Quanta Computer NYA User Manual

Wireless home health management system

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____________________________________________________________________________

HUAYA PLANT

QUANTA COMPUTER INC.

_________________________________________________________________

Wearable ECG Monitoring

Device

User Manual

Ver. 1.0

_________________________________________________________________

2014 Quanta Computer Inc. Huaya Plant

CI2418-01_2A

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Summary of Contents for Quanta Computer NYA

Page 1 ____________________________________________________________________________ HUAYA PLANT QUANTA COMPUTER INC. _________________________________________________________________ Wearable ECG Monitoring Device User Manual Ver. 1.0 _________________________________________________________________ 2014 Quanta Computer Inc. Huaya Plant All rights reserved. CI2418-01_2A...
Page 2: Table Of Contents
A.NB / PC ............................... 13 EQUIPMENT OPERATING INSTRUCTIONS..........15 A. P (NB/ PC) ....................... 15 ERSONAL OMPUTER B. Q ECG M , NYA- D - CMD [ UANTA ONITOR APPLICATION FOR USE ON PERSONAL (NB / PC)] ......................... 16 COMPUTERS C. NYA B ...........................
Page 3: Warnings And Reminders
____________________________________________________________________________ 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. The NYA Quanta Wireless Home Health Management System consists entirely of sophisticated medical electrical devices so maintenance can only be carried out by professional technicians.
Page 4: Reminders
Please read through this user guide carefully before using the NYA Quanta Wireless Home Health Management System. If the NYA Quanta Wireless Home Health Management System must be used to take measurements over an extended period of time, please inspect the contact point of the electrodes at least once every 8 hours to make sure that the electrodes are in the right position and there is no allergic skin reaction from the user.
Page 5 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.
Page 6: Year Of Manufacture
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 In the serial number on the...
Page 7 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...
Page 8: Supplier's Declaration
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 Emission Testing...
Page 9 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. No part of the NYA Quanta Wireless Home health management System should be placed near portable and mobile radio-frequency communications equipment. The recommended safety distance can be calculated using the radio frequency and the following formula.
Page 10 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. The user should maintain the recommended safety distance with the devices and portable/mobile RF communications equipment listed in the following table (corresponding to the maximum output of the RF transmitter).
Page 11: Regulatory Marks
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Regulatory Marks The Wireless Home Health Management System conforms to the following regulatory requirements. Administrative Regulations on Low Power Radio Waves Radiated Devices (930322) Article 12 Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to an approved low power radio-frequency devices.
Page 12 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.
Page 13: Introduction
Wireless Home Health Management System ____________________________________________________________________________ Introduction "Electrocardiogram" (ECG) Waveform Required equipment Remarks Smart phone (E)＋ NYA body monitor (G) Choose one of the two measurement options on the ECG electrode (I) ＋ Body Monitoring left based on the usage...
Page 14: Equipment
B. NYA Body Monitor Function The ECG signal measured through this device is wirelessly transmitted using low-power Bluetooth technology to the smart phone for processing. The data is then uploaded via 3G wireless network to the cloud server.
Page 15 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...
Page 16: Equipment Operating Instructions
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.
Page 17: Quanta Ecg Monitor Application, Nya- Data- Cmd [For Use On Personal Computers (Nb / Pc)]
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"...
Page 18 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.
Page 19 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".
Page 20 QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ f. Screen description: A. Displays the basic information of the case. B. Displays the time elapsed for the test. C. Displays the battery life of the hardware. D. Displays whether a Fall Event occurs. Click "Cancel" to execute Cancel Fall Event command.
Page 21 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.
Page 22: Nya Body Monitor
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: Male-end of magnetic clip...
Page 23 ____________________________________________________________________________ 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.
Page 24 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 Application icon Note: Before launching the application, only one body monitor can be used/activated at any time.
Page 25 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.
Page 26: Nya Body Monitor Accessory
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...
Page 27: Ecg Electrodes
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.
Page 28: Nya Charger
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.
Page 29 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...
Page 30: Cleaning Of The Wireless Home Health Management System
Cleaning Method Body Monitor NYA Target Wipe with dry cloth 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...
Page 31: Product List
QUANTA COMPUTER INC. Wireless Home Health Management System ____________________________________________________________________________ Product List Part Name/Model Part Description ___________________________________________________________________________ User Manual V1.0 Page: 30...

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