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Quanta Computer ecg103-K1 User Manual

Qoca portable ecg monitoring device
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QOCA PORTABLE ECG MONITORING DEVICE
User Manual
CIH418-01 Ver.: 2B

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  • Page 1 QOCA PORTABLE ECG MONITORING DEVICE User Manual CIH418-01 Ver.: 2B...

  • Page 2: Table Of Contents

    TABLE OF CONTENTS Safety Notes ............4 Product Overview ..........10 Indication for Use ............10 Package Contents ............. 11 Product Configurations........12 Components .............. 13 Sensor ..............13 Charger ..............15 Body Patch ............17 Sensor Holder & Cable ........18 12-unit Charger (Charging 12 sensors at the same time) ............
  • Page 3 Getting Started ........... 24 Pairing ................ 24 Wearing the ECG Sensor ......... 25 Wearing the sensor holder ........26 Removing the ECG Sensor from the Holder ..29 Wearing the body patch ........... 30 The QOCA ecg APP ........... 33 Main Screen ...............
  • Page 4 Charger Specifications........45 Troubleshooting ............45 Gateway mode information ........45 Gateway Compatible Specifications ....46 Customer Support ............. 47 EU Representative ..........47 Label Information: ..........47 Federal Communications Commission (FCC) Statement ..............48 Regulatory Marks ..........50 Supplier’s Declaration ..........53 CIH418-01...

  • Page 5: Safety Notes

    SAFETY NOTES • 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.
  • Page 6 • 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.
  • Page 7 • Pay attention to ensure that the QOCA PORTABLE ECG MONITORING DEVICE is not swallowed by pets or children. • Cardiac pacemakers or other electrical stimulators may affect the accuracy of the measurements of the QOCA PORTABLE ECG MONITORING DEVICE. •...
  • Page 8 • 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 can only take measurements while the subject is at rest (e.g., while sitting or lying down) or engaging in ordinary activity.
  • Page 9 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. •...
  • Page 10 • Please do not use any other cables or accessories not approved by the manufacturer in this manual to avoid negative influence on electromagnetic compatibility. • Due to electrostatic discharge (ESD) sparks may cause sparks. QOCA PORTABLE ECG MONITORING DEVICE is not suitable for use in an explosive environment.

  • Page 11: Product Overview

    PRODUCT OVERVIEW Indication for Use The QOCA WEARABLE ECG MONITORING DEVICE is intended for non-invasive measurement of Electrocardiogram (ECG) and heart rate (HR) of patients at rest in hospitals, healthcare institutes, and home environments. The QOCA WEARABLE ECG MONITORING DEVICE will process ECG signals and calculate HR on continuous, spot check, or event record mode.

  • Page 12: Package Contents

    The device is intended for use on patients 20 years of age and older. The QOCA WEARABLE ECG MONITORING DEVICE is only available by prescription and be used by or under the instruction of medical personnel. Package Contents After purchasing the QOCA PORTABLE ECG MONITORING DEVICE , please check the product package to ensure that the following items are included: ecg103 product package...

  • Page 13: Product Configurations

    Cable x 1 Product Configurations The following table lists the sensor related items included in the various packages available for the QOCA Portable ECG Monitoring Device. Product Package Part Name Model Number ecg103-K1 ecg103-K2 ✓ ✓ QOCA PORTABLE ECG MONITORING ecg103 DEVICE ✓...

  • Page 14: Components

    ✓ ecg103-P1 Body Patch* Components Sensor Front CIH418-01...
  • Page 15 Power Button Battery LED (see LED Indicators for more information) Indicator LED (see LED Indicators for more information) Back Charging Contacts Holder Connectors CIH418-01...

  • Page 16: Charger

    Laser Printing Area NOTE: Electrode button connector will support plug in/off test under 1000 times. Charger CIH418-01...
  • Page 17 Charging Contacts USB Charging Port CIH418-01...

  • Page 18: Body Patch

    Body Patch Front Exterior (with pocket closed) Contact Point Material Made from Nonwoven CIH418-01...

  • Page 19: Sensor Holder & Cable

    Sensor Holder & Cable Front Sensor Connectors Material Made from Polydefin Foam Cable Connector CIH418-01...
  • Page 20 Back Electrode Connectors IMPORTANT: If any damage to the wire shielding is found on the holder, replace immediately. CIH418-01...

  • Page 21: 12-Unit Charger (Charging 12 Sensors At The Same Time)

    12-unit Charger (Charging 12 sensors at the same time) Specification: Charging indicator LED on Sensor 5 ~ 35⁰C (Sensor working temp is 5 ~ Working temp 35⁰C when it is charging) -20 ~ 60⁰C Storage temp Input 12V/2A Size 241.3 mm * 166.4 mm * 66.25 mm ⚫...

  • Page 22: Product Requirements

    Product Requirements In order to properly use the QOCA 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 8.x or above and a display resolution of 1920x1080 or 2560x1440) •...

  • Page 23: Before You Start

    BEFORE YOU START Before you start using the QOCA PORTABLE ECG MONITORING DEVICE you must: Charge the battery on the Sensor Install the QOCA ecg APP on your Android smartphone Enable Bluetooth on your smartphone Charging the Battery Sensor Adapter Charger CIH418-01...

  • Page 24: Installing The App

    To charge the battery: 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. AC adaptor part is not included in the package. Please must use compatible AC adaptor.

  • Page 25: Getting Started

    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: Pair your smartphone to the ECG sensor via Bluetooth Wear the QOCA PORTABLE ECG MONITORING DEVICE Pairing After creating a profile, please enter the pairing page.

  • Page 26: Wearing The Ecg Sensor

    NOTE: If pairing within the QOCA ecg APP fails, please check the Bluetooth status on the smartphone. Wearing the ECG Sensor Depending on the model you have purchased, you may either wear the ECG sensor using the provided body patch, or wear the ECG sensor with the sensor holder.

  • Page 27: Wearing The Sensor Holder

    Wearing the sensor holder To wear the ECG sensor directly on your body, follow the directions below: 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.
  • Page 28 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). NOTE: Once connected, the status indicator on the sensor will light green then slowly flash indicating that the sensor is connected to the holder but that the holder has not properly made contact with a body.
  • Page 29 Adhere the electrode attached to the cable to the area under your right collarbone (see image below). Once the ECG sensor is properly positioned on your body, wait half a minute then check the QOCA ecg APP to see if a real-time ECG reading is shown on the main screen on the app.

  • Page 30: Removing The Ecg Sensor From The Holder

    WARNING: When wearing the ECG sensor directly on your body, ensure that all 3 electrodes are firmly adhered to your body. Ensure that no parts of the sensor holder are dangling (as shown below), which can lead to damage or cause the device to short-circuit if the electrodes comes into contact with the electrical contacts on another powered device.

  • Page 31: Wearing The Body Patch

    Wearing the body patch The following steps describe the body patch wearing process: A. Preparing the Skin Step 1: Remove all hair over sternal area by shaving close to the skin. Do not merely clip hair. The prepared area should extend 2 inches past where the sensor will be placed.
  • Page 32 B. Wearing the body patch Step 3: The left hand is naturally placed downwards. Step 4: Attach the ECG sensor on Body Patch. And adhere the body patch under clavicle near the center with angle 45º ~ 60 º as shown. Step 5: Hand pressure on the body patch (especially on the connect point) for at least 30 seconds.
  • Page 33 IMPORTANT: Able to engage in daily activities, do not do strenuous exercise, or swimming. IMPORTANT: The Patch needs 24 hours to fully stick to your skin, we recommend showering briefly with your back to the water, and avoid any activities that cause sweating during this period.

  • Page 34: The Qoca Ecg App

    THE QOCA ECG APP Main Screen Once you have successfully launched and worn the ECG sensor, the QOCA ecg APP’s main screen will display on your mobile device. The main screen (as below figure) displays ECG records which should be shown to a medical professional for evaluation.

  • Page 35: Take A Measurement

    Take a Measurement When you tap the + button in the QOCA ecg APP’s main screen, a measurement page will appear on the screen. It will show real time ECG waveform in the middle of screen. Real time ECG waveform Measuring button CIH418-01...
  • Page 36 Once you tap the measuring button, it will start taking ECG measurement for 2 minutes. And you could see the countdown time bar is counting. Countdown time bar CIH418-01...

  • Page 37: Check The Device And User Information

    NOTE: When the Bluetooth is disconnected, it would show the BT disconnected message below. NOTE: When the ECG sensor is worn inappropriately, it would show the lead off message below. Check the Device and User Information When you tap the Human figure button in the top-left corner of QOCA ecg APP’s main screen, a device and user information page will appear on the screen.

  • Page 38: Measuring Ecg When Bluetooth Is Disconnected

    Measuring ECG when Bluetooth is Disconnected The device is designed with embedded storage so that after initial setup is complete if the Bluetooth connection between the sensor and the smartphone is disconnected, the ECG data will still be stored in the device’s embedded storage.
  • Page 39 You can also retrieve the ECG data stored in the device’s embedded storage by physically connecting the sensor directly to the PC using the Micro-USB cable included in the package. Blow is ECG data stored in the device. CIH418-01...

  • Page 40: Additional Information

    ADDITIONAL INFORMATION LED Indicators The following tables describe the indicators on both the sensor and charger: Sensor Status Indicator Event Action Behavior • Both Battery LED Press power & Indicator LED Power on button flashing green 3 times • Solid blue light for both Battery LED Long press and Indicator LED...
  • Page 41 • Indicator LED User do not Lead off flashing orange wear device light When it’s lead Event • on and press Indicator LED Recording power button flashing blue light • Battery LED Low battery N/A flashing orange light • Battery LED Charging Put on charger flashing blue light...

  • Page 42: Cleaning

    Cleaning The table below describes the appropriate cleaning methods for each item included with the QOCA PORTABLE ECG MONITORING DEVICE: Item Cleaning Method Wipe with a dry cloth when it’s Sensor dirty. And clean it every day if it is frequently used. Wipe with a dry cloth when it’s Charger dirty.

  • Page 43: Ecg Electrode Information

    ECG Electrode Information When using the Sensor Holder for the QOCA 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 44: Specifications

    Specifications Sensor Specifications Continuous ECG data acquisition and calculation Measuring Lead: Lead 2 Frequency Response: Monitor 0.05 to 40 Hz (-3db) Heart rate measurement range*: 30 – 240 bpm** Heart rate accuracy: ± 3 bpm or ±3% whichever is greater ECG Sensor Differential Input Impedance: >...
  • Page 45 Bluetooth BLE 5.0: Transmit Data distance: 10 meters (open Transmission space) Micro USB cable USB2.0 Battery 3.8V/340mAh Storage mode: 14 Days or 5 Days Battery Life @ 256Hz Sample rate Working 5 – 45⁰C, 10% – 95% non- Temperature / condensing Humidity Storage...

  • Page 46: Charger Specifications

    35(L) x 35(W) x 8.85(H) ±0.2 (mm) Dimension for ecg103 Charger Specifications Input 5V/0.5A Working 5 – 35°C Temperature Storage -20 – 60°C Temperature Weight 22 ± 0.5 g 42 mm (L) x 40.0 mm (W) x 12.0 Dimension mm (H) ±0.2 mm Troubleshooting Cannot pair the QOCA PORTABLE ECG MONITORING DEVICE with the QOCA ecg APP.

  • Page 47: Gateway Compatible Specifications

    different ECG-sensors to server at the same time. The Gateway part is not included in the package. You must use compatible gateway device for the multi-ECG-sensors to work properly. System setting will allow ECG-sensors (not over 6 sets) to connect gateway data transmission together, or any gateway device that meeting the following specifications: Gateway Compatible Specifications...

  • Page 48: 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: MedicalService@quantatw.com EU Representative EU Representative: MedNet EC-REP GmbH Address: Borkstrasse 10, 48163 Münster, Germany...

  • Page 49: Federal Communications Commission (Fcc) Statement

    Federal Communications Commission (FCC) Statement The FCC ID is HFSCIH 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. Operation is subject to the following two conditions: This device may not cause interference and This device must accept any interference, including...
  • Page 50 accordance with the instructions, may 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:...

  • Page 51: Regulatory Marks

    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.
  • Page 52 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 body 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...
  • Page 53 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...

  • Page 54: Supplier's Declaration

    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. Manufacturer’s declaration-electromagnetic emissions The ecg103 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
  • Page 55 RF emissions Class B The ecg103 is suitable for CISPR 11 use in all establishments, including domestic Harmonic establishments and those emissions Class A directly connected to the IEC 61000-3-2 public low-voltage power Voltage supply network that fluctuations Compliance supplies buildings used for /flicker domestic purposes.
  • Page 56 Manufacturer’s declaration-electromagnetic immunity The ecg103 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the ecg103 should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic test...
  • Page 57 IEC 61000- + 1kV for home healthcare input/ applicable environment. output lines Surge + 0.5kV, + 0.5kV, Mains power +1kV +1kV quality should be line(s) to line(s) to that of a typical IEC 61000- line(s) line(s) Not home healthcare applicable environment.
  • Page 58 Power 30 A/m 30 A/m The ecg103 power frequency(5 frequency magnetic 50 Hz or 60 50 Hz 0, 60 Hz) fields should be at magnetic levels characteristic of field a typical location in a typical home IEC 61000- healthcare environment. NOTE UT is the a.c.
  • Page 59 Manufacturer’s declaration-electromagnetic immunity The ecg103 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the ecg103 should assure that it is used in such and environment. Immunity IEC 60601 Compliance Electromagnetic test...
  • Page 60 applicable to the radio frequency of the bands transmitter. between 80 % AM at 1 0,15 MHz and 80 MHz Recommended 10 V/m separation Radiated distance: 80 MHz – 2,7 80 % d = 1,2 √P AM at 1 IEC 61000- 80 % AM at 1 d = 1,2 √P 80MHz to 800...
  • Page 61 recommended separation distance in metres (m). Interference may occur in the vicinity of equipment marked with the following symbol: NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 62 The ecg103 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 ecg103 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ecg103 as recommended below, according to the maximum output power of the...
  • Page 63 power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 64 interference in nearby electronic equipment. RF emissions Class B The ecg103 is suitable for CISPR 11 use in all establishments, including domestic Harmonic establishments and those emissions directly connected to the Class A IEC 61000-3-2 public low-voltage power supply network that supplies Voltage buildings used for domestic purposes.

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