____________________________________________________________________________ QUANTA COMPUTER INC. HUAYA PLANT _________________________________________________________________ Wearable ECG Monitoring Device User Manual Ver. 1.0 _________________________________________________________________ 2014 Quanta Computer Inc. Huaya Plant CI2418-01_2A All rights reserved.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ INDEX WARNINGS AND REMINDERS ............................................................................. 2 WARNINGS: ........................................................................................................................................................ 2 REMINDERS:..........................................................................................
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Warnings and Reminders Warnings: The NYA Quanta Wireless Home Health Management System is to be used for clinical assessment and reference only. The NYA Quanta Wireless Home Health Management System is not intended for diagnostic use.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Reminders: Please read through this user guide carefully before using the NYA Quanta Wireless Home Health Management System.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Federal Communications Commission (FCC) Statement 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Year of Manufacture 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 In the serial number on the product label, the 7th character starting from the left (“14” in the shown example) represents the sensor and charger's year of manufacture.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ 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 ___________________________________________________________________________ User Manual V1.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Supplier's Declaration The NYA Quanta Home Health Management System conforms to the international EN 60601-1 and EN 60601-1-2 standards for electromagnetic compatibility with medical electrical devices and systems. Compliant Electromagnetic Environment Guidelines Standard The recommended electromagnetic environment for this instrument is shown in the table below.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Supplier's declaration and guidelines—Electromagnetic Immunity IEC 60601-1-2 Compliant Electromagnetic Environment Testing testing Standard Guidelines The recommended electromagnetic environment for this instrument is shown in the table below. The customer or user should ensure that it is used in the described environment.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Recommended safety distance The following table lists the recommended safety distance between the device and mobile RF communications equipment. The recommended EM environment for the NYA Quanta Wireless Home Health Management System is where RF interference is controlled.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Regulatory Marks The Wireless Home Health Management System conforms to the following regulatory requirements.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ 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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ 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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Equipment A.NB / PC Functions The device requires a commercially available personal computer (NB/PC) with Bluetooth capabilities. In addition to the basic functions of a computer, the installation provides an exclusive application (UI, as below) capable of performing electrocardiogram (ECG) measurements.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ C. NYA Body Monitor Accessory Function 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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Equipment Operating Instructions A. Personal Computer (NB/ PC) According to the specifications of individual personal computers (NB / PC). Operating Instructions: Start up the computer After starting up your personal computer (NB / PC), users can access the available functions. Shut down the computer To shut down your personal computer (NB / PC), click Shut Down.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ B. Quanta ECG Monitor application, NYA- Data- CMD [for use 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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ 1. Communication 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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ 2. Create New Case Clicking "New Case" will display the following window: Create a New Case as follows: a. Click "New Case" to display the following window. Confirm the subject in the Subject field. Enter the Resting HR of the Subject and click "OK". b. Ensure Bluetooth has been properly connected to the Serial Port of the hardware. c.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ f. Screen description: A. B. C. D. Displays the basic information of the case. Displays the time elapsed for the test. Displays the battery life of the hardware. Displays whether a Fall Event occurs. Click "Cancel" to execute Cancel Fall Event command. E. Auto ECG command.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Correct the two values, Min and Span, on the General Tab. Min is the starting value of Y-axis; Span is the length of Y-axis. Battery life display of monitoring device Under normal connection and usage, the battery life symbol will display as follows. Different battery bars represent different battery life. High battery life, estimated usage time of 12 to 16 hours.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ C Subject & Case Management After executing "Subject & Case", the following screen will be displayed: A. 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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Bluetooth matching (These settings will be set by the service representative) (1) When the “Smart Phone” or “NYA Monitor” is used for the first time or updated they must be paired. (2) Open the smart phone and make sure that it has Bluetooth enabled (See E. Smart Phone Instructions).
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Attention: The ECG electrodes and accessory must not be worn in the following manner for an extended period of time. This prevents the dangling end from short-circuiting with any power supply. Wire-side hanging 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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Other body monitor information: (a) If the monitor has a low battery, the orange LED light will blink. (b) When the monitor is placed on the accessory (or body monitoring shirt), the green LED light on the monitor will blink for 5 seconds before going out. (c) During standby and measurement, the monitor's status light will not be shown except when power is blow.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ 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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ E. ECG Electrodes The ECG Electrodes are conductors placed on the skin of the chest for transmitting the signal generated by the beating of the heart. The signal is transmitted to the body monitor for amplification and processing into the ECG signal.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ F. NYA Charger Charger function: Magnetic clip female connector Charger detection probe LED status light (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.
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ (3) Once the monitor is fully charged, the orange LED on the charger goes out and the green LED comes on. Remove the charger from the socket, open the 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.
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QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Product List Part Name/Model Part Description ___________________________________________________________________________ User Manual V1.
