Test Report

Applicant: Shenzhen huerkang Medical Technology Co., Ltd.

Product Name: Infared Forehead Thermometer

Brand Name: N/A

Model No.: F103

Date of Receipt : Apr.16, 2020

Date of Test: Apr.16-17, 2020
Date of Report: Apr.17, 2020

Prepared by: Shenzhen Most Technology Service Co., Ltd.

The EMC testing has been performed on the submitted samples .

Shenzhen Most Technology Service Co., Ltd.

No.5, 2nd Langshan Road, North District, Hi-tech Industry Park,
Nanshan, Shenzhen, Guangdong, China
Phone: 86-755-86026850
Fax: 86-755-26013350
http:// www.szmost.com
 TABLE OF CONTENTS

Description Page
Test Report Declaration……………………………..…………………………………4
1. GENERAL INFORMATION ....................................................................................................... 5
1.1. Description of Device (EUT) ................................................................................................................ 5
1.2. Operational Mode(s) of EUT................................................................................................................. 5
1.3. Test Voltage(s) of EUT ......................................................................................................................... 5
1.4. Compliance with the EN 60601-1-2:2015 chapter 6 requires. .............................................................. 6
2. DESCRIPTION OF TEST STANDARD ................................................................................... 15
3. LABORATORY INFORMATION............................................................................................. 16
3.1. Laboratory Name ................................................................................................................................. 16
3.2. Location ............................................................................................................................................... 16
3.3. Test facility .......................................................................................................................................... 16
3.4. Measurement Uncertainty.................................................................................................................... 16
4. SUMMARY OF TEST RESULTS.............................................................................................. 17
5. BLOCK DIAGRAM OF TEST SETUP ..................................................................................... 18
5.1. Block Diagram of connection between EUT and simulation-EMS..................................................... 18
6. TEST INSTRUMENT USED ...................................................................................................... 19
6.1. For Conducted Disturbance at Mains Terminals Emission Test ......................................................... 19
6.2. For Radiation Test(In Anechoic Chamber)(Below 1000MHz) ........................................................... 19
6.3. For Radiation Test (In Anechoic Chamber)(Above 1000MHz) .......................................................... 19
6.4. For Harmonic / Flicker Test ................................................................................................................ 19
6.5. For Electrostatic Discharge Immunity Test ......................................................................................... 20
6.6. For RF Strength Susceptibility Test .................................................................................................... 20
6.7. For Electrical Fast Transient/Burst Immunity Test ............................................................................. 20
6.8. For Surge Test ..................................................................................................................................... 20
6.9. For Injected Currents Susceptibility Test ............................................................................................ 20
6.10. For Magnetic Field Immunity Test ...................................................................................................... 20
6.11. or Voltage Dips and Interruptions Test ............................................................................................... 21
7. CONDUCTED DISTURBANCE AT MAINS TERMINALS TEST ....................................... 22
7.1. Configuration of Test System .............................................................................................................. 22
7.2. Test Standard ....................................................................................................................................... 22
7.3. Power Line Conducted Disturbance at Mains Terminals Limit .......................................................... 22
7.4. Test Procedure ..................................................................................................................................... 22
7.5. Conducted Disturbance at Mains Terminals Test Results .................................................................. 23
8. RADIATED DISTURBANCE TEST ......................................................................................... 24
8.1. Configuration of Test System .............................................................................................................. 24
8.2. Test Standard ....................................................................................................................................... 24
8.3. Radiated Disturbance Limit ................................................................................................................. 24
8.4. Operating Condition of EUT ............................................................................................................... 24
8.5. Test Procedure ..................................................................................................................................... 25
8.6. Radiated Disturbance Test Results ...................................................................................................... 25
9. HARMONIC CURRENT TEST ................................................................................................. 26
9.1. Configuration of Test System .............................................................................................................. 26
9.2. Test Standard ....................................................................................................................................... 26
9.3. Test Limits ........................................................................................................................................... 26
9.4. Test Results ......................................................................................................................................... 26
10. VOLTAGE FLUCTUATIONS & FLICKER TEST ................................................................ 27
10.1. Configuration of Test System .............................................................................................................. 27
10.2. Test Standard ....................................................................................................................................... 27
10.3. Test Limits ........................................................................................................................................... 27

Report No. MTET20040455 Page 2 of 46

 10.4. Test Results ......................................................................................................................................... 27
11. IMMUNITY PERFORMANCE CRITERIA............................................................................. 28
12. ELECTROSTATIC DISCHARGE IMMUNITY TEST .......................................................... 29
12.1. Configuration of Test System .............................................................................................................. 29
12.2. Test Standard ....................................................................................................................................... 29
12.3. Severity Levels and Performance Criterion......................................................................................... 30
12.4. Test Procedure ..................................................................................................................................... 30
12.5. Test Results ......................................................................................................................................... 30
13. RF FIELD STRENGTH SUSCEPTIBILITY TEST ................................................................ 32
13.1. Configuration of Test System .............................................................................................................. 32
13.2. Test Standard ....................................................................................................................................... 32
13.3. Severity Levels and Performance Criterion......................................................................................... 32
13.4. Test Procedure ..................................................................................................................................... 33
13.5. Test Results ......................................................................................................................................... 33
14. ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST ......................................... 36
14.1. Configuration of Test System .............................................................................................................. 36
14.2. Test Standard ....................................................................................................................................... 36
14.3. Severity Levels and Performance Criterion......................................................................................... 36
14.4. Test Procedure ..................................................................................................................................... 37
14.5. Test Results ......................................................................................................................................... 37
15. SURGE TEST ............................................................................................................................... 38
15.1. Configuration of Test System .............................................................................................................. 38
15.2. Test Standard ....................................................................................................................................... 38
15.3. Severity Levels and Performance Criterion......................................................................................... 38
15.4. Test Procedure ..................................................................................................................................... 39
15.5. Test Results ......................................................................................................................................... 39
16. INJECTED CURRENTS SUSCEPTIBILITY TEST ............................................................... 40
16.1. Configuration of Test System .............................................................................................................. 40
16.2. Test Standard ....................................................................................................................................... 40
16.3. Severity Levels and Performance Criterion......................................................................................... 40
16.4. Test Procedure ..................................................................................................................................... 41
16.5. Test Results ......................................................................................................................................... 41
17. MAGNETIC FIELD IMMUNITY TEST .................................................................................. 42
17.1. Configuration of Test System .............................................................................................................. 42
17.2. Test Standard ....................................................................................................................................... 42
17.3. Severity Levels and Performance Criterion......................................................................................... 42
17.4. Test Procedure ..................................................................................................................................... 43
17.5. Test Results ......................................................................................................................................... 43
18. VOLTAGE DIPS AND INTERRUPTIONS TEST ................................................................... 45
18.1. Configuration of Test System .............................................................................................................. 45
18.2. Test Standard ....................................................................................................................................... 45
18.3. Severity Levels and Performance Criterion......................................................................................... 45
18.4. Test Procedure ..................................................................................................................................... 46
18.5. Test Results ......................................................................................................................................... 46

APPENDIX I (2 pages)
APPENDIX II (Test Photos) (1 page)
APPENDIX III (Photos of the EUT) (5 pages)

Report No. MTET20040455 Page 3 of 46

 TEST REPORT DECLARATION

Report Number MTET20040455

Shenzhen huerkang Medical Technology Co., Ltd.

Applicant Room 604, 6th Floor, Building 1, No. 12, Baida Street, Xikeng Community, Yuanshan
Street, Longgang District, Shenzhen
Shenzhen huerkang Medical Technology Co., Ltd.
Manufacturer
Room 604, 6th Floor, Building 1, No. 12, Baida Street, Xikeng Community, Yuanshan
Street, Longgang District, Shenzhen
Product Name Infared Forehead Thermometer

Product Model No. F103

Power Supply DC3V(by Batteries)

Test Result The EUT was found compliant with the requirement(s) of the standards.

EN 60601-1-2:2015
Standard (CISPR 11:2015+A1:2016+A2:2019, IEC 61000-4-2:2008,
IEC 61000-4-3:2006+A1:2007+A2:2010,IEC 61000-4-8:2009)

*Note
The above device has been tested by Shenzhen Most Technology Service Co., Ltd. To determine the
maximum emission levels emanating from the device and the severe levels of the device can endure and
its performance criterion. The test record, data evaluation & Equipment Under Test (EUT)
configurations represented are contained in this test report and Shenzhen Most Technology Service Co.,
Ltd. Is assumed full responsibility for the accuracy and completeness of test. Also, this report shows that
the EUT is technically compliant with the requirement of the above standards.

This report applies to above tested sample only. This report shall not be reproduced except in full,
without written approval of Shenzhen Most Technology Service Co., Ltd., this document may be altered
or revised by Shenzhen Most Technology Service Co., Ltd.., personal only, and shall be noted in the
revision of the document.

Prepared by
Lili Lu(Engineer)

Reviewed by
Sunny Deng(Engineer)

Approved by
Yvette Zhou(Manager)

Report No. MTET20040455 Page 4 of 46

1. GENERAL INFORMATION

1.1. Description of Device (EUT)

Description : Infared Forehead Thermometer

Model Number : F103

Remark : N/A

1.2. Operational Mode(s) of EUT

Order Number : Test Mode(s)
1 : Running

1.3. Test Voltage(s) of EUT

Order Number : Test Voltage(s)
1 : DC 3V by Batteries

Report No. MTET20040455 Page 5 of 46

 1.4. Compliance with the EN 60601-1-2:2015 chapter 6 requires.
We are used the check list for compliance with the EN 60601-1-2:2015 chapter 6 requires.

Clause Requirement / Description Remark Verdict

6 Identification, marking and documents Passed
6.1.201 Making on the outside of EQUIPMENT or EQUIPMENT parts Passed
6.1.201.1 Making on the outside of EQUIPMENT or EQUIPMENT parts that N/A
include RF transmitters or that apply RF electromagnetic energy for
diagnosis or treatment
EQUIPMENT and SYSTEMS that include RF transmitters or that N/A
intentionally apply RF electromagnetic energy for diagnosis or
treatment shall be labeled with the following symbol for non-ionizing
radiation [IEC 60417-5140];

6.1.201.2 Making on the outside of EQUIPMENT or EQUIPMENT parts for N/A

which the connector testing exemption specified in 36.202.2 b) 3) is
used

For EQUIPMENT and SYSTEM or which the connector testing N/A

exemption specified in 36.202.2 b) 3) is used, the following symbol for
ESD sensitivity shall be applied adjacent to each connector for which
the testing exemption is used [IEC 60417-5134];

6.1.201.3 Making on the outside of EQUIPMENT and SYSTEMS that are N/A
specified for use only in a shielded location
EQUIPMENT and SYSTEMS specified for use only in a shielded N/A
location shall be labeled with a warning that they should be used only
in the specified type of shielded location (see 6.8.3.201 c))
Passed ACCOMPANYING DOCUMENTS Passed
6.8.201
6.8.2.201 Instructions for use Passed
a) Requirements applicable to all EQUIPMENT and SYSTEMS Passed
Instructions for use shall included the following:
1) a statement that MEDICAL ELECTRICAL EQUIPMENT needs Passed
special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided in the
ACCOMPANYING DOCUMENTS;
2) a statement that portable and mobile RF communications Passed
equipment can affect MEDICAL ELECTRICAL EQUIPMENT.
Report No. MTET20040455 Page 6 of 46
 b) Requirements applicable to EQUIPMENT and SYSTEM for which N/A
the connector testing exemption specified in 36.202.2. b) 3) is used

For EQUIPMENT and SYSTEM for which the connector testing

exemption specified in 36.202.2. b) 3) is used, the instructions use
shall include the following:
1) a reproduction of the ESD warning symbol (IEC 60417-5134, as N/A
shown in 6.1.201.2);
2) a warning that pins of connectors identified with the ESD warning N/A
symbol should not be touched and that connections should not be
made to these connectors unless ESD precautionary procedures
are used;
*3) a specification of the ESD precautionary procedures; N/A
*4) a recommendation that all staff involved receive an explanation N/A
of the ESD warning symbol and training in EED precautionary
procedures;
*5) a specification of the minimum contents of ESD precautionary N/A
procedure training.
c) Minimum amplitude or value of PATIENT physiological signal N/A
For EQUIPMENT and SYSTEM without a manual sensitivity
adjustment and for which the manufacture specifies a minimum
amplitude or value of PATIENT physiological signal (see 36.202.1
g), first dash), the instruction for use shall include the following:
1) the minimum amplitude or value of PATIENT physiological N/A
signal;
2) a warning that operation of the EQUIPMENT and SYSTEM N/A
below this amplitude or value may cause inaccurate results.
6.8.3.201 Technical description Passed
a) Requirements applicable to all EQUIPMENT and SYSTEMS Passed
For all EQUIPMENT and SYSTEMS, the ACCOMPANYING
DOCUMENTS shall include the following information:
*1) A list of all cables and maximum lengths of cables (if Passed
applicable), transducers and other ACCESSORIES with which
the manufacturer of the EQUIPMENT and SYSTEM claims
compliance with the requirements of 36.201 and 36.202.
ACCESSORIES that do not affect compliance with the
requirements of these subclasses need not be listed.
ACCESSORIES, transducers and cables may be specified either
generically (e.g. shielded serial cable, load impedance) or
specifically (e.g. by manufacturer and model or part number).
*2) A warning that the use of ACCESSORIES, transducers and Passed
cables other than those specified, with the exception of
transducers and cables sold by the manufacturer or the
EQUIPMENT or SYSTEM as replacement parts for internal
components, may result in increased EMISSIONS or decreased
IMMUNITY of the EQUIPMENT or SYSTEM.

*3) Table 201, with the modifications specified below.3.4 The Passed
flowchart in Figure 201 is the requirement in step-by-step
Report No. MTET20040455 Page 7 of 46
 graphical form for completion of Table 201 for CISPR 11
EQUIPMENT and YSTEMS. The flowchart in Figure 202 is the
requirement in step-by-step graphical form for completion of
Table 201 for CISPR 14 and CISPR 15 EQUIPMENT.
- For CISPR 11 EQUIPMENT and SYSTEMS, “[EQUIPMENT
or SYSTEMS]” shall be replaced with the MODEL OR TYPE
REFERECE of the EQUIPMENT or SYSTEMS.
- For CISPR 14 and CISPR 15 EQUIPMENT,
“[EQUIPMENT]” shall be replaced with the MODEL OR
TYPE REFERECE of the EQUIPMENT.
- For CISPR 11 Group 1 EQUIPMENT and SYSTEMS, rows 5,
11 and 12 shall be deleted.
- For CISPR 11 Group 2 EQUIPMENT and SYSTEMS, rows 4,
11 and 12 shall be deleted.
- For EQUIPMENT that complies with CISPR 14-1, rows 4
through 6 and row 12 shall be deleted.
- For EQUIPMENT that complies with CISPR 15, rows 4
through 6 and row 11 shall be deleted.
- For CISPR 11 EQUIPMENT and SYSTEMS that comply with
Class A, “[A or B]” in column 2 of row 6 shall be replaced with
“A”. For CISPR 11 EQUIPMENT and SYSTEMS that comply
with Class B, “[A or B]” in column 2 of row 6 shall be replaced
with “B”.
- For EQUIPMENT and SYSTEMS that comply with IEC
61000-3-2. “[Class A, B, C, D, or Not applicable]” in column 2
of row 7 shall be replaced with the class of the EQUIPMENT
and SYSTEMS according to IEC 61000-3-2. For EQUIPMENT
and SYSTEMS that comply with IEC 61000-3-2. “[Complies or
Not applicable]” in column 2 of row 8 shall be replaced with
“Complies”. For EQUIPMENT and SYSTEMS for which IEC
61000-3-2 and IEC 61000-3-3 are not applicable, “[Class A, B,
C, D, or Not applicable]” and “[Complies or Not applicable]”
shall each be replaced with “Not applicable”.
- For CISPR 11 EQUIPMENT and SYSTEMS, column 3 of
rows 6, 7 and 8 shall be merged into one cell. For CISPR 11
EQUIPMENT and SYSTEMS that comply with Class B and
with IEC 61000-3-2 and IEC 61000-3-3, the text in column 3 of
row 9 shall be moved into the merged cell. For CISPR 11
EQUIPMENT and SYSTEMS that comply with Class A or
which IEC 61000-3-2 and IEC 61000-3-3 are not applicable,
the text in column 3 of row 10 shall be moved into the merged
cell.
- For CISPR 14 or CISPR 15 EQUIPMENT, column 3 of rows 7
and 8 shall be merged into one cell. For CISPR 14 or CISPR 15
EQUIPMENT that comply with IEC 61000-3-2 and with IEC
61000-3-3, the text in column 3 of row 9 shall be moved into
the merged cell. For CISPR 14 or CISPR 15 EQUIPMENT for
which IEC 61000-3-2 and IEC 61000-3-3 are not applicable,
the text in column 3 of row 10 shall be moved into the merged
cell.
- For EQUIPMENT and SYSTEMS specified for use only in a
shielded location and for which the electromagnetic radiation
disturbance allowance or the mains terminal disturbance

Report No. MTET20040455 Page 8 of 46

 voltage allowance in 36.201.1 a) 4) is used, the text specified by Passed
6.8.3.201 c) 2) shall be added.
- Rows 9 and 10 shall be deleted.
- The row numbers shall be deleted.
*4) A warning that EQUIPMENT or SYSTEM should not be used Passed
adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, the EQUIPMENT or SYSTEM
should be observed to verify normal operation in the
configuration in which it will be used.
*5) A justification for each COMPLIANCE LEVEL that is lower Passed
than the IEC 60601 TEST LEVEL for that IMMUNITY test.
These justifications shall be based only on physical,
technological or physiological limitations that prevent
compliance at the IEC 60601 TEST LEVEL
*6) Table 202, completed as specified below 5 . The flowchart in Passed
Figure 203 is the requirement in step-by-step graphical form for
completion of Table 202.
-“[EQUIPMENT or SYSTEM]”shall be replaced with the
MODEL OR TYPE REFERENCE Of the EQUIPMENT or
SYSTEM

NOTE There are four places in Table 202 where “[EQUIPMENT or

SYSTEM]” must be replaced.

*- Column 3 of Table 202 shall be filled in with the

IMMUNITY COMPLIANCE LEVEL for each test in
accordance with the requirements of 6.8.3.201 and 36.202.
If a COMPLIANCE LEVEL lower or higher than the IEC
60601 TEST LEVEL is claimed, it shall be one of the
levels listed in the referenced basic EMC IMMUNITY
standard unless the COMPLIANCE LEVEL is outside the
range of levers listed in referenced basic EMC
IMMUNITY standard, the actual IMMUNITY LEVEL
shall be stated, rounded to one significant digit. If
according to 36.202 or the scope of the EMC basic
standard a test does not apply to the EQUIPMENT or
SYSTEM, or it is not possible to perform the test on the
EQUIPMENT or SYSTEM, columns 3 and 4 of Table 202
shall state that the test it not applicable.
*-For the electrostatic discharge (ESD)IMMUNITY test (IEC
61000-4-2), the electrical fast transient/burst IMMUNITY
test (IEC 61000-4-4), the surge IMMUNITY test (IEC
61000-4-5), the voltage dips, . short interruptions and
voltage, variations IMMUNITY test (IEC 61000-4-11) and
the power frequency magnetic fields IMMUNITY test (IEC
61000-4-8):

• If a COMPLIANCE LEVEL is lower than an

IMMUNITY TEST LEVEL specified in 36.202.2,

Report No. MTET20040455 Page 9 of 46

 36.202.4, 36.202.5, 36.202.7, or 36.202 8.1. the text in
column 4 in the corresponding row of Table 202 shall be
replaced with a description of the actions the customer or
user must take to reduce environmental levels of the
DISTURBANCE so that they are less than or equal to the Passed
COMPLIANCE LEVEL listed in Column 3.
• If a COMPLIANCE LEVEL is higher than an
IMMUNITY TEST LEVEL specified in 36.202.2,
36.202.4, 36.202.5, 36.202.7 or 36.202.8.8.1, the text in
column 4 in the corresponding row of Table 202 may be
replaced with a description of the environment for which
the EQUIPMENT or SYSTEM is suitable.
*b) Requirements applicable to EQUIPMENT and SYSTEMS other Passed
than those specified for use only in a shielded location
For EQUIPMENT and SYSTEMS other than those specified for use
only in a shielded location, the ACCOMPANYING DOCUMENTS
shall include the following information:
The applicable tables, 203 and 205 or 204 and 206 Tables 203 and
205 shall be used for LIFE-SUPPORTING EQUIPMENT and
SYSTEMS. Tables 204 and 206 shall be used for EQUIPMENT and
SYSTEMS that are not LIFE-SUPPORTING. The tables shall be
completed for the conducted and radiated RF IMMUNITY tests as
specified below 6. The flowchart in Figure 204 is the requirement in
step-by-step graphical form for completion of Tables 203 and 205
and the flowchart in Figure 205 is the requirement in step-by-step
graphical form for completion of Tables 204 and 206.
1) “[EQUIPMENT or SYSTEM]” shall be replaced with the Passed
MODEL OR TYPE REFERENCE of the EQUIPMENT or
SYSTEM.
2) Column 3 of Table 203 or 204, as applicable, shall be filled in Passed
with the IMMUNITY COMPLIANCE LEVEL in accordance
with the requirements of 6.8.3.201, and of 36.202. If a
COMPLIANCE LEVEL lower or higher than the IEC 60601
TEST LEVEL is claimed, it shall be one of the levels listed tn
the referenced basic EMC IMMUNITY standard unless the
COMPLIANCE LEVEL is outside the range of levels listed. If
the COMPLIANCE LEVEL is outside the range of levels listed
in the referenced basic EMC IMMUNITY standard, the actual
IMMUNITY LEVEL shall be stated, rounded to one significant
digit.
3) The expressions in square brackets ([ ]) that contain V1,V2 and E1 Passed
in column 4 of Table 203 or 204, as applicable, and in Table 205
or 206, as applicable, shall be calculated, rounded to two
significant digits, and the results substituted in place of the
corresponding expressions. V1 and V2 are the COMPLIANCE
LEVELS for the IEC 61000-4-6 test end E1 is the COMPLIANCE
LEVEL for the IEC 61000-4-3 test. V1 and V2 are in V and E1 is in
V/m. The value of V1 shall also be substituted for“[V1]” in the table
footnote in Table 203 or 204, as applicable.

Report No. MTET20040455 Page 10 of 46

 4) Table 205 or 206. as applicable, shall be completed by calculating Passed
the distance corresponding to each entry in columns 2 through 5 in
Table 205 or columns 2 through 4 in Table 206, as applicable,
using the equation in that column and the output power that
appears in column l of that row .The calculated distances shall be
rounded to two significant digits and entered in Table 205 or 206,
as applicable.
c) Requirements applicable to EQUIPMENT and SYSTEMS specified N/A
for use only in a shielded location
For EQUIPMENT and SYSTEM9 specified for use only in a shielded
location, the ACCOMPANYING DOCUMENTS shall include the
following information:
1) A warning that the EQUIPMENT or SYSTEM should be used
only in the specified type of shielded location.
*2) If the electromagnetic radiation disturbance allowance or the N/A
mains terminal disturbance voltage allowance in 36.201.1 a) 4)is
used:
- the following text, added to column 2 of the CISPR row of
Table 201, after or below the CISPR class:
(The [EQUIPMENT or SYSTEM] in combination with the
shielded location)
where “[EQUIPMENT or SYSTEM]” shall be replaced with the
MODEL OR TYPE REFERENCE of the EQUIPUENT or
SYSTEM;
- the following text, appended to the beginning of the text in
column 3 of Table 201 in the merged cell of the CISPR 11, IEC
61000-3-2 and IEC 61000-3-3 rows:
the [EQUIPMENT or SYSTEM] must be used only in a
shielded location with a minimum RF shielding effectiveness
and, for each cable that exits the shielded location, a minimum
RF filter attenuation of [shielding effectiveness /filter
attenuation specification].
where “[EQUIPMENT or SYSTEM]” shall be replaced with the
MODEL OR TYPE REFERENCE of the EQUIPMENT or
SYSTEM and “[shielding effectiveness / filter attenuation
specification]” shall be replaced with the specification for
minimum RF shielding effectiveness and RF filter attenuation.7
The specification for minimum RF shielding effectiveness and
RF filter attenuation shall meet the following requirements:
• the specified RF shielding effectiveness and RF filter attenuation
shall be expressed in dB, shall be rounded to the nearest integer
and shall be at least 20 dB;
• the RF shielding effectiveness and RF filter attenuation
specification shall include the frequency range over which the
RF shielding effectiveness and RF filter attenuation apply, and
this frequency range shall be at least one decade in width;
• the specified value(s) for minimum RE filter attenuation shall be
identical to the specified value(s) for minimum RF shielding
effectiveness in each frequency range for which they are
specified;

Report No. MTET20040455 Page 11 of 46

 • in frequency ranges for which the minimum RF shielding
effectiveness and RF filter attenuation are not specified or are
specified to be less than 20 dB, the RF shielding effectiveness
and RF filter attenuation shall be assumed to be 0 dB for the
purpose of this standard;
- the following text, added to replace “The [EQUIPMENT or
SYSTEM] is suitable” in the text in column 3 of Table 201 in
the merged cell of the CISPR 11, IEC 61000-3-2 and IEC
61000-3-3 rows:
The [EQUIPMENT or SYSTEM], when installed in such a
shielded location, is suitable
where “[EQUIPMENT or SYSTEM]” shall be replaced with the
MODEL OR TYPE REFERENCE of the EQUIPMENT or
SYSTEM;
- the folium note, added to the bottom of Table 201:
NOTE It is essential that the actual RF shielding effectiveness and
filter attenuation of the shielded location be verified to ensure that
they meet or exceed the specified minimum values,

*3) A specification of the EMISSIONS characteristics of other N/A

equipment allowed inside the shielded location with the
EQUIPMENT or SYSTEM, a list of specific equipment allowed
or
a list of types of equipment prohibited (see 36.202.3 a) 3) and a
recommendation that a notice containing this information be
posted at the entrance(s) to the shielded location.
*4) The applicable table, 207 or 208. Table 207 shall be used for N/A
LIFE-SUPPORTING EQUIPMENT and SYSTEMS. Table 208
shall be used for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING. The tables shall be completed as follows.
8

- “[EQUIPMENT or SYSTEM]” shall be replaced with the

MODEL OR TYPE REFERENCE of the
EQUIPMENT or SYSTEM;

NOTE There are six places in Tables 207 and 208 where “[EQUIPMENT
or SYSTEM]” must be replaced.

- column 3 of table 207 or 208, as applicable, shall be filled in

with
the IMMUNITY COMPLIANCE LEVEL in accordance with
the requirements of 6.8.3.201 and of 36.202. If an IMMUNITY
COMPLIANCE LEVEL lower or higher than the IEC 60601
TEST LEVEL is claimed, it shall be one of the levels listed in
the referenced basic EMC IMMUNITY standard unless the
COMPLIANCE LEVEL is outside the range of levels listed, If
the COMPLIANCE LEVEL is outside the range of levels listed
in the referenced basic EMC IMMUNITY standard, the actual
IMMUNITY LEVEL shall be stated, rounded to one significant
digit;

Report No. MTET20040455 Page 12 of 46

 - in column 4 0f Table 207 or 208, as applicable, “[shielding
effectiveness / filter attenuation specification]” shall be
replaced with the specification for minimum RF shielding
effectiveness and RF filter attenuation, which shall meet the
requirements specified, in 2), above; “[appropriate section of
ACCOMPANYING DOCUMENTS]” shall be replaced with a
reference to the location in the ACCOMPANYING
DOCUMENTS where the information required by 6.8.3.201 c)
3) can be found; and “[field strength]” shall be replaced with
the maximum field strength in V/m, rounded to one significant
digit, of fixed RF transmitters that when attenuated by the
specified minimum RF shielding effectiveness and filter
attenuation, will not exceed the COMPLIANCE LEVEL for
any of the frequency ranges. For calculating “[field strength]’,
the COMPLIANCE LEVELS for the IEC 61000-4-6 test shall
be considered to be in units of V/m;
- in table footnote b of Table 207 or table footnote a of Table
208, as applicable,”[field strength]” shall be replaced as
specified above for column 4 of the table.
d) Requirements applicable to EQUIPMENT and SYSTEMS that N/A
intentionally apply RF energy for diagnosis or treatment
For EQUIPMENT and SYSTEMS that intentionally apply RF energy
for diagnoses or treatment, the ACCOMPANYING DOCUMENTS
shall include guidelines for avoiding or identifying and resolving
adverse electromagnetic effects on other equipment that may result
from operation of the EQUIPMENT or SYSTEM
e) Requirements applicable to EQUIPMENT and SYSTEMS that N/A
intentionally receive RF electromagnetic energy for the purpose of
their operation
For EQUIPMENT and SYSTEMS that intentionally receive RF
electromagnetic energy for the purpose of their operation, the
ACCOMPANYING DOCUMENTS shall include the following
information:
1) each frequency or frequency band of reception; the preferred N/A
frequency or frequency band, if applicable; and the bandwidth of the
receiving section of the EQUIPMENT or SYSTEM in those bands;
2) a warning that the EQUIPMENT or SYSTEM may be interfered N/A
with by other equipment, even if that other equipment complies
with CISPR EMISSION requirements.
f) Requirements applicable to EQUIPMENT and SYSTEMS that N/A
include RF transmitters
For EQUIPMENT and SYSTEMS that include RF transmitters, the
ACCOMPANYING DOCUMENTS shall include each frequency or
frequency band of transmission, the type and frequency
characteristics of the modulation and the EFFECTIVE RADIATED
POWER.

Report No. MTET20040455 Page 13 of 46

*g) Requirements applicable to cables, transducers and other N/A
ACCESSORIES that could affect compliance with the requirements
of 36.201 and 36.202
For cables, transducers and other ACCESSORIES that could affect
compliance with the requirements of 36.201 and 36.202 the
ACCOMPANYING DOCUMENTS shall include the following
information:
1) a list of all EQUIPMENT and SYSTEMS with which the N/A
ACCESSORY, transducer or cable may be used and that are
claimed by the manufacturer of the ACCESSORY, transducer or
cable to be in compliance with the requirements of 36. 201 and
36.202 when used with the ACCESSORY, transducer or cable.
References shall be specific (e.g. by manufacturer and MODEL
OR TYPE REFERENCE);
2) a warning that the use of the ACCESSORY, transducer or cable N/A
with EQUIPMENT and SYSTEMS other than those specified
may result in increased EMISSIONS or decreased IMMUNITY
of the EQUIPMENT or SYSTEM.
h) Requirements applicable to LARGE, N/A
PERMANENTLY-INSTALLED EQUIPMENT and SYSTEMS
For LARGE, PERMANENTLY-INSTALLED EQUIPMENT and
SYSTEMS for which the exemption specified in 36.202.3 b) 1) is
used, the ACCOMPANYING DOCUMENTS shall include the
following information:
1) a statement that an exemption has been used and that the N/A
EQUIPMENT or SYSTEM has not been tested for radiated RF
IMMUNITY over the entire frequency range 80 MHz to 2.5 GHz;
2) a warning that the EQUIPMENT or SYSTEM has been tested for N/A
radiated RF IMMUNITY only at selected frequencies;
*3) a list of the transmitters or equipment used as RF test sources and N/A
the frequency and modulation characteristics of each source.
i) Requirements applicable to EQUIPMENT and SYSTEMS found by a N/A
risk analysis to have no ESSENTIAL PERFORMANCE
1) For EQUIPMENT and SYSTEMS found by a risk analysis to have N/A
no ESSENTIAL PERFORMANCE and which were not tested for
IMMUNITY or for which the IMMUNITY COMPLIANCE
CRITERIA were considered to allow all DEGRADATIONS, the
ACCOMPANYING OCUMENTS shall include, instead of the
information specified in 6.8.3.201 a) 5) and 6), b), c) 3) and 4), and
h), a statement that the EQUIPMENT or SYSTEM was not tested
for IMMUNITY to ELECTROMAGNETIC DISTURBANCES.

2) For EQUIPMENT and SYSTEMS found by a risk analysis to have N/A

no ESSENTIAL PERFORMANCE and for which FUNCTIONS
were tested for IMMUNITY and the IMMUNITY COMPLIANCE
CRITERIA were considered to apply to all DEGRADATIONS, the
ACCOMPANYING DOCUMENTS shall include information
applicable to the EQUIPMENT or SYSTEM as specified in 6.8.
3.201 a) through h).

Report No. MTET20040455 Page 14 of 46

2. DESCRIPTION OF TEST STANDARD
The intention of this publication is to establish uniform requirements for the radio disturbance
level of the equipment contained in the scope, to fix limits of disturbance, to describe methods of
measurement and to standardize operating conditions and interpretation of results.

The following referenced standard are indispensable for the application of this report.

Referenced Description below:

EN 60601-1-2:2015
Medical electrical equipment-Part 1-2: General requirements for basic safety and essential
performance-collateral standard: Electromagnetic compatibility-Reqirements and tests.

Report No. MTET20040455 Page 15 of 46

3. LABORATORY INFORMATION

3.1. Laboratory Name

Shenzhen Most Technology Service Co., Ltd.

3.2. Location
No.5, 2nd Langshan Road, North District, Hi-tech Industrial Park, Nanshan, Shenzhen,
Guangdong, China

3.3. Test facility

3m Anechoic Chamber : Nov. 28, 2012 File on Federal
Communication Commission
Registration Number:490827

Shielding Room : Nov. 28, 2012 File on Federal

Communication Commission
Registration Number:490827

EMC Lab. : Accredited by TUV Rheinland Shenzhen

Audit Report: UA 50149851
Mar. 12, 2009

Accredited by Industry Canada

Registration Number: 7103A-1
Oct. 22, 2012

Accredited by TIMCO
Registration Number: Q1460
March 28, 2010

3.4. Measurement Uncertainty

No. Item Uncertainty
1. Uncertainty for Conducted Disturbance Test 1.25dB
2. Uncertainty for Radiated Disturbance Test 3.15dB

Report No. MTET20040455 Page 16 of 46

4. SUMMARY OF TEST RESULTS
EMISSION(EN 60601-1-2:2015)
Test Item Standard Limits Results
Conducted disturbance CISPR 11:2015+A1:2016+
Class B N/A
at mains terminals A2:2019
CISPR 11:2015+A1:2016+
Radiated disturbance Class B PASS
A2:2019
EN IEC 61000-3-2:2019
Harmonic current emissions Class D N/A

EN 61000-3-3:2013+
Voltage fluctuations & flicker --- N/A
A1:2019
IMMUNITY (EN 60601-1-2:2015)
Performance
Test Item Basic Standard Results
Criteria
Electrostatic discharge (ESD) IEC 61000-4-2:2008 --- PASS
Radio-frequency, IEC61000-4-3:2006+A1:2007
--- PASS
Continuous radiated disturbance +A2:2010

Electrical fast transient (EFT) IEC61000-4-4:2012 --- N/A

Surge (Input a.c. power ports) IEC 61000-4-5:2014+ --- N/A
Surge (Telecommunication ports) A1:2017+A1:2017 --- N/A
Radio-frequency,
IEC 61000-4-6:2013 --- N/A
Continuous conducted disturbance
Power frequency magnetic field IEC 61000-4-8:2009 --- PASS
Voltage dips, >95% reduction --- N/A
IEC 61000-4-11:2004+
Voltage dips, 30% reduction --- N/A
A1:2017
Voltage interruptions --- N/A

N/A is an abbreviation for Not Applicable.

Report No. MTET20040455 Page 17 of 46

5. BLOCK DIAGRAM OF TEST SETUP
The equipments are installed test to meet CISPR 11 requirement and operating in a manner which
tends to maximize its emission characteristics in a normal application. EUT was tested in normal
configuration (Please See following Block diagrams)

EUT
DC 3V by
Batteries

(EUT: Infared Forehead Thermometer)

5.1. Block Diagram of connection between EUT and simulation-EMS

EUT
DC 3V by
Batteries

(EUT: Infared Forehead Thermometer)

Report No. MTET20040455 Page 18 of 46

6. TEST INSTRUMENT USED
6.1. For Conducted Disturbance at Mains Terminals Emission Test
Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. Test Receiver Rohde & Schwarz ESCI 100492 Mar. 06, 20 1 Year
2. L.I.S.N. Rohde & Schwarz ENV216 100093 Mar. 06, 20 1 Year
3. Coaxial Switch Anritsu Corp MP59B 6200283933 Mar. 06, 20 1 Year
4. Terminator Hubersuhner 50 No.1 Mar. 06, 20 1 Year
5. RF Cable SchwarzBeck N/A No.1 Mar. 06, 20 1 Year

6.2. For Radiation Test(In Anechoic Chamber)(Below 1000MHz)

Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. Test Receiver Rohde & Schwarz ESCI 101202 Mar. 06, 20 1 Year
2. Bilog Antenna Sunol JB3 A121206 Mar. 06, 20 1 Year
3. Cable Resenberger N/A NO.1 Mar. 06, 20 1 Year
4. Cable SchwarzBeck N/A NO.2 Mar. 06, 20 1 Year
5. Cable SchwarzBeck N/A NO.3 Mar. 06, 20 1 Year
6. DC Power Filter DuoJi DL230B N/A N/A N/A
7. Single Phase Power DuoJi FNF 202B30 N/A N/A N/A
Line Filter
8. 3 Phase Power Line DuoJi FNF 402B30 N/A N/A N/A
Filter

6.3. For Radiation Test (In Anechoic Chamber)(Above 1000MHz)

Item Equipment Manufacturer Model No. Serial No. Last Cal.
Cal.
Interval
1 Spectrum Analyzer Agilent E4408B MY414400460 Mar. 06, 20 1 Year
2 Pre-Amplifier DCS PAP-0118 24001 Mar. 06, 20 1 Year
3 Horn Antenna Schwarzback BBHA9120 D69250 Mar. 06, 20 1 Year
D
4 RF Cable Schwarzback LL142-10 RF Cable No.1 Mar. 06, 20 1 Year
5 RF Cable Schwarzback LL142-0.05 RF Cable No.2 Mar. 06, 20 1 Year
6 DC Power Filter DuoJi DL230B N/A N/A N/A
7 Single Phase Power DuoJi FNF 202B30 N/A N/A N/A
Line Filter
8 3 Phase Power Line DuoJi FNF 402B30 N/A N/A N/A
Filter

6.4. For Harmonic / Flicker Test

Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. AC Power Source Kikusui AC40MA LM003232 Mar. 06, 20 1 Year
2. Test Analyzer Kikusui KHA1000 LM003720 Mar. 06, 20 1 Year
3. Line Impendence Kikusui LIN40MA- LM002352 Mar. 06, 20 1 Year
Network PCR-L

Report No. MTET20040455 Page 19 of 46

6.5. For Electrostatic Discharge Immunity Test
Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. ESD Tester Zhongsheng ESD-203AX 023K14538 Mar. 06, 20 1 Year

6.6. For RF Strength Susceptibility Test

Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. Signal Generator IFR 2032 203002/100 Mar. 06, 20 1 Year
2. Amplifier A&R 150W1000 301584 NCR NCR
3. Dual Directional Coupler A&R DC6080 301508 Mar. 06, 20 1 Year
4. Power Sensor A&R PH2000 301193 Mar. 06, 20 1 Year
5. Power Meter A&R PM2002 302799 Mar. 06, 20 1 Year
6. Field Monitor A&R FM5004 300329 Mar. 06, 20 1 Year
7. Field Probe A&R FP5000 300221 Mar. 06, 20 1 Year
8. Log-periodic Antenna A&R AT1080 17512 Mar. 06, 20 1 Year
9. RF Cable MIYAZAKI N/A No.1/No.2 Mar. 06, 20 1 Year

6.7. For Electrical Fast Transient/Burst Immunity Test

Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. EMCPRO System EM Test UCS-500-M4 V0648102026 Mar. 06, 20 1 Year

6.8. For Surge Test

Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. EMCPRO System EM Test UCS-500-M4 V0648102026 Mar. 06, 20 1 Year

6.9. For Injected Currents Susceptibility Test

Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. Signal Generator IFR 2032 203002/100 Mar. 06, 20 1 Year
2. Amplifier A&R 150W1000 301584 NCR NCR
3. CDN FCC FCC-801-M2-25 47 Mar. 06, 20 1 Year
4. CDN FCC FCC-801-M3-25 107 Mar. 06, 20 1 Year
5. EM Injection Clamp FCC F-203I-23mm 403 Mar. 06, 20 1 Year
6. RF Cable MIYAZAKI N/A No.1/No.2 Mar. 06, 20 1 Year

6.10.For Magnetic Field Immunity Test

Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. EMCPRO System EM Test UCS-500-M4 V0648102026 Mar. 06, 20 1 Year

Report No. MTET20040455 Page 20 of 46

6.11.or Voltage Dips and Interruptions Test
Item Equipment Manufacturer Model No. Serial No. Last Cal. Cal.
Interval
1. EMCPRO System EM Test UCS-500-M4 V0648102026 Mar. 06, 20 1 Year

Report No. MTET20040455 Page 21 of 46

7. CONDUCTED DISTURBANCE AT MAINS TERMINALS TEST

7.1. Configuration of Test System

7.2. Test Standard

CISPR 11:2015+A1:2016+A2:2019

7.3. Power Line Conducted Disturbance at Mains Terminals Limit

Maximum RF Line Voltage
Frequency Quasi-Peak Level Average Level
dB(V) dB(V)
150kHz ~ 500kHz 66 ~ 56* 56 ~ 46*
500kHz ~ 5MHz 56 46
5MHz ~ 30MHz 60 50
Notes: 1. * Decreasing linearly with logarithm of frequency.
2. The lower limit shall apply at the transition frequencies.

7.4. Test Procedure

The EUT was placed on a non-metallic table, 80cm above the ground plane. The EUT Power
connected to the power mains through a line impedance stabilization network (L.I.S.N. 1#).
This provided a 50-ohm coupling impedance for the EUT (Please refer to the block diagram
of the test setup). The other peripheral devices power cord connected to the power mains
through a line impedance stabilization network (L.I.S.N.#2). Both sides of power line were
checked for maximum conducted interference. In order to find the maximum emission, the
relative positions of equipments and all of the interface cables were changed according to
CISPR 11 Class B on conducted Disturbance test.

The bandwidth of test receiver is set at 9kHz.

The frequency range from 150kHz to 30MHz is checked. The test result are reported on
Section 7.5.

Report No. MTET20040455 Page 22 of 46

7.5. Conducted Disturbance at Mains Terminals Test Results
7.5.1. Test Results: N/A

7.5.2. If the average limit is met when using a quasi-peak detector, the EUT shall be deemed
to meet both limits and measurement with average detector is unnecessary.

7.5.3. Emission Level= Correct Factor + Reading Level.

Report No. MTET20040455 Page 23 of 46

8. RADIATED DISTURBANCE TEST

8.1. Configuration of Test System

8.2. Test Standard

CISPR 11:2015+A1:2016+A2:2019

8.3. Radiated Disturbance Limit

All emanations from a Class B computing devices or system, including any network of
conductors and apparatus connected thereto, shall not exceed the level of field strengths
specified below:
FREQUENCY DISTANCE FIELD STRENGTHS LIMITS
(MHz) (Meters) (dBV/m)
30 ~ 230 10 30(QP)
230 ~ 1000 10 37(QP)
1000-3000 3 70(Peak) 50(AV)
3000-6000 3 74(Peak) 54(AV)
Note: 1.The lower limit shall apply at the transition frequencies.
2. Distance refers to the distance in meters between the test antenna and the
closed point of any part of the EUT.

8.4. Operating Condition of EUT

8.4.1.Environmental Conditions:
Ambient Temperature: 26℃, Relative Humidity: 60 %
8.4.2.Setup the EUT and the simulators as shown on Section 5.1.

8.4.3.Turn on the power of all equipments.

8.4.4.Let the EUT work in test mode (Running) and test it.

Report No. MTET20040455 Page 24 of 46

8.5. Test Procedure
The EUT was placed on a non-metallic table, 80 cm above the ground plane inside a
semi-anechoic chamber. An antenna was located 3m from the EUT on an adjustable mast. A
pre-scan was first performed in order to find prominent radiated emissions. For final
emissions measurements at each frequency of interest, the EUT were rotated and the antenna
height was varied between 1m and 4m in order to maximize the emission. Measurements in
both horizontal and vertical polarities were made and the data was recorded. In order to find
the maximum emission, the relative positions of equipments and all of the interface cables
were changed according to CISPR 11 Class B on Radiated Disturbance test.

The bandwidth setting on the test receiver is 120 kHz.(frequency range from 30MHz to
1000MHz) and 1MHz (frequency range from 1000MHz to 6000MHz).

The frequency range from 30MHz to 6000MHz is checked. The test result are reported on
Section 8.6
.

8.6. Radiated Disturbance Test Results

8.6.1. Test Results: PASS

8.6.2. Emission Level= Correct Factor + Reading Level.

8.6.3. All reading are Quasi-Peak values.

8.6.4. The test data and the scanning waveform are attached within Appendix I.
Note:All test modes are performed, only the worst case is recorded in this report.

Report No. MTET20040455 Page 25 of 46

9. HARMONIC CURRENT TEST

9.1. Configuration of Test System

9.2. Test Standard

EN IEC 61000-3-2:2019;

9.3. Test Limits

For Class A equipment, the hamonics of the input current shall not exceed the values given
in below:

Harmonic order Maximum permissible

n Harmonic current
A
Odd harmonics
3 2.30
5 1.14
7 0.77
9 0.40
11 0.33
13 0.21
15≦n≦39 0.15 15/n
Even harmonics
2 1.08
4 0.43
6 0.30
8≦n≦40 0.23 8/n

9.4. Test Results

No limits apply for equipment with an active input power less than or equal to 75W.

Report No. MTET20040455 Page 26 of 46

10. VOLTAGE FLUCTUATIONS & FLICKER TEST

10.1.Configuration of Test System

Same as Section 9.1.

10.2.Test Standard
EN 61000-3-3:2013+A1:2019

10.3.Test Limits
The limits shall be applicable to voltage fluctuations and flicker ata the supply
terminal s of the equipment under test, the following limites apply:
the value of Pst shall not be greater than 1.0;
the value of Plt shall not be greater than 0.65;
the value of d(t) during a voltage change shall not exceed 3.3% for more than 500ms;
the relative steady-state voltage change, dc, shall not exceed 3.3%;
the maximum relative voltage change dmax, shall not exceed
a) 4% without additional conditions;
b) 6% for equipment which is:
Switched manually, or
Swithced automatically more frequently than twice per day, and also has either a delayed
restart(the delay being not less than a few thens of seconds), or manual restart, after a
power supply interruption.
c) 7%for equipment which is
Attended whilst in use (for example: hair dryers, vacuum cleaners, kitchen equipment
such as mixers, garden equipment such as lawn mowers, portable tools such as electric
drills), or
switched on automatically, or is intended to be switched on manually, no more than twice
per day, and also has either a delayed restart(the delay being not less than a few tens of
seconds) or manual restart, after a power supply interruption.

10.4.Test Results
10.4.1.Test Results: N/A

Report No. MTET20040455 Page 27 of 46

11. IMMUNITY PERFORMANCE CRITERIA
Under the test conditions specified in EN 60601-1-2 chapter 36.201 *j), the EQUIPMENT or
SYSTEM Shall be able to provide the ESSENTAL PERFORMANCE and remain safe. The follow
DEGRATIONS associated with ESSENTIAL PERFORMANCE and safety shall not be allowed:
- component failures;
- changes in programmable parameters;
- reset to factory defaults (manufacturer’s presets);
- change of operating mode;
- false alarms
- cessation or interruption of any intended operation, even if accompanied by an alarm;
- initiation of any unintended operation, including unintended or uncontrolled motion, even if
accompanied by an alarm;
- error of a displayed numerical value sufficiently large to affect diagnosis or treatment;
- noise on a waveform in which the noise is indistinguishable from physiologically-produced
signals or the noise interferes with interpretation of physiologically-produced signals;
- artifact or distortion in an image in which the artifact is indistinguishable from
physiologically-produced signals or the distortion interferes with interpretation of
physiologically-produced signals;
- failure of automatic diagnosis or treatment EQUIPMENT and SYSTEM to diagnose or treat,
even if accompanied by an alarm.

For EQUIPMENT and SYSTEM with multiple FUNCTIONS, the criteria apply to each,
parameter, and channel.
All immunity test item on this report are compliance with EN 60601-1-2 chapter 36.201 *j)
require.

Report No. MTET20040455 Page 28 of 46

12. ELECTROSTATIC DISCHARGE IMMUNITY TEST

12.1.Configuration of Test System

12.1.1. Configuration of ESD Test System(Direct Discharge)

12.1.2.Configuration of ESD Test System(Indirect Discharge)

12.2.Test Standard
EN 60601-1-2:2015 (IEC 61000-4-2:2008)
(Severity Level 4 for Air Discharge at 15KV,
Severity Level 4 for Contact Discharge at 8KV)

Report No. MTET20040455 Page 29 of 46

12.3.Severity Levels and Performance Criterion
12.3.1.Severity level
Level Test Voltage Test Voltage
Contact Discharge (KV) Air Discharge (KV)
1. 2 2
2. 4 4
3. 6 8
4. 8 15
X Special Special

12.4.Test Procedure
12.4.1.Air Discharge:
The test was applied on non-conductive surfaces of EUT. The round discharge tip of
the discharge electrode was approached as fast as possible to touch the EUT. After each
discharge, the discharge electrode was removed from the EUT. The generator was
re-triggered for a new single discharge and repeated 20 times for each pre-selected test
point. This procedure was repeated until all the air discharge completed
12.4.2.Contact Discharge:
All the procedure was same as Section 12.4.1. except that the generator was
re-triggered for a new single discharge and repeated 50 times for each pre-selected test
point. the tip of the discharge electrode was touch the EUT before the discharge switch
was operated.

12.5.Test Results
12.5.1.Test Results: PASS

12.5.2.Test data on the following pages.

Report No. MTET20040455 Page 30 of 46

 Electrostatic Discharge Test Results
Shenzhen Most Technology Service Co., Ltd.

Test Voltage : 1 Test Date: Apr.17, 2020

Test Mode : 1
Temperature: 24℃ Humidity: 54%
Air Discharge: ±15KV # For Air Discharge each Point Positive 10 times and negative
10 times discharge.
Contact Discharge: ±8KV # For Contact Discharge each point positive 10 times and negative
10 times discharge
Test Results Description
Kind
Location Result
A-Air Discharge
C-Contact
Discharge

Gaps A PASS

Switch A PASS

Keys A PASS

HCP C PASS

VCP of Front C PASS

VCP of Rear C PASS

VCP of Left C PASS

VCP of Right C PASS

Remark : No degradation in the performance of the EUT was observed

Discharge was considered on Contact and Air and Horizontal Coupling Plane (HCP) and Vertical Coupling Plane
(VCP).

Reviewer :

Report No. MTET20040455 Page 31 of 46

13. RF FIELD STRENGTH SUSCEPTIBILITY TEST

13.1.Configuration of Test System

Anechoic
Room
4m

3m
3m EUT
1.5
0.8 m
m

7m

13.2.Test Standard
EN 60601-1-2:2015 (IEC 61000-4-3:2006+A1:2007+A2:2010)
(Severity Level: 1 at 3V/m)

13.3.Severity Levels and Performance Criterion

13.3.1.Severity level
Level Test Field Strength V/m
1. 1
2. 3
3. 10
X Special

Report No. MTET20040455 Page 32 of 46

13.4.Test Procedure
Testing was performed in a Fully anechoic chamber as recommended by IEC 61000-4-3.
The EUT was placed on an 80 cm high non-conductive table located in the area of field
uniformity. The radiating antenna was placed 3m in front of the EUT and Support system,
and dwell time of the radiated interference was controlled by an automated,
computer-controlled system. The signal source was stepped through the applicable frequency
range at a rate no faster than 1％ of the fundamental. The signal was amplitude modulated
80％ over the frequency range 80 MHz to 2.7GHz at a level of 3 V/m. The dwell time was
set at 1.5 s. Field presence was monitored during testing via a field probe placed in close
proximity to the EUT. Throughout testing, the EUT was closely monitored for signs of
susceptibility. The test was performed with the antennae oriented in both a horizontal and
vertical polarization.

All the scanning conditions are as follows :

Condition of Test Remarks
---------------------------------------------- ----------------------------------
1. Test Fielded Strength 3 V/m (Severity Level 2)
2. Radiated Signal 80% amplitude modulated with a
1kHz sine wave
3. Scanning Frequency 80 - 2700 MHz
4. Sweeping time of radiated 0.0015 decade/s
5. Dwell Time 1.5 Sec.

13.5.Test Results
13.5.1.Test Results: PASS

13.5.2.Test data on the following pages.

Report No. MTET20040455 Page 33 of 46

 RF Field Strength Susceptibility Test Results
Shenzhen Most Technology Service Co., Ltd.

Test Voltage : 1 Test Date: Apr.17, 2020

Test Mode : 1 Frequency Range: 80-2700MHz
Field Strength : 3 V/m
Temperature: 24℃ Humidity: 54%
Modulation:  AM  Pulse  none 1 kHz 80%
Test Results Description
Frequency Rang 1:
80MHz - 2700 MHz
Steps 1% 1%
Horizontal Vertical
Front PASS PASS
Right PASS PASS
Rear PASS PASS
Left PASS PASS

Note: No function loss

No degradation in the performance of the EUT was observed

Reviewer :

Report No. MTET20040455 Page 34 of 46

 Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment
Test Maximum IMMUNITY Result
Band a) Distance
Frequency Service a) Modulation b) Power TEST LEVEL
(MHz) (m)
(MHz) (W) (V/m)
Pulse
1,8
385 380 –390 TETRA 400 modulation b) 0,3 27 PASS
18 Hz
FM c)
430 – GMRS 460, ± 5 kHz
450 2 0,3 28 PASS
470 FRS 460 deviation
1 kHz sine
710 Pulse
704 – LTE Band 13, PASS
745 modulation b) 0,2 0,3 9
787 17
780 217 Hz
810 GSM 800/900,
870 TETRA 800, Pulse
800 – PASS
iDEN 820, modulation b) 2 0,3 28
960
930 CDMA 850, 18 Hz
LTE Band 5
1 720 GSM 1800;
1 845 CDMA 1900;
GSM 1900; Pulse
1 700 – PASS
DECT; modulation b) 2 0,3 28
1 990
1 970 LTE Band 1, 217 Hz
3,
4, 25; UMTS
Bluetooth,
WLAN, Pulse
2 400 –
2 450 802.11 b/g/n, modulation b) 2 0,3 28 PASS
2 570
RFID 2450, 217 Hz
LTE Band 7
5 240 Pulse
5 100 – WLAN 802.11
5 500 modulation b) 0.2 0,3 9 PASS
5 800 a/n
5 785 217 Hz
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the
ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC
61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does
not
represent actual modulation, it would be worst case.

Report No. MTET20040455 Page 35 of 46

14. ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST

14.1.Configuration of Test System

14.2.Test Standard
EN 60601-1-2:2015 (IEC 61000-4-4:2012)
(Severity Level 3 for power line at 2KV,
Severity Level 2 for input/output port at 1KV)

14.3.Severity Levels and Performance Criterion

14.3.1.Severity level
Open Circuit Output Test Voltage ±10％
Level On Power Supply On I/O (Input/Output)
Lines Signal data and control lines
1. 0.5 KV 0.25 KV
2. 1 KV 0.5 KV
3. 2 KV 1 KV
4. 4 KV 2 KV
X Special Special

Report No. MTET20040455 Page 36 of 46

14.4.Test Procedure
The EUT and its simulators were placed on a the ground reference plane and were insulated
from it by an wood support 0.1m + 0.01m thick. The ground reference plane was 1m*1m
metallic sheet with 0.65mm minimum thickness. This reference ground plane was project
beyond the EUT by at least 0.1m on all sides and the minimum distance between EUT and
all other conductive structure, except the ground plane was more than 0.5m. All cables to
the EUT was placed on the wood support, cables not subject to EFT/B was routed as far as
possible from the cable under test to minimize the coupling between the cables.
14.4.1.For input and AC power ports:

14.4.2.The EUT was connected to the power mains by using a coupling device which
couples the EFT interference signal to AC power lines. Both positive transients and
negative transients of test voltage was applied during compliance test and the duration
of the test can’t less than 2mins.

14.4.3.For signal lines and control lines ports:

14.4.4.It’s necessary to test.

14.4.5.For DC input and DC output power ports:

14.4.6.It’s unnecessary to test.

14.5.Test Results
14.5.1.Test Results: N/A

Report No. MTET20040455 Page 37 of 46

15. SURGE TEST

15.1.Configuration of Test System

15.2.Test Standard
EN 60601-1-2:2015 (IEC 61000-4-5:2014+A1:2017+A1:2017)
(Severity Level : Line to Line was Level 2 at 1KV
Line to PE was Level 3 at 2KV)

15.3.Severity Levels and Performance Criterion

15.3.1.Severity level
Severity Level Open-Circuit Test Voltage
KV
1 0.5
2 1.0
3 2.0
4 4.0
* Special

Report No. MTET20040455 Page 38 of 46

15.4.Test Procedure
15.4.1.Set up the EUT and test generator as shown on Section 15.1.

15.4.2.For line to line coupling mode, provide a 1KV 1.2/50us voltage surge (at
open-circuit condition) and 8/20us current surge to EUT selected points, and for
active line / neutral line to ground are same except test level is 2KV.

15.4.3.At least 5 positive and 5 negative (polarity) tests with a maximum 1/min repetition
rate are applied during test.

15.4.4.Different phase angles are done individually.

15.4.5.Record the EUT operating situation during compliance test and decide the EUT
immunity criterion for above each test.

15.5.Test Results
15.5.1.Test Results: N/A

Report No. MTET20040455 Page 39 of 46

16. INJECTED CURRENTS SUSCEPTIBILITY TEST

16.1.Configuration of Test System

16.2.Test Standard
EN 60601-1-2:2015 (IEC61000-4-6:2013)
(Severity Level 2 at 3V (r.m.s.) and frequency is from 0.15MHz to 80MHz)

16.3. Severity Levels and Performance Criterion

16.3.1.Severity level
Level Voltage Level (e.m.f.) V
1. 1
2. 3
3. 10
X Special

Report No. MTET20040455 Page 40 of 46

16.4.Test Procedure
16.4.1.Set up the EUT, CDN and test generators as shown on Section 16.1.

16.4.2.Let the EUT work in test mode and test it.

16.4.3.The EUT are placed on an insulating support 0.1m high above a ground reference
plane. CDN (coupling and decoupling device) is placed on the ground plane about
0.3m from EUT. Cables between CDN and EUT are as short as possible, and their
height above the ground reference plane shall be between 30 and 50 mm (where
possible).

16.4.4.The disturbance signal description below is injected to EUT through CDN.

16.4.5.The EUT operates within its operational mode(s) under intended climatic conditions
after power on.

16.4.6.The frequency range is swept from 0.150MHz to 80MHz using 3V signal level, and
with the disturbance signal 80% amplitude modulated with a 1KHz sine wave.

16.4.7.The rate of sweep shall not exceed 1.5*10-3decades/s. Where the frequency is swept
incrementally, the step size shall not exceed 1% of the start and thereafter 1% of the
preceding frequency value.

16.4.8.Recording the EUT operating situation during compliance testing and decide the EUT
immunity criterion.

16.5.Test Results
16.5.1.Test Results: N/A

Report No. MTET20040455 Page 41 of 46

17. MAGNETIC FIELD IMMUNITY TEST

17.1.Configuration of Test System

EUT
0.1 m thickness
Insulating Support

Magnetic Field
Tester

Ground Reference Plane

17.2.Test Standard
EN 60601-1-2:2015 (IEC 61000-4-8:2009)
(Severity Level 4 at 30A/m)

17.3.Severity Levels and Performance Criterion

17.3.1.Severity level
Level Magnetic Field Strength A/m

1. 1
2. 3
3. 10
4. 30
5. 100
X. Special

Report No. MTET20040455 Page 42 of 46

17.4.Test Procedure
The EUT was subjected to the test magnetic field by using the induction coil of standard
dimensions (1m*1m) and shown in Section 17.1. The induction coil was then rotated
by 90°in order to expose the EUT to the test field with different orientations.

17.5.Test Results
17.5.1.Test Results: PASS

17.5.2.Test data on the following pages.

Report No. MTET20040455 Page 43 of 46

 Magnetic Field Immunity Test Results
Shenzhen Most Technology Service Co., Ltd.

Test Voltage : 1 Test Date: Apr.17, 2020

Test Mode : 1
Temperature: 24℃ Humidity: 54%
Test Results Description
Test Level Testing Duration Coil Orientation Result

30A/m 5 mins X PASS

30A/m 5 mins Y PASS

30A/m 5 mins Z PASS

Remark: No function loss.

No degradation in the performance of the EUT was observed.

Reviewer :

Report No. MTET20040455 Page 44 of 46

18. VOLTAGE DIPS AND INTERRUPTIONS TEST

18.1.Configuration of Test System

18.2.Test Standard
EN 60601-1-2:2015 (IEC 61000-4-11:2004+A1:2017)
(Severity level: 5% 250 periods
5% 0.5 period
40% 5 periods
70% 25 periods )

18.3.Severity Levels and Performance Criterion

18.3.1.Severity level
Test Level Voltage dip and short Duration
%UT interruptions (in period)
%UT
<5 >95 250

<5 >95 0.5

<5 >95 1

70 30 25

Report No. MTET20040455 Page 45 of 46

18.4.Test Procedure
18.4.1.The EUT and test generator were setup as shown on Section 18.1.

18.4.2.The interruptions is introduced at selected phase angles with specified duration.

18.4.3.Record any degradation of performance.

18.5.Test Results
18.5.1.Test Results: N/A
Compliance Criteria for Voltage Dips, Short Interruptions and Voltage Variations:
refer to EN 60601-1-2:2015 chapter 36.202.7.
Equipment and system with a rated input power of 1KVA or less and all
life-supporting equipment and systems shall comply with the requirements of
36.202.1j

Report No. MTET20040455 Page 46 of 46

APPENDIX I
EUT: Infared Forehead Thermometer M/N: F103
Mode: Running Phase: Horizontal
Test by: Jaya Power: DC 3V by Batteries
Temperature: / Humidity 26.0℃/ 55.0% Test date: 2020-04-17
EUT: Infared Forehead Thermometer M/N: F103
Mode: Running Phase: Vertical
Test by: Jaya Power: DC 3V by Batteries
Temperature: / Humidity 26.0℃/ 55.0% Test date: 2020-04-17
APPENDIX II
(Test Photos)
Radiated Test Setup Photograph

ESD Test Setup Photograph

 APPENDIX III
(Photos of the EUT)
 Figure 1
General Appearance of the EUT

Figure 2
General Appearance of the EUT
 Figure 3
Inside of the EUT

Figure 4
Components side of the PCB
 Figure 5
Components side of the PCB

Figure 6
Components side of the PCB
 Figure 7
Components side of the PCB

Figure 8
Components side of the PCB
 Figure 9
Components side of the PCB

Figure 10
Battery