Attachment 8. IEC 60601-1-2 Test Report

IEC 60601 1 2 2007 EMC MEASUREMENT AND TEST REPORT FOR Ageless Health Industrial Ltd 3 F A1 Bldg Dongshen Sima Industrial Area No 33 Shenbei Road Sima Village Changping Town Dongguan Guangdong China October 29 2012 This Report Concerns Original Report Equipment Type AGE Automatic Wrist Blood Pressure Monitor Test Engineer Hu Yaohuang Test Date 03 July 2012 to 29 October 2012 Reviewed By Huang Jian Approved By HeHe PingPing CHINA CEPREI SICHUAN LABORATORY Prepared By CHINA CEPREI SICHUAN LABORATORY No 45 Wen Ming Dong Road Longquanyi Chengdu 610100 P R China MODEL BW 601 BW 602 BW 603 BW 605 BW 606 BW 611 BW 612 BW 613 IEC 60601 1 2 2007 Test Report Report SCC 11 618 9 12 EMC Page 2 of 32 TABLE OF CONTENTS GENERAL INFORMATION 4 PRODUCT DESCRIPTION FOR EQUIPMENT UNDER TEST EUT 4 OBJECTIVE 4 EQUIPMENT MODIFICATIONS 4 1 EMISSION AND IMMUNITY TEST IEC 60601 1 2 2007 5 1 1 CONDUCTED DISTURBANCE AT THE MAINS TERMINALS 5 1 1 1 TEST EQUIPMENT LIST AND DETAILS 5 1 1 2 TEST PROCEDURE 5 1 1 3 POWER LINE CONDUCTED EMISSION LIMIT CLASS B EQUIPMENT 5 1 1 4 CONFIGURATION 6 1 1 5 TEST RESULTS 6 1 2 RADIATED DISTURBANCES 6 1 2 1 TEST EQUIPMENT LIST AND DETAILS 6 1 2 2 TEST PROCEDURE 7 1 2 3 RADIATED EMISSION LIMIT CLASS B EQUIPMENT 7 1 2 4 CONFIGURATION 7 1 2 5TEST RESULTS 8 1 2 6 VERDICT THE EUT MET THE REQUIREMENT 9 1 3 ESD 9 1 3 1 TEST EQUIPMENT LIST AND DETAILS 9 1 3 2 TEST REQUIREMENTS 10 1 3 3 CONFIGURATION 10 1 3 4 TEST DATA AND RECORDS 10 1 3 5 VERDICT 11 1 4 EFT B 11 1 4 1 TEST EQUIPMENT LIST AND DETAILS 11 1 4 2 TEST REQUIREMENTS 11 1 4 3 CONFIGURATION 12 1 4 4 TEST DATA AND RECORDS 12 1 4 5 VERDICT 12 1 5 RADIO FREQUENCY ELECTROMAGNETIC FIELD 12 1 5 1 TEST EQUIPMENT LIST AND DETAILS 12 1 5 2 TEST REQUIREMENTS 13 1 5 3 CONFIGURATION 13 1 5 4 TEST DATA AND RECORDS 13 1 5 5 VERDICT 13 1 6 RADIO FREQUENCY CONTINUOUS CONDUCTED 0 15 MHZ TO 80 MHZ 14 1 6 1 TEST EQUIPMENT LIST AND DETAILS 14 1 6 2 TEST REQUIREMENTS 14 1 6 3 CONFIGURATION 15 1 6 4 TEST DATA AND RECORDS 15 1 6 5 VERDICT 15 1 7 SURGES 15 1 7 1 TEST EQUIPMENT LIST AND DETAILS 15 1 7 2 TEST REQUIREMENTS 15 1 7 3 CONFIGURATION 16 1 7 4 TEST DATA AND RECORDS 16 1 7 5 VERDICT 16 1 8 VOLTAGE DIPS AND INTERRUPTIONS 16 1 8 1 TEST EQUIPMENT LIST AND DETAILS 16 1 8 2 TEST REQUIREMENTS 16 1 8 3 CONFIGURATION 17 1 8 4 TEST DATA AND RECORDS 17 1 8 5 VERDICT 17 IEC 60601 1 2 2007 Test Report Report SCC 11 618 9 12 EMC Page 3 of 32 1 9 POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST 18 1 9 1 TEST EQUIPMENT LIST AND DETAILS 18 1 9 2 TEST REQUIREMENTS 18 1 9 3 BLOCK DIAGRAM OF TEST SETUP 18 1 9 4 TEST SETUP AND PROCEDURE 18 1 9 5 TEST RESULT 19 2 HARMONIC CURRENT EMISSIONS IEC 60601 1 2 2007 CLAUSE 6 1 3 1 1 20 2 1 TEST EQUIPMENT LIST AND DETAILS 20 2 2 LIMITS 20 2 3 BLOCK DIAGRAM OF TEST SETUP 20 2 4 TEST DATA AND RECORDS 21 2 5 VERDICT 21 3 VOLTAGE CHANGES VOLTAGE FLUCTUATIONS AND FLICKER IEC 60601 1 2 2007 CLAUSE 6 1 3 1 2 22 3 1 TEST EQUIPMENT LIST AND DETAILS 22 3 2 LIMITS 22 3 3 CONFIGURATION 22 3 4 TEST DATA AND RECORDS 23 3 5 VERDICT 23 APPENDIX I TEST PHOTOGRAPH 26 APPENDIX II EQUIPMENT PHOTOGRAPH 28 IEC 60601 1 2 2007 Test Report Report SCC 11 618 9 12 EMC Page 4 of 32 GENERAL INFORMATION Product Description for Equipment under Test EUT The product that is produced by Ageless Health Industrial Ltd Test model BW 601 The Application Model are BW 601 BW 602 BW 603 BW 605 BW 606 BW 611 BW 612 BW 613 or the EUT as referred to in this report is an AGE Automatic Wrist Blood Pressure Monitor All the models have the same electric parameter electrical components They also have the similar constructions and electrical connections except for outlook On the basis of these similarities among these models of this manufacturer this EMC report is also applicable to above mentioned models Objective In order to meet the EMC requirements approved by CENELEC the following standards will be cited 1 IEC 60601 1 2 2007 Electrical equipment for measurement control and laboratory use EMC requirements The objective of the manufacturer is to demonstrate compliance with the limits for the standard Limits and methods of measurement Notice The test results of this report relate only to the tested sample identified in this report Equipment Modifications No modification to the EUT was made by China Ceprei Sichuan Laboratory to make sure the EUT comply with applicable limits The test results of this report relate only to the tested sample identified in this report IEC 60601 1 2 2007 Test Report Report SCC 11 618 9 12 EMC Page 5 of 32 1 Emission and Immunity Test IEC 60601 1 2 2007 1 1 Conducted disturbance at the Mains Terminals 1 1 1 Test Equipment List and Details ManufacturerDescriptionModel Serial Number Last Cal Date Cal Period Albatross Projects GmbH Shield RoomSite 1 2011 102 Year R 2 The value of Plt shall not be greater than 0 65 3 The value of d t during a voltage change shall not exceed 3 3 for more than 500ms 4 The relative steady state voltage change dc shall not exceed 3 3 5 The maxim relative voltage change dmax shall not exceed 4 Notes Pst Short term flicker indicator The flicker severity evaluated over a short period in minutes Pst 1 is the conventional threshold of irritability Plt long term flicker indicator the flicker severity evaluated over a long period a few hous Using successive Pst values dc the relative steady state voltage change dmax maximum relative voltage change d t the value during a voltage change 3 3 Configuration IEC 60601 1 2 2007 Test Report Report SCC 11 618 9 12 EMC Page 23 of 32 3 4 Test Data and Records The test item does not be applicable 3 5 Verdict Not applicable IEC 60601 1 2 2007 Test Report Report SCC 11 618 9 12 EMC Page 24 of 32 4 Identification marking and documents IEC 60601 1 2 2007 Clause 5 ClauseRequirement TestResult RemarkVerdict 5Identification marking and documentsPass 5 1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts N A 5 1 1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts that include RF transmitters or that apply RF electromagnetic energy for diagnosis or treatment No RF transmitter N A 5 1 2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts for which the connector testing exemption specified in 6 2 2 2 c is used N A 5 1 3 Marking on the outside of ME EQUIPMENT and ME SYSTEMS that are specified for use only in a shielded location Not specified for use only in a shielded location N A 5 2ACCOMPANYING DOCUMENTSPlease refer to User manual Pass 5 2 1Instructions for usePlease refer to User manual Pass 5 2 1 1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS Pass 5 2 1 2 Requirements applicable to ME EQUIPMENT and ME SYSTEMS for which the connector testing exemption specified in 6 2 2 2 c is used N A 5 2 1 3 Minimum amplitude or value of PATIENT physiological signal N A 5 2 1 4 Requirements applicable to TYPE A PROFESSIONAL ME EQUIPMENT and ME SYSTEMS N A 5 2 2Technical descriptionPlease refer to User manual Pass 5 2 2 1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS Please refer to User manual Pass 5 2 2 2 Requirements applicable to ME EQUIPMENT and ME SYSTEMS other than those specified for use only in a shielded location N A 5 2 2 3 Requirements applicable to ME EQUIPMENT and ME SYSTEMS specified for use only in a shielded location N A 5 2 2 4 Requirements applicable to ME EQUIPMENT and ME SYSTEMS that intentionally apply RF energy for diagnosis or treatment N A 5 2 2 5 Requirements applicable to ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation N A 5 2 2 6 Requirements applicable to ME EQUIPMENT and ME SYSTEMS that include RF transmitters N A 5 2 2 7 Requirements applicable to cables transducers and other ACCESSORIES that could affect compliance with the requirements of 6 1 and 6 2 N A 5 2 2 8 Requirements applicable to LARGE PERMANENTLY INSTALLED ME EQUIPMENT and ME SYSTEMS N A IEC 60601 1 2 2007 Test Report Report SCC 11 618 9 12 EMC Page 25 of 32 ClauseRequirement TestResult RemarkVerdict 5 2 2 9 Requirements applicable to ME EQUIPMENT and ME SYSTEMS found to have no ESSENTIAL PERFORMANCE N A 5 2 2 10 Requirements applicable to TYPE A PROFESSIONAL ME EQUIPMENT and ME SYSTEMS N A IEC 60601 1 2 2007 Test Report Report SCC 11 618 9 12 EMC Page 26 of 32 APPENDIX I TEST PH