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CIB418-01

Lead off

User do not
wear device

•

Indicator LED
flashing orange
light

Event
Recording

When 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

Summary of Contents for QOCA

Page 1: ...QOCA PORTABLE ECG MONITORING DEVICE User Manual ...

Page 2: ...n for Use 11 Package Contents 12 Product Configurations 14 Components 15 Sensor 15 Charger 17 Body Patch 18 Sensor Holder Cable 19 12 unit Charger Charging 12 sensors at the same time 21 Product Requirements 22 Before You Start 23 Charging the Battery 23 Installing the App 24 ...

Page 3: ...ting a Profile 25 Pairing 27 Wearing the ECG Sensor 28 Wearing the sensor holder 29 Removing the ECG Sensor from the Holder 32 Wearing the body patch 33 The Q ecg App 35 Main Screen 35 Menu 38 History 39 Profile 45 Pairing 45 Clear Data 45 Setting 46 Quit 46 ...

Page 4: ...Indicator 48 Cleaning 50 ECG Electrode Information 51 Specifications 52 Sensor Specifications 52 Charger Specifications 54 Troubleshooting 54 Gateway mode information 55 Gateway Compatible Specifications 55 Customer Support 57 EU Representative 57 Label Information 57 Federal Communications Commission FCC Statement 58 ...

Page 5: ...CIB418 01 4 Regulatory Marks 60 Supplier s Declaration 63 ...

Page 6: ...h 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 device s 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...

Page 7: ...ecessary please check to ensure the ECG is continuing to take measurements normally See The Q 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 User...

Page 8: ...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...

Page 9: ...the 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 rel...

Page 10: ...e QOCA PORTABLE ECG MONITORING DEVICE is 2 years If you feel very itching or find redness when wearing the body patch remove the body patch immediately 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 avoi...

Page 11: ...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 electromagnetic interference such as electric blankets when using the QOCA PORTABLE ECG MONITORING DEVICE When the ECG signal is always unstable please con...

Page 12: ...e tags to the ECG signals by pressing the button ECG and HR data will be transferred to a smartphone via Bluetooth and displayed on the smartphone screen via a dedicated application called Q 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 PORTABLE ECG MONITORING D...

Page 13: ...hasing the QOCA PORTABLE ECG MONITORING DEVICE please check the product package to ensure that the following items are included Q ecg wu3 product package wu3 ECG Sensor x 1 Charger x 1 Protection bag x 1 USB Charging Cable x 1 User Manual x 1 ...

Page 14: ...CIB418 01 13 Q ecg wu5 product package wu5 ECG Sensor x 1 Charger x 1 Protection bag x 1 USB Charging Cable x 1 User Manual x 1 ...

Page 15: ...CIB418 01 14 Product Configurations The following table lists the sensor related items included in the various packages available for the QOCA Portable ECG Monitoring Device ...

Page 16: ...CIB418 01 15 Components Sensor Front 1 Power Button 2 Battery LED see LED Indicators for more information 3 Indicator LED see LED Indicators for more information 1 2 3 3 ...

Page 17: ...CIB418 01 16 Back 1 Charging Contacts 2 Holder Connectors 3 Label Area NOTE Electrode button connector will support plug in off test under 1000 times 1 2 3 1 2 3 ...

Page 18: ...CIB418 01 17 Charger 1 Charging Contacts 2 USB Charging Port 1 2 1 2 ...

Page 19: ...CIB418 01 18 Body Patch Front Exterior with pocket closed 1 Gel 2 Contact Point Material Made from Nonwoven 2 1 2 ...

Page 20: ...CIB418 01 19 Sensor Holder Cable Front 1 Sensor Connectors Material Made from Polydefin Foam 2 Cable Connector 1 2 ...

Page 21: ...CIB418 01 20 Back 1 Electrode Connectors IMPORTANT If any damage to the wire shielding is found on the holder replace immediately 1 1 1 ...

Page 22: ...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 ...

Page 23: ...1080 or 2560x1440 or iPhone iOS 12 above The ECG Sensor Q 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 5 x or above and a display resolution of 1920x1080 or 2560x1440 or i...

Page 24: ... you start using the QOCA PORTABLE ECG MONITORING DEVICE you must 1 Charge the battery on the Sensor 2 Install the Q ecg app on your Android smartphone 3 Enable Bluetooth on your smartphone Charging the Battery S C Adapter Sensor Charger ...

Page 25: ...so that 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 Q ecg on Google Play Store NOTE In order to install the Q ecg app your smartphon...

Page 26: ...E 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 QOCA PORTABLE ECG MONITORING DEVICE Creating a Profile The first time you launch the Q ecg app you will need to create a profile Fill in the following fields to create your profile ...

Page 27: ... When filling in your resting heart rate you may ask a trained medical professional to measure your resting heart rate or determine your resting heart rate by measuring your heart rate after at least 5 minutes of inactivity Once you have filled in your profile tap Done to continue ...

Page 28: ...LE devices Please select the name CIBXSXXXXXXX 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 NOTE If pairing within the Q ecg app fails as shown below please check the Bluetooth status on the smartphone ...

Page 29: ...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 professional or physician ...

Page 30: ...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 ...

Page 31: ...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...

Page 32: ...ight collarbone see image below 7 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 33: ...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...

Page 34: ...ng 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 ...

Page 35: ...the connect point for 30 seconds 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 ...

Page 36: ... 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 1 2 3 4 5 6 ...

Page 37: ...the profile creation process For more information on changing profile settings see 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 Points on the ...

Page 38: ...attery 5 Conne ction Status Displays the connection status for the ECG sensor If the ECG sensor becomes disconnected while in use see Pairing for instructions on pairing your device 6 Filter mode Select Select Diagnostic mode or Monitor mode NOTE If the Bluetooth connection between the device and your smartphone is disconnected the battery status icon will display a red question mark and the conne...

Page 39: ... sensor in different mode But this feature is not open for user only for special group Please contact us if you need this function Quit Menu When you tap the menu button in the Q ecg app s main screen a menu will appear on the left side of the main screen The menu allows you to view the real time ECG reading view ECG history change profile settings pair your ECG sensor to an Android smartphone res...

Page 40: ...CIB418 01 39 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 2 1 3 4 5 ...

Page 41: ...CIB418 01 40 No Item Description 1 Date Button Tap to view an ECG from a different date 2 Menu Button Tap to access the app menu ...

Page 42: ...ft or right to move to forward or backward in your ECG history 4 Display Options Button Tap to adjust rescale the view of the ECG history For more information see Display Options 5 Quick Search Button Tap to open the quick search scroll bar see Quick Search Scroll Bar ...

Page 43: ...led 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 14 days Q ecg wu3 up to 5 days Q ecg wu5 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 ...

Page 44: ...wing the ECG history Speed Using a lower speed option will shrink the ECG along the horizontal axis of the grid and using a higher speed option will expand the ECG along the horizontal axis of the grid 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 ...

Page 45: ...int 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 Points on the scroll bar that are dark blue feature ECG readings Tap Hide to return to the main toolbar for the History screen ...

Page 46: ...pair the ECG sensor to a smartphone 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 receiv...

Page 47: ... 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 See History for more information You can also retrieve the ECG data stored in the device s em...

Page 48: ...CIB418 01 47 ...

Page 49: ...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 ...

Page 50: ... 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 ...

Page 51: ...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 ...

Page 52: ... 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 MDD93 42 EEC CE Marked FDA certified ...

Page 53: ...art rate 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 Q ecg app will display Activity Detection Activity Status detection by G sensor G sensor 3 axis 8g G sensor sampling rate 52Hz G sens...

Page 54: ...etooth BLE 5 0 Transmit distance 10 meters open space 2 Micro USB cable USB USB2 0 Battery 3 8V 530mAh or 3 8V 220mAh Battery Life Storage mode 14Days or 6Days 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 ...

Page 55: ...39 L x 39 W x 8 2 H 0 2 mm for Q ecg wu5 Charger Specifications Input 5V 0 5A Working Temperature 5 35 C Storage Temperature 20 60 C Weight 20 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 Q ecg app Refer to the notes listed in Pairing ...

Page 56: ...ckage 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 Blue tooth BT 4 2 or above WIFI 2 4GHz 5GHz 802 11 a b g n ac Storage 4GB Ethernet 10 100 1000M Connectivity Up to...

Page 57: ...CIB418 01 56 The gateway mode is designed to collect multi ECG sensors data information only ...

Page 58: ...r 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 Label Information ...

Page 59: ...erence 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 interference in a residential installation This equipment...

Page 60: ...a 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 other antenna or transmitter For body worn operation ...

Page 61: ...e frequency enhance transmitting power or alter original 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 c...

Page 62: ...d 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 reference number or reorder number Indicates the manufacture s serial number ...

Page 63: ...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 ...

Page 64: ...nd systems Manufacturer s declaration electromagnetic emissions The Q ecg wu3 Q ecg wu5 is intended for use in the electromagnetic environment for home and professional healthcare specified below The customer or the user of the Q ecg wu3 Q ecg wu5 should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance for home and professional healthcare ...

Page 65: ...nce in nearby electronic equipment RF emissions CISPR 11 Class B The Q ecg wu3 Q ecg wu5 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 Compliance ...

Page 66: ...of the Q ecg wu3 Q ecg wu5 should assure that it is used in such an environment Immun ity test IEC 60601 test level Complianc e level Electromagnetic environment guidance for home and professional healthcare environment Electro static dischar ge ES D Contact 8 kV Air 2 kV 4 kV 8 Contact 8 kV Air 2 kV 4 kV 8 Floors should be wood concrete or ceramic tile If floors are covered with synthetic materia...

Page 67: ...s 1kV for input outp ut lines 2kV for power supply lines Not applicable Mains power quality should be that of a typical home healthcare environment Surge IEC 61000 4 5 0 5kV 1kV line s to line s 0 5kV 1kV 2kV line s to earth 0 5kV 1kV line s to line s Not applicable Mains power quality should be that of a typical home healthcare environment ...

Page 68: ... cycles Voltage interrup tions 0 UT 250 cycle Mains power quality should be that of a typical home healthcare environment If the user of the Q ecg wu3 Q ecg wu5 requires continued operation during power mains interruptions it is recommended that the Q ecg wu3 Q ecg wu5 be powered from an uninterruptible power supply or a battery Power freque ncy 50 60 Hz 30 A m 30 A m 50 Hz The Q ecg wu3 Q ecg wu5...

Page 69: ...acturer s declaration electromagnetic immunity The Q ecg wu3 Q ecg wu5 is intended for use in the electromagnetic environment for home and professional healthcare specified below The customer or the user of the Q ecg wu3 Q ecg wu5 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 ...

Page 70: ... 80 MHz 3 Vrms 0 15 MHz 80 MHz 6 Vrms in ISM and amateur radio bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Portable and mobile RF communications equipment should be used no closer to any part of the Q ecg wu3 Q ecg wu5 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter ...

Page 71: ... 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 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 recommended separation ...

Page 72: ...ity 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 73: ... which radiated RF disturbances are controlled The customer or the user of the Q ecg wu3 Q ecg wu5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Q ecg wu3 Q ecg wu5 as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation d...

Page 74: ... transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where p is the maximum output 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 applie...

Page 75: ...CIB418 01 74 NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ...

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