE PRODUCT. THE INFORMATION IN THIS MANUAL HAS BEEN CAREFULLY CHECKED AND IS BELIEVED TO BE ACCURATE. HOWEVER, NO RESPONSIBILITY IS ASSUMED FOR INACCURACIES.

NOTICE – CONTACT INFORMATION

NOTICE – DISCLAIMER

BC BIOMEDICAL

BC GROUP INTERNATIONAL, INC.

PO BOX 25125

9415 GENTRY AVE

ST. LOUIS, MO 63125

USA

1-800-242-8428

314-638-3800

www.bcgroupintl.com

sales@bcgroupintl.com

www.bcgroupintl.com

Made in the USA

10/07 Rev 01

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BC BIOMEDICAL

ESU-2300

ELECTROSURGICAL UNIT ANALYZER

The Model ESU-2300 is a high-accuracy Electrosurgical Analyzer. The “measurement engine” of the ESU-2300 is a specially-engineered True-RMS RF Ammeter and Wattmeter, particularly suited to measuring the complex RF waveforms produced by electrosurgical generators. The ESU-2300 has been designed to comply with electrosurgical manufacturer industry standard current sensing technology, and thus utilizes an internal precision RF Current Transformer. The analyzer utilizes a precision internal test load resistor network. The ESU-2300 is intended to be routinely used to measure the various parameters relating to the testing and performance validation of electrosurgical generators. The Patent Pending

DFA

Technology allows the ESU-2300 to aggressively digitize the complex electrosurgical generator waveform, analyze its components and provide highly accurate and stable results. It may be used as a stand-alone meter or in conjunction with a PC utilizing the optional software.

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The following are highlights of some of the main features:

• TRUE RMS READINGS USING PATENT PENDING DFA TECHNOLOGY

• INDUSTRY STANDARD CURRENT SENSING TECHNOLOGY

• RF CURRENT (mA) AND POWER (WATTS) CAN BE

DISPLAYED

• INTERNAL PRECISION LOAD RESISTOR NETWORK: 50 Ω TO 750 Ω OHMS IN 50 Ω INCREMENTS

• EXTERNAL LOAD RESISTOR CAPABILITY – USES THE EXTERNAL RESISTOR VALUE AS A DISCRETE VALUE OR ADD IT TO ANY INTERNAL LOAD RESISTOR VALUE

• 2.5% OF READING ACCURACY ON RF CURRENT (mA)

• 4% OF READING ACCURACY ON RF POWER (WATTS)

• INTERNAL LOAD RESISTOR NETWORK IS COOLED WITH

TEMPERATURE AND POWER CONTROLLED COOLING FAN

• USES AN INTERNAL 0.1:1 RATIO PRECISION RF CURRENT TRANSFORMER

• INDEPENDENT CQM (REM/ARM) RESISTOR NETWORK: 1 Ω TO 500 Ω IN 1 Ω INCREMENTS

• RF LEAKAGE MEASUREMENTS THROUGH 200 Ω TEST LOAD

• INTERNAL RECHARGEABLE BATTERY ALLOWS OPERATION

INDEPENDENT OF LINE POWER

• LARGE GRAPHICS DISPLAY WITH CURSOR SELECTION OF OPTIONS AND SETUP OF PARAMETERS

• DIGITAL DATA OUTPUT VIA USB

• REMOTE CAPABILITIES USING RS232 AND USB

• PC BASED INTERFACE PROGRAM OPTIONAL

• DIGITAL CALIBRATION – NO POTS TO TURN

• SELECTABLE DISPLAY OPTIONS

• TACTILE KEYS WITH AUDIO FEEDBACK

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STANDARD ACCESSORIES:

BC20 – 00125 ACCESSORY KIT (TEST LEADS) BC20 – 21105 UNIVERSAL POWER SUPPLY BC20 – 41352 COMMUNICATIONS CABLE (USB) BC20 – 41341 COMMUNICATIONS CABLE (RS232) BC20 – 205XX STANDARD POWER ADAPTER (International Options, see Page 15 for details)

OPTIONAL ACCESSORIES:

BC20 – 00232 BNC TO BNC CABLE BC20 – 41356 CD, ESU2300 INTERFACE SOFTWARE

VISHAY-DALE NH-250 PRECISION 1% TOLERANCE NON-INDUCTIVE LOAD RESISTORS:

BC20-00200 5 Ω, 250 WATT RESISTOR

BC20-00201 10 Ω, 250-WATT RESISTOR BC20-00202 20 Ω, 250-WATT RESISTOR BC20-00203 30 Ω, 250-WATT RESISTOR BC20-00204 50 Ω, 250-WATT RESISTOR BC20-00205 100 Ω, 250-WATT RESISTOR

BC20-00206 200 Ω, 250-WATT RESISTOR

BC20-00207 300 Ω, 250-WATT RESISTOR

BC20-00208 500 Ω, 250-WATT RESISTOR

BC20-00209 1000 Ω, 250-WATT RESISTOR

BC20-00210 2000 Ω, 250-WATT RESISTOR

BC20-00211 3000 Ω, 250-WATT RESISTOR

BC20-00212 4000 Ω, 250-WATT RESISTOR

BC20-00213 5000 Ω 250-WATT RESISTOR

BC20-00240 POWER RESISTOR BANANA JACK ADAPTER

(2 PER SET)

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OVERVIEW

This section looks at the layout of the ESU-2300 and gives descriptions of the elements that are present.

High Impact Kydex Case

Large LCD Graphical Display with High Intensity Backlight

Back Light Key for turning on and off the backlight

Ventilation Grill (Both Sides) for efficient load resistor cooling

Handle 5 Light Touch Keys for Dynamic functions: These keys are labeled in the bottom portion of the screen and change function based on operating mode.

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Oscilloscope Output BNC connector

Dispersive Jacks Banana Jacks for connection to generator patient return path

ux Test Load Jacks Banana Jacks for use during RF leakage tests

ctive Jack Banana Jack input for RF signal from generator

CQM Test Jacks Banana Jacks for use during CQM (REM/ARM) and

M Tests

REC

Loop Jack Banana Jack for use when an external load resistor is attached

Earth/Ground Jack Banana Jack for use connecting the unit to a ground when running Leakage Tests while utilizing battery powe

Earth/Ground Reference Jacks Banana Jacks for use during RF leakage tests

Power On/Off Rocker Switch

RS232 (DB9) Comm Port

USB

omm Port

LED Indicators Line Power Battery Charging

External Power Supply Kycon 3 position locking connector

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Accessory Kit, BC20 – 00125:

ctive

Leads

RECQM Lead (Prong)

CQM Lead (No Prong)

Dispersive Lead

Jumper Leads

Earth/Gound Lead

Banana Jack

lligator

Clips

Ground Lug

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GENERAL OPERATION

The ESU-2300 is controlled by 5 light touch keys for navigation, plus 1 light touch key for

LCD display backlight control. The navigation keys allow the user to move around within

the displayed parameters, select the desired options, choose a specific category and

control the setup for the unit. When a key is depressed there is an audio click when it is

accepted, or a “Razz” tone if the key is invalid.

A large LCD graphics display with high intensity white backlight provides the user with

information about the current status of the device configuration options, test results and

more. The display identifies the function of each key on a dynamic basis. As the operation

mode changes, the key functions change to suit the operating mode.

BACKLIGHT KEY

The Graphic LCD display may be viewed with or without the backlight. Depressing any key

will activate the backlight. However, since the backlight will drain the internal rechargeable

battery at an accelerated rate if left on, it will automatically be shut off after a user

programmable delay when running the ESU-2300 on battery power.

The key is provided to toggle the backlight on or off at any time.

NOTE: The backlight parameter in the System Setup screen may be set to Off, 1-20 sec or

Always On.

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FUNCTION KEYS

There are five keys that are used to provide general operational control. The

functions of the keys vary depending on the current screen. The section of the screen

just above the key indicates its current meaning.

NOTE: Only functions that are available to the user will be visible at any given time.

Sample Function Key Labeling

SERIAL COMMUNICATION

There are two serial ports on the side panel. One is a standard USB port and the other is a

DB9 RS232 port. The RS-232 Port is used for field Firmware upgrades via the FLASH

Update PC Utility and the USB Port is used to interface with a PC for remote control

operation or digitized electrosurgical waveform capture.

OSCILLOSCOPE OUTPUT

A BNC connector is provided to connect an oscilloscope to the unit. This output is an

uncalibrated attenuated version of the ESU Generator output waveform.

POWER SWITCH

The main power switch for the Analyzer is located on the side panel.

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LINE POWER

A Kycon 3 position locking connector is provided for the 9 VDC external universal power

supply for using the ESU-2300 with line power. When connected to line power, this

connection provides a connection for Earth/Ground.

NOTE: While operating the ESU-2300 on battery power, a Jumper Lead must be run

from the Earth/Ground Jack to an Earth/Ground point for all of the RF leakage tests.

(See Leakage Tests for more information.)

The Universal Power Supply takes a Standard Power Adapter Cable with Small

Standard Product Plug and Required International Connector (See Options Below).

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POWER UP SETTINGS

The unit may be setup to turn on using either the factory default settings or a custom set of

parameters as previously saved by the user (See Power Up Settings section for details).

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SCREENS

DISPLAY SCREEN

When the ESU-2300 is first powered up, the DISPLAY SCREEN will be shown. This

screen contains 1 or 2 DISPLAY ZONES, the LOAD SETTING and the available

FUNCTION KEYS. Each Display Zone can be customized to show the desired parameter

of RF RMS Current in mA or RF RMS Power in Watts. The Load Mode Setting can be set

to show the desired Internal, External and Internal/External loads. The Load Selection can

be set to change the internal, external, or internal plus external load resistances.

DISPLAY ZONES

Sample Display Screen with

The Display Zones can be toggled through using .

The parameters can be changed using the key to enter the Display

Parameters Configuration Screen.

one Display Zone

Sample Display Screen with two Display Zones

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LOAD SETTING

The Load Setting portion of the Display Screen shows the load selection and value that will

be used in testing. There are three load set up choices for testing with the ESU-2300:

Internal, External and Internal/External.

The Load Setting and value can be toggled through using the key to enter the

Display Parameters Configuration Screen.

In Internal mode, the user applies the Active Lead to the Active Jack and the Dispersive

Lead to the Dispersive Jack. The RF current is routed through the selected internal loads

and through the RF Current Transformer to measure the current and power.

In External mode, the user applies the Active Lead to the Active Jack and then connects

another lead from the Loop Jack to whichever external load resistor is in use. The

Dispersive Lead then goes to the other side of the external load resistor. In this mode, the

only component that sees the ESU Generator output in the ESU-2300 is the RF current

transformer. It is important to make sure that the external load resistance parameter in the

ESU-2300 is set to the real value of the external load(s) as this is what is used to calculate

Power.

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In Internal/External mode, the user applies the Active Lead to the Active Jack and then

connects another lead from the Dispersive Jack to whichever external load resistor is in

use. The Dispersive Lead then goes to the other side of the external load resistor. It is

important to make sure that the external load resistance parameter in the ESU-2300 is set

to the real value of the external load(s) as this is what is used to calculate Power.

FUNCTION KEYS

DISPLAY – This key will toggle between one or two Display Zones.

CHANGE – This key will enter the Display Parameters Configuration Screen where

parameters can be selected and changed.

HOLD – This key will freeze the current reading in the Display Zone.

RECQM – This key will enter the RECQM Test Screen.

SETUP – This key will enter the System Setup Screen.

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DISPLAY PARAMETERS CONFIGURATION SCREEN

The parameters on the DISPLAY SCREEN can be changed by using the key

to enter the DISPLAY PARAMETERS CONFIGURATION SCREEN. This screen adds a

highlight line to the DISPLAY SCREEN and changes the FUNCTION KEYS.

Sample Display Parameters Configuration Screen with the load value highlighted

Use the keys to highlight the parameter to change. The last

FUNCTION KEY will be . Use this key to return to the DISPLAY SCREEN.

Use the keys to sequence through the available values of the

highlighted parameter. The last FUNCTION KEY will be . Use this key to

save the current value.

NOTE: Using the keys to highlight the next parameter will also

save the current value.

NOTE: To save a custom configuration, see Power Up Settings section.

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SYSTEM SETUP SCREEN

The SETUP Mode allows the user to adjust the configuration of the unit. The SETUP

SCREEN can be entered using the key.

Sample System Setup Screen

Use the keys to highlight the parameter to change. The last

FUNCTION KEY will be . Use this key to return to the DISPLAY SCREEN.

Use the keys to sequence through the available values of the

highlighted parameter. The last FUNCTION KEY will be . Use this key to

save the current value.

NOTE: Using the keys to highlight the next parameter will also

save the current value.

NOTE: To save a custom configuration, see Power Up Settings section.

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The following is a breakdown of the parameters available in the configuration of the unit

and their available options:

System Setup Configuration

Parameter Description Range

Off, 0-20 sec,

Always on

(Factory Default = 10)

0-100% (Read Only)

Battery or Line

(Read Only)

Defaults

Custom

Set Current as Custom

Backlight

Battery Life

Power Source

Power up with

Controls whether the backlight is on or off or how long to wait for user input before automatically turning off the backlight in battery powered mode.

Displays remaining battery life (charge) in percent

Displays whether the unit is on battery power or line powered

Determines the power up mode of the ESU-2300. The default mode shows a single mA parameter display. Set this parameter to custom to display the saved startup mode. Set this parameter to Save current as custom to save the settings for the next time power is cycled.

1024 2048 4096

8192 16384 32768

Num A/D Samples

Sets the number of A/D converter readings used in each mA RMS computation. A higher setting requires more computation and is slower, but results in a more stable reading.

(Factory Default =

32768)

Sets the number of mA RMS readings that are

Display Averaging

Software

averaged. A higher number will cause the display to update slower, but will give a more stable reading.

Displays current software program.

1-30 Readings

(Factory Default = 15)

(Read Only)

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CQM/RECQM (REM/ARM) TEST SCREEN

The RECQM TEST SCREEN can be entered using the key from the

DISPLAY SCREEN.

Sample RECQM Test Screen

Use the keys to change the value of the resistance setting. This

setting ranges from 1 Ω to 500 Ω in 1Ω increments. The last FUNCTION KEY will be

. Use this key to return to the DISPLAY SCREEN.

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POWER UP SETTINGS

The ESU-2300 allows the user to customize the settings that the unit will have on Power

Up. The “Power up with” parameter in the System Setup Menu allows for the selection of

either Default or Custom selections.

Use to enter the SETUP SCREEN. Use the keys to

highlight the “Power up with” parameter.

Use the keys to change the parameters to Default, Custom or Set

Current as Custom. The last FUNCTION KEY will be . Use this key to

save the current value.

NOTE: Using the keys to highlight the next parameter will also

save the current value.

The last FUNCTION KEY will then be . Use this key to return to the

DISPLAY SCREEN.

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Default

If this option is selected, the unit will power up to the dual display zone screen, which will:

• Show the mA and Watts readings

• Put the ESU-2300 into Internal Load mode

• Use 300 ohms as the default internal load

Custom

If this option is selected, the unit will Power Up using the unique sets of parameters that

were last customized and saved by the user. The DISPLAY SCREEN will use the

parameters in the Display Zones that were last configured and saved by the user.

Set Current as Custom

This choice is provided to create the set of custom startup screen parameters. The user

simply configures each screen to show the desired parameters and then enters the Set

Current as Custom choice in the SETUP SCREEN. The current configuration is saved as

the Custom Power Up values and will be used when the “Power up with” parameter is set to

Custom. This configuration will remain the Custom configuration until it is written over

using the Set Current as Custom option in the “Power up with” parameter.

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TEST SETUPS

The purpose of this test is to verify the output accuracy of the Electrosurgical Generator

Device Under Test (DUT) at a given RF power setting, based on the selected internal

precision test load (50 Ω to 750 Ω in 50 Ω increments) from the ESU-2300 resistor

network. The ESU-2300 should always be set to match the electrosurgical generator

manufacturer’s specified test load for the mode and output waveform selected.

Connections

Monopolar ouputs:

1. Yellow Active Lead from Active Jack on ESU-2300 to DUT Output.

GENERATOR OUTPUT TESTS USING INTERNAL

2. Blue Dispersive Lead from Dispersive Jack on ESU-2300 to DUT Dispersive.

ESU (DUT)

Active

Electrode

ESU (DUT)

Patient Return/

Dispersive

Electrode

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Bipolar outputs:

1. Yellow Active Lead from Active Jack on ESU-2300 to DUT Bipolar Output

Electrode #1.

2. Second Yellow Active Lead from Dispersive Jack on ESU-2300 to DUT Bipolar

Output Electrode #2.

Bipolar

Electrode #1

ESU-2300 Screen

ESU (DUT)

Bipolar

Electrode #2

DISPLAY SCREEN with LOAD SETTING set to Internal and Load Value set to the

desired number.

Results

Watts reading on DISPLAY SCREEN will display the measured power through the

currently selected load resistance. The DUT specs should be verified based on this

information.

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Information

Many electrosurgical generators vary their output power based on the measured load

impedance (the resulting electrical impedance of the human tissue being cut or

coagulated). One such trade-name for this functional characteristic is “Tissue

Response Technology” (which was originally offered by Covidien Valleylab, Boulder,

Colorado). They start out by applying a lower power signal to measure the load, and

then adjust the final output to match what is set on the front panel control setting.

When testing electrosurgical generators that utilize this level of technology, it is

advisable to give the ESU-2300 analyzer a few seconds to accurately measure the final

power of the generator. There is almost always a specified power curve that plots

output power to load resistance. Many electrosurgical generators have a peak power at

around 300-500 ohm range, with decreased delivered power to the actual load at lower

and higher impedances.

A typical power output vs. test load impedance “load curve” for an electrosurgical

generator is as follows:

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GENERATOR OUTPUT TESTS WITH EXTERNAL LOADS

The purpose of this test is to verify the output accuracy of the Electrosurgical Generator

Device Under Test (DUT) at a given RF power setting, based upon an attached external

load resistor. The external load resistor attached to the ESU-2300 should always be set

to match the electrosurgical generator manufacturer’s specified test load for the mode

and output waveform selected.

Connections

Monopolar:

1. Yellow Active Lead from Active Jack on ESU-2300 to External Load.

2. External Load to DUT Output.

3. Blue Dispersive Lead from Loop Jack on ESU-2300 to DUT Dispersive.

ESU (DUT)

Active

ESU (DUT)

Patient Return/

Dispersive

Electrode

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Bipolar:

1. Yellow Active Lead from Active Jack on ESU-2300 to External Load.

2. External Load to DUT Bipolar Output Electrode #1.

3. Second Active Lead from Loop Jack on ESU-2300 to DUT Bipolar Output

Electrode #2.

ESU (DUT)

Bipolar

Electrode #1

ESU (DUT)

Bipolar

Electrode #2

ESU-2300 Screen

DISPLAY SCREEN with LOAD SETTING set to External and Load Value set to the

desired number.

Results

Watts reading on DISPLAY SCREEN will display the measured power through the

external load resistance(s). The DUT specs should be verified based on this

information.

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