Rigel 62353 PLUS User manual

Innovating Together
RIGEL 62353 PLUS
electrical safety analyser
Copyright © 2016SEAWARD GROUP
Last Update: 20th April 2016
Instruction Manual
407A556 Revision 1.4

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 62353+ Electrical Safety 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 2016
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 62353+ has been designed and manufactured with high quality
materials and components, which can be recycled and reused.
Please familiarise yourself with the appropriate local separate collection system
for electrical and electronic products or contact your local supplier for further
information.
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.

1
Statement of Conformity
This product is manufactured by:
Seaward Electronic Ltd, Bracken Hill, South West Industrial Estate, Peterlee, County
Durham, SR8 2SW, UK
As the manufacturer of the apparatus listed, we declare under our sole responsibility
that the product:
Rigel 62353 plus - Electrical Medical Safety Analyser
Conforms with the relevant Directives and conformity is indicated by the symbol ,
i.e. “Conformité Européenne”
Seaward Electronic Ltd. is registered under BS EN ISO9001 Certificate No.: Q05356.
A copy of the Declaration of Conformity and a copy of our ISO certificate are available
in the Support & Resources area of the Seaward website www.seaward.co.uk".

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Index
User Notes.................................................................................................................4
1Introduction .......................................................................................................5
1.1 Rigel 62353 Plus includes: .................................................................................... 5
1.2 Optional Accessories............................................................................................ 5
1.3 Key Features........................................................................................................ 6
1.4 Interfaces ............................................................................................................ 7
1.5 Unique use of ICONS............................................................................................ 8
2Setting-up your tester.....................................................................................- 9 -
2.1 Test Sequences.................................................................................................- 9 -
2.2 Asset Trace Variables ......................................................................................- 22 -
2.3 System Config.................................................................................................- 23 -
2.4 Change User ...................................................................................................- 25 -
2.5 Restore Factory Settings .................................................................................- 25 -
2.6 About .............................................................................................................- 26 -
3Automatic Mode ..........................................................................................- 27 -
3.1 Asset ID ..........................................................................................................- 28 -
3.2 Run Mode.......................................................................................................- 28 -
3.3 Test Period .....................................................................................................- 29 -
3.4 Configure the Applied Parts ............................................................................- 29 -
3.5 Trace Variables ...............................................................................................- 31 -
3.6 View Results...................................................................................................- 38 -
4Manual Mode ..............................................................................................- 39 -
5Data.............................................................................................................- 56 -
5.1 View Data.......................................................................................................- 56 -
5.2 View Data Options..........................................................................................- 59 -
5.3 Data Transfer..................................................................................................- 59 -
5.4 Memory options.............................................................................................- 65 -
6Trouble Shooting ..........................................................................................- 66 -
7Maintaining the Rigel 62353 Plus .................................................................- 67 -
7.1 Cleaning the Analyser .....................................................................................- 67 -
7.2 User Maintenance ..........................................................................................- 67 -
7.3 Return Instructions. ........................................................................................- 68 -
8Technical Specifications ................................................................................- 69 -

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Appendix A Definition of IEC 62353 tests ..........................................................- 72 -
Appendix B Pass / Fail limits of IEC 62353.........................................................- 77 -
Appendix C IEC 60601-1 Measuring Device .......................................................- 78 -
Appendix D Firmware Route Map.....................................................................- 79 -
Appendix E Available Application Notes...........................................................- 80 -
Appendix F Connection diagram AP lead..........................................................- 81 -

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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 62353
Plus.
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, during many of the leakage tests the PROTECTIVE EARTH
CONDUCTOR to the appliance under test is interrupted. For this reason
additional means of protection are required in order to comply with the
relevant safety standards. For EN60601-1 leakage tests, it is recommended
that this additional protection is in the form of an isolation transformer,
with an isolated reference ground, used to power the entire system.
Do not connect any probe combination to the maximum permitted
voltage of 30 V AC/DC with respect to earth potential when
performing non-power tests. Danger of electric shock.
Symbol used for tips and guidance notes in this manual.
Application note(s) available, see Appendix E.

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1 Introduction
The Rigel 62353 Plus is the first dedicated IEC 62353 Plus safety analyser that is able
to provide automatic test sequences, onboard data storage and data entry in a
ergonomic hand-held enclosure. This will allow for high flexibility in the field.
With the introduction of the IEC 62353 Plus (2007) standard for in-service and after-
repair testing of medical electronic devices, the market for hand-held medical safety
testers has changed. The globally recognised IEC 62353 Plus has become the
accepted guideline for routine testing for many leading medical device manufacturers
and offers faster and easier test methods.
Designed to address the increasing demand for smaller more comprehensive test
equipment, the Rigel 62353 Plus has been designed to test to the latest standard for in-
service and after repair testing of medical electronic devices, the IEC 62353 (2007).
The Rigel 62353 Plus’s large internal memory facilitates the storage of test results for
safety audit and traceability purposes. Comprehensive database software is available to
ensure fast and easy download of test results, managing your asset database, creation
of test sequences, scheduling of Preventative Product Maintenance and producing test
certificates. Stored data can be transferred immediately and directly from the tester to
PC-based record keeping systems at the touch of a button.
Comprehensive database software is available to ensure fast and easy download of test
results, managing your asset database, creation of test sequences, scheduling of
Preventative Product Maintenance and producing test certificates.
PC connection means that stored data can be transferred immediately and directly from
the tester to PC-based record keeping systems at the touch of a button.
1.1 Rigel 62353 Plus includes:
Calibration Certificate
Carrying Case
Earth bond test probe with clip
Earth bond clip lead
2-way Patient Applied Part lead
Detachable 2 meter mains cable
1.2 Optional Accessories
Med-eBase PC Download software (p/n 383A910)
RS232 download cable (p/n 331A952)
Single Applied Part leakage lead (p/n 331A953)

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1.3 Key Features
Hand-held - Using purpose designed robust enclosure, the Rigel 62353 Plus is truly
hand-held, easy to hold single handed thus enabling one hand operation and navigation
Easy to use - A full graphic, monochrome LCD display (1/4 VGA minimum) in
combination with an integral alpha-numeric ABCD-key-board.
Manual and Automatic test modes - Able to perform UTS (Unique Test Sequence)
and allows fully automatic, semi automatic and fully manual testing.
Versatile - Test in Accordance with the leakage requirements of
IEC/EN 62353 as well as;
NFPA (USA version)
AS/NSZ 3551 (Australian / New Zealand version)
Dedicated measuring devices are available according to IEC 60601 and AAMI
requirements
User definable test routines - Users have the ability to amend the default programs or
create new programs by copying the preset test programs. Each program will have a
unique Identifier.
Multiple Applied Part function - This feature gives the user the capability of testing up
to 2 individual Applied Parts from different Modules or classes e.g. BF and CF class, or
Bf ECG and Bf SPO2 module.
Internal Asset management facilities - Store up to 10,000 test records, custom test
routines, visual inspections and performance tests and download to and from PC via
RS232 Interface.