Test report link - 29 pages Collateral Standard
Contents
1. V1 0 Page 8 of 24 Report No TRE11120098 IC Registration No 5377A The 3m Alternate Test Site of Shenzhen Huatongwei International Inspection Co Ltd has been registered by Certification and Engineering Bureau of Industry Canada for the performance of radiated measurements with Registration No 5377A on Jan 25 2011 valid time is until Jan 24 2014 ACA Shenzhen Huatongwei International Inspection Co Ltd EMC Laboratory can also perform testing for the Australian C Tick mark as a result of our A2LA accreditation NEMKO Aut No ELA125 Shenzhen Huatongwei International Inspection Co Ltd has been assessed the quality assurance system the testing facilities qualifications and testing practices of the relevant parts of the organization The quality assurance system of the Laboratory has been validated against ISO IEC 17025 or equivalent The laboratory also fulfils the conditions described in Nemko Document NLA 10 the authorization is valid through Oct 07 2013 VCCI The 3m Semi anechoic chamber 12 2m x 7 95m x 6 7m and Shielded Room 8m x4m x 3m of Shenzhen Huatongwei International Inspection Co Ltd has been registered in accordance with the Regulations for Voluntary Control Measures with Registration No G 292 Date of Registration Dec 24 2010 Valid time is until Dec 23 2013 Main Ports Conducted Interference Measurement of Shenzhen Huatongwei International Inspection Co Ltd has been registered in accord2. PASS affect EMC performance C Table 1 modified as appropriate Please refer to User manual PASS d A warning regarding stacking and location close to N A other equipment e A justification for each immunity compliance level N A below 60601 test level f Table 2 completed as appropriate N A 5 2 2 2 Equipment not specified for use only in shielded location PASS Table 3 and Table 5 shall be used for LIFE SUPPORTING Table 4 and Table 6 shall be PASS used are not LIFE SUPPORTING selected and completed as appropriate a ME EQUIPMENT or ME SYSTEM shall be replaced with the MODEL OR TYPE PASS REFERENCE of the ME EQUIPMENT or SYSTEM V1 0 Page 11 of 24 Report No TRE11120098 b Table 3or Table 4 as applicable shall be filled in with the IMMUNITY COMPLIMENT LEVEL in PASS accordance with the requirements of 5 2 2 and 6 2 C The expressions of Table 3 Table 4 and Table 5 Table 6 as applicable shall be calculated the PASS results substituted in place of the COMPLIANCE LEVELS for IEC61000 4 6and IEC61000 4 3 test d Table 5 and Table 6 as applicable shall be completed by calculating the distance PASS corresponding to each entry in columns 2 through 5 in Table5 or in columns 2 through 4 in Table 6 e If according to 6 2 or the scope of the EMC basic standard not apply to the corresponding entries PASS shall state not applicable 5 2 2 3 Equipment specified for use
3. SCAN TABLE test Field 30M 1G QP Short Description Field Strength 30M 1G Start Stop Step Detector Meas IF Transducer Frequency Frequency Width Time Bandw 30 0 MHz 1 0 GHz 60 0 kHz QuasiPeak 1 0 s 120 kHz HL562 Level dBu V m ScCTOEE te al 95 PE T ee EA EEA D D D T t 0 30M 40M 50M 60M 70M 100M 200M 300M 400M 500M Frequency Hz x x xMES HTWO104403_ fin MES HTW0104403 pre LIM EN 55011 CLASS B F QP Field Strength QP Limit MEASUREMENT RESULT HTW0104403 fin 1 4 2012 29 12AM Frequency Level Transd Limit Margin Det Height Azimuth Polarization MHz dBuV m dB dByuV m dB cm deg 30 000000 17 80 11 3 40 0 22 2 QP 100 0 319 00 VERTICAL 96 090000 18 90 19 9 40 0 21 1 QP 100 0 0 00 VERTICAL 98 030000 17 30 19 9 40 0 28 7 QP 100 0 14 00 VERTICAL 294 360000 25 50 17 4 47 0 21 5 QP 100 0 50 00 VERTICAL 311 860000 24 10 16 3 47 0 22 9 QP 100 0 91 00 VERTICAL 860 040000 32 00 7 5 47 0 15 0 QP 100 0 3 00 VERTICAL Page 1 1 1 4 2012 9 12AM HTW0104403 V1 0 Page 16 of 24 Report No TRE11120098 SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO LTD RADIATED EMISSION EN 55011 CLASS B EUT Blood Pressure Monitor Upper arm type M N ORA211 Manufacturer Ningbo Ourui New Material Technology Development Co Ltd Operating Condition ON Test Site 3M CHAMBER Operator JONY Test Specification DC 6V Comment Start of Test 1 4 2012 9 12 39AM SCAN TABLE test Field 30M
4. 4 Test specification Test frequency m 50 Hz m 60 Hz Continuous field E 3 A m Test duration B 5mins Antenna factor 0 917 A m Axis E x axis E y axis 4 10 5 Test result No degradation of function Comply with EN 60601 1 2 2007 4 11 Voltage Dips and Interruptions The test is not applicable to the EUT E z axis V1 0 Page 23 of 24 Report No TRE11120098 5b External and Internal Photos of the EUT 5 1 External photos of the EUT V1 0 Page 24 of 24 Report No TRE11120098 5 2 Internal photos of the EUT 4 e aa TUNING XUL V1 0 A1 Report No TRE11120098 Annex of Report Manufacturer s Declaration of the EUT altogether 5 pages V1 0 A2 Report No TRE11120098 Guidance and manufacturer s declaration electromagnetic emission for all EQUIPMENT AND SYSTEMS Row 1 Guidance and manufacturer s declaration electromagnetic emission The ORA211 Blood Pressure Monitor Upper arm type is intended for use in the electromagnetic environment 2 specified below The customer or the user of ORA211 Blood Pressure Monitor Upper arm type should assure that it is used in such an environment 3 Emissions test Compliance Electromagnetic environment guidance The ORA211 Blood Pressure Monitor Upper arm type uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissi
5. The top end of Electrostatic Discharge simulator should aim at the center of one border of the VCP for at least 10 times discharge The top end of Electrostatic Discharge simulator should place at the point 0 1m away from EUT on the horizontal coupling plane HCP At least 10 times discharge should be done for every pre selected point around EUT Record any performance degradation of the EUT during the test and judge the test result according to performance criterion 4 5 3 3 Photo of the test set up 4 5 4 Test specification Contact discharge voltage m 2kV W 4kV m 6kV Number of discharges E 10 25 Air discharge voltage BH 2kV E 4kV m 8kV Number of discharges 10 E 25 Type of discharge Direct discharge W Air discharge W Contact discharge Indirect discharge W Contact discharge Polarity W Positive W Negative Discharge location E see photo documentation of the test set up E all external locations accessible by hand B horizontal coupling plane HCP B vertical coupling plane VCP V1 0 Page 19 of 24 Report No TRE11120098 4 5 5 Testresult No degradation of function Comply with EN 60601 1 2 2007 4 6 Radiated radio frequency electromagnetic field For test instruments and accessories used see section 3 6 4 6 1 Description of the test location and date Test location Shielded room No 4 Date of test Jan 05 2012 Operator Jony 4 6 2 Severity levels of radiated radio freque
6. Upper arm type differences in Table Model Name ORA211 ORA210 Measurement methods Oscillometric Yes Yes d ber 30 280mmHG Yes Yes measuring range Pulse measurement 40 195 Yes Yes range pulse min Pressure accuracy 3mmHG Yes Yes Pulse accuracy 5 Yes Yes Micro pump Inflatable automatic Yes Yes inflatable Pressure detection Semiconductor Yes Yes Memory 2x90 2x90 Power supply 6V 4 AA 6V 4 AA Time Yes Yes V1 0 Page 6 of 24 Report No TRE11120098 Average Yes Yes Voice Yes No Blood partition Y Y Tips es es Armband size 22 32cm 22 32cm Display Size 57 558mm 57 558mm Serial number prototype 2 4 EUT operation mode The equipment under test was operated during the measurement under the following conditions Test program customer specific Emissions tests According to EN 60601 1 2 searching for the highest disturbance Immunity tests According to EN 60601 1 2 searching for the highest susceptivity Harmonic current Not performed according to EN 61000 3 2 Voltage fluctuation Not performed according to EN 61000 3 3 2 5 EUT configuration The following peripheral devices and interface cables were connected during the measurement W supplied by the manufacturer o supplied by the lab o NIBP Simulator Manufacturer FLUKE M N BP Pump 2 V
7. 1 0 Page 7 of 24 Report No TRE11120098 2 6 Compliance criteria Under the test conditions specified in 6 2 1 10 of EN 60601 1 2 2007 the equipment of system shall be able to provide the essential performance and remain safe 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 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 artifact or distortion in an image in which the artifact 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 For equipment and systems with multiple functions the criteria apply to each function parameter and channel The equipment or system may exhibit degradation of performance e g deviation from manufacturer s specifications that does not affect essential performance or safety 3 TEST ENVIRONMENT 3 1 Address of the test laborat
8. 1G QP Short Description Field Strength 30M 1G Start Stop Step Detector Meas IF Transducer Frequency Frequency Width Time Bandw 30 0 MHz 1 0 GHz 60 0 kHz QuasiPeak 1 0 s 120 kHz HL562 Level dBy V m l l ES P Ue beeper ee Peace ey epee ee l l Lu I I d 4 2 Ek 1 4 I 1 e I 4 0 30M 40M 50M 60M 70M 100M 200M 300M 400M 500M 700M Frequency Hz x x xMES HTWO104404 fin MES HTWO104404 pre LIM EN 55011 CLASS B F QP Field Strength QP Limit MEASUREMENT RESULT HTW0104404 fin 1 4 2012 29 24AM Frequency Level Transd Limit Margin Det Height Azimuth Polarization MHz dByv m dB dByV m dB cm deg 30 000000 17 20 11 3 40 0 22 8 QP 100 0 39 00 HORIZONTAL 96 090000 14 90 19 9 40 0 25 1 QP 100 0 151 00 HORIZONTAL 158 290000 20 70 22 8 40 0 19 3 QP 100 0 39 00 HORIZONTAL 292 420000 34 00 17 4 47 0 13 0 QP 100 0 133 00 HORIZONTAL 519 850000 42 30 12 9 47 0 4 7 QP 100 0 3 00 HORIZONTAL 955 290000 38 30 Tal 47 0 8 7 QP 100 0 181 00 HORIZONTAL Page 1 1 1 4 2012 29 24AM HTW0104404 V1 0 Page 17 of 24 Report No TRE11120098 4 2 Conducted disturbance The test is not applicable to the EUT 4 3 Harmonic current The test is not applicable to the EUT 4 4 Voltage Fluctuation and Flicker The test is not applicable to the EUT 4 5 Electrostatic discharge For test instruments and accessories used see section 3 6 4 5 1 Description of the test location and date Test loc
9. 7 Non standard test method Test Report Form No HTWEMCCE 1A TRF Originator ss Shenzhen Huatongwei International Inspection Co Ltd Master MRE B8 Dated 2006 06 Shenzhen Huatongwei International Inspection Co Ltd All rights reserved This publication may be reproduced in whole or in part for non commercial purposes as long as the Shenzhen Huatongwei International Inspection Co Ltd is acknowledged as copyright owner and source of the material Shenzhen Huatongwei International Inspection Co Ltd takes no responsibility for and will not assume liability for damages resulting from the reader s interpretation of the reproduced material due to its placement and context Test item description Blood Pressure Monitor Upper arm type Manufacturer uesssssss Ningbo Ourui New Material Technology Development Co Ltd Model Type reference ORA211 Listed models ORA210 Ratings 9 sss DC 6V 500mA 3W CSI 0 Positive V1 0 Page 2 of 24 Report No TRE11120098 EMC TEST REPORT Jan 09 2012 Date of issue Equipment under Test f Blood Pressure Monitor Upper arm type Model Type ORA211 Listed Model ORA210 Applicant Ningbo Ourui New Material Technology Development Co Ltd Address No 9 Xiahengd
10. ORA211 Blood Pressure Monitor Upper arm type should assure that it is used in such an environment Immunity test EN 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the ORA211 Blood Pressure Monitor Upper arm type including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms N A 4 5 d WP EN 61000 4 6 150 kHz to 80 MHz Vi 3 5 d VP_ 80 MHz to 800 MHz Radiated RF 3 V m 3 V m Ei EN 61000 4 3 80 MHz to 2 5 GHz a WP 800 MHz to 2 5 GHz E 1 where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol e NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations fo
11. PASS a A statements that medical electrical equipment Please refer to User manual PASS needs special precautions regarding EMC and needs to be installed according to EMC information b A statement that RF communications equipment Please refer to User manual PASS can effect medical electrical equipment 5 2 1 2 Equipment for which the connector testing exemption is used N A a A reproduction of the ESD warning symbol N A IEC 60417 5134 b A warning that pins of connectors marked with the N A warning symbol shall not be touched and connections shall not be made without special precautions C A specification of precautionary procedures N A d A recommendation that all staff receive N A explanation and training in ESD procedures e A specification of the minimum contents of ESD N A precautions procedure training 5 2 1 3 For equipment and systems without a manual sensitivity adjustment and for which PASS the manufacturer specifies a minimum amplitude or signal a The minimum amplitude or value of signal Please refer to User manual PASS b A warning that operation of the equipment below Please refer to User manual PASS that value may cause incorrect results 5 2 1 4 Requirements applicable to TYPE A N A PROFESSIONAL SYSTEMS 5 2 2 TECHNICAL DESCRIPTION PASS 5 2 2 1 All equipment and systems PASS a List of cables and accessories Please refer to User manual PASS b A warning that other cables and accessories may Please refer to User manual
12. Shenzhen Huatongwei International Inspection Co Ltd Os or Keji S 12th Road Hi tech Industrial Park Shenzhen Guangdong China Nac MEA cic Phone 86 755 26748019 Fax 86 755 26748089 http www szhtw com en LINN ur GA W a CNASL1225 TEST REPORT EN 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Report Reference No TRE11120098 Compiled by position printed name signature File administrators Vivi Zhou Less Supervised by NX 2 9 position printed name signature Technique principal Sam Wang sss ER oa Approved b sr a Hin Diener iid name signature Manager Tony Jiang s rA Date of issue 0 0ccceeceeeeeeeeeeeeeeee Jan 09 2012 Testing Laboratory Name Shenzhen Huatongwei International Inspection Co Ltd Address BE d Keji S 12th Road Hi tech Industrial Park Shenzhen Guangdong China Testing location procedure Full application of Harmonised standards DX Partial application of Harmonised standards Other standard testing methods Applicant s name Ningbo Ourui New Material Technology Development Co Ltd Address 88 No 9 Xiahengdai Road Lanjiang Street Yuyao Zhejiang China Test specification TEC Se EN 60601 1 2 200
13. a minimum distance between portable and mobile RF communications equipment transmitters and the ORA211 Blood Pressure Monitor Upper arm type as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Rated maximum 3 5 3 5 7 output of transmitter d WP d WP d WP Vi Ei Ei WwW 0 01 0 12 0 23 0 1 0 38 0 73 1 1 2 2 3 10 3 8 73 100 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people
14. ai Road Lanjiang Street Yuyao Zhejiang China Mdanutacturer Ningbo Ourui New Material Technology Development Co Ltd Address No 9 Xiahengdai Road Lanjiang Street Yuyao Zhejiang China Test Result according to the Positive standards on page 4 The test report merely corresponds to the test sample It is not permitted to copy extracts of these test result without the written permission of the test laboratory V1 0 1 2 3 1 3 2 3 3 3 4 3 5 3 6 5 5 1 5 2 Page 3 of 24 Report No TRE11120098 Contents TEST STANDARDS uuillin2cc i iislEevcuaerseiiinewutndeecdtencid a ur oe A 4 SUMMARY ie ore ete sc crevs asain ul Vua ei eeu aid ave ea der i lead baleen era e o dure da esr red n as 5 General Remarks Equipment Under Test Short description of the Equipment under Test EUT EUT operation mode EUT configuration Compliance criteria TEST ENVIRONMENT 1 xaniiewkacncacic e airveeicalercemeiii averec ecce 7 Address of the test laboratory Test Facility Environmental conditions Test Description Statement of the measurement uncertainty Equipments Used during the Test TEST CONDITIONS AND RESULTS eet 13 Radiated Emission Conducted disturbance Harmonic current Voltage Fluctuation and Flicker Electrostatic discharge Radiated radio frequency electromagnetic field Electrical fast transients Burst Surge Conducted disturbances induced by radio frequ
15. ance with the Regulations for Voluntary Control Measures with Registration No C 2726 Date of Registration Dec 20 2009 Valid time is until Dec 19 2012 Telecommunication Ports Conducted Interference Measurement of Shenzhen Huatongwei International Inspection Co Ltd has been registered in accordance with the Regulations for Voluntary Control Measures with Registration No T 1837 Date of Registration May 07 2010 Valid time is until May 06 2013 DNV Shenzhen Huatongwei International Inspection Co Ltd has been found to comply with the requirements of DNV towards subcontractor of EMC and safety testing services in conjunction with the EMC and Low voltage Directives and in the voluntary field The acceptance is based on a formal quality Audit and follow ups according to relevant parts of ISO IEC Guide 17025 2005 in accordance with the requirements of the DNV Laboratory Quality Manual towards subcontractors Valid time is until Aug 24 2013 3 3 Environmental conditions During the measurement the environmental conditions were within the listed ranges Temperature 22 25 C Humidity 40 54 Atmospheric pressure 950 1050mbar V1 0 3 4 Test Description Page 9 of 24 Report No TRE11120098 Emission Measurement Test Note N A means not applicable EN 61000 4 11 2004 The measurement uncertainty is not included in the test result Radiated Emissio
16. ation Shielded room No 1 Date of test Jan 05 2012 Operator Jony 4 5 2 Severity levels of electrostatic discharge Special Special Note equipment and systems shall comply with the requirements of 6 2 2 of EN 60601 1 2 2007 at immunity test levels of 2KV 4KV and 8KV for air discharge and 2KV 4KV and 6KV for contact discharge 4 5 3 Description of the test set up 4 5 3 1 Operating Condition The EUT is turned on during the test and the results of the maximum susceptive results are recorded 4 5 3 2 Test Configuration and Procedure Air Discharge This test is done on a non conductive surfaces The round discharge tip of the Electrostatic Discharge simulator shall be approached as fast as possible then to touch the EUT After each discharge the simulator shall be removed from the EUT The simulator is then re triggered for a new single discharge and repeated 25 times for each pre selected test point This procedure shall be repeated until all the air discharge completed Contact Discharge All the procedure shall be same as air discharge except using the acute discharge tip The top end of the Electrostatic Discharge simulator is touch the EUT all the time when the simulator is re triggered for V1 0 Page 18 of 24 Report No TRE11120098 a new single discharge and repeated 10 times for each pre selected test point Indirect Discharge The vertical coupling plane VCP is placed 0 1m away from EUT
17. ei International Inspection Co Ltd quality system acc to DIN EN ISO IEC 17025 Furthermore component and process variability of devices similar to that tested may result in additional deviation The manufacturer has the sole responsibility of continued compliance of the device Hereafter the best measurement capability for Shenzhen Huatongwei laboratory is reported Test Range Measurement Notes Uncertainty Radiated Emission 30 1000MHz 4 65dB 1 1 This uncertainty represents an expanded uncertainty expressed at approximately the 95 confidence level using a coverage factor of k 2 V1 0 Page 12 of 24 3 6 Equipments Used during the Test Report No TRE11120098 Radiated Emission Item Test Equipment Manufacturer Model No Serial No Last Cal ULTRA BROADBAND 1 ANTENNA ROHDE amp SCHWARZ HL562 100015 2011 05 2 EMI TEST RECEIVER ROHDE amp SCHWARZ ESI 26 100009 2011 10 3 RF TEST PANEL ROHDE amp SCHWARZ TS RSP 335015 0017 2011 10 4 TURNTABLE ETS 2088 2149 2011 10 5 ANTENNA MAST ETS 2075 2346 2011 10 EMI TEST 6 SOFTWARE ROHDE amp SCHWARZ ESK1 N A 2011 10 Electrostatic Discharge Item Test Equipment Manufacturer Model No Serial No Last Cal 1 ESD 30 System EM TEST ESD 30C V0511100210 2011 10 RF Field Strength Susceptibility Item Te
18. ency fields Magnetic Field Immunity Voltage Dips and Interruptions EXTERNAL AND INTERNAL PHOTOS OF THE EUT 23 External photos of the EUT Internal photos of the EUT ANNEX ONE PAGES se cee cee cee cee cee cee cee cee cee cee ee ee renren ee eee ee ee ee ee ee et AD AS NOOO oi N d0o0 l 23 24 V1 0 Page 4 of 24 Report No TRE11120098 1 TEST STANDARDS The tests were performed according to following standards EN 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Remark This EUT is ranged to the Group 1 Class B apparatus according to the standard of EN 55011 2009 clause 5 2 V1 0 2 SUMMARY E Specified by manufacturer O Not specified 2 1 General Remarks Date of receipt of test sample Testing commenced on Testing concluded on 2 2 Equipment Under Test Power supply system utilised Power supply voltage Page 5 of 24 Dec 27 2011 Report No TRE11120098 Dec 30 2011 Jan 05 2012 o 230V 50Hz B 6V DC o 115V 60Hz o 24V DC o Other specified in blank below 2 3 Short description of the Equipment under Test EUT The EUT is an Blood Pressure Monitor Upper arm type and this EUT is ranged to the Group 1 Class B apparatus according to the standard of EN 55011 2009 clause 5 2 Blood Pressure Monitor
19. licable to the EUT 4 8 Surge The test is not applicable to the EUT V1 0 Page 21 of 24 Report No TRE11120098 4 9 Conducted disturbances induced by radio frequency fields The test is not applicable to the EUT 4 10 Magnetic Field Immunity For test instruments and accessories used see section 3 6 4 10 1 Description of the test location and date Test location Shielded room No 1 Date of test Jan 05 2012 Operator Jony 4 10 2 Severity levels of magnetic field immunity Magnetic Field Strength A m Special X immunity test levels of 3A m 4 10 3 Description of the test set up 4 10 3 1 Operating Condition Note equipment and systems shall comply with the requirements of 6 2 8 of EN 60601 1 2 2007 at The EUT is turned on during the test and the results of the maximum susceptive results are recorded 4 10 3 2 Test Configuration and Procedure EUT is placed on an insulating support of 0 1m high above a table of 0 8m high There is a minimum 1m 1m ground metallic plane put on this table EUT is put in the center of the magnetic coil then three orientations of the magnetic coil X Y and Z shall be rotated in order to expose the EUT to the difference polarization magnetic field Record any performance degradation of the EUT during the test and judge the test result according to performance criterion V1 0 Page 22 of 24 4 10 3 3 Photo of the test set up Report No TRE11120098 4 10
20. n EN 60601 1 2 2007 EN 55011 2009 iix Conducted Disturbance EN 60601 1 2 2007 A 0 15 30MHz EN 55011 2009 Harmonic Current EN 60601 1 2 2007 N A EN 61000 3 2 2006 A1 2009 A2 2009 Voltage Fluctuation and Flicker EN 60601 1 2 2007 N A EN 61000 3 3 2008 Immunity Measurement Electrostatic Discharge EN 60601 1 2 2007 EN 61000 4 2 2009 dii RF Field Strength Susceptibility EN 60601 1 2 2007 ea 80 2500MHz EN 61000 4 3 2006 Electrical Fast Transient Burst EN 60601 1 2 2007 veel EN 61000 4 4 2004 A1 2010 En Surge Test EN 60601 1 2 2007 NA EN 61000 4 5 2006 Conducted Susceptibility Test EN 60601 1 2 2007 KR EN 61000 4 6 2009 Power Frequency Magnetic Field EN 60601 1 2 2007 Susceptibility Test EN 61000 4 8 2010 PASS Voltage Dips and Interruptions EN 60601 1 2 2007 N A V1 0 Page 10 of 24 EN 60601 1 2 Report No TRE11120098 Requirement Test Verdict 5 IDENTIFICATION MARKING AND DOCUMENTS PASS 5 1 Marking on the outside of ME EQUIPMENT OR ME EQUIPMENT parts N A 5 1 1 RF equipment marked with symbol N A IEC 60417 5140 5 1 2 Equipment for which the connector testing N A exemption is used marked with symbol IEC 60417 5134 5 1 3 Equipment specified for use only in shielded N A location has appropriate marking 5 2 ACCOMPANYING DOCUMENTS PASS 5 2 1 Instructions for use PASS 5 2 1 1 All equipment and systems
21. ncy electromagnetic field Field Strength V m Special Note equipment and systems shall comply with the requirements of 6 2 3 of EN 60601 1 2 2007 at immunity test levels of 3V m tee X 4 6 3 Description of the test set up 4 6 3 1 Operating Condition The EUT is turned on during the test and the results of the maximum susceptive results are recorded 4 6 3 2 Test Procedure EUT and its auxiliary instrument are placed on a turntable which is 0 8 meter above ground Transmitting antenna mounted on an antenna mast is set 3 meter away from the EUT During the test each of the four sides of EUT will face the transmitting antenna with the turntable cycled Both horizontal and vertical polarization of the antenna are set on test and measured individually In order to judge the performance of the EUT a set of monitor system is used Record any performance degradation of the EUT during the test and judge the test result according to performance criterion V1 0 Page 20 of 24 Report No TRE11120098 4 6 3 3 Photo of the test set up 4 6 4 Test specification Frequency range m 80 MHz to 2500 MHz Field strength W 3 V m EUT antenna separation E 3m Modulation W AM 80 E sinusoidal 2Hz Frequency step W 1 with 3s dwell time Antenna polarisation B horizontal W vertical 4 6 5 Test result No degradation of function Comply with EN 60601 1 2 2007 4 7 Electrical fast transients Burst The test is not app
22. ned on during the test and the maximum emanating results are recorded 4 1 3 2 Test Configuration and Procedure EUT is tested in Semi Anechoic Chamber EUT is placed on a nonmetal table above a grounded turntable The turntable can rotate 360 degrees to determine the azimuth of the maximum emission level EUT is set 3 meters away from the center of receiving antenna The antenna can move up and down from 1 to 4 meter to find out the maximum emission level Both horizontal and vertical polarizations of the antenna are set on the test 4 1 3 3 Photos of the test set up TM aaee nangi M LITITIZSEDPFIIIU ELLILLPLILLIIJ 1 ILES LI IJ IJ 4 wiv TY TY T0 paseneers a LI J J au en _ V1 0 Page 14 of 24 Report No TRE11120098 4 1 4 Test result The requirements are Fulfilled Band Width 120kHz Frequency Range 30MHz to 1000MHz Remarks The limits are kept For detailed results please see the following page s Margin limit level Level read values transducer Transducer antenna factor pre amplifier factor cable loss V1 0 Page 15 of 24 Report No TRE11120098 SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO LTD RADIATED EMISSION EN 55011 CLASS B EUT Blood Pressure Monitor Upper arm type M N ORA211 Manufacturer Ningbo Ourui New Material Technology Development Co Ltd Operating Condition ON Test Site 3M CHAMBER Operator JONY Test Specification DC 6V Comment Start of Test 1 4 2012 9 00 34AM
23. nt ines 1 kV differential Surge ode Seep Mains power quality should be that of a N A typical commercial or hospital EN 61000 4 5 d EV common inode environment 5 96 Ur 295 dip in Ur for 0 5 cycle Mains power quality should be that of a typical commercial or hospital Voltage dips short 40 Ur environment If the user of the interruptions and 60 dip in Ur ORA211 Blood Pressure Monitor voltage variations for 5 cycles N A Upper arm type requires continued on power supply operation during power mains input lines 70 Ur interruptions it is recommended that the 30 dip in Ur ORA211 Blood Pressure Monitor EN 61000 4 11 for 25 cycles Upper arm type be powered from an uninterruptible power supply or a 5 Ur battery gt 95 dip in Ur for 5 sec S060 aoe Power frequency magnetic fields should magnete field 3 Alm 3 Alm be at levels characteristic of a typical EN 61000 4 8 location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level V1 0 A4 Report No TRE11120098 Guidance and manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic immunity The ORA211 Blood Pressure Monitor Upper arm type is intended for use in the electromagnetic environment specified below The customer or the user of the
24. only in shielded location N A a A warning that equipment should be used only in N A the specified type of shielded location b Tables modified if disturbance allowance N A according in 6 1 1 1 d is used C A specification of allowed emission of other N A equipment located within the shielded location d Table 7 shall be used for LIFE SUPPORTING N A Table 8 shall be used are not LIFE SUPPORTING 5 2 2 4 Equipment that intentionally apply RF energy N A 5 2 2 5 Equipment that intentionally receive RF energy N A 5 2 2 6 Equipment that includes RF transmitters N A 5 2 2 7 Requirements of cables and accessories Please refer to User manual PASS 5 2 2 8 Requirements applicable to large permanently N A installed equipment and systems 5 2 2 9 Requirements applicable to equipment that has no N A essential performance 5 2 2 10 Requirements applicable to TYPE A N A PROFESSIONAL SYSTEMS 6 ELECTROMAGNETIC COMPATIBILITY se appended table 3 5 Statement of the measurement uncertainty The data and results referenced in this document are true and accurate The reader is cautioned that there may be errors within the calibration limits of the equipment and facilities The measurement uncertainty was calculated for all measurements listed in this test report acc to CISPR 16 4 Specification for radio disturbance and immunity measuring apparatus and methods Part 4 Uncertainty in EMC Measurements and is documented in the Shenzhen Huatongw
25. ons 4 Group 1 EN 55011 RF emissions 5 Class B The ORA211 Blood Pressure Monitor Upper arm type is suitable f EN 55011 or use in all establishments including domestic establishments and Harmonic emissions those directlyconnected to the public low voltage power 6 N A supplynetwork that supplies buildings used for domestic purposes EN 61000 3 2 Voltage fluctuations 7 flicker emissions N A EN 61000 3 3 V1 0 A3 Report No TRE11120098 Guidance and manufacturer s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity The ORA211 Blood Pressure Monitor Upper arm type is intended for use in the electromagnetic environment specified below The customer or the user of the ORA211 Blood Pressure Monitor Upper arm type should assure that it is used in such an environment Immunity test EN 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Floors should be wood concrete or discharge ESD EDAD CORIQUE OKY contaci ceramic tile If floors are covered with synthetic material the relative humidity EN 61000 4 2 soU SEM should be at least 30 2 kV for power EE Bion supply lines Mains power quality should be that of a transient burst s N A typical commercial or hospital i EN 61000 4 4 s 1 kV for input output environme
26. ory Shenzhen Huatongwei International Inspection Co Ltd Keji S 12th Road Hi tech Industrial Park Shenzhen Guangdong China Tel 86 755 26715686 Fax 86 755 26748089 3 2 Test Facility The test facility is recognized certified or accredited by the following organizations CNAS Lab Code L1225 Shenzhen Huatongwei International Inspection Co Ltd has been assessed and proved to be in compliance with CNAS CLO01 Accreditation Criteria for Testing and Calibration Laboratories identical to ISO IEC 17025 2005 General Requirements for the Competence of Testing and Calibration Laboratories Date of Registration Mar 30 2009 Valid time is until Mar 29 2012 A2LA Lab Cert No 2243 01 Shenzhen Huatongwei International Inspection Co Ltd EMC Laboratory has been accredited by A2LA for technical competence in the field of electrical testing and proved to be in compliance with ISO IEC 17025 2005 General Requirements for the Competence of Testing and Calibration Laboratories and any additional program requirements in the identified field of testing Valid time is until Sep 30 2013 FCC Registration No 662850 Shenzhen Huatongwei International Inspection Co Ltd EMC Laboratory has been registered and fully described in a report filed with the FCC Federal Communications Commission The acceptance letter from the FCC is maintained in our files Registration 662850 Renewal date Jul 01 2009 valid time is until Jun 30 2012
27. r radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ORA211 Blood Pressure Monitor Upper arm type is used exceeds the applicable RF compliance level above the ORA211 Blood Pressure Monitor Upper arm type should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ORA211 Blood Pressure Monitor Upper arm type Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m V1 0 A5 Recommended separation distances between portabl Report No TRE11120098 e and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the ORA211 Blood Pressure Monitor Upper arm type The ORA211 Blood Pressure Monitor Upper arm type is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ORA211 Blood Pressure Monitor Upper arm type can help prevent electromagnetic interference by maintaining
28. st Equipment Manufacturer Model No Serial No Last Cal SIGNAL 1 GENERATOR IFR 2032 203002 100 2011 10 2 AMPLIFIER AR 150W1000 301584 2011 10 DUAL DIRECTIONAL 3 COUPLER AR DC6080 301508 2011 10 4 POWER HEAD AR PH2000 301193 2011 10 POWER METER AR PM2002 302799 2011 10 TRANSMITTING 6 AERIAL AR AT1080 28570 2011 10 7 POWER AMPLIFIER AR 25S1G4A 0325511 2011 10 DUAL DIRECTIONAL 8 COUPLER AR DC7144A 0325100 2011 10 TRANSMITTING 9 AERIAL AR AT4002A 0324848 2011 10 Power Frequency Magnetic Field Susceptibility Item Test Equipment Manufacturer Model No Serial No Last Cal ULTRA COMPACT 1 SIMULATOR EM TEST UCS500M6 202304 060 2011 10 MOTOR DRIVEN 2 VOLTAGE EM TEST MV2616 302205 2011 10 TRANSFORMER CURRENT 3 TRANSFORMER EM TEST MC2630 302389 2011 10 4 MAGNETIC COIL EM TEST MS100 0010230A 2011 10 V1 0 Page 13 of 24 Report No TRE11120098 4 TEST CONDITIONS AND RESULTS 4 1 Radiated Emission For test instruments and accessories used see section 3 6 4 1 1 Description of the test location Test location Shielded room No 4 4 1 2 Limits of disturbance Class B Frequency MHz Distance Meters Field Strengths Limits dBuV m Note 1 The tighter limit shall apply at the edge between two frequency bands 2 Distance refers to the distance in meters between the test instrument antenna and the closest point of any part of the E U T 4 1 3 Description of the test set up 4 1 3 1 Operating Condition The EUT is tur
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