QOCA PORTABLE ECG MONITORING DEVICE User Manual Model name：ecg102D CIE418-01 Ver.
TABLE OF CONTENTS Safety Notes ............................................... 3 Product Overview ...................................... 8 Indication for Use .............................................8 Package Contents .............................................9 Components ................................................... 10 ECG Sensor .............................................. 10 Product Requirements .................................. 12 Before You Start ......................................
The QOCA ecg App .................................. 21 Main Screen .................................................... 21 Real-Time ECG ............................................... 22 History ...................................................... 23 Profile ....................................................... 24 Specifications ................................................ 26 Sensor Specifications ............................. 26 Bluetooth Specifications ........................
SAFETY NOTES Please read through this user guide carefully before using QOCA PORTABLE ECG MONITORING DEVICE. The QOCA PORTABLE ECG MONITORING DEVICE is to be used for clinical assessment and personal reference only. The QOCA PORTABLE ECG MONITORING DEVICE consists entirely of sophisticated medical electrical parts. Maintenance can only be carried out by professional technicians. Unauthorized disassembly of the device by the user is not allowed.
Avoid using devices that can affect the accuracy of the readings when the QOCA PORTABLE ECG MONITORING DEVICE is taking measurements (e.g., using a blood pressure monitor will affect the ECG’s pulse measurement). Avoid using other electronic devices when the QOCA PORTABLE ECG MONITORING DEVICE is taking measurements. If using another other electronic device is necessary, please check to ensure the ECG is continuing to take measurements normally.
The conductive parts of the electrodes and associated connectors for type BF applied parts, which are parts that make conductive contact with the heart, including the neutral electrode, should not make contact with other conductive parts including the ground. Direct contact with other conductive parts may result in electric shock. Do not use high-frequency instruments or electrical medical equipment such as defibrillators when using the QOCA PORTABLE ECG MONITORING DEVICE.
The QOCA PORTABLE ECG MONITORING DEVICE has been tested and certified to international electromagnetic compatibility (EMC) standards for medical equipment (EN 60601-1 and EN 60601-1-2). If abnormal behavior is observed due to EMC disturbances, please relocate the device accordingly. Battery Caution: There is a risk of explosion if the battery for the QOCA PORTABLE ECG MONITORING DEVICE is replaced by an incorrect battery type.
QOCA PORTABLE ECG MONITORING DEVICE does not support with the devices that apply highfrequency voltage to patients (such as electrosurgical equipment and some respiratory sensors); if such devices are used at the same time, it may cause adverse consequences. For procedures that require the use of high-frequency surgical equipment, QOCA PORTABLE ECG MONITORING DEVICE should be removed beforehand.
PRODUCT OVERVIEW Indication for Use The QOCA Portable ECG Monitoring Device is intended for use by trained medical personnel and trained adults to measure Electrocardiogram (ECG) and heart rate (HR) in hospitals, healthcare institutes, or home environments. The transmission, storage, and display of ECG and HR data are available with dedicated software. The device is intended for use on adult patients who are not in critical condition. CIE418-01 Ver.
Package Contents After purchasing the QOCA PORTABLE ECG MONITORING DEVICE , please check the product package to ensure that the following items are included: ECG Sensor x 1 User Manual x 1 *Model name: ecg102D *The package includes coin battery(CR2016) 1pcs for device test use CIE418-01 Ver.
Components ECG Sensor Front 1 2 3 Indicator LED (LED flash blue light when user’s fingers touch the two electrodes.) Strap Holes ECG Electrodes CIE418-01 Ver.
Back 1 2 Label Area Battery cover (Coin Battery CR2016) CIE418-01 Ver.
Product Requirements In order to properly use the QOCA PORTABLE ECG MONITORING DEVICE the following items are required: The ECG Sensor (Included coin battery CR2016) A Bluetooth-enabled Android Smartphone* (with Android version 8.x or above and a display resolution of 1560x720) QOCA ECG App* * Items not included in the product package. CIE418-01 Ver.
BEFORE YOU START Before you start using the QOCA PORTABLE ECG MONITORING DEVICE you must: 1. 2. 3. ECG Sensor requires a coin battery (CR2016) Install the QOCA ECG app on your smartphone Enable Bluetooth on your smartphone Installing the App To install QOCA ECG app on your smartphone. NOTE: In order to install the QOCA ECG app your smartphone will need at least 15MB of storage capacity available. Enabling Bluetooth To enable Bluetooth, enter the Settings menu on your smartphone and enable Bluetooth.
GETTING STARTED Once you have completed the steps described in Before You Start, you can begin using the QOCA PORTABLE ECG MONITORING DEVICE by following these steps: 1. 2. 3. Binding Prepare to record ECG Start to record ECG CIE418-01 Ver.
Sensor binding To pair the sensor and mobile phone, please select the "Upload Record" method of use. If pairing is not required, please select the "Personal use" method for direct measurement. Upload Record : • User account: Please fill in user account. Please contact the service staff for user account information • Please follow the instructions of the app to complete the operation setting. • The page will go into main screen when sensor binding.
• The page will go into main screen when sensor binding. Main screen If the measurement process cannot be completed, the screen will jump out of the measurement page and return to the operation instructions and display the prompt "Recording failed, please measure it again". CIE418-01 Ver.
Prepare to record ECG Before you start to record ECG you must: 1. 2. Lay ECG sensor on a flat surface near your smartphone. Launch QOCA ECG app and tap “+” button (lower-right corner) on the screen. It will enter Real-Time ECG page. Note: Make sure Bluetooth of your smartphone is turned on. CIE418-01 Ver.
Start to record ECG Follow the on-screen instruction, you have to place your fingers from each hand on the two electrodes. Please put the device on the table before ECG recording. This will help the device to get more stable ECG waveform data. CIE418-01 Ver.
After a while, app will start to record ECG and count down automatically. Please keep fingers attaching to the electrodes until the time counting is completed. Note: It is critical to led fingers stable to avoid unwanted failure while recording ECG. Note: The app will show “Recording complete” when you finished the measurement CIE418-01 Ver.
Note: The app will show” Recording fail, please try it again” when the sensor has a “lead-off” condition. CIE418-01 Ver.
THE QOCA ECG APP Main Screen Main screen is the list of ECG recordings. The following items can be found on the screen: No 1 2 Item Profile Icon ECG Recording CIE418-01 Ver.3A Description Tap profile icon to enter profile page. Each ECG recording is displayed first 3 seconds. You can tap to enter History page to review ECG recording.
3 “+” Button Tap “+” button to enter RealTime ECG page. Real-Time ECG The screen displays Real-Time ECG while the app receives signals from ECG sensor. The following items can be found on the screen: CIE418-01 Ver.
No 1 2 3 4 Item On-screen Instruction Heartbeat ECG Timer Description Instruct user how to record ECG. Real-time heartbeat, Real-time ECG Timer, Circular process bar History The complete ECG is displayed on history page. CIE418-01 Ver.
Profile (Upload record) No Item 1 Profile 2 Device CIE418-01 Ver.
Profile (Personnel use) No 2 Item Description Device Device ID, Measurement mode, Firmware version, Software version, Device testing, Data clean, Waveform Enhanced CIE418-01 Ver.
Specifications Sensor Specifications Continuous ECG data acquisition and calculation ECG Sensor Lead-off Detection CIE418-01 Ver.3A Measuring Lead: Lead 2 Frequency Response: Monitor 0.5 to 40 Hz (-3db) Heart rate measurement range*: 30 – 240 bpm** Heart rate accuracy: ± 3 bpm or ±3% whichever is greater Differential Input Impedance: > 10MΩ Common Mode Rejection Ratio: > 70 dB Sampling rate: default at 256Hz *Heart rate is calculated based on the R-R interval of the ECG.
Data Transmission Bluetooth BLE 5.0: Transmit distance: 1 meters (open space) Battery CR2016 Working Temperature / Humidity 5 – 45⁰C, 10% – 95% noncondensing Storage Temperature / Humidity -20 – 60⁰C, 20% – 95% noncondensing Enclosure Rating IP21 Weight Dimension CIE418-01 Ver.3A 17g 92.7 x 31.0 x 4.0 ± 0.
Bluetooth Specifications Operating Frequencies 2402~2480MHz Channel Spacing 2MHz Channel number 40 Operating Voltage 1.8V Modulation GFSK Antenna Gain PCB Antenna, Peak Gain: : 0.46 dBi Rated Power (EIRP) 7.01 dBm Device cleaning 1. Please clean the device with dry cloth when it is dirty or wet. CIE418-01 Ver.
Troubleshooting 1) 2) 3) 4) Cannot bind the device with the QOCA ecg app If the ECG monitor cannot be binded with the mobile phone, please refer to the instructions and recheck it again. If the light of the love icon does not light up in blue. Please check whether the battery is power. Open the battery cover, replace the new battery and use it again.
• 5) 6) 7) Use water lotion if the surface of your fingers is too dry • Please use the sensor on a flat table. Relax your hand muscles during measurement and keep your hands and fingers stable during measurement. Moving the finger will cause signal instability and noise during the measuring. Please press the metal electrode normally with your fingers, do not squeeze it hard. • During the measurement, please do not place the sensor location higher than the heart or lower than the navel.
Customer Support For additional technical information, contact Quanta Customer Support Department. Quanta Computer Inc.(QCI) Address: No. 188, Wenhua 2nd Rd., Guishan Dist., Taoyuan City 333, Taiwan TEL: +886-3-327-2345 FAX: +886-3-318-4207 Email: MedicalService@quantatw.com EU Representative EU Representative: MedNet EC-REP GmbH Address: Borkstrasse 10, 48163 Münster, Germany CIE418-01 Ver.
Federal Communications Commission (FCC) Statement The FCC ID is HFSCIE 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. 15.19 This device complies with part 15 of the FCC Rules.
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.
Regulatory Marks The QOCA PORTABLE ECG MONITORING DEVICE 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.
the interference from legal communications or ISM radio wave radiated devices. CE Mark: Indicates that the body sensor has been certified and conforms to EC Directive 93/42/EEC on medical devices. Type applied part Indicates that the sensor is classified as electrical or electronic equipment requiring proper disposal (WEEE Directive) Indicates the manufacturer's catalogue number Attention: Catalogue number may also be referred to as the reference number or reorder number. CIE418-01 Ver.
Indicates the manufacture's serial number. Indicates the manufacturer's name and address To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. 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.
IP21 CIE418-01 Ver.
Supplier’s Declaration The QOCA PORTABLE ECG MONITORING DEVICE conforms to the international EN 60601-1 and EN 60601-1-2 standards for electromagnetic compatibility with medical electrical devices and systems. CIE418-01 Ver.
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ME Equipment that intentionally receive RF energy shall include: frequency and/or band and bandwidth of receiving section ME Equipment that include transmitters shall include frequency and/or band, modulation, and ERP CIE418-01 Ver.
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