QOCA Wireless Digital Stethoscope User Manual ModelQ-steth-w1 Please read this user manual before use. Version: 3A Indication for Use:
QOCA Wireless Digital Stethoscope picks up the sounds from the heart, lungs, anterior/posterior chest, abdomen from a patients body. And when user puts QOCA Wireless Digital Stethoscope on the patients heart, it could detect ECG signal at the same time. ECGHRSound data will be transferred to a smartphone via Bluetooth and displayed on the smartphone screen. QOCA Wireless Digital Stethoscope is intended for trained medical personal use. Function Introduction:
Stethoscope:
With embedded microphone, it could pick up the sound of adults heart lungBlood vessel. With sound signal amplifying and filtering, user can hear the sound through earphones or on smartphone via Bluetooth transmission. Single lead ECG:
storage. Through two metal electrodes on the button of QOCA Wireless Digital Stethoscope, it could detect the ECG signal and heart rate of adult. And those data will be transferred to a smartphone via Bluetooth for further display and Product Introduction:
QOCA Wireless Digital Stethoscope is simple use, which can be used as a stand-alone device with headphones. The heart rate and measurement results will be displayed on the screen. In addition, you can install a software-specific APP on your mobile device to receive auscultation sounds, ECG signals, and heartbeats through Bluetooth, display, store, record, and play, and manage data (auscultation sounds, ECG, and heartbeats). Built-in lithium battery, it can be used continuously for 3 hours when It is intended for trained medical personal use with patient not in critical fully charged. conditions. 1 Precautions:
In order to reduce the risks related to charging, please follow the charging conditions in this manual, set up and comply with the requirements of the charging mode. In order to reduce the risk of incorrect results, personal injury and equipment damage, please follow the recommended instructions in this manual to store and operate this product. In order to reduce the risk of damaging the auscultation head, please do not place the auscultation head close to a strong sound source. To reduce the risk of infection, please follow the cleaning and disinfection instructions in the manual. In order to reduce the risk of ear canal damage, please hold the instrument firmly to avoid sudden fall. In order to reduce the risk of extremely strong magnetic fields, when using this product, please avoid close to strong radio frequency signals or portable and/or mobile radio frequency equipment. If you hear sudden or unexpected sounds, move away from any radio transmitting In order to reduce the risk of damage to the stethoscope, please put the stethoscope body in the pocket of the doctor's suit to avoid sudden Please use the accessories provided or recommended by Quanta to antennas. fall. avoid danger. Do not immerse the stethoscope in liquid, or immerse it in any disinfectant, which may cause damage to the equipment. The battery must be charged continuously for at least 8 hours before using it for the first time. Otherwise, the service life of the battery may be shortened. To store and transport this product, please follow the product storage specifications in the manual. Do not replace the lithium battery arbitrarily. Do not modify or fix this product arbitrarily. Do not use it the environment of cotton lint, dust, and sunlight. It is use for people who is over 20 years old. And do not use it on critical condition patient. The measured ECG data is for reference only, do not use for diagnosis. Do not apply on one specific location over 30 seconds. 2 Package Contents After purchasing the QOCA Wireless Digital Stethoscope, please check the product package to ensure that the following items are included:
Product Package Q-steth-w1 Q-steth-w1-C1 Sensor x 1 Charger x 1 USB type-C cable x 1 Length 100cm)
(Material TPE;
User Manual x 1 Before You Start:
charging. Before you start using the QOCA Wireless Digital Stethoscope you must:
1. Place the QOCA digital stethoscope on charger & contact the five pogo pins for
(As below figure) 3 The following icon shown on screen while charging 2. Install the QOCA steth APP on your Android smartphone 3. Enable Bluetooth on your smartphone Getting Started:
1.Power on:
Long Press the power touch key for 3 seconds till the screen is light up. The power touch key is on the button of screen. 2.Launch QOCA steth APP:
Press the following Icon on your smart phone to launch the QOCA steth APP The icon of QOCA steth APP 3.Connecting via Bluetooth:
Select the name of MH9XSXXXXXXX on the list for Bluetooth connection. 4 The launch screen of QOCA steth APP QOCA Wireless Digital Stethoscope:
1. The touch keys:
There are Six touch keys on the top of device which are volume upvolume down recordnext usermode selectpower key. The location of each touch key is showed as below figure. Figure 2. The top view of QOCA digital stethoscope showing the location of six touch keys 5 Table 1. The function of six touch keys Touch Key Function Power Mode select volume up Icon Fn
REC NEXT volume down Recording ECG dataheart or lung sound To the next patient (Disable in current version) 1-1. Power on / Power off:
Long Press the power touch key for 3 seconds till the screen is light up. In the power on state, Long Press the power touch key for 3 seconds till the screen is light off. 1-2. Mode:
QOCA Wireless Digital Stethoscope has three modes. There are Bell mode, Diaphragm mode and extended mode. User can switch mode by press the following touch key
(The mode icon as below figures) 1-3. Record Data:
While connecting to QOCA steth APPPress the REC key. It would take a 30 seconds data recording and the following icon would be shown on screen. 6 2. Display:
The display shows the following information on screen: volume status Bluetooth connection statusbattery statusrecording statusmode status. The detail is described as below figure and table. 1 2 3 Table 2. Indication on screen Area The indication on screen Show the volumeBluetooth connectionbattery status Show current mode in figures Show current mode in wordings and status (recording) The layout of QOCA Wireless Digital Stethoscopes screen 7 QOCA steth APP on Smart Phone:
1. Main Page QOCA steth APP is able to display the modeECG waveformaudio waveform. Check below figure. Area The indication on screen Show ECG waveform Show sound waveform in time domain For volume up/down To select the mode To enable recording Show the connected devices serial number 1 2 3 4 5 6 8 Take Measurement:
1. Sounds:
Place QOCA Wireless Digital Stethoscope at the position to be sound measured. Below figure is the suggestive location for sound measurement. 2. ECG measurement:
QOCA Wireless Digital Stethoscope is able to measure single lead ECG. And the two dry electrodes in on the bottom side of device. Place QOCA Wireless Digital Stethoscope on the heart with QOCA wording in level, and it should not be inclined. 9 LL are introduced as below. From the top view of QOCA Wireless Digital Stethoscope, the ECG leads RA and 10 Important: Be sure to perform the measurement according to the specific position, the other ECG measurement position is not be referenced. Important: Wipe the measuring area with a wet tissue or saline before taking an ECG measurement. diagnosis. Important: ECG signal and heart rate are only for reference. Do not use it for Product Specification:
Item ECG monitor Sampling rate: default at 256Hz Specification Single lead Continuous ECG data acquisition and calculation Frequency Response: Monitor 0.5 to 40 Hz (-3db) Differential Input Impedance: > 10M Common Mode Rejection Ratio: > 70 dB Heart rate measurement range*: 30 240 bpm
*Heart rate is calculated based on the R-R interval of the ECG. Heart rate accuracy: 3 bpm or 3% whichever is greater Lead-off detection Detect when the target gets loosened from patch BT connectivity BT 5.10 (10m at open space) Diaphragm (100~500Hz) / Bell mode (20~200Hz) /
Battery indication 100%, 70%, 30%, 10%(low battery) Audio Audio frequency range Volume level degree Record time Battery Battery life Screen Key Working temp Storage temp Extended (20~1000Hz) 20 Hz ~ 2000 Hz 10 levels 20 sec, 30 sec, 40 sec 3.85V/220mAh Continuous use for 2 hours 0.96 OLED Six touch keys (Power, Mode, volume up, volume down, record, next) Temperature: 5 ~ 45C, Humidity: 10% ~ 95% (non-condensing) Temperature: -20 ~ 60C humidity: 10% ~ 95% (non-condensing) 11 Name Model Number Adapter input Charger Q-steth-w1-c1 5V/0.5A Working Temperature 5 35C, 10% ~ 95% (non-condensing) Storage Temperature
-20 60C, 10% ~ 95% (non-condensing) Cleaning and Maintance:
The table below describes the appropriate cleaning methods for each item Parts Method QOCA Wireless Digital Carefully wipe with a cloth with 75% alcohol. Stethoscope Charger wipe with a dry cloth Troubleshooting If you encounter any problems when using the device, try the following solutions. Problem Possible Cause Solution The device cannot be turned on. APP cannot detect the device. The battery is low. Device malfunction. The device is turned off. Charge the battery and try again. Please contact Quanta Customer Support. Press the Power button to turn the device on. The Bluetooth function on your smartphone is disabled. Go to Settings > Bluetooth and set the setting to ON to turn on the Bluetooth function. Both devices are out of the Keep both devices within 5 meters. 12 Bluetooth transmission range. Sound measurement Cannot hear the measured sound ECG measurement No ECG waveform Retry power on/off the device. Or please contact Quanta customer support. Wipe the measuring area with a wet tissue or saline Place on the heart and keep QOCA wording in level. 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 13 Federal Communications Commission (FCC) Statement The FCC ID is HFSMH9 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 1) This device may not cause interference and 2) This device must accept any interference, including interference that may cause undesired operation of the device. 15.21 15.19 conditions:
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. 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. 14 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 Article 12 Article 14 achieved. The QOCA WIRELESS DIGITAL STETHOSCOPE conforms to the following regulatory requirements. Administrative Regulations on Low Power Radio Waves Radiated Devices (930322) 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 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 Indicates that the body sensor is classified as electrical or electronic equipment requiring proper disposal (WEEE Directive) 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. Protected against solid objects down to 12mm. IP22 Protection against low pressure jets of water, limited ingress permitted. 15 Suppliers Declaration The QOCA WIRELESS DIGITAL STETHOSCOPE conforms to the international EN 60601-1 and EN 60601-
1-2 standards for electromagnetic compatibility with medical electrical devices and systems. Manufacturers declaration-electromagnetic immunity The Q-steth-w1 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-steth-w1 should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment-guidance test level
(for home and professional healthcare environment) Electrostatic Contact:8 kV Contact:8 kV Floors should be wood, concrete or ceramic discharge(ESD) Air2 kV,4 kV,8 kV,15 kV Air2 kV,4 kV,8 tile. If floors are covered with synthetic IEC 61000-4-2 kV,15 kV material, the relative humidity should be at least 30%
Electrical fast
+ 2kV for power supply lines
+ 2kV for power Mains power quality should be that of a typical transient/burst
+ 1kV for input/output lines supply lines home and professional healthcare IEC 61000-4-4 Not applicable environment. Surge
+ 0.5kV, +1kV line(s) to line(s)
+ 0.5kV, +1kV line(s) Mains power quality should be that of a typical IEC 61000-4-5
+ 0.5kV, +1kV,+ 2kV line(s) to to line(s) Not home and professional healthcare earth applicable environment. Voltage Dips, short Voltage dips:
Voltage dips:
Mains power quality should be that of a typical interruptions and voltage 0 % UT; 0,5 cycle 0 % UT; 0,5 cycle home and professional healthcare variations on power 0 % UT; 1 cycle 0 % UT; 1 cycle environment. If the user of the Q-steth-w1 supply input lines 70 % UT; 25/30 cycles 70 % UT; 30 cycles requires continued operation during power IEC 61000-4-11 mains interruptions, it is recommended that the Voltage interruptions:
Voltage interruptions:
Q-steth-w1 be powered from an uninterruptible 0 % UT; 250/300 cycle 0 % UT; 300 cycle power supply or a battery. Power frequency(50, 60 30 A/m 30 A/m The Q-steth-w1 power frequency magnetic Hz) magnetic field 50 Hz or 60 Hz 50 Hz and 60 Hz fields should be at levels characteristic of a IEC 61000-4-8 typical location in a typical home and professional healthcare environment. NOTE UT is the a.c. mains voltage prior to application of the test level. 16 below. The Q-steth-w1 is intended for use in the electromagnetic environment (for home and professional healthcare) specified Manufacturers declaration-electromagnetic immunity The customer or the user of the Q-steth-w1 should assure that it is used in such and environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
(for home and professional healthcare environment) Conducted RF 3 Vrms:
3 Vrms:
Portable and mobile RF communications IEC 61000-4-6 0,15 MHz 80 MHz 0,15 MHz 80 MHz equipment should be used no closer to any 6 Vrms:
6 Vrms:
part of the Q-steth-w1 including cables, than in ISM bands between in ISM bands between the recommended separation distance 0,15 MHz and 80 0,15 MHz and 80 calculated from the equation applicable to the frequency of the transmitter. MHz 3 Vrms MHz 3 Vrms 0,15 MHz 80 MHz 0,15 MHz 80 MHz 6 V m) in ISM and 6 V m) in ISM and amateur radio bands amateur radio bands between between 0,15 MHz and 80 MHz 0,15 MHz and 80 MHz 80 % AM at 1 kHz 80 % AM at 1 kHz Radiated RF Recommended separation distance:
IEC 61000-4-3 10Vm 10Vm d = 1,2 80 MHz 2,7 GHz 80 MHz 2,7 GHz d = 1,2 80MHz to 800 MHz 80 % AM at 1 kHz 80 % AM at 1 kHz 800MHz to 2,7 GHz d = 2,3 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 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. 17 450 710 745 780 810 870 930 1 720 1 845 1 970 5 240 5 500 5 785 Manufacturers declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The Q-steth-w1 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-steth-w1 should assure that it is used in such an environment. Test frequency
(MHz) Band a)
(MHz) Service a) Modulation b) Maximum power
(W) Distance
(m) IMMUNITY TEST LEVEL
(V/m) 385 380 390 TETRA 400 1,8 0,3 27 Pulse modulation b) 18 Hz FM c) 5 kHz deviation 1 kHz sine 430 470 GMRS 460, FRS 460 2 0,3 28 704 787 LTE Band 13, 17 Pulse modulation b) 217 Hz 0,2 0,3 9 9 800 960 Pulse modulation b) 18 Hz 2 0,3 28 28 Compliance LEVEL
(V/m)
(for home and professional healthcare) 27 28 1 700 1 990 Pulse modulation b) 217 Hz 2 0,3 28 28 2 450 2 400 2 570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 2 0,3 28 28 5 100 5 800 WLAN 802.11 a/n Pulse modulation b) 217 Hz 0,2 0,3 9 9 If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting NOTE antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. 18 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25;
UMTS Recommended separation distance between portable and mobile RF communications equipment and the Q-steth-w1 The Q-steth-w1 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-steth-w1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Q-steth-w1 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 =1,2 d =1,2 d =2,3 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. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. W 0,01 0,1 1 10 100 0,12 0,38 1,2 3,8 12 19 Manufacturers declaration-electromagnetic emissions The Q-steth-w1 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-steth-w1 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment-guidance RF emissions CISPR 11 Group 1 The Q-steth-w1 uses RF energy only for its internal
(for home and professional healthcare environment) function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The Q-steth-w1 is suitable for use in all Harmonic emissions establishments, including domestic establishments IEC 61000-3-2 Class A and those directly connected to the public low-
Voltage fluctuations voltage power supply network that supplies
/flicker emissions IEC Compliance buildings used for domestic purposes. 61000-3-3 Bluetooth Technical Specification:
Technical Specification Value Operating Frequencies 2402~2480MHz Channel Spacing Channel number Operating Voltage Modulation Antenna Gain 2MHz 40 3.3V GFSK PCB printed antenna, Peak Gain: 0.825 dBi Rated Power (ERP) 2.59 dBm 20