FCC ID: 2ADB6-HR2B9D Cardiac Monitor

Cardiac Monitor ModelHR2000 series User manual CAC-I0121(V1.0) 2012/07/25 1 BioSenseTek Corp. 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. 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 2 Built-in rechargeable 650mAh Li-ion batteryvoltage 3.7V 7 days after fully charged (real working time varied based on battery condition and RF environment) Taiwan : 922MHz ~ 928MHz, USA : 902MHz~928MHz

(Alternative options available according to local legislation, ex: 315/433/868/915MHz) 10dBm(max) to antenna for rated battery voltage 62 x 55 x 13 mm(thickest part)

<50ginclude a patient lead wire for ECG signal 15~40 Accessories HR2B8D HR2B9D HR2B8M HR2B9M Specification Wireless Vital Sign Transmitter Wireless Vital Sign receiver Lead wire for ECG signal Charging cable Vital Sign Transducer - transmitter Power Operating Time RF range Output power of RF Dimensions Weight Suggesting operating temperature Suggesting operating humidity Storage and transportation temperature Humidity for storage and transportation Lead Input dynamic range DC offset range CMRR Frequency response Input interface Patient lead wire Dimensions Connector Snap 30~80%no condensation

-10~65 30~80%no condensation III or III Lead 1.25mV 1250mV

>90dB 0.5Hzmax ~ 40Hz Snap-type lead wire 600mm in length Custom connector 4.2mm(male side 3.9mm) CAC-I0121(V1.0) 2012/07/25 3 72mm x 57mm x 14mm(excluding antenna) 56.6mm190mm Taiwan : 922MHz ~ 928MHz, USA : 902MHz~928MHz

(Alternative options available according to local legislation, ex: 315/433/868/915MHz)

<200mA DC 5V 500mA 10/100Mbs Ethernet Vital Sign Transducer Receiver Dimension Length of antenna RF range Power consumption Power supply Wired transmission interface Charging Cable Length Connector Maximum current Operate system requirements 1000mm5%

USB / Custom connector 500mA Operating systemWindows XP (32bites/64bites)Windows 7 (32bites/64bites) Hardware CPUIntel Pentium 4 / Celeron 2.0 GHz or above Memory2 GB or above Residual HD space2 GB or above InterfaceInternet / USB / Sound Suggested Screen ResolutionParallel 1280 pixels Vertical 960 pixels Suggested Screen Size17 inch or above(16:9 wide-screen) CD-ROM8x or above CD-ROM or DVD-ROM PC multimedia speakersOutput 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 4 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 the patient. 14. The product has been certified as a low-powered RF transmission device. Any enterprises, shops, and user is not allowed to modify the working frequency, enhancing the amplifier, or altering the original function 15. Low-powered RF transmission devices are not allowed to interfere with flying safety and legal telecommunication. If the interference is detected, stop using the device and change the working frequency to the band without interference. 16. The mentioned telecommunication refers to wireless telecommunication which follow the related laws. Low-powered RF transmission devices should be able to endure the interference of legal telecommunication, and science and medical radio wave-generated electronic facilities 17.Power failure or not normal shutdown software may cause data loss Dont close PC or software while system is operatingif PC or software is accidentally closed please reopen PC and execute the system software. 18. Dont be used in the intensive care unit (ex. ICU, CCU) CAC-I0121(V1.0) 2012/07/25 5 FCC Compliance and Advisory Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference and

(2) This device must accept any interference received, including interference that may cause undesired operation. FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

-Reorient or relocate the receiving antenna.

-Increase the separation between the equipment and receiver.

-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

-Consult the dealer or an experienced radio/ TV technician for help. CAUTION:

Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the equipment. CAC-I0121(V1.0) 2012/07/25 6 Contraindication 1. Physically impaired people may not have safe and accurate testing result. 2. Without the permission of patient. 3. Not allow for Fetal Troubleshooting Please check the following list If there is abnormal situation while using the physiological signal transducer, If the problem still exist, please contact us. 1. Check if the transmitter is connected to the patient lead wire properly. 2. Check if the electrode is tightly contact with users skin. 3. If the noise in the test result is too serious, the subjects skin may be too dry, or cause by improper grounding of computer, or interference on the background. Please check the surrounding for the interference of electronic devices, and make sure the computer is grounding properly, and apply some water or alcohol to clean subjects skin then perform the test again. Please dispose the transducer properly according to the local laws www.biosensetek.com Tel:(+886)2-8791-2600 11494 5F., No.145, Xinhu 1st Rd., Neihu Dist., Fax:(+886)2-8791-2489 Taipei City 114, Taiwan (R.O.C.) Advantech Europe BV 1 Ekkersrijt 5708, 5692 ER, Son, The Netherlands 0434 CAC-I0121(V1.0) 2012/07/25 7 Please follow the instruction Recycling sign for electric and electronic device Manufacturer Manufacture date Instruction of signs 2 0 1 2 CE mark 0434 Electrode contact part with body-Protection level BF sign (Electrode patch, which is used to transfer electric energy and physiological signal.) Serial number Lot number Direct current European Authorized Representative FCC Logo Prescription only CAC-I0121(V1.0) 2012/07/25 8 The maximum valid transducing distance is 30M in idea open space, but varies with different actual using scenario. It is suggested receiver be set at the center of users activity area and have it up-side down, ex: The receiver of patients transmitter in hospital should be placed up side down at the center 4 Connect the physiological signal transmitter with patient lead wire 5 Press the power on bottom of vital sign transmitter Operation Instruction 1 Screw the antenna on to the wireless transmission receiver or 190mm

. 56.6mm 2 Connect the USB DC 5V 500mA power supply to the wireless transmission receiver

(Power supply is not included in the standard accessory, please use the proper power supply according to the local regulation.) 3 Connect wireless transmission receiver and PC via RJ45 Or connect receiver and PC with 10/100Mbps Ethernet switch Hub Switch HUB CAC-I0121(V1.0) 2012/07/25 9 6 Clip the ECG electrode with vital sign transmitter and attach it to the lower right torso. Clip another ECG electrode with patient lead wire snap and attach it to the upper right torso. 8.3 Connect the USB side of the charging wire to 5V 500mA power supply to begin charging. (power supply is not included)

(Power supply in the picture is for reference. Please use the proper power supply according to the local regulation) 8.4 LED on the switch will turn red while charging. 8.5 LED on the switch will turn green when fully charged. 8.6 The charging time is roughly 2.5 hours, depending on the condition of the battery. Indication signals on the receiver Light AP LAN Instruction Lights-on after internet connected Always on after 10 seconds blinking Blinking while receiving data Power indicator VT PWR 9 Setup multimedia speakers(Speakers in the picture is for reference. Please use the speaker can output sound pressure above 60dBA. Ex: Logitech Stereo Speaker Z120) 9.1 In accordance with the multimedia speakers the original instructions book installed and connected to the PC

(Please choose the ECG electrode conform to standard of the medical regulation) 7 Switch off: Shut down automatically while charging. 8 Charging 8.1 Unplug the patient lead wire 8.2 Plug in the charging cable. CAC-I0121(V1.0) 2012/07/25 10 small voice will cause not hear to the voice prompts) 9.2 Set the sound output of the operating system to execute Control Panel 9.3 Execute Sounds and Audio Device 9.4 Confirm the device volume adjustment to the maximum 9.5 Confirm the mute option is canceled 9.6 Multimedia speaker volume knob up to maximum (Attention! Had a CAC-I0121(V1.0) 2012/07/25 11 Software installation instruction 1. Execute \HR2000\Setup.exe in CD-ROM

(ex: The CD-ROM symbol is Dexecute D:\HR2000\Setup.exe) 2. Follow the prompts to complete the software installation 2 Enter user name 3 Enter department name 4 1 5 6 3. After installation the shortcutHR2000will be auto-generated on windows desktop CAC-I0121(V1.0) 2012/07/25 12 Start Home Key System preference Print the latest 8-sec waveform of all active patients on windows desktopFollow GUI will appear Execute shortcut

(After installing when the computer starts automatically execute the program) Admit a patient Current time Start setup Exit 1. Press the switch

(All LED on => white) Switch 2. Begin setting form any unused display section Start CAC-I0121(V1.0) 2012/07/25 13 3. Select room number and bed number 4. Enter patients name and ID ( ID required) 5. Set normal HR range

(The default does not apply to all cases Please modify the settings according to the actual situation Software re-open the settings will be retained) 3. Cyclic selection of room # & bed #

4. Patient ID &

name 5. Upper and lower HR range Pop-up room # selection 6. Select Admission icon 7. Pop-up message to confirm new Transciever is powered on. Press Yes. 8. Ten seconds waveform recorded on work station AP if Transciever work properly

(Random fluctuation noise appeared if no simulator is used) 9. Transciever auto hibernates 10seconds later. 1 Ten second calibration waveform 10. Snap two pre-gel electrodes to RA and LL position and remove the adhesive back layer to position the sensor and electrode properly on to the patients chest surface Transducer auto sleep after 10 sec Upper right torso for RA Lower left torso for transducer CAC-I0121(V1.0) 2012/07/25 14 11. Press the ON switch again for patient monitoring User scenario switch 1. Black background indicates under normal operation Current Bad Name Power ID 1mV scale 2. Red background indicating battery depletion, it turns off automatically after fully 1second scale charged transmitter be installed 3. Cyan-Blue background indicating the detected HR is out of limit, it turns off automatically when HR returned to limit, double click left mouse button on speaker icon to turn off the sound, until next double click will turn on.

(The maximum delay time of RF communication under normal circumstance is the reciprocal of HR times 6, exHR 50 bpm((1/50)x6)=0.12 minabout 7.2 sec delay) HR upper limit HR lower limit Detected HR Speaker icon 4. Yellow background shows up indicating transmitter RF link failed for more than 5 sec, it turns off automatically after RF link return normal. (Maximum delay time about 5 sec) CAC-I0121(V1.0) 2012/07/25 15 5. Screen message annotation Background HR section Background priorityYellow > Red > Cyan-BlueHigh priority will be to cover the lowerUntil the status lifted HR sectionDisplay Heart Raterange 10~300 bpm, Exceeds a set upper and lower limit flicker Status notes after software restart Red background, if the battery depletion continues, will shows up after receiving data from transmitter. Yellow background, if RF link failure continues the background will be black without any waveform after software restart and patient data will be saved. Cyan-Blue background, if the detected HR keep staying out of preset range, will shows up after delay time(the reciprocal of detected HR times 6) under normal RF communication (exHR 50 bpmdelay about 7.2 sec) 6. Patient information modification during monitoring (ID can NOT be changed) Select patient to be modified Modify patients name CAC-I0121(V1.0) 2012/07/25 16 Confirm modification by selecting the modification key 7. HR limit modification during monitoring Select patient to be modified Change to new threshold limit Press confirm modification key Change room (bed)procedure

(The default does not apply to all casesPlease modify the settings according to the actual situation Software re-open the settings will be retained) 1. Click the number of current bed which is to be changed. 2. Click the Room changing button. 3. Pop-up message Shift to New Room shows up; confirm the action of bed (room) changing. CAC-I0121(V1.0) 2012/07/25 17 4. Choose the new bed (room) number. Click to change room number. Click to change bed number. 5. Confirm new bed (room) number then click the room-changing button. 6. Pop-up message showing Old bed number to new bed number shows up. 7. Finished. Transmitter changing process

(Transmitter changing while low battery, blackout or other condition) 1. Press the ON switch of new transmitter to start it at monitoring computer in nursing station. (All LEDs will flash simultaneously) NEW ON switch 2. Click the number of current bed whose Transmitter is to be changed. CAC-I0121(V1.0) 2012/07/25 18 3. Click the transmitter-changing button. 4. Pop-up message to confirm that new transmitter is powered on. 5. Click the transmitter changing confirmation button to confirm the action. 6. Old transmitter should be closed at wards and new transmitter be set up at nursing station and shows the ten seconds waveform.

(ECG waveform only shows up when the VT sensor connected to patient or simulator, if not, there will be random fluctuation noise.) 7. New transmitter auto sleep , reopen it when reach the patient side. Ten seconds waveform test. 8. Remove the old transmitter and electrodes then put on the new ones. Transducer auto sleep CAC-I0121(V1.0) 2012/07/25 19 Upper right torso for RA NEW Lower left torso for transducer 9. Press the ON switch to start monitoring. NEW ON switch 10. Place the old transmitter in the charging base for future use. Discharge procedure 1. Select room and bed # to be discharged 2. Press discharge key 3. Message to confirm discharge patient and shut down transmitter 4. Transmitter power-off and no waveform can be seen. CAC-I0121(V1.0) 2012/07/25 20 5. Place the transmitter in the charging base for future use. Retrieve(Data retrieval) 1. Select the room & bed # to retrieve the recorded data 2. Select retrieve key 3. Initial retrieve display Name 1mscale 1 sec scale Date selection Hourly selection To be shown below Current HR Patient ID Waveform Time Waveform selection Hourly waveform CAC-I0121(V1.0) 2012/07/25 21 4. Select the date of retrieval year month 5. Select an hour during the 24 hrs period Available date on blue background 24H data An hour waveform display with color status indication Selected hour in green background Red waveformBattery is depleted CAC-I0121(V1.0) 2012/07/25 22 Yellow waveform: Disconnected RF link Cyan-Blue waveform: HR over preset threshold 6. Detailed waveform display. Choose time point to display in hourly waveform Time of interest in green block drag to move selection time Upper window to display selected ECG waveform 10 sec mean HR 7. Data storage Data will be temporarily kept before stored as official file after 1 hour, all temporary data less than 1 hour will be lost in case of abnormal software closure (didnt execute discharge for all current used bed#) Turn off sofrware Click turn off buttonAll bed need to execute the discharge flow can be turned off software CAC-I0121(V1.0) 2012/07/25 23 Visual indication and Alarm 1. User interface A. Black, normal. B. Red backgroundDepleted battery. C. Yellow backgroundRF disconnected more than 5 seconds. D. Cyan-Blue backgroundHR over threshold limit(Software continuously beeping. Alert speaker can be switch off by double click the speaker icon) 2. The screen prompts delay time Upper Limit Lower Limit HR Speaker RedEvery 10 minutes to detectthe maximum delay time is 10 min. Yellowindicating transmitter RF link failed for more than 5 sec, Maximum delay time about 5 sec Cyan-blueMeasured the heart rate exceeds a set upper and lower limits will show up, Delay time and measurement of heart rate are related to, The maximum delay time in the heart rate falls below the lower limit, The minimum delay time in the heart rate higher than the upper limit, Delay time calculated the reciprocal of the heart rate multiplied by 6(Under normal conditions in the wireless communications) ExLower limit of 51, when measured continuous heart rate 50 bpm, Delay time = (1/50bpm)6 = 0.12 min = 7.2 sec. Upper limit of 119bpm, when measured continuous heart rate 120 bpm, Delay time = (1/120bpm)6 = 0.05 min = 3 sec. CAC-I0121(V1.0) 2012/07/25 24 3. Verify RedContinuous operate transducer and to observe whether to produce prompt YellowExecute admit patient flow, Not connected to the body directly to the transducer charging observed to generate prompts Cyan-blueCan in 10 seconds of test time of admission procedures of step 8 or step10 connect transducer and patient simulator, Adjusting the simulator output observation function correctly 4. Transmitter sound indicater Condition Indicate 1 beep

~Transmitter start up

~Set-up completed

~After 10 sec test, transmitter auto-sleep Transmitter closed 3 beeps Continuous beeps Abnormal communication 2 beeps 3 beeps for 1~2 mins Continuous communication failure over 2 mins Frequency N.C. N.C. N.C. About 4 times per second About once per minute 5. Transmitter LED indicater Sign Blue Green Red Red Green Blue+Green LED status Device status Flashing Flashing Flashing Communication normal Switch to other receiver Receiver signal lost Low battery Continuous Charging *

Continuous Charging completed Flashing Auto-sleep to be restart by patient side Start to be set up Frequency About 1 time/ 4 sec. About 1 time/ 4 sec. About 1 time/ 4 sec. About 1 time/ 4 sec. N.C. N.C. About 1 time/ 1 sec. About 1 time/ 1 sec. Red+Blue+Green Flashing

* Be sure to remove from body while charging CAC-I0121(V1.0) 2012/07/25 25