Page : 2 / 38 TABLE OF CONTENTS 1. GENERAL DESCRIPTION OF EUT 3 2. GENERAL INFORMATION OF TEST 4 3.1 CONDUCTED EMISSION TEST 7 3.2 RADIATED EMISSION TEST 11 3.3 ELECTROSTATIC DISCHARGE IMMUNITY TEST 14 3.4 RF ELECTROMAGNETIC FIELD IMMUNITY TEST 17 3.5 FAST TRANSIENTS IMMUNITY TEST 20 3.6 SURGES IMMUNITY TEST 22 3.7 RF COMMON MODE IMMUNITY TEST 24 3.8 VOLTAGE DIPS AND INTERRUPTIONS IMMUNITY TEST 26 3.9 POWER FREQUENCY MAGNETIC FIELD 28 3.10 POWER FREQUENCY HARMONICS AND FLICKER EMISSION TESTS 30 4. EUT PHOTOGRAPHS 34 5. DESCRIPTION OF EUT MODIFICATION 37
Page : 3 / 38 1. General Description of EUT 1.1 Applicant Company Name : HANMED Co., Ltd. Address : #112 Gimhae Bio Medical Center, 155-1, Nogso-ri, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, Korea 1.2 Manufacture Company Name : HANMED Co., Ltd. Address : #112 Gimhae Bio Medical Center, 155-1, Nogso-ri, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, Korea 1.3 Basic Description of EUT Product Name Model Name Serial Number Input Rating : Orthopedics appliance : KNX-7000 : Prototype : AC 100 ~ 240 V, 50/60 Hz
Page : 4 / 38 2. General Information of Test 2.1 Test Facility This test was carried out by SGS Tesco Korea. Test Site Location : 413-15, Gomae-dong, Giheung-gu, Yongin-si, Gyeonggi-do, Korea TEL : 82-31-8005-6020, FAX : 82-31-8005-6025 2.2 Standard for Methods of Measurement Basic Standard Description Test Result EN 55011:2007 CISPR 11:2003+A1:2004 Conducted Emission Pass Fail Radiated Emission Pass Fail EN61000-4-2 / IEC61000-4-2 Electrostatic Discharge Pass Fail EN61000-4-3 / IEC61000-4-3 RF Electromagnetic field Pass Fail EN61000-4-4 / IEC61000-4-4 Fast Transient/burst Pass Fail EN61000-4-5 / IEC61000-4-5 Surge Pass Fail EN61000-4-6 / IEC61000-4-6 RF common mode Pass Fail EN61000-4-11 / IEC61000-4-11 Voltage Dips & Interruptions Pass Fail EN61000-4-8 / IEC61000-4-8 Power-frequency Magnetic Field Pass Fail EN 61000-3-2:2006 * Harmonic Current Emission Pass Fail EN 61000-3-3:1995 +A1:2001+A2:2005 * Voltage Fluctuations and Flicker Pass Fail * This test was performed by the LTA Co., Ltd., which is our sub-contracted Laboratory
Page : 5 / 38 2.3 Description of EUT modification Used ferrite core and noise filter (Refer to photograph of page 37 ~ 38) 2.4 Variations covered by this report N/A 2.5 Additional information related to Testing Test results apply only to the particular sample tested and functionality described in this test report. This report may be reproduced in full. Partial reproduction may only be made with the written permission of the SGS Tesco Korea. 2.6 Test Conditions EUT Operating Mode EUT was tested according to the following operation modes provided by the specifications given by the manufacturer and reported the worst emissions. Operation Modes Worst Case Mode The EUT set up normal operating by program. 2.7 Immunity Method Observation of display & operating condition. Test System layout on EUT and peripherals Power cable, Signal cable AC 230V EUT PC SYSTEM EUT
Page : 6 / 38 2.8 Description of Test System Type of Peripheral Equipment Used: Description Model Name Serial No. Manufacturer PC N/A N/A N/A Monitor MY19PS N960HVCQA12596F SAMSUNG ELECTRONICS Keyboard TGK-7500 165856846000969 Goldland Electronics.,Ltd. Mouse AN3050 N/A AIONTECH CO., LTD. Type of Cables Used: Device from Device to Type of Cable Length (m) Type of shield EUT AC Power Power 1.8 Unshield EUT EUT Signal 2.0 Unshield Criteria description The following degradations 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 - Fuse 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 waveform in which in which the artefact would interfere with diagnosis, treatment or monitoring - Failure of automatic diagnosis or treatment equipment and systems to diagnose or treat, even if accompanied by an alarm
Page : 7 / 38 3.1 Conducted Emission Test Disturbance voltages at the mains terminal were measured from 150 khz to 30 MHz with a bandwidth of 9 khz on the 230 V AC power input terminal. The EUT was placed on a nonmetallic stand in a shielded room 0.8 meters above the ground plane as shown in photograph of test setup. The interface cables and equipment positioning were varied within limits of reasonable applications to determine the position producing maximum conducted emissions. 3.1.1 Test Condition Frequency Range of Test : 150 khz to 30 MHz Test Standard : EN 60601-1-2:2007 Test method : EN 55011:2007 Group 1, Class A Test Date : August 10, 2009 Temperature/Humidity : (21 ± 1) C / (43 ± 2) % R.H. Input Voltage : AC 230 V / 50 Hz 3.1.2 Test Standard. Frequency Range (MHz) Quasi-Peak Limit db( μv ) Average-Peak 0.15 ~ 0.5 79.0 66.0 0.5 ~ 30 73.0 60.0 3.1.3 Test Equipment List. Equipment Type Model Manufacture Serial No Cal Due Date Use 2-LINE V-NETWORK ENV216 R&S 100415 2010.06.22 EMI TEST RECEIVER ESU8 R&S 100128 2010.01.19 PULSE LIMITER ESH3-Z2 R&S 100850 2009.09.14
Page : 8 / 38 3.1.4 Test Result of Conducted Emission Test Results: PASS Test data sheets follow. Frequency C.F. Phase Quasi-Peak Mode Average Mode Limit Result Margin Limit Result Margin [MHz] [db] [N/L1] db[uv] db[uv] db[uv] db[uv] db[uv] db[uv] 5.310 19.5 L1 73.0 59.0 14.0 60.0 36.0 24.0 5.574 19.6 N 73.0 58.1 14.9 60.0 36.3 23.7 6.378 19.6 L1 73.0 60.9 12.1 60.0 36.6 23.4 6.634 19.6 N 73.0 62.0 11.0 60.0 35.8 24.2 7.534 19.6 L1 73.0 61.5 11.5 60.0 38.4 21.6 Notes : 1. C.F = LISN Factor + Cable Loss + Pulse Limiter Loss / Result = Reading Level + C.F 2. All modes of operation were investigated and the worst-case emissions are reported. 3. Measurement uncertainty estimated at ± 3.76 db. The measurement uncertainty is given with a confidence of 95.45 % with the coverage factor, k=2. 4. See next page for measurement graph. Tested by Seung-bum Cho
Page : 9 / 38 80 70 CISPR11 CLASS A Gruop 1 QP 60 CISPR11 CLASS A Gruop 1 AV 50 Level in db 킮 40 30 20 10 0 150k 300 400 500 800 1M 2M 3M 4M 5M 6 8 10M 20M 30M Frequency in Hz <N LINE> 80 70 CISPR11 CLASS A Gruop 1 QP 60 CISPR11 CLASS A Gruop 1 AV 50 Level in db 킮 40 30 20 10 0 150k 300 400 500 800 1M 2M 3M 4M 5M 6 8 10M 20M 30M Frequency in Hz <L1 LINE>
Page : 10 / 38 3.1.5 Photographs of Conducted Emission Test Configuration
Page : 11 / 38 3.2 Radiated Emission Test Radiated disturbance from 30 MHz to 1 GHz were measured with a bandwidth of 120 khz for both vertical and horizontal polarization of the measuring antenna according to the methods defines in EN 60601-1-2:2007. The EUT was placed on a non-metallic table in the semi-anechoic chamber, 0.8 meter above the ground plane, and the measurement distance from the measuring antenna to the center of the EUT was set to 10m distance as shown in Test setup photograph. The measuring antenna was adjusted in height of 1m to 4m range for the maximum emission. The interface cables and equipment positions were varied within limits of reasonable applications to determine the positions producing maximum radiated emissions. 3.2.1 Test Condition Frequency Range of Test : 30 MHz to 1 GHz Test Standard : EN 60601-1-2:2007 Test Method EN 55011:2007 Group 1, Class A Test Date : August 10, 2009 Temperature/Humidity : (29 ± 1) C / (52 ± 2) % R.H. 3.2.2 Test Standard Frequency Range (MHz) Limit Quasi-Peak db( μv /m) 30 ~ 230 40 230 ~ 1 000 47 3.2.3 Test Equipment List Equipment Type Model Manufacture Serial No Cal Due Date Use EMI TEST RECEIVER ESU8 R&S 100128 2010.01.19 Antenna Mast Antenna Turntable Controller ANTENNA MAST AM4.0 Turntable TT1.2 SI-0 MATURO GMBH N/A N/A MATURO GMBH N/A N/A BILOG ANT CBL6112D TESEQ 25233 2010.06.02 Preamplifier AM-1431 MITEQ 1336160 2010.07.08
Page : 12 / 38 3.2.4 Test Result of Radiated Emission Antenna : Horizontal / Vertical Distance : 10 m Test Results : PASS Test data sheets follow. Frequency (MHz) Quasi-Peak db(uv/m) Antenna height (cm) Polarity Turntable position (deg) Corr. (db) Margin (db) Limit db(uv/m) 42.12 33.7 180 V 200-24.4 6.3 40.0 67.83 32.1 120 V 230-29.1 7.9 40.0 163.37 35.4 100 H 60-24.2 4.6 40.0 232.73 33.9 150 V 170-21.5 13.1 47.0 450.98 39.7 130 H 300-15.1 7.3 47.0 471.83 41.1 220 H 255-14.6 5.9 47.0 511.60 41.2 250 H 310-13.8 5.8 47.0 Notes 1. H : Horizontal polarization, V : Vertical polarization 2. QuasiPeak Level = Reading + Corr.(Antenna factor + Cable loss PreAmplifier) 3. Margin value = Limit QuasiPeak Level 4. Measurement uncertainty estimated at ± 4.86 db. The measurement uncertainty is given with a confidence of 95.45 % with the coverage factor, k = 2. 5. The result was passed but within measurement uncertainty Tested by Seung-bum Cho
Page : 13 / 38 3.2.5 Photographs of Radiated Emission Test Configuration
Page : 14 / 38 3.3 Electrostatic Discharge Immunity Test Enclosure Port The EUT was set-up on insulators 0.5 mm above the Horizontal Coupling Plane and tested in accordance with EN 61000-4-2. Air Discharge A potential of 2 kv was initially applied to each applicable test point in both polarities, then verity level was increased to 4 kv and then to 8 kv. The full discharge level was applied a total of 20 times to each test point, 10 positive discharges and 10 negative discharges. The interval between discharges was a minimum of 1 second. Contact Discharge A potential of 2 kv was initially applied to all user accessible conductive surfaces. The level was increased to 6 kv. The full discharge level of 6 kv was then applied to each test point, 25 positive discharges and 25 negative discharges. Each vertical side of the EUT was subjected to Vertical Coupling Plane (VCP) discharges of 6 kv, 25 positive discharges and 25 negative discharges. The base of EUT was subjected to Horizontal Coupling Plane (HCP) discharges of 6 kv, 25 positive discharges and 25 negative discharges. Correct functioning of the EUT was checked throughout this test. 3.3.1 Test Condition Test Standard : EN 60601-1-2:2007 Test Method : EN61000-4-2:1995+A1:1998+A2:2001 Test Date : August 11, 2009 Performance criterion : Refer to Criteria description of page 6 Temperature/Humidity/Pressure : (24 ± 1) C / (41 ± 2) % R.H./ 100.2 kpa 3.3.2 Test Equipment List Equipment Type Model Manufacture Serial No Cal Due Date Use ESD SIMULATOR ESS-2000 NOISEKEN ESS0422543 2010.06.22 3.3.3 Test Result of Electrostatic Discharge Immunity Test Electrostatic Discharge Immunity Test : PASS The equipment meets the requirements.
Page : 15 / 38 Test data sheet follows. Discharge Type Test Point CD=Contact AD=Air Test Voltage(kV) Tested No Observation Result VCP CD ±2,4,6 kv Each 25 times Normal PASS Screw CD ±2,4,6 kv Each 25 times Normal PASS Enclosure CD ±2,4,6 kv Each 25 times Normal PASS Seat AD ±2,4,8 kv Each 10 times Normal PASS Cable AD ±2,4,8 kv Each 10 times Normal PASS LED AD ±2,4,8 kv Each 10 times Normal PASS Tested by Seung-bum Cho [Test Point] AD / CD Remarks The primary functions as described below were fully functional during and after test. 1. There is no deterioration on the EUT
Page : 16 / 38 3.3.4 Photographs of Electrostatic Discharge Immunity Test Configuration
Page : 17 / 38 3.4 RF Electromagnetic Field Immunity Test Tests were conducted in accordance with EN 60601-1-2:2007 over the frequency range of 80 MHz to 2.5 GHz. The transmitting antenna was located 3 meters(or 1.8 meter) from the EUT at a height of 1 meter above the floor. Sides of the EUT were exposed to a uniform field of 3 V/m using both horizontal and vertical antenna polarizations. 3.4.1 Test Condition Test Standard : EN 60601-1-2:2007 Test Method : EN 61000-4-3: 2002+A1:2002 Test Date : August 12, 2009 Test field strength (V/m) 3 V/m Performance criterion : Refer to Criteria description of page 6 Temperature/Humidity/Pressure : (20 ± 1) C / (46 ± 2) % R.H./ 100.3 kpa 3.4.2 Test Equipment List Equipment Type Model Manufacture Serial No Cal Due Date Use AMPLIFIER 250W1000A AR 0327278 N/A AMPLIFIER 60S1G3 AR 0327239 N/A POWER METER NRVD R&S 101297 2009.11.13 SIGNAL GENERATOR SMR40 R&S 100540 2010.01.19 HIGH GAIN LOG- PERIODIC ANTENNA HL046E R&S 100043 N/A 10V INSERTION UNIT URV5-Z2 R&S 100346 2009.11.13 10V INSERTION UNIT URV5-Z2 R&S 100347 2009.11.13 FIELD PROBE HI-6005 ETS-LINDGREN 0086968 2010.01.31 3.4.3 Test Result of RF Electromagnetic Field immunity test Electromagnetic field immunity test : PASS The equipment meets the requirements.
Page : 18 / 38 Test data sheet follows. Frequency Range (MHz) Position (Angle) Antenna Polarity Field Strength (V/m) Modulation Result 80~2 500 Front Vertical 3 80 % AM(1 khz) PASS 80~2 500 Rear Vertical 3 80 % AM(1 khz) PASS 80~2 500 Right Vertical 3 80 % AM(1 khz) PASS 80~2 500 Left Vertical 3 80 % AM(1 khz) PASS 80~2 500 Front Horizontal 3 80 % AM(1 khz) PASS 80~2 500 Rear Horizontal 3 80 % AM(1 khz) PASS 80~2 500 Right Horizontal 3 80 % AM(1 khz) PASS 80~2 500 Left Horizontal 3 80 % AM(1 khz) PASS Tested by Seung-bum Cho Remarks The primary functions as described below were fully functional during and after test. 1. There is no deterioration on the EUT
Page : 19 / 38 3.4.4 Photographs of Electrostatic Discharge Immunity Test Configuration
Page : 20 / 38 3.5 Fast Transients Immunity Test Tests were conducted in accordance with EN 60601-1-2:2007. Tests were performed to 2 kv to AC Power lines. 3.5.1 Test Condition Test Standard : EN 60601-1-2:2007 Test Method : EN 61000-4-4:2004 Test Date : August 11, 2009 Test Voltage : ± 2 kv Performance criterion : Refer to Criteria description of page 6 Temperature/Humidity/Pressure : (24 ± 1) C / (41 ± 2) % R.H./ 100.2 kpa 3.5.2 Test Equipment List Equipment Type Model Manufacture Serial No Cal Due Date Use Combinded test system ECOMPACT 4 Haefely 170328 2010.06.18 3.5.3 Test Result of Electrical fast transient/burst immunity test Electrical fast transient/burst immunity test : PASS The equipment meets the requirements.
Page : 21 / 38 Test data sheet follows. Line Voltage Coupling Inject Time (sec) Result N ± 2 kv Direct 60 PASS L1 ± 2 kv Direct 60 PASS PE ± 2 kv Direct 60 PASS N,L1 ± 2 kv Direct 60 PASS L1,PE ± 2 kv Direct 60 PASS N,PE ± 2 kv Direct 60 PASS L1,N,PE ± 2 kv Direct 60 PASS Remarks Tested by Seung-bum Cho The primary functions as described below were fully functional during and after test. 1. There is no deterioration on the EUT 3.5.4 Photographs of Fast Transient Immunity Test Configuration
Page : 22 / 38 3.6 Surges Immunity Test Tests were conducted in accordance with EN 60601-1-2:2007. Tests were performed to 1 kv to AC Line to Line, 2 kv to AC Line to PE. 3.6.1 Test Condition Test Standard : EN 60601-1-2:2007 Test Method : EN61000-4-5:2006 Test Date : August 11, 2009 Test Voltage : ±1 kv(line to Line), ± 2 kv(line to PE) Performance criterion : Refer to Criteria description of page 6 Temperature/Humidity/Pressure : (24 ± 1) C / (41 ± 2) % R.H./ 100.2 kpa 3.6.2 Test Equipment List Equipment Type Model Manufacture Serial No Cal Due Date Use Combinded test system ECOMPACT 4 Haefely 170328 2010.06.18 3.6.3 Test Result of Surge immunity test Surge immunity test : PASS The equipment meets the requirements.
Page : 23 / 38 Test data sheet follows. Line Voltage Coupling Phase (Degree) Inject (count - min) Result L1-N ± 1 kv 2 Ω, 18 μf 0,90,180,270 5 times - 5 min Pass L1-PE ± 2 kv 12 Ω, 9 μf 0,90,180,270 5 times - 5 min Pass N-PE ± 2 kv 12 Ω, 9 μf 0,90,180,270 5 times - 5 min Pass Tested by Seung-bum Cho Remarks The primary functions as described below were fully functional during and after test. 1. There is no deterioration on the EUT 3.6.4 Photographs of Surges Immunity Test Configuration
Page : 24 / 38 3.7 RF Common Mode Immunity Test Tests were conducted in accordance with EN 60601-1-2:2007. Over the frequency range of 150 khz to 80 MHz. Tests were performed at 3 V on power line. 3.7.1 Test Condition Test Standard : EN 60601-1-2:2007 Test Method : EN 61000-4-6:1996+A1:2001 Test Date : August 11, 2009 Test Voltage : 3 V Performance criterion : Refer to Criteria description of page 6 Temperature/Humidity/Pressure : (24 ± 1) C / (41 ± 2) % R.H./ 100.2 kpa 3.7.2 Test Equipment List Equipment Type Model Manufacture Serial No Cal Due Date Use CONTINUOUS WAVE SIMULATOR CWS 500 C S1 EM TEST 0744103074 2010.04.22 CDN M2/M3 EM TEST 1107-59 2010.05.14
Page : 25 / 38 3.7.3 Test Result of RF Common Mode immunity test Conducted immunity test : PASS The equipment meets the requirements. Tes data sheet follows. Frequency (MHz) Coupling Test voltage Dwell time Modulation Step Size Result 0.15 ~ 80 CDN(M3) 3 V 3 s 80 % AM @ 1 khz 1.0 % Pass Tested by Seung-bum Cho Remarks The primary functions as described below were fully functional during and after test. 1. There is no deterioration on the EUT 3.7.4 Photographs of RF Common Mode immunity test Configuration
Page : 26 / 38 3.8 Voltage Dips and Interruptions Immunity Test Voltage Dips and Interruptions tests were conducted in accordance with EN 60601-1-2:2007. 3.8.1 Test Condition Test Standard : EN 60601-1-2:2007 Test Method : EN 61000-4-11:2004 Test Date : August 11, 2009 Test Voltage : AC 120 V, AC 230 V Voltage Dip and Voltage interruptions : 100 % (0.5 cycle), 60 % (5 cycle), 30 % (25 cycle) 100 % (250 cycle) Performance criterion : The EUT remains safe, experiences no component failures ant is restorable to the pre-test state with operator intervention. Temperature/Humidity/Pressure : (23 ± 1) C / (40 ± 2) % R.H./ 100.2 kpa 3.8.2 Test Equipment List Equipment Type Model Manufacture Serial No Cal Due Date Use Combinded test system ECOMPACT 4 Haefely 170328 2010.06.18 3.8.3 Test Result of Voltage Dips and Voltage interruptions immunity test Voltage Dips and Voltage interruptions immunity test : PASS The equipment meets the requirements.
Page : 27 / 38 Test data sheet follows. Residual Voltage (%) Cycle Angle ( ) Result 0 0.5 0,180 Pass 40 5 0,180 Pass 70 25 0,180 Pass 0 250 0,180 Pass(Note 1) Remarks The primary functions as described below were fully functional during and after test. Note 1. The EUT turn on/off during test but after test there have been no deterioration of EUT. 3.8.4 Photographs of Voltage Dips and Interruptions Immunity Test Configuration Tested by Seung-bum Cho
Page : 28 / 38 3.9 Power Frequency Magnetic Field Tests were conducted in accordance with EN 61000-4-8. 3.9.1 Test Condition Test Standard : EN 60601-1-2:2007 Test Method : EN 61000-4-8:1993+A1:2001 Test Date : August 11, 2009 Test Voltage : 3 A/m Performance criterion : Refer to Criteria description of page 6 Temperature/Humidity/Pressure : (23 ± 1) C / (40 ± 2) % R.H./ 100.2 kpa 3.9.2 Test Equipment List Equipment Type Model Manufacture Serial No Cal Due Date Use Magnetic Field Coil MFS100 HAEFELY 1684 2009.09.09 3.9.3 Test Result of Power Frequency Magnetic Field immunity test Conducted immunity test : PASS The equipment meets the requirements.
Page : 29 / 38 Test data sheet follows. Test Current Frequency Axis Test Time Result 3 A/m 50Hz X, Y, Z 60 s Pass 3 A/m 60Hz X, Y, Z 60 s Pass Tested by Seung-bum Cho Remarks The primary functions as described below were fully functional during and after test. 1. There is no deterioration on the EUT 3.9.4 Photographs of Power Frequency Magnetic Field Configuration
Page : 30 / 38 3.10 Power Frequency Harmonics and Flicker Emission Tests 3.10.1 Test Procedure Flicker Emission Tests : The total impedance of the test circuit, excluding the appliance under test, but including the internal impedance of the supply source, shall be equal to the reference impedance. The stability and tolerance of the reference impedance shall be adequate to ensure that the overall accuracy of ±8% is achieved during the whole assessment procedure. 3.10.2 Test Condition Test Standard : EN61000-3-2:2006 EN61000-3-3:1995+A1:2001+A2:2005 Test Date : August 13, 2009 Temperature/Humidity : (23 ± 1) C / (42 ± 2) % R.H. 3.10.3 Test Result of Harmonics and Flicker Emission Tests Power Frequency Harmonics : PASS Flicker Emission Tests : PASS
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Page : 37 / 38 5. Description of EUT modification - Ferrite Core(Manufacture : TDK / Model No.:ZCAT3035) - Ferrite Core x 2(Manufacture : E-TECH / Model No.:CU1330B) - Ferrite Core(Manufacture : TDK / Model No.:ZCAT3035)
Page : 38 / 38 - Noise Filter(Manufacture : FINE SUNTRONIX / Model No.:SN-M6H-CM)