CIB QOCA Portable ECG Monitoring Device Users Manual

 

QOCA PORTABLE ECG MONITORING DEVICE User Manual TABLE OF CONTENTS Safety Notes ....................................................................... 5 Product Overview ............................................................ 11 Indication 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 CIB418-01 1 Enabling Bluetooth ................................................... 24 Getting Started ................................................................ 25 Creating 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 CIB418-01 2 Measuring ECG when Bluetooth is Disconnected 46 Additional Information .................................................... 48 LED Indicators ........................................................... 48 Sensor Status 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 CIB418-01 3 Regulatory Marks ................................................ 60 Suppliers Declaration .............................................. 63 CIB418-01 4 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. 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 ECG MONITORING DEVICE is low on battery power, it will automatically stop taking measurements and the corresponding indicator lights will blink. Please charge the sensors battery as soon as it shows a low battery state. CIB418-01 5 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 ECGs 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. 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 104F 113F (40 45C), do not use the QOCA PORTABLE ECG MONITORING DEVICE because it may cause low temperature burns. Users must purchase Sensor HolderECG electrodes or Body Patch separately when using the Sensor Holder or Body Patch. The specification can be found in ECG Electrode Information. CIB418-01 6 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. The conductive parts of the electrodes and associated connectors for type BF applied parts, which are parts that 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. If QOCA PORTABLE ECG MONITORING DEVICE must be used to take measurements over an extended period of time, please inspect the contact point of the electrodes at least once every 24 hours to make sure that the electrodes are in the right position and that there is no allergic reaction on the users skin. CIB418-01 7 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 stationary (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. 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 relevant local regulations. The QOCA PORTABLE ECG MONITORING DEVICE has been tested and certified to international electro-magnetic compatibility (EMC) standards for medical equipment (EN 60601-1 and EN 60601-1-2). CIB418-01 8 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. 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 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. CIB418-01 9 QOCA PORTABLE ECG MONITORING DEVICE does not support with 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 electromagnetic interference (such as electric blankets) when using the QOCA PORTABLE ECG MONITORING DEVICE. When the ECG signal is always unstable, please contact the manufacturer. CIB418-01 10 PRODUCT OVERVIEW Indication for Use The QOCA PORTABLE ECG MONITORING DEVICE is intended for non-invasive measurement of a functional Electrocardiogram (ECG) and heart rate (HR) in hospitals, healthcare institutes, and home environments by trained medical professionals and trained adult. The QOCA PORTABLE ECG MONITORING DEVICE will process ECG signals and calculate HR on continuous, spot check, or event record mode. Users can also add time 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 DEVICE is available to professional organizations such as home caregivers, clinics, or hospitals. It is not available to the general public. It should only be used by medical personnel or trained adult patients. Use by unauthorized users is not allowed. CIB418-01 11 Package Contents After purchasing 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 CIB418-01 12 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 CIB418-01 13 Product Configurations The following table lists the sensor related items included in the various packages available for the QOCA Portable ECG Monitoring Device. CIB418-01 14 Components Sensor Front 1 2 3 1 2 3 Power Button Battery LED (see LED Indicators for more information) Indicator LED (see LED Indicators for more information) CIB418-01 15 3 1 2 3 1 2 3 Charging Contacts Holder Connectors Label Area NOTE: Electrode button connector will support plug in/off test under 1000 times. Back CIB418-01 16 1 2 3 1 2 Charger 1 2 Charging Contacts USB Charging Port CIB418-01 17 1 2 Body Patch Front Exterior (with pocket closed) 1 2 2 1 2 Material Made from Nonwoven Gel Contact Point CIB418-01 18 Sensor Holder & Cable Front 1 2 Sensor Connectors 1 Material Made from Polydefin Foam 2 Cable Connector CIB418-01 19 Back 1 1 1 Electrode Connectors IMPORTANT: If any damage to the wire shielding is found on the holder, replace immediately. CIB418-01 20 1 12-unit Charger (Charging 12 sensors at the same time) Specification :

Charging indicator LED on Sensor Working temp Storage temp Input Size 5 ~ 35C (Sensor working temp is 5 ~

35C when it is charging)

-20 ~ 60C 12V/2A 241.3 mm * 166.4 mm * 66.25 mm NOTE: 12-unit charger can only be used by trained person/adult. CIB418-01 21 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 5.x or above and a display resolution of 1920x1080 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 iPhone (iOS 12 above) The ECG Sensor Q-ecg App*

* Items not included in the product package. CIB418-01 22 BEFORE YOU START Before you start using the QOCA PORTABLE ECG MONITORING DEVICE you must:

1. 2. 3. Charge the battery on the Sensor Install the Q-ecg app on your Android smartphone Enable Bluetooth on your smartphone Charging the Battery Adapter Charger CIB418-01 23 Sensor Sensor Charger To charge the battery:

1. 2. 3. Plug the chargers 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. 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 smartphone will need at least 5MB of storage capacity available. Enabling Bluetooth To enable Bluetooth, enter the Settings menu on your smartphone and enable Bluetooth. CIB418-01 24 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. Create a profile in the Q-ecg app 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:

CIB418-01 25 Name Gender Birthday Height Weight

[Optional] Resting Heart Rate NOTE: 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. CIB418-01 26 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 CIBXSXXXXXXX which is the same as serial number on the back of sensor. It takes a few seconds to do the pairing. Please wait for a while. 2. 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. CIB418-01 27 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 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 professional or physician. CIB418-01 28 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. 1. 2. CIB418-01 29 3. 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). 4. 5. 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. 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. If an electrode does not adhere securely, please replace it with a new electrode. CIB418-01 30 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 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. CIB418-01 31 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. 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 damage the holder. CIB418-01 32 Wearing the body patch The following 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 45 ~ 60 CIB418-01 33 Step5. Hand pressure on the body patch (especially on 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. CIB418-01 34 THE Q-ECG APP Main Screen Once you have successfully paired and worn the ECG sensor, the Q-ecg apps 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 CIB418-01 35 Description Tap to access the app menu. For more information see Menu. Displays the profile settings that were entered during 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. N o 1 Item Menu Button 2 Profile Setting s 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 CIB418-01 36 scroll bar that are dark blue feature ECG readings. Tap Hide to return to the main toolbar for the History screen. Profile. Displays your real-time ECG in 5 second intervals. Displays the current charge level of the battery. 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. Select Diagnostic mode or Monitor mode 3 4 5 6 Real-

Time ECG Battery Status Conne ction Status Filter mode Select 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 connectivity icon will display a red X, as seen in the image below. CIB418-01 37 NOTE: When using the Q-ecg app, the default Back button on your Android smartphone will become disabled. To exit the Q-ecg app, you must use the Quit button in the Q-ecg apps menu. For more information, see Setting It is able to set ECG 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 apps 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, reset the Q-

ecg app, setting, or exit the Q-ecg app. CIB418-01 38 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 5 4 CIB418-01 39 No 1 2 Item Description Date Button Menu Button Tap to view an ECG from a different date. Tap to access the app menu. CIB418-01 40 3 ECG History 4 5 Display Options Button Quick Search Button Tap to display your ECG history. Swipe left or right to move to forward or backward in your ECG history. Tap to adjust/rescale the view of the ECG history. For more information, see Display Options. Tap to open the quick search scroll bar, see Quick Search Scroll Bar. CIB418-01 41 Date When you tap the date button in the History screen, a calendar view will appear. Dates on which you recorded an ECG are circled. 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 CIB418-01 42 activity (in millivolts). Adjust the display options for the ECG history for a more detailed or a more general view of the ECG data. The following display options are available when viewing 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. CIB418-01 43 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 scroll bar that are dark blue feature ECG readings. Tap Hide to return to the main toolbar for the History screen. CIB418-01 44 Profile Tap Profile in the Q-ecg app menu to change the profile settings used in the Q-ecg app. Follow the same instructions in Creating a Profile to change the profile settings. Pairing Tap Pairing in the Q-ecg app menu to pair/re-pair the ECG sensor to an Android smartphone. Follow the instructions in described in Pairing to 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 receive an Android system message stating the USB device is not recognized by the system, you will need to reset the sensor by tapping Reset Device. CIB418-01 45 Setting It is able to set ECG 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 Tap Quit in the Q-ecg app to exit the app. 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 devices 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 devices 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. CIB418-01 46 CIB418-01 47 ADDITIONAL INFORMATION LED Indicators The following tables describe the indicators on both the sensor and charger:

Sensor Status Indicator Event Action Behavior Power on Press power button Power off Long press power button for 5 seconds 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 CIB418-01 48 Lead off User do not wear device Event Recording When its lead on and press power button Low battery N/A Charging Put on charger Indicator LED flashing orange light Indicator LED flashing blue light Battery LED flashing orange light 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 CIB418-01 49 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 Cleaning Method Wipe with a dry cloth when its dirty. And clean it every day if it is frequently used. Wipe with a dry cloth when its dirty. And clean it every day if it is frequently used. Carefully wipe with a dry cloth when its dirty. And clean it every day if it is frequently used. CIB418-01 50 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:

Adapter: Stud Biocompatibility:

ISO 10993 approved Latex free CE Mark according to MDD93/42/EEC CE Marked FDA certified CIB418-01 51 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 Differential Input Impedance: >

10M 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 Status detection by G-

sensor G-sensor (3 axis): 8g G-sensor sampling rate: 52Hz G-sensor accuracy: 0.0156g ECG Sensor Activity Detection CIB418-01 52 Energy Expenditure Calculated from HR and activity data Lead-off Detection Detect when the sensor gets loosened from holder or body patch Data Transmission USB Battery Battery Life Working Temperature /

Humidity Storage Temperature /

Humidity Atmospheric Pressure Range

(1) Bluetooth BLE 5.0: Transmit distance: 10 meters (open space)

(2) Micro USB cable USB2.0 3.8V/530mAh or 3.8V/220mAh Storage mode : 14Days or 6Days

@ 256Hz Sample rate 5 45C, 10% 95% non-

condensing

-20 60C, 10% 95% non-

condensing 800 hPa to 1013 hPA Altitude 2000m Enclosure Rating IP26 CIB418-01 53 Weight 24.4 0.5 g for Q-ecg-wu3 18.4 0.5 g for Q-ecg-wu5 Dimension 39(L) x 39(W) x 11.2(H) 0.2 (mm) for Q-ecg-wu3 39(L) x 39(W) x 8.2(H) 0.2 (mm) for Q-ecg-wu5 Charger Specifications Input 5V/0.5A Working Temperature Storage Temperature 5 35C

-20 60C 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. CIB418-01 54 Gateway mode information When using QOCA PORTABLE ECG MONITORING DEVICE, the data needs to be transmitted from many 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 or above 2.4GHz/5GHz 802.11 a/b/g/n/ac WIFI Storage Ethernet 4GB 10/100/1000M Connectivity Up to 6 ECG sensor devices CIB418-01 55 The gateway mode is designed to collect multi-ECG-

sensors data information only. CIB418-01 56 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: MedicalSales@quantatw.com EU Representative EU Representative: MedNet GmbH Address: Borkstrasse 10, 48163 Mnster, Germany Label Information:

CIB418-01 57 Federal Communications Commission (FCC) Statement The FCC ID is HFSCIB 15.21 1) 2) 15.105(b) You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the users 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 interference that may cause undesired operation of the device. 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 generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no CIB418-01 58 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. 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, this device has been tested and meets FCC RF exposure guidelines. When used with an accessory that contains metal may not ensure compliance with FCC RF exposure guidelines CIB418-01 59 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 Article 14 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. 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 Telecommunications Act. The low power radio-frequency CIB418-01 60 devices must be susceptible with the interference from legal communications or ISM radio wave radiated 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. CIB418-01 61 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. Protection against low pressure jets of water, limited ingress permitted. IP26 CIB418-01 62 Suppliers Declaration The QOCA PORTABLE ECG MONITORING DEVICEconforms to the international EN 60601-1 and EN 60601-1-2 standards for electromagnetic compatibility with medical electrical devices and systems. Manufacturers 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 Compliance Electromagnetic test environment-guidance

(for home and professional healthcare environment) CIB418-01 63 The Q-ecg-wu3/Q-ecg-

wu5 uses 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. 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. Group 1 RF emissions CISPR 11 Class B Class A Compliance RF emissions CISPR 11 Harmonic emissions IEC 61000-

3-2 Voltage fluctuations

/flicker emissions IEC 61000-

3-3 CIB418-01 64 Manufacturers 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 an environment. Immun ity test IEC 60601 Complianc Electromagnetic e level environment-

test level guidance

(for home and professional healthcare environment) Electro static dischar ge(ES D) Contact

:8 kV Contact:

8 kV Air2 kV,4 kV,8 Air2 kV,4 kV,8 Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity CIB418-01 65 IEC 61000-

4-2 kV,15 kV kV,15 kV should be at least 30%

Electric al fast transie nt/burst

+ 2kV for power supply lines IEC 61000-

4-4

+ 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.

+ 0.5kV,

+1kV line(s) to line(s) 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 CIB418-01 66 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. Voltag e Dips, short interru ptions and voltage variatio ns on power supply input lines IEC 61000-

4-11 Voltage dips:

Voltage dips:

0 % UT;

0,5 cycle 0 % UT;

1 cycle 70 %

UT;

25/30 cycles Voltage interru ptions:

0 % UT;

250/300 cycle 0 % UT;

0,5 cycle 0 % UT;

1 cycle 70 % UT;

25 cycles Voltage interrup tions:

0 % UT;

250 cycle Power freque ncy(50, 60 Hz) 30 A/m 30 A/m 50 Hz The Q-ecg-wu3/Q-

ecg-wu5 power frequency magnetic fields should be at levels characteristic CIB418-01 67 of a typical location in a typical home healthcare environment. 50 Hz or 60 Hz magnet ic field IEC 61000-

4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. Manufacturers 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 Compliance Electromagnetic level IEC 60601 test level environment-

guidance (for home and professional CIB418-01 68 healthcare environment) 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. Conducted RF IEC 61000-4-6 3 Vrms:

3 Vrms:

0,15 MHz 80 MHz 6 Vrms:

0,15 MHz 80 MHz 6 Vrms:

Radiated RF in ISM and amateur radio bands between 0,15 MHz and 80 MHz in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz CIB418-01 69 IEC 61000-4-3 80 % AM at 1 kHz 10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz 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 CIB418-01 70 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. CIB418-01 71 Recommended separation distance between portable and mobile RF communications equipment and the Q-ecg-wu3/Q-ecg-wu5 The Q-ecg-wu3/Q-ecg-wu5 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 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 Separation distance according to frequency of transmitter maximum output m CIB418-01 72 power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,7 GHz d =1,2P d =1,2P d =2,3P W 0,01 0,1 1 10 100 0,12 0,38 1,2 3,8 12 0,12 0,38 1,2 3,8 12 0,23 0,73 2,3 7,3 23 For 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 applies. CIB418-01 73 NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. CIB418-01 74