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RIGEL UNI-THERM

electrosurgical analyser

Copyright © 2015 SEAWARD GROUP

Last Update: 7th August 2015

Instruction Manual

398A550 Revision 1.4

Rigel Medical 24 Month Warranty Statement

Rigel Medical provides a standard 12month 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 & 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 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 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; / / . i

© 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. ii

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 2012/19/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. iii

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 identified above conforms to the requirements of Council

Directive 2004/108/EC and 2006/95/EC.

This Conformity is indicated by the symbol

, i.e. “Conformité Européenne”

Seaward Electronic Ltd. is registered under BS EN ISO9001:2008 Certificate

No.: Q05356. iv

Index

1 Introduction .............................................................................................................. 3

1.1 Analyser Functions ....................................................................................................... 3

1.2 Key Features ................................................................................................................ 4

1.3 Unpacking the Uni-Therm ............................................................................................ 4

1.4 Optional Accessories .................................................................................................... 4

1.5 Warnings and Cautions ................................................................................................ 5

1.6 User Notes ................................................................................................................... 5

1.7 Safety Notes ................................................................................................................ 5

2 Uni-Therm Overview ................................................................................................. 7

2.1 Simulation panel .......................................................................................................... 8

2.2 Side panel .................................................................................................................... 8

3 Getting started ......................................................................................................... 9

3.1 Connecting your Analyser............................................................................................. 9

3.2 Rear panel ................................................................................................................... 9

3.3 Simulation connection panel ........................................................................................ 9

3.4 Side panel ESU to ESA connections ............................................................................. 10

3.5 Home screen .............................................................................................................. 10

4 Manual Mode ......................................................................................................... 11

4.1 Contact Quality Monitoring (CQM) or REM test .......................................................... 11

4.2 HF Leakage ................................................................................................................ 13

4.3 Power Test ................................................................................................................ 15

5 Automatic Mode ..................................................................................................... 21

5.1 Stopping or Failing a Test Sequence ............................................................................ 25

6 Data ....................................................................................................................... 26

6.1 View Data .................................................................................................................. 27

6.2 Transfer Data ............................................................................................................. 28

6.3 Download Data .......................................................................................................... 28

6.4 Upload Data .............................................................................................................. 30

6.5 Import Power Reference Curves ................................................................................. 31

6.6 Transfer Test Sequences ............................................................................................. 32

7 Bluetooth Favourites ............................................................................................... 33

8 Setup ...................................................................................................................... 35

8.1 Test Sequence ............................................................................................................ 36

8.2 Time Date ................................................................................................................ 41

1 | Page Rigel Medical Uni-Therm user Manual V1.4

8.3 Language ................................................................................................................... 41

8.4 Factory Restore .......................................................................................................... 42

8.5 About ........................................................................................................................ 43

9 Maintaining the Rigel Uni-Therm ............................................................................ 44

9.1 Cleaning the Analyser ................................................................................................ 44

9.2 User Maintenance ...................................................................................................... 44

9.3 Firmware Upgrade ..................................................................................................... 44

9.4 Return Instructions. ................................................................................................... 45

10 Specifications .......................................................................................................... 46

10.1 Technical Specification ............................................................................................... 46

10.2 General Specification ................................................................................................. 47

10.3 Load Power rating Rigel Uni-Therm ............................................................................ 48

11 Support ................................................................................................................... 50

11.1 Contact Us ................................................................................................................. 50

12 Appendix A IEC 60601-2-2 Leakage Tests ................................................................ 51

13 Appendix B Additional Leakage Tests ...................................................................... 55

14 Appendix C IEC 60601-2-2 Power Tests .................................................................... 57

15 Appendix D Creating a power reference curve ........................................................ 58

16 Appendix E Firmware Route Map ............................................................................ 60


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 standalone 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 Security (CQM) or return electrode monitoring (REM)

For the power test, an internal array of resistors provide a safe variable load of 0-

51

15Ω in 5Ω 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.


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

 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 0 to

5115

Ω in 5Ω 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

475

Ω in 1 Ω 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


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. 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.

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

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.

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.


2 Uni-Therm Overview

1

2

3

4

5

8

6

7

1. ON / OFF button

2. Function keys (F1-F4)

3. Start / Confirm key (Green)

4. Rotary encoder / main navigation key

5. Simulation panel

6. Colour screen

7. Stop / Cancel key (Red)

8. Hinged feet


1

1

2.1 Simulation panel

2

1. CQM/ REM output connection (Black)

2. CUT footswitch control output (Yellow)

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

3

2

3

4

1. Variable load bank connections

(Red & Black)

2. Oscilloscope output*

3. Measuring connections (White)

Device

4. HF Leakage connections

*Note; The scope output (SMB connector) provides an 10kV isolated waveform monitoring output however the scope output is not calibrated.


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). This arrangement also ensures that test leads carrying high frequency power are kept as short as possible, and directly facing the equipment under test.

3.1 Connecting your Analyser

Elevate the Rigel Uni-Therm on its two hinged feet at the front base.

Ensure none of the large base and rear ventilation inlets are obstructed during operation,

3.2 Rear panel

Connect the mains cable to the IEC connector on the rear panel.

3.3 Simulation connection panel

For automatic control during HF leakage and Power tests, connect the ESU footswitch COAG and CUT contacts to the blue and yellow terminals.

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 diathermy machine under test.

For CQM / plate security test use the black terminals.


3.4 Side panel ESU to ESA connections

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.

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;

ON

/

OFF butt on

F1 F2

F3

F4


4 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:

 CQM / REM test

 HF Leakage

 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 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 autocalibrate the CQM / REM potentiometer;


Once the calibration has completed, the CQM / REM test screen will appear;

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.


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.

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 deactivate 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.


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. 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;


The Rigel Uni-Therm could display the following details after the test;

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.

4.3 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.


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

in the

Load Power rating Rigel Uni-Therm

.

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.




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 unticked 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.

Press the HOLD button to freeze the display


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

.



START LOAD is required to determine the starting resistance at which the power curve measurement is carried out.


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.




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.



During the Graph power test, the Rigel Uni-Therm will display the power distribution 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 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.

The maximum current measurement during this test is limited to 8A rms.




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.





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.




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;

In the following screen, an asset ID number can be entered using the rotary encoder, barcode scanner or a PS2 keyboard.

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 “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;


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 C hapter

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.

The next step is a custom test to instruct the user to disconnect the neutral electrodes.


Either press PASS (F2) or the GREEN button to continue,

The next step in SEQUENCE2 is the HF leakage test;

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.

Either press PASS (F2) or the GREEN button to continue

The next step in SEQUENCE2 is the POWER GRAPGH test;


The Rigel Uni-Therm will display the settings. Press SHOW DIAGRAM (F3) to show the connection diagram;

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. Switch from GRAPGH to DATA (F4) mode to view actual results.


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 following option menu will appear;

 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.


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);

This leads to 3 options;

 View data (see

Chapter 6.1

)

 Transfer data (see

Chapter 6.2

)

 BT favourites (see

Chapter

7)


6.1 View Data

Stored data can be viewed by selecting the VIEW (F2) from the DATA screen as shown above.

Data can be sorted using the SORT (F4) key which will sort on asset number and date either 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;

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;


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. 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.


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

.

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.


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)

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.



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 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 (F2) to change.

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.

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.


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).

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;

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.


Sequence_01012015_109837.sss with the numbers indicating the date and time.


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 :

 Barcode (Scanner)

To start the pairing process, select DATA from the home screen, followed by BT

FAVOURITES.

From the BT Favourites screen, press the SEARCH button to list all the Bluetooth devices within reach. (Ensure your device is in “discovery” mode.)


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;

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;

Check that the correct devices are paired for each function and press the back arrow to exit and complete the pairing;

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)


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

 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


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;

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;

Press the GREEN button to confirm or RED button to cancel.


Press the EDIT (F3) button to open the test sequence for editing;

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;


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.

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);


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;

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:

The new test sequence has now been added to the test library;


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


8.2 Time Date

To modify the time or date including time format (12 / 24h clock), select the Time

/ Date (F3) option in the setup menu;

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;

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.


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;

An overview of the memory usage is provided;

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


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.


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.

If 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.

If the Rigel Uni-Therm is subject to condensation, allow the Analyser to completely dry before use.

 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.

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 Uni-Therm will need to be registered; this will also provide automatic upgrade alerts to the user.


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 [email protected]

[email protected]

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:

 Instruments name and model

 Serial number

 Firmware version


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

Ranging

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)

0 - 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 - 5115

Ω, steps @ 5Ω

Ceramic Resistors (Non inductive)

±(1%, + 0.5, -0.5

Ω of set load)

See load/power graph

Up to 100% at 60 seconds ON time,

see load/power graph

2 x 200Ω

±1%, + 0.5,-

0.0 Ω

20 Watt (100% duty cycle)

0 - 475

Ω, 1Ω step

Motor driven potentiometer

±5% ± 2 Ω

High and low, manual confirmation

Manual or automatic


Oscilloscope output

Connections

Variable load 0

– 5115Ω

Fixed Load x 200Ω

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

10.2 General Specification

Dimensions

Weight

Operating Temperature

Storage Temperature

Mains power

Fuses

0.5V/A, 100mA RF current minimum input, un-calibrated , indication only

2 x 4mm Red = Active, Black = Plate

1 x 4 mm black (common), 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

2 x 1.6 A (T) ceramic


900

800

700

600

500

400

300

200

100

0

5

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

800

600

400

200

0

1 10 100

Ohms

Max Watt at

60sec On / 15sec Off duty cycle

5 - 100 ohms

15 25 35 45 55

Ohms

65

1000

75 85 95

10000


Max Amps at

15sec On / 15sec Off 50% duty cycle

5 - 5115 ohms

7.00

6.00

5.00

4.00

3.00

2.00

1.00

0.00

1 10 100

Ohms

1000

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

5 15 25 35 45 55

Ohms

65 75 85 95

10000


11 Support

11.1 Contact Us

Part of

Rigel Medical Contact details

Sales and Delivery enquiries

Tel: +44 (0) 191 587 8730

Fax: +44 (0) 191 586 0227

Email: [email protected]

Technical enquiries

Tel: +44 (0) 191 587 8701


CalibrationHouse Contact details

Service, Calibration and Repair

Tel: +44 (0) 191 587 8739

Fax: +44 (0) 191 518 4666


Rigel Medical Address details

Rigel Medical

15 - 18 Bracken Hill


Peterlee, County Durham

SR8 2SW, United Kingdom

CalibrationHouse Address details

CalibrationHouse

11 Bracken Hill


Peterlee, County Durham

SR8 2SW, United Kingdom


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




A BIPOLAR ELECTRODE

EARTH ISOLATED ESU


MODE SECOND ELECTRODE

TEST CODE 1121




A BIPOLAR ELECTRODE

EARTH ISOLATED ESU

BIPOLAR ELECTRODE COAG


TEST CODE 1122




A BIPOLAR ELECTRODE

EARTH ISOLATED ESU



TEST CODE 1211

IEC 601-2-2 part 1 FIGURE


LEAKAGE CURRENT WITH

NEUTRAL ELECTRODE

ISOLATED FROM EARTH AT

HIGH FREQUENCY EARTH

ISOLATED ESU MONO-

POLAR ELECTRODE CUT

MODE ACTIVE ELECTRODE


TEST CODE 1212




NEUTRAL ELECTRODE



ISOLATED ESU MONO-

POLAR ELECTRODE CUT

MODE

ELECTRODE

NEUTRAL

TEST CODE 1221




NEUTRAL ELECTRODE



ISOLATED ESU MONO-

POLAR ELECTRODE COAG

MODE

ACTIVE ELECTRODE

TEST CODE 1222




NEUTRAL ELECTRODE



ISOLATED ESU MONO-


MODE

NEUTRAL ELECTRODE

TEST CODE 2111




A BIPOLAR ELECTRODE

EARTH `REFERENCED ESU




TEST CODE 2112




A BIPOLAR ELECTRODE

EARTH REFERENCED ESU



TEST CODE 2121




A BIPOLAR ELECTRODE




TEST CODE 2122




A BIPOLAR ELECTRODE




TEST CODE 2211




NEUTRAL ELECTRODE

REFERENCED TO EARTH

AND LOAD FROM ACTIVE

ELECTRODE TO EARTH


MONO-POLAR ELECTRODE

CUT MODE ACTIVE

ELECTRODE

TEST CODE 2212




NEUTRAL ELECTRODE

REFERENCED TO EARTH

AND LOAD BETWEEN

ELECTRODES EARTH

REFERENCED ESU MONO-

POLAR ELECTRODE CUT


MODE

ELECTRODE

NEUTRAL

TEST CODE 2221




NEUTRAL ELECTRODE

REFERENCED TO EARTH

AND LOAD FROM ACTIVE

ELECTRODE TO EARTH


MONO-POLAR ELECTRODE

COAG MODE ACTIVE

ELECTRODE

TEST CODE 2222




NEUTRAL ELECTRODE

REFERENCED TO EARTH

AND LOAD BETWEEN

ELECTRODES EARTH



MODE NEUTRAL

ELECTRODE


13 Appendix B Additional Leakage Tests

EST CODE 2113


N/A MEASUREMENT OF H.F.


A BIPOLAR ELECTRODE

EARTH ISOLATED ESU



TEST CODE 2114




A BIPOLAR ELECTRODE

EARTH ISOLATED ESU



TEST CODE 2115




A BIPOLAR ELECTRODE

EARTH ISOLATED ESU



TEST CODE 2213




NEUTRAL ELECTRODE

REFERENCED TO EARTH

AND LOAD BETWEEN

ELECTRODES EARTH


POLAR ELECTRODE CUT

MODE

ELECTRODE

NEUTRAL


TEST CODE 2223




NEUTRAL ELECTRODE

REFERENCED TO EARTH

AND LOAD BETWEEN

ELECTRODES EARTH



MODE

ELECTRODE

NEUTRAL


14 Appendix C IEC 60601-2-2 Power Tests

TEST CODE 0110


106 MEASUREMENT OF

OUTPUT POWER BI-POLAR

OUTPUT USER SET LOAD

RESISTANCE BI-POLAR

ELECTRODE CUT MODE

BOTH ELECTRODES

TEST CODE 0120


106 MEASUREMENT OF

OUTPUT POWER BI-POLAR

OUTPUT USER SET LOAD

RESISTANCE BI-POLAR

ELECTRODE COAG MODE

BOTH ELECTRODES

TEST CODE 0210


105 MEASUREMENT OF

OUTPUT POWER MONO-

POLAR OUTPUT USER SET

LOAD RESISTANCE MONO-

POLAR ELECTRODE CUT

MODE ACTIVE AND

NEUTRAL ELECTRODE

TEST CODE 0220


105 MEASUREMENT OF

OUTPUT POWER MONO-

POLAR OUTPUT USER SET

LOAD RESISTANCE MONO-


MODE ACTIVE AND

NEUTRAL ELECTRODE


15 Appendix D 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 t he file ‘refgraphtemplate.csv' available at: http://www.rigelmedical.com/rigel-downloads?id=Application

Notes

[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 (Ω). Column B is the Y axis and represents the Power (W). In this example, line 3 is a plot of 25W at 35

Ω.

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

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.


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.

Select the UPPER and LOWER limit graphs by pressing UPPER and LOWER respectively and select the corresponding graphs;


16 Appendix E Firmware Route Map

Menu

Auto

Mode

Data

Setup

View Data

Transfer

Date

BT

Favourites

Test

Sequences

Time Date

REM test

HF

Leakage

Power

Language

Factory

Restore

About

View test results

Download and upload results

Import reference curves

Pair PC and barcode scanners

View, create and edit test sequences

Change time and date settings

Change language settings

Restore instrument to factory default

View firmware revision and serial number.

Manual testing of the REM function

Manual testing of the HF leakage

Manual testing of the

Power output


5781 A4 cover template in-house prod manuals

Innovating Together

RIGEL UNI-THERM

electrosurgical analyser

1 Introduction

1.1 Analyser Functions

1.2 Key Features

1.3 Unpacking the Uni-Therm

1.4 Optional Accessories

1.5 Warnings and Cautions

1.6 User Notes

1.7 Safety Notes

2 Uni-Therm Overview

2.1 Simulation panel

2.2 Side panel

3 Getting started

3.1 Connecting your Analyser

3.2 Rear panel

3.3 Simulation connection panel

3.4 Side panel ESU to ESA connections

3.5 Home screen

4 Manual Mode

4.1 Contact Quality Monitoring (CQM) or REM test

4.2 HF Leakage

4.3 Power Test

5 Automatic Mode

5.1 Stopping or Failing a Test Sequence

6 Data

6.1 View Data

6.2 Transfer Data

6.3 Download Data

6.4 Upload Data

6.5 Import Power Reference Curves

6.6 Transfer Test Sequences

7 Bluetooth Favourites

8 Setup

8.1 Test Sequence

8.2 Time Date

8.3 Language

8.4 Factory Restore

8.5 About

9 Maintaining the Rigel Uni-Therm

9.1 Cleaning the Analyser

9.2 User Maintenance

9.3 Firmware Upgrade

9.4 Return Instructions.

10 Specifications

10.1 Technical Specification

10.2 General Specification

10.3 Load Power rating Rigel Uni-Therm

11 Support

11.1 Contact Us

12 Appendix A IEC 60601-2-2 Leakage Tests

13 Appendix B Additional Leakage Tests

14 Appendix C IEC 60601-2-2 Power Tests

15 Appendix D Creating a power reference curve

16 Appendix E Firmware Route Map

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Table of contents