SMBE 3423 CLINICAL

ENGINEERING
ELECTRICAL SAFETY TEST

School of Biomedical Engineering and Health

Sciences

Faculty of Engineering
Topic : Electrical Safety Test
Lecturer : Dr. Arief Ruhullah Haris
Section : 02
Group No. :6
Group : Pavitra a/p Saravanabavan (A15MB4004)
Member : Mohamad Ajma'in Bin Mohamed Arbi (A16MB0094)
: Muhammad Khairul Asyraf Bin Suaimi (A16MB0117)
: Nurdania Binti Abdul Rahman (A15MB0225)
: Umar Mahfudz Bin Md Ashari (A17MB0241)
: Abdullah Nasir Ahmed (A15MB4004)
: Raihanah Syahirah binti Mohd Zahrim (A15CS0167)
1.0 Introduction.

Electrical safety testing (EST) is a test for a medical device which will determine
the safety of medical equipment use to the patient . This is because we want to
prevent hazards such as explosion, burns, electrical shock (whether micro or macro)
due to ground failures and failure of power delivery system. These type of hazards
can be avoided by doing the EST to a medical device before use it to the patient.
There are two types of standard use for EST test of medical equipment which are MS
IEC 60601 and also MS IEC 62353. These are the standard that been used in our
country and it difference on each country. Our country used the standard of MS IEC
60601 and it is adopted from the UK guidelines (BS 5724). Medical device produced
in Malaysia follows the MS IEC 60601 standard but medical device with with high
current usage will follow MS IEC 62353 standard. Our task for this week is to do the
PPM electrical safety test on ECG device. Besides, safety test also for the acceptance
testing, maintenance and also for the calibration purposes. To do this test, it should be
done by a competent person which have the knowledge of electrical safety standards,
practical experiences and have clear understanding to avoid any danger. For the EST
PPM, we recorded the model and serial number of the ECG device and not the model
and serial number of the electrical safety analyzer (ESA). Some of the parameters
measured for example protective earth resistance value have to refer with the standard
value for medical equipment class 1 type B, BF and CF. The resistance value must be
less than 0.1 ohm or maximum 0.2 ohm to determine whether the protective earth
resistance is functioning well . Lastly, the test are measuring three important things
which are the earth continuity (ground), insulation, and also the leakage current.
2.0 MATERIALS AND EQUIPMENTS

Electrical Safety Analyzers (ESA) Test Box

Portable ECG MAC 1600

Red Probe
Applied parts
3.0 METHODS
1. Before carry out the Electrical Safety Test (EST), check all physical-condition of the
device (ECG machine) and ESA (Electrical Safety Analyser). Make sure the device
was in good condition and safe. Connect and switch on the power supply.
2. Check model and the serial number of the device to make sure the device was correct.
3. After finish checking the condition of the device, Voltage, Live to Neutral test was
carried out. Before starting the test, we need to set up the setting for the ESA by
choosing the mode SETUP → INSTRUMENT → STANDARD → 60601 Mode V
was pressed on the ESA to measure the voltage. The reading was recorded.
4. Next, we carried out the protective Earth Resistance test. Mode Ω was chosen on ESA.
A calibration process was carried out by connecting the probe to G! on ESA test box.
“Zero lead” is shown on the screen of ESA test box. The reading is recorded.
5. To conduct the equipment current test, mode A was chosen and the tested device was
turned on. The screen ESA will be shown “on” after the device was turned on. Check
the maximum current supplied from the device. The reading was recorded and
compared with the maximum current of device (stated at the back of the device).
6. Insulation resistance, Mains-PE test was carried out. Press the MΩ and choose
“main-PE” mode on ESA. After that press the TEST button to start the test. The
reading was recorded.
7. Another test was carried which is Insulation Resistance, Main to Applied Part. All the
applied parts are connected to ESA and ESA is set to the “mains-AP” mode TEST
button is press and the reading recorded.
8. We continued the test by changing the mode on ESA to “A.P NE” in order to carry out
the test of Insulation Resistance, Applied Part to None-Eart. Make sure the applied part
is still connected to ESA and the red probe was connected to the protective earth of the
device (ground) TEST button was pressed on ESA and the reading is recorded.
9. Leakage Current, Earth, N.C (normal condition) tests were carried out. µA is pressed
on ESA and “earth” mode was choose. Make sure the Live, Neutral and Ground are
connected. Polarity button was pressed on ESA to choose the “normal” mode. Neutral
button is pressed to choose the “closed” mode on ESA. After that “AC+DC” mode is
selected by pressing the ↑ and ↓ button on ESA. Record the reading.
10. After finishing measuring Leakage Current, earth now the Enclosure Leakage Current,
SFC has to be measured. For this case. The Neutral and Earth should be changed to
open. And all the probes had to be connected to the case. To conduct the test, START
TEST button has to be pressed.
11. After taking the read of Leakage Current of Enclosure, SFC, Patient Leakage Current,
all N.C (normal condition) has to be measure. For this situation, Neutral and Earth
should be closed. And all the applied parts have to be connected. As the Philips
Pagewriter had been used so all the ECG leads have to be used. All to Earth, RA to
Earth, RL to Earth, LA to Earth, LL to Earth, V1-V6 to Earth leads have to be
connected to the case. To conduct the test START TEST button has to be pressed.
12. Now, Leakage Currrent on RA, SFC lead has to be measured. For this situation, the
Neutral option should be kept open. And all the applied parts have to be connected. But
to complete the test only RA has to be selected on ESA after the START TEST has to
be selected for completing the test.
13. Patient Auxiliary Leakage Current has to be conducted after that. The polarity has to be
changed to normal. And LA to ALL has to be connected LA has to be selected and
START TEST has to be selected to complete the test.
14. For measuring the Direct Equipment Leakage in NC first it is needed to go back to the
main menu. And for selecting the standard in IEC62353 the setup has to pressed and
followed by Instruments, Standards. Standards have to be changed into IEC62353.
After that done has to be pressed followed by SAVE button. To complete the test, all
Applied parts have to be connected and probe to the case.
15. After completing the Direct Equipment Leakage, Differential Equipment Leakage in
Reverse Polarity has to be measured to complete the electrical safety test. All the
applied parts have to be removed and the red probe has to be disconnected to complete
the test.
4. RESULTS AND ANALYSIS

CLINICAL ENGINEERING LAB SHEET

SMBE 3472
FACULTY OF BIOSCIENCES AND MEDICAL
ENGINEERING
UNIVERSITI TEKNOLOGI MALAYSIA

PLAN PREVENTIVE MAINTENANCE

ELECTRICAL SAFETY TEST

Date 22/11/2018 PM Due Date: 6 months

Location Clinical Lab
Model Number MAC1600
Serial Number SOE12310083NA
No Parameter Reading Pass/Fail Instruction / Remarks
1 Voltage, Live to Neutral 246.3V / Select IEC60601-1, Measure line voltage
2 Protective Earth Resistance 0.135Ω / Connect probe to G1 on ESA test box
3 Equipment current 0.1mA F Turn ON the DUT, Start process
4 Insulation Resistance, Mains - PE OL / Press MΩ on ESA
5 Insulation Resistance, Mains to Connect all applied parts, turn ON DUT
OL /
Appiled Part main switch
6 Insulation Resistance, Applied Part Connect all applied parts, connect red
57.5MΩ /
to None-Earth probe to case
7 Leakage Current, Earth, N.C. AC:201µA Press μA on ESA, Select AC+DC
DC:0.2µA /
(Normal Condition)
8 Leakage Current, Enclosure, SFC Connect probe to case
298 µA /
(Open Neutral, Open Earth)
9 Leakage Current, Patient, ALL, N.C Connect all applied parts
1.4 µA /
(Normal Condition)
10 Leakage Current, RA only, SFC Connect all applied parts, Select only RA
1.5 µA /
(Open Neutral) on ESA
11 Leakage Current, Auxillary, Normal Select the symbol where LA is lifted
0.3 µA /
Condition, LA to ALL
12 Direct Equipment Leakage, NC AC:0.1µA Select IEC62353, connect all applied
DC:0.1µA /
parts, connect probe to case
13 Differential Equipment Leakage, Remove all applied parts, disconnect red
159 µA /
REVERSE Polarity probe
REMARKS:

Engineer Signature: Customer Signature:

Name: Name:
Date: Date:

Note: Refer ESA manual for detailed instruction.

In this lab we learn how to do the electrical safety test for medical devices starting by
checking the manual of electrical safety tester to know the function and feature of
tester. In addition to know the cables and ports which are inputs which need to be
connect with the medical device we want to test. So basically this tester will give
measurements like voltage, current and resistance using the manual of electrical
circuit design of the medical device. Finally, we have done all tests required for
electrical safety successfully passed expect the Equipment Current measured reading
was 0.1mA which mean failed as it is should 0.85mA.

5.0 DISCUSSIONS
Electrical safety test is very crucial part in plan preventive maintenance (PPM)
in order to maintain the performance satisfaction and safety of medical devices.
Electrical safety test of a medical device is very important to avoid short circuit and
leakage current in medical device which can cause danger to the patient.
In this lab, we did the electrical safety test on a portable electrocardiogram which is
classified under Class 1 and type BF. Class 1 device has 3- prong power cord and has
protection between live parts and exposed conductive parts. There were two electrical
safety test standard which are IEC60601-1 and IEC 62353 that need to be considered
during PPM.PPM for electrical safety test for a medical device need to conducted for
every 6 months.
For the first part, we used standard IEC60601-1 to calculate few parameters. For
voltage, live to neutral, we obtain a reading of 246.3V which is less than the normal
range which is 240.5V. So, the first parameter passed the test. For the protective earth
resistance, we get a value of 0.135ohm. Since the value is within the range of
0.1-0.2ohm, this parameter also passed the test. To check the equipment current, we
need to turn on the machine because this parameter will measure the current used by
the machine. This parameter failed since we obtain a value of 0.1A which is higher
than the maximum value of current that the device can sustain which is 0.85A. For the
insulation resistance Mains-PE and insulation resistance, mains to applied parts we
get open loop (OL) which means infinity (test passed). For the insulation resistance of
applied part to none earth, we obtain 57.5 Mega ohm. This value also passed the test
since it is higher than the standard value given.
For the leakage current test, earth under normal condition we get a value of
201microampere for AC and 0.2microampere for DC. For the enclosure leakage
current (SFC), patient leakage current(ALL-normal), leakage current for RA
only(SFC) and leakage current for auxiliary under normal condition (LA to ALL) we
obtain 298microampere, 1.4microampere, 1,5 microampere and 0.3 microampere
respectively. All these parameters passed the test because the values were within the
range.
For direct equipment leakage, this test purposely to test a leakage current that appear
on the equipment enclosure. During the test, the standard need to be change to
IEC62353. upon the test, all the applied part is connected to EST, and connect probe
to case. The results we get for AC its 0.1mircroampere and fir DC its
0.1microampsere as well, both results are passed. For differential equipment leakage,
we choose reverse polarity. All the applied part are removed, and probe disconnect
prob from casing. The test results is 159microampere and its pass.
The electrical safety analyser’s calibration date that was used in our testing was
expired. This cause the reading of the most of the parameters to be inaccurate. So, in
order to obtain an accurate reading, we must send the ESA to be calibrated or use
another electrical safety analyser to avoid error.

6.CONCLUSIONS

In conclusion we managed to do the electrical safety test for ECG machine. The
voltage, protective earth resistance, insulation resistance, leakage current, direct
equipment leakage and differential equipment leakage of the ECG machine are tested
and is classified as a Pass(/) as each of the recorded value is within the tolerance range.
Exceptionally for the Equipment Current test which is fail. Hence the electrical test of
the ECG machine is concluded as a Pass even though we had failed for the Equipment
Current test these is because the calibration for the electrical safety analyser have due
two years ago.