Rigel Uni-Therm User manual

Uni-THERM
Innovating Together.
Electrosurgical Analyser
Copyright © 2012 SEAWARD GROUP
Last Update: 5th July 2012
Instruction Manual
398A550 Revision 1.0

i
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 & 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; / / .

ii
© Copyright 2012
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.

iii
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 2002/96/EC.
Please familiarise yourself with the appropriate local separate collection system for
electrical and electronic products or contact your local supplier for further
information.
Please dispose of this product according to local regulations. Do not dispose of this
product along with normal waste material. By offering your old products for
recycling, you will help prevent potential negative consequences for the environment
and human health.

iv
Certificate of Conformity
Manufactured by:
Seaward Electronic Ltd, Bracken Hill, South West Industrial Estate, Peterlee, County
Durham, SR8 2SW, England
Statement of Conformity
As the manufacturer of the apparatus listed, declare under our sole responsibility that
the product:
Rigel Uni-Therm Electrosurgical Analyser
To which the declaration relates are in conformity with the relevant clauses of the
following standard:
BS EN 61010-1:2010
Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 1: General requirements.
BS EN 61326:2006
Electrical equipment for measurement, control, and laboratory use - EMC
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 ISO9001:2000 Certificate No.:
Q05356.

1 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
Index
Introduction............................................................................................................................. 2
Analyser Functions.............................................................................................................. 2
Key Features ....................................................................................................................... 3
Unpacking the Uni-Therm.................................................................................................... 3
Optional Accessories........................................................................................................... 3
Warnings and Cautions ....................................................................................................... 4
User Notes........................................................................................................................... 4
Safety Notes........................................................................................................................ 4
Uni-Therm Overview............................................................................................................... 5
Front panel........................................................................................................................... 6
Side panel............................................................................................................................ 6
1 Getting started...................................................................................................... 7
1.1 Connecting your Analyser .................................................................................... 7
1.2 Rear panel............................................................................................................ 7
1.3 Front connection panel......................................................................................... 7
1.4 Side panel ESU to ESA connections.................................................................... 8
1.5 Home screen........................................................................................................ 8
2 Manual Mode........................................................................................................ 9
2.1 Plate Security (REM) test..................................................................................... 9
2.2 HF Leakage........................................................................................................ 10
2.3 Power Test......................................................................................................... 13
3 Automatic Mode ................................................................................................. 18
3.1 Stopping or failing a test sequence .................................................................... 21
4 Data.................................................................................................................... 23
4.1 View Data........................................................................................................... 23
4.2 Transfer Data ..................................................................................................... 24
4.3 Download data ................................................................................................... 25
4.4 Upload data........................................................................................................ 26
4.5 Import power reference curves........................................................................... 27
4.6 Transfer test sequences..................................................................................... 27
5 Bluetooth Favourites .......................................................................................... 29
6 Setup.................................................................................................................. 31
6.1 Test sequence.................................................................................................... 31
6.2 Time Date......................................................................................................... 36
6.3 Language ........................................................................................................... 36
6.4 Factory restore ................................................................................................... 37
6.5 About.................................................................................................................. 38
7 Maintaining the Rigel Uni-Therm........................................................................ 39
7.1 Cleaning the Analyser ........................................................................................ 39
7.2 User Maintenance .............................................................................................. 39
7.3 Firmware Upgrade.............................................................................................. 39
7.4 Return Instructions. ............................................................................................ 40
8 Specifications ..................................................................................................... 41
8.1 Technical Specification....................................................................................... 41
8.2 General Specification ......................................................................................... 42
8.3 Load Power rating Rigel Uni-Therm................................................................... 43
9 Support............................................................................................................... 45
9.1 Contact Us.......................................................................................................... 45
Appendix A IEC 60601-2-2 Leakage Tests.............................................................. 46
Appendix B IEC 60601-2-2 Power Tests.................................................................. 50
Appendix C Creating a power reference curve................................................................... 51
Appendix D Firmware Route Map.............................................................................. 53

2 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
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).
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)
Plate Security (REM, Remote Electrode Monitoring)
For the power test, an internal array of resistors provide a safe variable load of 0-5115Ω
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 (REM) 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 upgrades can be efficiently installed by users, without risk to stored
data.
The new Rigel Uni-Therm forms part of a comprehensive range of high performance
specialist biomedical test equipment supplied by Rigel Medical, part of the Seaward
Group.

3 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
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 5115Ω
in 5Ω steps – Accurate, fast, and flexible
 Plate Security (REM) test – using electronic potentiometer range up to 475Ω 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
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 Bluetooth Adaptor
3 x Jumper Links (p/n 43B759)
Optional Accessories
Finger switch adaptor
Foot switch adaptor cable set (manufacturer specific, please specify)
Trolley style hard carry case
SMB to BNC Oscilloscope connection lead (p/n 367A950)

4 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
Warnings and Cautions
Before you power up - Ensure the mains switch positioned at the base panel of the Rigel
Uni-Therm is set to the appropriate voltage range i.e. 230VAC or 120 VAC.
Before you power up - Ensure none of the ventilation holes are covered during operation
including the ones on the base panel. We strongly recommend positioning the Rigel Uni-
Therm on its two hinged feet at the front base.
User Notes
The following symbols are used throughout this Instruction Manual.
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 front panel of the Rigel Uni-
Therm. Failure to comply with this will void the warranty and might lead to
internal damage of circuits.
Safety Notes
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.

5 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
Uni-Therm Overview
1. ON / OFF button
2. Function keys (F1-F4)
3. Start / Confirm key (Green)
4. Rotary encoder / main navigation
key
5. Front panel connections
6. Colour screen
7. Stop / Cancel key (Red)
8. Hinged feet
1
8
6
2
3
4
5
7

6 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
Front panel
Side panel
*Note; The scope output (SMB connector) provides an 10kV isolated waveform
monitoring output however the scope output is not calibrated.
1. REM output connection (Black)
2. CUT footswitch control output (Yellow)
3. COAG footswitch control output (Blue)
1. Variable load bank connections (Red
& Black)
2. Oscilloscope output*
3. Measuring Device connections
(White)
4. HF Leakage connections
1
2
3

7 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
1 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.
1.1 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,
1.2 Rear panel
Connect the mains cable to the IEC connector on the rear
panel.
1.3 Front 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 REM / plate security test use the black terminals.

8 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
1.4 Side panel ESU to ESA connections
Follow the on-screen instruction diagrams for correct test connection. See appendices A
and Bfor 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.
1.5 Home screen
Upon power-up of the Rigel Uni-Therm, the display will be showing the HOMESCREEN;
ON /
OFF
F1 F2 F3 F4

9 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
2 Manual Mode
The manual mode provides the user with the features for testing a specific individual
function and or test condition; for example to aid fault diagnostic procedures. These tests
are available from the home screen.
Available tests are:
REM test
HF Leakage
Power Test
2.1 Plate Security (REM) test
This test will control a motor driven potentiometer to trigger the neutral (patient plate)
alarm on electrosurgical generators by simulating fault conditions (ie resistance too high
or too low, a variation in resistance etc). The variable resistance (0 – 475 Ω) is
connected to the two black connectors on the front panel.
Select the REM test from the home screen shown below.
During the initial REM test selection, the Rigel Uni-Therm will auto-calibrate the REM
potentiometer;

10 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
Once the calibration has completed, the 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.
2.2 HF Leakage
The HF Leakage test measures the HF leakage current in various test configurations
(see appendix A), and compares the result to a user set pass/fail value.
Select the HF LEAKAGE test from the main menu, shown below.
Use the rotary encoder to navigate the screen

11 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
Select the required setting and press the rotary encoder to activate the field. Once
activated, use the rotary encoder to change the settings. Confirm and de-activate the
field by pressing the encoder once again.
START DELAY will allow the user to set a measurement delay for generators operating
in a soft start mode.
The TEST TIME will display the total test time of the leakage test and dictate the amount
of tests done as a result of the selected ON TIME and OFF TIME.
Note: the D/CYCLE is limited to 50% or less during the leakage test with a
maximum ON time of 15 seconds. To increase the ON TIME, the OFF TIME must be
increased first in order to remain within the duty cycle limits. This is done to
protect the EUT from overheating. If the selected ON / OFF time is above the 50%
duty cycle (the Uni-Therm will calculate this automatically), the duty cycle factor
appears in red. It’s not possible to continue without reducing the duty cycle. A
valid duty cycle will appear in black.
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.

12 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
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.

13 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
2.3 Power Test
The output power of the Active Electrodes (CUT / COAG and BIPOLAR) is measured,
either at a fixed load (Continuous Single Test) or at a range of loads (Power Distribution
Graph). The load will vary from a start value to an end value with a number of intervals
(resolution). The Rigel Uni-Therm will control the EUT by using the internal footswitch
controller.
Select Power test from the home screen; (CONT) or GRAPH mode using the fast keys;
and select either the Continuous, Graph or External Load test. Use the rotary encoder or
the dedicated function keys to navigate.
2.3.1 Continuous mode
The continuous mode allows the user to monitor the power characteristics under a
specific load condition.
Ensure that the power settings on the EUT do not exceed those specified in the
Load Power rating Rigel Uni-Therm.

14 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
Use the rotary encoder to navigate the screen. The selected field is marked with a red
border, presses the rotary encoder to activate the field to allow changes. Confirm and
de-activate the field by pressing the encoder once again.
LOAD is required to determine the resistance at which the power measurement is carried
out.
START DELAY will allow the user to set a measurement delay for generators operating
in a soft start mode.
The TEST TIME will display the total test time of the leakage test and dictate the amount
of tests done as a result of the selected ON TIME and OFF TIME.
The BIPOLAR / MONO POLAR and COAG / CUT settings determine the type of
connection diagrams when the SHOW DIAGRAM button is pressed. The COAG / CUT
settings also determine the activation of the foot paddle control on the front of the Uni-
Therm.
Note: the duty cycle is limited to 50% or less when the high duty cycle box is un-
ticked to protect the EUT from overheating. It is 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

15 | P a g e R i g e l M e d i c a l U n i - T h e r m u s e r M a n u a l V 1 . 0
2.3.2 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.
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 display the total test time of the leakage test and dictate the amount
of tests done as a result of the selected ON TIME and OFF TIME and the number of test
points.
The BIPOLAR / MONO POLAR and COAG / CUT settings determine the type of
connection diagrams when the SHOW DIAGRAM button is pressed. The COAG / CUT
settings also determine the activation of the foot paddle control on the front of the Uni-
Therm.
Note: the duty cycle is limited to 50% or to protect the EUT from overheating. To
increase the ON time, the OFF time must be increased first in order to remain
within the duty cycle limits.