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Summary of Contents for Quanta Computer QUANTA
- Page 1 “QUANTA” PORTABLE ECG MONITORING DEVICE User Manual...
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Page 2: Table Of Contents
TABLE OF CONTENTS Safety Notes............3 Product Overview ........... 6 Indication for Use ..............6 Package Contents ..............7 Product Configurations ..................8 Components ................8 Sensor ........................8 Charger ........................9 Body Patch ......................10 Sensor Holder....................... 10 Product Requirements ............12 Before You Start ........... - Page 3 Main Screen ................19 Menu ..................20 History ........................22 Profile ........................24 Pairing ........................24 Clear Data ......................25 Quit ........................25 Measuring ECG when Bluetooth is Disconnected ....25 Additional Information ......... 26 LED Indicators ................ 26 Sensor Status Indicator ..................26 Cleaning ..................
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Page 4: Safety Notes
Damaged or faulty accessories and electrodes should not be used. When the “QUANTA” PORTABLE ECG MONITORING DEVICE is low on battery power, it will automatically stop taking measurements and the corresponding indicator lights will blink. - Page 5 “QUANTA” PORTABLE ECG MONITORING DEVICE defibrillators when using the The “QUANTA” PORTABLE ECG MONITORING DEVICE can only take measurements while the subject is stationary (e.g., while sitting or lying down) or engaging in ordinary activity. Any activities not permitted by the attending physician may affect the accuracy of the measurements.
- Page 6 PORTABLE ECG MONITORING DEVICE 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.
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Page 7: Product Overview
PRODUCT OVERVIEW Indication for Use The “ QUANTA ” PORTABLE ECG MONITORING DEVICE is intended for non- invasive 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. -
Page 8: Package Contents
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... -
Page 9: Product Configurations
Product Configurations The following table lists the sensor related items included in the various packages available for the “QUANTA” PORTABLE ECG MONITORING DEVICE . Product Package Part Name Model Number Q-ecg-wu2-K1 Q-ecg-wu2-K2 “QUANTA” PORTABLE Q-ecg-wu2 ECG MONITORING DEVICE ... -
Page 10: Charger
Back Charging Contacts Holder Connectors Label Area Charger Charging Contacts USB Charging Port CIR418-01... -
Page 11: Body Patch
Body Patch Front Exterior (with pocket closed) Contact Point Material Made from Nonwoven Length 124 mm Sensor Holder & Cable Front Sensor Connectors Material Made from Polydefin Foam Length 600 mm CIR418-01... - Page 12 Back 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) 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...
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Page 13: Product Requirements
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) ... -
Page 14: Before You Start
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... -
Page 15: Getting Started
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. -
Page 16: Pairing
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. -
Page 17: Wearing The Sensor Holder
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). Electrode Information NOTE: For more information on electrode specifications, see ECG 2. -
Page 18: Removing The Ecg Sensor From The Holder
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. -
Page 19: Wearing The Body Patch
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. -
Page 20: The Q-Ecg App
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. Item Description Tap to access the app menu. -
Page 21: Menu
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. - Page 22 CIR418-01...
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Page 23: History
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: Item Description Tap to view an ECG from a different date. For more information, see Date Button Date. - Page 24 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.
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Page 25: Profile
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. -
Page 26: Clear Data
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. -
Page 27: Additional Information
• Indicator LED with solid blue light Cleaning The table below describes the appropriate cleaning methods for each item included with the “QUANTA” PORTABLE ECG MONITORING DEVICE : Item Cleaning Method Sensor Wipe with a dry cloth when it’s dirty. And clean it every day if it is frequently used. -
Page 28: Ecg Electrode Information
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. Suggested electrodes include Kendall Ag/AgCl electrodes, or any electrodes that meeting the following specifications: ... -
Page 29: Charger Specifications
23 ± 0.5 g Dimension 72.8 mm (L) x 42.1 mm (W) x 12.5 mm (H) ±0.2 mm Troubleshooting 1) Cannot pair the “QUANTA” PORTABLE ECG MONITORING DEVICE with the Q-ecg app. Refer to the notes listed in Pairing. CIR418-01... -
Page 30: Customer Support
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.com EU Representative EU Representative: MedNet GmbH Address: Borkstrasse 10, 48163 Münster, Germany... - Page 31 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. Operation is subject to the following two conditions: 1) This device may not cause interference and 2) This device must accept any interference, including interference that may cause...
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Page 32: Regulatory Marks
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. - Page 33 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.
- Page 34 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 Electromagnetic environment-...
- Page 35 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance...
- Page 36 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. The customer or the user of the Q-ecg-wu2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Q-ecg-wu2 as recommended below, according to the maximum output power of the communications equipment.
- Page 37 Manufacturer’s declaration-electromagnetic immunity Test specifications for to RF wireless communications equipment ENCLOSURE PORT 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. Compliance LEVEL Test...
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