“QUANTA” PORTABLE ECG MONITORING DEVICE User Manual
TABLE OF CONTENTS Safety Notes............................................................ 3 Product Overview ................................................... 6 Indication for Use ..................................................................... 6 Package Contents .................................................................... 7 Product Configurations ......................................................................................... 8 Components...........................................
Main Screen ............................................................................ 19 Menu ........................................................................................ 20 History................................................................................................................... 22 Profile .................................................................................................................... 24 Pairing .............................................................
SAFETY NOTES The “QUANTA” PORTABLE ECG MONITORING DEVICE is to be used for clinical assessment and personal reference only. The “QUANTA” 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. The “QUANTA” PORTABLE ECG MONITORING DEVICE must be used with its specified accessories and electrodes.
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. Please read through this user guide carefully before using “QUANTA” PORTABLE ECG MONITORING DEVICE.
Due to electrostatic discharge (ESD) sparks may cause sparks. “QUANTA” PORTABLE ECG MONITORING DEVICE is not suitable for use in an explosive environment. “QUANTA” PORTABLE ECG MONITORING DEVICE does not support with the devices that apply high-frequency 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.
PRODUCT OVERVIEW Indication for Use The “ QUANTA ” PORTABLE ECG MONITORING DEVICE is intended for noninvasive measurement of a functional Electrocardiogram (ECG) and heart rate (HR) in hospitals, healthcare institutes, and home environments by trained medical professionals and trained adult. The “QUANTA” PORTABLE ECG MONITORING DEVICE will process ECG signals and calculate HR on continuous, spot check, or event record mode. Users can also add time tags to the ECG signals by pressing the button.
Package Contents After purchasing the “QUANTA” PORTABLE ECG MONITORING DEVICE , please check the product package to ensure that the following items are included: ECG Sensor x 1 Charger x 1 USB Charging Cable x 1 User Manual x 1 CIR418-01 7
Product Configurations The following table lists the sensor related items included in the various packages available for the “QUANTA” PORTABLE ECG MONITORING DEVICE .
Back 1 2 3 1 2 3 Charging Contacts Holder Connectors Label Area Charger 1 2 1 2 Charging Contacts USB Charging Port CIR418-01 9
Body Patch Front Exterior (with pocket closed) 2 1 1 2 Material Length Gel Contact Point Made from Nonwoven 124 mm Sensor Holder & Cable Front 1 1 Sensor Connectors Material Made from Polydefin Foam Length 600 mm CIR418-01 10
Back 1 1 1 Electrode Connectors IMPORTANT: If any damage to the wire shielding is found on the holder, replace immediately. 12-unit Charger (Charging 12 sensors at the same time) 1 Specification for Charger Dock: Charging indicator LED on Sensor Working temp 5 ~ 35⁰C (Sensor working temp is 5 ~ 35⁰C when it is charging) Storage temp -20 ~ 60⁰C Input 12V/2A Size 241.3 mm * 166.4 mm * 66.25 mm NOTE: 12-unit charger can only be used by trained person/adult.
Product Requirements In order to properly use the “QUANTA” PORTABLE ECG MONITORING DEVICE the following items are required: For Body Patch: The ECG Sensor The Body Patch A Bluetooth-enabled Android Smartphone* (with Android version 5.x or above and a display resolution of 1920x1080 or 2560x1440) or iPhone (iOS 12 above) The ECG Sensor Q-ecg App* * Items not included in the product package.
BEFORE YOU START Before you start using the “QUANTA” PORTABLE ECG MONITORING DEVICE you must: 1. Charge the battery on the Sensor 2. Install the Q-ecg app on your smartphone 3. Enable Bluetooth on your smartphone Charging the Battery Sensor Adapter Charger To charge the battery: 1. Plug the charger’s AC adapter (with 5V/1A and conform to standard 60950) into a power source (i.e., wall outlet) and connect the charging cable. Connect the other end of the charging cable to the charger. 2.
GETTING STARTED Once you have completed the steps described in Before You Start, you can begin using the “QUANTA” PORTABLE ECG MONITORING DEVICE by following these steps: 1. Create a profile in the Q-ecg app 2. Pair your smartphone to the ECG sensor via Bluetooth 3. Wear the “QUANTA” PORTABLE ECG MONITORING DEVICE Creating a Profile The first time you launch the Q-ecg app you will need to create a profile.
Pairing After creating a profile, please enter the pairing page. To pair the sensor to your smartphone: 1. When enter the pairing page, it would show the nearby BLE devices. Please select the name “CIRXSXXXXXXX” which is the same as serial number on the back of sensor. 2. It takes a few seconds to do the pairing. Please wait for a while. 3. Wait until a message displays on your smartphone indicating that the pairing is complete.
Wearing the sensor holder To wear the ECG sensor directly on your body, follow the directions below: 1. Attach an ECG electrode to each of the 3 connectors on the back of the sensor holder (see image below). NOTE: For more information on electrode specifications, see ECG Electrode Information. 2. Attach the ECG sensor to the front of the sensor holder so that all four holder connectors on the sensor are properly clicked into the four sensor connectors on the holder (see image below).
6. Once the ECG sensor is properly positioned on your body, wait half a minute then check the Q-ecg app to see if a real-time ECG reading is shown on the main screen on the app. If a real-time ECG is shown on the app, the ECG sensor has been properly worn. WARNING: When wearing the ECG sensor directly on your body, ensure that all 3 electrodes are firmly adhered to your body.
Wearing the body patch The following steps describe the body patch wearing process: Step1. Attach the Device on the body patch before put on body. Step2. Wipe with alcohol cotton on the left chest. Step3. Left hand naturally put down. Step4. Put body patch under clavicle with angle 45º ~ 60 º Step5. Hand pressure on the body patch (especially on the connect point) for 30 seconds.
THE Q-ECG APP Main Screen Once you have successfully paired and worn the ECG sensor, the Q-ecg app’s main screen will display on your mobile device. The main screen (shown below) displays a real-time ECG which should be shown to a medical professional for evaluation. 4 5 1 2 3 No Item 1 Menu Button 2 Profile Settings CIR418-01 Description Tap to access the app menu. For more information see Menu. Displays the profile settings that were entered during the profile creation process.
3 4 Real-Time ECG Battery Status 5 Connection Status The numbers on the scroll bar represent the hour of the day shown, and each point on the scroll bar represents 10 minutes. Points on the scroll bar that are dark blue feature ECG readings. Tap Hide to return to the main toolbar for the History screen. Profile. Displays your real-time ECG in 5 second intervals. Displays the current charge level of the battery. Displays the connection status for the ECG sensor.
CIR418-01 21
History Tap History in the Q-ecg app menu to view a scrollable and scalable ECG history. The following items can be found on the ECG history screen: 1 2 4 5 3 No Item 1 Date Button 2 Menu Button 3 ECG History 4 Display Options Button 5 Quick Search Button CIR418-01 Description Tap to view an ECG from a different date. For more information, see Date. Tap to access the app menu. Tap to display your ECG history. Swipe left or right to move to forward or backward in your ECG history.
Date When you tap the date button in the History screen, a calendar view will appear. Dates on which you recorded an ECG are circled. Tap on a circled date to view your ECG on days when an ECG data from that day. NOTE: The Q-ecg app stores ECG data for up to 7 days. Display Options The ECG displayed on the Q-ecg app is displayed on a graph, on which the horizontal axis measures time (in seconds), and the vertical axis measures the electrical activity (in millivolts).
Sensitivity: Using a lower sensitivity option will shrink the ECG along the vertical axis of the grid, and using a higher sensitivity option will expand the ECG along the vertical axis of the grid. Quick Search Scroll Bar The quick search scroll bar allows you to quickly scroll to a different point in the ECG history by swiping left or right on the scroll bar. The numbers on the scroll bar represent the hour of the day shown, and each point on the scroll bar represents 10 minutes.
Clear Data Tap Clear Data in the Q-ecg app to clear the profile settings, ECG history, and pairing information saved in the smartphone only. After clearing the data the user will need to pair the smartphone to the ECG sensor again by following the steps described in Pairing. NOTE: If you upload ECG data to a smartphone with the double-sided Micro-USB cable and receive a system message stating the USB device is not recognized by the system, you will need to reset the sensor by tapping Reset Device.
ADDITIONAL INFORMATION LED Indicators The following tables describe the indicators on both the sensor and charger: Sensor Status Indicator Event Action Behavior Power on Press power button Power off Long press power button for 10 seconds • Both Battery LED & Indicator LED flashing green 3 times • • Solid blue light for both Battery LED and Indicator LED while press the button After 5 seconds turn off lights Lead off User do not wear device • Indicator LED flashing orange light Event Recordin
ECG Electrode Information When using the Sensor Holder for the “QUANTA” PORTABLE ECG MONITORING DEVICE, you must use compatible electrodes (sold separately) for the ECG sensor to work properly.
patch Data Transmission (1) Bluetooth BLE 4.2: Transmit distance: 10 meters (open space) (2) Micro USB cable USB USB2.0 Battery 3.7V/600mAh Battery Life Storage mode: 14 Days @ 250 Hz sample rate Working Temperature / Humidity 5 – 45⁰C, 10% – 95% non-condensing Storage Temperature / Humidity -20 – 60⁰C, 10% – 95% non-condensing Atmospheric Pressure Range 800 hPa to 1013 hPA Altitude 2000m Enclosure Rating IPX6 Weight 28.8 ± 0.5 g Dimension 68 mm (L) x 37.3 mm (W) x 10.8 mm (H) ±0.
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: MedicalSales@quantatw.
Federal Communications Commission (FCC) Statement The FCC ID is HFSCIR. 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.
Regulatory Marks The “QUANTA” 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.
Supplier’s Declaration The Quanta “QUANTA” 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. Manufacturer’s declaration-electromagnetic emissions The Q-ecg-wu2 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-ecg-wu2 should assure that it is used in such an environment.
Manufacturer’s declaration-electromagnetic immunity The Q-ecg-wu2 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-ecg-wu2 should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level test level Electrostatic discharge(ESD) Electromagnetic environmentguidance (for home and professional healthcare environment) Floors should be wood, concrete or ceramic tile.
Manufacturer’s declaration-electromagnetic immunity The Q-ecg-wu2 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-ecg-wu2 should assure that it is used in such and environment.
Recommended separation distance between portable and mobile RF communications equipment and the Q-ecg-wu2 The Q-ecg-wu2 is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances are controlled.
Manufacturer’s declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The Q-ecg-wu2 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-ecg-wu2 should assure that it is used in such an environment.
