Uni-THERM - Rigel Medical
Contents
1. Max Watts at 15sec On 15sec Off 50 duty cycle 5 5115 ohms 1600 1400 1200 1000 800 s 600 400 200 0 1 10 100 1000 10000 Ohms Max Watt at 60sec On 15sec Off duty cycle 5 100 ohms Watts Ohms 43 Page Rigel Medical Uni Therm user Manual V1 Max Amps at 15sec On 15sec Off 50 duty cycle 5 5115 ohms 7 00 6 00 5 00 4 00 3 00 Amps rms 2 00 1 00 0 00 100 1000 10000 Ohms O Max Amps at 60sec On 15sec Off duty cycle 5 100 ohms 5 00 4 50 4 00 3 50 3 00 2 50 2 00 1 50 1 00 0 50 0 00 Amps rms Ci Qi N Ci CD Qi A Qi Qi Qi O Qi NI Qi Co Ci CO Qi 9 Support 9 1 Contact Us Rigel Medical Contact details Sales and Delivery enquiries Tel 44 0 191 587 8730 Fax 44 0 191 586 0227 Email sales rigelmedical com Technical enquiries Tel 44 0 191 587 8701 Email support rigelmedical com CalibrationHouse Contact details Service Calibration and Repair Tel 44 0 191 587 8739 Fax 44 0 191 518 4666 Email info calibrationnouse com Part of SEAWARD 45 Page Rigel Rigel Medical Address details Rigel Medical 15 18 Bracken Hill South West Industrial Estate Peterlee County Durham SR8 2SW United Kingdom CalibrationHouse Address details CalibrationHouse 11 Bracken Hill South West Industrial Estate Peterlee County Durham SR82. ra GURO Front panel connections Colour screen Stop Cancel key Red Hinged feet Rigel Medical Uni Therm user Manual V1 1 Front panel 1 REM output connection Black 2 CUT footswitch control output Yellow 3 COAG footswitch control output Blue Side panel 1 Variable load bank connections Red 3 Measuring Device connections amp Black White 2 Oscilloscope output 4 HF Leakage connections Note The scope output SMB connector provides an 10kV isolated waveform monitoring output however the scope output is not calibrated 6 Page Rigel Medical Uni Therm user Manual V1 1 Getting started 1 The Rigel Uni Therm has been designed to ensure that the user is able to test quickly easily and safely The interfaces to the Rigel Uni Therm have been segregated into a high voltage area side panel and a safe low voltage area front panel This arrangement also ensures that test leads carrying high frequency power are kept as short as possible and directly facing the equipment under test ra OROROLORORO 200000000 120208089 o 25 I2 89 Q O o 06 O ZORORORORORORORO GRORORORORORORORORO eee eee eee OROROSORORORO ROBO BORO BORO QBS OBOE OBR ER OB OR OBO ROR 50 OROSOROBOROSOROROROROROS OROROROROROROR A22 2229 C25 SLOLS26L5R6 CORGSOROBOROSOSOROKOM OROORO RORO SORO ROSOKORORORORS 3 ROROROROROROSOSOSORO TESS 29983928 LOBOR RORO SORO RO BOROROROROS
3. 5000ms 10ms resolution 0 51150 steps 50 Ceramic Resistors Non inductive 1 0 5 0 0 Q of set load See load power graph Up to 100 at 60 seconds ON time see load power graph 2 x 2000 1 0 5 0 0 O 20 Watt 100 duty cycle 0 4750 10 step Motor driven potentiometer 5 20 High and low manual confirmation Manual or automatic 0 5V A 100mA RF current minimum input un calibrated indication only Rigel Medical Uni Therm user Manual V1 1 Connections Variable load O 51150 Fixed Load x 2000 Measuring device MD Oscilloscope output REM test 0 475 ohm Remote foot switch control CUT Remote foot switch control COAG USB B port USB A port Data Storage and Recall Memory Output 8 2 General Specification Dimensions Weight Operating Temperature Storage Temperature Mains power Fuses 42 Page Rigel Medica 2 x 4mm Red Active Black Plate 1 x4 mm black common 2 x 4 mm red 2 x 4mm White SMB coaxial connector 2 x 4mm black 2 x 4mm yellow Single relay contact 2 X4 mm blue Single relay contact PC interface Key board 4Mb CSV format sss test sequences results reference power graphs 370 X 300 X 204mm 11 Kg 10 Cto 40 C 0 C to 50 C 115 230 10 VAC 48 to 66 Hz 35 VA 2 x 1 6 A T ceramic Uni Therm user Manual V1 1 8 3 Load Power rating Rigel Uni Therm External Load mode Current Limit 8 A rms No power rating user supplied Load
4. www rigelmedical com Prior to returning your unit for service please contact our service department to obtain a Returns Number By obtaining a Returns Number your service request can be booked in advance thus reducing the down time of your equipment When asking for a Returns Number please quote v Instruments name and model v Serial number v Firmware version 40 Page Rigel Medical Uni Therm user Manual V1 1 8 Specifications 8 1 Technical Specification HF Power Watt RMS Accuracy HF Current RMS Accuracy Voltage RMS Accuracy Voltage peak Accuracy Crest Factor RMS Bandwidth instrument only RMS Bandwidth with load bank Interference Frequency Filter Isolation earth to measurement device Measurement delay adjustment Variable Load Load Resistor Type Accuracy Power rating Duty cycle Fixed Loads Accuracy Power rating Plate Security REM resistor Accuracy Alarm register Ranging Oscilloscope output 41 Page True RMS Watts O 500W Refer to load power graph 1W 5 of reading 0 6000mA with load bank 0 8000mA external load test 2 of reading 10mA 0 700V 2 of reading 2V 0 10KV Peak Closed load only 10 of reading 50V 1 4 20 Vpeak V RMS The higher of the 2 peak voltage measurements is used 30 Hz to 10MHz MHz 3 dB 30 Hz to 2 5 MHz 3 dB 100 Hz high pass filter 10kV Foot switch delay selectable between 200
5. 92983 25 O o ORORORORORO BORO ALE AYG SOROR O YAY AYA 62852 O PORO OROROROS ROROROROS OLO 020 020926 02020629 Gov Oo Connecting your Analyser 1 1 Elevate the Rigel Uni Therm on its two hinged feet at the front base A O ORO o 02 U 030863 lo OOs020 LEIR LS pa P030305055 NG A A KA K N OO Q OO 050 SOREROLOROSOROSOR OSOA 2 gt 2505250 HQ p x Kayo o O O3050503040 OO ORO 030080030030 08070r 3 I w OO 030030 3030300230 020 ORC ORO RCAOROCAO ROARS pt BBQ 229022022022028 20980 BORORO SONORO ROS OROSO SmI O O50 Q O50 69 O o 9 o xe Q ZOROKOROROROR OSOSO8O8580 0528059 o Ensure none of the large base and rear ventilation inlets are obstructed during operation 20252025 LOLS 0005 0505 5055 GAGL20202022029202020 O20209 B99293220292029292202 ORORORORORO mg Pai OAC 22 O O BORSRORS 0020005 BA939992 ag C SOROS Q ORC Oe 12 Rear panel Connect the mains cable to the IEC connector on the rear panel 1 3 Front connection panel 8 For automatic control during HF leakage and Power tests connect the ESU footswitch COAG and CUT contacts to the blue and yellow terminals rather than manually switching the output of the electrosurgical diathermy machine It is strongly advised to always use the Rigel Uni Therm s built in automatic control under test For REM
6. ISOLATED ESU MONO POLAR ELECTRODE COAG MODE ACTIVE ELECTRODE TEST CODE 1222 IEC 601 2 2 part 1 FIGURE 103 MEASUREMENT OF HF LEAKAGE CURRENT WITH NEUTRAL ELECTRODE ISOLATED FROM EARTH AT HIGH FREQUENCY EARTH ISOLATED ESU MONO POLAR ELECTRODE COAG MODE NEUTRAL ELECTRODE TEST CODE 2111 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF HF LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH REFERENCED ESU BIPOLAR ELECTRODE CUT MODE FIRST ELECTRODE TEST CODE 2112 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF HF LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH REFERENCED ESU BIPOLAR ELECTRODE CUT MODE SECOND ELECTRODE Link 14344 47 Page Rigel Medical Uni Therm user Manual V1 1 TEST CODE 2121 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF HF LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH REFERENCED ESU BIPOLAR ELECTRODE COAG MODE FIRST ELECTRODE TEST CODE 2122 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF HF LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH REFERENCED ESU BIPOLAR ELECTRODE COAG MODE SECOND ELECTRODE Link 14344 TEST CODE 2211 IEC 601 2 2 part 1 FIGURE 102 MEASUREMENT OF HF LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH AND LOAD FROM ACTIVE ELECTRODE TO EARTH EARTH REFERENCED ESU MONO POLAR ELECTRODE CUT MODE ACTIVE ELECTRODE Link 3 4 TEST CODE 2212 EARTH IEC 601 2 2 part 1 FIGURE 101 j REF ESU MEASUREMENT OF H F a 4 LEAKAGE CURRENT WITH NEUTRAL ELECTR
7. requirements Performance The instrument operates within specification when used under the conditions in the above standards EMC and Safety Standards The product identified above conforms to the requirements of Council Directive 2004 108 EC and 2006 95 EC This Conformity is indicated by the symbol CE Le Conformit Europ enne Seaward Electronic Ltd is registered under BS EN ISO9001 2000 Certificate No Q05356 oiya e U ai ty EEE E E EEN PEEN ce nee IRIS EPE eee ee ee ee JET 2 ANAS FUNCIONS sina aan 2 sA AA af A A SIGN A uaeenss 3 Unpacking the Uni Therm tsk L Rr KRR ER 3 ODUNAACGESSONE Skansinn in 3 MANS GAUOS ssp bg GA lg 4 Joer NOOO aka NANANG NAN AA AA ne la a aa 4 a NAA CA skata gd a lJ na 4 Uni Therm Overview 01111 11 a 5 Bigla DANS AAP AA PAA AAP 6 ela DANS AA AA PNPA AA 6 1 IA Aa KALA ee GA AG O T 1 1 Connecting your Analyser 2 aa T 1 2 Real PANG AA TE T 1 3 Front connection panel 2 22 2 Q Q Q aa T 1 4 Side panel ESU to ESA connections rss 8 1 5 POMES COC aa NANA AA 8 2 bl Ah a AAP 9 2 1 Plate Security REM TES L A NAA ia 9 2 2 HE LEAK o ee AS AA AA 10 2 3 Power Test u s AALAGA AA Aa 13 3 AA 3 lt A acs sae cae ce La AA JONR ONO EETA 18 3 1 Stopping or failing a test sequence aaa 21 4 LO a AA AA AA 23 4 1 NOV BEC is a AA A EE EAEE E T 23 4 2 Transfer Data 2 Ha 2
8. BT Favourites 4 1 View Data ae ee ees Stored data can be viewed by selecting the VIEW DATA from the DATA screen as shown above View Data Asset Date Status 1234567890 11 09 2012 Fail 1234567890 11 09 2012 Pass 12345abed 11 09 2012 Pass Data can be sorted using the SORT key which will sort on asset number and date either ascending or descending 23 Page Rigel Medical Uni Therm user Manual V1 1 From the view data screen results and test sequences can be viewed by pressing the VIEW button and transferred to a PC by pressing TRANSFER To view data use the rotary encoder to select the asset ID press to select or press VIEW This shows the test results for the selected asset ID Asset ID 1234567890 11 09 2012 11 03 48 Tested On Test Sequence Koo Seq Test results can be viewed by pressing the RESULTS button test settings can be viewed by pressing TEST SEQ button and deleted by pressing the DELETE button SEQUENCE When power distribution graphs are part of the test sequence the results can be displayed in graph mode and data mode see below In graph mode the reference graph is also shown GRAPH POWER TEST GRAPH POWER TEST Test Load 2500 Ohms W rms mA rms v rms V peak CF CO aE wt a saa ta 1 000 1 500 2 000 2 500 Ohms 462 642 1 4 DIAGRAM GRAPH 4 2 Transfer Data The Rigel Uni Therm is able to transfer data to and from the PC In addition power distribution
9. SET LOAD RESISTANCE MONO POLAR 7 ELECTRODE COAG MODE Ha ACTIVE AND NEUTRAL a ELECTRODE 50 Page Rigel Medical Uni Therm user Manual V1 1 Appendix C Creating a power reference curve The Rigel Uni Therm is able to automatically compare the measured power distribution graph against a preset template or reference curve You will require two reference curves one for the upper and one for the lower limits Open the file refgraphtemplate csv provide on the application disc or available on request through support rigelmedical com REFGRAPH Upper curv 10 NN 25 35 REFGRAPH and END must remain at the beginning and end 175 290 Upper Curve is the name of the graph and can be changed 250 290 This will be the name of your graph once uploaded to the Rigel 325 290 Uni Therm 400 290 10 is the number of points on the graph this can be changed 475 590 but the lines of data must reflect this number Column A is the X axis and represents the Load Q Column 550 290 l B is the Y axis and represents the Power W In this example 625 260 line 3 is a plot of 290W at 1750 700 220 END Once you have completed plotting the points in the CSV file select File Save As and save the file with a recognisable name and as file type csv Follow the instructions in this manual to upload the reference graphs To use the uploaded reference curves go to MENU SETUP TEST SEQUENCES Then either add a new test sequence or edit an
10. affected Individual assets can be deleted from the view data menu see chapter 4 1 37 Page Rigel Medical Uni Therm user Manual V1 1 6 5 About The about screen shows the firmware versions and serial number of your device Ensure you have this information available when contacting Rigel Medical for Technical Support or Service See chapter 7 4 for more information on Service and Calibration About Test Sequences Display Version 6 02 REM Controller Version 6 01 Time Date Measurement Controller Version 6 03 Language Serial number 780 0395 Factory Restore CT Serial number 0004 This Software is based in part on the work of the Gwt project http qwt sf net 38 Page Rigel Medical Uni Therm user Manual V1 1 7 Maintaining the Rigel Uni Therm 7 14 Cleaning the Analyser The Rigel Uni Therm case can be cleaned with a damp cloth with if necessary a small amount of mild detergent Prevent excessive moisture around the socket panel Do not allow liquid inside the Rigel Uni Therm or near the sockets Do not use abrasives solvents or alcohol If any liquid is spilt into the Rigel Uni Therm case the analyser should be returned for repair stating the cause of the defect 2 User Maintenance The Rigel Uni Therm is a rugged quality instrument However care should always be taken when using transporting and storing this type of equipment Failure to treat the product with care will reduce both the lif
11. frequency leakage high power current and power distribution and patient return plate alarm testing A newly designed ultra low inductive load bank provides highly accurate and stable test conditions at high frequency currents Utilising a large full colour graphical display the Rigel Uni Therm is a fully stand alone electrosurgical analyser that can offer true intuitive user friendly operation and operator safety Tests can be carried out on an individual basis see chapter 2 and as part of an automatic sequence see chapter 3 Data can be stored viewed and transferred from within the instrument see chapter 4 Customisation of the Rigel Uni Therm can be carried out in the setup see chapter 6 Analyser Functions The Rigel Uni Therm is able to measure the following parameters both automatically and manually e Power Test W mA rms V peak and crest factor e HF Leakage mA rms e Plate Security REM Remote Electrode Monitoring For the power test an internal array of resistors provide a safe variable load of 0 51150 in 50 steps enabling the production of accurate and detailed power distribution curves with an instant tabular view of test results A unique feature of the HF leakage test is on screen graphics illustrating correct test connection configurations complete with user set pass fail limits The plate security REM test offers a unique isolated motor driven potentiometer which provides a continuous swept re
12. plate security test use the black terminals o V1 Medical Uni Therm user Manual Rigel 7 Page 14 Side panel ESU to ESA connections N REFER TO USER MANUAL FOR LOAD PERFORMANCE Jumper Links 0 5115 1 Follow the on screen instruction diagrams for correct test connection See appendices A and B for embedded connection diagrams Connect the ESU active and neutral electrodes to the side panel as indicated also fit jumper links positions 1 2 3 4 as required to complete circuits Link 1134 NB each connection diagram has a unique reference code eg 1112 for identification 1 5 Home screen Upon power up of the Rigel Uni Therm the display will be showing the HOMESCREEN UNI THERM E 10 ON F1 Fa MG F4 OFE 8 Page Rigel Medical Uni Therm user Manual V1 1 2 Manual Mode The manual mode provides the user with the features for testing a specific individual function and or test condition for example to aid fault diagnostic procedures These tests are available from the home screen Available tests are v REM test v HF Leakage v Power Test 2 1 Plate Security REM test This test will control a motor driven potentiometer to trigger the neutral patient plate alarm on electrosurgical generators by simulating fault conditions ie resistance too high or too low a variation in resistance etc The variable resistance O 475 Q is connected to the two black connectors on the front panel
13. reference curves can be uploaded to the instrument to allow quick check of power performance against manufacturer curves 24 Page Rigel Medical Uni Therm user Manual V1 1 Menu Auto Mode KK AUTO DATA SETUP 4 3 Download data Stored data can be downloaded to the PC in several formats To capture data as a text file CSV select either CSV full or CSV summary To download the test results into Med eBase select the SSS format Data Transfer Number of Assets 3 status Idle Port USB PC Connection Operation Export 555 Change the data format between Export SSS Export CSV full Export CSV summary Export Test Sequences Import results Import Ref Graph and Import Test Sequences by pressing the OPERATION button Change between USB USB memory stick and Bluetooth using the PORT key Start download by pressing START Note that for the EXPORT SSS format must be selected when data is downloaded to Med eBase software Transfer Ready Transfer Ready Results ready for copying Attach the unitto a Pc via a USB cable and copy the results file from the removable drive that appears 25 Page Rigel Medical Uni Therm user Manual V1 1 The Rigel Uni Therm will act as a REMOVABLE DISC data storage device and the data file can be copied from the drive that appears in explorer Note that when using med eBase the export and import of data will commence from the software once the Uni Therm is in the TRANSFER READY state
14. test from the main menu shown below Use the rotary encoder to navigate the screen 10 Page Rigel Medical Uni Therm user Manual V1 1 Select the required setting and press the rotary encoder to activate the field Once activated use the rotary encoder to change the settings Confirm and de activate the field by pressing the encoder once again START DELAY will allow the user to set a measurement delay for generators operating in a soft start mode The TEST TIME will display the total test time of the leakage test and dictate the amount of tests done as a result of the selected ON TIME and OFF TIME Note the D CYCLE is limited to 50 or less during the leakage test with a maximum ON time of 15 seconds To increase the ON TIME the OFF TIME must be increased first in order to remain within the duty cycle limits This is done to protect the EUT from overheating If the selected ON OFF time is above the 50 duty cycle the Uni Therm will calculate this automatically the duty cycle factor appears in red It s not possible to continue without reducing the duty cycle A valid duty cycle will appear in black HF Leakage Test Settings HF Leakage Test Settings ESU CONTROL ESA SETTINGS ESU CONTROL DICYCLE ss STARTDELAY 200ms DICYCLE so ONTIME i5s TESTTIME ON TIME OFFTIME 2s OFFTIME 2s Press NEXT to confirm and start selecting the appropriate leakage tests Four different measurement scenarios have been described
15. the rotary encoder or the dedicated function keys to navigate 2 3 1 Continuous mode The continuous mode allows the user to monitor the power characteristics under a specific load condition A Ensure that the power settings on the EUT do not exceed those specified in the Load Power rating Rigel Uni Therm CONTINUOUS MODE POWER TEST SETTINGS ESA SETTINGS ESU CONTROL BIPOLAR MONO POLAR LOAD START DELAY 200 ms _ 13 Page Rigel Medical Uni Therm user Manual V1 1 Use the rotary encoder to navigate the screen The selected field is marked with a red border presses the rotary encoder to activate the field to allow changes Confirm and de activate the field by pressing the encoder once again LOAD is required to determine the resistance at which the power measurement is carried out START DELAY will allow the user to set a measurement delay for generators operating in a soft start mode The TEST TIME will display the total test time of the leakage test and dictate the amount of tests done as a result of the selected ON TIME and OFF TIME The BIPOLAR MONO POLAR and COAG CUT settings determine the type of connection diagrams when the SHOW DIAGRAM button is pressed The COAG CUT settings also determine the activation of the foot paddle control on the front of the Uni Therm Note the duty cycle is limited to 50 or less when the high duty cycle box is un ticked to protect the EUT from overheating It is ho
16. x Mame Size Type Date Modified GjrefGraphs Fil 2908 M2012 15 56 E O setting Fil 29 08 2012 16 13 Ca Fil 11 09 2012 11 03 GjtestSaquences Fil 11092012 09 17 E 555 Export 11094012 135605 SKB File 110912012 13 56 Data transfer will commence automatically if the Bluetooth port is selected Ensure that the Med eBase software is ready to receive 4 4 Upload data Test data can be uploaded to the Rigel Uni Therm by adding downloaded files see data download above into the folder that appears in the explorer window Using Med eBase software work and assets can be scheduled see Med eBase user manual Data Transfer Humber Of Records Pc Status Port Option Operation lt Format Port Start Change between USB and Bluetooth using the PORT key Start upload by pressing F4 Start refer to Med eBase user manual for procedures on Med eBase When the Uni Therm is put in the upload menu data transfer the Uni Therm will appear as a removable drive Copy the test results information into the testresults folder The data has now been uploaded to the Uni Therm x Mame Size Type Date Modified GjrefGraphs Fil 908 201 15 56 a O setting Fil 29 08 2012 16 13 Fil 11 09 2012 11 03 Gjtest EQUENCE S Fil 11 09f 012 09 17 E 555 Export 11094012 135605 SKB File 11 09 2012 13 56 26 Page Rigel Medical Uni Therm user Manual V1 1 4 5 Import power reference curves To assist with the power distribut
17. 10 design requirements Do not connect any active power electrodes to the front panel of the Rigel Uni Therm Failure to comply with this will void the warranty and might lead to internal damage of circuits Safety Notes gt See Pe The Rigel Uni Therm Electrosurgical Analyser is designed for use by adequately trained technical personnel only The Rigel Uni Therm Electrosurgical Analyser is designed for use within the published specifications Any application outside of these specifications or any unauthorised user modifications may result in hazardous conditions or improper operation and will void the product warranty Operation Refer to the Device Under Test DUT manufacturer operating instructions to ensure safe operation whilst analysing the DUT Safety Use extreme caution when working with voltages greater than 30 Volts Safety Where safe operation of the Uni Therm is no longer possible it should be immediately shut down and secured to prevent accidental operation lt must be assumed that safe operation is no longer possible if the instrument or leads show any sign of damage or the instrument does not function or after long periods of storage under adverse environmental conditions Page Rigel Medical Uni Therm user Manual V1 1 Uni Therm Overview RON 5 Page ON OFF button Function keys F 1 F4 Start Confirm key Green Rotary encoder main navigation key
18. 2SW United Kingdom Medical Uni Therm user Manual V1 1 Appendix A IEC 60601 2 2 Leakage Tests TEST CODE 1111 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF HF LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED ESU BIPOLAR ELECTRODE CUT MODE FIRST ELECTRODE TEST CODE 1112 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF HF LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED er BIPOLAR ELECTRODE MODE SECOND ELECTRODE eS TEST CODE 1121 IEC 601 2 2 part 1 FIGURE 104 ISO ESU MEASUREMENT OF HF AG 4 LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED ESU BIPOLAR ELECTRODE COAG MODE FIRST ELECTRODE TEST CODE 1122 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF HF LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED ESU BIPOLAR ELECTRODE COAG MODE SECOND ELECTRODE TEST CODE 1211 IEC 601 2 2 part 1 FIGURE 103 MEASUREMENT OF HF LEAKAGE CURRENT WITH NEUTRAL ELECTRODE ISOLATED FROM EARTH AT HIGH FREQUENCY EARTH ISOLATED ESU MONO POLAR ELECTRODE CUT MODE ACTIVE ELECTRODE Link 3 4 46 Page Rigel Medical Uni Therm user Manual V1 1 TEST CODE 1212 IEC 601 2 2 part 1 FIGURE 103 MEASUREMENT OF HF LEAKAGE CURRENT WITH NEUTRAL ELECTRODE ISOLATED FROM EARTH AT HIGH FREQUENCY EARTH ISOLATED ESU MONO POLAR ELECTRODE CUT MODE NEUTRAL ELECTRODE TEST CODE 1221 IEC 601 2 2 part 1 FIGURE 103 MEASUREMENT OF HF LEAKAGE CURRENT WITH NEUTRAL ELECTRODE ISOLATED FROM EARTH AT HIGH FREQUENCY EARTH
19. 4 4 3 DOWO CN AA 25 4 4 COAG CUM AA AA 26 4 5 Import power reference curves 2 a 27 4 6 Transfer test sequences aaa 27 gt Enea rn nl in in hn 29 6 a AA AA 31 6 1 Test SEQUENCE a AA nia ATA ENANA AA AG 31 6 2 MNO VANS ANA AA AG 36 6 3 LANGA HAKA 36 6 4 FAGI LES 0 S a RA ARA 37 6 5 AVOUT si a E parties nea NAA A 38 T Maintaining the Rigel Uni Therm 11111112112 aaa 39 7 1 Cleaning the Analyser 2 2 a 39 7 2 WISE VFS ANG ska a AA 39 7 3 Firmware Upgrade AA a a Ra eaka N ERRIENT 39 7 4 BS SUA WISE UC BEC RA AA AE 40 8 a un AA E T ETE E 41 8 1 Technical Specification 0 ec ec cece sec eeeeeseeeeeeeeceeeeeeeeeeeeeeeeneceeteeeeeeeeeeeeeeeeeeaes 41 8 2 General Specification 0 0 trans 42 8 3 Load Power rating Rigel Uni Therm 1 220222 aa 43 9 AA E 45 9 1 CORAT 0 AA AA a ra ia 45 Appendix A IEC 60601 2 2 Leakage Tests cccccceccecceeceeeeeeseeteeeeeeseeeeeeeeeeeeeeees 46 Appendix B IEC 60601 2 2 Power OS isl 50 Appendix C Creating a power reference curve aaa 51 Appendix D 1 Page Firmware Route Map RS TR 53 Rigel Medical Uni Therm user Manual V1 1 Introduction Thank you for purchasing the Rigel Uni Therm Electrosurgical Analyser The new high performance Rigel Uni Therm accurately measures the performance of electrosurgical generators Measurements include high
20. ECTRODE REFERENCED TO EARTH AND LOAD BETWEEN ELECTRODES EE EARTH ISOLATED ESU EARTH REFERENCED ESU E EIFOLAR ELECTRODE MONO POLAR ELECTRODE E FIRST ELECTRODE MS ACTIVE Ei TRODE SET LEAKAGE man a LOAD LIMIT peta RUN me CIRCUIT DETAIL RUN 3 The Rigel Uni Therm could display the following details after the test Load 200 ohms Load 200 ohms Leakage 0 mA Leakage 125 mA Limit 200 mA Limit 200 mA Pass Ta Test Complete Press the HOLD key to freeze the reading on the screen The test can be aborted by pressing the red STOP button on the front of the Uni Therm After a test is completed either PASS or FAIL press the green START button on the front of the Uni Therm 12 Page Rigel Medical Uni Therm user Manual V1 1 2 3 Power Test The output power of the Active Electrodes CUT COAG and BIPOLAR is measured either at a fixed load Continuous Single Test or at a range of loads Power Distribution Graph The load will vary from a start value to an end value with a number of intervals resolution The Rigel Uni Therm will control the EUT by using the internal footswitch controller Choose Type of Power Test RIGEL a UNI THERM vera DATE 1009 2012 TIME 2 11 45 pm HF POWER XEN CONT GRAPH EXT MED LEAKAGE TEST cont man eT Select Power test from the home screen CONT or GRAPH mode using the fast keys and select either the Continuous Graph or External Load test Use
21. ODE REFERENCED TO EARTH AND LOAD BETWEEN ELECTRODES EARTH REFERENCED ESU MONO POLAR ELECTRODE MODE NEUTRAL ELECTRODE Link 14344 TEST CODE 2221 IEC 601 2 2 part 1 FIGURE 102 MEASUREMENT OF H F me LEAKAGE CURRENT WITH Af co NEUTRAL ELECTRODE j 52001 REFERENCED TO EARTH AND i LOAD FROM ACTIVE ELECTRODE TO EARTH EARTH REFERENCED ESU MONO POLAR ELECTRODE COAG MODE ACTIVE ELECTRODE NEUT EARTH ESU Link 3 4 E 48 Page Rigel Medical Uni Therm user Manual V1 1 TEST CODE 2222 IEC 601 2 2 part 1 FIGURE 101 MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH AND LOAD BETWEEN ELECTRODES Link 143444 EARTH REFERENCED ESU MONO POLAR ELECTRODE MODE NEUTRAL ELECTRODE 49 Page Rigel Medical Uni Therm user Manual V1 1 Appendix B IEC 60601 2 2 Power Tests TEST CODE 0110 IEC 601 2 2 part 1 FIGURE 106 MEASUREMENT OF OUTPUT POWER BI POLAR OUTPUT USER SET LOAD RESISTANCE BI POLAR ELECTRODE CUT MODE BOTH ELECTRODES 0110 TEST CODE 0120 IEC 601 2 2 part 1 FIGURE 106 MEASUREMENT OF OUTPUT POWER BI POLAR OUTPUT USER SET LOAD RESISTANCE BI POLAR ELECTRODE COAG MODE BOTH ELECTRODES 0120 TEST CODE 0210 IEC 601 2 2 part 1 FIGURE 105 MEASUREMENT OF OUTPUT POWER MONO POLAR OUTPUT USER SET LOAD RESISTANCE MONO POLAR ELECTRODE CUT MODE ACTIVE AND NEUTRAL ELECTRODE TEST CODE 0220 IEC 601 2 2 part 1 FIGURE 105 MEASUREMENT OF OUTPUT POWER MONO POLAR OUTPUT USER
22. OPERATIONS PORT START Press start to connect the Uni Therm as an external drive to the PC Using Med eBase import the test sequences by following the instructions in the Med eBase instruction manual When using windows Explorer locate the REMOVABLE DISC and navigate to the corresponding folder x Mame Size Type Date Modified a GjrefGraphs Fil 2908 2012 15 56 Fil 29 08 2012 16 13 Fil 11 09 2017 11 03 Fil 11 09 2017 09 17 SKB File 1110912012 13 56 Pa Name Size Type Date Modified pa E SEQUENCE1 LIKE File O7109 2012 13 59 o BEN I KE File 11 09 2012 10 59 Select the sequence or all and copy them to a folder of choice The files can then be shared between other PC s and uploaded back into other Uni Therms To import the test sequence s put the sequence in the corresponding folder as shown above The new test sequences will now appear in the Uni Therm test sequence library 28 Page Rigel Medical Uni Therm user Manual V1 1 5 Bluetooth Favourites In order for the Rigel Uni Therm to automatically connect to the correct Bluetooth accessory details of that accessory must be stored into the Bluetooth Favourites list pairing The Bluetooth Favourites list comprises of two device types each of which can store up to 3 devices of the same type The sub lists are shown below v Barcode Scanner v Computer To start the pairing process select DATA from the home screen followed by BT FAVOURI
23. RAPGH to DATA mode to view actual results GRAPH POWER TEST GRAPH POWER TEST TestLaad 500 Ohms W rms mA rms V rms v peak CF a 3 1 Stopping or failing a test sequence During the test the sequence can be interrupted or cancelled Press the red button on the front panel The following option menu will appear 21 Page Rigel Medical Uni Therm user Manual V1 1 Abort Fail Menu Restart Test Sequence Next Test End Test Sequence Save Results Abort Test Sequence Don t Save RESTART NEXT ABORT TEST TEST SEG Restart Test will continue the test sequence from where it was interrupted Restart Test Sequence will start the sequence from the beginning Next Test will skip the current test and move to the next test note that a failure will be reported for the skipped test End Test Sequence will stop the test sequence and store the results fail Abort Test Sequence will stop the test sequence No data is stored NS NN 22 Page Rigel Medical Uni Therm user Manual V1 1 4 Data Stored data can be viewed and transferred to and from the PC such as test results and power distribution reference curves To enter the Data menu select the MENU key F1 from the home screen and then DATA Menu UNI THERM DATE 10 09 2012 TIME2 17 45 pm HF POWER This leads to 3 options v View data see chapter 4 1 v Transfer data see chapter 4 2 v BT favourites see chapter 5 Transfer Data
24. RIGEL gt MEDICAL Gl nt rqe Rnecrf cp UNI THERM Gcarnus g I _jwacp Copyright 2012 SEAWARD GROUP Instruction Manual Last Update 15th October 2013 398A550 Revision 1 1 October 2013 2013 Seaward Group Issue 1 1 RIGEL MEDICAL R Rigel Uni Therm Electrosurgical Analyser Instruction Manual 398A550 Issue 1 1 Rigel Medical 24 Month Warranty Statement Rigel Medical provides a standard 12 month manufacturer s warranty against breakdown during normal use This warranty can be upgraded to a 24 month warranty terms and conditions apply Problems caused through misuse damage fair wear 8 tear consumables and accessories are excluded from standard warranty Such components found to be being used in excess of their manufacturer s operating recommendations are also excluded Shipping to an authorised service centre is the responsibility of the sender Terms and Conditions of 24 Month Warranty The Rigel product must be registered with Rigel Medical within 30 days of purchase to be eligible for the extended 24 month warranty Instruments must be returned to an authorised service centre complete with proof of purchase within 13 months of purchase for calibration at the current rate Any items returned for calibration outside of the 13 month period stated above may not be eligible for the second 12 month section of warranty The second 12 month section of the warranty begins at the expiry of the initi
25. Rigel Uni Therm Electrosurgical Analyser Mains Power Lead Calibration Certificate Uni Therm Quick Start Guide Utilities Disc USB Bluetooth Adaptor 3 x Jumper Links p n 43B759 Optional Accessories Finger switch adaptor Foot switch adaptor cable set manufacturer specific please specify Trolley style hard carry case SMB to BNC Oscilloscope connection lead p n 367A950 3 Page Rigel Medical Uni Therm user Manual V1 1 Warnings and Cautions Before you power up Ensure the mains switch positioned at the base panel of the Rigel Uni Therm is set to the appropriate voltage range i e 230VAC or 120 VAC Before you power up Ensure none of the ventilation holes are covered during operation including the ones on the base panel We strongly recommend positioning the Rigel Uni Therm on its two hinged feet at the front base User Notes The following symbols are used throughout this Instruction Manual gt B BB Warning of electrical danger Indicates instructions must be followed to avoid danger to persons Important follow the documentation This symbol indicates that the operating instructions must be adhered to in order to avoid danger When operating the Rigel Uni Therm at its maximum capability in ambient temperature of 40 C and only during certain power tests the surface temperature of the top cover may exceed temperatures of 50 C but not exceed a surface temperature of 70 C as is permitted under the IEC 610
26. S2 keyboard Auto Mode Asset ID 1234567890 Test Sequence SEQUENCE When using the barcode scanner ensure the barcode scanner is paired with the Rigel Uni Therm see chapter 5 The Rigel Uni Therm will only support the Seaward barcode scanner p n 339A923 When the barcode is ready to scan the word OK will appear in the asset ID field Enter data with the rotary encoder push to select character or keyboard note that the enter key is not required Press NEXT to choose an available test sequence 18 Page Rigel Medical Uni Therm user Manual V1 1 SEQUENCE Next select the test Sequence box push to select and select the required test sequence To add new test sequences see chapter 6 1 From the auto mode screen press NEXT to start the sequence In the example below SEQUENCE will be used which was created in chapter 6 1 The first test in SEQUENCE is the REM test Use either the AUTO UP or MANUAL UP to increase the REM resistance As soon as the EUT goes into alarm capture the alarm by pressing CAPTURE ALARM Then continue by selecting the AUTO DOWN or MANUAL DOWN to reduce the resistance and capture the corresponding alarm Auto Mode REM Test ALARM LIMIT OHMS 53 AUTO UP UP ALARM 1480 MANUAL UP SETUPLIMIT 1650 AUTODOWN SETDOWN LIMIT 500 MANUAL DOWN DOWN ALARM 00 MAN ALARM The next step is a custom test to instruct the user to disconnect the neut
27. Select the REM test from the home screen shown below RIGEL UNI THERM DATE 10 09 2012 TIME 2 11 45 pm HF POWER LEAKAGE TEST During the initial REM test selection the Rigel Uni Therm will auto calibrate the REM potentiometer AUTO UP UP ALARM MANUAL UP SETUPLIMIT 4000 CJ AUTO DOWN SET DOWN LIMIT 1000 Calibrating h r 9 Page Rigel Medical Uni Therm user Manual V1 1 Once the calibration has completed the REM test screen will appear ALARM LIMIT OHMS AUTO UP UP ALARM jog J MANUAL UP SET UP LIMIT 400 0 AUTO DOWN SET DOWN LIMIT MANUAL DOWN DOWNALARM OQ Select automatic up or down or manual up or down control by using the dedicated AUTO MAN key This key is also used to set the limits Once the SET LIMITS field is highlighted in green use and press the rotary encoder to manipulate the UP and DOWN limits Press the Green button to start the test for automatic mode only Then capture the alarm value by pressing the dedicated Capture Alarm key on the screen In MANUAL UP and DOWN mode the rotary encoder is used to directly control the potentiometer The alarm value is then captured by pressing the dedicated Capture Alarm key on the screen 2 2 HF Leakage The HF Leakage test measures the HF leakage current in various test configurations see appendix A and compares the result to a user set pass fail value Select the HF LEAKAGE
28. TES Menu Auto Mode View Data Transfer Data From the BT Favourites screen press the SEARCH button to list all the Bluetooth devices within reach Ensure you re your barcode scanner and or PC or in discovery mode BT Favourites searching for devices Computer Bar Code The devices found in range will be listed Wait until the search has been completed which can take up to 15 seconds Once the search is completed press the back arrow key 29 Page Rigel Medical Uni Therm user Manual V1 1 search complete OPL 2724 35ED To pair the appropriate device to the corresponding function select and open the drop down box using the rotary encoder and press SELECT for each correct device Select Computer OPL 2 24 35ED SELLTO47 Check that the correct devices are paired for each function and press the back arrow to exit and complete the pairing BT Favourites Computer SELLTO47 T Bar Code OPL 2724 35ED Note If the required device is not shown check that it is powered on with the Bluetooth function active then repeat the search Some Bluetooth devices do not report a recognisable name and may cause confusion when setting up Favourites Turn off or disable unused Bluetooth devices when configuring Favourites Note Seaward and Rigel accessories do not require a PIN When the PC requires an authorisation some Windows version might ask enter 0000 four zero s 30 Page Rigel Medic
29. age Manual testing of the HF leakage Power Manual testing of the Power output 53 Page Rigel Medical Uni Therm user Manual V1 1
30. al 12 month period not when the unit is calibrated Details correct at time of going to print The manufacturer retains the right to make amendments to the above terms and conditions without prior notice Calibration Statement The Rigel Uni Therm Electrosurgical Analyser is fully calibrated and found to be within the specified performance and accuracy at the time of production The Seaward Group provides its products through a variety of channels therefore it may be possible that the calibration date on the provided certificate may not represent the actual date of first use Experience has indicated that the calibration of this instrument in not effected by storage prior to receipt by the user We therefore recommend that the recalibration period be based on a 12 month interval from the first date the unit is placed in to service Date received into service Copyright 2013 All rights reserved Nothing from this edition may be multiplied or made public in any form or manner either electronically mechanically by photocopying recording or in any manner without prior written consent from the SEAWARD GROUP This also applies to accompanying drawings and diagrams Due to a policy of continuous development the SEAWARD GROUP reserves the right to alter the equipment specification and description outlined in this publication without prior notice and no part of this publication shall be deemed to be part of any contract for the equip
31. al Uni Therm user Manual V1 1 6 Setup To enter the setup mode select the MENU key F1 from the home screen and then SETUP Menu RI G ka L Auto Mode UNI THERM DATE 10 09 2012 TIME 2 11 45 pm Time Date Language Factory Restore About KR TEST SEQ TIME ABOUT View edit or create test sequences see chapter 6 1 Configure the local time and date settings see chapter 6 2 Change the menu language see see chapter 6 3 Restore factory settings see chapter 6 4 View the about screen see chapter 6 5 CNN NAN 6 1 Test sequence The Rigel Uni Therm can be set up to perform automatic test sequences These can be created by the user and can be specific to for example manufacturers recommendations The total number of possible test sequences is 100 From SETUP menu select the test sequence option 31 Page Rigel Medical Uni Therm user Manual V1 1 6 1 1 Creating a new test sequence Select test sequences from the SETUP menu Test Sequences Select NEW to open a new test sequence and enter a name use the rotary encoder or USB keyboard to enter data Select KEYBOARD to change the format from QWERTY to ABCD style Enter new test sequence name Press the EDIT button to open the test sequence for editing 32 Page Rigel Medical Uni Therm user Manual V1 1 Edit Test sequence sequence Name SEQUENCE note when no individual tests are inserted the EDIT and OPTIONS buttons are not active Sta
32. between GRAPH MODE and DATA by pressing the GOTO DATA fast key In the automatic mode a reference graph can be included in the test to automatically detect of the current graph meets the criteria of the reference graph A full description of how to create a power reference graph is provided in Appendix D 2 3 3 External Load mode The external load mode allows the user to monitor the power characteristics under a specific load condition utilising external loads or under short circuit condition i e for calibration purpose During the test the EUT is connected to the external loads and then to the measuring device of the Uni Therm MD The Uni Therm will calculate the power characteristics at the set external load by measuring the HF current through the MD A The maximum current measurement during this test is limited to 8A rms EXTERNAL LOAD MODE POWER TEST SETTINGS ESA SETTINGS ESU CONTROL BIPOLAR COAG O MONO POLAR CUT Ce EXTLOAD l630 START DELAY res TNE 16 Page Rigel Medical Uni Therm user Manual V1 1 Use the rotary encoder to navigate the screen The selected field is marked with a red border presses the rotary encoder to activate the field to allow changes Confirm and de activate the field by pressing the encoder once again EXT LOAD is required to determine the correct power calculation and is for reference only The Uni Therm s load bank is not part of the test setup START DELAY will allow the user to se
33. e measurement is carried out START DELAY will allow the user to set a measurement delay for generators operating in a soft start mode END LOAD will set the highest resistance at which the power curve measurement is carried out TEST POINTS determines the number of test points resolution of the power distribution graph The higher the number the more detailed the power distribution graphs The TEST TIME will display the total test time of the leakage test and dictate the amount of tests done as a result of the selected ON TIME and OFF TIME and the number of test points The BIPOLAR MONO POLAR and COAG CUT settings determine the type of connection diagrams when the SHOW DIAGRAM button is pressed The COAG CUT settings also determine the activation of the foot paddle control on the front of the Uni Therm Note the duty cycle is limited to 50 or to protect the EUT from overheating To increase the ON time the OFF time must be increased first in order to remain within the duty cycle limits 15 Page Rigel Medical Uni Therm user Manual V1 1 Press SHOW DIAGRAM to obtain help on the connection between the Uni Therm and the EUT Press START to confirm the settings and start the test During the Graph power test the Rigel Uni Therm will display the power distribution graph GRAPH POWER TEST p GRAFH POWER TEST Test Load 7500 C ae Sda NA en 1 000 1 500 2 000 2 500 Ohms At the end of the test toggle
34. e of the instrument and its reliability If the Rigel Uni Therm is subject to condensation allow the Analyser to completely dry before use v Always check the Rigel Uni Therm and all test leads for signs of damage and wear before use Do not open the Rigel Uni Therm under any circumstances Keep the instrument clean and dry Avoid testing in conditions of high electrostatic or electromagnetic fields Maintenance should only be performed by authorised personnel Apart from the mains cable and fuses there are no user replaceable parts in the Rigel Uni Therm The unit should be regularly calibrated Se N NN N 7 3 Firmware Upgrade The Rigel Uni Therm is designed to allow service agents and users to easily upgrade the firmware by using the internet to download the latest firmware a loading application and instructions The firmware is installed using a PC via the USB port or via a USB stick To obtain the latest firmware the Rigel Uni Therm will need to be registered this will also provide automatic upgrade alerts to the user 39 Page Rigel Medical Uni Therm user Manual V1 1 7 4 Return Instructions For repair or calibration return the instrument to Rigel Medical Service Dept p a CalibrationHouse Bracken Hill South West Industrial Estate Peterlee Co Durham SR8 2SW England Tel 44 0 191 587 8739 Fax 44 0 191 586 0227 sales rigelmedical com service calibrationhouse com www calibrationhouse com
35. ed with a red border Press the rotary encoder to open the field for editing User Test Disconnect the Neurtal electrodes from the REM test and combine to form a single connection Unit f o 34 Page Rigel Medical Uni Therm user Manual V1 1 In case the user test requires data entry such as a result the user test can also include an engineer unit such as Ohms Watts Celsius etc Confirm the entry by pressing the UPDATE button Once the test sequence is completed press the back arrow key and confirm the changes save changes Save changes save Changes to the current test sequence The new test sequence has now been added to the test library Test Sequences SEQUENCE Edit sequence name Copy or Delete test sequence From the Test Sequences menu select OPTION SEQUENCE Test Sequences SEQUENCE a DELETE COPY RENAME To delete a test sequence press DELETE To copy a test sequence press COPY To rename a test sequence RENAME 35 Page Rigel Medical Uni Therm user Manual V1 1 6 2 Time Date To modify the time or date including time format 12 24h clock select the Time Date option in the setup menu see below Setup Test Sequences Na 0 28 39 pm Language Factory Restore Date 11 09 2012 About Date Format dd MMAYYY Press 24H to change between 12H AM PM and 24H clock format Press MM DD to change between MM DD and DD MM format Use the rotary encoder to na
36. existing test sequence as covered in this manual Once you have added a Power Graph test Highlight the test and select EDIT REF GRAPH and UPPER or LOWER Highlight the correct file and SELECT This will set the new file as the upper or lower limit of the graph GRAPH MODE POWER TEST SETTINGS GRAPH POWER TEST TINGS SU CON Watt ESUP 100 ESA SETTINGS ESU CONTROL ower BI POLAR COAG MONO POLAR CUT START LOAD brevets 5 5 5 stant DELAY 200 75 owe END LOAD 3 l OFF TIME TEST POINTS POWER 80s TEST TIME REF SHOW PDAT UPPER LOWER vpoate 4am upper Lower 51 Page Rigel Medical Uni Therm user Manual V1 1 Select the UPPER and LOWER limit graphs by pressing UPPER and LOWER respectively and select the corresponding graphs Test Sequences Test Sequences NONE Lower refgraphtemplate csv Upper refgraphtemplate csv 52 Page Rigel Medical Uni Therm user Manual V1 1 Appendix D Firmware Route Map Menu Auto Mode Data View Data View test results Transfer Date Download and upload results Import reference curves Transfer test sequences BT Favourites Pair PC and barcode scanners Setup Test Sequences View create and edit test sequences Time Date Change time and date settings Language Change language settings Factory Restore Restore instrument to factory default About View firmware revision and serial number REM test Manual testing of the REM function HF Leak
37. in the particular standard IEC 60601 2 2 See appendix for all available leakage settings Use the rotary encoder to change between the different leakage configurations Use either the DIAGRAM mode shown below HF Leakage Test Settings TEST CODE 1111 HF Leakage Test Settings IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE ISO ESU EE EARTH ISOLATED ESU EE EPIPOLAR ELECTRODE Fa MM FIRST ELECTRODE Link 24344 SET LEAKAGE LOAD Kate z LIMIT dem orcun oera ma CIRCUIT DETAIL SET LEAKAGE LOAD LIMIT dem orcun beru CIRCUIT DETAIL 11 Page Rigel Medical Uni Therm user Manual V1 1 or the IEC 60601 2 2 reference details SHOW DETAIL The rotary encoder can be used to scroll the different test setups or to SET LOAD and LEAKAGE LIMIT values The selected field is highlighted in red Press the rotary encoder to activate the field field turn blue and use the rotary encoder to change the settings Press the rotary encoder again to confirm Return to the DIAGRAM mode by using the SHOW DIAGRAM fast key Start the test by pressing the RUN button and confirm with the green START button on the front of the Uni Therm HF Leakage Test Settings TEST CODE 1111 TEST CODE 2223 IEC 601 2 2 part 1 FIGURE 104 IEC 6501 2 2 part 1 FIGURE n a MEASUREMENT OF H F LEAKAGE CURRENT FROM A MEASUREMENT OF H F LEAKAGE CURRENT WITH BIPOLAR ELECTRODE NEUTRAL EL
38. ion graph tests expected or reference curves can be uploaded to the instrument for quick comparison An upper and lower limit graph can be uploaded by selecting Import Ref Graph on the data transfer screen Use OPERATION to change Data Transfer Number of Assets 3 Status Idle Port USB PC Connection Operation Import Ref Graph Change between USB and Bluetooth using the PORT key When using Med eBase to upload the reference curves refer to the Med eBase user manual for procedures When using Windows Explorer press START and locate the REMOVABLE DISC x Mame Size Type Date Modified Fil 29 06 2012 15 55 IG settings Fil 29 08 2012 16 13 O testResulks Fil 11 09 2017 11 03 GjtestSequences Fil 11092012 09 17 E 555 Export 11094012 135605 SKB File 11 09 2012 13 56 Copy the reference curve csv files into the corresponding folder This has now stored the reference curves on the Rigel Uni Therm 4 6 Transfer test sequences Test sequences can be created on both the Rigel Uni Therm and in Med eBase software Test sequences can then be shared across a number of Rigel uni Therm s in order to have identical configuration of test sequences Export test sequences from the data transfer screen select the Export Test Sequences press OPERATION 27 Page Rigel Medical Uni Therm user Manual V1 1 Data Transfer Number of Assets Status Idle Port USB PC Connection Operation Export Test Sequences a
39. ment unless specifically referred to as an inclusion within such contract Disposal of old product The Rigel Uni Therm has been designed and manufactured with high quality materials and components which can be recycled and reused When this symbol is attached to a product it means the product is covered by the European Directive 2012 96 EC Please familiarise yourself with the appropriate local separate collection system for electrical and electronic products or contact your local supplier for further information Please dispose of this product according to local regulations Do not dispose of this product along with normal waste material By offering your old products for recycling you will help prevent potential negative consequences for the environment and human health Certificate of Conformity Manufactured by Seaward Electronic Ltd Bracken Hill South West Industrial Estate Peterlee County Durham SR8 2SW England Statement of Conformity As the manufacturer of the apparatus listed declare under our sole responsibility that the product Rigel Uni Therm Electrosurgical Analyser To which the declaration relates are in conformity with the relevant clauses of the following standard BS EN 61010 1 2010 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements BS EN 61326 2006 Electrical equipment for measurement control and laboratory use EMC
40. ral electrodes User Test Disconnect the Neurtal electrodes from the REM test and combine to form a single connection 19 Page Rigel Medical Uni Therm user Manual V1 1 Either press PASS or the GREEN button to continue The next step in SEQUENCE is the HF leakage test HF Leakage Test Settings EARTH r um EARTH ISO ESU ui la 50 ESU Link 344 LEAKAGE LIMIT KI DIAGRAWT Run MA Ba pera PEN Follow the connection instructions on the main screen and press RUN to confirm and start the HF leakage test The next step is a custom test to instruct the user to set the output power to maximum 300W in this example User Test Set the ESU to maximum power 300W Either press PASS or the GREEN button to continue The next step in SEQUENCE is the POWER GRAPGH test GRAPH MODE POWER TEST SETTINGS ESA SETTINGS ESU CONTROL BIPOLAR O COAG O MONO POLAR GUT ol START LOAD DGYCLE 50x ON II NE zs FIL TE Bae SHOW DIAGRAM START 20 Page Rigel Medical Uni Therm user Manual V1 1 The Rigel Uni Therm will display the settings Press SHOW DIAGRAM to show the connection diagram Check connections and confirm by pressing START Start Test S Press the GREEN button to start the test The Rigel Uni Therm will now activate the EUT through the foot paddle control on the front panel During the test the screen will update the graph after each measurement is taken Switch from G
41. rt adding individual tests to the test sequence by pressing the ADD button Select Test to Add HF Leakage Test Continuous Power Test Graph Power Test External Load Power Test User Test Highlighted the required test using the rotary encoder and press to select Edit Test Sequence sequence Name SEQUENCE Repeat the above steps until the required test sequence is completed Note that additional tests can be inserted in the test sequence by highlighting the position in the sequence and press the ADD button The test will be inserted AFTER the highlighted position 33 Page Rigel Medical Uni Therm user Manual V1 1 REM Test User Test HF Leakage Test 1111 5 Continuous Power Test 0210 User Test The individual tests can now be edited configured to the specific requirements Once an individual test has been configured they can be copied and pasted repeatedly by selecting the OPTIONS button Edit individual tests by selecting the required test and press EDIT Edit Test Sequence l SET UP LIMIT 165 0 User Test k HF Leakage Test 1111 4 User Test Continuous Power Test 0210 User Test Once the selected criteria have been set confirm by pressing the UPDATE button User tests can be inserted and used for providing instructions to the test engineer Select the user test and press EDIT SET DOWN LIMIT 500 In the user test screen select the field you want to edit which is highlight
42. sistance change enabling accurate and fast testing of alarms complete with user set pass fail limits Any future firmware upgrades can be efficiently installed by users without risk to stored data The new Rigel Uni Therm forms part of a comprehensive range of high performance specialist biomedical test equipment supplied by Rigel Medical part of the Seaward Group 2 Page Rigel Medical Uni Therm user Manual V1 1 Key Features V V V KAS Fully compliant with IEC 60601 2 2 One instrument for full compliance testing offering peace of mind Accurate and Safe Utilising full 10kV isolation on all measuring systems High current test capability Allows accurate calibration and measurement of currents up to 8A High Frequency Leakage Easy to connect with on screen help for each configuration Power distribution curves Variable load with full 10kV isolation from O to 51150 in 5Q steps Accurate fast and flexible Plate Security REM test using electronic potentiometer range up to 4750 in 1 Q steps with high and low alarms Stand alone Not relying on PC or laptop Stylish and rugged enclosure with small footprint ideal for in situ testing Graphic colour user interface for fast and easy navigation and connection to DUT Future upgrade ready download future upgrades from the web into your tester Unpacking the Uni Therm Carefully unpack all items from the box and ensure the following items are included
43. t a measurement delay for generators operating in a soft start mode The TEST TIME will display the total test time of the leakage test and dictate the amount of tests done as a result of the selected ON TIME and OFF TIME The BIPOLAR MONO POLAR and COAG CUT settings determine the type of connection diagrams when the SHOW DIAGRAM button is pressed The COAG CUT settings also determine the activation of the foot paddle control on the front of the Uni Therm Note the duty cycle is limited to 50 or to protect the EUT from overheating To increase the ON time the OFF time must be increased first in order to remain within the duty cycle limits Press SHOW DIAGRAM to obtain help on the connection between the Uni Therm and the EUT Press START to confirm the settings and start the test 17 Page Rigel Medical Uni Therm user Manual V1 1 3 Automatic Mode The automatic mode allows the user to select a test sequence which will carry out a pre determined set of tests against user definable limits Test results are stored at the end of the test for future reference To view or transfer stored data please refer to chapter 4 To enter the automatic mode select the MENU key F1 from the home screen and then AUTOMODE Menu UNI THERM DATE 1009 2012 TIME 211 45 pm ba Bia i AUTO DATA SETUP baii LEAKAGE TEST Gm In the following screen an asset ID number can be entered using the rotary encoder barcode scanner or a P
44. vigate push to activate field and change values using the rotary encoder Press SAVE to confirm 6 3 Language To change the language select the language option in the setup menu see below Setup Language Test Sequences English Factory Restore pana About Italian a TEST SEQ TIME ABOUT Use the rotary encoder to navigate push to select the language Press the back button F1 to confirm or return to previous menu The list of languages might change from that in this manual as they are continuously updated 36 Page Rigel Medical Uni Therm user Manual V1 1 6 4 Factory restore Restore instrument to factory default settings can delete all user created test sequences reference graphs and can also be used to clear the memory The user is given an option to select which part of the memory is being restored to the factory default To restore factory default select the factory restore option in the setup menu see below Setup Test Sequences Time Date Language K8 TEST SEQ TIME ABOUT An overview of the memory usage is provided Memory Usage Restore Factory Settings Number of Assets C Set Default Settings Number of Test Sequences 3 O Delete Test Sequences Number of Reference Graphs 2 Delete Reference Graphs O Delete Test Results Press NEXT to select which part of the memory to restore to factory default Total Memory Used 0 0 Use the rotary encoder to select which part of the memory is being
45. wever possible to obtain up to 60 seconds on time For this to happen the high duty cycle box must be ticked To increase the on time the off time must be increased first in order to remain within the duty cycle limits This is done to protect the EUT from overheating Press SHOW DIAGRAM to obtain help on the connection between the Uni Therm and the EUT Press START to confirm the settings and start the test During the Continuous power test the display will show continuously updated readings CONTINUOUS POWER TEST Load 200 0 ohms Rms Power 216 W Rms Current 1172 mA Rms Voltage 236 V Peak Voltage Fi V Crest Factor SHOW Press the HOLD button to freeze the display 14 Page Rigel Medical Uni Therm user Manual V1 1 2 3 2 Graph mode The graph mode allows the user to monitor the power characteristics under a range of loads A Ensure that the power settings on the EUT do not exceed those specified in the Load Power rating Rigel Uni Therm GRAPH MODE POWER TEST SETTINGS ESA SETTINGS ESU CONTROL BIPOLAR O MONO POLAR srarrioap 100 START DELAY 200m END LOAD TEST POINTS TEST TIME M2003 Use the rotary encoder to navigate the screen The selected field is marked with a red border presses the rotary encoder to activate the field to allow changes Confirm and de activate the field by pressing the encoder once again START LOAD is required to determine the starting resistance at which the power curv
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