VH-2600 and VH-2600 CE EMC Test Report Technical Compliance Statement Sept 2015

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EMC TEST REPORT for Great Group Medical CO., LTD. Respiratory Humidifier Model No.: (1)VH-2600A (2)VH-2600

Prepared for : Great Group Medical CO., LTD. No.168, Xingong 2nd Rd., Tianzhong Township, Changhua County 52046, Taiwan (R.O.C)

Prepared By : AUDIX Technology Corporation EMC Department No. 53-11, Dingfu, Linkou Dist., New Taipei City 244, Taiwan Tel : (02) 2609-9301, 2609-2133 Fax : (02) 2609-9303

File Number Report Number Date of Test Date of Report

(Rev. 01)

： ： ： ：

C1M1310156 EM-E1020700 Oct. 16 ~ Nov. 06, 2013 Dec. 18, 2013

AUDIX Technology Corporation.

Report No.: EM-E1020700

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TABLE OF CONTENTS Description

Page

TEST REPORT VERIFICATION...4 1. DESCRIPTION OF REVISION HISTORY ...5 2. SUMMARY OF STANDARDS AND RESULTS...6 2.1. 2.2.

Description of Standards and Results... 6 Description of Compliance Criteria... 7

3. GENERAL INFORMATION...8 3.1. 3.2. 3.3. 3.4.

Description of Device (EUT) ... 8 Tested Supporting System Details... 9 Description of Test Facility ... 9 Measurement Uncertainty ... 9

4. CONDUCTED DISTURBANCE MEASUREMENT...10 4.1. 4.2. 4.3. 4.4. 4.5. 4.6.

Test Equipment... 10 Block Diagram of Test Setup ... 10 Limits for Conducted Disturbance Voltage (CISPR 11, Group I/Class B)... 11 Operating Condition of EUT ... 11 Test Procedure ... 11 Conducted Disturbance Measurement Results ... 12

5. RADIATED DISTURBANCE MEASUREMENT ...15 5.1. 5.2. 5.3. 5.4. 5.5. 5.6.

Test Equipment... 15 Block Diagram of Test Setup ... 15 Limits for Radiated Disturbance (CISPR 11, Group I/Class B) ... 16 Operating Condition of EUT ... 16 Test Procedure ... 17 Radiated Disturbance Measurement Results ... 17

6. POWER HARMONICS AND FLICKER MEASUREMENT ...20 6.1. 6.2. 6.3. 6.4. 6.5.

Test Equipment... 20 Block Diagram of Test Setup ... 20 Test Standard ... 20 Operating Condition of EUT ... 20 Test Results... 21

7. ELECTROSTATIC DISCHARGE IMMUNITY TEST...25 7.1. 7.2. 7.3. 7.4. 7.5. 7.6. 7.7.

Test Equipment... 25 Block Diagram of Test Setup ... 25 Test Standard ... 26 Severity Levels and Performance Criterion ... 26 Operating Condition of EUT ... 26 Test Procedure ... 27 Test Results... 27

8. RF FIELD STRENGTH IMMUNITY TEST ...29 8.1. 8.2. 8.3. 8.4. 8.5. 8.6. 8.7.

Test Equipment... 29 Block Diagram of Test Setup ... 30 Test Standard ... 30 Severity Levels and Performance Criterion ... 31 Operating Condition of EUT ... 31 Test Procedure ... 31 Test Results... 32

9. ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST...34 9.1. 9.2. 9.3. 9.4. 9.5. (Rev. 01)

Test Equipment... 34 Block Diagram of Test Setup ... 34 Test Standard ... 34 Severity Levels and Performance Criterion ... 35 Operating Condition of EUT ... 35 AUDIX Technology Corporation.

Report No.: EM-E1020700

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9.6. 9.7.

Test Procedure ... 35 Test Results... 35

10. SURGE IMMUNITY TEST...37 10.1. Test Equipment... 37 10.2. Block Diagram of Test Setup ... 37 10.3. Test Standard ... 37 10.4. Severity Levels and Performance Criterion ... 37 10.5. Operating Condition of EUT ... 38 10.6. Test Procedure ... 38 10.7. Test Results... 38

11. CONDUCTED DISTURBANCE IMMUNITY TEST...40 11.1. Test Equipment... 40 11.2. Block Diagram of Test Setup ... 40 11.3. Test Standard ... 40 11.4. Severity Levels and Performance Criterion ... 40 11.5. Operating Condition of EUT ... 41 11.6. Test Procedure ... 41 11.7. Test Results... 41

12. POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST ...43 12.1. Test Equipment... 43 12.2. Block Diagram of Test Setup ... 43 12.3. Test Standard ... 43 12.4. Severity Levels and Performance Criterion ... 43 12.5. Operating Condition of EUT ... 44 12.6. Test Procedure ... 44 12.7. Test Results... 44

13. VOLTAGE DIPS AND INTERRUPTIONS IMMUNITY TEST ...46 13.1. Test Equipment... 46 13.2. Block Diagram of Test Setup ... 46 13.3. Test Standard ... 46 13.4. Severity Levels and Performance Criterion ... 47 13.5. Operating Condition of EUT ... 47 13.6. Test Procedure ... 47 13.7. Test Results... 48

14. PHOTOGRAPHS ...50 14.1. Photos of Conducted Disturbance Measurement ... 50 14.2. Photos of Radiated Disturbance Measurement at Open Area Test Site... 51 14.3. Photo of Harmonic and Flicker Emission Measurement... 52 14.4. Photos of Electrostatic Discharge Immunity Test ... 53 14.5. Photos of RF Field Strength Immunity Test ... 56 14.6. Photo of Electrical Fast Transient/Burst Immunity Test... 58 14.7. Photo of Surge Immunity Test... 58 14.8. Photos of Conducted Disturbance Immunity Test ... 59 14.9. Photo of Power Frequency Magnetic Field Immunity Test... 59 14.10. Photo of Voltage Dips and Interruptions Immunity Test ... 60

APPENDIX I (Photos of EUT)

(Rev. 01)

AUDIX Technology Corporation.

Report No.: EM-E1020700

Page 4 of 60

TEST REPORT VERIFICATION Applicant

： Great Group Medical CO., LTD.

Manfuacturer

： Great Group Medical CO., LTD.

EUT Description

： Respiratory Humidifier (A) Model No. (B) Serial No. (C) Power Supply (D) Test Voltage

： ： ： ：

(1)VH-2600A (2)VH-2600 N/A AC 115V/60Hz AC 115V/60Hz

Measurement Standard Used: EN 60601-1-2:2007 +AC:2010 (IEC 60601-1-2: 2007): Electromagnetic Compatibility Emission: CISPR 11:2009 +A1:2010, Class B EN 61000-3-2:2006 +A1:2009 +A2:2009 and EN 61000-3-3:2008 Immunity: IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-4:2012, IEC 61000-4-5:2005, IEC 61000-4-6:2008, IEC 61000-4-8:2009, IEC 61000-4-11:2004 The device described above was tested by AUDIX Technology Corporation to determine the maximum emission levels emanating from the device, its ensured severity levels, and performance criterion. This test report contains the measurement results, and AUDIX Technology Corporation assumes full responsibility for the accuracy and completeness of these measurements. Also, this report shows that the EUT is technically compliant with the requirements of EN 60601-1-2 standards. This report applies to above tested sample only and shall not be reproduced in part without written approval of AUDIX Technology Corporation. Date of Test:

Oct. 16 ~ Nov. 06, 2013

Date of Report:

Dec. 18, 2013

Producer : (Julie Hsu/Administrator) Signatory : (Leon Liu/Deputy General Manager)

(Rev. 01)

AUDIX Technology Corporation.

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1. DESCRIPTION OF REVISION HISTORY

(Rev. 01)

Edition No.

Date of Rev.

Revision Summary

0

Nov. 11, 2013

Original Report (Model: VH2600A)

EM-E1020700

Rev. 01

Dec. 18, 2013

To add a new model “VH-2600” for appearance label different.

EM-E1020700

AUDIX Technology Corporation.

Report No.

Report No.: EM-E1020700

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2. SUMMARY OF STANDARDS AND RESULTS 2.1. Description of Standards and Results The EUT have been tested according to the applicable standards as referenced below. EMISSION Description of Test Item

Standard

Limits

Results

Conducted disturbance

CISPR 11:2009 +A1:2010 Group 1, Class B

PASS

Radiated disturbance

CISPR 11:2009 +A1:2010 Group 1, Class B

PASS

Harmonic distortion

EN 61000-3-2:2006 +A1:2009 +A2:2009

Class A

PASS

Voltage fluctuations and flicker

EN 61000-3-3:2008

Section 5

PASS

IMMUNITY [EN 60601-1-2:2007 +AC:2010 (IEC 60601-1-2:2007)] Basic Standard

Performance Criteria

Results

Electrostatic discharge (ESD)

IEC 61000-4-2:2008

Section 6.2.1.10

PASS

Radiated RF electromagnetic fields

IEC 61000-4-3:2010

Section 6.2.1.10

PASS

Electrical fast transients and bursts

IEC 61000-4-4:2012

Section 6.2.1.10

PASS

Surge

IEC 61000-4-5:2005

Section 6.2.1.10

PASS

Conducted disturbances, induced by RF fields

IEC 61000-4-6:2008

Section 6.2.1.10

PASS

Power frequency magnetic fields

IEC 61000-4-8:2009

Section 6.2.1.10

PASS

Section 6.2.1.10

PASS

Section 6.2.1.10

PASS & NOTE

Description of Test Item

Voltage dips Voltage interruptions

IEC 61000-4-11:2004

N/A is an abbreviation for Not Applicable. NOTE: means a deviation from the requirement of EN 60601-1-2 Section 6.2.1.10), but it’s allowed.

(Rev. 01)

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2.2. Description of Compliance Criteria Examples of conformance to the compliance criteria: - an imaging ME SYSTEM displays an image that may be altered, but in a way that would not affect the diagnosis or treatment; - a heart rate monitor displays a heart rate that may be in error, but by an amount that is not clinically significant; - a PATIENT monitor exhibits a small amount of noise or a transient on a waveform and the noise or transient would not affect diagnosis, treatment or monitoring. Examples of ME EQUIPMENT and ME SYSTEMS with multiple FUNCTIONS: - multi-parameter monitors; - anaesthesia ME SYSTEMS with monitors; - ventilators with monitors; - multiple instances of the same FUNCTION (e.g. multiple invasive blood pressure sensors). Failure of therapy ME EQUIPMENT to terminate a treatment at the intended time is considered cessation or interruption of an intended operation related to ESSENTIAL PERFORMANCE. If the effect of the test signal on ME EQUIPMENT or an ME SYSTEM is so brief as to be transparent to the PATIENT or OPERATOR and does not affect diagnosis, monitoring or treatment of the PATIENT, this can be considered not to be cessation or interruption of an intended operation. For example, if in response to the IMMUNITY TEST LEVEL a ventilator stops pumping for 50 ms and then resumes operation such that accuracy is within acceptable limits, this would not be considered cessation or interruption of an intended operation.

(Rev. 01)

AUDIX Technology Corporation.

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3. GENERAL INFORMATION 3.1. Description of Device (EUT) Description

:

Respiratory Humidifier

Model Number

:

(1)VH-2600A (2)VH-2600 Above models is appearance label different. The model VH-2600A is tested in this report.

Serial Number

:

N/A

Applicant

:

Great Group Medical CO., LTD. No.168, Xingong 2nd Rd., Tianzhong Township, Changhua County 52046, Taiwan (R.O.C)

Manufacturer

:

Great Group Medical CO., LTD. No.168, Xingong 2nd Rd., Tianzhong Township, Changhua County 52046, Taiwan (R.O.C)

Disp autofeed humidifier Chamber

:

Hose: Detachable, 1.2m

Temperature Probe

:

GGM, M/N HWP-73015 Cable: Non-Shielded, Detachable, 1.9m

Heater Wire Adapter (Y-Type)

:

GGM, M/N HWA-2600F02 Cable: Non-Shielded, Detachable, 0.13m+0.7m+0.22m

Test Lung 1.0L w/Trachea

:

Trachea #1: Detachable, 1.5m (White) Trachea #2: Detachable, 1.63m (Blue)

Hose

:

#1: Detachable, 1.5m #2: Detachable, 2.0m

AC Power Cord

:

Non-Shielded, Detachable, 3.0m (3 Pin)

Date of Receipt of Sample

:

Oct. 14, 2013

Date of Test

:

Oct. 16 ~ Nov. 06, 2013

Remark : The re-issue report (Revise 01. version) is to add a new model “VH-2600” for appearance label different.

(Rev. 01)

AUDIX Technology Corporation.

Report No.: EM-E1020700

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3.2. Tested Supporting System Details 3.2.1. BEAR 33 VENTILATOR Model Number Serial Number Brand Power Cord

： ： ： ：

BV843-01 13308436 Allied Healthcare Products, Inc. Non-Shielded, Detachable, 1.8m

3.3. Description of Test Facility Name of Firm

：

AUDIX Technology Corporation EMC Department No. 53-11, Dingfu, Linkou Dist., New Taipei City 244, Taiwan

Test Facility & Location (C3/R6)

：

No. 3 Shielded Room & No. 6 Open Area Test Site & No. 67-4, Dingfu, Linkou Dist., New Taipei City 244, Taiwan Immunity Test Site No. 53-11, Dingfu, Linkou Dist., New Taipei City 244, Taiwan

NVLAP Lab. Code

：

200077-0

TAF Accreditation No.

：

1724

3.4. Measurement Uncertainty Test Item

Frequency Range

Uncertainty (dB)

Conduction Test

150kHz~30MHz

± 1.73dB

Radiation Test (Distance: 10m)

30MHz~300MHz

± 2.99dB

300MHz~1000MHz

± 2.73dB

80MHz ~ 200MHz

±1.505dB

200MHz ~ 1000MHz

±1.461dB

RF Field Strength Susceptibility Test

1GHz ~ 6GHz Remark：Uncertainty = kuc(y)

(Rev. 01)

± 1.906dB

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4. CONDUCTED DISTURBANCE MEASUREMENT 4.1. Test Equipment The following test equipment was used during the conducted disturbance measurement: (No. 3 Shielded Room) Item Type 1. Test Receiver 2. A.M.N. 3. L.I.S.N. 4. Pulse Limiter

Manufacturer Model No. Serial No. R&S ESCS30 100337 Kyoritsu KNW-244C 8-1373-5 Kyoritsu KNW-407 8-1370-9 R&S ESH3-Z2 100041

Last Cal. Next Cal. Mar. 22, 13’ Mar. 21, 14’ Mar. 22, 13’ Mar. 21, 14’ Mar. 04, 13’ Mar. 03, 14’ Feb. 02, 13’ Feb. 01, 14’

4.2. Block Diagram of Test Setup AC POWER SOURCE

TRANSFORMER PULSE LIMITER TEST RECEIVER

PC SYSTEM

A.M.N.

WATER*

DISP AUTOFEED HUMIDIFIER CHAMBER* RESPIRATORY HUMIDIFIER *

PRINTER TEST LUNG 1.0L *

50 OHM TERMINATOR

(Rev. 01)

L.I.S.N.

: POWER LINE

: TRACHEA

: SIGNAL LINE

: HOSE

BEAR 33 VENTILATOR

*: EUT (Respiratory Humidifier)

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Report No.: EM-E1020700

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4.3. Limits for Conducted Disturbance Voltage (CISPR 11, Group I/Class B) Frequency

Maximum RF Line Voltage Quasi-Peak Level Average Level 150kHz ~ 500kHz 66 ~ 56 dBμV 56 ~ 46 dBμV 500kHz ~ 5MHz 56 dBμV 46 dBμV 5MHz ~ 30MHz 60 dBμV 50 dBμV Remark1.: If the average limit is met when using a Quasi-Peak detector, the EUT shall be deemed to meet both limits and measurement with the average detector is unnecessary. 2.: The lower limit applies at the band edges.

4.4. Operating Condition of EUT 4.4.1. Set up the EUT and simulator as shown on 4.2. 4.4.2. To turn on the power of all equipment. 4.4.3. The EUT was tested in normal operation mode during all testing.

4.5. Test Procedure The EUT was put on table which was above the ground by 80cm and it’s power cord connected to the AC mains through an Artificial Mains Network (A.M.N.). This provided a 50 ohm coupling impedance for the measuring equipment. Both sides of A.C. line were checked to find out the maximum conducted emission according to ISPR 11 Class B regulations during conducted disturbance measurement. The bandwidth of the R&S Test Receiver ESCS30 was set at 9kHz. The frequency range from 150kHz to 30MHz was checked using a peak detector. The all reading of measurements were with the Quasi-Peak detector and Average detector. (Remark: If the Average limit is met when using a Quasi-Peak detector, the Average detector is unnecessary)

(Rev. 01)

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4.6. Conducted Disturbance Measurement Results PASSED.

All emissions not reported below are too low against the prescribed limits.

The EUT with following test mdoes was measured during this section testing and the test results are listed in next pages. EUT：Respiratory Humidifier Test Date：Oct. 31, 2013

Model No.：VH-2600A

Temperature：22℃

Humidity：52%

The details are as follows：

(Rev. 01)

Mode

Test Voltage

Operating of EUT

1.

AC 115V/60Hz

Charging

Reference Test Data No. Neutral

Line

# 29

# 30

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(Rev. 01)

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(Rev. 01)

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5. RADIATED DISTURBANCE MEASUREMENT

5.1. Test Equipment The following test equipments are used during the radiated disturbance measurement：(At No. 6 Open Area Test Site) Item Type Manufacturer Model No. Serial No. Last Cal. Next Cal. Agilent 1. Spectrum Analyzer N9010A-507 MY49061167 Mar. 11, 13’ Mar. 10, 14’ Mar. 01, 13’ Feb. 28, 14’ R&S ESCS30 100339 2. Test Receiver NCR NCR HP 8447D 2727A05737 3. Amplifier Mar. 02, 13’ Mar. 01, 14’ Schaffner CBL6112B 2818 4. Bilog Antenna

5.2. Block Diagram of Test Setup 5.2.1. Block Diagram of connection between EUT and simulators DISP AUTOFEED HUMIDIFIER CHAMBER*

WATER*

RESPIRATORY HUMIDIFIER * AC POWER SOURCE

TEST LUNG 1.0L *

BEAR 33 VENTILATOR

(Rev. 01)

: POWER LINE

: TRACHEA

: SIGNAL LINE

: HOSE

*: EUT (Respiratory Humidifier)

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5.2.2. Semi-Anechoic Chamber (10m) Setup Diagram ANTENNA TOWER

ANTENNA ELEVATION VARIES FROM 1 TO 4 METERS 10 METERS

EUT

0.8 m TURN TABLE GROUND PLANE TEST EQUIPMENT

5.3. Limits for Radiated Disturbance (CISPR 11, Group I/Class B) FREQUENCY

DISTANCE

FIELD STRENGTHS LIMITS

(MHz)

(Meters)

(dBμV/m)

30 ~ 230

10

30

10 37 230 ~ 1000 Note : (1) The tighter limit applies at the edge between two frequency bands. (2) Distance refers to the distance in meters between the measuring instrument antenna and the closed point of any part of the E.U.T.

5.4. Operating Condition of EUT Same as conducted measurement which is listed in 4.4. except the test set up replaced by section 5.2

(Rev. 01)

AUDIX Technology Corporation.

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5.5. Test Procedure The EUT was placed on a turn table which was 0.8 meter above ground. The turn table can rotate 360 degrees to determine the position of the maximum emission level. EUT was set to 10 away from the receiving antenna which was mounted on an antenna tower. The antenna could be moved up and down between 1 to 4 meters to find out the maximum emission level. Broadband antennas were used as a receiving antenna. Both horizontal and vertical polarization of the antenna were set on measurement. In order to find the maximum emission, all of the interface cables were manipulated according to CISPR 11 requirement. The bandwidth of the R&S Test Receiver ESCS30 was set at 120kHz. The frequency range from 30MHz to 1000MHz was pre-scanned with a peak detector and all final readings of measurement were with Quasi-Peak detector.

5.6. Radiated Disturbance Measurement Results PASSED.

All emissions not reported below are too low against the prescribed limits.

The EUT with following test modes was measured during this section testing and the test results are listed in next pages. EUT：Respiratory Humidifier Test Date：Oct. 16, 2013

Model No.：VH-2600A

Temperature：56℃

Humidity：27%

The details are as follows： Mode 1.

(Rev. 01)

Test Voltage AC 115V/60Hz

Reference Test Data No. Horizontal

Vertical

#2

#1

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*

3. The worst emission was detected at 204.548Hz with corrected signal level of 21.38dBμV/m (limit is 30.0dBμV/m) when the antenna was at horizontal polarization and was at 4m high and the turn table was at 100°. 4. 0°was the table front facing the antenna. Degree is calculated from 0°clockwise facing the antenna.

(Rev. 01)

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Report No.: EM-E1020700

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*

3.

4.

(Rev. 01)

The worst emission was detected at 220.227MHz with corrected signal level of 24.42dBμV/m (limit is 30.0dBμV/m) when the antenna was at vertical polarization and was at 1m high and the turn table was at 50°. 0°was the table front facing the antenna. Degree is calculated from 0°clockwise facing the antenna.

AUDIX Technology Corporation.

Report No.: EM-E1020700