User Manual
Contents
1. iv Produce current over 200 mArms 570 mApp compliance with the standard requirement v With the amplified built in sine wave generator the output voltage can be up to 10 Vrms at 50 O impedance vi Capability to measure to the upper limit of the contact impedance of the neutral electrode at 50 Q Vii Frequency is adjustable from 50 kHz to 5 MHz Note An oscilloscope shall be used with the HFPA150 to measure the output voltage and current The HFPA150 is equipped with a built in conversion circuit so that no additional current probe is required to measure the current value User may simply connect the Current Monitor port with an oscilloscope to obtain the current value For details please refer to Chapter 6B lt How to monitor the HFPA150 output voltage and current gt www whaleteq com Page 3 of 19 aw WHALETEQ HFPA150 User Manual 2 Safety Summary Please review the following safety warnings to avoid injuries and prevent damage to this product or any related products To avoid potential hazards only use the product in accordance with this instruction Only Whaleteq qualified professionals should repair adjust the operation program To avoid fire or personal injuries only use the original factory supplied power supply e The equipment shall be operated by a qualified electrical engineer or a professional with equivalent qualification and knowledge in the principle of high frequency insulation and2. impedance shall not exceed 50 Q Stop increasing the gain in such event and record the rms voltage and current Calculate the contact impedance value for the neutral electrode 6 Adjust the frequency to 500 kHz 1 MHz 2 MHz 5 MHz and repeat step 4 and 5 www whaleteq com Page 18 of 19 aw WHALETEQ HFPA150 User Manual HFPA150 BNC Alligator Cable BNC BNC Cable Oscilloscope Neutral Electrode Metal Plate Ground Voltage Probe Figure 7 HFPA150 connection for neutral electrode contact impedance test 9 Contact WhaleTeq Email service whaleteq com Address 8F 3 No 106 Minquan W Rd Taipei City 10361 Taiwan Phone 886 2 25501239 Website www whaleteq com www whaleteq com Page 19 of 19
3. is built with a set of overcurrent protection circuit When Detected circuits detects an overcurrent it will target the Power Amp Turn Off to reduce immediately In case the limit is reached the MCU receives the signal and subsequently adjusts the Variable Amp of the gain value to O Figure 6 below illustrates the principle of the protection circuit activation Power Supply Over current Detected a Det circuits Output Figure 6 Protective circuit block diagram Instant current rise will results in an event that the impedance of the analyte is very low or even short circuit In such case using firmware to control MCU and further adjusting the gain value is not going to be responsive enough The protection circuit works in the way of turning on the hardware as soon as overcurrent is being detected so that the Power Amp is reduced immediately At this point waveforms will distort Figure B due to the current decrease There could also be no waveforms Figure C when the MCU adjusts the Variable Amp to Low gain 0 Both waveform distortion Figure B and no waveform Figure C indicate the protection circuit is activated Readjust the gain value increase or decrease as needed www whaleteq com Page 16 of 19 aT WHALETEQ HFPA150 User Manual 100mA i am Figure A Normal waveforms on the oscilloscope display Before protection circuit is
4. oscilloscope use Please read this user manual carefully for the working principles and possible risks before first operating the HFPA150 e If the power output is over 2 watts pay special attention to the heat and power tolerance while connecting the load Always use safe work practices when using electrical equipment to avoid the risk of electric shock and fire www whaleteq com Page 4 of 19 aT WHALETEQ HFPA150 User Manual Main applications IEC60601 2 2 2009 Measurement of neutral electrode contact impedance Recommended test instruments Testing of neutral electrode according to IEC 60601 2 2 2009 v 6 z g l s 201 15 101 8 3 E 3 2 Neutral Electrodes 2 Ee SS es S x 3 6 a T T 8 g 201 15 101 1 Not testin General requirements for E ar NEUTRAL ELECTRODES q 201 15 101 2 y NE code attachment 201 15 101 3 NE cord connector no Use test finger conductive parts on patient 201 15 101 4 y y NE cord insulation 201 15 101 5 P NE thermal performance Y v v Referto Note 201 15 101 7 NE adhesion Non electrical test 201 15 101 8 NE shelf life Note 1 WhaleTeq HFIT600A High Frequency Insulation Tester For insulation and current leakage test of cord and surgical instruments Visit http www whaleteq com products_detail 71 Note 2 No current probe is required when the HFIT600A is used as
5. a generator In the NE thermal performance test IEC standard stated that the NE under test shall be applied on human skin surrogate media or test devices with electrical and thermal equivalent properties Since impedance varies with different contact surfaces in some cases especially with high impedance the HFIT600A is not capable to provide current up to 770mArms maximum output of HFIT600A is150W and in such case an ESU along with a current probe will be required to conduct the test www whaleteq com Page 5 of 19 aw WHALETEQ 3 Specifications HFPA150 User Manual Parameters HFPA150 Specification Frequency range 50 kHz to 5 MHz Maximum voltage 11 Vrms 31 Vpp 250 Q Maximum Current gt 200 mArms lt 500 Waveform Sine Frequency Response lt 40 8 dB 50 Q THD lt 0 3 50 4 dB at 200 mArms 50 Q 1 MHz Impedance lt 3 20 j0 4 pH Auxiliary equipment for contact impedance test Oscilloscopes Ch1 connects with voltage probe to measure voltage Ch2 connects with HFPA150 current monitoring interface to measure the current value Current Measurement Accuracy lt 5 Frequency Range 50 kHz to 5 MHz Connector Type BNC General Power Source Power Adapter Input 100 240 V 50 60 Hz Output 12 VDC 2 A Environment 10 C to 40 C 30 to 90 RH Dimensions Weight 18X18X4 8 c
6. aT WHALETEQ HFPA150 User Manual WHALETEQ ESU Neutral Electrodes Impedance Tester Model HFPA150 User Manual Current Monitor ay HFPA150 Output Gain Indicator Version2014 10 30 Hardware Version1 3 x www whaleteq com aw WHALETEQ HFPA150 User Manual 1 Introduction HFPA150 is a unique tester specifically designed for the testing of neutral electrode NE impedance in electrosurgical system The HFPA150 is built to satisfy the testing requirements for contact impedance test as stated in IEC60601 2 2 2009 According to IEC 60601 2 2 2009 clause 201 15 101 6 the impedance of the electrical contact between the surface of the NE application site and the NE cord connection shall be low enough to prevent a risk of patient burn due to ohmic heating during the passage of HF surgical current It is evident that hazard of patient burn during the use of electrosurgical system is present The main contribution to the risk of patient burn is caused by the high impedance of the NE application site and the NE cord connection Thus this safety test is especially important for the neutral electrode manufacturers The HFPA150 generates specific NE impedance test signals per requirement of the IEC standard The built in generator is capable of generating signals with frequency ranging from 50 kHz to 5 MHz producing current over 200 mArms and sine wave with THD lt 0 3 The HFPA150 is built with high stabilit
7. activated Run _ 2 00us lI y lt a S Idim Figure C No waveform displayed after MCU adjusts the Variable TT Low gain 0 Page 17 of 19 aw WHALETEQ 8 HFPA150 User Manual Test example Test of ESU Neutral Electrodes Impedance Test Refer to Figure 7 for HFPA150 connection for neutral electrode contact impedance test 1 Connect the original factory supplied BNC Alligator cord from the Output port to the neutral electrode NE plates Connect the red alligator clip to the NE connector and the black alligator clip to the adhesive metallic plate 2 Connect the oscilloscope probe CH1 to the same point as the red alligator clip on the NE connector and connect the ground end of the probe to the adhesive metallic plate 3 Connect the HFPA150 Current Monitor port and the oscilloscope CH2 using the original factory supplied BNC BNC cord 4 Adjust HFPA150 Gain and Frequency to CH2 200 kHz Vrms 200mVrims This indicates Irms 200mArms 5 Measure Vrms voltage of CH1 Use the equation Z V I to get the contact impedance value Note Turning the Gain Knob clockwise will increase gain and output power accordingly When the output voltage exceeded 10 Vrms while the output current does not reach 200mArms this is an indication that the neutral contact impedance of tested negative plate is more than 500 IEC60601 2 2 2009 clause 201 15 101 6 stated that the neutral electrode
8. ain knob to increase gain the power output also increases accordingly If the power output is over 2W pay special attention to the heat and power tolerance while connecting the load Always use safe work practices every time electrical equipment is used to avoid the risk of electric shock or fire While using the BNC Alligator cord avoid contacting the two alligator clips together Contacting the two alligator clips under no load condition can cause output short circuit equipment damage and possible risk of fire and electric shock www whaleteq com Page 14 of 19 a WHALETEQ HFPA150 User Manual Frequency Frequency 100kHz 10K O0OKHz 10KH Frequency Frequency knob use for frequency output adjustment Monitor the oscilloscope to adjust the desired frequency Turning the knob clockwise to increase the frequency counter clockwise to reduce frequency 100KHz indicator Illuminates to indicate for 100 kHz selection Frequency is adjusted to be 100 kHz per step 10KHz indicator Illuminates to indicate for 10 kHz selection Frequency is adjusted to be 10 kHz per step 100KHz 10KHz Frequency switch button Press for switch between 100 kHz and 10 kHz www whaleteq com Page 15 of 19 aw WHALETEQ HFPA150 User Manual 7 Overcurrent protection To ensure the safety operation and avoid the risk of damage to equipment due to improper use the HFPA150
9. ance test frequency shall range from 200 kHz to 5 MHz As the frequency changes the small capacitance of the test cord with the HFPA150 resistor results in noticeable RC effect leading to significant deviation of frequency response The original factory supplied cords with the HFPA150 are designed to resolve the above described issues It is strongly recommended to use the original factory supplied cords for measurements The specifications of the cord are as follows a BNC BNC cord Exclusively designed for HFPA150 current monitoring the BNC BNC cord connects the current monitoring port with the oscilloscope The indication of 1 mV is equivalent to 1 mA current flowing through the DUT Coaxial Cable BNC Connector RG58 U la Male 500 500 5mm Figure 3 BNC BNC cord www whaleteq com Page 10 of 19 aT HFPA150 User Manual WHALETEQ Length 50 cm Cord Capacitor 50 pF 5 pF Impedance 500 Type of cord RG58U b BNC Alligator cord The BNC alligator clips on the short cord is specifically designed for NE tests It connects the HFPA150 with the DUT Each of the alligator clip connects the wire connection port of the DUT neutral electrode and the metallic plate prosthesis BNC Connector Male 50Q Wire UL1007 16 200420mm Figure 4 BNC Alligator cord Length 20 cm Cord Capacitor lt 20 pF Impedance 500 Type of cord RG58U Note W
10. and turn counter 6 Gain Gain knob clockwise to decrease amplitude Read Chapter 6C lt Gain Adjustment gt before operation Gaa eee aren The flashing light indicates signal 7 output The light will be solid Indicator Green A green when there is no signal www whaleteq com Page 8 of 19 aw WHALETEQ HFPA150 User Manual output or when the reset button is pressed 8 Gain Reset Gain reset Press to reset gain to zero Connect the oscilloscope with the original factory supplied BNC Current Current monitoring cord to monitor the current Monitor port value The oscilloscope shows 1 mV is equivalent to 1 mA of current flowing through the DUT www whaleteq com Page 9 of 19 a WHALETEQ 5 HFPA150 User Manual Original factory supplied connection cords HFPA150 is capable to measure the output current value through a current monitor port with direct connection to the oscilloscope using the BNC BNC cord This unique design saves cost and the need of an expensive current probe A BNC Alligator cord is supplied for the connection to the signal output port in order to pass the test signal to the connection points and metallic plate of NE To control the accuracy of monitoring the current to 5 the HFPA150 measures the current by means of a 1 Q shunt together with the frequency compensation circuit According to IEC60601 2 2 clause 201 15 101 6 NE contact imped
11. hen using the BNC Alligator cord avoid contacting the two alligator clips together Contacting the two alligator clips under no load condition can cause output short circuit equipment damage and possible risk of fire and electric shock www whaleteq com Page 11 of 19 a WHALETEQ 6 Instructions A Power DC Power Port HFPA150 User Manual Power DC IN 12V 1 Connect the power adapter 100 V 240 V 50 60 Hz Always use the original factory supplied power supply Powering up 1 Switch the HFPA150 on Off On 2 Upon powering on the HFPA150 the green Gain Indicator and the yellow 10KHz indicators illuminate Frequency initiates at 50 kHz with no voltage through Output port B How to monitor the HFPA150 output voltage and current HFPA150 measures the output voltage and current through two connecting ports of the oscilloscope 1 Connect the original factory supplied BNC BNC cord with the Current Monitoring port and oscilloscope CH2 2 Connect the Output port with the BNC Alligator cord Connect the other end of this cord to the analytes DUT and voltage probes connect with the oscilloscope CH1 as shown in Figure 5 3 Power up the HFPA150 turn the Gain knob clockwise to read a 50 kHz signals from CH1 CH2 The HFPA150 is working properly when amplitude increases with gain increase The 1 mVrms at CH2 is e
12. m LxWxH 0 7 kg Use with original factory supplied connection cord BNC BNC and test cords BNC Alligator See Chapter 5 for cord specifications www whaleteq com Page 6 of 19 aw WHALETEQ HFPA150 User Manual 4 Labels A Power DC IN 12V oco 2 1 Figure 1 HFPA150 back panel Back panel labels Figure 1 Item Label Name Description 12 VDC power input connecting to 1 DCIN 12V Power Interface the power supply 2 On Off Power switch On Off Switch www whaleteq com Page 7 of 19 aw WHALETEQ Current Monitor O a Gain Indicator HFPA150 Reset HFPA150 User Manual Frequency Output 100KHz O O 100KHz 10KHz Frequency 9 8 5 2 1 Figure 2 HFPA150 front panel Front panel labels Figure 2 Item Label Name Description 1 Output Signal output port Signal output BNC connector Turn clockwise to increase 2 Frequency Preguan frequency and turn counter adjustment knob clockwise to decrease frequency 100 kHz indicator Illuminates to indicate for 100 3 100KHz Green kHz selection Frequency is adjusted to be 100 kHz per step 10 kHz indicator illuminates to indicate for 19 kHz 4 10KHz Yellow selection Frequency is adjusted to be 10 kHz per step 5 100K 10KHz 100 kHz 10 kHz Press for switch between 100 kHz Frequency Switch button and 10 kHz Turn clockwise to increase amplitude
13. quivalent to 1 mArms www whaleteq com Page 12 of 19 a WHALETEQ HFPA150 User Manual current CH1 voltage and frequency indicates the output voltage and frequency HFPA150 BNC Alligator Cable BNC BNC Cable Oscilloscope Voltage Probe Figure 5 Test wiring diagram To achieve HFPA150 current monitoring accuracy lt 5 use the original factory supplied connection cords www whaleteq com Page 13 of 19 aw WHALETEQ HFPA150 User Manual C Parameter adjustment Gain 1 Gain knob use for gain output adjustment Gain Indicator Gain Monitor the oscilloscope to adjust the desired voltage current Turing the knob clockwise to increase the gain counter clockwise to reduce the A gain 2 A flashing Gain Indicator indicates signal being Gain output The light will be solid green when there is Reset no signal output or the reset button is pressed 3 Gain Reset Press to reset gain to zero For safety reason always reset gain when replacing analytes Notes While doing gain adjustment always monitor the current voltage by an oscilloscope Overcurrent will activate the protection circuit See Chapter 7 lt Overcurrent protection gt When replacing the analyte press Gain Reset to avoid hazard to operators or damage to HFPA150 unit due to sudden load reduction and current increase While turning the G
14. y output adjustable frequency and gain functions In addition to neutral electrode test it could also be used as a measurement tool for general purpose generator where the specifications are appropriate Features i A sine wave generator user may adjust the frequency and gain to meet the needs of high power sine wave output ii Stable frequency output equipped with DDS direct digital synthesis technology a frequency synthesizer for generating arbitrary waveforms from a single fixed frequency reference clock Together with an embedded DC fan for ventilation and control of the internal temperature the HFPA150 is not susceptible to temperature fluctuation which facilitates great output stability Compared to a conventional sine wave generator which creates waveforms based on the charging and discharging of the capacitor the stability of waveforms is therefore determined by the capacity of the capacitor However the capacity change is proportional to the ambient temperature while inversely to the generated frequency Thus acommon problem with the conventional sine wave generator occurs with the heat generated from prolong usage and resulted with the lower frequency generated www whaleteq com Page 2 of 19 aw WHALETEQ HFPA150 User Manual iii Compliance with IEC60601 2 2 2009 testing requirements the HFPA150 is designed according to the standard of the neutral electrode Neutral Electrode NE contact impedance test
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