Rigel 377 User manual

Rigel 377
Electrosurgical Analyser
Instruction Manual
367A550 Issue 1.0
November 2010
© 2010 Seaward Group
Issue 1.0

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Limited Warranty & Limitation of Liability
Rigel Medical, part of the SEAWARD GROUP guarantees this product for a period of 1
year. The period of warranty will be effective at the day of delivery.
Calibration Statement
The Rigel 377 Electrosurgical Analyser is fully calibrated and found to be within the
specified performance and accuracy at the time of production. The Seaward Group
provides its products through a variety of channels; therefore it may be possible that the
calibration date on the provided certificate may not represent the actual date of first use.
Experience has indicated that the calibration of this instrument in not effected by
storage prior to receipt by the user. We therefore recommend that the recalibration
period be based on a 12 month interval from the first date the unit is placed in to
service.
Date received into service; / / .
© Copyright 2010
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 377 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 dipose 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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Contents
DECLARATION OF CONFORMITY............................ - 5 -
BEFORE YOU POWER UP......................................... - 6 -
USER NOTES ............................................................. - 6 -
1. INTRODUCTION................................................. - 7 -
1.1. Analyser Functions ....................................................- 7 -
1.2. Key Features .............................................................- 8 -
2. GETTING STARTED .......................................... - 9 -
2.1. Connecting your Analyser .........................................- 9 -
2.2. Rigel 377 includes: ..................................................- 10 -
2.3. Optional Accessories...............................................- 10 -
3. TEST MODES ................................................... - 11 -
3.1. Plate Security (REM) test ........................................- 11 -
3.2. HF Leakage .............................................................- 12 -
3.3. Power Test...............................................................- 15 -
4. ABOUT.............................................................. - 17 -
5. MAINTAINING THE RIGEL 377 ....................... - 18 -
5.1. Cleaning the Analyser .............................................- 18 -
5.2. User Maintenance ...................................................- 18 -
5.3. Firmware Upgrade...................................................- 18 -
5.4. Return Instructions. .................................................- 19 -
6. SPECIFICATIONS ............................................ - 20 -
6.1. Technical Specification............................................- 20 -
6.2. General Specification ..............................................- 21 -
APPENDIX A IEC 60601-2-2 LEAKAGE TESTS - 22 -
APPENDIX B IEC 60601-2-2 POWER TESTS.... - 25 -

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Declaration of Conformity
Rigel 377 Electrosurgical Analyser
Manufactured by:
Seaward Electronic Ltd, Bracken Hill, South West Industrial Estate
Peterlee, County Durham, SR8 2SW, England
Millennium Statement
This product is Millennium compliant, and conforms fully to the document BSI DISC
PD2000-1.
Statement of Conformity
Based on test results using appropriate standards, the product conforms with
Electromagnetic Compatibility Directive 89/336/EEC and Low Voltage Directive
73/23/EEC
Standards used:
EN 60601-1 (1990) Medical Electrical Equipment. General Requirements for Safety
EN 61010-1 (1993) Safety Requirements for Electrical Equipment for Measurement,
Control, and Laboratory Use
EN 50081-1 (1992) Electromagnetic Compatibility. Generic Emission Standard:
EN55022 Class B
EN 50082-1 (1992) Electromagnetic Compatibility. Generic Immunity Standard:
IEC1000-4-2, -4-3, -4-4, -4-5
The tests have been performed in a typical configuration.
This Conformity is indicated by the symbol , i.e. “Conformité Européenne”

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Before you power up
Ensure the mains switch positioned at the base panel of the Rigel 377 is set to the
appropriate voltage range i.e. 230VAC +/- 10% or 120 VAC +/- 10%.
Ensure none of the ventilation holes are covered during operation including the ones on
the base panel. We strongly recommend positioning the Rigel 377 on its two hinged feet
at the front base.
User Notes
These operating instructions are intended for the use of adequately trained
personnel.
The following symbols are used in these operating instructions and on the Rigel 377.
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.
Warning, when operating the Rigel 377 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 377. Failure to comply with this will void the warranty and
might lead to internal damage of circuits.

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1. Introduction
The Rigel 377 Electrosurgical Analyser is a versatile bench-mounted yet portable tool,
for testing the performance of electrosurgical equipment.
Utilising a large, full colour graphical display, the Rigel 377 is the first fully stand-alone
electrosurgical analyser that can offer true intuitive, user friendly operation and operator
safety.
1.1. Analyser Functions
The Rigel 377 Electrosurgical Analyser enables biomedical engineers to efficiently
analyse the output of electrosurgical diathermy machines. The RF signal input is
simultaneously digitally analysed to provide all the characteristics of interest: Watts,
current, peak Voltage, crest factor. The Rigel 377 can also produce load/ power curves
automatically analysing the load/power performance of an electrosurgical diathermy
machine.
The Rigel 377 is able to measure the following parameters manually;
1. Power
2. HF Leakage
3. Plate Security (REM, Remote Electrode Monitoring)
For the power test, an internal array of resistors provide a safe variable load of 10-
5100Ωin 10Ωsteps; 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, electronically 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 efficently installed by users, without risk to stored
data.
The new Rigel 377 forms part of a comprehensive range of high performance specialist
biomedical test equipment supplied by Rigel Medical, part of the Seaward Group.

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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
 Multiple Load Resistors – For simpler user test configurations, benefiting
speed and ease-of-use
 High Frequency Leakage – Easy to connect with on screen help for each
configuration
 Power distribution curves - Variable load with full 10kV isolation from 10 to
5100Ωin 10Ωsteps – Accurate, fast, and flexible
 Plate Security (REM) test – using electronic potentiometer range up to 500Ωin
1 Ωsteps 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

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2. Getting started
The Rigel 377 has been designed to ensure that the user is able to test: quickly, easily
and safely. The interfaces to the Rigel 377 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.
2.1. Connecting your Analyser
Elevate the Rigel 377 on its two hinged feet at the front
base.
Ensure none of the large base and rear ventilation
inlets are obstructed during operation,
Rear panel
Connect the mains cable to the IEC connector on the rear
panel.
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 377’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.

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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.
Do not use MD alone, always combine with load resistance.
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 ‘0210’ for identification.
Side panel ESA to Oscilloscope connections
The scope output (SMB connector) provides an isolated* waveform monitoring output.
Note: The scope output is not calibrated, * 10kV isolation from HF signal.
2.2. Rigel 377 includes:
•Calibration Certificate
•Detachable 2 metre mains cable
•Removable ‘quick start’ card
•Instruction Manual (p/n 367a550)
•3 x Jumper Links (p/n 43b759)
2.3. Optional Accessories
•Finger switch adaptor
•Foot switch adaptor cable set
•Hard carry case
•SMB to BNC Oscilloscope connection lead (p/n 367A950)

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3. Test Modes
The test modes provide the user with the features for testing a specific individual
test 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
3.1. 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 – 500 Ω) is
connected to the two black connectors on the front panel.
Select the REM test from the main menu shown below.

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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.
3.2. 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.

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Use the rotary encoder to navigate the screen
Select the required setting and press the rotary encoder to activate the field. Once
activated, use the rotary encoder to change the settings. Confirm and de-activate the
field by pressing the encoder once again.
START DELAY will allow the user to set a measurement delay for generators operating
in a soft start mode.
The TEST TIME will display the total test time of the leakage test and dictate the
amount of tests done as a result of the selected ON TIME and OFF TIME.
Note: note the D/CYCLE is limited to 50% or less. 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 the TICK mark 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 graph mode, shown below.

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or the IEC 60601-2-2 reference details (SHOW DETAIL).
Press the rotary encoder to activate the SET LOAD and LEAKAGE LIMIT
return to the GRAPH mode by using the SHOW DIAGRAM fast key.
The Rigel 377 could display the following details after the test.
Press the HOLD key to freeze the reading on the screen.

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3.3. 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 377 will control the EUT by using the internal footswitch
controller.
Select Power test from the main menu.
Select either the Continuous Single test (CONT) or GRAPH mode using the fast keys;
CONT mode GRAPH mode

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Use the rotary encoder to navigate the screen
Select the required setting and press the rotary encoder to activate the field. Once
activated, use the rotary encoder to change the settings. Confirm and de-activate the
field by pressing the encoder once again.
START LOAD is required to determine the resistance at which the power measurement
is begun.
START DELAY will allow the user to set a measurement delay for generators operating
in a soft start mode.
END LOAD (GRAPH mode only), will set the highest resistance at which power
measurements are done.
TEST POINTS (GRAPH mode only), determines the number of test points (resolution)
of the power distribution graph. The higher the number, the more detailed the power
distribution graph.
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 duty cycle is limited to 50% or less. 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 RUN / TICK to confirm the settings and start the test.
During the Continuous power test, the
Rigel 377 will display continuously
updated readings.
During the Graph power test, the Rigel
377 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.

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4. About
This screen provides details on the Rigel 377’s firmware version
Ensure you have this information available when contacting Rigel Medical for Technical
Support or Service. See section 5.3 for more information on Service and Calibration.

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5. Maintaining the Rigel 377
5.1. Cleaning the Analyser
The Rigel 377 case can be cleaned with a damp cloth with, if necessary, a small
amount of mild detergent. Prevent excessive moisture around the socket panel or in the
lead storage area.
Do not allow liquid inside the Rigel 377 or near the sockets. Do not use: abrasives,
solvents, or alcohol.
If any liquid is spilt into the Rigel 377 case, the analyser should be returned for repair,
stating the cause of the defect.
5.2. User Maintenance
The Rigel 377 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 377 is subject to condensation, allow the Analyser to completely dry before
use.
•Always check the Rigel 377 and all test leads for signs of damage and wear
before use.
•Do not open the Rigel 377 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.
•There are no user replaceable parts in the Rigel 377.
•The unit should be regularly calibrated.
5.3. Firmware Upgrade
The Rigel 377 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.
To obtain the latest firmware, the Rigel 377 will need to be registered; this will also
provide automatic upgrade alerts to the user.

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5.4. Return Instructions.
For repair or calibration return the instrument to:-
Rigel Medical
Service Dept.,
p.a. Seaward Electronic Limited.
Bracken Hill
South West Industrial Estate
Peterlee, Co. Durham
SR8 2SW, England
Tel : [phone]
Fax: [phone]
[email protected]
[e-mail]
www.seaward.co.uk
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

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6. Specifications
6.1. Technical Specification
HF Power Watt (RMS) True RMS Watts (0 -500W)
Refer to load/power graph)
Accuracy ±5%,±1W of value
HF Current (RMS) 0 – 2200mA
Accuracy ±2%,±10mA of value
Voltage (RMS) 0 - 700V
Accuracy ±3%, ± 5V of value
Voltage (peak) 0 – 10KV (Peak) – Closed load only
Accuracy ±10% ± 50V of value.
Crest Factor 1.4 – 20 (± Vpeak / V RMS)
RMS Bandwidth 30 Hz to 2.5 MHz (-3 dB)
Interference Frequency Filter 100 Hz high pass filter
Isolation (earth to measurement device)10kV
Measurement delay adjustment 200 – 2000ms (10ms resolution)
Variable Load 10 – 5100Ω, steps @ 10Ω
Load Resistor Type Ceramic Resistors (Non inductive)
Accuracy ±1%, + 0.5, -0.0 Ωof set load
Power rating (Refer to load/power graph)
Duty cycle * (see load rating graph below) 50%
Fixed Loads 2 x 200Ω
Accuracy ±1%, + 0.5,-0.0 Ω
Power rating 150 Watt (50% duty cycle)
Plate Security (REM) resistor 0 - 500Ω, 1Ωstep
Motor driven potentiometer
Accuracy ±5% ± 2 Ω
Alarm register High and low, manual confirmation
Ranging Manual or automatic
Oscilloscope output 5V/A, un-calibrated , indication only
Connections
Variable load 10 – 5100Ω2 x 4mm Red = Active, Black = Plate
Fixed Load x 200Ω1 x 4 mm - black (common), 2 x 4 mm - red
Measuring device (MD) 2 x 4mm White
Oscilloscope output SMB coaxial connector
REM test 0-500 ohm 2 x 4 mm - black
Remote foot switch control (CUT) 2 x 4 mm - yellow, Single relay contact
Remote foot switch control (COAG) 2 x 4 mm - blue, Single relay contact
USB port PC interface