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CIH418-01

anufacturer’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

test

IEC 60601

test level

Compliance

level

Electromagnetic

environment-
guidance (for

home and

professional

healthcare

environment)

Conducted
RF

IEC 61000-
4-6

3 Vrms:

0,15 MHz –

80 MHz

6 Vrms:

in ISM
and
amateur

3 Vrms:

0,15 MHz – 80

MHz

6 Vrms:

in ISM and

amateur

radio bands

between

0,15 MHz and
80 MHz

Portable and

mobile RF

communications

equipment

should be used

no closer to any

part of the

ecg103

including cables,

than the

recommended

separation

distance

calculated from the

equation

Содержание ecg103-K1

Страница 1: ...QOCA PORTABLE ECG MONITORING DEVICE User Manual CIH418 01 Ver 2B ...

Страница 2: ...0 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 20 Product Requirements 21 Before You Start 22 Charging the Battery 22 Installing the App 23 Enabling Bluetooth 23 ...

Страница 3: ...lder 29 Wearing the body patch 30 The QOCA ecg APP 33 Main Screen 33 Take a Measurement 34 Check the Device and User Information 36 Measuring ECG when Bluetooth is Disconnected 37 Additional Information 39 LED Indicators 39 Sensor Status Indicator 39 Cleaning 41 ECG Electrode Information 42 Specifications 43 Sensor Specifications 43 ...

Страница 4: ...roubleshooting 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 ...

Страница 5: ...th its specified accessories and electrodes The use of accessories and electrodes from other brands can damage the device or cause inaccurate readings For more information see Product Requirements Do not allow the connectors or contacts on the devices to come into contact with any kind of power source during use Damaged or faulty accessories and electrodes should not be used When the QOCA PORTABLE...

Страница 6: ...essary please check to ensure the ECG is continuing to take measurements normally See The QOCA ecg APP to see how to check if the device taking measurements normally Do not use the QOCA PORTABLE ECG MONITORING DEVICE near open flames or in excessive heat When ambient temperature is 104 F 113 F 40 45 C do not use the QOCA PORTABLE ECG MONITORING DEVICE because it may cause low temperature burns Use...

Страница 7: ...ct 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 If QOCA PORTABLE ECG MONITORING DEVICE must be used to take measurements over an extended period of time pleas...

Страница 8: ...e measurements Do not expose QOCA PORTABLE ECG MONITORING DEVICE to extreme temperatures extremely moist environments dust or direct sunlight 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 Disposal of the device and its accessories should comply with the relev...

Страница 9: ...A PORTABLE ECG MONITORING DEVICE is 2 years People with sensitive skin or with known skin conditions should use the QOCA PORTABLE ECG MONITORING DEVICE with caution If irritation such as redness severe itching or allergic symptoms i e hives develop instruct patients to remove the QOCA PORTABLE ECG MONITORING DEVICE immediately and have them contact their physician Do not use ECG sensor on patients...

Страница 10: ...ith 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 For procedures that require the use of high frequency surgical equipment QOCA PORTABLE ECG MONITORING DEVICE should be removed beforehand Avoid using heavy electronic equipment or other sources of el...

Страница 11: ... data will be transferred to a smartphone via Bluetooth and displayed on the smartphone screen via a dedicated application called QOCA ecg The data can be further transferred to cloud server for storage The device should be worn on the human body along with a body patch or a sensor holder with gel electrodes The QOCA WEARABLE ECG MONITORING DEVICE is available to professional organizations such as...

Страница 12: ...s 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 ecg103 ECG Sensor x 1 Charger x 1 Protection bag x 1 ...

Страница 13: ... 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 DEVICE ecg103 Charger ecg103 C1 USB Charging Cable NA Sensor Holder ecg103 P5 ...

Страница 14: ...CIH418 01 13 Body Patch ecg103 P1 Components Sensor Front 1 2 3 ...

Страница 15: ...CIH418 01 14 1 Power Button 2 Battery LED see LED Indicators for more information 3 Indicator LED see LED Indicators for more information Back 1 Charging Contacts 2 Holder Connectors 1 2 3 ...

Страница 16: ...CIH418 01 15 3 Laser Printing Area NOTE Electrode button connector will support plug in off test under 1000 times Charger 1 2 ...

Страница 17: ...CIH418 01 16 1 Charging Contacts 2 USB Charging Port ...

Страница 18: ...CIH418 01 17 Body Patch Front Exterior with pocket closed 1 Gel 2 Contact Point Material Made from Nonwoven 1 2 ...

Страница 19: ...CIH418 01 18 Sensor Holder Cable Front 1 Sensor Connectors Material Made from Polydefin Foam 2 Cable Connector 1 2 ...

Страница 20: ...CIH418 01 19 Back 1 Electrode Connectors IMPORTANT If any damage to the wire shielding is found on the holder replace immediately 1 1 ...

Страница 21: ...e same time Specification Charging indicator LED on Sensor Working temp 5 35 C Sensor working temp is 5 35 C when it is charging Storage temp 20 60 C 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 ...

Страница 22: ...d a display resolution of 1920x1080 or 2560x1440 The QOCA ecg APP Items not included in the product package For Sensor Holder Cable The ECG Sensor The Sensor Holder Cable 3 ECG Electrodes NOTE For more information on electrode specifications see ECG Electrode Information A Bluetooth enabled Android Smartphone with Android version 8 x or above and a display resolution of 1920x1080 or 2560x1440 The ...

Страница 23: ...e you start using the QOCA PORTABLE ECG MONITORING DEVICE you must 1 Charge the battery on the Sensor 2 Install the QOCA ecg APP on your Android smartphone 3 Enable Bluetooth on your smartphone Charging the Battery Adapter Sensor Charger ...

Страница 24: ...at the sensor snaps into the charger and the charging contacts on both the sensor and charger make contact 3 Allow the sensor to charge until the charging indicator light on the charger shows solid green 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 NOTE In order to install the QOCA ecg APP your smar...

Страница 25: ... PORTABLE ECG MONITORING DEVICE 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 CIHXSXXXXXXX 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 ...

Страница 26: ...provided body patch or wear the ECG sensor with the sensor holder IMPORTANT When wearing the ECG sensor directly you must use compatible electrodes sold separately for the device to work properly For more information on electrode specifications see ECG Electrode Information IMPORTANT If the skin at the contact point develops a rash blisters reddening or other irritation please contact a medical pr...

Страница 27: ...e 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 2 ECG Electrode Information ...

Страница 28: ...n slowly flash indicating that the sensor is connected to the holder but that the holder has not properly made contact with a body 4 Remove the paper backing on the contact side of each of the ECG electrodes 5 Adhere the 2 electrodes located near the sensor under your left pectoral area see image below NOTE The electrodes feature adhesive on the contact side to ensure secure contact with your body...

Страница 29: ...ght collarbone see image below 7 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 If a real time ECG is shown on the app the ECG sensor has been properly worn ...

Страница 30: ...ad to damage or cause the device to short circuit if the electrodes comes into contact with the electrical contacts on another powered device Removing the ECG Sensor from the Holder When removing the ECG sensor from the holder always remove the sensor by holding the sensor and gently detaching it from the sensor holder as shown below WARNING Never remove the sensor by pulling the cable This can da...

Страница 31: ... the skin Do not merely clip hair The prepared area should extend 2 inches past where the sensor will be placed Step 2 Use all prep pads provided in the box Shown as below figure to clean area shown SCRUB the skin with the prep pads until they appear clean after use Skin should be scrubbed well enough to be slightly reddened Allow the skin to dry for 1 minute prior to applying ...

Страница 32: ...and 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 ...

Страница 33: ...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 Skin exfoliation will help the contact of patch ...

Страница 34: ...ed 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 1 Enable ECG measuring 2 Record List list ECG 3 Device and User Info ...

Страница 35: ...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 1 Measuring button 2 Real time ECG waveform ...

Страница 36: ...CIH418 01 35 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 1 Countdown time bar ...

Страница 37: ...ensor 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 It will show the detailed user profile and device information ...

Страница 38: ...tup 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 In these situations once the Bluetooth connection is restored the ECG data will be automatically transferred to your smartphone and displayed in the History screen ...

Страница 39: ...ou 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 ...

Страница 40: ...e sensor and charger Sensor Status Indicator Event Action Behavior Power on Press power button Both Battery LED Indicator LED flashing green 3 times Power off Long press power button for 5 seconds Solid blue light for both Battery LED and Indicator LED while press the button After 5 seconds turn off lights ...

Страница 41: ... it s lead on and press power button Indicator LED flashing blue light Low battery N A Battery LED flashing orange light Charging Put on charger Battery LED flashing blue light Fully charged Put on charger Battery LED solid blue light USB connected Plug sensor to USB Indicator LED with solid blue light ...

Страница 42: ...ONITORING DEVICE Item Cleaning Method Sensor Wipe with a dry cloth when it s dirty And clean it every day if it is frequently used Charger Wipe with a dry cloth when it s dirty And clean it every day if it is frequently used Sensor holder Carefully wipe with a dry cloth when it s dirty And clean it every day if it is frequently used ...

Страница 43: ...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 Adapter Stud Biocompatibility ISO 10993 approved Latex free CE Mark according to MDD 93 42 EEC CE Marked FDA certified ...

Страница 44: ...ate 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 If the heart rate falls out of the 30 240 bpm range the QOCA ecg APP will display Energy Expenditure Calculated from HR and activity data Lead off Detection Detect when the sensor gets loosened ...

Страница 45: ...V 340mAh Battery Life Storage mode 14 Days or 5 Days 256Hz Sample rate Working Temperature Humidity 5 45 C 10 95 non condensing Storage Temperature Humidity 20 60 C 10 95 non condensing Atmospheric Pressure Range 800 hPa to 1013 hPa Altitude 2000m Enclosure Rating IP26 Material flame retardant PC ABS UL94V2 Weight 19 g for ecg103 ...

Страница 46: ...age Temperature 20 60 C Weight 22 0 5 g Dimension 42 mm L x 40 0 mm W x 12 0 mm H 0 2 mm Troubleshooting 1 Cannot pair the QOCA PORTABLE ECG MONITORING DEVICE with the QOCA ecg APP Refer to the notes listed in Pairing Gateway mode information When using QOCA PORTABLE ECG MONITORING DEVICE the data needs to be transmitted from many ...

Страница 47: ...etting 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 Blue tooth BT 4 2 above WIFI 2 4GHz 5GHz 802 11 a b g n ac Storage 4GB Ethernet 10 100 1000M Connectivity Up to 6 ECG sensor devices The gateway mode is designed to collect multi ECG sensors data information on...

Страница 48: ...port 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 Label Information ...

Страница 49: ...llowing two conditions 1 This device may not cause interference and 2 This device must accept any interference including interference that may cause undesired operation of the device 15 105 b This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful ...

Страница 50: ...ing measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help FCC RF Radiation Exposure Statement 1 This Transmitter must not be co located or operating in conjunction with any...

Страница 51: ... characteristic as well as performance to an approved low power radio frequency devices Article 14 The low power radio frequency devices shall not influence aircraft security and interfere with legal communications If found the user shall cease operation immediately until no interference is achieved The said legal communications means radio communications is operated in compliance with the Telecom...

Страница 52: ...ces 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 reference number or reorder number Indicates the manufacture s serial number ...

Страница 53: ...he 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 IP26 Protected against solid objects down to 12mm Protection against low pressure jets of water limited ingress permitted ...

Страница 54: ...or 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 Emission test Compliance Electromagnetic environment guidance for home and professional healthcare environment RF emissions CISPR 11 Group 1 The ecg103 uses RF energy only for its internal function Therefore its R...

Страница 55: ...FPC Antenna Peak Gain 1 52 dBi Rated Power ERP 0 66 dBm RF emissions CISPR 11 Class B The ecg103 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Compli...

Страница 56: ...test level Compliance level Electromagnetic environment guidance for home and professional healthcare environment Electrostatic discharge ESD IEC 61000 4 2 Contact 8 kV Air 2 kV 4 kV 8 kV 15 kV Contact 8 kV Air 2 kV 4 kV 8 kV 15 kV Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst...

Страница 57: ...ons and voltage variations on power supply input lines IEC 61000 4 11 Voltage dips 0 UT 0 5 cycle 0 UT 1 cycle 70 UT 25 30 cycles Voltage interruptions 0 UT 250 300 cycle Voltage dips 0 UT 0 5 cycle 0 UT 1 cycle 70 UT 25 cycles Voltage interruptions 0 UT 250 cycle Mains power quality should be that of a typical home healthcare environment If the user of the ecg103 requires continued operation duri...

Страница 58: ... 61000 4 8 30 A m 50 Hz or 60 Hz 30 A m 50 Hz The ecg103 power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment NOTE UT is the a c mains voltage prior to application of the test level ...

Страница 59: ...ity test IEC 60601 test level Compliance level Electromagnetic environment guidance for home and professional healthcare environment Conducted RF IEC 61000 4 6 3 Vrms 0 15 MHz 80 MHz 6 Vrms in ISM and amateur 3 Vrms 0 15 MHz 80 MHz 6 Vrms in ISM and amateur radio bands between 0 15 MHz and 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the ecg103 inc...

Страница 60: ...t 1 kHz 80 AM at 1 kHz 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80MHz to 800 MHz d 2 3 P 800MHz to 2 7 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the ...

Страница 61: ...ng 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 Recommended separation distance between portable and mobile RF communications equipment and the ecg103 ...

Страница 62: ...mmended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not...

Страница 63: ... people Manufacturer s declaration electromagnetic emissions 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 Emission test Compliance Electromagnetic environment guidance for home and professional healthcare environment RF emissions CISP...

Страница 64: ...uitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Compliance ...

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