Rigel Medical SafeTest 50 User manual

rigelmedical.com
SafeTest 50
USER MANUAL

RIGEL MEDICAL SafeTest 50 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 SafeTest 50 hand-held electrical safety analyzer 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 is not affected 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.
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 SafeTest 50 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 SafeTest 50 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 SafeTest 50 has a protection rating of IP40 and is rated for operation at pollution
degree 2 according to IEC 60529.
The following symbols are used in these operating instructions and on the Rigel SafeTest
50.

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Safety Notes
If the SafeTest 50 is used in a manner not specified by these operating
instructions, then the protection provided may be impaired.
Only accessories recommended or approved by the manufacturer should be used
with the SafeTest 50.
Do not connect the SafeTest 50 to electrical circuits with nominal voltage greater
than CAT II 300 V AC/DC.
Do not touch test probes beyond the hand barrier on the test probe.
The SafeTest 50 may apply high voltage or mains power to the appliance under
test. Do not touch conductive parts of the appliance while tests are active.
Do not open the SafeTest 50, no user serviceable parts
Do not operate the SafeTest 50 in an explosive gas or dust environment.
The SafeTest 50 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.
Where safe operation of the SafeTest 50 is no longer possible it should be
immediately shut down and secured to prevent accidental operation
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 5
1.1. Key Features 5
1.2. Rigel SafeTest 50 Includes: 6
1.3. Interfaces 7
1.4. Optional Accessories 8
1.5. Unique use of ICONS 8
2. Getting Started 10
2.1. Setting your Language and Preferred Test Standard 10
3. Ground Bond Testing 12
4. NFPA-99 Leakage Testing 14
5. AAMI ES 60601 Leakage Testing 16
6. IEC 62353 Leakage Testing 18
7. IEC 61010 Touch Leakage & Voltage Testing 20
8. Displaying Mains Voltage, Frequency and Load Current 22
9. Minimise your Power Breaks in IEC 60601 23
10. Point to Point Testing 24
11. Warning Messages 25
12. About 26
13. Maintaining the Rigel SafeTest 50 27
13.1. Cleaning the Analyzer 27
13.2. User Maintenance 27
13.3. Return Instructions 28
14. Technical Specifications 29
14.1. General Specifications 30
15. Environmental Conditions 30
Appendix A Pass / Fail Limits 31
A.1. NFPA 99 31
A.2. ES 60601 31
A.3. IEC 62353 32
A.4. IEC 61010 32
Appendix B ES 60601-1 Measuring Device 33

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1. Introduction
The Rigel SafeTest 50 is a dedicated medical safety analyzer, ideal for testing high
volumes of basic medical and laboratory equipment. A robust and reliable design ensures
that the SafeTest 50 can withstand a busy schedule of testing medical equipment that
does not require patient
centrifuges, etc.
tests with a single key press, while a fast step-through of the test routine makes the
testing process speedy and dependable. Though physically small, the SafeTest 50
includes a range of safety tests to enable compliance with a range of international safety
standards, including leakage testing to NFPA-99, AAMI ES 60601, IEC 62353 and 61010,
ground bond testing to NFPA-99, IEC 62353 and 61010 (Annex F).
Full manual control offers the benefit of executing only those specific tests that are
required and provide the user with full control of the power cycles, making testing simple,
easy and fast. An automatic warning of secondary ground paths ensures users are made
aware when invalid readings are made, thus ensuring correct and accurate test results first
time, every time.
1.1. Key Features
•Compact, robust and portable design
•Fast step-through of test routines with minimised power breaks
•Manual control of fault conditions
•Tests to a range of international standards including IEC 60601, 62353, 61010
and NFPA-99
•Large, highly visible color display
•Secondary earth warnings to ensure valid test setup
•Accurate high current, low energy ground bond testing
•Supplied with free, protective carry case
•Multi voltage - operates on any mains supply between 90-264V / 48-64Hz

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1.2. Rigel SafeTest 50 Includes:

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1.3. Interfaces
Point to point
auxiliary probe.
Ground bond
and chassis
leakage probe.
EUT socket,
90-264 VAC,
48-64Hz
Mains inlet
90-264 VAC
48-64Hz
Function
keys F1-F5
Single Fault
Open Earth
Open Neutral
Mains
Start, Stop,
Reversed keys

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1.4. Optional Accessories
Ground bond cable 44B154
Carry case 410A950
1.5. Unique use of ICONS
The Rigel SafeTest 50 features a high resolution color graphic back lit display provides a
unique user experience and to help guide the user through the different test steps.
Below are of some of the icons used in the Rigel SafeTest 50:
Select Ground Bond Testing
Select Leakage Testing
Select Point to Point Testing
Select Settings menu (change Language and Test Standard)
Select to the required standard
Change to the required language
Product information, serial number
Confirm / OK
Display Line voltage, frequency and load current
Applies normal mains to EUT
Applies reversed mains to the EUT
Interrupts mains to EUT

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Warning, EUT socket live
Select Ground leakage (in IEC60601 setting)
Select Chassis leakage (in IEC60601 setting)
Select Touch Leakage (in IEC61010 setting)
Select Touch Voltage (in IEC61010 setting)
Open Earth single fault condition key
Open Neutral single fault condition key
Ground bond test lead compensated
Ground bond test running
Go to Home screen

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2. Getting Started
The Rigel SafeTest 50 is pre-programmed to perform electrical safety tests in accordance
with a variety of international standards. To get started, simply follow these instructions;
Switch ON:
To switch on the Rigel SafeTest 50, please insert the mains cable to the power inlet, the
SafeTest 50 will automatically power up in the HOME SCREEN.
2.1. Setting your Language and Preferred Test Standard
From the home screen, select Settings to select the required language and test standard;
Settings menu
Press from Home screen to enter Settings menu;
Press the key to change to the required language
Press the key to change to the required test standard
Press the key to view the firmware and hardware information
Press the key confirm and return to the Home menu

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Note: The Rigel SafeTest 50 will store the most recent settings in the Settings menu.
From the Home screen, select the required test;
To select Ground bond Testing
To select Leakage Testing
To select Insulation Testing
To select Point to Point Testing
To select Settings Menu (change Language and Test Standard)

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3. Ground Bond Testing
To perform a ground bond test, select the icon from Home screen.
The SafeTest 50 will automatically start the test when it is selected and will automatically
stop by pressing the Leakage, Point To Point or Home icon.
Connection Between EUT and SafeTest 50;
Ground bond Testing
Note: Each time the ground bond probe is placed on a new test point, the zap circuit will
be reactivated, ensuring accurate readings at every measurement point.
Do not exceed the maximum permitted voltage of 30 V AC/DC with respect to
earth potential! Electric Shock danger!
To compensate for the test cable resistance, connect the test cable between the black
Ground bond socket and the EUT earth, then press the button on the front panel.
When the lead compensation is activated, the icon will appear on the screen.
M
M

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To remove the lead compensation, remove the probe and press the button.
When different ground bond cables are used, the Null function must be repeated
for each different cable.
Note: Switching off the Rigel SafeTest 50

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4. NFPA-99 Leakage Testing
To perform an NFPA-99 leakage test, press from Home screen to enter Leakage test.
If the required test standard needs to change, please press Home and see 2.1.
To apply mains voltage in Normal Polarity and START the test, press the button on
the front panel. The test will run until the button is pressed.
To apply mains in Reversed Polarity and START the test, press the button on the front
panel. The test will run until the button is pressed.
To minimise the power breaks during your tests, please see 8.
will appear on the screen when the DUT socket is activated.
Connection Between EUT and SafeTest 50;
Ground Leakage NFPA-99
When the Safetest 50 is set to test to NFPA-99, the will go to Chassis leakage and
to Ground leakage.
M
M

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To activate single fault conditions, use the and buttons on the front panel.
opens the Earth fault condition relay whilst the opens the Neutral fault condition
relay.
The leakage screen will indicate the current state of the selected fault conditions;
Connection Between EUT and SafeTest 50;
Chassis Leakage NFPA-99
For All Applied Parts
Leakage Current Type
NC
SFC
Ground Leakage
0.3mA
1mA
Chassis Leakage
0.1mA
0.5mA
M
M

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5. AAMI ES 60601 Leakage Testing
To perform an ES 60601 leakage test, press from Home screen to enter Leakage test.
If the required test standard needs to change, please press Home and see 2.1.
To apply mains voltage in Normal Polarity and Start the test, press the button on the
front panel. The test will run until the button is pressed.
To apply mains in Reversed Polarity and Start the test, press the button on the front
panel. The test will run until the button is pressed.
To minimise the power breaks during your tests, please see Error! Reference source not f
ound.8.
will appear on the screen when the DUT socket is activated.
Connection Between EUT and SafeTest 50;
Ground Leakage
When the Safetest 50 is set to test to IEC 60601, the will go to Enclosure Leakage and
to Ground Leakage.

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To activate single fault conditions, use the and buttons on the front panel.
opens the Earth fault condition relay whilst the opens the Neutral fault condition
relay.
The leakage screen will indicate the current state of the selected fault conditions;
Connection Between EUT and SafeTest 50;
Enclosure Leakage
All Applied Parts
Leakage Current Type
NC
SFC
Ground Leakage (3rd edition) *
5mA
10mA
Ground Leakage (General)
0.5mA
1mA
Enclosure Leakage
0.1mA
0.5mA
* The pass-fail limit for Ground Leakage in the 3rd edition of IEC 60601 has been increased
from 500μA under normal condition to 5000μA for class I equipment with NO exposed
metal parts that may become live when a fault appears.
M

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6. IEC 62353 Leakage Testing
To perform an IEC 62353 leakage test, press from Home screen to enter Leakage test.
If the required test standard needs to change, please press Home and see 2.1.
To apply mains voltage in Normal Polarity and START the test, press the button on
the front panel. The test will run until the button is pressed.
To apply mains in Reversed Polarity and START the test, press the button on the front
panel. The test will run until the button is pressed.
To minimise the power breaks during your tests, please see chapter 9.
will appear on the screen when the DUT socket is activated.
When the Safetest 50 is set to test to IEC 62353, the Single Fault buttons and are
deactivated in order to perform the test as per IEC 62353 requirements.
Connection Between EUT and SafeTest 50;
Equipment Leakage IEC 62353
M
M

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Current in µA (RMS)
All Applied Parts
Equipment leakage direct method.
•Class I Equipment
•Class II Equipment (touch current)
0.5mA
0.1mA