5781 A4 cover template in-house prod manuals
Contents
1. CONTINUOUS POWER TEST Load 300 0 ohms Rms Power 405 W Rms Current 1160 mA Rms Voltage 390 V Peak Voltage 502 V Peak to Peak 997 Y Crest Factor 1 44 SHOW DIAGRAM Press the HOLD button to freeze the display 17 Page Rigel Medical Uni Therm user Manual V1 4 4 3 2 Graph Mode The graph mode allows the user to monitor the power characteristics under a range of loads 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 COAG O MONO POLAR 8 CUT a START LOAD DICYCLE START DELAY 200 ms ONTIME END LOAD OFF TIME TEST POINTS TEST TIME 200s 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 curve 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 displa2. 4 Hard Disk Drives 1 System C a m 152 GB free of 232 GB 4 Devices with Removable Storage 2 Removable Disk F Sd DVD RW Drive D S my 29 5 MB free of 29 7 MB 6 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 Number of Assets 30 status Idle Port USB PC Connection Operation Export 555 Change between USB Memory Stick or Cable using the PORT F3 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 test results folder The data has now been uploaded to the Uni Therm 4 Hard Disk Drives 1 System C 152 GB free of 232 GB 4 Devices with Removable Storage 2 i Removable Disk F i DVD RW Drive D AZ 29 5 MB free of 29 7 MB 30 Page Rigel Medical Uni Therm user Manual V1 4 Sequences for Med eBase will have the file name Sequence_01012015 109837 sss with the numbers indicating the date and time All Sequences will be uploaded in one file 6 5 Import Power Reference Curves To assist with the power distribution graph tests expected or ref
3. DATE 10 09 2012 TIME 2 11 45 pm Time Date Language Factory Restore About ua testseo 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 LNNN A 35 Page Rigel Medical Uni Therm user Manual V1 4 8 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 8 1 1 Creating a new test sequence Select test sequences from the SETUP menu Test Sequences EX JHEED EDIT OPTION Select NEW F2 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 SEQUENCE 2 0 1 2 3 4 38 6 Ff 8 9 QO WERT U O P ASDF FH J KL Z xX CG V BNM Space GREEN Button OK RED button Cancel Delete shift Keyboard Press the GREEN button to confirm or RED button to cancel 36 Page Rigel Medical Uni Therm user Manual V1 4 Test Sequences SEQUENCE SEQUENCE2 em new cor Dornan Press the EDIT F3 button to open the test sequence f
4. 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 21 Page Rigel Medical Uni Therm user Manual V1 4 SEQUENCE Next select the Test Sequence box push to select and select the required test sequence To add new test sequences see Chapter 8 1 From the auto mode screen press NEXT to start the sequence In the example below SEQUENCE2 will be used which was created in Chapter 8 1 The first test in SEQUENCE2 is the REM test Use either the AUTO UP or MANUAL UP F2 to increase the REM resistance As soon as the EUT goes into alarm capture the alarm by pressing CAPTURE ALARM F3 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 QHMS 53 O AUTO UP UP ALARM 148 0 MANUAL UP SET UP LIMIT 1650 O AUTO DOWN SET DOWN LIMIT 50 0 8 MANUAL DOWN DOWN ALARM 00 MAN ALARM The next step is a custom test to instruct the user to disconnect the neutral electrodes 22 Page Rigel Medical Uni Therm user Manual V1 4 User Test Disconnect the Neurtal electrodes from the REM test and combine to form a single connection Either press PASS F2 or the GREEN button to continue The next step in SEQUENCE2 is the HF leakage test HF Leakage Test
5. REFERENCED TO EARTH AND LOAD FROM ACTIVE Link 3 4 ELECTRODE TO EARTH EARTH REFERENCED ESU MONO POLAR ELECTRODE MODE ACTIVE ELECTRODE TEST CODE 2212 IEC 601 2 2 part 1 FIGURE 101 MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH AND LOAD BETWEEN Link 1 5 4 ELECTRODES EARTH REFERENCED ESU MONO POLAR ELECTRODE CUT 53 Page Rigel Medical Uni Therm user Manual V1 4 MODE NEUTRAL ELECTRODE TEST CODE 2221 IEC 601 2 2 part 1 FIGURE REF ESU 102 MEASUREMENT OF H F i dl LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH AND LOAD FROM ACTIVE Link 3 4 ELECTRODE TO EARTH EARTH REFERENCED ESU MONO POLAR ELECTRODE MODE ACTIVE ELECTRODE 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 Link 1 3 4 ELECTRODES EARTH REFERENCED ESU MONO POLAR ELECTRODE COAG MODE NEUTRAL ELECTRODE 54 Page Rigel Medical Uni Therm user Manual V1 4 13 Appendix B Additional Leakage Tests EST CODE 2113 IEC 601 2 2 part 1 FIGURE N A MEASUREMENT OF H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED ESU BIPOLAR ELECTRODE CUT MODE FIRST ELECTRODE TEST CODE 2114 IEC 601 2 2 part 1 FIGURE N A MEASUREMENT OF H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED ESU BIPOLAR ELECTRODE CUT MODE FIRST ELECTRODE TEST CODE 2115 IEC 601 2 2 part 1 FIGURE N A MEASUREMENT OF H F L
6. RIGEL MEDICAL aa RIGEL UNI THERM electrosurgical analyser Copyright 2015 SEAWARD GROUP Instruction Manual Last Update 7th August 2015 398A550 Revision 1 4 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 amp 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 ourchase 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 initial 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 c
7. 50 steps Accurate fast and flexible Voltage measurements RMS Peak as well as Peak to Peak voltage Plate Security CQM test using electronic potentiometer range up to 4750 in 1 O 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 1 3 Unpacking the Uni Therm Carefully unpack all items from the box and ensure the following items are included Rigel Uni Therm Electrosurgical Analyser Mains Power Lead Calibration Certificate Uni Therm Quick Start Guide Utilities Disc USB Cable 3 x Jumper Links p n 43B759 1 4 Optional Accessories Foot switch adaptor cable set manufacturer specific please specify Trolley style hard carry case SMB to BNC Oscilloscope connection lead p n 367A950 Full accessory list available at http www rigelmedical com downloads Rigel Uni Therm Accessory Datasheet Rev1 2 pdf 4 Page Rigel Medical Uni Therm user Manual V1 4 1 5 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 e 230VAC or 120 VAC Before you power up Ensure none of the ventilation holes are covered during Operation including the ones
8. Uni Therm will need to be registered this will also provide automatic upgrade alerts to the user 44 Page Rigel Medical Uni Therm user Manual V1 4 9 4 Return Instructions For repair or calibration return the instrument to Rigel Medical Service Dept p a Calibration House 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 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 Y Serial number v Firmware version 45 Page Rigel Medical Uni Therm user Manual V1 4 10 Specifications 10 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 Rang
9. ascending or descending 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 F2 This shows the test results for the selected asset ID Asset Details Asset ID 1234567890 11 09 2012 Tested On 11 03 48 Test SEQUENCE Sequence Results Delete Test results can be viewed by pressing the RESULTS F2 button test settings can be viewed by pressing TEST SEQ F3 button and deleted by pressing the DELETE F4 button 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 27 Page Rigel Medical Uni Therm user Manual V1 4 GRAPH POWER TEST GRAPH POWER TEST Test Load 2500 O A O O O O O E E 1 000 1 500 2 000 2 500 Ohms 6 2 Transfer Data The Rigel Uni Therm is able to transfer data to and from the PC In addition power distribution reference curves can be uploaded to the instrument to allow quick check of power performance against manufacturer curves Menu ROE AUTO DATA SETUP 6 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 for
10. on the base panel We strongly recommend positioning the Rigel Uni Therm on its two hinged feet at the front base 1 6 User Notes The following symbols are used throughout this Instruction Manual A A A A 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 61010 design requirements Do not connect any active power electrodes to the simulation panel of the Rigel Uni Therm Failure to comply with this will void the warranty and might lead to internal damage of circuits 1 7 Safety Notes A A 5 Page 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 Rigel Medical Uni Therm user Manual V1 4 A gt A Operation Re
11. 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 19 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 This product is manufactured by Seaward Electronic Ltd Bracken Hill South West Industrial Estate Peterlee County Durham SR8 2SW UK 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 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements BS EN 61326 Electrical equipment for measurement control and laboratory use EMC requirements Performance The instrument operates within specification when used under the conditions in the above standards EMC and Safety Standards The product ident
12. the socket panel Do not allow liquid inside the Rigel Uni Therm or near the sockets Do not use abrasives solvents or alcohol lf any liquid is spilt into the Rigel Uni Therm case the analyser should be returned for repair stating the cause of the defect 9 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 life of the instrument and its reliability lf 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 LNN NN S 9 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
13. 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 19 Page Rigel Medical Uni Therm user Manual V1 4 EXTERNAL LOAD MODE POWER TEST SETTINGS ESA SETTINGS ESU CONTROL BIPOLAR COAG Q MONO POLAR 8 CUT Ol EXTLOAD 630 DICYCLE star oeav 200 ms onne TEST TIME OFF TIME SHOW 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 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
14. 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 12 Page Rigel Medical Uni Therm user Manual V1 4 4 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 test from the main menu shown below HF Leakage Test Settings ESA SETTINGS ESU CONTROL R G E START DELAY 200 ms DICYCLE 50 TEST TIME ON TIME UNI THERM 0ATE 10 09 2012 TIME 2 11 45 pm HF POWER Use the rotary encoder to navigate the screen 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
15. AND NEUTRAL ELECTRODE 57 Page Rigel Medical Uni Therm user Manual V1 4 15 Appendix D Creating a power reference curve The Rigel Uni Therm is able to automatically compare the REFGRAPH AANS Upper curv 10 measured power distribution graph against a preset template or 25 35 reference curve You will require two reference curves one for 100 290 the upper and one for the lower limits 175 290 250 290 Open the file refgraphtemplate csv available at 325 290 400 290 http www rigelmedical com rigel downloads id Application 475 290 Notes 550 290 625 260 700 220 END REFGRAPH and END must remain at the beginning and end of the file Upper Curve is the name of the graph and can be changed This will be the name of your graph once uploaded to the Rigel Uni Therm 10 is the number of points on the graph this can be changed but the lines of data must reflect this number Column A is the X axis and represents the Load Q Column B is the Y axis and represents the Power W In this example line 3 is a plot of 25W at 350 Once you have completed plotting the points in the CSV file select File and then Save As Save the file with a recognisable name including RefGraph and with a Sss extension e g RefGraph sss A Rename message should appear as you have changed the file extensive from csv to sss Rename A If you change a file name extension the file might become unusable Are you sure you want to change i
16. BOUT An overview of the memory usage is provided Memory Usage Restore Factory Settings Number of Assets 3 0 Set Default Settings Number of Test Sequences 3 DO Delete Test Sequences Number of Reference Graphs 2 C Delete Reference Graphs O Delete Test Results lt I RESTORE 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 affected Individual assets can be deleted from the view data menu see chapter 4 1 42 Page Rigel Medical Uni Therm user Manual V1 4 8 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 Seq vences Display Version 6 02 REM Controller Version 6 01 Time Date Measurement Controller Version 6 03 Language Fact Rest serial number 280 0395 td e CT Serial number 0004 This Software is based in part on the work of the Cnvt project http qwt sf net KE TEST SEQ TIME ABOUT 43 Page Rigel Medical Uni Therm user Manual V1 4 9 Maintaining the Rigel Uni Therm 9 1 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
17. Dd Soe OK 0 E 5 ls O Cc O C C Oo O T 3 a n e lt C y O W gt qu See Dd lt 2 O fr 7 IN CO NG J For automatic control during HF leakage and Power tests connect the ESU footswitch COAG and CUT contacts to the blue and yellow terminals A Connect the mains cable to the IEC connector on the rear panel 3 3 Simulation connection panel 3 2 Rear panel It is strongly advised to always use the Rigel Uni Therm s built in automatic control rather than manually switching the output of the electrosurgical For CQM plate security test use the black terminals diathermy machine under test Rigel Medical Uni Therm user Manual V1 4 9 Page 3 4 Side panel ESU to ESA connections Jumper Links A REFER TO USER MANUAL FOR LOAD PERFORMANCE 10 51000 0 51150 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 1 3 4 NB each connection diagram has a unique reference code eg 1112 for identification 3 5 Home screen Upon power up of the Rigel Uni Therm the display will be showing the HOMESCREEN UNI THERM DATE 10 09 2012 TIME 2 11 45 pm ON Fi F2 F3 F4 10 Page Rigel Medical Uni Therm user Manual V1 4 4 Man
18. EAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED ESU BIPOLAR ELECTRODE CUT MODE FIRST ELECTRODE TEST CODE 2213 IEC 601 2 2 part 1 FIGURE N A MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH AND LOAD BETWEEN Link 2 3 4 ELECTRODES EARTH REFERENCED ESU MONO POLAR ELECTRODE CUT MODE NEUTRAL ELECTRODE 55 Page Rigel Medical Uni Therm user Manual V1 4 TEST CODE 2223 IEC 601 2 2 part 1 FIGURE N A MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH AND LOAD BETWEEN Link 2 3 4 ELECTRODES EARTH REFERENCED ESU MONO POLAR ELECTRODE COAG MODE NEUTRAL ELECTRODE 56 Page Rigel Medical Uni Therm user Manual V1 4 14 Appendix C 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 de RESISTANCE BI POLAR 0110 ELECTRODE CUT MODE BOTH ELECTRODES TEST CODE 0120 IEC 601 2 2 part 1 FIGURE 106 MEASUREMENT OF OUTPUT POWER BI POLAR OUTPUT USER SET LOAD RESISTANCE BI POLAR H ELECTRODE COAG MODE 0120 BOTH ELECTRODES 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 SET LOAD RESISTANCE MONO de POLAR ELECTRODE COAG 0220 MODE ACTIVE
19. Settings as NEUT EARTH q n ISO ESU Link 3 4 LEAKAGE cur OS DIAGRAM gt z ZE ana pre ONTO HF Leakage Test Settings ale MEUT EARTH S Fo pa En ES Start Test 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 3S00VV Either press PASS F2 or the GREEN button to continue The next step in SEQUENCE2 is the POWER GRAPGH test 23 Page Rigel Medical Uni Therm user Manual V1 4 GRAPH MODE POWER TEST SETTINGS ESU CONTROL Eein WEYL ON TIME OFF TIME POWER f show T DIAGRAM PART The Rigel Uni Therm will display the settings Press SHOW DIAGRAM F3 to show the connection diagram Check connections and confirm by pressing START Start Test 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 GRAPGH to DATA F4 mode to view actual results GRAPH POWER TEST GRAPH POWER TEST Tae Lonas 200 meso I KO V peak Ohms SHOW SHOW Holt lomcraml para 24 Page Rigel Medical Uni Therm user Manual V1 4 5 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 follow
20. T ELECTRODE SET 7 LEAKAGE SET LEAKAGE LOAD 200 2 LIMIT Loap Loo Lime 200 mA NEXT DIAGRAM aa lt A DIAGRAM CIRCUIT DETAIL CIRCUIT DETAIL 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 14 Page Rigel Medical Uni Therm user Manual V1 4 HF Leakage Test Settings HF Leakage Test Settings TEST CODE 1111 TEST CODE 2223 IEC 601 2 2 part 1 FIGURE 104 IEC 601 2 2 pan 1 FIGURE n a MEASUREMENT OF H F LEAKAGE CURRENT FROM A MEASUREMENT OF H F LEAKAGE CURRENT WITH BIPOLAR ELECTRODE NEUTRAL ELECTRODE REFERENCED TO EARTH AND LOAD BETWEEN ELECTRODES EE EARTH ISOLATED ESU WM EARTH REFERENCED ESU EE BIPOLAR ELECTRODE MN MONO POLAR ELECTRODE me CUT COAG EE FIRST ELECTRODE me ACTIVE ELECTRODE start Test onc The Rigel Uni Therm could display the following details after the test Load 200 ohms Leakage 0 mA Limit 200 mA SHOW Press the HOLD key to freeze the reading on the screen The test can be aborted by pressing the red STOP but
21. TED FROM EARTH AT HIGH FREQUENCY EARTH Link 3 4 ISOLATED ESU MONO POLAR ELECTRODE CUT MODE NEUTRAL ELECTRODE TEST CODE 1221 IEC 601 2 2 part 1 FIGURE 103 MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE ISOLATED FROM EARTH AT HIGH FREQUENCY EARTH Link 3 4 ISOLATED ESU MONO POLAR ELECTRODE COAG MODE ACTIVE ELECTRODE TEST CODE 1222 IEC 601 2 2 part 1 FIGURE 103 MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE ISOLATED FROM EARTH AT HIGH FREQUENCY EARTH Link 3 4 ISOLATED ESU MONO POLAR ELECTRODE COAG MODE NEUTRAL ELECTRODE TEST CODE 2111 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH REFERENCED ESU ds BIPOLAR ELECTRODE CUT Link 2 3 4 MODE FIRST ELECTRODE 52 Page Rigel Medical Uni Therm user Manual V1 4 TEST CODE 2112 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH REFERENCED ESU BIPOLAR ELECTRODE CUT MODE SECOND ELECTRODE TEST CODE 2121 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF H F 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 H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH REFERENCED ESU BIPOLAR ELECTRODE COAG MODE SECOND ELECTRODE TEST CODE 2211 IEC 601 2 2 part 1 FIGURE 102 MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE
22. Test 38 Page Rigel Medical Uni Therm user Manual V1 4 Once the selected criteria have been set confirm by pressing the UPDATE F4 button User tests can be inserted and used for providing instructions to the test engineer Select the user test and press EDIT F3 In the user test screen select the field you want to edit which is highlighted 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 i m 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 39 Page Rigel Medical Uni Therm user Manual V1 4 Test Sequences SEQUENCE SEQUENCE Edit Sequence Name Copy or Delete the test sequence from the Test Sequences menu select OPTION Test Sequences SEQUENCE SEQUENCE1 SEQUENCE mma Rename DELETE COPY RENAME To delete a test sequence press DELETE To copy a test sequence press COPY To rename a test sequence RENAME 40 Page Rigel Medical Uni Therm user Manual V1 4 8 2 Time Date To modify the tim
23. ada 30 6 5 Import Power Reference Curves ccscecsccscsceccccscsceccccscscsccccccscscescecscsceccecscscscescecces 31 6 6 Transfer Test SEQUENCES ii lana 32 BIMCTOOLT FAVOUTILGS A oa 33 SOUUD sci veictvcccdedscsuudedecgectocdceeuecsteaceiecersendeveceeddeccudeceesdenceveseeseniadensececisenwicesbeacetadereeese 35 8 1 TeSt SCQUCIICE ica 36 8 2 me Date iaa ia EE A AS AA a 41 1 Page Rigel Medical Uni Therm user Manual V1 4 8 3 LIN 41 8 4 Factory RESUON Civic cscs ir aa aaa a 42 8 5 A A o E 43 9 Maintaining the Rigel Uni TherM cccccccccccsceccccccsceccccccscsccccccscecescececsceccccecsceccccecs 44 9 1 Cleanine the Anas ias 44 9 2 User Maitena Cesar 44 9 3 Firmware Uperade rior 44 9 4 R t rn INSTTUCHONS circadiano dida deidad idad a 45 TO SPEeCITICA ON Said 46 10 1 Technical Specification ais 46 102 General SOCCITICATION oia 47 10 3 Load Power rating Rigel Uni TherM ccccsccscscessccscscsccccscsceccccccscsceccecscsceseececscesess 48 TE SUPPO avatar cieeieccsacveucerenesansacucacersaeciecaspoxcunsouensescasacensevenseecescounsasenexsencsaccnessteeete secon 50 TELL COMUACU US core a a ao a ani n 50 12 Appendix A IEC 60601 2 2 Leakage Tests sccsceccccccecsccccccsceccccccscescccecsceccccecscecess 51 13 Appendix B Additional Leakage Tests csccccccscescccscscsccccccsceccccccsceccccecscescccecscecens 55 14 Appendix C IEC 60601 2 2 Power TesStS sessesesessesescesesoesescecesosoesoscoesosc
24. 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 lf 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 13 Page Rigel Medical Uni Therm user Manual V1 4 HF Leakage Test Settings HF Leakage Test Settings ESA SETTINGS ESU CONTROL ESA SETTINGS ESU CONTROL START DELAY DICYCLE s8 START DELAY DICYCLE 50 TEST TIME ON TIME TEST TIME ON TIME OFFTIMEJ2s OFFTIME 2s Press NEXT to confirm and start selecting the appropriate leakage tests Four different measurement scenarios have been described in the particular standard IEC 60601 2 2 See appendix A 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 HF Leakage Test Settings TEST CODE 1111 IEC 50 1 2 2 part 1 FIGURE 104 MEASUREMENT OF H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EE EARTH ISOLATED ESU EE BIPOLAR ELECTRODE zl Link 2 3 4 MM FIRS
25. ata From the BT Favourites screen press the SEARCH button to list all the Bluetooth devices within reach Ensure your device is in discovery mode BT Favourites Computer Bar Code 33 Page Rigel Medical Uni Therm user Manual V1 4 search complete 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 SELLTOA7 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 BT Favourites Check that the correct devices are Computer paired for each function and press the back arrow to exit and complete the pairing Bar Code OPL 2724 35ED bl 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 OOOO four zero Ss 34 Page Rigel Medical Uni Therm user Manual V1 4 8 Setup To enter the setup mode select the MENU key F1 from the home screen and then SETUP Menu RIGEL Cn UNI THERM
26. cal 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 SR8 2SW United Kingdom Rigel Medical Uni Therm user Manual V1 4 12 Appendix A IEC 60601 2 2 Leakage Tests TEST CODE 1111 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF H F 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 H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED ESU BIPOLAR ELECTRODE CUT MODE SECOND ELECTRODE TEST CODE 1121 IEC 601 2 2 part 1 FIGURE 104 MEASUREMENT OF H F 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 H F LEAKAGE CURRENT FROM A BIPOLAR ELECTRODE EARTH ISOLATED ESU BIPOLAR ELECTRODE COAG Link 1 3 4 MODE SECOND ELECTRODE TEST CODE 1211 IEC 601 2 2 part 1 FIGURE 103 MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE ISOLATED FROM EARTH AT HIGH FREQUENCY EARTH Link 3 4 ISOLATED ESU MONO POLAR ELECTRODE CUT MODE ACTIVE ELECTRODE 51 Page Rigel Medical Uni Therm user Manual V1 4 TEST CODE 1212 IEC 601 2 2 part 1 FIGURE 103 MEASUREMENT OF H F LEAKAGE CURRENT WITH NEUTRAL ELECTRODE ISOLA
27. cted 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 16 Page Rigel Medical Uni Therm user Manual V1 4 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 however 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
28. e or date including time format 12 24h clock select the Time Date F3 option in the setup menu Setup Screen Test Sequences l o Time Date Time f 28 39 pm _ Language Factory Restore Date 11 09 2012 About Date Format dd MMAywyy TEST SEQ TIME ABOUT Press 24H F2 to change between 12H AM PM and 24H clock format Press MM DD F3 to change between MM DD and DD MM format Use the rotary encoder to navigate push to activate field and change values using the rotary encoder Press SAVE to confirm 8 3 Language To change the language select the language option in the setup menu see below Setup Language Test Sequences English Pome sie About Italian Spanish XK y 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 41 Page Rigel Medical Uni Therm user Manual V1 4 8 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 Test Sequences Time Date Language zc TEST SEQ TIME A
29. erence 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 F2 to change Data Transfer Number of Assets 3 Status Idle Port USB PC Connection Operation Import Ref Graph Change between USB Memory Stick or Cable using the PORT F3 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 4 Hard Disk Drives 1 System C DA 152 GB free of 232 GB 4 Devices with Removable Storage 2 Removable Disk F DVD DVD RW Drive D z Laaa Sj 29 5 ME free of 29 7 MB Copy the reference curve sss files into the corresponding folder This has now stored the reference curves on the Rigel Uni Therm Please see application note 0031 Upload Reference Curve to Rigel Uni Therm for more details on creating curves 31 Page Rigel Medical Uni Therm user Manual V1 4 6 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 F2 Data Transter Number of Assets 3 Status ldle Par
30. fer 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 It 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 6 Page Rigel Medical Uni Therm user Manual V1 4 2 Uni Therm Overview ON OFF button Function keys F1 F4 Start Confirm key Green Rotary encoder main navigation key simulation panel Colour screen Stop Cancel key Red Hinged feet E ES O 7 Page Rigel Medical Uni Therm user Manual V1 4 2 1 Simulation panel FOOT SWITCH Cur A ee O 5000 lt 50mA 1 CQM REM output connection Black 2 CUT footswitch control output Yellow 3 COAG footswitch control output Blue the Rigel Uni Therm Failure to comply with this will void the warranty Do not connect any active power electrodes to the simulation panel of and might lead to internal damage of circuits 2 2 Side panel 1 Variable load bank connections 3 Measuring Device Red amp Black connections White 2 Oscilloscope
31. ified above conforms to the requirements of Council Directive 2004 108 EC and 2006 95 EC This Conformity is indicated by the symbol CE e Conformit Europ enne Seaward Electronic Ltd is registered under BS EN 1509001 2008 Certificate No Q05356 Index 1 A cies ia dace T O OTE O O Saaeen aan 3 1 1 Analyser FUNCION Sissi iii aia 3 1 2 KEV ECAUTOS sous 4 1 3 Unpacking the Uni Therm ina ANNA 4 1 4 Optional ACTOS Pda 4 1 5 Warnings and Cautions cia 5 1 6 User INOUCS is clnsucsiacosscutaes A a a a 5 1 7 Saret NOS a nce nase E A O O 5 Uni Therm QVCIVICW AAA AAA 7 2 1 Simulation pane l snra a a 8 2 2 side pane A a canna was ue souons sue ves eeeunteseee 8 GOEGING Started siii a 9 3 1 Connecting your ANAIS iaa 9 3 2 o A ssa ca seas sais wae eas anc acs es ccc aa sa ac hea aac cua taaeeaeancetenaeiaoaeeae 9 3 3 Simulation connection panel sia ia 9 3 4 Side panel ESU to ESA connections sessssessssesessessssessssesesseoesseossssossseoesssoesssossseoseee 10 3 5 ROME O 10 Manal Mod ana 11 4 1 Contact Quality Monitoring CQM or REM test csccscsccsssccscecsscsssccsccccsceccscecesces 11 4 2 PIF LO AK AGS aa 13 4 3 Power ROO aa a e a S EE 15 PULOMGUC MONO 21 5 1 Stopping or Failing a Test SEQUENCE ccscscecsscscsccccccscececcccscsceccccscnceccececscesescscscssess 25 DOUG ari A NA E A E 26 6 1 VIEW Data urraca 27 6 2 Transiter Datacenter 28 6 3 Download Data da ooo cesan 28 6 4 Upload Data cada d
32. ing 46 Page True RMS Watts 0 500W Refer to load power graph 1W 5 of reading 0 6000mA with load bank 0 8000mA external load test 2 of reading 10mA O 700V 10 of reading 5V 0 10KV Peak Closed load only 10 of reading 15V 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 5000ms 10ms resolution 0 51150 steps 50 Ceramic Resistors Non inductive 1 0 5 0 5 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 45 120 High and low manual confirmation Manual or automatic Rigel Medical Uni Therm user Manual V1 4 Oscilloscope output Connections Variable load 0 51150 Fixed Load x 2000 Measuring device MD Oscilloscope output REM test 0 475 ohm Remote foot switch control CUT control Remote foot switch COAG USB B port USB A port Data Storage and Recall Memory Output 10 2 General Specification Dimensions Weight Operating Temperature Storage Temperature Mains power Fuses 47 Page 0 5V A 100mA RF current minimum input un calibrated indication only 2 x 4mm Red Active Black Plate 1 x 4mm black co
33. ing option menu will appear Abort Fail Menu Restart Test Sequence Next Test End Test Sequence Save Results Abort Test Sequence Don t Save TEST TEST SEQ 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 SSS SS 25 Page Rigel Medical Uni Therm user Manual V1 4 6 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 F3 Menu RIGEL so UNI THERM DATE 10 08 2012 TIME 2 11 45 pm Data Transfer Data BT Favourites This leads to 3 options v View data see Chapter 6 1 v Transfer data see Chapter 6 2 v BT favourites see Chapter 7 26 Page Rigel Medical Uni Therm user Manual V1 4 6 1 View Data stored data can be viewed by selecting the VIEW F2 from the DATA screen as shown above View Data Asset Date Status 2 1234567890 11 09 2012 Pass 12345abed 11 09 2012 Pass Data can be sorted using the SORT F4 key which will sort on asset number and date either
34. mat 28 Page Rigel Medical Uni Therm user Manual V1 4 Data Transfer Number of Assets 3 Status Idle Part 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 F2 button Change between USB USB Memory Stick using the PORT F3 key Start Download by pressing START F4 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 unit to a Pc via a USB cable and copy the results file from the removable drive that appears 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 Results for Med eBase will have the file name Results 01012015 109837 sss with the numbers indicating the date and time of download All results stored on the unit will be downloaded in one file Sequences for Med eBase will have the file name Sequences 01012015 109837 sss with the numbers indicating the date and time All Sequences from the unit will be downloaded in one file 29 Page Rigel Medical Uni Therm user Manual V1 4
35. mmon 2 x 4 mm red 2 x 4mm White SMB coaxial connector 2 x 4 mm black 2 x 4 mm yellow Single relay contact 2 x 4 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 C to 40 C 0 C to 50 C 115 230 10 VAC 48 to 66 Hz 35 VA 2x 1 6 A T ceramic Rigel Medical Uni Therm user Manual V1 4 10 3Load Power rating Rigel Uni Therm External Load mode Current Limit 8 A rms No power rating user supplied Load Max Watts at 15sec On 15sec Off 50 duty cycle 5 5115 ohms Max Watt at 60sec On 15sec Off duty cycle 5 100 ohms 48 Page Rigel Medical Uni Therm user Manual V1 4 Max Amps at 15sec On 15sec Off 50 duty cycle 5 5115 ohms w E Y Q E lt Max Amps at 60sec On 15sec Off duty cycle 5 100 ohms 49 Page Rigel Medical Uni Therm user Manual V1 4 11 Support 11 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 calibrationhouse com Part of E SEAWARD 50 Page Rigel Medical Address details Rigel Medi
36. oesescesesceoee 57 15 Appendix D Creating a power reference CUfVe seeseseeoesesoecesoccesoscoesosoesescesesceoee 58 16 Appendix E Firmware Route Map esessesesoeseseecesoscesesceoesoeoesoccoesosoesosoesosoesescesesceoee 60 2 Page Rigel Medical Uni Therm user Manual V1 4 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 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 1 1 Analyser Functions The Rigel Uni Therm is able to measure the following parameters both automatically and manually Power Test W mA rms V peak and crest factor HF Leakage mA rms Peak and Peak to Peak voltage Plate Sec
37. onditions 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 2015 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 equipment 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
38. or editing Edit Test Sequence sequence Name SEQUENCE am w EDIT OPTIONS Note when no individual tests are inserted the EDIT and OPTIONS buttons are not active Start adding individual tests to the test sequence by pressing the ADD F2 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 37 Page Rigel Medical Uni Therm user Manual V1 4 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 F2 button The test will be inserted AFTER the highlighted position Edit Test Sequence sequence Name SEQUENCE REM Test 2 User Test 4 UserTest yg Oaa 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 F3 Edit Test Sequence REM Test Settings sequence Name SEQUENCE SETUPLIMIT 1650 User Test SET DOWN LIMIT 50 0 HF Leakage Test 1111 nino User Test 5 Continuous Power Test 0210 User
39. 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 8 Page Rigel Medical Uni Therm user Manual V1 4 segregated into a high voltage area side panel and a safe low voltage area quickly easily and safely The interfaces to the Rigel Uni Therm have been front panel The Rigel Uni Therm has been designed to ensure that the user is able to test 3 Getting started 525 200000009 OQO OSORO ROO SRLOLOROS 0202020 SOLO LO LORO LOL OLE LOROS ra J BLSLGLOL6Lq6L5252 0000000000 7 This arrangement also ensures that test leads carrying high frequency power are kept as short as possible and directly facing the equipment under test AN Elevate the Rigel Uni Therm on its two hinged 3 1 Connecting your Analyser OLOLSL6L5L5L626L0285 90000009 DLGESLSLOLOLSLGLSLGLOLGR626 2 00000000000000 feet at the front base _ AO O ORORORORLOROS Ma O OLOLSLSLSLGL52026 Oe RR RARO LAN LOR85L525208525252562520 O20209 LLORO ROSALES QEL5L524 OOTOLO LOOO LOROLO 52020909 20259520 LORO LO LEROLERES O20200 OLO Lo Lo Lolo Lolo lolo Lodo BLOLG2 LGLSORLGOGLGLGOGLELGHLGL DADA 0503208070320 25080 252090 5009520002000020 OOL OOO LLORO LOROLOLOSE 999090 OOOO OO SOO OOOO p LINK STORAGE Soe rey O 5 y O v o yv n O Sz 2 Dd DO See
40. t 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 existing test sequence as covered in this manual 58 Page Rigel Medical Uni Therm user Manual V1 4 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 POWER TEST ESU Power 100 Select the UPPER and LOWER limit graphs by pressing UPPER and LOWER respectively and select the corresponding graphs Test Sequences Test Sequences NONE l o Lower refgraphtemplate csv Lowerrefgraphtemplate csv 59 Page Rigel Medical Uni Therm user Manual V1 4 16 Appendix E Firmware Route Map Mode Data A A eat aus Transfer Download and upload o results Import reference curves Pair PC and barcode Favowrtes e _ EST w a re create and edit test Sequences sequences oo Cenas time and date settings oo Language _ Change language settings Restore factory default and serial number HE oee function O Leakage leakage Power output 60 Page Rigel Medical Uni Therm user Manual V1 4
41. t USB PC Connection Operation Export Test Sequences 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 4 Hard Disk Drives 1 System C A 152 GB free of 232 GB 4 Devices with Removable Storage 2 Removable Disk F El DVD RW Drive D WEA 29 5 MB free of 29 7 MB select the Sequence file and copy to the folder of choice The file can then be shared between other PC s and uploaded back into other Uni Therm units 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 Sequences for Med eBase will have the file name Sequence_01012015 109837 sss with the numbers indicating the date and time 32 Page Rigel Medical Uni Therm user Manual V1 4 7 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 is compatible with the Barcode scanner only v Barcode Scanner To start the pairing process select DATA from the home screen followed by BT FAVOURITES Menu Auto Mode View Data Transfer D
42. 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 20 Page Rigel Medical Uni Therm user Manual V1 4 5 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 6 To enter the automatic mode select the MENU key F1 from the home screen and then AUTOMODE Menu RIGEL UNI THERM DATE 10 08 2012 TIME 2 11 45 pm HF POWER qua AUTO DATA SETUP In the following screen an asset ID number can be entered using the rotary encoder barcode scanner or a PS2 keyboard Auto Mode Asset ID 1234567890 Test Sequence SEQUENCE bi When using the barcode scanner ensure the barcode scanner is paired with the Rigel Uni Therm see Chapter 7 The Rigel Uni Therm will only support the Seaward barcode scanner p n 339A923 When the barcode is ready to scan the word
43. ton 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 4 3 Power lest 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 15 Page Rigel Medical Uni Therm user Manual V1 4 Choose Type of Power Test RIGEL UNI THERM External Load DATE 10 09 2012 TIME 2 11 45 pm HF POWER Select Power test from the home screen then select F2 CONT F3 GRAPH or F4 EXT modes using the fast keys to select either the Continuous Graph or External Load test Use the rotary encoder or the dedicated function keys to navigate 4 3 1 Continuous mode The continuous mode allows the user to monitor the power characteristics under a specific load condition Ensure that the power settings on the EUT do not exceed those specified A in the Load Power rating Rigel Uni Therm CONTINUOUS MODE POWER TEST SETTINGS ESA SETTINGS Bl POLAR O MONO POLAR ESU CONTROL COAG CUT DicvcLE ON TIME START DELAY TEST TIME OFF TIME 30s HIGH DYCYCLE _ 408 SHOW DIAGRAM alizidi Use the rotary encoder to navigate the screen The sele
44. ual 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 Y CQM REM test v HF Leakage v Power Test 4 1 Contact Quality Monitoring CQM or 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 0 475 O is connected to the two black connectors on the front panel Select the CQM REM test from the home screen shown below RIGEL UNI THERM DATE 10 08 2012 TIME 2 11 45 pm HF POWER ci Rem LEAKAGE TEST During the initial CQM REM test selection the Rigel Uni Therm will auto calibrate the CQM REM potentiometer 11 Page Rigel Medical Uni Therm user Manual V1 4 Run Return Electrode Monitoring Test a 0 8 AUTO UP UP ALARM MANUAL UP SET UP LIMIT AUTO DOWN SETDOWNLIMIT 1000 A T Calibrating Once the calibration has completed the CQM REM test screen will appear Run Return Electrode Monitoring Test o ALARM LIMIT OHMS 0 8 AUTO UP UP ALARM 0 MANUAL UP SET UP LIMIT 41 O AUTO DOWN SET DOWN LIMIT Select automatic up or down or manual up or down control by
45. urity CQM or return electrode monitoring REM 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 CQM test offers a unique isolated motor driven potentiometer which provides a continuous swept resistance change enabling accurate and fast testing of alarms complete with user set pass fail limits Any future firmware upgrade 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 3 Page Rigel Medical Uni Therm user Manual V1 4 1 2 Key Features Y LS SSS 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
46. y 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 18 Page Rigel Medical Uni Therm user Manual V1 4 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 During the Graph power test the Rigel Uni Therm will display the power distribution graph GRAPH POWER TEST GRAPH POWER TEST TestLoad 2500 Ohms W rms mA rms V rms v peak CF O O Oa ie a 1 000 1 500 2 000 2 500 Ohms AGRAM _ GRAPH DIAGRAMU GRAPH At the end of the test toggle 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 4 3 3 External Load Mode The external load mode allows
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