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1 | User Manual | Users Manual | 1.70 MiB | November 24 2020 / May 23 2021 | delayed release |
QOCA PORTABLE ECG MONITORING DEVICE User Manual CI6418-01 Ver.: 3A TABLE OF CONTENTS Safety Notes .......................................................... 4 Product Overview ............................................... 11 Indication for Use ..................................................... 11 Package Contents .................................................... 11 Components ............................................................. 13 Sensor ................................................................. 13 Charger ............................................................... 15 Body Patch & sensor cable .............................. 16 12-unit Charger (Charging 12 sensors at the same time) .......................................................... 18 Product Requirements ............................................ 19 Before You Start ................................................. 20 Charging the Battery ............................................... 20 Installing the App ..................................................... 21 Enabling Bluetooth .................................................. 21 Getting Started .................................................... 22 Pairing ....................................................................... 22 CI6418-01 1 Wearing the ECG Sensor ........................................ 25 The QOCA ecg APP ............................................ 36 Main Screen .............................................................. 36 Event record ............................................................. 38 Check the Device Information ................................ 39 Device test .................................. !
Additional Information ....................................... 41 LED Indicators .......................................................... 41 Sensor Status Indicator .................................... 41 Cleaning .................................................................... 43 Specifications ........................................................... 44 Sensor Specifications ....................................... 44 Charger Specifications ...................................... 45 Troubleshooting ....................................................... 45 Gateway mode information ..................................... 46 Gateway Compatible Specifications ................ 46 Customer Support ................................................... 48 EU Representative ............................................. 48 CI6418-01 2 Label Information: ............................................. 48 Federal Communications Commission (FCC) Statement .................................................................. 50 Regulatory Marks ............................................... 52 Suppliers Declaration ............................................. 55 CI6418-01 3 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 body patch. The use of accessories and body patch from other brands can damage the device or cause inaccurate readings. 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. CI6418-01 4 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 make sure the QOCA PORTABLE ECG MONITORING DEVICE continues to take measurements normally. See The QOCA ecg APP to see how to do device test. Do not use the QOCA PORTABLE ECG MONITORING DEVICE near open flames or in excessive heat. When ambient temperature is 104F 113F (40 45C), do not use the QOCA PORTABLE ECG MONITORING DEVICE because it may cause low temperature burns. 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. CI6418-01 5 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 body patch at least once every 24 hours to make sure that the body patch is in the right position and that there is no allergic reaction on the users skin. 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 CI6418-01 6 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). 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 is NOT intended for use on patients CI6418-01 7 weighing less than 45lbs (20 kg). It is intended for use on adult patients only. 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. 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 CI6418-01 8 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. The body patch is a single-use part. Re-use of the body patch will decrease its adhesion and cause incorrect ECG and heart rate measurement. Do not use the body patch if the user is allergic to hydrogel or tape adhesive. The body patch should be placed on patients by trained medical personnel. The wear time of the body patch is up to 7 days. The wear duration may decrease by improper placement or differ by individual skin condition and activity level. We suggest users avoid sweating to extend the wearing time. Before wearing the body patch, the applied skin area should be properly prepared by following the steps described in Wearing the ECG Sensor section. CI6418-01 9 Do not submerge, bath, or swim with QOCA Portable ECG monitoring device and the body patch. Do not apply any lotion or skin care products on applied area. Remove the body patch with cautions and do not damage the skin. If the skin at the contact point develops a rash, blisters, reddening, or other irritation, please contact a medical professional or physician. CI6418-01 10 PRODUCT OVERVIEW Indication for Use The QOCA Portable ECG Monitoring Device is intended for use by trained medical personnel and trained adults to measure Electrocardiogram (ECG) and heart rate (HR) in hospitals, healthcare institutes, or home environments. The transmission, storage, and display of ECG and HR data are available with dedicated software. The device is intended for use on adult patients who are not in critical condition. Package Contents After purchasing the QOCA PORTABLE ECG MONITORING DEVICE , please check the product package to ensure that the following items are included:
QOCAecg701 product package CI6418-01 11 QOCAecg701 ECG Sensor x 1 Charger (ecg701-
C1) x 1 Protection bag x 1 USB Charging Cable x 1 User Manual x 1 Body patch
(ecg701-P1)* x 1
*The body patches are consumables and are sold along with sensor but in a standalone package. Contact with manufacturer for procurement. CI6418-01 12 Components Sensor (ecg701) Front 2 1 3 1 2 3 Power Button Battery LED (see LED Indicators for more information) Indicator LED (see LED Indicators for more information) CI6418-01 13 3 Back 2 3 1 1 2 3 Charging Contacts Holder Connectors Positioning groove NOTE: Electrode button connector will support plug in/off test under 1000 times. CI6418-01 14 1 2 3 Charger(ecg701-C1) 1 2 1 2 Charging Contacts USB Charging Port CI6418-01 15 1 2 2 2 Body Patch (ecg701-P1) Main patch (ecg701-P1a) 1 3 Main patch 1 2 3 Material Gel Sensor connector Cable connector Made from Nonwoven CI6418-01 16 Chest lead patch (ecg701-P1b) 1 1 1 2 Material Cable connector gel Made from Nonwoven Sensor cable (ecg701-P1c) 1/2 Patch connector 2 2 CI6418-01 17 1 1 12-unit Charger (optional, 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 l NOTE: The 12-unit charger is an optional accessory and can only be used by trained person/adult. CI6418-01 18 1 Product Requirements In order to properly use the QOCA PORTABLE ECG MONITORING DEVICE the following items are required:
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. CI6418-01 19 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 QOCA ecg APP on your Android smartphone Enable Bluetooth on your smartphone Charging the Battery Sensor Charger Adapter To charge the battery:
CI6418-01 20 Sensor Charger 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 blue. 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 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. CI6418-01 21 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. Pair your smartphone to the QOCA PORTABLE ECG MONITORING DEVICE via Bluetooth 2. Wear the QOCA PORTABLE ECG MONITORING DEVICE Pairing Launch the QOCA ecg App and choose sensor type to pair the sensor to your smartphone:
22 CI6418-01 1. 2. 3. After selecting CI6, it would show the nearby CI6 devices. Please select the name CI6XSXXXXXXX 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. After pairing, the App will guide you to do device test. Place fingers on the four holder connectors on the bottom side of the sensor. You should see ECG waveform (one lead only) shortly. Click Complete when the test is done. 4. After test is done, the App will return to the page as illustrated below. CI6418-01 23 Note: At this moment the sensor is not yet applied to the body. Once your fingers are released from the sensor, the QOCA ecg app should pop up lead-off notification on the screen. This notification will go off once the sensor is worn on body. CI6418-01 24 Wearing the ECG Sensor IMPORTANT:
l l l l l l l The body patch is a single-use part. Re-use of the body patch will decrease its adhesion and cause incorrect ECG and heart rate measurement. Do not use the body patch if the user is allergic to hydrogel or tape adhesive. The body patch should be placed on patients by trained medical personnel. The wear time of the body patch is up to 7 days. The wear duration may decrease by improper placement or differ by individual skin condition and activity level. We suggest users avoid sweating to extend the wearing time. Before wearing the body patch, the applied skin area should be properly prepared by following the steps described in Wearing the ECG Sensor section. Do not submerge, bath, or swim with QOCA Portable ECG monitoring device and the body patch. CI6418-01 25 l l Do not apply any lotion or skin care products on applied area. Remove the body patch with cautions and do not damage the skin. If the skin at the contact point develops a rash, blisters, reddening, or other irritation, please contact a medical professional or physician. Step 1. 1. Install the sensor on the body patch before putting on body. The heart mark tip should point downward 2. Connect main patch and chest lead patch with the sensor cable CI6418-01 26 3. If the sensor is powered off, press the power button until the LEDs flashes green and then release the button (After powered on, the LED will keep flashing orange until the patch is well attached to user body. CI6418-01 27 Step 2. Prepare the skin of applied area 1. Confirm the applied main patch area. A. Point the main patch label arrow up towards the collarbone junction. B. Make sure ECG heart mark tip point downward. Confirm the applied chest lead area (Choose any one from V1~V6. Here V4 is illustrated as the example.) CI6418-01 28 Chest Lead location V1 V2 Fourth intercostal space at the right sternal border Fourth intercostal space at the left sternal border V3 (C3) Half way between V2 and V4 V4 Fifth intercostal space in the midclavicular line CI6418-01 29 V5 V6 Left anterior axillary line on the same horizontal plane as V4. Left midaxillary line on the same horizontal plane as V4 and V5 2. Remove body hair in the area of patch placement. 3. Use abrader disc to clean the skin first (horizontal by 10 times and vertical by 10 times) and alcohol pad cleaning. Allow site to dry. Note: If necessary, medical personnel may adjust chest lead area to fit different body shape or skin condition. CI6418-01 30 Step 3. Place body patch 1. Remove the central release paper. Do not touch the stick area. 2. Point the main patch label arrow up towards the collarbone junction. Users arms are placed on the side. Press the central area to stick the patch on body (avoid pressing the power button) CI6418-01 31 3. Remove the left release paper. Press the left area to stick the patch on body. CI6418-01 32 4. Remove the right release paper. Press the right area to stick the patch on body. CI6418-01 33 5. Remove the release paper of chest lead patch. Point the red positioning dot to the chest lead appointed by the physician. 6. Press and stick the patch on chest lead area. CI6418-01 34 7. After completing the steps above, the event LED will flash blue 5 times and then distinguish. Step 4. Hand pressure on both main and chest lead patch
(especially on the connect point) for 30 seconds. 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. CI6418-01 35 THE QOCA ECG APP Main Screen Once you have successfully launched and worn the ECG sensor, the QOCA ecg APPs main screen will display on your mobile phone. The main screen (shown below) displays ECG records which should be shown to a medical professional for evaluation. Main screen without records CI6418-01 36 4 Main screen with records 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. CI6418-01 37 Event record The ECG data is automatically saved in the embedded storage in the sensor. When you feel a symptom, you can press the button on the sensor or the heart button on the main screen to record this event. The recorded event will be saved in the sensor as well as in the QOCA ecg app. You can find the recorded event in the main screen. The ECG data will also be stored in the sensors embedded storage for back up. CI6418-01 38 Check the Device Information Tap the user icon on the left top side of the main screen to check device information and access other settings. Set the chest lead : You can choose any chest lead from V1~V6). Event record duration: Options include 30 seconds/1 min/2 mins/5 mins (default setting is 30 secs) CI6418-01 39 Device Test: You can see real-time waveform with this option, but the waveform will not be saved to App. Clear data: You can unpair the sensor from the mobile phone by using this option. All data will be erased from the App. CI6418-01 40 5 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 Both Battery LED
& Indicator LED keep flashing and then extinguish when power on is done. Indicator LED will flash orange until the device is lead-on. CI6418-01 41 Power off Long press power button for 5 seconds Lead off User do not wear device Solid blue light for both Battery LED and Indicator LED while press the button After 5 seconds turn off lights Indicator LED flashing orange light Event Recording When its lead on and press power button Indicator & battery LEDs flashing blue light Low battery N/A Charging Put on charger Battery LED flashing orange light Battery LED flashing blue light CI6418-01 42 Fully charged Put on charger Battery LED solid blue light USB connected Plug sensor to USB 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 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. CI6418-01 43 Specifications Sensor Specifications Item Spec(design input) Continuous ECG data acquisition and calculation Measuring Lead: lead I, II, III, aVR, aVL, aVF and one chest lead(choose any one from V1~V6) 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: 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 --.
(1) Bluetooth BLE 5.0: Transmit distance:
10 meters (open space) 3.8V/530mAh Up to 7 days @ 256 Hz sampling rate, holter mode
(Spot check mode: TBD) 44 ECG Sensor Data Transmission Battery Battery Life CI6418-01 Battery charging time Working Temperature /
Storage Humidity Temperature /
Atmospheric Humidity Pressure Range Altitude Enclosure Rating Material flame retardant Weight Dimension 3 hours 5 45C, 10% 95% non-condensing
-20 60C, 10% 95% non-condensing 800 hPa to 1013 hPa 2000m IP26 PC+ABS, UL94V2 27.5 0.5 g 65.8 x 65.8 x 10.2 0.2 mm Charger Specifications Item Input Working Temperature Storage Temperature Enclosure Rating Weight Dimension Spec(design input) 5V/0.5A 5 35C, 10% 95% non-condensing
-20 60C, 10% 95% non-
condensing IP21 18 0.5 g 51.7 x 51.7 x 12.65 0.2 mm Troubleshooting 1) Make sure the Bluetooth function of your mobile phone is enabled. If the problem is not resolved, contact manufacturer for assistance. CI6418-01 45 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 4GB 10/100/1000M Connectivity Up to 6 ECG sensor devices WIFI Storage Ethernet The gateway mode is designed to collect multi-ECG-
sensors data information only. CI6418-01 46 CI6418-01 47 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.com EU Representative EU Representative: MedNet EC-REP GmbH Address: Borkstrasse 10, 48163 Mnster, Germany Label Information:
CI6418-01 48 CI6XS2034001 CI6XK2034001 49 CI6418-01 In the serial number at the bottom side of the product:
The 6th and 7th character from the left represents the sensor and charger's year of manufacture, and The 8th and 9th character represents the week of manufacture. In the example shown, the 20 represents a manufacture year of 2020 and the 34 represents the 34th week of 2020. Federal Communications Commission (FCC) Statement The FCC ID is HFSCI6 15.21 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:
CI6418-01 50 This device may not cause interference and This device must accept any interference, including interference that may cause undesired operation of the device. 1) 2) 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 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 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. 51 CI6418-01 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 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 CI6418-01 52 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 Telecommunications Act. The low power radio-frequency 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 CI6418-01 53 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. CI6418-01 54 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 Suppliers Declaration The QOCA PORTABLE ECG MONITORING DEVICE conforms to the international EN 60601-1 and EN 60601-1-
2 standards for electromagnetic compatibility with medical electrical devices and systems. CI6418-01 55 Manufacturers declaration-electromagnetic emissions The QOCAecg701 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the QOCAecg701 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment-guidance
(for home and professional healthcare environment) The QOCAecg701 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 QOCAecg701 is suitable for use in all establishments, including domestic establishments and those directly RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Class B Class A CI6418-01 56 Voltage fluctuations Compliance
/flicker emissions IEC 61000-3-3 connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Bluetooth Technical Specification:
Technical Specification Value Operating Frequencies 2402~2480MHz Channel Spacing 2MHz Channel number Operating Voltage Modulation Antenna Gain 40 1.8V GFSK Chip Antenna, Peak Gain:
-1.45 dBi Rated Power (EIRP) 4.03dBm Manufacturers declaration-electromagnetic immunity The QOCAecg701 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. CI6418-01 57 The customer or the user of the QOCAecg701 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment-
guidance (for home and professional healthcare environment) Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Mains power quality should be that of a typical home healthcare environment. Mains power quality should be that of a typical Electrostatic discharge
(ESD) IEC 61000-
4-2 Electrical fast transient/
burst IEC 61000-
4-4 Surge CI6418-01 Contact:
8 kV Contact:8 kV Air2 kV,4 kV,8 kV,15 kV
+ 2kV for power supply lines
+ 1kV for input/
output lines
+ 0.5kV,
+1kV Air2 kV, 4 kV,8 kV,15 kV
+ 2kV for power supply lines Not applicable
+ 0.5kV,
+1kV line(s) to 58 IEC 61000-
4-5 line(s) to line(s) line(s) Not applicable home healthcare environment. Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-
4-11
+ 0.5kV,
+1kV,+
2kV line(s) to earth 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 30 A/m 30 A/m 50 Hz or 60 Hz 50 Hz Power frequency(5 0, 60 Hz) magnetic field CI6418-01 59 Mains power quality should be that of a typical home healthcare environment. If the user of the QOCAecg701 requires continued operation during power mains interruptions, it is recommended that the QOCAecg701 be powered from an uninterruptible power supply or a battery. The QOCAecg701 power frequency magnetic fields should be at levels characteristic of a typical location in a IEC 61000-
4-8 typical home healthcare environment. NOTE UT is the a.c. mains voltage prior to application of the test level. CI6418-01 60 Manufacturers declaration-electromagnetic immunity The QOCAecg701 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the QOCAecg701 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) Portable and mobile RF communications equipment should be used no closer to any part of the QOCAecg701 including cables, than the recommended separation distance calculated from the 3 Vrms:
3 Vrms:
Conducted RF IEC 61000-
4-6 0,15 MHz 80 MHz 6 Vrms:
in ISM and amateur 0,15 MHz 80 MHz 6 Vrms:
in ISM and amateur radio bands between 0,15 MHz and 80 MHz 61 CI6418-01 Radiated RF IEC 61000-
4-3 80 % AM at 1 kHz 10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz radio bands between 0,15 MHz and 80 MHz 80 %
AM at 1 kHz 10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz equation 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 CI6418-01 62 d is the 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. CI6418-01 63 Recommended separation distance between portable and mobile RF communications equipment and the QOCAecg701 The QOCAecg701 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 QOCAecg701 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the QOCAecg701 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter (m) 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 CI6418-01 0,23 0,73 2,3 7,3 23 0,12 0,38 1,2 3,8 12 64 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. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Manufacturers declaration-electromagnetic emissions The QOCAecg701 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the QOCAecg701 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment-guidance
(for home and professional healthcare environment) CI6418-01 65 The QOCAecg701 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 QOCAecg701 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. RF emissions CISPR 11 Group 1 Class B RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations
/flicker emissions IEC 61000-3-3 Compliance CI6418-01 66
1 | Label Information | ID Label/Location Info | 822.98 KiB | November 24 2020 |
MODEL : ecg701 FCC ID: HFSCI6 MODEL : ecg701 FCC ID: HFSCI6 MODEL : ecg701 FCC ID: HFSCI6 MODEL : ecg701 FCC ID: HFSCI6 9 8 7 6 5 4 3 2 1 1 2 F
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1 | Agent Authorization Letter | Cover Letter(s) | 312.65 KiB | November 24 2020 |
=e Quanto Computer Date: October 26, 2020 TO Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding FCC ID: HFSCI6 To whom it may concern:
We, the undersigned, hereby authorize Kevin Tsai / Deputy Manager of Compliance Certification Services Inc. to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a) Where our agent signs the application for certification on our behalf, | acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Quanta Computer Inc This authorization is valid until further written notice from the applicant. Quanta Computer Inc Joyce Kuo /
1 | Applicant Declaration Letter | Cover Letter(s) | 1.14 MiB | November 24 2020 |
SGS North Am f hoon Pecan Applicant Declaration SUITE 100 Suwanee, Georgia 30028 United States Applicant Legal Business Name Quanta Computer Inc a Address 0: 188, Wenhua 2nd Road, Guishan District, Taoyuan City 33377, Taiwan GranleeCode 4 HFS ;
FocID | HFSCI6 7 Authorized Contact Name Joyce Kuo _ Contact Email "| joyce kuo@iquavitatw.com _ Contact Phone | 7886-3-3272345 ext.1S7I4
|, the undersigned, certify that | am an authonzed signatory for the Applicant and therefore declare;
8) in accordance with 47CFR2.911(d). all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief b) in accepting a Grant of Equipment Authorization tssued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for-
(1) labeling the equipment with the exact FCC iD as specified in this application,
(2) compliance statement labeling pursuant to the applicable rules,
(3) compliance of the equipment with the applicable technical rules, C) if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. d) in accordance with 47 CFR 2.909 and KDB394321. the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321.
@) in accordance with 1S017065, FCC KDB641 163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements.
(1) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing.
(2) the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED.
(3) the Applicant shall, upon request by SGS, at the Applicant's expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes F CC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for Possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. g) the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologi -innovation-division/rules-requlations-title-47 Link to KDBs: https://apps. fcc. qov/oetcf/kdb/index.cfm Link to RSP-100: https:/Avww.ic.qc.ca/eic/site/smt-gst.nsf/eng/sf01130.htmi Applicant Signature: Date:November 11, 2020 _) bv ne
| PrintName: | Joyd Title: Coordinator NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database Applicant Declaration Rev:0.0
1 | Confidentiality Letter | Cover Letter(s) | 110.43 KiB | November 24 2020 |
Quente Computer Date: October 26, 2020 To. SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia United States. From. Quanta Computer inc. No. 188, Wenhua 2nd Rd , Guishan Dist, Taoyuan City, Tanwan Regarding: Confidentiality Request regarding application for FCC ID. HFSCI6 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commission's rules, the applicant hereby request Confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. If the device is marketed within 180 days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. External Photos Internal Photos Test Setup Photos User manual(s) Sincerely,
1 | Test Setup Photos | Test Setup Photos | 705.16 KiB | November 24 2020 / May 23 2021 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2020-11-24 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2020-11-24
|
||||
1 | Applicant's complete, legal business name |
Quanta Computer Inc
|
||||
1 | FCC Registration Number (FRN) |
0006267215
|
||||
1 | Physical Address |
No. 188, Wenhua 2nd Road, Guishan District
|
||||
1 |
Taoyuan City, N/A
|
|||||
1 |
Taiwan
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
u******@sgs.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
HFS
|
||||
1 | Equipment Product Code |
CI6
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J****** K******
|
||||
1 | Telephone Number |
+886-******** Extension:
|
||||
1 | Fax Number |
+886-********
|
||||
1 |
j******@quantatw.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Compliance Certification Services Inc. Wugu Lab.
|
||||
1 | Name |
A****** C********
|
||||
1 | Physical Address |
No.11, Wugong 6th Rd., Wugu Dist.
|
||||
1 |
New Taipei City, 24891
|
|||||
1 |
Taiwan
|
|||||
1 | Telephone Number |
886-2******** Extension:
|
||||
1 | Fax Number |
886-2********
|
||||
1 |
c******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Compliance Certification Services Inc. Wugu Lab.
|
||||
1 | Name |
A******** C****
|
||||
1 | Physical Address |
No.11, Wugong 6th Rd., Wugu Dist.
|
||||
1 |
New Taipei City, 24891
|
|||||
1 |
Taiwan
|
|||||
1 | Telephone Number |
886-2******** Extension:
|
||||
1 | Fax Number |
886-2********
|
||||
1 |
c******@sgs.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 05/23/2021 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | ecg701 | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power output listed is conducted. This is a portable device. The antenna used for this transmitter must not be co-located or operating in configuration with any other antenna or transmitter. End users must be provided with specific instructions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Compliance Certification Services Inc. Wugu Lab.
|
||||
1 | Name |
H******** L****
|
||||
1 | Telephone Number |
886-2******** Extension:
|
||||
1 | Fax Number |
+886-********
|
||||
1 |
h******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0028000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC