Rigel Medical 288+ User manual

rigelmedical.com
288+
USER MANUAL

RIGEL MEDICAL 288+USER MANUAL
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Limited Warranty & Limitation of Liability
Rigel Medical, 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+ 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 into service.
For information on service or calibration please go to the link below.
www.rigelmedical.com/calibration
Date received into service; / / .
© Copyright 2021
All rights reserved. Nothing from this edition may be reproduced, or made public in any
form, either electronically, mechanically, by photocopying, recording, or in any manner,
without prior written consent from Rigel Medical. This also applies to accompanying
drawings and diagrams.
Due to a policy of continuous development Rigel Medical 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 288+ 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.
User Notes
These operating instructions are intended for the use of adequately trained personnel.
Environmental Conditions
The 288+ has been designed to be operated for indoor use in a dry environment, at a
temperature of 0 to 40 degrees C without moisture condensation, and at an operating
altitude 0 2000m.
The 288+ has a protection rating of IP40 and is rated for operation at pollution degree 2
according to IEC 60529.

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Safety Notes
The following symbols are used in these operating instructions and on the Rigel 288+.
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.
Do not operate the 288+ in an explosive gas or dust environment.
The 288+ and all associated cables and leads must be checked for signs of
damage before equipment is operated. Do not use if there are signs of damage.
It must be assumed that safe operation is no longer possible:
•if the instrument or leads show visible signs of damage or
•the instrument does not function or
•after long periods of storage under adverse environmental conditions.
To verify the correct operation of the unit, perform test functions using a known
appliance or checkbox or return the unit to an approved agent for service.

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1. Introduction 7
1.1. Key Features 7
1.2. Rigel 288+ Includes: 8
1.3. Interfaces 9
1.4. Optional Accessories 10
1.5. Tes 10
1.6. Unique use of ICONS 11
2. Logging on 12
3. Getting Started 13
4. Automatic Mode 14
4.1. Asset ID 14
4.2. Test Codes 14
4.3. Test Period 15
4.4. Trace Variables 15
4.5. Performing an Automatic Test 15
4.5.1 Semi-Automatic Test Mode 15
4.6. Failure Menu 26
26
4.8. Options Menu 26
4.9. View Results 27
5. Manual Mode 28
5.1. Earth Continuity 30
5.2. Insulation Resistance EUT 31
5.3. Insulation Resistance Applied Parts 32
5.4. Insulation Resistance Applied Parts to Mains 34
5.5. Equipment Leakage (Direct) 34
5.6. Equipment Leakage (Differential) 36
5.7. Equipment Leakage (Alternative) 38
5.8. Applied Part Leakage (Direct) 39
5.9. Applied Part Leakage (Alternative) 40
5.10. Earth Leakage Test 42
5.11. Enclosure Leakage Test (mains powered) 43
5.12. Point to Point Enclosure Leakage Test (battery powered) 44
5.13. Patient Leakage 45

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5.14. Patient Leakage F-Type 47
5.15. Patient Auxiliary Current 48
5.16. Load Test 49
5.17. IEC Lead Test 50
6. Customising your tester 52
6.1. Test Sequences 52
6.1.1. User definable tests 53
6.1.2. View, Delete or Copy an existing Test Routine 53
6.1.3. Modifying (Edit) Existing Test Sequences 54
6.1.4. Edit individual Test 56
6.1.5. Insert an individual safety test 57
6.1.6. Insert a non-electrical safety test 59
6.1.7. Create a new Test Sequence 61
6.2. Test Codes 63
6.2.1. Create New Test Codes 63
6.2.2. Configuring the Applied Part Module 65
6.3. Asset Trace Variables 69
6.4. System Config 70
6.4.1. Asset ID 70
6.4.2 After Test 71
6.4.3. Comments 71
6.4.4. Applied Part Results 71
6.4.5. Language 72
6.4.6. Check IEC lead Polarity 72
6.4.7. Date / Time 72
6.5. Bluetooth Favourites 73
6.6. User Admin 76
6.6.1. Preferences 77
6.6.2. Change User 78
6.6.3. Change Password 79
6.6.4. User Profile 79
6.7. Memory Options 80
6.8. Restore Factory Settings 81
7. View Data 82

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7.1. View Results 83
7.2. Search the database 84
7.3. View Data Options 85
8. Data Transfer 86
8.1. Download to PC 86
8.2. Upload from PC 88
8.3. Configuration Data 88
8.3.1. Send Config Data 88
8.3.2. Receive Config Data 90
8.4. Clone Data 90
8.5. Load TnT Logo 91
9. About 92
10. Maintaining the Rigel 288 plus 93
10.1. Cleaning the Analyser 93
10.2. User Maintenance 93
10.3. Return Instructions 93
11. Technical Specifications 95
11.1 General Specifications 96
Appendix A Definition of IEC 60601 tests 97
A.1. Earth Continuity Tests 97
A.2. Earth Leakage Test 97
A.3. Enclosure Leakage Test 98
A.4. Patient Leakage 99
A.5. Patient Leakage F-Type 101
A.6. Patient Auxiliary Current 102
Appendix B Pass / Fail Limits of IEC 60601-1 104
Appendix C Definition of IEC 62353 tests 105
C.1. Earth Continuity Tests 105
C.2. Equipment Leakage 105
C.3. Applied Part Leakage 107
Appendix D Pass / Fail limits of IEC 62353 110
Appendix E IEC 60601-1 Measuring Device 111
Appendix F Firmware Route Map 112
Appendix H Connection diagram AP box 113

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1. Introduction
The Rigel 288+ 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+ can conduct 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+ has added two new insulation resistance tests (50VDC and 100VDC) to
complement the 250VDC and 500VDC insulation tests that were present in its
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+ 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+, a range of accessories,
including Bluetooth printers and barcode scanners are available.
The Rigel 288+ 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
•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

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1.2. Rigel 288+ Includes:

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1.3. Interfaces

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1.4. Optional Accessories
Med-eBase PC Download software (p/n 383A910)
RS232 download cable (p/n 331A952)
Single Applied Part leakage lead (p/n 331A953)
Bluetooth Barcode scanner (p/n 339A923)
(p/n 339A980)
(p/n 339A970)
10-way Applied part adaptor box (p/n 331A680)
1.5.
The Rigel 288 plus is compatible w
•Robust and durable labels
•Resistant to most solvents used in the medical sector
•Free opportunity to advertise your logo and company details or emergency
•Automatic barcode generation to provide easy use of the barcode scanner thus
speeding up your test time
Note:The unique
asset ID number, and person conducting the test. For more information on using the Test
.

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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
Print
Add
Less
Applied Parts
Repeat
Copy
Save
Delete
Search
Edit
Settings
Help
Single Fault
Menu List
Shift
Home
Mute
New
Sound
OK - PASS

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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).
Note:In case a password is lost, and the unit is blocked, please call our helpdesk on +44 (0)
191 5878701 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.

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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 Safety 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.

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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.
Note: 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, i.e. when the ASSET ID field is used to
enter the Model, description (i.e. 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
asset ID field and the
288 plus will automatically be configured to test that type of bed. Then simply overwrite
This can be repeated if .
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 0 more information on Test Codes.)

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Test Sequence
The Rigel 288 plus comes standard with preset test routines to meet the requirements of:
•IEC 60601-1
•IEC 62353
•AAMi (US version)
•NFPA-99 (US version)
•VDE 0701 / 0702
•IEC 61010 test sequences can be programmed.
In addition, the user can create a total of 50 preset test sequences to meet local or specific
requirements. (See 0 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 0, 0 and Error! Reference s
ource not found. for more information)
4.5. Performing an Automatic Test
The automatic mode provides an option to test in full automatic or semi automatic 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.
Note: See Application notes at www.rigelmedical.com 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).
Note: 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.

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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 Safety 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 Error! Reference source not f
ound.)
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.

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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 0 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 0 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.

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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 0) will not appear during the automatic tests.
Note: 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),
•Earth bond 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 following the successful safety test.
The Applied Part Configuration is set to default and the test is executed in Semi-
Automatic mode.

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Visual Test:
This is the first test in the test sequence;
Press the corresponding appropriate button to select the outcome of the visual test.
Note: Custom Visual tests can be created. See 0 for more information.
If one or more Visual tests result in a failure, a Failure menu will appear.
Provided the test has Passed, the next test will be the Earth Continuity
Attention!Ensure the earth bond test lead is connected to the lower (black) 4 mm
socket when testing between probe and EUT earth.
Press the Calc button (F2) to calculate the pass fail limit based on the type of cable (mm²)
and cable length.
Pressing the button (F3) will bring up the failure menu (see 0)
Press the Green start key to start the earth continuity test.