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Rigel Medical UNI-THERM Manual

Electrosurgical analyser
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Innovating Together
RIGEL UNI-THERM
electrosurgical analyser
Copyright © 2020
Instruction Manual
398A552 Revision 1.6

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  • Page 1 Innovating Together RIGEL UNI-THERM electrosurgical analyser Copyright © 2020 Instruction Manual 398A552 Revision 1.6...
  • Page 2 *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.
  • Page 3 © Copyright 2020 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.
  • Page 4 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. Please familiarise yourself with the appropriate local separate collection system for electrical and electronic products or contact your local supplier for further information.
  • Page 5 County Durham, SR8 2SW, UK As the manufacturer of the apparatus listed, we declare under our sole responsibility that the product: Rigel Uni-Therm – Electrosurgical Analyser Conforms with the relevant Directives and conformity is indicated by the , i.e. “Conformité Européenne”...

  • Page 6: Table Of Contents

    View Data ........................28 Transfer Data ......................29 Download Data ......................29 Upload Data ......................31 Import Power Reference Curves ................. 32 Transfer Test Sequences ..................... 33 Bluetooth Favourites ....................34 Setup ........................37 1 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 7 10.1 Technical Specification ....................49 10.2 General Specification ....................50 10.3 Load Power rating Rigel Uni-Therm ................51 11 Support ........................53 11.1 Contact Us ......................... 53 12 Appendix A IEC 60601-2-2 Leakage Tests ..............54 13 Appendix B Additional Leakage Tests ............... 58 14 Appendix C IEC 60601-2-2 Power Tests ..............

  • Page 8: Introduction

    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.

  • Page 9: Key Features

    Rigel Medical, part of the Seaward Group. 1.2 Key Features ✓ 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 ✓...

  • Page 10: Warnings And Cautions

    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 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.
  • Page 11 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.

  • Page 12: Uni-Therm Overview

    5. Simulation panel 2. Function keys (F1-F4) 6. Colour screen 3. Start / Confirm key (Green) 7. Stop / Cancel key (Red) 4. Rotary encoder main 8. Hinged feet navigation key 7 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 13: Simulation Panel

    3. COAG footswitch control output (Blue) 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. 2.2 Side panel 1.
  • Page 14 *Note; The scope output (SMB connector) provides an 10kV isolated waveform monitoring output however the scope output is not calibrated. 9 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 15: Getting Started

    3 Getting started 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).

  • Page 16: Side Panel Esu To Esa Connections

    (positions 1, 2, 3, 4) as required to complete circuits. 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; 11 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 17: Manual Mode

    (0 – 475 Ω) is connected to the two black connectors on the front panel. Select the CQM / REM test from the home screen shown below. During the initial CQM / REM test selection, the Rigel Uni-Therm will auto- calibrate the CQM / REM potentiometer; 12 | Page...
  • Page 18 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. 13 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 19: Hf Leakage

    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.
  • Page 20 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; 15 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 21: Power Test

    (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.

  • Page 22: Continuous Mode

    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. 17 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 23 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.

  • Page 24: Graph Mode

    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. 19 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 25 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.
  • Page 26 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.

  • Page 27: Automatic Mode

    PS2 keyboard. When using the barcode scanner, ensure the barcode scanner is paired with the Rigel Uni-Therm, see 7. (The Rigel Uni-Therm will only support the Chapter Seaward barcode scanner, p/n 339A923). When the barcode is ready to scan, the word “OK”...
  • Page 28 ALARM (F3). Then continue by selecting the AUTO DOWN or MANUAL DOWN to reduce the resistance and capture the corresponding alarm. The next step is a custom test to instruct the user to disconnect the neutral electrodes. 23 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 29 (300W) in this example. Either press PASS (F2) or the GREEN button to continue The next step in SEQUENCE2 is the POWER GRAPGH test; 24 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 30 Check connections and confirm by pressing START. 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.

  • Page 31: Stopping Or Failing A Test Sequence

    ✓ 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. 26 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 32: Data

    MENU key (F1) from the home screen and then DATA (F3); This leads to 3 options; ✓ View data (see Chapter 6.1 ✓ Transfer data (see Chapter 6.2 ✓ BT favourites (see Chapter 27 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 33: View Data

    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; 28 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 34: Transfer Data

    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. 6.3 Download Data Stored data can be downloaded to the PC in several formats.
  • Page 35 Med-eBase software 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.

  • Page 36: Upload Data

    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.

  • Page 37: Import Power Reference Curves

    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. 32 | Page...

  • Page 38: Transfer Test Sequences

    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.

  • Page 39: Bluetooth Favourites

    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 : ✓...
  • Page 40 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. 35 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 41 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) 36 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 42: Setup

    8 Setup To enter the setup mode, select the MENU key (F1) from the home screen and then SETUP; The SETUP menu allows the user to customise the Rigel Uni-Therm; ✓ View, edit or create test sequences, see chapter 6.1 ✓...

  • Page 43: Test Sequence

    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;...
  • Page 44 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; Highlighted the required test using the rotary encoder and press to select; 39 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 45 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); 40 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 46 UPDATE button. Once the test sequence is completed, press the back arrow key and confirm the changes: The new test sequence has now been added to the test library; 41 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 47 Edit Sequence Name, Copy or Delete the test sequence from the Test Sequences menu, select OPTION; To delete a test sequence, press DELETE To copy a test sequence, press COPY To rename a test sequence, RENAME 42 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 48: Time Date

    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. 43 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 49: Factory Restore

    Press NEXT to select which part of the memory to restore to factory default; 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 44 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 50: About

    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 for more information on Service chapter 7.4 and Calibration.

  • Page 51: Maintaining The Rigel Uni-Therm

    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 the socket panel. Do not allow liquid inside the Rigel Uni-Therm or near the sockets. Do not use: abrasives, solvents, or alcohol.
  • Page 52 To obtain the latest firmware, the Rigel Uni-Therm will need to be registered; this will also provide automatic upgrade alerts to the user. 47 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 53: Return Instructions

    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: ✓ Instruments name and model ✓ Serial number ✓ Firmware version 48 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 54: Specifications

    Power rating 20 Watt (100% duty cycle) 0 - 475Ω, 1Ω step Plate Security (REM) resistor Motor driven potentiometer ±5% ± 2 Ω Accuracy Alarm register High and low, manual confirmation 49 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 55: General Specification

    11 Kg 10 ˚C to 40 ˚C Operating Temperature 0˚C to 50 ˚C Storage Temperature Mains power 115/230 ±10% VAC; 48 to 66 Hz, 35 Fuses 2 x 1.6 A (T) ceramic 50 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 56: Load Power Rating Rigel Uni-Therm

    10.3 Load 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 1600 1400 1200 1000...
  • Page 57 1.00 0.00 1000 10000 Ohms 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 Ohms 52 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 58: Support

    CalibrationHouse Tel: +44 (0) 191 587 8739 11 Bracken Hill Fax: +44 (0) 191 518 4666 South West Industrial Estate Email: info@calibrationhouse.com Peterlee, County Durham SR8 2SW, United Kingdom Part of 53 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 59: Appendix Aiec 60601-2-2 Leakage Tests

    BIPOLAR ELECTRODE COAG 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 ISOLATED MONO- 54 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 60 POLAR ELECTRODE COAG MODE NEUTRAL ELECTRODE TEST CODE 2111 IEC 601-2-2 part 1, FIGURE 104 MEASUREMENT OF H.F. LEAKAGE CURRENT FROM BIPOLAR ELECTRODE EARTH `REFERENCED ESU BIPOLAR ELECTRODE CUT MODE FIRST ELECTRODE 55 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 61 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 LOAD BETWEEN ELECTRODES EARTH 56 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 62 TEST CODE 2222 IEC 601-2-2 part 1 FIGURE 101 MEASUREMENT OF H.F. LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH LOAD BETWEEN ELECTRODES EARTH REFERENCED ESU MONO- POLAR ELECTRODE COAG MODE NEUTRAL ELECTRODE 57 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 63: Appendix B Additional Leakage Tests

    TEST CODE 2213 IEC 601-2-2 part 1 FIGURE N/A MEASUREMENT OF H.F. LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH LOAD BETWEEN ELECTRODES EARTH REFERENCED ESU MONO- POLAR ELECTRODE MODE NEUTRAL ELECTRODE 58 | Page Rigel Medical Uni-Therm user Manual V1.6...
  • Page 64 TEST CODE 2223 IEC 601-2-2 part 1 FIGURE N/A MEASUREMENT OF H.F. LEAKAGE CURRENT WITH NEUTRAL ELECTRODE REFERENCED TO EARTH LOAD BETWEEN ELECTRODES EARTH REFERENCED ESU MONO- POLAR ELECTRODE COAG MODE NEUTRAL ELECTRODE 59 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 65: Appendix Ciec 60601-2-2 Power Tests

    ELECTRODE MODE ACTIVE NEUTRAL ELECTRODE TEST CODE 0220 IEC 601-2-2 part 1 FIGURE MEASUREMENT OUTPUT POWER MONO- POLAR OUTPUT USER SET LOAD RESISTANCE MONO- POLAR ELECTRODE COAG MODE ACTIVE NEUTRAL ELECTRODE 60 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 66: Appendix D Creating A Power Reference Curve

    “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.
  • Page 67 This will set the new file as the upper or lower limit of the graph. Select the UPPER and LOWER limit graphs by pressing UPPER and LOWER respectively and select the corresponding graphs; 62 | Page Rigel Medical Uni-Therm user Manual V1.6...

  • Page 68: Appendix E Firmware Route Map

    Restore factory default About View firmware revision and serial number. REM test Manual testing of the REM function Manual testing of the HF Leakage leakage Power Manual testing Power output 63 | Page Rigel Medical Uni-Therm user Manual V1.6...

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