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Quanta Computer QOCA ECG User Manual

Portable ecg monitoring device
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QOCA PORTABLE ECG MONITORING DEVICE
User Manual
CI9418-01 Ver.: 3A

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Summary of Contents for Quanta Computer QOCA ECG

  • Page 1 QOCA PORTABLE ECG MONITORING DEVICE User Manual CI9418-01 Ver.: 3A...
  • Page 2 TABLE OF CONTENTS Safety Notes ............... 4 Product Overview ............ 10 Indication for Use ............10 Package Contents ............. 11 Components .............. 12 Sensor (ecg901) ............12 Charger(CR6P) ............13 Body Patch (ecg901-P1) ..........14 Product Requirements ..........17 Before You Start ............18 Charging the Battery..........
  • Page 3 The QOCA ecg APP ..........32 Main Screen ............... 32 Event record .............. 34 Check the Device Information ......... 34 Additional Information ..........37 LED Indicators ............37 Sensor Status Indicator ..........37 Cleaning ..............39 Specifications ............40 Sensor Specifications ..........40 Charger Specifications..........
  • Page 4 Regulatory Marks ............47 Supplier’s Declaration ..........51 CI9418-01...
  • Page 5 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 If using another other electronic device is necessary, please make sure the QOCA PORTABLE ECG MONITORING DEVICE continues to take measurements normally. See The QOCA ecg APP to see how to do device test. • Do not use the QOCA PORTABLE ECG MONITORING DEVICE near open flames or in excessive heat.
  • Page 7 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 QOCA PORTABLE ECG MONITORING DEVICE.
  • Page 8 • The ECG sensor should be cleaned before providing to another patient. Please follow the cleaning instruction in this manual. Do not clean the QOCA PORTABLE ECG MONITORING DEVICE with corrosive or abrasive cleaning agents. • The QOCA PORTABLE ECG MONITORING DEVICE and its accessories should be disposed of properly.
  • Page 9 • Do not use QOCA PORTABLE ECG MONITORING DEVICE in MRI or X-ray room. • This device should not be used adjacent to or stacked with other equipment. • Please do not use any other cables or accessories not approved by the manufacturer in this manual to avoid negative influence on electromagnetic compatibility.
  • Page 10 • Tear open the body patch bag only when it is time to wear the body patch. Once the body patch bag is opened, wear the body patch as soon as possible. • Re-use of the body patch will decrease its adhesion and cause incorrect ECG and heart rate measurement.
  • Page 11 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.
  • Page 12 Package Contents Component Model Quantity Sensor ecg901 Charger* CR6P USB charging cable* Body patch* ecg901-P1 1 set Main patch ecg901-P1a Chest lead ecg901-P1b patch Sensor cable ecg901-P1c2 ecg901-P1c4 ecg901-P1c5 Abrader disc* *The items marked with * are optional. Contact manufacturer for procurement.
  • Page 13 Components Sensor (ecg901) Power button Indicator LED Battery LED Charging Holder contacts contacts CI9418-01...
  • Page 14 Charger(CR6P) Charging contacts USB-C charging port CI9418-01...
  • Page 15 Body Patch (ecg901-P1) Main patch (ecg901-P1a) Material：Nonwoven Holder Cable Cable contacts connector connect Cable connector CI9418-01...
  • Page 16 Chest lead patch (ecg901-P1b) Material：Nonwoven Cable connector CI9418-01...
  • Page 17 Sensor cable (ecg901-P1c2/ ecg901-P1c4/ ecg901-P1c5) Patch connector Patch connector *Note: Please follow the table below to connect the right sensor cable to the chest leads. Lead Model ecg901-P1c2 ecg901-P1c4 ecg901-P1c5 Connector yellow blue orange color CI9418-01...
  • Page 18 Android Smartphone* with Android version 10 or above, BT5.0 or above, and a display resolution of 1920x1080 or above. • iPhone* with iOS 13.0 (or above) • The QOCA ecg APP * * Items not included in the product package. CI9418-01...
  • Page 19 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 smartphone Enable Bluetooth on your smartphone Charging the Battery Sensor Adapter Charger...
  • Page 20 This indicates that the battery is fully charged. Installing the App To install the app, search for and download “QOCA ecg APP” on Google Play Store or Apple Store. NOTE: In order to install the QOCA ecg APP, your smartphone will need at least 5MB of storage capacity available.
  • Page 21 MONITORING DEVICE by following these steps: Pair your smartphone to the QOCA PORTABLE ECG MONITORING DEVICE via Bluetooth Wear the QOCA PORTABLE ECG MONITORING DEVICE Pairing Launch the QOCA ecg App and choose sensor type to pair the sensor to your smartphone: CI9418-01...
  • Page 22 After selecting CI9 (9-lead), it would show the nearby CI9 devices. Please select the name “CI9XSXXXXXXX” which is the same as serial number on the back of sensor. After selecting the device number, the App will pop out message requesting to press power button on CI9 within 10 seconds (the LED on CI9 will flash blue in the meantime).
  • Page 23 Note: At this moment the sensor is not yet applied to the body. Once your fingers are released from the sensor, the QOCA ecg app should pop up lead-off notification on the screen. This notification will go off once the sensor is worn on body.
  • Page 24 Wearing the ECG Sensor IMPORTANT: ⚫ Tear open the body patch bag only when it is time to wear the body patch. Once the body patch bag is opened, wear the body patch as soon as possible. ⚫ The body patch is a single-use part. ⚫...
  • Page 25 ⚫ Do not apply any lotion or skin care products on applied area. ⚫ Remove the body patch with cautions and do not damage the skin. If the skin at the contact point develops a rash, blisters, reddening, or other irritation, please contact a medical professional or physician.
  • Page 26 （2）. Connect main patch and chest lead patch with the sensor cable. V2(yellow)/V4(blue)/V5(orange) （3）. If the sensor is powered off, press the power button until the LEDs flashes green and then release the button (After powered on, the LED “ ”will keep flashing orange until the patch is well attached to user body.
  • Page 27 Step 2. Prepare the skin of applied area （1）. Confirm the applied main patch area. A. Point the main patch label arrow up towards the collarbone junction. B. Make sure ECG heart mark tip point down right side. CI9418-01...
  • Page 28 Confirm the applied chest lead area (V2/V4/V5 illustrated as follows.) Chest Lead location Fourth intercostal space at the left sternal border Fifth intercostal space in the midclavicular line Left anterior axillary line on the same horizontal plane as V4. （2）. Remove body hair in the area of patch placement. CI9418-01...
  • Page 29 （3）. Use abrader disc to clean the skin first (horizontal by 10 times and vertical by 10 times) and alcohol pad cleaning. Allow site to dry. Note: If necessary, medical personnel may adjust chest lead area to fit different body shape or skin condition. CI9418-01...
  • Page 30 Step 3. Place body patch （1）. Remove the right release paper. Do not touch the stick area. （2）. Point the main patch label arrow up towards the collarbone junction. User’s arms are placed on the side. Press the central area to stick the patch on body (avoid pressing the power button) （3）.
  • Page 31 （4）. Remove the release paper of chest lead patch. Point the red positioning dot to the chest lead appointed by the physician. CI9418-01...
  • Page 32 （5）. Press and stick the patch on chest lead area. （6）. After completing the steps above, the event LED “ ” will flash blue 5 times and then distinguish. Step 4. Hand pressure on both main and chest lead patch (especially on the connect point) for 30 seconds.
  • Page 33 Main Screen Once you have successfully launched and worn the ECG sensor, the QOCA ecg APP’s main screen will display on your mobile phone. The main screen (shown below) displays ECG records which should be shown to a medical professional for evaluation.
  • Page 34 NOTE: When the Bluetooth is disconnected, it would show the BT disconnected message in blue box below. NOTE: When the ECG sensor is worn inappropriately, it would show the lead off message in orange box below. CI9418-01...
  • Page 35 The recorded event will be saved in the sensor as well as in the QOCA ecg app. You can find the recorded event in the main screen.
  • Page 36 Chest lead : V2/V4/V5 are set and cannot be changed. Event duration: Options include 30 seconds/1 min/2 mins/5 mins (default setting is 30 secs) Device Test: You can see real-time waveform with this option, but the waveform will not be saved to App. Replace ECG device: You can change ECG device by using this option.
  • Page 37 Erase all records and settings: You can unpair the sensor from the mobile phone by using this option. All data will be erased from the App. Note: To preserve battery energy, turn off the App after completing event record or setting changes. CI9418-01...
  • Page 38 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 & Indicator LED keep flashing and then extinguish Press power Power on when power on is button done.
  • Page 39 while press the button • After 5 seconds turn off lights • Indicator LED User do not Lead off flashing orange wear device light • When it’s lead Indicator & battery Event on and press LEDs flashing Recording power button blue light •...
  • Page 40 • Plug sensor to Indicator LED with connected solid blue light 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.
  • Page 41 Specifications Sensor Specifications Item Spec Continuous ECG data acquisition and Measuring Lead: lead I, II, III, aVR, calculation aVL, aVF, V2, V4, V5 Frequency Response: Monitor 0.05 to ECG Sensor Heart rate measurement range*: 30 – 40 Hz (-3db) Heart rate accuracy: ± 3 bpm or ±3% 240 bpm** Differential Input Impedance: >...
  • Page 42 Working 5 – 45⁰C, 10% – 95% non-condensing Temperature / Humidity Storage & -20 – 60⁰C, 10% – 95% non- transportation condensing Temperature / Humidity Atmospheric 800 hPa to 1013 hPa Altitude 2000m Pressure Range Enclosure IP26 Material flame PC+ABS, UL94V2 Rating Weight 19.7±...
  • Page 43 Body Patch Specifications Dimension 134.72 x 112.23 ±0.2 mm 50.8 x 69.5 ±0.2 mm Weight 43.3g 1 – 30°C, 10% – 95% non- Storage & transportation condensing Temperature/humidity Troubleshooting Make sure the Bluetooth function of your mobile phone is enabled. If the problem is not resolved, contact manufacturer for assistance.
  • Page 44 5 minutes, remove the body patch and prepare the skin again. If the device cannot connect to QOCA ecg App, make sure the Bluetooth of the smart phone is enabled. If there is still no connection, restart the App or the device to build up the connection again.
  • Page 45 Storage Ethernet 10/100/1000M Connectivity Up to 6 ECG sensor devices The gateway mode is designed to collect multi-ECG-sensors data information only. CI9418-01...
  • Page 46 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: QOCA@quantatw.com EU Representative EU Representative: MedNet EC-REP GmbH Address: Borkstrasse 10, 48163 Münster, Germany...
  • Page 47 The FCC ID is HFSCI9 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: This device may not cause interference and This device must accept any interference, including...
  • Page 48 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.
  • Page 49 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 50 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 51 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 52 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 ecg901 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
  • Page 53 RF emissions Group 1 The ecg901 uses CISPR 11 RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B The ecg901 is CISPR 11 suitable for use in all establishments,...
  • Page 54 Bluetooth Technical Specification: Technical Value Specification Operating 2402~2480MHz Frequencies Channel Spacing 2MHz Channel number Operating Voltage 1.8V Modulation GFSK Antenna Gain FPC Antenna, Peak Gain: -1.74 dBi Rated Power (EIRP) 4.03dBm Manufacturer’s declaration-electromagnetic immunity The ecg901 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
  • Page 55 The customer or the user of the ecg901 should assure that it is used in such an environment. Immunity Complianc Electromagnetic test 60601 e level environment- guidance (for test home and level professional healthcare environment) Electrostat Contact Contact: Floors should be ±8 kV wood, concrete :±8 kV...
  • Page 56 + 1kV for home healthcare 61000-4-4 input/ applicabl environment. output lines Surge + 0.5 + 0.5 kV, Mains power kV, +1 +1 kV quality should be line(s) to that of a typical line(s) line(s) home and 61000-4-5 professional line(s) healthcare environment.
  • Page 57 Voltage Voltag Voltage Mains power Dips, e dips: dips: quality should be short that of a typical interruptio home and 0 % UT; ns and professional 0,5 cycle voltage healthcare 0 % UT; variations environment. If the cycle 1 cycle on power user of the ecg901 70 % UT;...
  • Page 58 0 % U 250/300 cycle Power 30 A/m 30 A/m The ecg901 power frequency( frequency 50, 60 Hz) magnetic fields 50 Hz or 60 Hz magnetic should be at levels 60 Hz field characteristic of a typical location in a typical home and 61000-4-8 professional...
  • Page 59 NOTE UT is the a.c. mains voltage prior to application of the test level. CI9418-01...
  • Page 60 Manufacturer’s declaration-electromagnetic immunity The ecg901 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the ecg901 should assure that it is used in such and environment. Immunity Compliance Electromagnetic test 60601...
  • Page 61 separation radio 0,15 MHz bands and 80 MHz distance calculated from between the equation applicable to the 0,15 frequency of the 80 % AM at transmitter. and 80 1 kHz 10 V/m Radiated 80 % Recommended AM at 1 80 MHz – separation distance: 2,7 GHz...
  • Page 62 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Interference may occur in the vicinity of equipment marked with the following symbol: CI9418-01...
  • Page 63 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. Recommended separation distance between portable and mobile RF communications equipment and the ecg901 The ecg901 is intended for use in an electromagnetic environment (for home and professional healthcare) in...
  • Page 64 Rated Separation distance according to maximum frequency of transmitter (m) output 150 kHz 80 MHz to 800 MHz to power of to 80 800 MHz 2,7 GHz transmitter d =1,2√P d =2,3√P d =1,2√P 0,01 0,12 0,12 0,23 0,38 0,38 0,73 For transmitters rated at a maximum output power not listed above, the recommended separation distance d...
  • Page 65 affected by absorption and reflection from structures, objects and people. Manufacturer’s declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The ecg901 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
  • Page 66 Compli ance IMMUN LEVEL Test Maxim Dista (V/m) freque Servic Modula TEST (for (MHz tion power LEVEL home (MHz) (V/m) professio Pulse healthcar TETRA modulat –390 ion b) 18 Hz FM c) GMRS ±5 kHz 460, – deviatio 1 kHz sine Pulse Band...
  • Page 67 1 720 1800; iDEN 1,70 820, Pulse 0 – CDMA modulat 1 845 850, ion b) 217 Hz Band 5 1 970 Blueto oth, Pulse WLAN, 00 – modulat 802.11 2 450 ion b) b/g/n, 217 Hz RFID Band 2450, 1, 3, Band 7 5 240...
  • Page 68 For some services, only the uplink frequencies are included. The carrier shall be modulated using a 50 % duty cycle square wave signal. As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
  • Page 69 Manufacturer’s declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to proximity magnetic fields The ecg901 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the ecg901 should assure that it is used in such an environment.
  • Page 70 photo below Pulse modulation points 134,2 kHz 65 (c) photo below 2,1 kHz Pulse modulation points 13,56 MHz 7,5 (c) photo below 50 kHz Note: (a) This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME AND PROFESSIONAL HEALTHCARE ENVIRONMENT.
  • Page 71 CI9418-01...