Rigel 288 PLUS User manual

Innovating Together
RIGEL 288 PLUS
electrical safety analyser
Copyright © 2016SEAWARD GROUP
Last Update: 20th April 2016
Instruction Manual
406A556 Revision 1.1

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 288 plus Plus hand-held 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; / / .
© 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.

Rigel 288 plus Instruction Manual –Revision 1.12
Disposal of old product
The Rigel 288 plus 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.

Rigel 288 plus Instruction Manual –Revision 1.13
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 288 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".

Rigel 288 plus Instruction Manual –Revision 1.14
Index
1. Introduction_______________________________________________________ 8
1.1. Key Features ________________________________________________________ 8
1.2. Rigel 288 plus includes:________________________________________________ 9
1.3. Interfaces__________________________________________________________ 10
1.4. Optional Accessories_________________________________________________ 11
1.5. Test ’n Tag Compatible _______________________________________________ 11
1.6. Unique use of ICONS_________________________________________________ 12
2. Logging on _____________________________________________________ - 13 -
3. Getting Started _________________________________________________ - 14 -
4. Automatic Mode ________________________________________________ - 15 -
4.1. Asset ID _________________________________________________________ - 15 -
4.2. Test Codes _______________________________________________________ - 15 -
4.3. Test Period_______________________________________________________ - 16 -
4.4. Trace Variables ___________________________________________________ - 16 -
4.5. Performing an Automatic Test: ______________________________________ - 16 -
4.5.1. Semi Automatic Test Mode __________________________________________ - 16 -
4.6. Failure Menu _____________________________________________________ - 27 -
4.7. Test ‘n Tag _______________________________________________________ - 27 -
4.8. Options Menu ____________________________________________________ - 27 -
4.9. View Results _____________________________________________________ - 28 -
5. Manual Mode __________________________________________________ - 29 -
5.1. Earth Continuity __________________________________________________ - 31 -
5.2. Insulation Resistance EUT___________________________________________ - 33 -
5.3. Insulation Resistance Applied Parts ___________________________________ - 34 -
5.4. Insulation Resistance Applied Parts to Mains ___________________________ - 35 -
5.5. Equipment Leakage (Direct) _________________________________________ - 36 -
5.6. Equipment Leakage (Differential) ____________________________________ - 37 -
5.7. Equipment Leakage (Alternative)_____________________________________ - 39 -
5.8. Applied Part Leakage (Direct)________________________________________ - 40 -
5.9. Applied Part Leakage (Alternative) ___________________________________ - 41 -
5.10. Earth Leakage Test ________________________________________________ - 43 -
5.11. Enclosure Leakage Test (mains powered) ______________________________ - 44 -
5.12. Point to Point Enclosure Leakage Test (battery powered) _________________ - 45 -
5.13. Patient Leakage___________________________________________________ - 46 -

Rigel 288 plus Instruction Manual –Revision 1.15
5.14. Patient Leakage –F-Type ___________________________________________ - 48 -
5.15. Patient Auxiliary Current ___________________________________________ - 49 -
5.16. Load Test ________________________________________________________ - 50 -
5.17. IEC Lead _________________________________________________________ - 51 -
6. Customising your tester __________________________________________ - 53 -
6.1. Test Sequences ___________________________________________________ - 53 -
6.1.1. User definable tests _________________________________________________ - 54 -
6.1.2. View, Delete or Copy an existing Test Routine._________________________ - 54 -
6.1.3. Modifying (Edit) Existing Test Sequences______________________________ - 55 -
6.1.4. Edit individual Test__________________________________________________ - 57 -
6.1.5. Insert an individual safety test ________________________________________ - 58 -
6.1.6. Insert a non-electrical safety test______________________________________ - 59 -
6.1.7. Create a new Test Sequence_________________________________________ - 62 -
6.2. Test Codes _______________________________________________________ - 64 -
6.2.1. Create New Test Codes _____________________________________________ - 64 -
6.2.2. Configuring the Applied Part Module __________________________________ - 66 -
6.3. Asset Trace Variables ______________________________________________ - 69 -
6.4. System Config ____________________________________________________ - 70 -
6.4.1. Asset ID ___________________________________________________________ - 71 -
6.4.2. After Test __________________________________________________________ - 71 -
6.4.3. Comments _________________________________________________________ - 72 -
6.4.4. Applied Part Results ________________________________________________ - 72 -
6.4.5. Language__________________________________________________________ - 72 -
6.4.6. Check IEC lead Polarity _____________________________________________ - 72 -
6.4.7. Date / Time ________________________________________________________ - 73 -
6.5. Blue Tooth Favourites______________________________________________ - 73 -
6.6. User Admin ______________________________________________________ - 77 -
6.6.1. Preferences ________________________________________________________ - 78 -
6.6.2. Change User _______________________________________________________ - 79 -
6.6.3. Change Password __________________________________________________ - 79 -
6.6.4. User Profile ________________________________________________________ - 80 -
6.7. Memory options __________________________________________________ - 80 -
6.8. Restore Factory Settings ____________________________________________ - 81 -
7. View Data _____________________________________________________ - 83 -
7.1. View Results _____________________________________________________ - 84 -
7.2. Search the database _______________________________________________ - 85 -
7.3. View Data Options ________________________________________________ - 86 -
8. Data Transfer __________________________________________________ - 87 -
8.1. Download to PC___________________________________________________ - 87 -
8.2. Upload from PC ___________________________________________________ - 89 -
8.3. Configuration Data ________________________________________________ - 89 -
8.3.1. Send Config Data___________________________________________________ - 89 -
8.3.2. Receive Config Data ________________________________________________ - 91 -
8.4. Clone Data _______________________________________________________ - 92 -

Rigel 288 plus Instruction Manual –Revision 1.16
8.5. Load TnT Logo ____________________________________________________ - 92 -
9. About _________________________________________________________ - 94 -
10. Maintaining the Rigel 288 plus___________________________________ - 95 -
10.1. Cleaning the Analyser ______________________________________________ - 95 -
10.2. User Maintenance_________________________________________________ - 95 -
10.3. Return Instructions. _______________________________________________ - 95 -
10 Technical Specifications __________________________________________ - 97 -
Appendix A Definition of IEC 60601 tests______________________________ - 100 -
Appendix B Pass / Fail Limits of IEC 60601-1 ___________________________ - 107 -
Appendix D Pass / Fail limits of IEC 62353 _____________________________ - 113 -
Appendix E IEC 60601-1 Measuring Device ____________________________ - 114 -
Appendix F Firmware Route Map ___________________________________ - 115 -
Appendix G Available Application Notes ______________________________ - 116 -
Appendix H Connection diagram AP box ______________________________ - 117 -

Rigel 288 plus Instruction Manual –Revision 1.17
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 288
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 G.

Rigel 288 plus Instruction Manual –Revision 1.18
1. Introduction
The Rigel 288 plus+ electrical safety analyzer offers an accurate and fast solution for
meeting international and local safety standards. Offering a complete range of tests
without the need for mains power, the 288 plus+ is capable of conducting battery-
powered insulation and earth/ground bond testing as well as touch and point-to-point
leakage testing. This offers complete freedom to move around in often crowded rooms
during the installation process, eliminating the inconvenience of trailing mains cables.
The 288 plus+ has added two new insulation resistance tests (50VDC and 100VDC) to
complement the 250VDC and 500VDC insulation tests that were present in its
predecessor, the Rigel 288 plus. These new tests conform to growing manufacturer’s
test requirements for increasingly popular equipment running on 24VDC and 48VDC,
such as operating tables, lights and mobile X-rays.
Combining automatic and manual test sequences, data storage and direct printing
facilities, the Rigel 288 plus+ remains the most compact electrical safety analyzer of its
kind. Automatic warning of secondary earth/ground paths ensures users are made
aware when invalid readings are made, thus ensuring correct and accurate test results
first time, every time.
To further improve the portability and flexibility of the 288 plus+, a range of accessories,
including Bluetooth printers and barcode scanners are available.
The Rigel 288 plus+ is available in a wide range of power configurations to suit local
requirements, and conforms to several international standards including IEC 62353,
60601-1, NFPA-99 and many other local variants
The comprehensive database software, Med-eBase, ensures fast and easy download of
test results, straightforward management of asset databases, creation of test
sequences and the ability to produce professional test certificates.
1.1. Key Features
Versatile - Test in Accordance with the leakage requirements of
All-in-one compliance with international standards
including IEC / EN 62353, AAMI / IEC / EN
60601-1, IEC 61010, NFPA-99, AS / NZ 3551
Built-in electronic data storage and automated
testing reduce paperwork and saves time
Flexible user-definable test routines to meet the needs of your organisation
Small and compact with direct printing via Bluetooth connectivity
Battery-powered leakage, insulation and earth/ground bond tests enable faster
and more convenient testing
50 / 100 / 250 / 500 VDC insulation testing allows testing on equipment running
on 24VDC and 48VDC up to 253VAC
Automatic secondary verification ensures the correct result first time
Accurate high current, low energy bond testing

Rigel 288 plus Instruction Manual –Revision 1.19
1.2. Rigel 288 plus includes:

Rigel 288 plus Instruction Manual –Revision 1.110
1.3. Interfaces

Rigel 288 plus Instruction Manual –Revision 1.111
1.4. Optional Accessories
Med-eBase PC Download software (p/n 301A920)
RS232 download cable (p/n 331A952)
Single Applied Part leakage lead (p/n 331A953)
Bluetooth Barcode scanner (p/n 339A923)
Bluetooth Test ‘N’ Tag Pro (p/n 339A980)
Bluetooth Test ‘N’ Tag Elite System (p/n 339A970)
10-way Applied part adaptor box (p/n 331A680)
1.5. Test ’n Tag Compatible
The Rigel 288 plus is compatible with the Seaward Test ‘n Tag and Elite system. Our
Test ‘n Tag systems allows you to print customised Thermal PASS / FAIL labels.
The benefits of using the Test ‘n Tag printers are:
Robust and durable labels
Resistant to most solvents used in the medical sector
Free opportunity to advertise your logo and company details or emergency
telephone number with every item you Test ‘n’ Tag.
Automatic barcode generation to provide easy use of the barcode scanner thus
speeding up your test time.
The unique Test ‘n’ Tag label provides test status and retest due date,
barcode and asset ID number, and person conducting the test. For more
information on using the Test ‘n Tag printer, see section 4.7.

Rigel 288 plus Instruction Manual –Revision 1.112
1.6. Unique use of ICONS
The Rigel 288 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 288 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

Rigel 288 plus Instruction Manual –Revision 1.1- 13 -
2. Logging on
When switching on the Rigel 288 plus, the user will be able to log-in to allow for specific
default user preferences and to provide traceability of test results. To increase the
security and protection of the user, a password can be set prior to using the Rigel 288
plus. See 6.6.3 for further details. The default password setting is OFF and the login
screen will not require a password. In case a user and password are set, the tester will
default to the last user / password.
To change the user, use the drop down menu provided [<>] and select the new user. In
case a password is set for the new user, please enter the password (case sensitive).
In case a password is lost and the unit is blocked, please call our helpdesk
on: [phone] or contact your local distributor and quote the 8-
digit code (shown below the password field) and the serial number of the
tester to allow a temporary password being created. For security reasons,
passwords can only be provided to the original purchaser of the device.
The Rigel 288 plus is designed to allow a user to customise test sequences and allow
default settings. This customisation can speed up testing by providing the user with
default manufacturer lists, model numbers, user text protocols, automatic printing post-
text and fault menus.

Rigel 288 plus Instruction Manual –Revision 1.1- 14 -
3. Getting Started
1) Setting the correct language: See chapter 6.4.5
2) Setting the correct time and date: See chapter 6.4.7
3) Start automatic safety test See below
The Rigel 288 plus is pre-programmed to perform electrical safety tests in
accordance with a variety of international standards. To start an automatic safety
test, simply
Press the button (F4) from the home screen and select Auto Mode. This
will show the Asset Details screen as detailed below;
Select the right criteria for the Satety Test from the Asset Details screen;
Enter the Asset ID number using the keypad or barcode scanner.*
Use the up, down, left and right keys to select the required default Test
Sequence
Select the Run Mode (Semi or Full Automatic) using the up, down, left
and right keys. See 4.5.1
Configure the Applied Part module when required by pressing the
button (F1). See 4.5 point 6
When all parameters are set, press the button (4) to enter
(optionally) information about the asset such as make model etc. See 4.4
for more details.

Rigel 288 plus Instruction Manual –Revision 1.1- 15 -
4. Automatic Mode
The Automatic mode provides the user with the ability to run a preset test sequence and
store the data afterwards.
4.1. Asset ID
Each test record is stored using the Asset ID number (25 character max) and date /
time of test. Multiple entries can be applied using the same Asset ID number. In this
case, the memory will hold all entries and differentiate using the test date.
The Asset ID field is used to store (and identify) the record in the Rigel
288 plus database. Additional input fields, referred to as ASSET TRACE
VARIABLES are available to distinguish between identical Asset ID
records, ie when the ASSET ID field is used to enter the Model,
description (ie “bed”, “ECG5” etc) or 4 digit fast code.
The benefit of using the Rigel 288 plus in this way is that similar items can be easily
retested using the same parameters. When an existing ASSET ID is entered in the 288
plus, the tester will automatically configure itself to re-perform the test without any
additional settings being required. Once the 288 plus has loaded the previous test
settings, the user can reconfirm the correct ASSET ID.
Example:
The user sets the Rigel 288 plus to test a hospital bed, when the correct test settings
are entered (test sequence, and applied parts, enter “bed” in the asset ID field.
Continue to the next screen and enter the “fixed” asset variables like description and
make model etc. Perform a full test. The next time you test a bed, enter “bed” in the
asset ID field and the 288 plus will automatically be configured to test that type of bed.
Then simply overwrite “bed” with the ASSET ID and your safety test will be saved under
the correct ID number. This can be repeated as long as the record “bed” is not deleted.
Identical ASSET RECORDS are also differentiated by TIME/DATE stamp, thus
ensuring no records are overwritten.
4.2. Test Codes
Instead of using the example above, users can also increase efficiency by using the 4-
digit Test Codes which allow the user to group certain Test Sequences with Applied
Part Configurations. See 6.2 more information on Test Codes.)
Test Sequence
The Rigel 288 plus comes standard with preset test routines to meet the requirements
of:

Rigel 288 plus Instruction Manual –Revision 1.1- 16 -
IEC 60601-1
IEC 62353
AAMi (US version)
NFPA-99 (US version)
VDE 0701 / 0702
IEC 61010 test sequences can be programmed. See Appendix G
for available application notes.
In addition, the user can create a total of 50 preset test sequences to meet local or
specific requirements. (See 6.1 more information on creating new test sequences)
4.3. Test Period
The re-test period allows the user to include the next test date on printed labels and PC
downloads that make it easier to schedule future work. More details on printing labels
see 4.2)
4.4. Trace Variables
To increase the traceability of the safety test, the user can include valuable data with
the test record such as Re-test period and Asset variables (see 6.3, 6.4.1 and 4.1 for
more information)
4.5. Performing an Automatic Test:
The automatic mode provides an option to test in full automatic or semi autoatic mode.
In full automatic mode, the Rigel 288 plus will step through the non powered tests and
once the powered tests (load and leakage tests) have started, all test conditions
including single fault conditions are executed automatically without the required
intervention of an operator.
See Application notes for suggestions when testing on isolated mains
supply or fixed installations.
4.5.1. Semi Automatic Test Mode
When testing Medical Devices, it is important that measurements are taken when the
Equipment Under Test (EUT) is fully operational (a requirement of IEC 60601-1 and
subsequent standards).
The Rigel 288 plus has a unique Semi Automatic Mode that allows
manual control of power-up and power-down of the EUT as well as
controlling the test sequence. This ensures that correct measurements
are performed and provide sufficient time to power-down any device
which is sensitive to power-breaks e.g. Ultrasound Equipment and PC
based ME Equipment.

Rigel 288 plus Instruction Manual –Revision 1.1- 17 -
Below is a graph highlighting the Grouping of Single Fault Conditions (booox) and the
delays which are manually controlled by the User (ta, tb, tc& td) and the time in which the
safety analyser performs the automatic test routines.
The following procedures describe the setup and completion of an automatic test
sequence. The steps are applicable to all available test sequences. As example we
describe a typical automatic test to IEC 60601.
Press the button (F4) from the home screen and select Auto Mode. This will show
the Asset Details screen as detailed below;
Select the right criteria for the Satety Test from the Asset Details screen;
1. Enter the Asset ID number using the keypad or barcode scanner.
2. Enter the Test Code if this has been created (see 4.2)
3. Use the up, down, left and right keys to select the required Test Sequence
4. Select the Run Mode (Semi or Full Automatic) using the up, down, left and right
keys.
5. Enter the required test period in months.

Rigel 288 plus Instruction Manual –Revision 1.1- 18 -
6. Configure the Applied Part module when required by pressing the
button (F1).
The following screen presents a default setup for:
10 x type CF (1..10)
To configure the Applied Part Module to meet your requirements, please see 4.5
for more information.
When the configuration has been completed, press the button (F4).
Pressing the button (F3) would return to the previous screen and lose
the settings.
7. Returning to the Asset Details screen, the button (F2) provides the user
with the option to modify or create a new Test Sequence from this menu. This
feature is identical to that of the Test Sequence feature in the Setup - Test
Sequence menu. (See 6.1 for more information)
When all parameters are set, press the button (4) to enter the Asset Trace
Variables screen (when applicable). In this example, all Asset Variables are activated.

Rigel 288 plus Instruction Manual –Revision 1.1- 19 -
8. Use the Up & Down Keys to navigate the menu and the Left & Right Keys to
open the drop down boxes [<>]. Select the required input and confirm with the
button (F4). Each variable entered during the automatic test will
automatically be added to the list for future use. Trace Variables that are de-
activated (set to NO in the Setup menu, section 6.3) will not appear during the
automatic tests.
A maximum of 40 individual entries are available for each Trace
Variable. Additional entries will overwrite on a first in first out basis.
When all information is provided, press the button (F4) to start the safety test.
To ensure the safety of the user, non-electrical tests are done prior to the powered
electrical safety tests.
Non-powered tests are deemed;
Visual and Custom tests (if applicable),
Earthbond test (class I)
Insulation test (if applicable)
In this example we will perform a safety test on Class I equipment, using a preset test
sequence, based on IEC 60601-1 with added Visual Test prior to the safety test and a
Custom Test followin the successful safety test.
The Applied Part Configuration is set to default and the test is executed in Semi
Automatic mode.