Guide to Performance and Safety Testing - Frank's …

1 ElectrosurgicalGeneratorsA preventative maintenance publicationwritten for the hospital's Director of Clinicaland Biomedical EngineeringTurnkey OEM/Private Label Design & Production ServicesSMGuide toPerformanceand SafetyTestingPublished byTektran IncorporatedEdmonds, Washington 98020-0665 1998 by the Author: Ronald L. Bussiere, Rights ReservedNo part of this publication may be reproducedin any form, in an electronic retrieval system orotherwise, without prior written permission ofthe in the United States of AmericaISBN: 0-9661128-1-4 Disclaimer:Tektran, Inc. has no affilation with the agencies or companies referenced within this booklet, nor do they endorse its booklet was written to assist the BMET and CCE or those responsible for Performance and Safety Testing of electrosurgerygenerators.

2 We highly recommend you use this booklet as a general Guide only and seek specific advice from the manufacturer ofany particular electrosurgery model generator prior to performing any of the tests covered OF CONTENTSG uide to Performance and Safety Testing - Electrosurgical GeneratorsIntroduction ..iiSECTION 1 Overview of Performance and Safety List of Definition and Purpose .. 1, 2, 3 SECTION 2 Instruments Recommended For Protocol Input Measurements .. Output Measurements .. Supplier Contact Information .. 4 SECTION 3 Performing Input AC Leakage .. Ground Continuity .. 5 SECTION 4 Performing Output RF Power Output.

3 7, Open Circuit Peak-to-Peak 8, 9, Crest Return-Fault Test .. REM Test .. Neuro-Muscular 11 SECTION 5 Preventative Maintenance Record Software vs. Hand Written Forms .. 12 Courtesy Form Templates to Assist in Protocol Blank Periodic Recording graphs for recording load-response measurementsAPPENDIXA. Food & Drug Administration - QSR-CGMP InformationB. Standard - Medical Equipment .. 16 Standard For Inspection and Record KeepingC.. 16 Standard HF-18 - Electrosurgical DevicesD. List of Other Electrosurgical Related Standards .. 17E. Global - Document Order Fulfillment 18F. Related Professional Associations.

4 18G. Organizations for CBET and CCE Certification .. 18H. Website Address Links to BMET Societies .. 18 State and International ChaptersI. Bar Coding and (Central Point Ordering).. 19J. Vendor Sources for Alternative Testing Devices .. 19K. RFI, EMI, and EMC - The Electromagnetic Environment .. 20 Definitions, problems each create, recognized test methods, and current standardsL. FDA/CGMP QS Regulations vs. ISO 21A Summary View of Improved ConformityiINTRODUCTIONThe Current GMPs (Good Manufacturing Practices) as required by the as of June 1997 follow the fulltwenty parts of ISO 9001with a few exceptions. ISO 9001 is the internationally recognized standard manufactur-ers follow when developing a Quality System Plan for are required under the Rules & Regulations (C) GMP Part 21 CFR 820 to train, test, andmonitor the Performance of any factory personnel placed in charge of inspection, measurement, testings, or ser-vice and to keep records of such tests as well as provide reliable equipment (periodically calibrated) to performthose activities during the production phase.

5 Paragraphs in "The Final Rule" dated October 7th, 1996 that relateto personnel training, Testing , and service are as follows:Subpart B - Quality System Requirement PersonnelSubpart G - Production & Process Control Inspection, Measuring, and Test EquipmentSubpart H - Servicing also referred to as the "Joint Commission", accredits hospitals and requires during their routine auditsthat the healthcare organization seeking accreditation have a preventative maintenance program in place as wellas record-keeping practices to insure the reliable operation of hospital equipment. They refer to the testingrequired as " Performance and Safety Testing " under their respective standard [ ]. A copy of this standardis reprinted in the Appendix section of this booklet.

6 This does not include or suggest the repair and replacementof internal parts by the hospital biomedical technician without proper certification or training to perform suchrepair. This is the reason that many manufacturers affix a seal to their unit cover and void the warranty should theseal be tampered a manufacturer of RF electrosurgical generators, we must be concerned about both complying with the as well as assist the healthcare provider who is our ultimate customer in performing the pre-op orperiodic Testing they must perform to insure that equipment is working up to standards. We feel that there hasbeen up to now some confusion about the standard above and the role of the biomedical technician. Inpart, due to the conflict that exist between, 's standard HF-18 ( ) and the FDA/GMP federalregulations above that all manufacturer's of medical devices must adhere to as a matter of is our position that to provide schematics or detailed service manuals to the hospital or any end-user would infact invite those who may not have proper certification to alter the internal workings of our generators, regard-less, whether or not they are CBET or even CCE certificated.

7 This is why we provide this booklet, instead, witheach generator sold, in addition to the Operating Manual. It is intended to assist the BMET to perform only the" Performance and Safety Tests" which are as a matter of standard practice performed by hospital the case of electrosurgical generators, this is easy, since there are two benchmark companies that have for yearsprovided special testers for use by hospital biomedical technicians, not only for electrosurgical generators, but forother modern electro-diagnostic and electro-therapeutic equipment employed by healthcare provider today. Thosetest instruments are featured in this booklet along with contact information of the suppliers. The measurementsthese testers provide have become a norm in the profession and, therefore, satisfy the JACHO standard [ ]in addition to the record keeping and other practices required under that :We suggest that if the results of these tests indicate a failure or defect in the operation of the generator , thegenerator be returned immediately for corrective action by the manufactuer or those service organizations thatare authorized to perform such repairs.

8 DO NOT Attempt to Make Internal Adjustment or Replace CONTENTS AND INSPECTIONO verview of Performance and Safety TestsSection and Safety MeasurementsThese tests can be conducted without removing the sealed cover of the generator. The objective is to test theinput and output characteristics of the generator against the standards given in the operating manual for eachgenerator. Normal practice is to test for the following:AC LeakageGround ContinuityRF LeakagePower OutputOpen Circuit Peak-to-Peak VoltageCrest FactorReturn Fault TestREM TestNeuro-Muscular and PurposeAC Leakage:This is a measurement of the AC input line current leakage from chassis and patient-connected probes to earthground respectively. For double-isolated ESUs this should not exceed 50uA (from chassis parts to earth ground),and 20uA (from ACTIVE and INACTIVE leads to earth ground when output is isolated).

9 Purpose: To insureagainst low frequency electrical shock. Refer to section Continuity:This is a measurement of resistance from any exposed metal part on the chassis to earth ground. This resistanceshould not exceed ohm. Purpose: To insure against the possibility of shock should live internal componentscome in contact with those metal parts on the chassis. Refer to section Leakage:This is a measurement of high frequency output current from either the ACTIVE or INVACTIVE (Return Elec-trode) to earth ground. Leakage should not exceed watts or 150 milliamps to earth ground when measuredthrough a simulated load of 200 ohms (non-inductive impedance). Purpose: To insure against alternative currentpaths that could cause unwanted burns or injury to the operator, staff, or patient.

10 The test is performed differ-ently for isolated and ground-referenced generators. Refer to section Output:This is a measurement of rms (root-mean-square) power in watts or Actual Power across a non-inductive resis-tance. The power should be at least within +/-15% or whatever tolerance the generator manufacturer has statedin its accompanying container documents as standard. Depending upon the purpose of the generator, the re-sponse or delivered power in watts across the Load (non-inductive resistance) is either flat or peaks at somedesirable impedance level. Some minimally invasive electrodes call for matched impedance levels as low as 10ohms and some as high as 1500 ohms. Typically, generators intended for general purpose applications or invasivesurgery have monopolar outputs rated at 300 ohms and remain flat from 100 ohms to 1000 ohms, depending uponthe output filter.