HF-400. Electrosurgical Analyzer for function tests of HF Surgical Equipment

Transcription

1 User manual HF-400 English Electrosurgical Analyzer for function tests of HF Surgical Equipment Instructions for the user: This manual is supplied in the form of a loose-leaf publication. Any necessary updates and additional pages can thus be included without difficulty later so that you always have the latest version of the manual. We provide you with supplements and/or changes to your manual along with technical modifications that are made to your testing system. The DIN/VDE symbols and drawings shown in this manual have been reproduced with the permission of the Deutsches Institut für Normung e.v. (DIN: German Institute for Standardization) and the Verband Deutscher Elektrotechniker e.v. (VDE: German Association of Electrical Engineers). In applying the relevant standards, it is important to use the versions with the most recent date of issue. We reserve the right to make any changes to the information in this manual without prior notice. Elektronik accepts no responsibility in this regard. The software that comes with this product is supplied within the framework of a License Agreement. The software may be used and copied only in accordance with the terms and conditions of the License Agreement. All rights pertaining to reprinting and reproducing the manual, or parts thereof, are reserved. No part of the manual may be reproduced in any form whatsoever (photocopy, microfilm or any other procedure) or processed, reproduced or distributed using electronic systems without prior written approval from Elektronik. Other products mentioned by name are trademarks or registered trademarks of their respective companies. Elektronik Forstweg 1 D Brieselang GERMANY Tel Fax Edition

2 European Union Declaration of Conformity EG-Konformitätserklärung Nr Hersteller: Produktbeschreibung: Modell: Elektronik, Forstweg 1, Brieselang Bundesrepublik Deutschland HF-Chirurgie Tester zur Funktionsprüfung von HF-Chirurgiegeräten HF-400 Konform mit den Bestimmungen folgender EU-Richtlinien: Richtlinie 2014/35/EU des Europäischen Parlaments und des Rates vom 26. Februar 2014 (Niederspannungsrichtlinie) Richtlinie 2011/65/EU des Europäischen Parlaments und des Rates vom 8. Juni 2011 zur Beschränkung der Verwendung bestimmter gefährlicher Stoffe in Elektro- und Elektronikgeräten (RoHS Richtlinie) Richtlinie 2014/30/EU des Europäischen Parlaments und des Rates vom 26. Februar 2014 (Elektromagnetische Verträglichkeit) Angewendete Normen und technische Spezifikationen: EN : , Sicherheitsanforderungen an elektrische Mess-, Steuer-, Regel-, und Laborgeräte, Teil1 Allgemeine Anforderungen (IEC : Cor. :2011) EN : Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen Teil 1: Allgemeine Anforderungen (IEC :2012); Deutsche Fassung EN :2013 EN : EN : EN : EN : EN : EN : EN : EN : Brieselang, den Bernd Schulz Elektronik 2

3 1 INTRODUCTION TECHNICAL SPECIFICATION MEASUREMENT ACCURACY FURTHER INFORMATION WARNING SIGNS AND SYMBOLS FUNCTIONAL DESCRIPTION PHYSICAL FUNDAMENTALS OF THE POWER MEASUREMENT AT ELECTRO SURGERY UNITS POWER MEASUREMENT AT HF ELECTROSURGICAL DEVICES LEAKAGE CURRENT MEASUREMENT AT HF ELECTROSURGICAL DEVICES FUNDAMENTAL MEASUREMENT SETUP NEUTRAL ELECTRODE TEST CREST FACTOR OPERATION INSTRUCTIONS HOW TO USE MAIN MENU POWER HF LEAKAGE CURRENT SETUP PC-OPERATION MEASUREMENT SERVICE AND CALIBRATION

4 1 Introduction The Electrosurgical Analyzer HF-400 serves to test the function of electro surgery units. The measurements and examinations are accomplished after the valid regulations as well as appropriate manufacturer recommendations. You can accomplish individual measurements with the device or let run off automatic examinations over the PC software. The operation of the device is cursor controlled and with a few YES / NO decisions the different functions of the device could be activated. The last choice you made will remain, also after switching the device off, so that you do not need to select everything again. In the stand-alone-operation, the device is used with 6 foil keys, which are integrated in the front panel. To control the HF-400, a 100% compatible IBM computer with industrial standards is needed. The communication between the PC and the HF-400 follows through the USB or RS-232 interface. Attention Safety instructions! During and after the measurements an increased danger of injury exits. During the measurements, suitable steps must guarantee the protection against dangerous voltage. 4

5 2 Technical specification Line voltage: 83 V 264 V ac, 50 / 60 Hz Power consumption: 50 VA Safety class: 1 ambient temperature: C Storage temperature: C Measuring ranges HF current : HF-Peak Current (V2): Discrimination: or HF output power: Crest Faktor (V2) HF leakage current: Discrimination: Neutral electrode test: Range: Measuring principle: Load resistors: Swing in time: Rated voltage: Output power: ma ma 0,1 ma Watt 1-10 (at > 1000 ma) ma 0,1 ma Ohm 0,3-10 MHz Thermal electric converter 10 Ohm, 25 Ohm Ohm in steps of 25 Ohm < 3 sec. max V 500 watt 1 min on, 5 min off Permanent max. 200 watt at 25 C environmental temperature ( Ohm) 5

6 2.1 Measurement accuracy Measurement Range Error HF output power: watt 1 watt or 2,5 % of measurement value HF-leakage current: ma 2 ma or 5 % of measurement value HF current : ma 2 ma or 4 % of measurement value HF-Peak Current (V2): ma 2 ma or 4 % of measurement value Load resistors: 10 Ohm, 25 Ohm 6375 Ohm 5 % (The specified measuring accuracy refers to the measuring element. Technical modifications and errors reserved. 05/2016) 2.2 Further information Keyboard: Display: Interfaces: Testing plugs: Accessories: Mechanical data: 6 key foil keyboard 4 x 20 char LCD B/W-Display 1 x USB for PC 1 x RS-232 for PC 1 x RS-232 for additional test devices 2 safety plugs 4 mm for HF output power 2 safety plugs 4 mm for HF leakage current 1 safety plug 4 mm for PE 1 x aquipotential 1 x potential balance cable 1 x RS-232 cable Light weight metal case 340 x 87 x 290 mm (W x H x D) Approx. 3,8 kg 6

7 3 Warning signs and symbols Please read this documentation before using the device. Within this manual potential hazards are advised and the actions necessary to avoid risks described. HINT: Labels and texts on the device are part of the documentation! All warning labels and symbols on the HF-400 are explained in the following: general warning signs (IEC :2011) Disregard documentation, read the manual! terminal for earth (IEC :2011) functional earth terminal replaced: OLD symbol HINT: Detachable power cords may not be replaced by poorly dimensioned power cords. 7

8 4 Functional description The HF-400 is a micro controller controlled testing device to test the function of electro surgery units in accordance with regulations and recommendations of the manufactures. The load resistor is adjustable to 10 Ohm and from Ohm in steps of 25 Ohm. The test parameters for testing can be laid down in a test instruction and can be tested automatically with a PC. This makes it possible to reduce the time for testing. On the front plate are 5 safety laboratory sockets. 2 safety laboratory sockets serve for the measurement of the HF resulting load current over the adjustable load resistance, which can be set from 10 ohms and 25 ohms 6375 ohms in 25 ohms steps. 2 safety laboratory sockets exclusively serve for the measurement of the HF leakage current through a fixed 200 ohms resistance. The 5-th Safety laboratory socket serves for the additional contacting of the equipotential-connection of the HF electro surgery devices to the measuring instrument. The normative demanded combinations can be made now by the operator by using safety laboratory lines which can he connected freely. This function mode offers a maximum of flexibility for the operator. Who is now in the situation to fulfill each also still so complex circuit instruction of the HF surgery devices manufacturers at minimum expenditure. At the same time the influence of the measuring instrument to the controller action of the HF electro surgery device is minimized and thus an improvement of the measuring behaviour is reached. The external variants have to be made as described in the appendix The following parameters can be determined: SPL551 SPL552 SPL553 SPL554 SPL555 SPL556 (V2) SPL557 (V2) SPL558 (V2) SPL559 HF output power HF leakage current HF-U RMS HF-I RMS HF-P M3 HF-U Peak HF-I Peak Crest Faktor Neutral Test 8

9 4.1 Physical fundamentals of the power measurement at electro surgery units Power output P L of electro surgery units is, as it is with all electrical generators, the product of the voltage U L at the load resistor R L and the current I L by the load resistor R L. (1) P L = U L x I L R i I L U 0 R L U L electrosurgery units I L and U L are dependent, as it is shown in the alternate circuit diagram, on the internal resistor R i of the surgical device and from the neutral voltage U 0 from the HF-generator within the HF surgical device: U0 (2) IL R R i L (3) U I R L L L U0 R R R i L L If you take the right sides of the equations (2) and (3) and put them in equation (1), then the dependence of power output P L from the electro surgery units on internal resistor Ri and on the load resistor R L is recognizable: (4) P L U0 R R i L 2 R L 9

10 With R L = 0 is P L = 0. This means that in case of short circuit, the power output is zero too. With R L = is P L = 0. This means that in case of neutral operation, the output power is zero. With R L = R i is P L = P Lmax. This means that the power P L reaches its maximum if the load resistor R L is equal to the internal resistor R i of the generator. With R L R i is P L < P Lmax. This means if the load resistor R L is larger or smaller than the internal resistor R i of the electro surgery units, the output power P L is smaller than its maximum output power P Lmax. This condition is called mismatching. Attention: The measurement of power only results in the maximum power in case of a power adaption, i.e. if the load resistor R L is equal to the internal resistor R i of the generator. If R L should be larger or smaller than R i, or is unknown, then the maximum power must be looked for by variation by R L. 4.2 Power measurement at HF Electrosurgical Devices The HF voltage of the HF Electrosurgical Analyzer is applied to a selectable load resistance. The current resulting from this HF voltage produces a HF voltage over a special current transformer proportional to the HF current. This HF voltage is loaded by a voltage divider and the signal resulting in such a way is down-divided to the input level of the RMS transducer. The RMS transducer works according to the thermoelectric principle. It consists of two equal measuring circles. Each measuring circle consists of a heating resistor and an infrared diode. The HF voltage arrived over a voltage divider on the heating resistor of the entrance circle and produces a temperature those for the rms of the HF voltage put on is proportional. The temperature of the heating resistor controls the resistor of the infrared diode. In the load circuit of the RMS transducer the second heating resistor will be heated with DC voltage, these change the resistor of the second infrared diode. A control circuit compares both of the heating power and regulates the secondary DC-voltage as long as both heating circles have the same temperature. DC voltage on the secondary winding, adjusting thereby, is proportional to the primary RMS voltage. The RMS value is digitized with an AD transducer, processed in Controller and shown on the display. Picture 6.1 and

11 4.3 Leakage current measurement at HF Electrosurgical Devices The HF leakage current of the HF Electrosurgical Devices is set to a 200 ohms load resistance. This current produces proportional HF voltage to the HF current over a special current transformer. This HF voltage is loaded by a voltage divider and the signal resulting in such a way is down-divided to the input level of the RMS transducer. Picture Fundamental measurement setup To start-up the device, connect it with the main voltage and if necessary start the connection with the PC over the provided RS-232 cable. At the PC put the RS-232 cable into RS-232 interface. The plug next to the PC plug (on the backside) of HF-400 with the description test adapter could be used for the connection with another testing device, e.g. modular test system GS-X. With the power switch the HF-400 is turned on. After switching on the self-check of the device begins. Afterwards the equipment is set into the mode of operation condition stand-alone. 4.5 Neutral electrode test The neutral electrode test is used to check the neutral electrode monitoring on RFsurgery devices. The neutral electrodes are connected to the Bi safety laboratory sockets according to picture After the selection of the function step (SPL559), the resistance is increased incrementally. While changing the resistance, the current in the RF surgery unit of the neutral electrodes changes too. This change has resulted, that the RF-surgery unit detects whether the neutral electrodes are correctly attached. Otherwise, the control refers to. The threshold of monitoring can check with this function step. Picture

12 4.6 Crest factor The crest factor describes the ratio of peak to RMS and serves as a characteristic value for the assessment of the waveform of the RF signal. High Crest factors mean a high proportion of harmonics. A sinusoidal alternating current has, for example, a crest factor of 1,414. The crest faktor measured under load, with a current rating of greater than 1000 ma. 12

13 5 Operation instructions 5.1 How to use The device works with six foil keys. ESC up left right down Enter The arrow keys serve the selection in the menu or to the parameter selection. The ENTER key serves as a start button. With the ESC key, the respective program can be broken off. The latest selection made is stored into the device, so it must not be selected again. 13

14 5.2 Main menu After switching on the device, you will see following announcement: * * * S. P. L. * * * E l e k t r o n i k H 2. 0 V After a short time, the main menu appears with following items: H F > H F p o w e r H F l e a k. c u r r. S e t u p H F > H F - U R M S H F - I R M S H F - P R M S V2: H F > H F - U P e a k H F - I P e a k C r e s t H F > N e u t r a l T e s t B i - B i 14

15 5.3 Power When you choose power with the ENTER-key, you can select the measurement sorted after different resistor values. S e l e c t l o a d r e s i s t Ω > 2 5 Ω 7 5 Ω Ω Ω Ω Ω With arrow keys RIGHT and LEFT you can select the value of the resistor you want. With arrow keys UP and DOWN you can change the selected resistor value in steps of 25 Ohm. With the ENTER key you start the measurement. With the ESC key, you will stop and leave the measurement. If you press the ESC key twice, you will be sent to the main menu. S P L H F o u t p u t p o w e r R L : 7 5 Ω H F p o w e r : W On the display the test step number, the test step description, the actual value, the measuring unit and the used load resistor are shown. The test step number has a three-figure number. 15

16 5.4 HF Leakage current If you choose HF leakage current with the ENTER key, you can select the measurement sorted after resistors. S e l e c t l o a d r e s i s t Ω > 2 5 Ω 7 5 Ω Ω Ω Ω Ω With arrow keys RIGHT and LEFT you select the value of the resistor you want. With arrow keys UP and DOWN you can change the selected resistor value in steps of 25 Ohm. With the ENTER key you start the measurement. With the ESC key, you will stop and leave the measurement. If you press the ESC key twice, you will be sent to the main menu. S P L H F L e a k a g e c u r r e n t R L : 7 5 Ω L e a k c u r r. : m A On the display the test step number, the test step description, the actual value, the measuring unit and the used load resistor are shown. The test step number has a three-figure number. 16

17 5.5 Setup If you choose current with the ENTER key, you can select the setup of date, time and language. H F t i m e & d a t e n e x t C a l i b r a t i o n c h o o s e l a n g u a g e With these setting you can set the real-time clock. H F t i m e & d a t e > : 0 8 : 2 6 H F c h o o s e l a n g u a g e > d e u t s c h With these settings, you can choose between following languages: german, english, france, polski, spanish, italian, portugese and turkish H F S e r i a l n u m b e r : n e x t C a l i b r a t i o n The date of the next recommended calibration and the Serial number is shown too. 17

18 5.9 PC-operation The communication between the PC and the HF-400 follows through the USB / RS-232 interface with a special PC-Software. Function steps from HF-400 SPL551 SPL552 SPL553 SPL554 SPL555 SPL556 (V2) SPL557 (V2) SPL558 (V2) SPL559 HF output power HF leakage current HF-U RMS HF-I RMS HF-P M3 HF-U Peak HF-I Peak Crest Faktor Neutral Test PC-Parameter from HF-400 Load resistor 10 Ohm, 25 Ohm to 6375 Ohm in steps of 25 Ohm 18

19 6 Measurement Picture 6. 1 Picture

20 Picture 6. 3 Picture

21 Picture 6. 5 Picture

22 Picture 6. 7 Picture

23 Picture 6. 9 Picture

24 Picture Picture

25 Picture Picture

26 Picture

27 7 Service and calibration The measuring - and test devices quality, manufactured from Elektronik Brieselang, is guaranteed by a multi-level quality control - and quality assurances in accordance to DIN EN ISO After final inspection and calibration each device gets an examine plaque and a calibration certificate. The calibration is enforced with standards, which are restorable to the standards of the Physical- Technical Federal Institution. In agreement with TÜV CERT, business-group TÜV Rheinland / Berlin- Brandenburg, is recommended for normal, accordingly to the corresponding use of the measuring and test devices form Elektronik Brieselang an annually calibration interval. The calibration includes a maintenance, update of the firmware, complete control of the accuracy of measurements for of all test steps by control with one or several reference-values and calibration. By an update of the firmware for example, changes in standards, expansions of the function of the devices etc. are automatically integrated. By the implemented inspection and calibration, the validity is fixed by the implemented measurement list in the associated user guide. The warranted characteristics for the PC-operation of the measuring - and test devices of Elektronik are guaranteed through the offered or authorized softwareprograms. For cleaning, you should wipe off your device with a moist cloth, which is impregnated with a mild detergent. It is important after that to rub your device dry. Attention Hint! Before cleaning always pull of the power plugs, otherwise danger for life exists Please take note in the use with the test system that it is despite of protected measuring channel inputs a sensitive measuring instrument. Waste disposal: Through the used parts of the measuring - and test devices of the Elektronik, etc. accumulators, Lithium batteries, and similar things, a professional waste disposal is necessary. This can be done through Elektronik, ear , if demand is enforced. 27