analizador electrobisturi_qaesu_1.30-3

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QA-ESUser Manual

QA-ES Electrosurgical Analyzer

P/N 14025V1.30-3


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Copyright 2002 by METRON. All rights reserved.

METRON:USA _ FRANCE ________________ NORWAY________________ 1345 Monroe NW, Suite 255A 30, rue Paul Claudel Travbaneveien 1Grand Rapids, MI 49505 91000 Evry, France N-7044 Trondheim, NorwayPhone: (+1) 888 863-8766 Phone: (+33) 1 6078 8899 Phone: (+47) 7382 8500Fax: (+1) 616 454-3350 Fax: (+33) 1 6078 6839 Fax: (+47) 7391 7009E-mail: [email protected] E-mail: [email protected] E-mail: [email protected]

Disclaimer METRON provides this publication as is without warranty of any kind, either express or implied,

including but not limited to the implied warranties of merchantability or fitness for any particular purpose. Further, METRON reserves the right to revise this publication and to make changes from time totime to the content hereof, without obligation to METRON or its local representatives to notify any per-son of such revision or changes. Some jurisdictions do not allow disclaimers of expressed or impliedwarranties in certain transactions; therefore, this statement may not apply to you.Li mited Warranty

METRON warrants that the QA-ES Electrosurgical Analyzer will substantially conform to publishedspecifications and to the documentation, provided that it is used for the purpose for which it was de-signed. METRON will, for a period of twelve (12) months from date of purchase, replace or repair anydefective system, if the fault is due to a manufacturing defect. In no event will METRON or its localrepresentatives be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of or inability to use the QA-ES Electrosurgical Analyzer, even if advised of the possibility of such damages. METRON or its local representatives are not responsible for any costs, loss of profits,loss of data, or claims by third parties due to use of, or inability to use the QA-ES Electrosurgical Ana-lyzer. Neither METRON nor its local representatives will accept, nor be bound by any other form of guarantee concerning the QA-ES Electrosurgical Analyzer other than this guarantee. Some jurisdictionsdo not allow disclaimers of expressed or implied warranties in certain transactions; therefore, this state-ment may not apply to you.
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


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Table of Con tents

1.1 QA-ES Description ................................................................................................................ 1-1 1.2 QA-ES Specifications ............................................................................................................ 1-1 1.3 General Information ............................................................................................................... 1-2 2.1 Receipt, Inspection and Return ........... .......... ........... .......... .......... ........... .......... ........... ......... 2-1 2.2 Setup ...................................................................................................................................... 2-1 2.3 PRO-Soft QA-ES ................................................................................................................... 2-2 3.1 Control Switches and Connections .......... .......... ........... .......... ........... .......... ........... .......... .... 3-1 3.2 QA-ES Menu and Function Keys .......................................................................................... 3-3 3.3 LCD Display Menu/ Messages (Overview) ........... .......... ........... .......... ........... .......... .......... . 3-3 3.4 LCD Display Menu/ Messages (Detail) .......... .......... ........... .......... ........... .......... ........... ....... 3-4 3.5 Printout .................................................................................................................................. 3-6 3.6 Foot Switch Output ................................................................................................................ 3-6 3.7 Main Switch On/Off ............................................................................................................... 3-6 4.1 Power Output Tests ................................................................................................................ 4-1 4.2 HF Current Leakage ............................................................................................................... 4-3 4.3 REM Alarm............................................................................................................................ 4-5

Appendix A Glossary of terms ...........................................................................................................A-1

Appendix B Error Report Form.........................................................................................................B-1

Appendix C Improvement Suggestion Form .....................................................................................C-1


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Manual Revis io n Record

This record page is for recording revisions to your QA-ES User & Service Manual that have been published by METRON AS or its authorized representatives. We recommend that only the man-agement or facility representative authorized to process changes and revisions to publications:

make the pen changes or insert the revised pages;

ensure that obsolete pages are withdrawn and either disposed of immediately, or marked as superseded and placed in a superseded document file, and;

enter the information below reflecting that the revisions have been entered.

Rev No Date Entered Reason Signature of Person Entering Change1.30-2 3-18-02 General Update

1.30-3 2007.01.22 Removed service informatin


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1. In t ro duc t ion

This chapter describes the METRON QA-ES Electrosurgical Analyz-er, including its features and specifications.

1.1 QA-ES DescriptionThe METRON QA-ES Electrosurgical Analyzer (QA-ES) is a preci-sion instrument designed to perform tests on high-frequency electro-surgical units (ESU) in accordance with national and internationalstandards, and is designed to be used by trained service technicians.Tests include:

automatic power distribution measurement;crest factor measurement;RF leak measurement, and;

return electrode monitor (REM) testTesting is accomplished by measuring the ESU output against testloads that are set and adjusted in the QA-ES. The QA-ES can auto-matically execute a power distribution test with a load resistance rang-ing from 10 ohms to a maximum of 5200 ohms. The automatic mea-suring of the QA-ES, comprising crest factor measurements with a

bandwidth of 10 MHz, ensures that the test result is reliable and re- producible.

Test results, shown in the QA- ES s LCD display, can be printed outdirectly, or transferred to a PC via the PRO-Soft QA-ES test automa-tion software. PRO-Soft lets you design test protocols, remotely con-trol the QA-ES, and store the test results.

1.2 QA-ES Specifications

Generator Output: RF LEAKAGE: From active electrode or neutral plate with an open or closed loadcircuit.

Mode Of Operation: Manual or user-programmable. Can beremotely controlled with PC utilizing acces-sory PRO-Soft QA-ES software and RS-232communication cable connection.

Measurements: True RMS value of applied waveform.

RMS Bandwidth: 30 Hz to 10 MHz (+3 dB).

Low Frequency Filter: 100 Hz filter to avoid low frequency distur-bance and/or interference.

Current: 20 mA to 2200 mA.

Current Accuracy: 20 - 2200 mA 2% of reading.

Load Resistance: 10 - 2500 ohms in steps of 25 ohms (@ dc).2600 - 5200 ohms in steps of 100 ohms (@


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dc).

Additional Fixed Load: 200 ohms, 500 watt maximum.

Crest Factor: The higher of the two peak-measurementsis used for calculation.

Range: 1.4 - 16 (V peak voltage / V RMS).

Foot Switch Output: The output triggers the measurement after aprogrammed delay time, defined as the timeperiod from the activation of the foot switchto the beginning of data processing. Thedelay time is 200 ms - 4000 ms.

Peak To Peak Voltage: 0 to 10 kV (closed load only) 10%. Mea-surement is taken between the active anddispersive electrodes with closed load only.

Oscilloscope Output: 5 V/A uncalibrated, 100 mA RF currentminimum input.

Isolation: 10 kV isolation between measurement de-vice and enclosure.

1.3 General InformationTemperature Requirements:

+15 C to +35 C when operating0 C to +50 C in storage

Display: Type LCD graphic display

Alphanumeric format 8 lines, 40 charactersGraphics mode: 240 x 64 point matrixDisplay control: 5 F-keys, enter, cancel and an encoder

Data Input/ Output (2): Parallel printer port (1); Bi-directional RS -

232C (1) for Computer control

Power Source: From 115 VAC to 230 VAC, 48/66 MHz.

Mechanical Specifications:Housing Metal caseHeight 13.2 cm / 4.48 in.Width 34.2 cm / 11.61 in.Length 39.5 cm / 13.41 in.Weight 9.8 kg / 21.6 lbs.

Standard Accessories: QA-ES Electrosurgical Analyzer (P.N. 14010)

Power Cord (P.N. 14300)QA-ES User and Service Manual (CD) (P.N. 14025)

Additional Accessories: E-Input Measuring Cable - Black (P.N. 11451)


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E-Input Measuring Cable - Red (P.N. 11452) Alligator Clamp - Black (P.N. 11461) Alligator Clamp - Red (P.N. 11462)Carrying case (P.N. 14100)

PRO-Soft QA-ES software (P.N. 12200)PRO-Soft QA-ES DEMO (P.N. 14201)PRO-Soft QA-ES User Manual (CD) (P.N. 14225)

Storage: Store in the carrying case in dry surroundings within the temper-ature range specified. There are no other storage requirements.

Periodic Inspection: The unit should be calibrated every 12 months.


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2. Ins tal lat ion

This chapter explains unpacking, receipt inspection and claims, andthe general procedures for QA-ES setup.

2.1 Receipt, Inspectionand Return

1. Inspect the outer box for damage.

2. Carefully unpack all items from the box and check to see that youhave the following items:

QA-ES Electrosurgical Analyzer (PN 14010)

Power Cord (PN 14300 )

QA-ES User and Service Manual (CD) (PN 14025)

3. If you note physical damage, or if the unit fails to function ac-cording to specification, inform the supplier immediately. WhenMETRON AS or the company s representative, is informed,measures will be taken to either repair the unit or dispatch a re-

placement. The customer will not have to wait for a claim to beinvestigated by the supplier. The customer should place a new

purchase order to ensure delivery.

4. When returning an instrument to METRON AS, or the companyrepresentative, fill out the address label, describe what is wrongwith the instrument, and provide the model and serial numbers. If

possible, use the original packaging material for return shipping.Otherwise, repack the unit using:

a reinforced cardboard box, strong enough to carry theweight of the unit. at least 5 cm of shock-absorbing material around the unit. nonabrasive dust-free material for the other parts.

Repack the unit in a manner to ensure that it cannot shift in the box during shipment.

METRON s product warranty is on page ii of this manual. Thewarranty does not cover freight charges. C.O.D. will not be ac-cepted without authorization from METRON A.S or its repre-sentative.

2.2 Setup

1. Equipment connection is as shown in the typical setup below (for Power Distribution Test).


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2. If you are using an oscilloscope, attach the BNC cable to theScope Output connector, located on the front of the QA-ES.

3. If PRO-Soft QA-ES is being used, attach an RS-232 (null mod-em/data transfer configured) cable to the 9-pin D-sub outlet portlocated at the rear of the QA-ES. Do not attach the printer cableto the QA-ES. See below . However, if you are not using PRO-Soft QA-ES, and are sending directly to a printer for printouts, at-tach the printer cable to the 25-pin outlet port.

2.3 PRO-Soft QA-ESPRO-Soft QA-ES is a front-end test automation and presentation toolfor METRON's ESU Performance Analyzer. It allows you to conductthe same tests, but by remote control via an IBM-compatible PC/XTwith MS Windows (Version 3.1 or later). Additionally, the programhas features to enhance your QA- ES s performance.

Each of the QA-ES tests can be run independently from PRO-Soft inthe Manual test mode. Results are shown on the PC screen duringtesting, and the user is prompted to set the tested equipment accor-dingly. At the conclusion of tests, the user may print a report, store thetest and results on disk, or both. Combinations of tests can be created

CAUTION

The QA-ES uses a 3-wire

power cord and plug for the user's safety. Use thispower cord in conjunctionwith a properly groundedelectrical outlet to avoidelectrical shock.


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and stored as Test Sequences. The program maintains a library of these sequences. In this way you can store and retrieve sequences thatare appropriate for each ESU being tested at your facility.

Sequences can then be used independently, or can be attached to achecklist, written procedure, and equipment data in the form of a testProtocol. The equipment data can be entered manually into the pr o-tocol, or it may be retrieved by PRO-Soft from a database program, or other equipment files. Protocols can be created easily for each ESU inyour inventory, and stored for use. Test protocols with results can be

printed, or stored on disk, and the results of testing can be sent back to the equipment database to close a work order and update the ser-vice history.

NOTE

PRO-Soft QA-ES has itsown user manual, whichcontains all the informationconcerning the program. If you order a demonstrationversion of the program youalso receive the manual.


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3. Operat in g QA -ES

This chapter explains the operating controls, switches and menusof the QA-ES, and details how to use them in ESU testing.

3.1 Control Switchesand Connections

Front Panel

1. Power Switch Turns the power on and off.

2. Encoder Sets values according to the specified range andchoose between different operations/ measurementranges.

3. Enter Admits newly specified information.

4. Cancel Cancels a new value and returns to previously cho-sen value.

5. LCD Display Shows messages, test results and function menus.

6. Function Keys Fl - F5 are used to select the functions shown onthe bottom line of the LCD display, i.e., for selectingthe function that is directly above the key.

7. RF-Detect Indicates when the ESU is activated.

8. Remote Indicates that REMOTE CONTR. (F4) has beenpressed.

9. Scope OutputConnector

BNC-cable connector for attenuator signal in realtime. (When oscilloscope output is desired.)


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3.2 QA-ES Menu andFunction Keys

The QA-ES uses a display, programmable function keys and a settingregulator to provide flexibility and control over the operations. The

upper part of the screen displays messages, status and results. Themenu bar is at the bottom of the display. The function keys are num-

bered from Fl to F5. A function is selected by pressing the key lo-cated directly under the Menu Item displayed in the menu bar.

3.3 LCD Display Menu/Messages (Overview)


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3.4 LCD Display Menu/Messages (Detail)

1. Startup Screen . The following screen will be displayed for 2seconds after the QA-ES has been switched on.

2. Main Menu

a. First Menu Bar (Page 1)

b. Second Menu Bar (Page 2)

3. SHOW CHOICES (F1). This function is activated when yousee an ast erisk (*) in the status field under Mode. Choose a testfunction by pressing UP (F2) or DOWN (F3) . (The encoder canalso be used for choosing a test function) Press ENTER (F5) tosave it under Mode in the STATUS field. Press CANCEL (F4)

to undo.

4. KNOB PARAM. (F2). With this function, you can choose be-tween Mode, Load and Delay in the STATUS field. (*marks the active item). If you choose Load , use the encoder toset the load from 10 ohms to 5200 ohms in steps of:

25 ohms from 50 ohms to 2500 ohms. 100 ohms from 2500 ohms to 5200 ohms.

Save the selected load in Mode under the STATUS field by pressing ENTER (F5) . Press CANCEL (F4) to undo. If you


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3.5 Printout

Press PRINT HEADER (F3) before printing out a page if you wantit to have a new heading. The QA-ES automatically prints out the test

results via the printer output after every measurement. See examplebelow.

3.6 Foot Switch Output A Foot Switch Output is activated by use of relays (K11), and locatedon the right side of the unit. This is used to trigger the foot switch in-

put on the ESU being tested.

3.7 Main Switch On/Off

The QA-ES has to be turned off for at least 5 seconds before turning iton again to allow the reset circuit to unload.


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4. ESU Tests w ith QA -ES

This chapter describes the tests that can be conducted by the QA-ESon an ESU, as well as the features available with the PRO-Soft QA-ES software accessory.

There are five available test modes with the QA-ES. They are:1) Continuous Operation, 2) Single Operation, 3) Power Distribution,4) RF Leakage, and 5) REM Test. These tests are accessed using thefollowing steps:

1. Push the F2 function button until the asterisk (*) symbol is in theMode position.

2. Turn the Encoder knob until the desired test mode appears on thescreen, then press the Enter button.

4.1 Power Output Tests

Power output tests can be done with the QA-ES in the ContinuousOperation, Single Operation, or Power Distribution mode, as de-scribed below. These tests check the power output characterist ics of the ESU and provide output current (A), power (W), peak-to-peak voltage (V), and crest factor values.

The following standards and setup diagram apply to any of the power output test modes.

Per IEC 601-2-2 the power output cannot be reduced by more than10W, or 5% of the minimum power output level. Per ANSI/AAMI

HF18-1993 the power output must be within 20% of the ESU manu- facturers specifications.

Load Res i s tance Range

Equ i pm e n t IEC ANSI/AAMI

Monopolar 100 - 1000 ohms 50 - 2000 ohms

Bipolar 10 - 500 ohms 10 - 1000 ohms


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Test setup for ESU power output tests:

Continuous Operation Test

In the Continuous Operation mode the QA-ES continues to take mea-

surements once the START key is pressed. The test is not completeduntil the STOP key is pressed. The QA-ES acts much like a meter during the test, showing increasing and decreasing values, as receivedfrom the ESU.

To run a test in Continuous Operation:

1. Set the test mode for * Cont. Oper .

3. Set the test load as required for the test.

4. Press the START (F3) key to begin testing.

5. Activate the ESU and note measurements on QA-ES.

6. Press STOP (F3) to end test.

Single Operation Test

In the Single Operation mode the QA-ES makes a single measurementof the ESU output after the set delay time. After the measurement istaken the test automatically stops.

To run a test in Single Operation:

1. Make connections between the QA-ES and ESU as shown above.

2. Set the test mode for *Singl. Oper.

3. Set the test Load as required for the test.

4. Set the Delay time as desired fort the test.4. Set and activate the ESU.

5. Press the START (F3) key to take a measurement. After the setdelay, the values will be recorded and displayed on the screen.


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6. After taking a measurement, the QA-ES is automatically reset andready for additional testing.

(If the QA-ES is connected to a printer, a line of test result is writtento the printer following each Single Operation test.)

Power Distribution Test

The Power Distribution test allows the user to check the power output performance of the ESU over a range of load resistances. The QA-ESallows you to specify a range of loads, over which you test the ESUoutput power to see if it is within the specified limits.

To run a Power Distribution Test:

1. Make connections between the QA-ES and ESU as shown above.

2. Set the test mode for *Power Dist. 3. Press the SETUP (F4) function key to access the setup menu for

this test.

4. Set the Start Load, End Load, and Step Size for the test. Use theKNOB PARAM. (F3) key, the Encoder knob, and Enter key tomake and confirm selections. Press QUIT MENU (F4) whenset.

5. Set and activate the ESU. (Keep ESU activated throughout test.)

6. Press the START (F3) key to begin test. The QA-ES will stepthrough the loads with a delay between each, as set in the testSETUP screen. Values are displayed on the screen for each load

as it steps through the test.(If the QA-ES is connected to a printer, a line of test result is writtenfor each step in the Power Distribution Test.)

4.2 HF Current LeakageThis test checks to see whether or not the active and dispersive lea-kage currents are within acceptable limits. There are four test setupsto accomplish this testing.

Per IEC 601-2-2 and ANSI/AAMI HF18-1993 the ESU shall be oper-ated at the maximum output setting in each operating mode. The l im-its for the acceptable leakage currents depend upon the test configura-

tion.

Tes t Conf igura t ion Limi t s of A cceptable Leakage Cur rent

Measured on electrodes The leakage current should not exceed 150 mA

Bipolar The leakage current should not exceed 1% of the


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Tes t Conf igura t ion Limi t s of A cceptable Leakage Cur rent maximum bipolar rated power output.

Measured at equipmentterminals

The leakage current should not exceed 100 mA.

1. Grounded HF Equipment: Measurements of the HF currentleakage. The ESU is grounded. The test load is 200 ohms andthe ESU must be operating at maximum power. The current lea-kage measured directly at the instrument's terminals must not ex-ceed 100 mA.

Test setup in compliance with IEC 601.2.2, sec. 19.101a, test 1,fig. 102 and sec. 19.102. (Adopted by ANSI/AAMI HF18-1993)

Test setup in compliance with IEC 601.2.2, sec. 19.101a, test 2,fig. 103 and sec. 19.102. (Adopted by ANSI/AAMI HF18-1993)

2. HF Isolated Equipment: Measurements of the HF currentleakage from the active and neutral electrodes. The test loadis 200 ohm and the ESU must be operating at maximum power.The current leakage measured directly at the instrument's termin-als must not exceed 100 mA.

Active electrode test setup in compliance with IEC 601.2.2, sec.19.101b, fig, 104 and sec. 19.102. (Adopted by ANSI/AAMIHF18-1993)


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Neutral electrode test setup in compliance with IEC 601.2.2, sec.19.101b, fig, 104 and sec. 19.102. (Adopted by ANSI/AAMIHF18-1993)

To run an HF Leakage Test:

1. Connect the QA-ES to the ESU to test leakage from the Activeelectrode using the appropriate setup, as shown above.

2. Set the QA-ES test mode for RF Leakage .

3. Set the ESU as prescribed by manufacturer for leakage tests andthen activate the ESU.

4. While the ESU is activated, press START (F3) key and leakagemeasurement is taken.

5. Repeat the leakage test for the Neutral electrode using the appropriate setup, as shown above.

(If the QA-ES is connected to a printer, a line of test result is writtento the printer following each HF Leakage test.)

4.3 REM AlarmThis test ensures that the ESU will sound an alarm if the resistance

between the two neutral electrodes exceeds your specified limit. The program directs the OA-ES to gradually increase the resistance, start-ing at 10 Ohm and increasing through all available load settings. At acertain value, the ESU should sound an alarm. Test setup for ESUREM alarm test.


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To run an REM Test:

1. Connect the QA-ES to the ESU as shown in the diagram above.

2. Set the QA-ES test mode for REM Test . (While the term REMis used, this mode is more generally test any of the monitoringand alarm systems for return, neutral, or dispersive electrodes.

3. Set the Delay time for the test. Metron recommends a significantdelay time (2000-4000 ms), so the alarm point can be more easilyidentified.

4. Press START (F3) key to begin the REM test.

5. When ESU alarm sounds, press STOP (F3) to end test. The loadat which the alarm was activated is held on the screen.

(If the QA-ES is connected to a printer, a line of test result is writtento the printer following the REM test.)


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Ap pend ix A - GLOSSARY OF TERMS USED

Bipolar Electrosurgery Electrosurgery where current flows between two bipolar electrodes that are posi-tioned around tissue to create a surgical effect. Current passes from one electrode,through the desired tissue, to the other electrode, thus completing the circuit with-out entering any other part of the patient's body. Neutral plates are not employed

in the bipolar technique. Both electrodes are generally of the same size.

Bipolar Output An isolated electrosurgical output where current flows between two bipolar elec-trodes that are positioned around tissue to create a surgical effect in that tissue(usually desiccation).

Blend A waveform that combines features of cut and coag waveforms; current that cutswith varying degrees of hemostasis.

Crest Factor The amount of heat generated is relative to the mean power value. The crest factor depends on the load resistance and is defined as the ratio of peak value to effectivevalue. A sine wave has a crest factor of 1.4 and provides the cleanest form of cut-ting.

Diathermy, also SurgicalDiathermy; Electrosurgery

A surgical technique used to cut or coagulate cellular tissue. To avoid muscle con-tractions, only high frequency currents and voltages of more than 100 kHz areused. The electric current directs the heat into the tissue. The patient is connectedto two electrodes, allowing the current to flow through the body. The active elec-trode will generate a large amount of heat, due to the high current density and thesmall surface of the electrode.

ESU Electrosurgical Unit. This is a term which is inclusive of both the electrosurgicalgenerator and its connecting cables.

Cut (Cut Mode, Pure Cut) A low voltage, continuous waveform optimized for electrosurgical cutting.

Isolated Output The output of an electrosurgical generator that is not referenced to earth ground.

Monopolar Electrosurgery A type of electrosurgery involving a small (active) electrode and a large neutral

(neutral plate) electrode. The small surface of the active electrode provides verygood results in coagulating and cutting. The neutral plate of modern units is split,thus controlling the circuit, including the contact between electrodes and patient.

Monopolar Output A grounded or isolated output on an electrosurgical generator that directs currentthrough the patient to a patient return electrode.

Resistance (Impedance) Resistance to the flow of alternating current, including simple direct current resis-tance and the resistance produced by capacitance or inductance. The resistance of a material is its tendency, measured in ohms, to oppose the flow of electric currentor, viewed another way, the material's tendency not to conduct the current.

REM Return Electrode Monitor.


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USA1345 Monroe NW, Suite 255AGrand Rapids, MI 49505Phone: (+1) 888 863-8766Fax: (+1) 616 454-3350E-mail: [email protected]

FRANCE30, rue Paul Claudel91000 Evry, FrancePhone: (+33) 1 6078 8899Fax: (+33) 1 6078 6839E-mail: [email protected]

NORWAYTravbaneveien 1N-7044 Trondheim, NorwayPhone: (+47) 7382 8500Fax: (+47) 7391 7009E-mail: [email protected]

From: (name) Phone: Address: Fax:

E-mail:

Date:

Error Repor t Product: Version: Serial no.:

Description of the situation prior to the error:

Description of the error:

(METRON AS internally)Comments:

Received date: Correction date: Ref No. Critical Normal Minor
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


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From:(name)

Phone:

Address: Fax:E-mail:Date:

Imp rovement Sugges t ion Product: Version:

Description of the suggested improvement:

(METRON AS internally)Comments:

Received date: Correction date: Ref No. Critical Normal Minor


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