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CI2418-01_2A

____________________________________________________________________________

QUANTA COMPUTER INC.

HUAYA PLANT

_________________________________________________________________

Wearable ECG Monitoring

Device

User Manual

Ver. 1.0

_________________________________________________________________

2014 Quanta Computer Inc. Huaya Plant

Содержание NYA

Страница 1: ..._________ QUANTA COMPUTER INC HUAYA PLANT _________________________________________________________________ Wearable ECG Monitoring Device User Manual Ver 1 0 _________________________________________________________________ 2014 Quanta Computer Inc Huaya Plant All rights reserved ...

Страница 2: ...ARNINGS 2 REMINDERS 3 YEAR OF MANUFACTURE 5 SUPPLIER S DECLARATION 7 REGULATORY MARKS 10 INTRODUCTION 12 EQUIPMENT 13 A NB PC 13 EQUIPMENT OPERATING INSTRUCTIONS 15 A PERSONAL COMPUTER NB PC 15 B QUANTA ECG MONITOR APPLICATION NYA DATA CMD FOR USE ON PERSONAL COMPUTERS NB PC 16 C NYA BODY MONITOR 21 D NYA BODY MONITOR ACCESSORY 25 E ECG ELECTRODES 26 F NYA CHARGER 27 CLEANING OF THE WIRELESS HOME ...

Страница 3: ...the machine s indicator lights are clearly readable in the current usage environment Damaged or faulty accessories and electrodes should not be used When the NYA Quanta Wireless Home Health Management System experiences an error it will automatically stop taking measurements and the corresponding indicator lights will blink When the NYA Quanta Wireless Home Health Management System is low on power...

Страница 4: ... measurements Do not use the NYA Quanta Wireless Home Health Management System in an excessively humid environment and never submerge it directly under water Do not clean or wipe the NYA Quanta Wireless Home Health Management System with corrosive and abrasive cleaning agents The NYA Quanta Wireless Home Health Management System consists entirely of sophisticated medical electrical devices so main...

Страница 5: ...e 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 ...

Страница 6: ...nufacture The year of manufacture label and format of the wireless home health management system s body monitor charger and ECG electrodes are shown below Sensor Charger Example If the serial number is QTCI2C425001 The 7th characters is mean 14 Then the year of manufacture is 2014 AD In the serial number on the product label the 7th character starting from the left 14 in the shown example represen...

Страница 7: ..._______________________________________________________________________ User Manual V1 0 Page 6 ECG Electrodes The effective date of the ECG electrodes is labeled along the lower edge of the packaging in impact type not printed as shown below Example 220801X 2015 07 Explanation 220801X Manufacturer lot number 2015 07 Valid before July 2015 ...

Страница 8: ...his instrument The emission energy is also very low and does not interfere with nearby electronic instruments RF Emissions CISPR 11 Class B This instrument is suitable for home use including residential or other mixed residential public low voltage power grids Harmonic Emissions IEC 61000 3 2 Voltage Fluctuations Flicker Emissions IEC 61000 3 3 Testing IEC 60601 1 2 testing Compliant Standard Elec...

Страница 9: ... 17 P d 1 17 P 80 MHz to 800MHz d 2 33 P 800MHz to 2 5 GHz P is the maximum output of the transmitter Unit Watt d is the recommended safety distance Unit Meter The field intensity of the fixed RF transmitter after an EM site survey should be lower than the recommended values for the above frequency ranges Interference may be produced near instruments that have the following symbol The field intens...

Страница 10: ...ommunications equipment listed in the following table corresponding to the maximum output of the RF transmitter Recommended Safety Distance corresponding to RF transmitter output Maximum output of RF transmitter Watt 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 If the maximum outpu...

Страница 11: ... legal communications If found the user shall cease operation immediately until no interference is achieved The said legal communications means radio communications is operated in compliance with the Telecommunications Act The low power radio frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices CE Mark Indicates that the body moni...

Страница 12: ..._______________________ User Manual V1 0 Page 11 Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot for a variety of reasons be presented on the medical device itself Indicates the need for the user to consult the instructions for use Indicates the identification of CLASS II EQUIPMENT only ...

Страница 13: ..._________________________________________ User Manual V1 0 Page 12 Introduction Electrocardiogram ECG Waveform Required equipment Remarks Smart phone E NYA body monitor G ECG electrode I Accessory H Body Monitoring Shirt J Choose one of the two measurement options on the left based on the usage requirements nursing personnel s requirements or user s personal preference ...

Страница 14: ... health information by uploading the measurements to the main server via Bluetooth Quanta ECG Monitor Application UI for use on NB PC Functions The application UI can be installed on any personal computer NB PC to provide ECG data measurement functions With the Quanta ECG Monitor device B body monitoring accessories D ECG electrode patches C measured data will be uploaded to the server via Bluetoo...

Страница 15: ...ion When the electrodes are used this accessory is used to attach the NYA Body Monitor B and transmit the ECG signal between electrodes Back Front D ECG Electrodes Function Attach to the designated location on the chest in order to capture physiological ECG signal for the NYA Body Monitor B for processing and upload E NYA Charger Function Used for charging the NYA Body Monitor B The charger has tw...

Страница 16: ...omputer NB PC users can access the available functions Shut down the computer To shut down your personal computer NB PC click Shut Down Bluetooth Functions Install a Bluetooth dongle on your personal computer NB PC Plug in your Bluetooth dongle to the USB port to turn the Bluetooth functions on or off Upon selecting and launching Bluetooth the Bluetooth interface will be displayed Click to search ...

Страница 17: ...on personal computers NB PC Operating Instructions Ensure that you have completed the installation of the Quanta ECG Monitor Please refer to the next chapter G Quanta ECG Monitor Body Monitoring Device for the instructions and diagrams On your computer s desktop click the NYA Data CMD UI icon as shown to launch the application The following window will be displayed upon launching the application B...

Страница 18: ...cation Port Settings Set up the com port to receive Vital Sign Sensor data Click System Com Port Setting to open the following window Port The system will automatically detect and list the current Com Ports on the computer Select the Port to connect to Baud Rate Select 115200 Parity Select None Date Bits Select 8 Stop Bits Select 1 After making the changes click Save to complete The changes will n...

Страница 19: ...click OK b Ensure Bluetooth has been properly connected to the Serial Port of the hardware c Click Open to open the Com Port as shown in the diagram below If correctly launched the Status will change to Connected as shown in the diagram below To close the Com Port click Close If during the measurement process the Com Port connection disconnects due to instability the system will close the Com Port...

Страница 20: ...lays the battery life of the hardware D Displays whether a Fall Event occurs Click Cancel to execute Cancel Fall Event command E Auto ECG command By clicking Auto ECG the ECG waveform will update every 3 seconds HR AAC PAC PAI PAEE and battery will update every 15 seconds and Steps Stride Speed Calories and Distance will update every 60 seconds ECG waveform display Enlarge will enlarge the ECG wav...

Страница 21: ...data is obtained by testing on a new product The actual usage time will defer with different conditions such as charging conditions number of times used environmental temperature distance from base station connectivity etc Condition Possible Reason Recommended Actions Data disconnected or omitted while sleeping The subject turns over or sleeps on one side causing the Quanta ECG Monitor to detach f...

Страница 22: ...Click New Subject button B Enter Name Sex Birthday Height and Weight C Click Save All to save into the database If the Name entered already exists the system will display the following alert message as shown in the diagram D Select the Subject Name in the Subject Name field The subject s test cases will display in the case list below C NYA Body Monitor External guide to body monitor LED status lig...

Страница 23: ...nitor to start pairing 4 During the pairing process the LED status light will alternatively blink green orange for 1 minute 5 Once pairing is successful the green LED will stay lit for 5 seconds and the mobile phone will show that it is connected 6 If pairing fails the LED status light on the monitor will alternatively blink green orange for 1 minute then stop pairing and searching All lights will...

Страница 24: ... loose Device side hanging loose 3 Clip the male magnetic male connector on the monitor to the female connector on the accessory as shown below Note The circular red or blue mark on the monitor must point upwards and must not be upside down Please see below Circular mark pointing upwards 4 Launch the NYA Data CMD Application on the PC NB Please see the previous section B shown below NYA Data CMD A...

Страница 25: ...y and measurement the monitor s status light will not be shown except when power is blow d When the monitor is being charged in the charger the status lights will remain off e As long as the monitor is not on the accessory tapping the monitor twice will cause the green LED to come on The monitor will then start transmitting data the smart phone app must be running and connected Once the transmissi...

Страница 26: ... 0 Page 25 D NYA Body Monitor Accessory Used for connecting the body monitor and ECG electrodes so the best ECG signal can be acquired Please see the previous section G NYA Body Monitor for further information and graphics Magnetic Clip Female Connector ECG wiring Pressure Clip Female Connector Front of accessory Reverse of accessory Attention If any wear or damage to the wire cladding is found du...

Страница 27: ... beating of the heart The signal is transmitted to the body monitor for amplification and processing into the ECG signal Pressure Clip Male Connector Front of electrodes Back of electrodes Attention Before attaching the ECG electrodes make sure that the skin surface is clean It may necessary to wipe the skin clean with a wet towel or alcohol swabs then wait for it to dry before attachment Electrod...

Страница 28: ...ht 1 The magnetic clip male connector on the monitor and the magnetic clip female connector of the charger clips with each other Pay attention to the direction when placing the monitor on the charger The charger detection port on the monitor must be aligned with the charger detection probe on the charger as shown below Charger detection probe Charger detection port 2 When the charger is closed and...

Страница 29: ...cover of the charger and insert finger into the ventral groove to pick up the monitor for use as shown below The green LED lights up after charging Insert finger into ventral groove and pick up monitor Other charger functions 1 When the charger is plugged into the socket by itself with no monitors the orange LED light lights up for two seconds 2 Place the monitor on the charger and connect the tra...

Страница 30: ...loth Charger NYA Charger Wipe with dry cloth Accessory S NYA Patch S Wipe with damp cloth Accessory M NYA Patch M Accessory L NYA Patch L Product Specifications HR Monitor Measuring Lead Lead I HR Range 30 240 Frequency response 0 1 40Hz Heart rate accuracy 3 or 3 Sampling rate 256Hz Activity G sensor 3 axis 8g G sensor sampling rate 52Hz Radio Bluetooth 3 0 EDR Tx 0 dbm Transmission range 10 mete...

Страница 31: ... Management System ____________________________________________________________________________ ___________________________________________________________________________ User Manual V1 0 Page 30 Product List Part Name Model Part Description ...

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