RP4ECGC4S0011-lead ECG recorder

BORSAMBiomedical InstrumentsCo.,Ltd. ECG-Check ECG-Check ECG-Check ECG-Check User User User UserManual Manual Manual Manual ThisdocumentcontainsproprietaryinformationofDocumentNo.Rev.Pageof BORSAMBiomedicalInstrumentsCo.,Ltd.ECGC-70-00302 123 UserManual ECG-Check-OTC RESTRICTION ON USE, DUPLICATION, OR DISCLOSURE OF PROPRIETARY INFORMATION This document contains proprietary information, which is the sole property of the company. The document is submitted to the recipient for his use only. By receiving this document the recipient undertakes not copy or disclose part of, or the whole of the information contained herein to any third party without receiving beforehand, written permission from submitting company. NameTitleSignatureDate WRITTENBYSHUIBINGYANTEAMLEADER APPROVEDBYMAODINGHONGMANAGINGDIRECTOR BORSAMBiomedical InstrumentsCo.,Ltd. ECG-Check ECG-Check ECG-Check ECG-Check User User User UserManual Manual Manual Manual ThisdocumentcontainsproprietaryinformationofDocumentNo.Rev.Pageof BORSAMBiomedicalInstrumentsCo.,Ltd.ECGC-70-00302223 Version Version Version VersionDate Date Date DateName Name Name NameDescription Description Description Description 011/16/2013C.PillarInitialDocument 021/18/2013M.JandesAddedscreenshotsofprogressbar ECGCheckWireless 1-LeadCardiacMonitor OTCUse ii Dear Dear Dear DearECG ECG ECG ECGCheck Check Check CheckOwner: Owner: Owner: Owner: ThankyouforselectingtheECGCheckcardiacmonitor. ThisuserguideincludesinformationandinstructionsaboutyournewECGCheck andwillhelpfamiliarizeyouwiththebasicskillsofusingyourECGCheck,soplease takeamomenttoreaditcarefullybeforeyoubegintesting. Wehaveincludedawarrantyregistrationcard. Pleasecompleteandreturnitpromptlytoenableustoprovideyouthefullbenefits regardingyourECGCheckproduct. Forthemostup-to-datelistofcompatibledevices,pleaserefertothesupportedlist athttp://www.bioxtime.com. Wecareaboutwhatyouthinkandwanttokeepyouinformedaboutitsuseandcare. IfyouhaveanyquestionsaboutyournewECGCheck,pleasecontact: BORSAMBiomedicalInstrumentsCo.,Ltd. Rm.502,UniversityInnovationPARK Lishanroad XiliTown 518055Shenzhen PEOPLE’SREPUBLICOFCHINA Email:[email protected] Website:www.bioxtime.com iii Copyright Copyright Copyright CopyrightDeclaration Declaration Declaration Declaration Copyright © BORSAMBiomedicalInstrumentsCo.,Ltd. Allrightsreserved. iPhone,iPad,iPod,iOSandtheApplelogoareeitherregisteredtrademarksor trademarksofAppleCorporationintheUnitedStatesand/orothercountries. BORSAMBiomedicalInstrumentsCo.,Ltd.,BORSAMlogo,andECGCheckandECG WebCenteraretrademarksorregisteredtrademarksofBORSAMBiomedical InstrumentsCo.,Ltd. Allotherbrandnamesandproductnamesusedinthisdocumentaretrade names,servicemarks,trademarks,orregisteredtrademarksoftheirrespective owners. Theinformationandscreensprovidedinthismanualaresubjecttochangewithout notice. BORSAMBiomedicalInstrumentsCo.,Ltd.SHALLNOTBELIABLEFORTECHNICAL OREDITORIALERRORSOROMISSIONSCONTAINEDHEREIN;NORFOR INCIDENTALORCONSEQUENTIALDAMAGESRESULTINGFROMTHE FURNISHING,PERFORMANCE,ORUSEOFTHISMATERIAL. AuthorizedRepresentatives: CHINA BORSAMBiomedicalInstrumentsCo.,Ltd. Rm.502,UniversityInnovationPARK Lishanroad XiliTown 518055Shenzhen 86-755-86325336 Declaration Declaration Declaration Declarationof of of ofConformity Conformity Conformity Conformity ConformancetoStandards–non-clinicaltestingdemonstratedconformance tovoluntarysafetyIEC60601-1andtoIEC60601-1-2-2001ClassB iv Warning:Changesormodificationstothisunitnotexpresslyapprovedbytheparty responsibleforcompliancecouldvoidtheuser’sauthoritytooperatetheequipment. NOTE:Thisequipmenthasbeentestedandfoundtocomplywiththelimitsfora ClassBdigitaldevice,pursuanttoPart15oftheFCCRules.Theselimitsare designedtoprovidereasonableprotectionagainstharmfulinterferenceina residentialinstallation.Thisequipmentgenerates,usesandcanradiateradio frequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions, maycauseharmfulinterferencetoradiocommunications. However,thereisnoguaranteethatinterferencewillnotoccurinaparticular installation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevision reception,whichcanbedeterminedbyturningtheequipmentoffandon,theuseris encouragedtotrytocorrecttheinterferencebyoneormoreofthefollowing measures: � � � � Reorientorrelocatethereceivingantenna. � � � � Increasetheseparationbetweentheequipmentandreceiver. � � � � Connecttheequipmentintoanoutletonacircuitdifferentfromthatto whichthereceiverisconnected. � � � �Consultthedealeroranexperiencedradio/TVtechnicianforhelp. ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothe followingtwoconditions: (1)thisdevicemaynotcauseharmfulinterference,and (2)thisdevicemustacceptanyinterferencereceived,includinginterference thatmaycauseundesiredoperation. BORSAMBiomedicalInstrumentsCo.,Ltd.’sQualitySystemconformsto21CFR820 andISO13485:2003 Danger Danger Danger Danger Equipmentnotsuitableforuseinthepresenceofflammableanestheticmixturewith airorwithOxygenorNitrousOxide. Graphic Graphic Graphic GraphicSymbols Symbols Symbols Symbolson on on onECG ECG ECG ECGCheck Check Check Check Thissymbolisintendedtoalerttheusertothepresenceof importantoperatingandmaintenance(servicing)instructions intheliteratureaccompanyingtheappliance. v ThissymbolindicatestypeBFequipmentclassifiedin accordancewithIECPublication601-1Safetyofmedical electricalequipment. Intended Intended Intended IntendedUse Use Use Use TheECGCheckisintendedforusewheneveryouareinterestedinyourcardiac activity.Itcanbeusedanytime,includingduringorafterstrenuousactivity(i.e., duringorafterexercise)orifyouexperiencethefollowingsymptomsthatare suggestiveofabnormalheartrhythms: •SkippedBeats •PoundingHeart(Palpitations)HeartRacingorIrregularPulse •LightheadednessorFaintness •HistoryofArrhythmias TheECGCheckisnotintendedfordiagnosticuseanddoesnotprovidediagnostic qualityECGdata. Contraindications Contraindications Contraindications Contraindications TherearenopotentialadverseeffectsoftheECGCheckonhealth. vi Who Who Who WhoShould Should Should…

Text truncated - open the document above for the full version.

External Photos

External Photos

Label Artwork and Location ECG Check FCC ID: RP4ECGC4S001 Label Size: 30mm (L)*12mm (W)

Label Artwork and Location ECG Check FCC ID: RP4ECGC4S001 Label Size: 30mm (L)*12mm (W)

Internal Photos Antenna

Internal Photos Antenna

1 INTERTEK TESTING SERVICES Analysis Report The equipment under test (EUT) is a portable 1-lead ECG recorder with Bluetooth function. The EUT is powered by CR2032 Li-ion battery (DC 3V)*1. For more detailed information pls. refer to the user manual. Modulation Type: GFSK Bluetooth Version: 4.0 (Single Mode) Antenna Type: Integral antenna Antenna Gain: 0dBi The nominal radiated output power (e.i.r.p) specified: 0 dBm (tolerance: +/- 4 dB) The nominal conducted output power specified: 0 dBm (tolerance: +/- 4dB) According to the KDB 447498: Th e worst-case radiated emission for the EUT is 94.7dBμV/m at 3m in the frequency 2.402GHz = [(FS*D) ^2 / 30] mW = -0.53 dBm which is within the production variation. The maximun conducted output power specified is 4 dBm = 2.51mW The source- based time-averaging conducted output power = 2.51 * Duty cycle mW= 2.51 mW The SAR Exclusion Threshold Level: = 3 . 0 * (min. test separation distance, mm) / sqrt(freq. in GHz) = 3.0 * 5 / sqrt (2.480) mW = 9.5 mW Since the source-based time-averaging conducted output power is well below the SAR low threshold level, so the EUT is considered to comply with SAR requirement without testing. Transmitter Duty Cycle Calculation The test signal of the EUT is Continuous emission, so the Duty Cycle is 100%. FCC ID: RP4ECGC4S001

• The test results reported in this test report shall refer only to the sample actually tested and shall not refer or be deemed to refer to bulk from which such a sample may be said to have been obtained. • This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to copy or distribute this report. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results referenced from this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. • For Terms And Conditions of the services, it can be provided upon request. • The evaluation data of the report will be kept for 3 years from the date of issuance. TRF No.: FCC 15C_TX_b Intertek Testing Services Shenzhen Ltd. Kejiyuan Branch 6F, D Block, Huahan Building, Langshan Road, Nanshan District, Shenzhen, P. R. China Tel: (86 755) 8601 6288 Fax: (86 755) 8601 6751 Website: www.china.intertek-etlsemko.com BORSAM Biomedical Instruments Co., Ltd. Application For Certification FCC ID: RP4ECGC4S001 1-lead ECG recorder Model: ECG01-4S 2.4GHz Transceiver Report No.: 130104001SZN-002 We hereby certify that the sample of the above item is considered to comply with the requirements of FCC Part 15, Subpart C for Intentional Radiator, mention 47 CFR [10-1-12] Prepared and Checked by: Approved by: Sign on file Robert Li Project Engineer Andy Yan Project Engineer Date: 31 January 2013 INTERTEK TESTING SERVICES TRF No.: FCC 15C_TX_b FCC ID: RP4ECGC4S001 i LIST OF EXHIBITS INTRODUCTION EXHIBIT 1: General Description EXHIBIT 2: System Test Configuration EXHIBIT 3: Emission Results EXHIBIT 4: Equipment Photographs EXHIBIT 5: Product Labelling EXHIBIT 6: Technical Specifications EXHIBIT 7: Instruction Manual EXHIBIT 8: Miscellaneous Information EXHIBIT 9: Test Equipment List INTERTEK TESTING SERVICES TRF No.: FCC 15C_TX_b FCC ID: RP4ECGC4S001 ii MEASUREMENT/TECHNICAL REPORT BORSAM Biomedical Instruments Co., Ltd.- MODEL: ECG01-4S FCC ID: RP4ECGC4S001 This report concerns (check one :) Original Grant X Class II Change Equipment Type: DXX - Part 15 Low Power Communication Device Transmitter Deferred grant requested per 47 CFR 0.457(d)(1)(ii)? Yes No X If yes, defer until: date Company Name agrees to notify the Commission by: date of the intended date of announcement of the product so that the grant can be issued on that date. Transition Rules Request per 15.37? Yes No X If no, assumed Part 15, Subpart C for intentional radiator − the new 47 CFR [10-1-12 Edition] provision. Report prepared by: Robert Li Intertek Testing Services Shenzhen Ltd. Kejiyuan Branch 6F, Block D, Huahan Building, Langshan Road, Nanshan District, Shenzhen, P. R. China Phone: (86 755) 8614 0657 Fax: (86 755) 8601 6751 INTERTEK TESTING SERVICES TRF No.: FCC 15C_TX_b FCC ID: RP4ECGC4S001 iii Table of Contents 1.0 General Description .................................................................................................................................. 2 1.1 Product Description ..................................................................................................................................... 2 1.2 Related Submittal(s) Grants ....................................................................................................................... 2 1.3 Test Methodology ........................................................................................................................................ 2 1.4 Test Facility ................................................................................................................................................. 2 2.0 System Test Configuration ..................................................................................................................... 4 2.1 Justification ................................................................................................ Error! Bookmark not defined. 2.2 EUT Exercising Software ............................................................................................................................ 4 2.3 Special Accessories .................................................................................................................................... 4 2.4 Equipment Modification .............................................................................................................................. 4 2.5 Measurement Uncertainty .......................................................................................................................... 5 2.6 Support Equipment List and Description ................................................................................................... 5 3.0 Emission Results ...................................................................................................................................... 7 3.1 Radiated Test Results................................................................................................................................. 8 3.1.1 Field Strength Calculation .......................................................................................................................... 8 3.1.2 Radiated Emission Configuration Photograph .......................................................................................... 9 3.1.3 Radiated Test Results ..........................................................................................................…

Text truncated - open the document above for the full version.

Radiated Photos