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.

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1.4 Interfaces
1) Alpha Numeric keyboard, Up / Down and Left / Right cursor control.
2) 4 Programmable soft keys below display
3) Larger Green and Red key
4) Full graphic Monochrone LCD, blue with white backlit, 1/4 VGA
5) EUT socket to meet local requirements
6) IEC input socket (IEC lead test)
7) Custom detachable mains cable inlet
8) 2 way Applied Part adapter box (see Appendix F for connection diagram)
9) 4mm Earth bond probe socket (Black)
10)4 mm Earth bond Auxiliary socket (Green)
11)RS232 connection

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1.5 Unique use of ICONS
The Rigel 62353 Plus features a hi resolution graphic back lit display which not only
provides highly visible and easy to follow menu structures but also allows the user to
operate the tester using intuitive icons to speed up their test routines.
Below are of some of the icons used in the Rigel 62353 Plus:
Escape
Add
Applied Parts
Copy
Delete
Edit
Help
Menu –List
Home
New
OK –PASS
Print
Less
Repeat
Save
Search
Settings
Single Fault
Shift
Mute
Sound

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2 Setting-up your tester
The Rigel 62353 Plus is designed to allow the user to customise the device to allow
default setting in order to speed up the testing such as, default lists of manufacturers,
model numbers, user test protocols, automatic printing following test, fault menu’s and
so on.
All custom facilities can be found under the SETUP menu. Simply press the [F4]
from the home screen and select Setup from the menu.
The underlined character acts as a short key to allow swift navigation
through the menu structure.
Available options
Test Sequences Modify or create test sequences (see 2.1)
Asset Trace Variables Generate default list of variables (see 2.2)
Systems Config Configure default test options (see 2.3)
Change User Setup users and preferences (see 2.4)
Restore Factory Settings Defaults the tester to factory settings (see 2.5)
About Identifies the equipment’s serial number, firmware
and hardware revisions. (see 2.6)
2.1 Test Sequences
The Rigel 62353 Plus can be set-up to create new test sequences to meet local
requirements or to modify existing test sequences to meet personal preference.
The preset Test Sequences are according to the applicable medical standard. Preset
test sequences cannot be changed by the user, however alterations are possible by
producing a copy of the default test sequence setting.

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2.1.1 User definable tests
This feature gives the Rigel 62353 Plus the capability of recording user defined visual
inspections, checks or tests including measurements from SPO2, ECG, NIBP, Defib,
Infusion, Ventilation, Pressure etc.
The input is text only as no measurements are performed by the Rigel 62353 Plus
during these tests. The user can enter questions or instructions followed by either a
PASS/FAIL result or alpha numeric input. Preset engineering units e.g. %, Joules,
mmHg, PSI, CmH2O etc are available.
2.1.2 View, Delete or Copy an existing Test Routine.
Preset test sequences cannot be deleted or changed by the user however, alterations
are possible by producing a copy of the default test sequence.
To enter the Test Sequences menu, click on , followed by Setup. Select the Test
Sequences from the list and press (F4).
The following overview is provided and shows the list of default and customised test
sequences availble. Copied Test Sequences will appear in the list with an *pre-fix.

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From this menu, the user is able to View a test sequence by pressing the View button
(F4). Default test settings cannot be altered at any stage.
To Copy or Delete an existing or default test sequence, use the Up & Down arrow keys
to highlight the test sequence and press the button (F2).
Use the Up & Down Arrow keys to select the required action and press the
(F4) to confirm. Press Escape (F3) to cancel and return to previous screen.
Copied Test Sequences will appear in the list with an *pre-fix. All Copied test
Sequences can be edited. See 3.1.3 for more on editing test sequences.
Delete Sequence will remove the highlighted test sequence from the memory of the
Rigel 62353 Plus.
Default Test Sequences cannot be Deleted.
2.1.3 Modifying (Edit) Existing Test Sequences
Preset test sequences cannot be modified by the user, however alterations are possible
by producing a copy of the default test setting (see 2.1.2).
Non-default Test Sequences can be modified from the Test Sequences menu. When
non-default Test Sequences are highlighted, the (F4) will appear in the menu
screen.

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Pressing the button (F4) will open the Test Sequence for Editing as shown
below;
To change the Name and or Class of the Test Sequence, press the Button (F4)
and enter the Name and or Class required.

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To change to upper or lower case or use language specific characters, press the
button (F1) and select the required entry.
To Delete a character, press the button (F2)
To return to the previous menu without changes, press the button (F3)
To confirm the entry, press the button (F4)
Confirm the changes with the button (F3) or cancel using the button
(F4).
To Insert a new test, highlight the test using the Up & Down arrow keys and press the
Insert button (F1)
To Delete an individual test, highlight the test using the Up & Down arrow keys and
press the button (F2)
To go back to the previous menu, highlight the test using the Up & Down arrow keys
and press the button (F3)
To modify an individual test, highlight the test using the Up & Down arrow keys and
press the Button (F4)

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2.1.4 Edit individual Test
Press the button (F4) as shown above. The sub menu will allow you to alter the
settings for; Test duration, Mains Limit, Single Fault Limit, Neutral Open*, Earth Open*,
Mains Reversal*.
Default test sequences have the appropiate Single Fault Conditions set to
meet the Standard Requirements. For specifc use, Single Fault Conditions
could be de-activated by selecting the drop down box using the up and
down keys and highlight the drop down box. Change the content using the
left and right keys.
Highlight the required field using the up and down keys. To change the content either
use the left and right keys or use the keypad to enter the correct data. To Delete the
field content, press the button as shown below.

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When the right settings have been achieved, press the button (F4) to save the
changes or press (F3) to return to the previous menu without changes.
Repeat this action for every test that requires editing. Once all the requires tests are
programmed, press (F3) to exit.
2.1.5 Insert an individual safety test
To insert an individual safety test we use the up and down keys to highlight the position
where a new test needs inserting and press the Insert button (F1) from the menu below.
Tests will be inserted before the highlighted position not after.
To modify a test sequence, please refer to 2.1.3.

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Once the Insert button (F1) has been pressed, a drop down box will appear with all
available safety and inspection tests. Activate the drop down box using the left key and
or scroll through the available tests using the up and down keys.
Once the desired test has been highlighted, confirm using the OK button (F4) and finally
confirm to insert into the test Sequence. Pressing the button (F3) will return to
the previous screen without changes being made.
The individual test has now been inserted and can be edited as described in 2.1.4.
Further electrical safety tests can be inserted or deleted by following the steps
described herein.
Proceed with non-electrical safety tests as described in the following or save the new
Test Sequence by following the steps below.
2.1.6 Insert a non-electrical safety test
Non-electrical safety tests are intended to allow the user to capture additional
information either prior to or after a safety test is completed. Such information could