QOCA PORTABLE ECG MONITORING DEVICE User Manual CIH418-01 Ver.
TABLE OF CONTENTS Safety Notes ......................................................... 4 Product Overview .............................................. 10 Indication for Use ...................................................... 10 Package Contents ..................................................... 11 Product Configurations...................................... 12 Components .............................................................. 13 Sensor .......................................................
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 ...................
Charger Specifications....................................... 45 Troubleshooting ........................................................ 45 Gateway mode information ...................................... 45 Gateway Compatible Specifications ................. 46 Customer Support ..................................................... 47 EU Representative .............................................. 47 Label Information: ..............................................
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. Unauthorized disassembly of the device by the user is not allowed. The QOCA PORTABLE ECG MONITORING DEVICE must be used with its specified accessories and electrodes.
• • • • • 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. If using another other electronic device is necessary, please check to ensure the ECG is continuing to take measurements normally.
• • • • • 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.
• • • • • • 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. Any activities not permitted by the attending physician may affect the accuracy of the measurements.
• • • • • • • 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. The QOCA PORTABLE ECG MONITORING DEVICE ’s use is not intended for use with infants weighing less than 45lbs. (20 kg). The expected service life of the QOCA PORTABLE ECG MONITORING DEVICE is 2 years.
• • • • • 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.
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.
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.
USB Charging Cable x 1 User Manual 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.
✓ ecg103-P1 Body Patch* Components Sensor Front 1 3 2 CIH418-01 13
1 2 3 Power Button Battery LED (see LED Indicators for more information) Indicator LED (see LED Indicators for more information) Back 1 2 3 1 2 Charging Contacts Holder Connectors CIH418-01 14
3 Laser Printing Area NOTE: Electrode button connector will support plug in/off test under 1000 times.
1 2 Charging Contacts USB Charging Port CIH418-01 16
Body Patch Front Exterior (with pocket closed) 2 1 1 2 Material CIH418-01 Gel Contact Point Made from Nonwoven 17
Sensor Holder & Cable Front 1 2 1 Material 2 CIH418-01 Sensor Connectors Made from Polydefin Foam Cable Connector 18
Back 1 1 1 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: Charging indicator Working temp Storage temp Input Size ⚫ LED on Sensor 5 ~ 35⁰C (Sensor working temp is 5 ~ 35⁰C when it is charging) -20 ~ 60⁰C 12V/2A 241.3 mm * 166.4 mm * 66.25 mm NOTE: 12-unit charger can only be used by trained person/adult.
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) • The QOCA ecg APP * * Items not included in the product package.
BEFORE YOU START Before you start using the QOCA PORTABLE ECG MONITORING DEVICE you must: 1. 2. 3.
To charge the battery: 1. 2. 3. 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. Place the sensor into the charger so that the sensor snaps into the charger and the charging contacts on both the sensor and charger make contact.
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: 1. 2. 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. To pair the sensor to your smartphone: 1. 2. 3. When enter the pairing page, it would show the nearby BLE devices.
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. 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.
Wearing the sensor holder To wear the ECG sensor directly on your body, follow the directions below: 1. 2. 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.
3. 4. 5. 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. Remove the paper backing on the contact side of each of the ECG electrodes.
6. Adhere the electrode attached to the cable to the area under your right 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.
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.
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. 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.
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.
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. Skin exfoliation will help the contact of patch.
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. 3. Device and User Info 2. Record List list ECG 1.
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. 2. Real time ECG waveform 1.
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.
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. It will show the detailed user profile and device information.
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. 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.
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.
ADDITIONAL INFORMATION LED Indicators The following tables describe the indicators on both the sensor and charger: Sensor Status Indicator Event Power on Power off Action Behavior • Both Battery LED & Indicator LED flashing green 3 times • Solid blue light for both Battery LED and Indicator LED while press the button After 5 seconds turn off lights Press power button Long press power button for 5 seconds • CIH418-01 39
• Lead off User do not wear device Event Recording When it’s lead on and press • power button Indicator LED flashing blue light • Battery LED flashing orange light • Battery LED flashing blue light • Battery LED solid blue light Low battery N/A Charging Put on charger Fully charged Put on charger USB connected Plug sensor to • USB CIH418-01 Indicator LED flashing orange light 40 Indicator LED with solid blue light
Cleaning The table below describes the appropriate cleaning methods for each item included with the QOCA PORTABLE ECG MONITORING DEVICE: Item Sensor Charger Sensor holder CIH418-01 Cleaning Method Wipe with a dry cloth when it’s dirty. And clean it every day if it is frequently used. Wipe with a dry cloth when it’s dirty. And clean it every day if it is frequently used. Carefully wipe with a dry cloth when it’s dirty. And clean it every day if it is frequently used.
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.
Specifications Sensor Specifications Continuous ECG data acquisition and calculation ECG Sensor 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 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.
(1) Data Transmission (2) Bluetooth BLE 5.0: Transmit distance: 10 meters (open space) Micro USB cable USB USB2.0 Battery 3.
Dimension 35(L) x 35(W) x 8.85(H) ±0.2 (mm) for ecg103 Charger Specifications Input 5V/0.5A Working Temperature 5 – 35°C Storage 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.
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 Blue tooth BT 4.2 above WIFI 2.4GHz/5GHz 802.
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.
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.
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: • Reorient or relocate the receiving antenna.
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 radiofrequency devices.
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 reference number or reorder number. Indicates the manufacture's serial number.
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 presented on the medical device itself Indicates the need for the user to consult the instructions for use. Protected against solid objects down to 12mm.
Supplier’s Declaration The QOCA PORTABLE ECG MONITORING DEVICE conforms to the international EN 60601-1 and EN 60601-12 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. The customer or the user of the ecg103 should assure that it is used in such an environment.
RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations Class B Class A Compliance /flicker emissions IEC 61000-3-3 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.
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.
IEC 610004-4 Surge IEC 610004-5 Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 610004-11 + 1kV for input/ output lines + 0.5kV, +1kV line(s) to line(s) + 0.5kV, +1kV,+ 2kV line(s) to earth Voltage dips: 0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles Not applicable home healthcare environment. + 0.5kV, +1kV line(s) to line(s) Not applicable Mains power quality should be that of a typical home healthcare environment.
Power 30 A/m frequency(5 50 Hz or 60 0, 60 Hz) Hz magnetic field 30 A/m 50 Hz IEC 610004-8 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.
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.
radio bands between 80 % AM at 1 kHz applicable to the frequency of the transmitter.
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.
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 communications equipment.
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.
interference in nearby electronic equipment. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations /flicker emissions IEC 61000-3-3 CIH418-01 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.
