emc test report - dimed laser€¦ · 0-413-eos3-lf 1726a00002 03/08/2019 3m semi-anechoic chamber...

Report No. : EED32K002117 of 51

中国认可国际互认

检测TESTINGCNAS L1910

EMC TEST REPORTProduct : Medical diode laser system

Trade mark : N/A

Model/Type reference : BERYLAS-15FJ, BERYLAS-15FI,BERYLAS-15F, BERYLAS-15J,BERYLAS-15I, BERYLAS-10FJ,BERYLAS-10FI, BERYLAS-10F,BERYLAS-10J, BERYLAS-10I

Serial number : N/A

Ratings : 100-240V~, 50/60Hz, 160VA

Report number : EED32K002117

Date : Aug. 19, 2018

Regulations : See below

Test Standards ResultsIEC 60601-1-2:2014EN 60601-1-2:2015

PASSPASS

Prepared for:

Wuhan Dimed Laser Technology Co., Ltd.3rd Floor, Guozhi Building, Great Wall Innovative Science Park, East

Lake High-tech Development Zone, Wuhan, China

Prepared by:

Centre Testing International Group Co., Ltd.Hongwei Industrial Zone, Bao’an 70 District,

Shenzhen, Guangdong, ChinaTEL: +86-755-3368 3668FAX: +86-755-3368 3385

Compiled by: Reviewed by:

Approved by: Approved date: Aug. 19, 2018

David Wang

Technical Supervisor Check No.: 3177404112


TABLE OF CONTENTS

1. GENERAL INFORMATION.........................................................................................................4

2. COMPLIANCE SUMMARY.........................................................................................................4

3. MEASUREMENT UNCERTAINTY............................................................................................ 7

4. PRODUCT INFORMATION AND TEST SETUP.....................................................................7

4.1 PRODUCT INFORMATION..................................................................................................74.2 TEST SETUP CONFIGURATION........................................................................................84.3 SUPPORT EQUIPMENT.......................................................................................................8

5. FACILITIES AND ACCREDITATIONS.....................................................................................8

5.1 TEST FACLITY.......................................................................................................................85.2 TEST EQUIPMENT LIST...................................................................................................... 95.3 LABORATORY ACCREDITATIONS AND LISTINGS...................................................10

6. CONTINUOUS DISTURBANCE..............................................................................................11

6.1 LIMITS....................................................................................................................................116.2 BLOCK DIAGRAM OF TEST SETUP..............................................................................116.3 TEST PROCEDURE............................................................................................................116.4 GRAPHS AND DATA..........................................................................................................12

7. RADIATION DISTURBANCE...................................................................................................16

7.1 LIMITS....................................................................................................................................167.2 BLOCK DIAGRAM OF TEST SETUP..............................................................................167.3 TEST PROCEDURE............................................................................................................167.4 GRAPHS AND DATA..........................................................................................................17

8. HARMONIC CURRENT EMISSION (HARMONIC)..............................................................21

8.1 LIMITS....................................................................................................................................218.2 BLOCK DIAGRAM OF TEST SETUP..............................................................................218.3 TEST PROCEDURE............................................................................................................218.4 TEST RESULTS...................................................................................................................21

9. VOLTAGE FLUCTUATIONS & FLICKER (FLICKER)........................................................24

9.1 LIMITS....................................................................................................................................249.2 BLOCK DIAGRAM OF TEST SETUP..............................................................................249.3 TEST PROCEDURE............................................................................................................249.4 TEST RESULTS...................................................................................................................24

10. IMMUNITY TEST......................................................................................................................26

10.1 ELECTROSTATIC DISCHARGE....................................................................................2710.1.1 TEST SPECIFICATION............................................................................................. 2710.1.2 BLOCK DIAGRAM OF TEST SETUP......................................................................2710.1.3 TEST PROCEDURE...................................................................................................2710.1.4 RESULTS & PERFORMANCE.................................................................................28

10.2 RADIO FREQUENCY ELECTROMAGNETIC FIELDS...............................................2910.2.1 TEST SPECIFICATION............................................................................................. 29


10.2.2 BLOCK DIAGRAM OF TEST SETUP......................................................................2910.2.3 TEST PROCEDURE...................................................................................................3010.2.4 RESULT & PERFORMANCE....................................................................................30

10.3 FAST TRANSIENTS..........................................................................................................3210.3.1 TEST SPECIFICATION............................................................................................. 3210.3.2 BLOCK DIAGRAM OF TEST SETUP......................................................................3210.3.3 TEST PROCEDURE...................................................................................................3210.3.4 RESULT & PERFORMANCE....................................................................................32

10.4 SURGES..............................................................................................................................3310.4.1 TEST SPECIFICATION............................................................................................. 3310.4.2 BLOCK DIAGRAM OF TEST SETUP......................................................................3310.4.3 TEST PROCEDURE...................................................................................................3310.4.4 RESULT & PERFORMANCE....................................................................................33

10.5 INJECTED CURRENTS....................................................................................................3410.5.1 TEST SPECIFICATION............................................................................................. 3410.5.2 BLOCK DIAGRAM OF TEST SETUP......................................................................3410.5.3 TEST PROCEDURE...................................................................................................3410.5.4 RESULT & PERFORMANCE....................................................................................34

10.6 POWER-FREQUENCY MAGNETIC FIELDS............................................................... 3510.6.1 TEST SPECIFICATION............................................................................................. 3510.6.2 BLOCK DIAGRAM OF TEST SETUP......................................................................3510.6.3 TEST PROCEDURE...................................................................................................3510.6.4 RESULTS & PERFORMANCE.................................................................................35

10.7 VOLTAGE DIPS AND INTERRUPTIONS..................................................................... 3610.7.1 TEST SPECIFICATION............................................................................................. 3610.7.2 BLOCK DIAGRAM OF TEST SETUP......................................................................3610.7.3 TEST PROCEDURE...................................................................................................3610.7.4 RESULT & PERFORMANCE....................................................................................36

APPENDIX 1 PHOTOGRAPHS OF TEST SETUP...................................................................37

APPENDIX 2 PHOTOGRAPHS OF PRODUCT........................................................................42

(Note: N/A means not applicable)


1. GENERAL INFORMATION

Applicant: Wuhan Dimed Laser Technology Co., Ltd.3rd Floor, Guozhi Building, Great Wall Innovative Science Park,East Lake High-tech Development Zone, Wuhan, China

Manufacturer: Wuhan Dimed Laser Technology Co., Ltd.3rd Floor, Guozhi Building, Great Wall Innovative Science Park,East Lake High-tech Development Zone, Wuhan, China

Product: Medical diode laser system

Trade mark: N/A

Model/Type reference: BERYLAS-15FJ, BERYLAS-15FI,BERYLAS-15F,BERYLAS-15J, BERYLAS-15I, BERYLAS-10FJ,BERYLAS-10FI, BERYLAS-10F,BERYLAS-10J, BERYLAS-10I

Serial number: N/A

Report number: EED32K002117

Sample Received Date: Aug. 03, 2018

Sample tested Date: Aug. 03, 2018 to Aug. 21, 2018

The tested sample(s) and the sample information are provided by the client.

2. COMPLIANCE SUMMARY

IEC 60601-1-2:2014 & EN 60601-1-2:2015

Clause Requirement + Test Result - Remark Verdict

5 ME EQUIPMENT and ME SYSTEMS identification, marking anddocuments

Pass

5.1 Additional requirements for marking on theoutside of ME EQUIPMENT andME SYSTEMS that are specified for use onlyin a shielded location SPECIAL

ENVIRONMENT

N/A

5.2 Accompanying documents Please refer to usermanual.

Pass

5.2.1 Instructions for use Please refer to usermanual.

Pass

5.2.1.1 General Pass

5.2.1.2 Requirements applicable to ME EQUIPMENTand ME SYSTEMS classified class A

according to CISPR 11

Please refer to usermanual.

Pass

5.2.2 Technical description Please refer to usermanual.

Pass


IEC 60601-1-2:2014 & EN 60601-1-2:2015

Clause Requirement + Test Result - Remark Verdict

5.2.2.1 Requirements applicable to all MEEQUIPMENT and ME SYSTEMS

Please refer to usermanual.

Pass

5.2.2.2 Requirements applicable to ME EQUIPMENTand ME SYSTEMS specified for use

only in a shielded location SPECIALENVIRONMENT

N/A

5.2.2.3 Requirements applicable to ME EQUIPMENTthat intentionally receives RF

electromagnetic energy for the purpose of itsoperation

N/A

5.2.2.4 Requirements applicable to ME EQUIPMENTthat includes RF transmitters

N/A

5.2.2.5 Requirements applicable to PERMANENTLYINSTALLED LARGE ME EQUIPMENT and

LARGE ME SYSTEMS

N/A

5.2.2.6 Requirements applicable to ME EQUIPMENTand ME SYSTEMS that claimcompatibility with HF SURGICALEQUIPMENT

N/A

Requirement – Test Result/Comments Verdict

Emissions

Classification

Class A or B................................................. : Class A —

Group 1 or 2................................................. : Group 1 —

CISPR 11, 14-1, or 15................................ : CISPR 11 —

Limits of mains terminal disturbance voltage : Yes Pass

Limits for radiated disturbance..................: Yes Pass

Limits for disturbance power (if applicable) : N/A —

Harmonic Current Emissions per

IEC 61000-3-2..:

Yes Pass

Voltage Fluctuations and Flicker per

IEC 61000-3-3

Yes Pass

Immunity

Electrostatic Discharges (ESD)................ : Yes Pass


Radiated RF electromagnetic Fields……………..: Yes Pass

Electrical Fast Transients and bursts.......: Yes Pass

Surges...........................................................: Yes Pass

Conducted Disturbances, induced by RF fields : Yes Pass

Voltage Dips, Interruptions, and variations : Yes Pass

Power-frequency Magnetic Fields............ : Yes Pass


3. MEASUREMENT UNCERTAINTY

Where relevant, the following measurement uncertainty levels have been estimatedfor tests performed on the Product as specified in CISPR 16-4-2. This uncertaintyrepresents an expanded uncertainty expressed at approximately the 95% confidence levelusing a coverage factor of k=2.

Test item Value (dB)

Continuous disturbance 3.4

Radiation disturbance 5.3

4. PRODUCT INFORMATION AND TEST SETUP4.1 PRODUCT INFORMATIONRatings: 100-240V~, 50/60Hz, 160VA

Use environment: Professional healthcare facility environment.Home healthcare environment.Special environment.

Model difference: All models are identical except the Wavelength and power . Thetest model is BERYLAS-15FJ and the test results are applicableto the others.

EUT description: Intended use:The BERYLAS medicial diode laser system is a surgical andtherapeutic device which can can realize wonderfulvaporization, incision and coagulation of the tissues with highpower beam laser from fiber ,designed for a wide variety ofdental and surgical procedures, as well as for use in providingtemporary relief of minor pain.The BERYLAS utilizes a solid state diode as a semiconductorsource for invisible infrared radiation. The energy is delivered tothe treatment site via flexible fiber connected the laser sourceand the Handpiece. Various types of handpieces, disposableparameter are designed and optimized for different applications.The device is activated by means of a footswitch.

Test model: ON(Laser output mode)

Main Performance and Technical Specification：

General

Product Name: Medical diode laser system

Model: BERYLAS-15FJ, BERYLAS-15FI,BERYLAS-15F,

BERYLAS-15J, BERYLAS-15I, BERYLAS-10FJ,

BERYLAS-10FI, BERYLAS-10F,BERYLAS-10J,

BERYLAS-10I

Weight: 2.1Kg

Dimensions: 160(W)*180(L)*235(H) mm


Wavelength: 810nm/ 940nm/ 980nm

Maximum Power: 10W/15W/30W(810nm + 980nm)

Pulse Duration: 10us- 3s

Repetition Rate: 0.2Hz- 50KHz

Pilot Beam: Red Diode Laser Of 650nm, Power<5mW

4.2 TEST SETUP CONFIGURATIONSee test photographs attached in Appendix 1 for the actual connections between Productand support equipment.

4.3 SUPPORT EQUIPMENTNo. Device Type Brand Model Series No. Data Cable Power Cord

1. --- --- --- --- --- ---

Notes:1. All the equipment/cables were placed in the worst-case configuration to maximize the emission duringthe test.2. Grounding was established in accordance with the manufacturer’s requirements and conditions for theintended use.

5. FACILITIES AND ACCREDITATIONS5.1 TEST FACLITYAll measurement facilities used to collect the measurement data are located at HongweiIndustrial Zone, 70 Area, Bao’an District, Shenzhen, Guangdong, China. The site andapparatus are constructed in conformance with the requirements of ANSI C63.4 and CISPR16-1-1 other equivalent standards.

The test facility is recognized, certified, or accredited by the following organizations:

CNAS-Lab Code: L1910Centre Testing International Group Co., Ltd. has been assessed and proved to be in

compliance with CNAS-CL01 Accreditation Criteria for Testing and Laboratories (identical toISO/IEC 17025: 2005 General Requirements) for the Competence of Testing andCalibration Laboratories.

A2LA-Lab Cert. No. 3061.01Centre Testing International Group Co., Ltd. EMC Laboratory has been accredited by

A2LA for technical competence in the field of electrical testing, and proved to be incompliance with ISO/IEC 17025: 2005 General Requirements for the Competence ofTesting and Calibration Laboratories and any additional program requirements in theidentified field of testing.

IC-Registration No.: 7408AThe 3m Alternate Test Site of Centre Testing International Group Co., Ltd. has been

registered by Certification and Engineering Bureau of Industry Canada for the performanceof radiated measurements.


IC-Registration No.: 7408BThe 10m Alternate Test Site of Centre Testing International Group Co., Ltd. has been

registered by Certification and Engineering Bureau of Industry Canada for the performanceof radiated measurements.

VCCICentre Testing International Group Co., Ltd.

Mains Ports Conducted Interference Measurement VCCI Registration No. is C-20007.Telecommunication Ports Conducted Disturbance Measurement VCCI Registration No. isT-20008.

3m AlternateRadiated Emission from 30MHz to 1GHz VCCI Registration No. is R-20006.Radiated Emission from 1GHz to 6GHz VCCI Registration No. is G-20021.

10m AlternateRadiated Emission from 30MHz to 1GHz VCCI Registration No. is R-20005.Radiated Emission from 1GHz to 6GHz VCCI Registration No. is G-10758.

5.2 TEST EQUIPMENT LISTInstrumentation: The following list contains equipments used at CTI for testing.The calibrations of the measuring instruments, including any accessories that may effectsuch calibration, are checked frequently to assure their accuracy. Adjustments are madeand correction factors applied in accordance with instructions contained in the manual forthe measuring instrument.

Equipment used during the tests:

Shielding Room No. 1 – Continuous disturbance Test

Equipment Manufacturer Model Serial No. Due Date

Receiver R&S ESCI 100009 05/24/2019

LISN R&S ENV216 100098 05/10/2019

Shielding Room No. 2 - Harmonic / Flicker Test (EN 61000-3-2) / (EN 61000-3-3)


Flicker & Harmonic Tester United States CIL 300-CTS-230 1724A02035 03/08/2019

POWER United States CIL15003ix-CTS-400-413-EOS3-LF

1726A00002 03/08/2019

3M Semi-anechoic Chamber (1)- Radiated disturbance Test


3M Chamber &Accessory Equipment

ETS-LINDGREN FACT-3 3510 06/04/2019

Spectrum Analyzer Agilent E4443A MY45300910 11/15/2018

Receiver R&S ESCI 100009 05/24/2019

TRILOG BroadbandAntenna

schwarzbeck VULB 9163 484 06/04/2019

Multi device Controller ETS-LINGREN 2090 00057230 N/A


Shielding Room No. 3 - Electrostatic discharge Test (IEC 61000-4-2)


ESD Simulator TESEQ NSG437 1182 07/24/2019

3M Full-anechoic Chamber - Radio-frequency electromagnetic field Test (IEC 61000-4-3)


3M Chamber &Accessory Equipment

ETS-LINDGREN FACT-3 3510 06/04/2019

ESG Vector signalgenerators

Agilent E4438C MY42082153 02/04/2019

Power Amplifier AR 150W1000 0322288 01/22/2019

Power Amplifier AR 25S1G4A 0321112 01/22/2019

Stacked double Log.-Per.Antenna

schwarzbeckSTLP 9128 E

special9128ES-110 N/A

Horn Antenna AR ATH800M5GA 0342530 N/A

5GHz Indoor Booster --- JJ55BTABCJJ55BTA00

0022N/A

Shielding Room No. 3 - Fast transients / Surges Test (IEC 61000-4-4) (IEC 61000-4-5)


Compact Generator EM-Test UCS500M/6B V0603101093 06/26/2019

Shielding Room No. 2 - Radio-frequency common mode Test (IEC 61000-4-6)


Signal Generator IFR 2023B 202307/883 11/15/2018

Power Amplifier AR 75A 250A 320297 N/A

Attenuator BIRD 75-A-MFN-06 543 08/05/2021

CDN EM-Test CDN M2/M3 0204-01 05/24/2019

Shielding Room No. 2 - Power-frequency magnetic fields Test (IEC 61000-4-8)

Compact Generator EM-Test UCS500M/6B V0603101093 06/26/2019

Induction Coil EM-Test MS100 0106-47 02/05/2019

Current Transformer EM-Test MC2630 0106-02 02/05/2019

Shielding Room No. 2 –Voltage dips and voltage interruptions Test (IEC 61000-4-11)


POWER United States CIL15003ix-CTS-400-413-EOS3-LF

1726A00002 03/08/2019

Electronic output switch United States CIL EOS3-230 1726A00001 03/08/2019

5.3 LABORATORY ACCREDITATIONS AND LISTINGSThe measuring equipment utilized to perform the tests documented in this report has beencalibrated once a year or in accordance with the manufacturer's recommendations, and istraceable under the ISO/IEC/EN 17025 to international or national standards. Equipment hasbeen calibrated by accredited calibration laboratories.


6. CONTINUOUS DISTURBANCE6.1 LIMITS

Limits for class A Group 1 Equipment

Frequency range

(MHz)

Limits

dB(μV)

Rated input power of ≤ 20 kVA

Quasi-peak Average

0,15 to 0,50 79 66

0,50 to 5 73 60

5 to 30 73 60

NOTE: The lower limit shall apply at the transition frequencies.

6.2 BLOCK DIAGRAM OF TEST SETUP

For mains port:

6.3 TEST PROCEDUREa. The Product was placed on a non-conductive table above the horizontal ground referenceplane, and 0.4 m from the vertical ground reference plane, and connected to the mainthrough Line Impedance Stability Network (L.I.S.N).

b. The RBW of the receiver was set at 200Hz in 9 kHz ~150 kHz with Peak and 9 kHz in 150kHz ~ 30MHz with Peak and AVG detector in Max Hold mode. Run the receiver’s pre-scanto record the maximum disturbance generated from Product in all power lines in the fullband.

c. For each frequency whose maximum record was higher or close to limit, measure its QPor AVG values and record.


6.4 GRAPHS AND DATA

Product : Medical diode laser system

Model/Type reference : BERYLAS-15FJ Temperature : 22℃

Power : AC 120V/60Hz Humidity : 53%

Mode : ON Phase : L





Mode : ON Phase : N





Mode : ON Phase : L





Mode : ON Phase : N


7. RADIATION DISTURBANCE

7.1 LIMITS

Limits for Group 1 class A Equipment

Frequency (MHz)Quasi-peak limits at 3m

dB(μV/m) (≤ 20 kVA)

30-230 50

230-1000 57

NOTE: The lower limit shall apply at the transition frequencies.


7.3 TEST PROCEDURE

a. The Product was placed on the non-conductive turntable 0.8m above the ground at achamber.

b. Set the spectrum analyzer/receiver in Peak detector, Max Hold mode, and 120 kHz RBW.Record the maximum field strength of all the pre-scan process in the full band when theantenna is varied between 1~4 m in both horizontal and vertical, and the turntable is rotatedfrom 0 to 360 degrees.

c. For each frequency whose maximum record was higher or close to limit, measure its QPvalue: vary the antenna’s height and rotate the turntable from 0 to 360 degrees to find theheight and degree where Product radiated the maximum emission, then set the testfrequency analyzer/receiver to QP Detector and specified bandwidth with Maximum HoldMode, and record the maximum value.


7.4 GRAPHS AND DATA




Mode : ON Polarization : Horizontal





Mode : ON Polarization : Vertical





Mode : ON Polarization : Horizontal





Mode : ON Polarization : Vertical


8. HARMONIC CURRENT EMISSION (HARMONIC)

8.1 LIMITS

Please refer to IEC 61000-3-2:2005+A1:2008+A2:2009 Clause 7.


8.3 TEST PROCEDURE

a. The Product was placed on the top of a non-conductive table above the ground andoperated to produce the maximum harmonic components under normal operatingconditions for each successive harmonic component in turn.

b. The correspondent test program of test instrument to measure the current harmonicsemanated from Product was chosen. The measure time shall be not less than the timenecessary for the Product to be exercised.

8.4 TEST RESULTS


Model/Type reference : BERYLAS-15FJ

Power : AC 230V/50Hz Temperature : 22℃

Mode : ON Humidity : 50%

Pass.


Harmonics – Class-A per Ed. 4.0 (2014)(Run time)

EUT: Medical diode laser system Tested by: LXGTest category: Class-A per Ed. 4.0 (2014) (European limits) Test Margin: 100Test date: 30/08/2018 Start time: 14:47:28 End time: 14:50:09Test duration (min): 2.5 Data file name: H-000048.cts_dataComment: BERYLAS-15FJCustomer: /

Test Result: Pass Source qualification: Normal

Current & voltage waveforms

-1.2

-0.6

0.0

0.6

1.2

1.8

-300

-200

-100

0

100

200

300

Cu

rre

nt

(Am

ps)

Vo

ltag

e (V

olts

)

Harmonics and Class A limit line European Limits

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Cu

rre

nt

RM

S(A

mp

s)

Harmonic #4 8 12 16 20 24 28 32 36 40

Test result: Pass Worst harmonics H6-11.3% of 150% limit, H6-10.8% of 100% limit


Current Test Result Summary

Test Result: Pass Source qualification: NormalTHC(A): 0.116 I-THD(%): 36.3 POHC(A): 0.017 POHC Limit(A): 0.251

Highest parameter values during test:V_RMS (Volts): 229.61 Frequency(Hz): 50.00I_Peak (Amps): 1.150 I_RMS (Amps): 0.357I_Fund (Amps): 0.320 Crest Factor: 3.330Power (Watts): 63.8 Power Factor: 0.807

Harm# Harms(avg) 100%Limit %of Limit Harms(max) 150%Limit %of Limit Status

2 0.017 1.080 1.6 0.026 1.620 1.6 Pass3 0.091 2.300 4.0 0.099 3.450 2.9 Pass4 0.030 0.430 7.0 0.050 0.645 7.7 Pass5 0.017 1.140 1.5 0.025 1.710 1.4 Pass6 0.032 0.300 10.8 0.051 0.450 11.3 Pass7 0.016 0.770 2.0 0.023 1.155 2.0 Pass8 0.017 0.230 7.4 0.029 0.345 8.5 Pass9 0.021 0.400 5.1 0.040 0.600 6.7 Pass

10 0.013 0.184 6.9 0.020 0.276 7.2 Pass11 0.021 0.330 6.5 0.036 0.495 7.3 Pass12 0.010 0.153 6.2 0.020 0.230 8.5 Pass13 0.011 0.210 5.1 0.022 0.315 6.8 Pass14 0.009 0.131 6.6 0.018 0.197 9.4 Pass15 0.008 0.150 5.2 0.017 0.225 7.4 Pass16 0.009 0.115 8.2 0.015 0.173 8.4 Pass17 0.006 0.132 4.9 0.018 0.198 8.8 Pass18 0.006 0.102 5.7 0.010 0.153 6.6 Pass19 0.007 0.118 5.8 0.013 0.178 7.2 Pass20 0.004 0.092 N/A 0.008 0.138 N/A Pass21 0.006 0.107 5.7 0.011 0.161 6.6 Pass22 0.005 0.084 N/A 0.008 0.125 N/A Pass23 0.005 0.098 N/A 0.007 0.147 N/A Pass24 0.007 0.077 9.6 0.010 0.115 9.0 Pass25 0.006 0.090 7.0 0.009 0.135 6.6 Pass26 0.008 0.071 10.8 0.011 0.107 10.4 Pass27 0.004 0.083 N/A 0.009 0.125 N/A Pass28 0.006 0.066 8.4 0.010 0.099 10.3 Pass29 0.007 0.078 8.6 0.012 0.116 10.0 Pass30 0.004 0.061 N/A 0.007 0.092 N/A Pass31 0.007 0.073 10.2 0.011 0.109 9.9 Pass32 0.004 0.058 N/A 0.007 0.086 N/A Pass33 0.004 0.068 N/A 0.008 0.102 N/A Pass34 0.003 0.054 N/A 0.008 0.081 N/A Pass35 0.004 0.064 N/A 0.006 0.096 N/A Pass36 0.003 0.051 N/A 0.006 0.077 N/A Pass37 0.003 0.061 N/A 0.007 0.091 N/A Pass38 0.002 0.048 N/A 0.004 0.073 N/A Pass39 0.004 0.058 N/A 0.006 0.087 N/A Pass40 0.002 0.046 N/A 0.004 0.069 N/A Pass


9. VOLTAGE FLUCTUATIONS & FLICKER (FLICKER)

9.1 LIMITS

Please refer to IEC 61000-3-3: 2013 Clause 5.


9.3 TEST PROCEDURE

a. The Product was placed on the top of a non-conductive table above the ground andoperated to produce the most unfavorable sequence of voltage changes under normaloperating conditions.

b. During the flick test, the measure time shall include that part of whole operation cycle inwhich the Product produce the most unfavorable sequence of voltage changes. Theobservation period for short-term flicker indicator is 10 minutes and the observation periodfor long-term flicker indicator is 2 hours.

9.4 TEST RESULTS



Power : AC 230V/50Hz Temperature : 22℃Mode : ON Humidity : 50%

Pass.


Flicker Test Summary

Test Result: Pass Status: Test Completed

Psti and limit line European Limits

0.25

0.50

0.75

1.00

Pst

15

:02

:56

Parameter values recorded during the test:Vrms at the end of test (Volt): 229.49T-max (mS): 0 Test limit (mS): 500.0 PassHighest dc (%): 0.00 Test limit (%): 3.30 PassHighest dmax (%): 0.00 Test limit (%): 4.00 PassHighest Pst (10 min. period): 0.064 Test limit: 1.000 Pass


10. IMMUNITY TEST

Immunity Performance Criteria

Required by IEC 60601-1-2:2014

During the immunity tests, the EUT was operated under conditions specified by clause 4.1of this report.

The particular performance criterion for the immunity tests are specified by manufacturer,with reference to the exampls in Annex I of IEC 60601-1-2:2014.

The equipment or system shall be able to provide the essential performance and remainsafe. The following degradations associated with essential performance and safety shallnot be allowed:

– malfunction;

– non-operation when operation is required;

– unwanted operation when no operation is required;

– deviation from normal operation that poses an unacceptable RISK to the PATIENT orOPERATOR;– component failures;

– change in programmable parameters;

– reset to factory defaults (MANUFACTURER’s presets);

– change of operating mode;

– a FALSE POSITIVE ALARM CONDITION;

– a FALSE NEGATIVE ALARM CONDITION (failure to alarm);

– cessation or interruption of any intended operation, even if accompanied by an ALARMSIGNAL;– initiation of any unintended operation, including unintended or uncontrolled motion,even if accompanied by an ALARM SIGNAL;– 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 ormonitoring;– 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 or ME SYSTEM todiagnose or treat, even if accompanied by an ALARM SIGNAL.

For equipment and systems with multiple functions, the criteria apply to each function,parameter and channel.The equipment and systems may exhibit degradation of performance (e.g. deviation frommanufacturer’s specifications) that does not affect essential performance or safety.


10.1 ELECTROSTATIC DISCHARGE

10.1.1 TEST SPECIFICATION

Basic Standard : IEC 61000-4-2:2008Test Port : Enclosure portDischarge Impedance : 330 ohm / 150 pFDischarge Mode : Single DischargeDischarge Period : one second between each discharge

10.1.2 BLOCK DIAGRAM OF TEST SETUP

10.1.3 TEST PROCEDURE

a. Electrostatic discharges were applied only to those points and surfaces of the Productthat are accessible to users during normal operation.

b. The test was performed with at least ten single discharges on the pre-selected points inthe most sensitive polarity.

c. The time interval between two successive single discharges was at least 1 second.

d. The ESD generator was held perpendicularly to the surface to which the discharge wasapplied and the return cable was at least 0.2 meters from the Product.

e. Contact discharges were applied to the non-insulating coating, with the pointed tip of thegenerator penetrating the coating and contacting the conducting substrate.

f. Air discharges were applied with the round discharge tip of the discharge electrodeapproaching the Product as fast as possible (without causing mechanical damage) to touchthe Product. After each discharge, the ESD generator was removed from the Product andre-triggered for a new single discharge. The test was repeated until all discharges werecomplete.

g. At least ten single discharges (in the most sensitive polarity) were applied to theHorizontal Coupling Plane at points on each side of the Product. The ESD generator waspositioned vertically at a distance of 0.1 meters from the Product with the dischargeelectrode touching the HCP.

h. At least ten single discharges (in the most sensitive polarity) were applied to the center ofone vertical edge of the Vertical Coupling Plane in sufficiently different positions that the fourfaces of the Product were completely illuminated. The VCP (dimensions 0.5m x 0.5m) wasplaced vertically to and 0.1 meters from the Product.


10.1.4 RESULTS & PERFORMANCE




DischargeMethod

Discharge PositionVoltage(±kV)

Min. No. ofDischarge per

polarity(Each Point)

Meet the ImmunityPerformance Criteria

ContactDischarge

Conductive Surfaces 8 10

EUT Operated as intended, nodegradation of function

Indirect Discharge VCP 8 10

Indirect Discharge HCP 8 10

AirDischarge

Slots, Apertures, andInsulating Surfaces

2,4,8,15 10

There was no observable degradation in performance.


10.2 RADIO FREQUENCY ELECTROMAGNETIC FIELDS


Basic Standard : IEC 61000-4-3:2006+A1:2007+A2:2010Test Port : Enclosure portStep Size : 1%Modulation : 1kHz, 80% AMDwell Time : 1 secondPolarization : Horizontal & Vertical


Below 1GHz:

Above 1GHz:



a. The testing was performed in a fully-anechoic chamber. The transmit antenna waslocated at a distance of 3 meters from the Product.

b. The frequency range is swept from 80MHz to 2700MHz, with the signal 80% amplitudemodulated with a 1 kHz sine wave. The rate of sweep did not exceed 1.5x 10-3 decade/s.Where the frequency range is swept incrementally, the step size was 1%.

c. The test was performed with the Product exposed to both vertically and horizontallypolarized fields on each of the four sides.

10.2.4 RESULT & PERFORMANCE




Frequency(MHz)

PositionField Strength

(V/m)Meet the Immunity

Performance Criteria

80 - 2700Front, Right,

Back, Left3

EUT Operated as intended, nodegradation of function.

See the Figure 1Front, Right,

Back, LeftSee the Figure 1

EUT Operated as intended, nodegradation of function.



Figure 1


10.3 FAST TRANSIENTS


Basic Standard : IEC 61000-4-4:2012Test Port : Input AC power portImpulse Frequency : 100 kHzImpulse Wave-shape : 5/50 nsBurst Duration : 0.75 msBurst Period : 300 msTest Duration : 2minutes per polarity


For input a.c. power port:


a. The Product and support units were located on a non-conductive table above groundreference plane.

b. A 0.5m-long power cord was attached to Product during the test.






CouplingVoltage

(kV)Polarity

Meet the Immunity PerformanceCriteria

L+N+PE 2 ±EUT Operated as intended, no

degradation of function.



10.4 SURGES


Basic Standard : IEC 61000-4-5:2005Test Port : input a.c. power portWave-Shape : Open Circuit Voltage - 1.2 / 50 us

Short Circuit Current - 8 / 20 usPulse Repetition Rate : 1 pulse / min.Test Events : 5 pulses (positive & negative) for each polarity



a. The surge is to be applied to the Product power supply terminals via the capacitivecoupling network. Decoupling networks are required in order to avoid possible adverseeffects on equipment not under test that may be powered by the same lines, and to providesufficient decoupling impedance to the surge wave.

b. The power cord between the Product and the coupling/decoupling networks shall be 2meters in length (or shorter). Interconnection line between the Product and thecoupling/decoupling networks shall be 2 meters in length (or shorter).






Coupling LineVoltage(±kV)

Phase AngleMeet the Immunity Performance

Criteria

L– N 0.5, 1

0°, 90°, 180°, 270°EUT Operated as intended, no

degradation of function.L - PE 0.5, 1, 2

N - PE 0.5, 1, 2



10.5 INJECTED CURRENTS


Basic Standard : IEC 61000-4-6:2013Test Port : input a.c. power portStep Size : 1%Modulation : 1 kHz 80% AMDwell Time : 1 second


For input a.c. power port:

10.5.3 TEST PROCEDUREFor input a.c. power port:a. The Product and support units were located at a ground reference plane with theinterposition of a 0.1 m thickness insulating support and the CDN was located on GRPdirectly.b. The frequency range is swept from 150 kHz to 80MHz, with the signal 80% amplitudemodulated with a 1 kHz sine wave. The rate of sweep did not exceed 1.5x 10-3 decade/s.Where the frequency range is swept incrementally, the step size was 1% of fundamental.c. The dwell time at each frequency shall be not less than the time necessary for the Productto be able to respond.

10.5.4 RESULT & PERFORMANCEProduct : Medical diode laser system




Inject LineFrequency

(MHz)Voltage Level

(V r.m.s.)Meet the Immunity Performance

Criteria

Power Line 0.15-803 EUT Operated as intended, no

degradation of function.6*

*:The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz .



10.6 POWER-FREQUENCY MAGNETIC FIELDS


Basic Standard : IEC 61000-4-8:2009Test Port : Enclosure portPower Frequency : 50Hz/60HzDuration : 5 MinDirection : X axis Y axis Z axis



a. The Product and support units were located on a table, 0.1m away from ground floor.b. The Product is configured and connected to satisfy its functional requirements. It shall be

place on the GRP with the interposition of a 0.1m thickness insulating support (e.g. drywood)

c. Setting the parameter of tests and then perform the test software of test simulator.d. The induction coil shall enclose the Product placed at its centre.

10.6.4 RESULTS & PERFORMANCE






DirectionField Strength

(A/m)Duration

(Min)Meet the Immunity

Performance Criteria

X axis 30 5EUT Operated as intended, no

degradation of function.Y axis 30 5

Z axis 30 5


10.7 VOLTAGE DIPS AND INTERRUPTIONS


Basic Standard : IEC 61000-4-11:2004Test Port : input a.c. power port



a. The Product and support units were located on a non-conductive table above groundfloor.

b. Set the parameter of tests and then perform the test software of test simulator.

c. Conditions changes to occur at 0 degree crossover point of the voltage waveform.




Power : AC 100/240V, 50Hz/60Hz Temperature : 24℃


Test Level% UT

Reduction(%)

CyclePhase Angle

Meet the ImmunityPerformance Criteria

(50Hz) (60Hz)

0 100 0.5 0.5 0°, 45°, 90°, 135°, 180°,225°, 270°, 315°

0 100 1 1 0°

70 30 25 30 0°

0 100 250 300 0°



APPENDIX 1 PHOTOGRAPHS OF TEST SETUP

Continuous Disturbance Test Setup

Radiation Disturbance Test Setup


Harmonic & Flicker Test Setup

Electrostatic Discharge Test Setup


Radio Frequency Electromagnetic Fields Test Setup

Fast Transients Test Setup


Surges Test Setup

Injected Currents Test Setup


Power-frequency magnetic fields

Voltage dips and interruptions


APPENDIX 2 PHOTOGRAPHS OF PRODUCT

View of Product-1

View of Product-2


View of Product-3

View of Product-4


View of Product-5

View of Product-6


View of Product-7

View of Product-8


View of Product-9

View of Product-10


View of Product-11

View of Product-12


View of Product-13

View of Product-14


View of Product-15

View of Product-16


View of Product-17

View of Product-18


View of Product-19

*** End of Report ***

The test report is effective only with both signature and specialized stamp. The result(s) shown in thisreport refer only to the sample(s) tested. Without written approval of CTI, this report can’t be reproducedexcept in full.

emc test report - dimed laser€¦ · 0-413-eos3-lf 1726a00002 03/08/2019 3m semi-anechoic chamber...

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