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

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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; / / .

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© 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.

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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.

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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.

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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