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Table of contents

Page
1. Summary of Test .................................................................................................................4
1.1 Purpose of test...........................................................................................................................................4
1.2 Standards ...................................................................................................................................................4
1.3 List of applied test to the EUT .................................................................................................................5
1.4 Performance Criteria .................................................................................................................................6
1.5 Monitoring of EUT .....................................................................................................................................6
1.6 Test Plan .....................................................................................................................................................6
1.7 Modification to the EUT by laboratory....................................................................................................6
2. Equipment Under Test ........................................................................................................7
2.1 General Description of equipment ..........................................................................................................7
2.2 EUT information .........................................................................................................................................7
2.3 Variation of the family model(s) ...............................................................................................................7
2.4 Operating mode .........................................................................................................................................7
3. Configuration of equipment ...............................................................................................8
3.1 Equipment(s) used ....................................................................................................................................8
3.2 Cable(s) used .............................................................................................................................................8
3.3 System configuration................................................................................................................................9
4. Conducted emission at mains port test information ......................................................10
4.1 Measurement procedure ........................................................................................................................10
4.2 Calculation method .................................................................................................................................10
4.3 Test data.................................................................................................................................................... 11
5. Radiated emission test information .................................................................................14
5.1 Measurement procedure ........................................................................................................................14
5.2 Calculation method .................................................................................................................................14
5.3 Test data....................................................................................................................................................15
6. Harmonic current emissions ............................................................................................18
6.1 Applied test condition .............................................................................................................................18
6.2 Sample test setup ....................................................................................................................................18
6.3 Test data....................................................................................................................................................19
7. Voltage Change, voltage fluctuation and flicker .............................................................21
7.1 Applied test condition .............................................................................................................................21
7.2 Sample test setup ....................................................................................................................................21
7.3 Test data....................................................................................................................................................22
8. Electrostatic discharge immunity ....................................................................................24
8.1 Applied test condition .............................................................................................................................24
8.2 Sample test setup ....................................................................................................................................24
8.3 Test data....................................................................................................................................................25
8.4 Discharge locations ................................................................................................................................27
9. Radio-frequency electromagnetic field immunity...........................................................32
9.1 Applied test condition .............................................................................................................................32
9.2 Sample test setup ....................................................................................................................................32
9.3 Test data....................................................................................................................................................33

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10. Electrical fast transient/burst immunity ........................................................................35

10.1 Applied test condition ........................................................................................................................... 35
10.2 Sample test setup ..................................................................................................................................35
10.3 Test data..................................................................................................................................................36
11. Surges immunity .............................................................................................................38
11.1 Applied test condition ...........................................................................................................................38
11.2 Sample test setup ..................................................................................................................................38
11.3 Test data ..................................................................................................................................................39
12. Conducted disturbances, induced by radio-frequency fields immunity.....................43
12.1 Applied test condition ........................................................................................................................... 43
12.2 Sample test setup ..................................................................................................................................43
12.3 Test data..................................................................................................................................................44
13. Power-frequency magnetic field immunity ...................................................................45
13.1 Applied test condition ........................................................................................................................... 45
13.2 Sample test setup ..................................................................................................................................45
13.3 Test data..................................................................................................................................................46
14. Voltage dips, short interruption and voltage variations immunity ..............................47
14.1 Applied test condition ........................................................................................................................... 47
14.2 Sample test setup ..................................................................................................................................47
14.3 Test data..................................................................................................................................................48
15. Uncertainty of measurement ..........................................................................................49
16. Laboratory description ...................................................................................................50
Appendix A. Test equipment ................................................................................................51
Appendix B. Configuration photographs ............................................................................54

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1. Summary of Test
1.1 Purpose of test

It is the original test in order to verify conformance to standards listed in section 1.2.

1.2 Standards

IEC 60601-1-2 Ed.3.0:2007

1.2.1 Test Methods

CISPR11:2009 Ed.5.0 + Amendment 1:2010

IEC 61000-3-2:2014 Ed.4.0
IEC 61000-3-3:2013 Ed.3.0
IEC 61000-4-2:2008 Ed.2.0
IEC 61000-4-3:2006 Ed.3.0 + Amendment 1:2007 + Amendment 2:2010
IEC 61000-4-4:2012 Ed.3.0
IEC 61000-4-5:2005 Ed.2.0
IEC 61000-4-6:2003 Ed.2.0 + Amendment 1:2004 + Amendment 2:2006
IEC 61000-4-8:2009 Ed.2.0
IEC 61000-4-11:2004 Ed.2.0

1.2.2 Deviation from standards

None

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1.3 List of applied test to the EUT

Classification
Test item Test Voltage Test Result Comment
of EUT
AC 100V 50Hz
Conducted emission
AC 120V 60Hz Applied PASS -
at mains port
AC 230V 50Hz
Group1 Class B
AC 100V 50Hz
Radiated emission AC 120V 60Hz Applied PASS -
AC 230V 50Hz

Classification
Test item Test Voltage Test Result Comment
of EUT
Harmonic current emissions Class A AC 230V 50Hz *1 Applied PASS *2
*1: Because tests at 100/120V are not prescribed in a standard, tests are not applied.
*2: Limit does not apply to the equipment with rated power of 75W or less.

Test item Test Voltage Test Result Comment

Voltage changes, voltage fluctuations and flicker AC 230V 50Hz *1 Applied PASS -
*1: Because tests at 100/120V are not prescribed in a standard, tests are not applied.

Test item Test Voltage Test Result Comment

AC 100V 50Hz
Electrostatic discharge immunity AC 120V 60Hz Applied PASS -
AC 230V 50Hz
AC 100V 50Hz
Radio-frequency electromagnetic field immunity AC 120V 60Hz Applied PASS -
AC 230V 50Hz
AC 100V 50Hz
Electrical fast transient / burst immunity AC 120V 60Hz Applied PASS -
AC 240V 50Hz
AC 100V 50Hz
Surges immunity AC 120V 60Hz Applied PASS -
AC 240V 50Hz
AC 100V 50Hz
Conducted disturbances, inducted by
AC 120V 60Hz Applied PASS -
radio-frequency fields immunity
AC 230V 50Hz
AC 100V 50/60Hz
Power frequency magnetic field immunity AC 120V 50/60Hz Applied PASS -
AC 230V 50/60Hz
AC 100V 50Hz
Voltage dips immunity AC 120V 60Hz Applied PASS -
AC 240V 50Hz
AC 100V 50Hz
Voltage short interruptions and
AC 120V 60Hz Applied PASS -
voltage variations immunity
AC 240V 50Hz

1.3.1 Test set up

Table-Top

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1.4 Performance Criteria

1.4.1 Manufacturer's Performance criteria specific to the EUT

Degradation of operation such as error message is permissible if EUT operates normally after restart by
operator.

1.4.2 Compliance Criteria (refer to IEC 60601-1-2)

6.2.1.10 Under the test conditions specified in 6.2, the ME EQUIPMENT or ME SYSTEM shall be able to
provide the BASIC SAFETY and ESSENTIAL PERFORMANCE*.
The following DEGRADATIONS if associated with BASIC SAFETY and ESSENTIAL
PERFORMANCE* and 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 would interfere with diagnosis, treatment or monitoring
- Artefact or distortion in an image in which the artefact would interfere with diagnosis, treatment
or monitoring
- Failure of automatic diagnosis or treatment ME EQUIPMENT and ME SYSTEMS to diagnose
or treat, even if accompanied by an alarm.
For ME EQUIPMENT and ME SYSTEMS with multiple FUNCTIONS,
The criteria apply to each FUNCTION, parameter and channel.
The ME EQUIPMENT or ME SYSTEM may exhibit DEGRADATION of performance
(e. g. deviation from manufacturer’s specifications) that does not affect BASIC SAFETY or
ESSENTIAL PERFORMANCE*.
*Following Essential Performance is identified by applicant.
1. Measurement must be performed correctly.
2. Monitor screen display must not be distorted.

1.5 Monitoring of EUT

In order to evaluate the performance of equipment during the test, it is confirmed visually whether
the EUT operates as intended.

1.6 Test Plan

All the tests in this test report are performed according to Test plan number: Z071Z-15087.

1.6.1 Deviation from the Test Plan

None

1.7 Modification to the EUT by laboratory

None

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2. Equipment Under Test

2.1 General Description of equipment

The EUT is a COMPUTERIZED TONOMETER.

2.2 EUT information

Applicant : TOPCON CORPORATION

75-1, Hasunuma-cho, Itabashi-ku Tokyo
174-8580 Japan
Phone: +81-3-3558-2569 Fax: +81-3-3965-6532

Equipment under test : COMPUTERIZED TONOMETER

Trade name : TOPCON

Model number : CT-800A

Serial number : DPM7

EUT condition : Pre-Production

Max. frequency : 50MHz

Power ratings : AC 100V 50-60Hz 30-40VA

AC 100-240V 50-60Hz 30-60VA

Size : (W) 321-340 × (D)523-539 × (H) 440-470 mm

2.3 Variation of the family model(s)

Not applicable

2.4 Operating mode

[Running mode]
i) Running mode is started.
ii) XYZ motor moves.
iii) The capture of the observation image is carried out and measurement arithmetic
processing is performed.
iv) Test data is printed out and LAN output after four second progress.
v) ii) to iv) is repeated

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3. Configuration of equipment
3.1 Equipment(s) used
No. Equipment Company Model No. Serial No. Comment
COMPUTERIZED
1 TOPCON CT-800A DPM7 EUT
TONOMETER
OPTO
2 Barcode Scanner OPL-5850-USB 047185 -
ELECTRONICS
HP Z230 SFF
3 Personal Computer HP JPA4503HVV -
WorkStation
CN-0XT086-74261
4 Display DELL E248WFPb -
-856-4DKU
5 Keyboard HP KU-1156 BDMJA0CVB6A5JC -
6 Mouse HP MSU1158 N/A -

3.2 Cable(s) used

No. Cable Length[m] Shield Connector Comment
1.5 No Plastic *1
a AC power cord for EUT
3.0 No Plastic *2
b USB cable 1.5 Yes Metal -
c LAN cable 3.0 Yes Plastic Cat.7
d Serial cable 1.8 Yes Metal -
e AC power cord for Personal Computer 2.0 No Plastic -
f HDMI-DVI conversion cable 0.2 Yes Metal -
g DVI cable 2.0 Yes Metal -
h AC power cord for Display 1.8 No Plastic -
i Keyboard cable 1.8 Yes Metal -
j Mouse cable 1.8 Yes Metal -
*1: Used in the AC100V 50Hz and AC120V 60Hz.
*2: Used in the AC230V 50Hz and AC240V 50Hz.

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3.3 System configuration

a AC Power source
AC in
(Note2)

b # 2. Barcode
USB
Scanner
1. COMPUTERIZED
TONOMETER e AC 100V 50Hz or
[EUT] AC 120V 60Hz

*c f *g h AC 100V 50Hz or
LAN 4. Display
AC 120V 60Hz
3. Personal
Computer
i #
5. Keyboard
*d
RS-232C

j #
6. Mouse

: Ferrite core
: Connecter
# : Un-detachable cable
* : Bundled excess cable
(CISPR 11 only)

Note1: Numbers assigned to equipment or cables on this diagram correspond to the list in “3.1 Equipment(s) used” and “3.2 Cable(s) used”.
Note2: Please refer to “1.3 List of applied test to the EUT” for test voltage.
Note3: Two ferrite cores of RGB cable (No.g) are accessories of Display (No.4).

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4. Conducted emission at mains port test information

4.1 Measurement procedure

Test was applied by following conditions.

Test method : CISPR 11

Frequency range : 0.15MHz to 30MHz
Test place : Open area test site
EUT was placed on : Wooden table / (W)2.3m × (D)1.0m × (H)0.8m
Vertical Metal Reference Plane : (W)2.4m × (H)2.7m 0.4m away from EUT
Horizontal Metal Reference Plane : 40.0m × 7.8m
Test receiver setting
- Detector : Quasi-peak, Average
- Bandwidth : 9kHz

EUT and peripherals are connected to 50Ω/50μH+5Ω and 50Ω/50μH Artificial Mains Network (AMN) which
are connected to reference ground plane, and are placed 80cm away from EUT. Excess of AC/DC power
cable is bundled in center. AMN for peripheral is terminated in 50Ω.
EUT operating mode is selected to emit the maximum noise. Overall frequency range is investigated with
spectrum analyzer using peak detector. Maximum emission configuration is determined by manipulating the
EUT, peripherals, interconnecting cables. Sufficient time for EUT, peripherals and test equipment is provided
in order for them to warm up to their normal operating condition. If the average limit is met when using a
quasi-peak detector receiver, the EUT shall be deemed to meet both limits.

- Test configuration

4.2 Calculation method

Emission level = Reading + (AMN. factor + Cable system loss)

Margin = Limit – Emission level

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4.3 Test data

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5. Radiated emission test information

5.1 Measurement procedure

Test was applied by following conditions.

Test method : CISPR 11

Frequency range : 30MHz to 1000MHz
Test place : Open area test site
EUT was placed on : Wooden table / (W)2.3m × (D)1.0m × (H)0.8m
Antenna distance : 10m

Test receiver setting

- Detector : Quasi-peak
- Bandwidth : 120kHz

EUT operating mode is selected to emit the maximum noise. Overall frequency range is investigated with
spectrum analyzer using peak detector. Then, emission measurements are performed with test receiver in
above setting. In order to find the maximum emissions, antenna is adjusted between 1m to 4m in height and
varied its polarization (horizontal and vertical), and EUT azimuth is also varied by rotating turntable 0 to 360
degrees. Sufficient time for EUT, peripherals and test equipment is provided in order for them to warm up to
their normal operating condition.

- Test configuration

5.2 Calculation method

Emission level = Reading + (Ant. factor + Cable system loss – Amp. Gain)
Margin = Limit – Emission level

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5.3 Test data

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6. Harmonic current emissions

6.1 Applied test condition

Test was applied by following conditions.

Items Description
Test method IEC 61000-3-2
POHC Limit 150 %
Classification of equipment A
Variability of results of Repeatability: ±5 % of the applicable limit
measurements Same EUT, same test system, same test conditions, repeated tests
Note: Limit does not apply to the equipment with rated power of 75W or less.

6.2 Sample test setup

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6.3 Test data

Operating mode : Running mode

Date of test : August 26, 2015
Test Place : Shielded room No.1
Climatic condition : 22.4ºC 48.2% 987hPa
Test engineer : Yoshiyuki Takahashi

Note: As a result of test performed based on Test plan, EUT passed the test.

This test data meets IEC 61000-3-2:2014

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This test data meets IEC 61000-3-2:2014

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7. Voltage Change, voltage fluctuation and flicker

7.1 Applied test condition

Test was applied by following conditions.

Items Description
Test method IEC 61000-3-3
120 min.
Observation period
1 min. × 24 times (Switched manually)

7.2 Sample test setup

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7.3 Test data

Operating mode : Running mode

Date of test : August 26, 2015
Test Place : Shielded room No.1
Climatic condition : 22.4ºC 48.2% 987hPa
Test engineer : Yoshiyuki Takahashi

Note: As a result of test performed based on Test plan, EUT passed the test.

This test data meets IEC 61000-3-3:2013.

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This test data meets IEC 61000-3-3:2013.

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8. Electrostatic discharge immunity

8.1 Applied test condition

Test was applied by following conditions.

Items Description
Test method IEC 61000-4-2
The equipment and/or system continued to perform its intended
Performance criterion
function as specified by the manufacturer.
Contact discharge : ±2kV, ±4kV, ±6kV
Test level
Air discharge : ±2kV, ±4kV, ±8kV
Contact discharge : 10 discharges
Number of discharge
Air discharge : 10 single discharge
Time interval 1 sec.
Table size Wooden table / (W)2.0m × (D)1.0m × (H)0.8m
Horizontal coupling plane size 1.6m × 0.8m
Vertical coupling plane size 0.5m × 0.5m

8.2 Sample test setup

1) Discharge to EUT
2) Discharge to Horizontal coupling plane
3) Discharge to Vertical coupling plane

*1: Used it for EUT Installation / Table-top only

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8.3 Test data

Operating mode : Running mode

Date of test : August 25, 2015
Test Place : Shielded room No.1
Climatic condition : 26.2ºC 39.7% 984hPa
Test engineer : Hiroomi Tsuchiya

Note: As a result of test performed based on Test plan, EUT passed the test.

[AC100V 50Hz]
[Contact discharge to conductive part]
Result of performance criterion
Discharge Point Test voltage Test voltage Test voltage
Test result
(Refer to discharge locations) 2kV 4kV 6kV
+ - + - + -
Contact discharge ( ) PASS PASS PASS PASS PASS PASS PASS

Horizontal Coupling Plane (Indirect)

PASS PASS PASS PASS PASS PASS PASS
Front, Right, Back, Left edge
Vertical Coupling Plane (Indirect)
PASS PASS PASS PASS PASS PASS PASS
Front, Right, Back, Left side

[Air discharge to insulating surface]

Result of performance criterion
Discharge Point Test voltage Test voltage Test voltage
Test result
(Refer to discharge locations) 2kV 4kV 8kV
+ - + - + -

Air discharge ( ) PASS PASS PASS PASS PASS PASS PASS

[AC120V 60Hz]
[Contact discharge to conductive part]
Result of performance criterion
Discharge Point Test voltage Test voltage Test voltage
Test result
(Refer to discharge locations) 2kV 4kV 6kV
+ - + - + -
Contact discharge ( ) PASS PASS PASS PASS PASS PASS PASS

Horizontal Coupling Plane (Indirect)

PASS PASS PASS PASS PASS PASS PASS
Front, Right, Back, Left edge
Vertical Coupling Plane (Indirect)
PASS PASS PASS PASS PASS PASS PASS
Front, Right, Back, Left side

[Air discharge to insulating surface]

Result of performance criterion
Discharge Point Test voltage Test voltage Test voltage
Test result
(Refer to discharge locations) 2kV 4kV 8kV
+ - + - + -

Air discharge ( ) PASS PASS PASS PASS PASS PASS PASS

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[AC230V 50Hz]
[Contact discharge to conductive part]
Result of performance criterion
Discharge Point Test voltage Test voltage Test voltage
Test result
(Refer to discharge locations) 2kV 4kV 6kV
+ - + - + -
Contact discharge ( ) PASS PASS PASS PASS PASS PASS PASS

Horizontal Coupling Plane (Indirect)

PASS PASS PASS PASS PASS PASS PASS
Front, Right, Back, Left edge
Vertical Coupling Plane (Indirect)
PASS PASS PASS PASS PASS PASS PASS
Front, Right, Back, Left side

[Air discharge to insulating surface]

Result of performance criterion
Discharge Point Test voltage Test voltage Test voltage
Test result
(Refer to discharge locations) 2kV 4kV 8kV
+ - + - + -

Air discharge ( ) PASS PASS PASS PASS PASS PASS PASS

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8.4 Discharge locations

Discharge point, : Contact discharge, : Air discharge

Number: Point where degradation of performance appeared.

Figure1

Figure2

Figure3

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Figure4

Figure5

Figure6

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Figure7

Figure8

Figure9

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Figure10

Figure11

Figure12

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Figure13

Figure14

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9. Radio-frequency electromagnetic field immunity

9.1 Applied test condition

Test was applied by following conditions.

Items Description
Test method IEC 61000-4-3
The equipment and/or system continued to perform its intended
Performance criterion
function as specified by the manufacturer.
Test level 3V/m
Frequency range 80MHz to 2500MHz
Frequency step 1%
Dwell time 3.0 sec.
Modulation AM80% 1kHz
EUT direction Front, Right, Back, Left
Antenna polarity Horizontal and Vertical
2.3m (80MHz to 1000MHz)
Test distance
3.0m (1000MHz to 2500MHz)
1.2m (80MHz to 1000MHz)
Antenna height
1.5m (1000MHz to 2500MHz)
Log periodic antenna (80MHz to 1000MHz)
Antenna type
Broadband horn antenna (1000MHz to 2500MHz)

9.2 Sample test setup

Test room Measurement room

AC outlet
2.3m or 3.0m 1m *1

Antenna
EUT AE

0.8m *2
or
0.1m
1m *1 RS Test System

*1: Wiring is left exposed to the electromagnetic field for a distance of 1m from the EUT.
Wire is arranged parallel to the uniform area of the field.
*2: EUT Installation / Table-top: 0.8m
EUT Installation / Floor-Standing: 0.1m

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9.3 Test data

Operating mode : Running mode

Date of test : August 26, 2015
August 27, 2015
Test Place : Small anechoic chamber
Climatic condition : 23.1ºC 58.8% 987hPa
23.8ºC 53.3% 986hPa
Test engineer : Hiroomi Tsuchiya

Note: As a result of test performed based on Test plan, EUT passed the test.

[AC100V 50Hz]
[80MHz to 1000MHz]
EUT direction Test level (V/m) Antenna polarity Test result
Horizontal PASS
Front (0°) 3
Vertical PASS
Horizontal PASS
Right (90°) 3
Vertical PASS
Horizontal PASS
Back (180°) 3
Vertical PASS
Horizontal PASS
Left (270°) 3
Vertical PASS

[1000MHz to 2500MHz]
EUT direction Test level (V/m) Antenna polarity Test result
Horizontal PASS
Front (0°) 3
Vertical PASS
Horizontal PASS
Right (90°) 3
Vertical PASS
Horizontal PASS
Back (180°) 3
Vertical PASS
Horizontal PASS
Left (270°) 3
Vertical PASS

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[AC120V 60Hz]
[80MHz to 1000MHz]
EUT direction Test level (V/m) Antenna polarity Test result
Horizontal PASS
Front (0°) 3
Vertical PASS
Horizontal PASS
Right (90°) 3
Vertical PASS
Horizontal PASS
Back (180°) 3
Vertical PASS
Horizontal PASS
Left (270°) 3
Vertical PASS

[1000MHz to 2500MHz]
EUT direction Test level (V/m) Antenna polarity Test result
Horizontal PASS
Front (0°) 3
Vertical PASS
Horizontal PASS
Right (90°) 3
Vertical PASS
Horizontal PASS
Back (180°) 3
Vertical PASS
Horizontal PASS
Left (270°) 3
Vertical PASS

[AC230V 50Hz]
[80MHz to 1000MHz]
EUT direction Test level (V/m) Antenna polarity Test result
Horizontal PASS
Front (0°) 3
Vertical PASS
Horizontal PASS
Right (90°) 3
Vertical PASS
Horizontal PASS
Back (180°) 3
Vertical PASS
Horizontal PASS
Left (270°) 3
Vertical PASS

[1000MHz to 2500MHz]
EUT direction Test level (V/m) Antenna polarity Test result
Horizontal PASS
Front (0°) 3
Vertical PASS
Horizontal PASS
Right (90°) 3
Vertical PASS
Horizontal PASS
Back (180°) 3
Vertical PASS
Horizontal PASS
Left (270°) 3
Vertical PASS

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10. Electrical fast transient/burst immunity

10.1 Applied test condition

Test was applied by following conditions.

Items Description
Test method IEC 61000-4-4
The equipment and/or system continued to perform its intended
Performance criterion
function as specified by the manufacturer.
Power port : ±2.0 kV
Test level
Signal port : ±1.0 kV
Spec. of wave form
Rise time of one pulse 5 ns
Impulse duration 50ns
Repetition frequency 5 kHz
Burst duration 15 ms
Burst period 300 ms
Duration 60 sec.

10.2 Sample test setup

Power port

Signal port
To AC outlet

AE EUT

0.1m
EFT/B Test
System

CLAMP

0.5m ±0.05m

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10.3 Test data

Operating mode : Running mode

Date of test : August 26, 2015
Test Place : Shielded room No.1
Climatic condition : 22.4ºC 48.2% 987hPa
Test engineer : Yoshiyuki Takahashi

Note: As a result of test performed based on Test plan, EUT passed the test.

[AC100V 50Hz]
Coupling Injection method Test voltage (kV) Polarity (+/-) Test result
AC power port + PASS
CDN 2
Line - PASS
AC power port + PASS
CDN 2
Neutral - PASS
AC power port + PASS*
CDN 2
Ground - PASS
AC power port + PASS
CDN 2
Line + Neutral + Ground - PASS
Signal port + PASS
Clamp 1
LAN - PASS
PASS*: Barcode Scanner connection stopped when applying disturbance. Barcode scanner is reconnected
by removing and inserting of the connector after the test. However the test result is “PASS” because
manufacturer judged that this degradation of performance does not endanger patient, and it doesn't
influence the essential performance.

[AC120V 60Hz]
Coupling Injection method Test voltage (kV) Polarity (+/-) Test result
AC power port + PASS
CDN 2
Line - PASS
AC power port + PASS
CDN 2
Neutral - PASS
AC power port + PASS*
CDN 2
Ground - PASS
AC power port + PASS
CDN 2
Line + Neutral + Ground - PASS
Signal port + PASS
Clamp 1
LAN - PASS
PASS*: Barcode Scanner connection stopped when applying disturbance. Barcode scanner is reconnected
by removing and inserting of the connector after the test. However the test result is “PASS” because
manufacturer judged that this degradation of performance does not endanger patient, and it doesn't
influence the essential performance.

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 37 of 61

[AC240V 50Hz]
Coupling Injection method Test voltage (kV) Polarity (+/-) Test result
AC power port + PASS
CDN 2
Line - PASS
AC power port + PASS
CDN 2
Neutral - PASS
AC power port + PASS*
CDN 2
Ground - PASS
AC power port + PASS
CDN 2
Line + Neutral + Ground - PASS
Signal port + PASS
Clamp 1
LAN - PASS
PASS*: Barcode Scanner connection stopped when applying disturbance. Barcode scanner is reconnected
by removing and inserting of the connector after the test. However the test result is “PASS” because
manufacturer judged that this degradation of performance does not endanger patient, and it doesn't
influence the essential performance.

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Test Report Rev.IECE1.1
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11. Surges immunity

11.1 Applied test condition

Test was applied by following conditions.

Items Description
Test method IEC 61000-4-5
The equipment and/or system continued to perform its intended
Performance criterion
function as specified by the manufacturer.
Line – Line: ±0.5 kV, ±1.0 kV
Test level
Line – Ground: ±0.5 kV, ±1.0 kV, ±2.0 kV
Spec. of wave form
Open-circuit voltage
Front time/ Time to half value 1.2 μs / 50μs
Short-circuit current
Front time/ Time to half value 8 μs / 20μs
AC power port : 90°, 180°, 270°
Phase angle Signal port : Asynchronous
DC power port : Asynchronous
Number of test 5 times
Repetition rate 1 min.

11.2 Sample test setup

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11.3 Test data

Operating mode : Running mode

Date of test : August 26, 2015
August 27, 2015
August 28, 2015
Test Place : Shielded room No.1
Climatic condition : 22.4ºC 48.2% 987hPa
22.9ºC 50.4% 986hPa
22.1ºC 49.8% 986hPa
Test engineer : Yoshiyuki Takahashi

Note: As a result of test performed based on Test plan, EUT passed the test.

[AC100V 50Hz]
Coupling Test voltage (kV) Phase angle Polarity (+/-) Test result
AC power port + PASS
Line - Neutral 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
AC power port + PASS
Line – Ground 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
+ PASS
2.0 90º
- PASS
+ PASS
2.0 180º
- PASS
+ PASS
2.0 270º
- PASS

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[AC100V 50Hz]
Coupling Test voltage (kV) Phase angle Polarity (+/-) Test result
AC power port + PASS
Neutral - Ground 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
+ PASS
2.0 90º
- PASS
+ PASS
2.0 180º
- PASS
+ PASS
2.0 270º
- PASS

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 Page 41 of 61

[AC120V 60Hz]
Coupling Test voltage (kV) Phase angle Polarity (+/-) Test result
AC power port + PASS
Line - Neutral 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
AC power port + PASS
Line – Ground 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
+ PASS
2.0 90º
- PASS
+ PASS
2.0 180º
- PASS
+ PASS
2.0 270º
- PASS
AC power port + PASS
Neutral - Ground 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
+ PASS
2.0 90º
- PASS
+ PASS
2.0 180º
- PASS
+ PASS
2.0 270º
- PASS

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 Page 42 of 61

[AC240V 50Hz]
Coupling Test voltage (kV) Phase angle Polarity (+/-) Test result
AC power port + PASS
Line - Neutral 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
AC power port + PASS
Line – Ground 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
+ PASS
2.0 90º
- PASS
+ PASS
2.0 180º
- PASS
+ PASS
2.0 270º
- PASS
AC power port + PASS
Neutral - Ground 0.5 90º
- PASS
+ PASS
0.5 180º
- PASS
+ PASS
0.5 270º
- PASS
+ PASS
1.0 90º
- PASS
+ PASS
1.0 180º
- PASS
+ PASS
1.0 270º
- PASS
+ PASS
2.0 90º
- PASS
+ PASS
2.0 180º
- PASS
+ PASS
2.0 270º
- PASS

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 Page 43 of 61

12. Conducted disturbances, induced by radio-frequency fields immunity

12.1 Applied test condition

Test was applied by following conditions.

Items Description
Test method IEC 61000-4-6
The equipment and/or system continued to perform its intended
Performance criterion
function as specified by the manufacturer.
Power port : 3V (e.m.f.)
Test level
Signal port : 3V (e.m.f.)
Frequency range 0.15MHz to 80MHz
Frequency step 1%
Dwell time 3.0 sec.
Modulation AM 80% 1kHz
CDN-M3 (AC power port): For EUT(Internal cable length of CDN:200mm)
CDN-M3 (AC power port): For Peripheral
Coupling & decoupling device CDN-S4 (Signal port)
CDN-S9 (Signal port)
EM clamp (Signal port)

12.2 Sample test setup

Power port

Signal port

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12.3 Test data

Operating mode : Running mode

Date of test : August 28, 2015
August 31, 2015
Test Place : Small anechoic chamber
Climatic condition : 23.8ºC 54.4% 988hPa
23.3ºC 56.5% 982hPa
Test engineer : Hiroomi Tsuchiya

Note: As a result of test performed based on Test plan, EUT passed the test.

[AC100V 50Hz]
Test level
Test port Injection method Test result
(e.m.f.)
AC power port 3V CDN-M3 PASS
Signal port
3V EM clamp PASS
LAN
Signal port
3V CDN-S4 PASS
USB
Signal port
3V CDN-S9 PASS
Serial

[AC120V 60Hz]
Test level
Test port Injection method Test result
(e.m.f.)
AC power port 3V CDN-M3 PASS
Signal port
3V EM clamp PASS
LAN
Signal port
3V CDN-S4 PASS
USB
Signal port
3V CDN-S9 PASS
Serial

[AC230V 50Hz]
Test level
Test port Injection method Test result
(e.m.f.)
AC power port 3V CDN-M3 PASS
Signal port
3V EM clamp PASS
LAN
Signal port
3V CDN-S4 PASS
USB
Signal port
3V CDN-S9 PASS
Serial

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13. Power-frequency magnetic field immunity

13.1 Applied test condition

Test was applied by following conditions.

Items Description
Test method IEC 61000-4-8
The equipment and/or system continued to perform its intended
Performance criterion
function as specified by the manufacturer.
Test level 3 A/m
Power frequency 50 Hz, 60 Hz
Test duration 1 min.
Induction coil 1m × 1m Square coil

13.2 Sample test setup

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13.3 Test data

Operating mode : Running mode

Date of test : August 26, 2015
Test Place : Shielded room No.1
Climatic condition : 22.4ºC 48.2% 987hPa
Test engineer : Yoshiyuki Takahashi

Note: As a result of test performed based on Test plan, EUT passed the test.

[AC100V 50Hz]
Test axis Test level (A/m) Test result
X axis 3 PASS
Y axis 3 PASS
Z axis 3 PASS

[AC 100V 60Hz]

Test axis Test level (A/m) Test result
X axis 3 PASS
Y axis 3 PASS
Z axis 3 PASS

[AC120V 50Hz]
Test axis Test level (A/m) Test result
X axis 3 PASS
Y axis 3 PASS
Z axis 3 PASS

[AC 120V 60Hz]

Test axis Test level (A/m) Test result
X axis 3 PASS
Y axis 3 PASS
Z axis 3 PASS

[AC230V 50Hz]
Test axis Test level (A/m) Test result
X axis 3 PASS
Y axis 3 PASS
Z axis 3 PASS

[AC 230V 60Hz]

Test axis Test level (A/m) Test result
X axis 3 PASS
Y axis 3 PASS
Z axis 3 PASS

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14. Voltage dips, short interruption and voltage variations immunity

14.1 Applied test condition

Test was applied by following conditions.

Description
Items
Voltage dips Voltage interruptions
Test method IEC 61000-4-11
The equipment and/or system continued to perform its intended
Performance criterion
function as specified by the manufacturer.
AC 100V 50Hz AC 100V 50Hz
Nominal voltage AC 120V 60Hz AC 120V 60Hz
AC 240V 50Hz AC 240V 50Hz
>95% Reduction, 0.5 periods
Test level 60% Reduction, 5 periods >95% Reduction, 5 second
30% Reduction, 25 periods
Repeat time 3 times (Interval time of 10 sec.) 3 times (Interval time of 10 sec.)
Phase angle 0º, 180º 0º, 180º

14.2 Sample test setup

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14.3 Test data

Operating mode : Running mode

Date of test : August 26, 2015
Test Place : Shielded room No.1
Climatic condition : 22.4ºC 48.2% 987hPa
Test engineer : Yoshiyuki Takahashi

Note: As a result of test performed based on Test plan, EUT passed the test.

[Voltage dips]
Nominal voltage (V) Reduction (%) Output Voltage (V) Periods Phase angle Test result
>95 0 0.5 0° PASS
>95 0 0.5 180° PASS
60 40 5 0° PASS
100
60 40 5 180° PASS
30 70 25 0° PASS
30 70 25 180° PASS
>95 0 0.5 0° PASS
>95 0 0.5 180° PASS
60 48 5 0° PASS
120
60 48 5 180° PASS
30 84 25 0° PASS
30 84 25 180° PASS
>95 0 0.5 0° PASS
>95 0 0.5 180° PASS
60 96 5 0° PASS
240
60 96 5 180° PASS
30 168 25 0° PASS
30 168 25 180° PASS

[Voltage interruptions]
Nominal voltage (V) Reduction (%) Output Voltage (V) Second Phase angle Test result
>95 0 5 0° PASS*
100
>95 0 5 180° PASS*
>95 0 5 0° PASS*
120
>95 0 5 180° PASS*
>95 0 5 0° PASS*
240
>95 0 5 180° PASS*
PASS*: Power of the EUT was turned off. EUT is recoverable to normal operation by re-setting up the system
after the test. However the test result is “PASS” because manufacturer judged that this degradation
of performance doesn't endanger the patient, and it doesn't influence the essential performance.

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15. Uncertainty of measurement

Expanded uncertainties stated are calculated with a coverage Factor k=2.
Please note that these results are not taken into account when determining compliance or non-compliance
with test result.

Test item Measurement uncertainty

Conducted emission at mains port ±3.0dB

Radiated emission (30MHz – 1000MHz) ±3.8dB

Harmonic current emissions ±2.8%

Voltage change, voltage fluctuations and flicker ±2.8%

Electrostatic discharge immunity ±2.8%

Radio-frequency electromagnetic field immunity(80 - 1000MHz) ±3.1dB

Radio-frequency electromagnetic field immunity(1GHz – 3GHz) ±3.2dB

Electrical fast transient/burst immunity ±2.7%

Surges immunity ±2.7%

Conducted disturbances, inducted by radio-frequency fields immunity ±2.7dB

Power frequency magnetic field immunity ±2.8%

Voltage dips, short interruptions and voltage variations immunity ±2.3%

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16. Laboratory description

1. Location:
TÜV SÜD Zacta Ltd. Yonezawa Testing Center
4149-7 Hachimanpara 5-chome Yonezawa-shi Yamagata 992-1128 Japan
Phone: +81-238-28-2880 Fax: +81-238-28-2888

2. Facility filing information:

1) NVLAP accreditation: NVLAP Lab. code: 200306-0

2) VLAC accreditation: Lab. code: VLAC-013

Conducted Conducted Radiated
Radiated
Site name emission for emission for emission Expiry Date
emission
mains port telecom port (CMAD)
3m Semi-anechoic chamber -
10m Semi-anechoic chamber No.1 VLAC-013
VLAC-013 Jul. 3, 2017
10m Semi-anechoic chamber No.2
Shielded room No.1 - VLAC-013 -

3) FCC filing:
Site name Registration Number Expiry Date
Site 3 91065 Oct. 1, 2017
3m Semi-anechoic chamber
10m Semi-anechoic chamber No.1
540072 Feb. 20, 2017
10m Semi-anechoic chamber No.2
Shielded room No.1

4) Industry Canada Oats site filing:

Site name Sites on file: Oats 3m/10m Expiry Date
Site 3 4224A-3
3m Semi-anechoic chamber 4224A-4 Dec. 3, 2017
10m Semi-anechoic chamber No.1 4224A-5
10m Semi-anechoic chamber No.2 4224A-6 Jan. 15, 2017

5) VCCI site filing:

Conducted Conducted
Radiated
Site name emission for emission for Expiry Date
emission
mains port telecom port
Site 3 R-138 C-134 T-1222 Nov. 16, 2017
3m Semi-anechoic chamber
10m Semi-anechoic chamber No.1 A-0166
Jul. 3, 2017
10m Semi-anechoic chamber No.2
Shielded room No.1 - A-0166

6) TÜV SÜD PS authorization:

Authorized as an EMC test laboratory

7) TÜV Rheinland authorization:

Authorized as an EMC test laboratory

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Test Report Rev.IECE1.1
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Appendix A. Test equipment

Conducted emission at mains port
Equipment Company Model No. Serial No. Cal. due Cal. Date
EMI Receiver ROHDE&SCHWARZ ESCI 100451 Dec. 31, 2015 Dec. 25, 2014
Artificial mains Kyoritsu Electrical
KNW-242C 8-1096-3 Mar. 31, 2016 Mar. 5, 2015
network for EUT Works, Ltd.
Artificial mains Kyoritsu Electrical
KNW-407 8-693-19 Mar. 31, 2016 Mar. 5, 2015
network for peripheral Works, Ltd.
Attenuator TYC BA-PJ-10 N/A(S347) Jun. 30, 2016 Jun. 11, 2015
Coaxial cable FUJIKURA 8D-2W/15m OATS#3C May. 31, 2016 May. 29, 2015
Coaxial cable FUJIKURA 5D-2W/1m OATS#3RC-001 May. 31, 2016 May. 29, 2015
Coaxial cable FUJIKURA 5D-2W/1m OATS#3RC-002 May. 31, 2016 May. 29, 2015
Coaxial switch ANRITSU MP59B 6201280329 May. 31, 2016 May. 29, 2015
50Ω terminator RS 090-0510 N/A(S058) Jan. 31, 2016 Jan. 16, 2015
PC NEC PC-MY18AEZE4 7Y007681A N/A N/A
Software TOYO Corporation EP5/CE-AJ 0611193/V5.6.000 N/A N/A

Radiated emission
Equipment Company Model No. Serial No. Cal. due Cal. date
EMI Receiver ROHDE&SCHWARZ ESCI 100451 Dec. 31, 2015 Dec. 25, 2014
Biconical antenna Schwarzbeck VHA9103/BBA9106 1627 Aug. 31, 2016 Aug. 6, 2015
Log periodic antenna Schwarzbeck UHALP9108A 0398 Aug. 31, 2016 Aug. 6, 2015
Attenuator TDC TAT-43B-03 N/A(S396) Jun. 30, 2016 Jun. 23, 2015
Attenuator TME CFA-01NPJ-3 N/A(S271) Jun. 30, 2016 Jun. 23, 2015
Coaxial cable FUJIKURA 8D-SFA/15m OATS#3R-001 May. 31, 2016 May. 29, 2015
Coaxial cable FUJIKURA 8D-SFA/15m OATS#3R-002 May. 31, 2016 May. 29, 2015
Coaxial cable FUJIKURA 8D-2W/8m OATS#3R-003 May. 31, 2016 May. 29, 2015
Coaxial cable FUJIKURA 5D-2W/1m OATS#3RC-001 May. 31, 2016 May. 29, 2015
Coaxial cable FUJIKURA 5D-2W/1m OATS#3RC-002 May. 31, 2016 May. 29, 2015
Preamplifier ANRITSU MH648A M96157 May. 31, 2016 May. 29, 2015
Coaxial switch ANRITSU MP59B 6201280329 May. 31, 2016 May. 29, 2015
Normalized Site Attenuation TÜV SÜD Zacta Ltd. N/A OATS#3 Aug. 31, 2016 Aug. 28, 2015
PC NEC PC-MY18AEZE4 7Y007681A N/A N/A
Software TOYO Corporation EP5/RE-AJ 0611193/V5.4.011 N/A N/A
Spectrum analyzer Agilent Technologies 8568B 2732A03847 Mar. 31, 2016 Mar. 11, 2015
Spectrum analyzer Display Agilent Technologies 85662A 2648A14093 Mar. 31, 2016 Mar. 11, 2015

Harmonic current emissions

Voltage change, Voltage fluctuation and flicker
Equipment Company Model No. Serial No. Cal. due Cal. Date
Power Analyzer KIKUSUI KHA1000 MC004192 Jul. 31, 2016 Jul. 6, 2015
Software KIKUSUI SD005-KHA Ver 3.63 N/A N/A
Interface NF Corporation 4471 N/A(1350) N/A N/A
Reference impedance network NF Corporation SEN35239 809289 Nov. 30, 2015 Nov. 29, 2014
Signal-phase master NF Corporation 4420 300116 Feb. 29, 2016 Feb. 20, 2015
AC Power Supply(Booster) NF Corporation 4421 192041 Feb. 29, 2016 Feb. 20, 2015
AC Power Supply(Booster) NF Corporation 4421 307873 Feb. 29, 2016 Feb. 20, 2015
AC Power Supply(Booster) NF Corporation 4421 337969 Feb. 29, 2016 Feb. 20, 2015
AC Power Supply(Booster) NF Corporation 4421 337975 Feb. 29, 2016 Feb. 20, 2015

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Electrostatic discharge immunity

Equipment Company Model No. Serial No. Cal. due Cal. Date
ESD simulator NoiseKen ESS-2002 ESS0493502 Sep. 30, 2015 Sep. 10, 2014
Horizontal coupling plane Zacta N/A N/A N/A N/A
Vertical coupling plane Matsushita Techno Trading N/A N/A N/A N/A

Radio-frequency electromagnetic field immunity

Equipment Company Model No. Serial No. Cal. due Cal. Date
Signal generator ROHDE&SCHWARZ SMB100A 100341 May. 31, 2016 May. 12, 2015
Log periodic antenna Schwarzbeck VULP9118E 901 Dec. 31, 2015 Dec. 21, 2014
Millivolt meter ROHDE&SCHWARZ URV5 841771/030 Apr. 30, 2016 Apr. 13, 2015
Power sensor ROHDE&SCHWARZ NRV-Z5 100149 May. 31, 2016 May. 12, 2015
Power sensor ROHDE&SCHWARZ NRV-Z5 100513 May. 31, 2016 May. 12, 2015
Electric field monitor Amplifier Research FM5004 22283 N/A N/A
RF Power Amplifier PRANA AP32MT255 0802-0844 May. 31, 2016 May. 5, 2015
Dual Directional Coupler WERLATONE C3908-727 56196 Oct. 31, 2015 Oct. 5, 2014
Small Semi anechoic Chamber TOKIN N/A N/A(9003) Mar. 31, 2016 Mar. 5, 2015
Software TSJ TEPTO-RS/ANT Ver.4.8.146 N/A N/A
Broad-Band Horn Antenna Schwarzbeck BBHA9120D BBHA9120D317 Nov. 30, 2015 Nov. 7, 2014
RF power amplifier OPHIR 5173F 1001 May. 31, 2016 May. 5, 2015
Electric field probe Amplifier Research FP5080 303195 Jun. 30, 2016 Jun. 2, 2014
Directional coupler WERLATONE C6187-10 99498 Feb. 29, 2016 Feb. 1, 2015

Fast transient/burst immunity

Equipment Company Model No. Serial No. Cal. due Cal. Date
Ultra compact simulator EM TEST UCS500M4 V0550100978 Aug. 31, 2016 Aug. 22, 2014
Capacitive coupling clamp EM TEST HFK N/A(0652) May. 31, 2017 May. 29, 2015

Surge immunity
Equipment Company Model No. Serial No. Cal. due Cal. Date
Ultra compact simulator EM TEST UCS500M4 V0550100978 Aug. 31, 2016 Aug. 22, 2014

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Conducted disturbances, induced by radio-frequency fields immunity

Equipment Company Model No. Serial No. Cal. due Cal. Date
Signal generator ROHDE&SCHWARZ SMB100A 100341 May. 31, 2016 May. 12, 2015
Millivolt meter ROHDE&SCHWARZ URV5 841771/030 Apr. 30, 2016 Apr. 13, 2015
Power sensor ROHDE&SCHWARZ NRV-Z5 100149 May. 31, 2016 May. 12, 2015
Power sensor ROHDE&SCHWARZ NRV-Z5 100513 May. 31, 2016 May. 12, 2015
RF power amplifier Amplifier Research 250A250A 312909 May. 31, 2016 May. 5, 2015
Attenuator Weinschel WA53-6-33 A797 Dec. 31, 2015 Dec. 12, 2014
Directional coupler WERLATONE C6021-10 99483 Feb. 29, 2016 Feb. 1, 2015
CDN-M3 Kyoritsu Electrical Works, Ltd. KSI-8003 8-1230-7 Mar. 31, 2016 Mar. 1, 2015
CDN Fischer Custom Communication, Inc. FCC-801-M2/M3 120565 Jun. 30, 2016 Jun. 1, 2015
CDN Fischer Custom Communication, Inc. FCC-801-M2/M3 120566 Jun. 30, 2016 Jun. 1, 2015
EM clamp Kyoritsu Electrical Works, Ltd. KT-30 8-1199-5 Jul. 31, 2016 Jul. 29, 2015
CDN-S9 Techno Science Japan TSCDN-S9 01049 Jul. 31, 2017 Jul. 29, 2015
CDN-USB Fischer Custom Communication, Inc. FCC-801-S4-USB 112178 Feb. 29, 2016 Feb. 1, 2015
50Ω terminator TDC TDL-21A N/A(S021) Oct. 31, 2015 Oct. 31, 2014
50Ω terminator HRS UG-88/U N/A(S061) Jan. 31, 2016 Jan. 16, 2015
50Ω terminator HRS UG-88/U N/A(S066) Jan. 31, 2016 Jan. 16, 2015
50Ω terminator HRS UG-88/U N/A(S068) Jan. 31, 2016 Jan. 16, 2015
50Ω terminator RS 090-0510 N/A(S058) Jan. 31, 2016 Jan. 16, 2015
Software TSJ TEPTO-S6V32 Ver.3.0.0011 N/A N/A
Artificial hand ZACTA N/A N/A N/A N/A

Power-frequency magnetic field immunity

Equipment Company Model No. Serial No. Cal. due Cal. Date
Magnetic field coil EM TEST MS100 N/A(1495) Dec. 31, 2015 Dec. 22, 2013
Current transformer EM TEST MC2630 0905-08 Dec. 31, 2015 Dec. 22, 2013
Magnetic field exposure level tester Narda S.T.S ELT-400 N-0037 May. 31, 2016 May. 20, 2015
AC power supply NF Corporation EPO4000S 9164181 N/A N/A

Voltage dips, short interruption and voltage variations immunity

Equipment Company Model No. Serial No. Cal. due Cal. Date
Ultra compact simulator EM TEST UCS500M4 V0550100978 Aug. 31, 2016 Aug. 22, 2014
External variac EM TEST MV2616 V0550100979 N/A N/A

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 54 of 61

Appendix B. Configuration photographs

Conducted emission at mains port
[AC100V 50Hz]

The photographs show maximized emission configuration.

Conducted emission at mains port

[AC120V 60Hz]

The photographs show maximized emission configuration.

Conducted emission at mains port

[AC230V 50Hz]

The photographs show maximized emission configuration.

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 55 of 61

Radiated emission
[AC100V 50Hz]

The photographs show maximized emission configuration.

Radiated emission
[AC120V 60Hz]

The photographs show maximized emission configuration.

Radiated emission
[AC230V 50Hz]

The photographs show maximized emission configuration.

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 56 of 61

Harmonic current emissions

Voltage change, Voltage fluctuation and flicker

Electrostatic discharge immunity

Contact discharge Air discharge

Radio-frequency electromagnetic field immunity [80MHz to 1000MHz]

[AC100V 50Hz / AC120V 60Hz]

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 57 of 61

Radio-frequency electromagnetic field immunity [1000MHz to 2500MHz]

[AC100V 50Hz / AC120V 60Hz]

Radio-frequency electromagnetic field immunity [80MHz to 1000MHz]

[AC230V 50Hz]

Radio-frequency electromagnetic field immunity[1000MHz to 2500MHz]

[AC230V 50Hz]

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 58 of 61

Fast transient/burst immunity (AC power port)

Fast transient/burst immunity (Signal port)

[AC100V 50Hz / AC120V 60Hz]

Fast transient/burst immunity (Signal port)

[AC240V 50Hz]

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 59 of 61

Surge immunity

Conducted disturbances, induced by radio-frequency fields immunity (AC power port)

Conducted disturbances, induced by radio-frequency fields immunity (Signal port)

[Clamp]

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 60 of 61

Conducted disturbances, induced by radio-frequency fields immunity (Signal port)

[CDN]

Power-frequency magnetic field immunity

[AC100V 50/60Hz / AC120V 50/60Hz]

Power-frequency magnetic field immunity

[AC230V 50/60Hz]

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1
 Page 61 of 61

Voltage dips, short interruption and voltage variations immunity

[AC100V 50Hz / AC120V 60Hz]

Voltage dips, short interruption and voltage variations immunity

[AC240V 50Hz]

TÜV SÜD Zacta Ltd. Report number: Z071C-15292

Test Report Rev.IECE1.1