Quanta Computer Q-steth-w1 QOCA Wireless Digital Stethoscope User Manual

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 patient’s body. And when user puts QOCA Wireless Digital Stethoscope on the patient’s 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 adult’s heart lung blood vessel. With sound signal amplifying and filtering, user can hear the sound through earphones or on smartphone via Bluetooth transmission.

Single lead ECG:
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 storage.

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 fully charged.
It is intended for trained medical personal use with patient not in critical conditions.

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 antennas.
• 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 fall.
• Please use the accessories provided or recommended by Quanta to 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.

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
Sensor x 1| Q-steth-w1-C1
Charger x 1| USB type-C cable x 1
(Material TPE; Length 100cm)| User Manual x 1

Before You Start:

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 charging.
   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 smartphone 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.
   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
   Table 1. The function of six touch keys Icon| Touch Key Function
   ---|---
   | Power
   Fn| Mode select
   +| volume up
   –| volume down
   REC| Recording ECG data、heart or lung sound
   NEXT| 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.

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.
   Table 2. Indication on screen Area| The indication on screen
   ---|---
   1| Show the volume、Bluetooth connection、batterystatus
   2| Show current mode in figures
   3| Show current mode in wordings and status (recording)

The layout of QOCA Wireless Digital Stethoscope’s screen

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
   ---|---
   1| Show ECG waveform
   2| Show sound waveform in time domain
   3| For volume up/down
   4| To select the mode
   5| To enable recording
   6| Show the connected device’s serial number

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.
   From the top view of QOCA Wireless Digital Stethoscope, the ECG leads RA and LL are introduced as below.
   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.
   Important: ECG signal and heart rate are only for reference. Do not use it for diagnosis.

Product Specification:

Continuous ECG data acquisition and calculation
Frequency Response: Monitor 0.5 to 40 Hz (-3db)
Differential Input Impedance: > 10MΩ
Common Mode Rejection Ratio: > 70 dB
Sampling rate: default at 256Hz
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)
Audio| Diaphragm (100-500Hz) / Bell mode (20-200Hz) /Extended (20-1000Hz)
Audio frequency range| 20 Hz — 2000 Hz
Volume level degree| 10 levels
Record time| 20 sec, 30 sec, 40 sec
Battery| 3.85V/220mAh
Battery life| Continuous use for 2 hours
Battery indication| 100%, 70%, 30%, 10%(low battery)
Screen| 0.96″ OLED
Key| Six touch keys (Power, Mode, volume up, volume down, record, next)
Working temp| Temperature: 545°C,
Humidity: 10% — 95% (non-condensing)
Storage temp| Temperature: -2060°C
humidity: 10% — 95% (non-condensing)
Name| Charger
---|---
Model Number| Q-steth-w1-c1
Adapter input| 5V/0.5A
Working Temperature| 5 – 35°C, 10% ~ 95% (non-condensing)
Storage Temperature| -20 – 60°C, 10% ~ 95% (non-condensing)

Cleaning and Maintance:

The table below describes the appropriate cleaning methods for each item

alcohol.
Charger| wipe with a dry cloth

Troubleshooting

If you encounter any problems when using the device, try the following solutions.

try
Device malfunction.| Please contact Quanta Customer Support.
APP cannot detect the device.| The device is turned off.| 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 Bluetooth transmission range.| Keep both devices within 5 meters.
Sound measurement| Cannot hear the measured sound| Retry power on/off the device. Or please contact Quanta customer support.
ECG measurement| No ECG waveform| 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 Münster, Germany

Federal Communications Commission (FCC) Statement

The FCC ID is HFSMH9
15.21
You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment.

15.19
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

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.

15.105(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.

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 WIRELESS DIGITAL STETHOSCOPE conforms to the following regulatory requirements. Administrative Regulations on Low Power Radio Waves Radiated Devices (930322) Article 12
Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to an approved low power 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
| 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.
IP22| Protected against solid objects down to 12mm.
Protection against low pressure jets of water, limited ingress permitted.

Supplier’s Declaration

The QOCA WIRELESS DIGITAL STETHOSCOPE conforms to the international EN 60601-1 and EN 606011-2 standards for electromagnetic compatibility with medical electrical devices and systems.

Manufacturer’s 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
test level| Compliance level| Electromagnetic environment- guidance (for home and professional healthcare environment)
---|---|---|---
Electrostatic discharge(ESD) IEC 61000-4-2| Contact:±8 kV
Air±2 kV.±4 kV ±8 kV.±15 kV| Contact±8 kV
Air±2 kV.±4 kV,±8
kV.±15 kV| Floors should be wood. concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast transienliburst IEC 610004-4| + 2kV for power supply lines + I kV for input/output lines _| + 2kV for power supply lines Not applicable| Mains power quality should be that of a typical home and professional healthcare environment.
Surge IEC 61000-4-5| + 0.5kV. +11W line(s) to line(s) + 0.5kV. + lkV.+ 2kV line(s) to earth| + 0.51W. +1kV line(s) to line(s) Not applicable| Mains power quality should be that of a typical home and professional healthcare environment.
Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 610004-11| 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; 30 cycles
Voltage interruptions:
0 % UT; 300 cycle| Mains power quality should be that of a typical home and professional healthcare
environment If the user of the 0-steth-wl
requires continued operation during power mains interruptions, it is recommended that the 0-stem-w1 be powered from an uninterruptible
power supply or a battery.
Power frequency(50. 60 Hz) magnetic field IEC 610004-8| 30 A/m
50 Hz or 60 Hz| 30 Alm
50 Hz and 60 Hz| The 0-steth-w1 power frequency magnetic
fields should be at levels characteristic of a typical location in a typical home and professional healthcare environment.
NOTE UT is the ac. mains voltage prior to application of the test level.

Manufacturer’s 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 and environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance (for home and professional healthcare environment)
---|---|---|---
Conducted RF
IEC 61000-4-6Radiated RF
IEC 61000-4-3| 3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM bands between
0,15 MHz and 80
MHz
3 Vrms
0,15 MHz – 80 MHz
6 V m) in ISM and
amateur radio bands
between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
10Vm
80 MHz – 2,7 GHz
80 % AM at 1 kHz| 3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM bands between
0,15 MHz and 80
MHz
3 Vrms
0,15 MHz – 80 MHz
6 V m) in ISM and
amateur radio bands
between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
10Vm
80 MHz – 2,7 GHz
80 % AM at 1 kHz| Portable and mobile RF communications equipment should be used no closer to any part of the Q-steth-w1 including cables, than the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter. Recommended separation distance:
d = 1,2
d = 1,2   80MHz to 800 MHz
d = 2,3   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 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.

Manufacturer’s 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 ”
(MHz)| Service E| Modulation 0| Maximum
power (W)| Distance (m)| IMMUNITY TEST
LEVEL (V/m)| Compliance
LEVEL (V/m)
(for home and
professional
healthcare)
---|---|---|---|---|---|---|---
385| 380 -390| TETRA 400| Pulse modulation b) 18 Hz| 1,8| 0.3| 27| 27
450| 430 – 470| GMRS 460.
FRS 460| FM c) ±5 kHz
deviation I kHz sine| 2| 0.3| 28| 28
710| 704 -787| LTE Band
13, 17| Pulse modulation b) 217 Hz| 0.2| 0.3| |
745
780
810| 800 – 960| GSM 800/900.
TETRA 800. iDEN 820. COMA 850. LTE Band 5| Pulse modulation b) 18 Hz| 2| 0.3| 28|
870
930
1720| 1 700-1 990| GSM 1800: CDMA 1900: GSM 1900: DECT:
LTE Band 1, 3.
4. 25:
U MTS| Pulse modulation b) 217 Hz| | | |
1845
1970
2450| 2400-2570| Bluetooth.
WLAN.
802.11 b/g/n,
RFID 2450.
LTE Band 7| Pulse modulation b) 217 Hz| 2| 0.3| 28| 28
5240| 5100 -5 800| WLAN
802.11 a/n| Pulse
modulation b) 217 Hz| 0.2| 0.3| 9| 9
5500
5785
NOTE If necessary to achieve the IMMUN TY TEST LEVEL, the dis ance between the transmitting 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.

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
W| Separation distance according to frequency of transmitter
m
---|---
150 kHz to 80 MHz
d =1.2| 80 MHz to 800 MHz
d =1.2| 800 MHz to 2,7 GHz
d =2.3
0,01| 0.12| 0,12| 0,23
0,1| 0.38| 0.38| 0,73
1| 1,2| 1.| 2.
10| 3,8| 4.| 7.
100| 12| 12| 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.

Manufacturer’s 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 (for home and professional healthcare environment)
---|---|---
RF emissions CISPR 11| Group  1| The Q-steth-w1 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.
RF emissions CISPR 11| Class B| The Q-steth-w1 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations /flicker emissions IEC 61000-3-3| Compliance

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