2ADB6-HR2B9MHR2000-HR2B9M

CAC-I0121(V1.0) 2012/07/25 1          Κ      ʳ BioSenseTek Corp. CAC-I0121(V1.0) 2012/07/25 2 Cardiac monitor system Caution! Please follow the instruction to use the product. This product should be used by doctors or trained staff under the guidance of doctor for clinical usage. This product is not the only means to provide basis for diagnosis. About HR2000 Cardiac monitor system is the medical instrument suitable for patient electrophysiological signal transducing, this instrument contains the ECG amplifier (Transducing terminal) and a patient lead which can obtain electrophysiological signal from patients. Electrophysiological signal is transferred wirelessly to the receiver, and then to the computer by TCP/IP. Cardiac monitor system will take a small, easy to carry device, so that patients can get continuous physiological signal monitoring; it can monitor several patients at once, protect patient safety, reduce the burden of health care workers, increasing productivity, improving the quality of health care. The system, using a set of wireless receiver, can simultaneously monitor multiple groups of wireless ECG machine, its signal transducing area can be modified in accordance with the current situation needs by the set-ups of antenna through major space. Feature 1. Suitable for continuous transmission of electrophysiological signal. 2. Detection of one of subsections I, II or III lead ECG signal. 3. Transferring signal to the computer via RF and TCP/IP. 4. A set of wireless receiver can simultaneously monitor up to six wireless ECG machine.Ζ 5. Signal connection indicate, signal interrupt and low battery warning. 6. Indicate the present and full charge status, charging auto cut off power. 7. Light weight and portable. 8. RF ranges U.S.A.: 902MHz~928MHz. Taiwan: 922MHz~928MHz (Alternative options available according to local legislation, ex: 315/433/868/915MHz) CAC-I0121(V1.0) 2012/07/25 3 Accessories HR2B8D HR2B9D Wireless Vital Sign Transmitter HR2B8M HR2B9M Wireless Vital Sign receiver Lead wire for ECG signal Charging cable Specification Vital Sign Transducer - transmitter Power Built-in rechargeable 650mAh Li-ion batteryΔvoltage 3.7V Operating Time 7 days after fully charged (real working time varied based on battery condition and RF environment) RF range Taiwan : 922MHz ~ 928MHz, USA : 902MHz~928MHz (Alternative options available according to local legislation, ex: 315/433/868/915MHz) Output power of RF 10dBm(max) to antenna for rated battery voltage Dimensions 62 x 55 x 13 mm(thickest part) Weight <50gΔinclude a patient lead wire for ECG signal Suggesting operating temperature 15к~40к Suggesting operating humidity 30~80%Δno condensation Storage and transportation temperature -10к~65к Humidity for storage and transportation 30~80%Δno condensation Lead IΕII or III Lead Input dynamic range ±1.25mV DC offset range ±1250mV CMRR >90dB Frequency response 0.5Hz max ~ 40Hz Input interface Snap-type lead wire Patient lead wire Dimensions 600mm in length Connector Custom connector Snap 4.2mm(male side 3.9mm) CAC-I0121(V1.0) 2012/07/25 4 Vital Sign Transducer – Receiver Dimension 72mm x 57mm x 14mm(excluding antenna) Length of antenna 56.6m mΔ190mm RF range Taiwan : 922MHz ~ 928MHz, USA : 902MHz~928MHz (Alternative options available according to local legislation, ex: 315/433/868/915MHz) Power consumption <200mA Power supply DC 5V 500mA Wired transmission interface 10/100Mbs Ethernet Charging Cable Length 1000mm±5% Connector USB / Custom connector Maximum current 500mA   Operate system requirements Operating systemΚWindows XP (32bites/64bites)ΔWindows 7 (32bites/64bites) HardwareΚ ԦCPUΚIntel Pentium 4 / Celeron 2.0 GHz or above ԦMemoryΚ2 GB or above ԦResidual HD spaceΚ2 GB or above ԦInterfaceΚInternet / USB / Sound ԦSuggested Screen ResolutionΚParallel 1280 pixels Vertical 960 pixels ԦSuggested Screen SizeΚ17 inch or above(16:9 wide-screen) ԦCD-ROMΚ8x or above CD-ROM or DVD-ROM ԦPC multimedia speakersΚOutput sound pressure 60dBA above Maintenance 1. Use soft and dry cloth to clean the surface of physiological signal transmitter. 2. Conductive gel or other stains can be cleaning using slide damp soft cloth. 3. Never use alcohol or other organic solution for cleaning 4. Connected to the Patient lead wire cleaning CAC-I0121(V1.0) 2012/07/25 5 Caution 1. The received data can help diagnosing for doctor. However, this is not the only way to provide basis for diagnosis. 2. Never put the product and related accessories under the exposure of sunlight or environment of high temperature. 3. Never deconstruct or try to fix the product without the help of manufacturer. It may cause the accuracy and safety of the product to deteriorate. 4. This product meets the standard of EMC requirement, However, we still suggest to use it away from microwave or other RF devices. 5. If there are other wireless transmission module, antennas, and other related facilities, please make sure the working RF band of our product is not overlapping by other devices. 6. Never pile up our product with other devices. If the piling is necessary, please check our product before using it. 7. Some stimulators may interfere with our wireless signal. 8. Never use sharp-pointed or hard objects to press the button. Please press it with finger. 9. Never clean the instrument and wire by soaking, steaming, and high-pressured cleanness. 10. This product should be kept in dry environment. Avoid any kind of liquid from going into the vital sign transmitter and receiver. 11. To avoid defibrillating casualty, please do not touch the transducer and lead while defibrillating. Place the electrode and defibrillator in proper position to lower the potential damage, or remove the device in the first place. 12. Extensive movement may cause lead to come off, or resulting of poor vital sign quality. 13. Please remove the transducer if there are safety concern or directly or indirectly causing discomfort to …

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Report No.: 14A0413R-RFUSP15V00 Page : 1 of 10 Attachment 2 : EUT Detailed Photographs (1) EUT Photo (2) EUT Photo Report No.: 14A0413R-RFUSP15V00 Page : 2 of 10 (3) EUT Photo (4) EUT Photo

BioSenseTek Corp. FCC ID.: 2ADB6-HR2B9M 6541 S.W. 127th Path Miami Florida United States +886-2-87912600 +886-2-87912600 FCC ID Label

BioSenseTek Corp. FCC ID.: 2ADB6-HR2B9M 6541 S.W. 127th Path Miami Florida United States +886-2-87912600 +886-2-87912600 The FCC ID Label will be placed on the equipment as shown in the photograph below.

Report No.: 14A0413R-RFUSP15V00 Page : 3 of 10 (5) EUT Photo (6) EUT Photo Report No.: 14A0413R-RFUSP15V00 Page : 4 of 10 (7) EUT Photo (8) EUT Photo Report No.: 14A0413R-RFUSP15V00 Page : 5 of 10 (9) EUT Photo (10) EUT Photo Report No.: 14A0413R-RFUSP15V00 Page : 6 of 10 (11) EUT Photo (12) EUT Photo Report No.: 14A0413R-RFUSP15V00 Page : 7 of 10 (13) EUT Photo (14) EUT Photo (Antenna: AIR WAVE, EA-179E) Report No.: 14A0413R-RFUSP15V00 Page : 8 of 10 (15) EUT Photo (Antenna: AIR WAVE, EA-231L) (16) EUT Photo Report No.: 14A0413R-RFUSP15V00 Page : 9 of 10 (17) EUT Photo (18) EUT Photo Report No.: 14A0413R-RFUSP15V00 Page : 10 of 10 (19) EUT Photo

Report No. 14A0413R-RFUSP15V00 Page: 1 of 30 FCC Test Report Product Name Cardiac Monitor Model No. HR2000-HR2B9M FCC ID 2ADB6-HR2B9M Applicant BioSenseTek Corp. Address 6541 S.W. 127th Path Miami Florida United States Date of Receipt Oct. 20, 2014 Issued Date Nov. 11, 2014 Report No. 14A0413R-RFUSP15V00 Report Version V1.0 The test results relate only to the samples tested. The test results shown in the test report are traceable to the national/international standard through the calibration report of the equipment and evaluated measurement uncertainty herein. This report must not be used to claim product endorsement by TAF or any agency of the government. The test report shall not be reproduced without the written approval of QuieTek Corporation. Report No. 14A0413R-RFUSP15V00 Page: 2 of 30 Test Report Issued Date: Nov. 11, 2014 Report No.: 14A0413R-RFUSP15V00 Product Name Cardiac Monitor Applicant BioSenseTek Corp. Address 6541 S.W. 127th Path Miami Florida United States Manufacturer BioSenseTek Corp. Model No. HR2000-HR2B9M EUT Rated Voltage AC 100-240V~50-60Hz, 0.3A EUT Test Voltage AC 120V/60Hz Trade Name Applicable Standard FCC CFR Title 47 Part 15 Subpart C: 2013 ANSI C63.10: 2009 Test Result Complied Documented By : ( Senior Engineering Adm. Specialist / Anita Chou ) Tested By : ( Engineer / Alan Chen ) Approved By : ( Director / Vincent Lin) Report No. 14A0413R-RFUSP15V00 Page: 3 of 30 TABLE OF CONTENTS Description Page 1. GENERAL INFORMATION .....................................................................................................4 1.1. EUT Description............................................................................................................................4 1.2. Operational Description ................................................................................................................6 1.3. Tested System Datails....................................................................................................................7 1.4. Configuration of Test System ........................................................................................................7 1.5. EUT Exercise Software .................................................................................................................7 1.6. Test Facility ...................................................................................................................................8 2. Conducted Emission....................................................................................................................9 2.1. Test Equipment..............................................................................................................................9 2.2. Test Setup ......................................................................................................................................9 2.3. Limits ..........................................................................................................................................10 2.4. Test Procedure .............................................................................................................................10 2.5. Uncertainty ..................................................................................................................................10 2.6. Test Result of Conducted Emission.............................................................................................11 3. Radiated Emission .....................................................................................................................13 3.1. Test Equipment............................................................................................................................13 3.2. Test Setup ....................................................................................................................................14 3.3. Limits ..........................................................................................................................................15 3.4. Test Procedure .............................................................................................................................16 3.5. Uncertainty ..................................................................................................................................16 3.6. Test Result of Radiated Emission................................................................................................17 4. Band Edge ..................................................................................................................................24 4.1. Test Equipment............................................................................................................................24 4.2. Test Setup ....................................................................................................................................24 4.3. Limits ..........................................................................................................................................25 4.4. Test Procedure .............................................................................................................................25 4.5. Uncertainty ..................................................................................................................................25 4.6. Test Result of Band Edge ............................................................................................................26 5. EMI Reduction Method During Compliance Testing ............................................................28 Attachment 1: EUT Test Photographs Attachment 2: EUT Detailed Photographs Report No. 14A0413R-RFUSP15V00 Page: 4 of 30 1. GENERAL INFORMATION 1.1. EUT Description Product Name Cardiac Monitor Trade Name Model No. HR2000-HR2B9M FCC ID 2ADB6-HR2B9M Frequency Range 922.3MHz~927.7MHz Channel Control Auto Channel Separation 0.45MHz Antenna Type Dipole Antenna C…

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Report No.: 14A0413R-RFUSP15V00 Page : 1 of 3 Attachment 1: EUT Test Setup Photographs Front View of Conducted Test Back View of Conducted Test Report No.: 14A0413R-RFUSP15V00 Page : 2 of 3 Front View of Radiated Test Back View of Radiated Test Report No.: 14A0413R-RFUSP15V00 Page : 3 of 3 Front View of Radiated Test (Horn) Back View of Radiated Test (Horn)