Inventec Q21 User manual

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Model: Q21
Chiline ECG Recorder
Instruction Manual
MOHW-MD-No. 006588
Please read the instruction manual carefully before using the product.

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1. Product Description
This product is a single-lead ECG recorder. It can record, display and analyze the ECG signals detected
through simple steps.
2. Product Features
1. Integrated design allows the recording and results being displayed on the cellphone screen for
bigger and better viewing.
2. Two types of recording tools (finger electrodes and cable electrodes) are supported for users’
convenience.
3. Discomfort marking feature allows users to mark the moment when discomfort of the chest is felt
during recording by pressing the power button. This feature helps physicians pinpoint the
problem.
4. It is a lightweight and portable device with 24-hour recording capacity. Recording can be done
anytime and anywhere without having to wait at a hospital.
3. Application
This product uses finger electrodes or cable electrodes to send the cardiac electrical current to the ECG
recorder to be recorded. Users may use this product with a physician’s recommendation and can operate
it without another person’s supervision. The recorder will provide real-time information to gain insight of
heart rate and rhythm. Users will receive results from a single-lead ECG. The device records, displays and
analyzes the ECG signals to aid physicians for further interpretation and diagnosis.
4. Contents
1. Chiline ECG recorder
2. Storage case
3. Cable electrodes
4. Charging cable
5. Main unit protective cover
6. Carrying case
7. Instruction manual
8. Warranty card
•Chiline ECG recorder
1) Power button (with LED indicator light)
2) Finger electrodes
3) Port for cable electrodes and charger
Note: For the specifications of the electrode pads needed for cable electrodes recording, please review
the details in section 9 “Others”.
5. Warnings
1. Do not use with a defibrillator.
2. Do not use with an MRI scanner.
3. Do not use with an electrosurgical unit.
4. Do not use this product in an environment with flammable anesthetic/medication, or hyperbaric

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oxygen.
5. Do not use this product on individuals under 18 years old.
6. Keep the conductive part of the product away from charged objects and from the ground.
7. Do not self-diagnose using the results from this product nor thereby alter the treatment plan on
your own.
8. Keep this product away from outside forces.
9. Do not disassemble or repair this product on your own.
10. Do not use or clean this product when it is being charged (an orange indicator light will be on
while charging).
11. When cleaning this product, do not submerge this product in water or other liquids.
12. Do not place this product in direct UV light.
13. Pacemakers and other implanted devices may affect the performance of this ECG recorder.
14. This product cannot be connected to other medical devices.
15. This product contains strong magnetic components. Stay away from other magnetic objects
while using the product.
16. Using this product in an environment with strong magnetic field will affect its performance.
17. Results from this product are only references for physicians; they do not serve a diagnostic
function.
18. If this product is being used in a medical facility, it is advised that the product is checked daily to
ensure that the device can be turned on and off properly and that there is no damage to the
cable electrodes.
19. Check the product before each use. Do not use the product if the device or the cable electrodes
have apparent damage.
20. When using the cable electrodes or the charger, be sure to plug and unplug by holding the plug,
not the cable. Do not shake the cables once it is plugged in.
21. This product is not waterproof. Do not use it in bathroom or humid area.
22. When the product is used on individuals with excessive or too little body fat, it may affect signal
transmission.
23. When using cable electrodes to record over a long period of time, be sure to check the location
of the electrodes so they are positioned correctly. In addition, check if the person being tested
develops any skin allergies. If so, stop using the device immediately.
24. Only certified professionals are authorized to repair the product.
25. Avoid storing the product in direct sunlight, or at high temperatures or high humidity.
26. Please follow local regulations when dispose of this product and its parts.
6. Instructions
6.1 Before using the product:
1) It is recommended to charge the device for more than 3 hours before first use.
2) Download the free Chiline app (scan the QR code on the packaging or on the back of the instruction
manual).
3) Go to “Settings” in your cellphone to turn on Bluetooth.
4) Press the power button for 3 seconds as illustrated in the image below until a green light appears.
Green light indicates that the device is on.
5) When all the above steps have been completed, open the Chiline app (main screen will look similar
to the image on the right)

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6.2 Start recording
1) Open the Chiline app, then tap “Record an ECG”.
2) The cellphone will search for the ECG recorder. A blue light will remain on when the Bluetooth
connection is successful (below image).
3) Choose a recording mode, type of electrodes and duration in the Chiline app to begin recording.
6.3 Recording mode
This device supports two types of recording:
•Resting
•Ambulatory
(below image)
6.3.1 Resting mode
Two types of electrodes supported:
•Finger electrodes
•Cable electrodes (below image). Recording time is available for either 30 or 60 seconds. A result is

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shown for every 30 seconds of recording (no result available for recording less than 30 seconds).
Finger electrodes:
Please follow the instructions in the app:
1) Rest both arms comfortably on a table. Orient the device so the power button is facing away from
you. Slightly press both thumbs on the front of the finger electrodes. Place index fingers at the
back of the finger electrodes but do not allow the index fingers to touch (below image). Stay
relaxed during the recording.
2) When the above steps are completed, the system will begin recording once an ECG signal is
detected (below image).
3) Real time display of waveforms is available in the app.
(Viewing available in both landscape and portrait orientations.)

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4) When recording is completed, the app will display the results (below image).
(Viewing available in both landscape and portrait orientations.)
Cable electrodes:
Instructions for using the cable electrodes are the same as that for recording in “ambulatory mode”.
6.3.2 Ambulatory mode:
Only cable electrodes can be used in ambulatory mode. Do not use the device in a bathroom or in a humid
area and avoid strenuous activities while recording in ambulatory mode.
1) Recording time is available from one minute to 24 hours (below image). A result is shown for every
minute of recording (no result available for recording less than one minute).
2) Please follow the next two steps (below images):

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Step 1: Plug the cable into the USB port.
Step 2: Attach the wires with the electrodes, then place the electrodes at the correct location on
the body (below image).
White electrode: Place at “RA”, below the right collarbone.
Green electrode: Place at “RL”.
Red electrode: Place at “LL”.
“RL” and “LL” are below the right and left rib cage respectively. They must align horizontally.
3) When the above steps are completed, the system will begin recording once an ECG signal is
detected.
4) Real time display of waveforms is available in the app (below image). The duration of waveform
displayed will depend on each cellphone’s performance. The device will continue to record offline
even if the waveforms are not displayed.
(Viewing available in both landscape and portrait orientations.)
5) Results are shown for every minute of recording.
(Viewing available in both landscape and portrait orientations.)
6) When recording is completed, the app will display the results.
(Viewing available in both landscape and portrait orientations.)
Results will show:

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•Subject
•Total time recorded
•Number of discomfort marked
•ECG results, number of results and percentage of each type of result.
7) If “Recording offline” is tapped
or if the Bluetooth connection is off before the recording ends, the device will continue to detect your
ECG signals until the end of recording. After the recording, tap “Tap to transfer data” on the main
screen to upload data.
8) If “Recording offline” or “Record an ECG” (images below and to the right) is tapped before the
recording ends, the device will reconnect to the cellphone and real-time ECG waveforms and
results from every minute of recording after the reconnection will be available for viewing again.

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(below image illustrates real-time waveforms)
9) When recording is completed, press the power button for three seconds to turn off the device (the
device will also turn off automatically after three minutes of inactivity).
Note 1: When recording in ambulatory mode, press the power button if you feel pain or discomfort in the
chest. The time when discomfort is felt will then be marked on the ECG report.
Note 2: When recording with cable electrodes, do not have directly skin contact with the device;
remember to store the main unit into the protective cover before placing the device into the pocket.
Note 3: If the Bluetooth connection is off when recording in resting mode, the recording will be terminated.
If it happens when recording in ambulatory mode, the device will switch to offline recording, and the
results will be available after the recording.
6.4 ECG results
1) Each resting ECG recording provides one of the following test results:
#
Result

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1
No abnormal waveforms detected (average HR = 51 –99 bpm)
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Tachycardia suspected (average HR = 100 –129 bpm). Relax, stay still and record again with cable
electrodes. Please consult a doctor if you have chest pain or discomfort.
3
Tachycardia suspected (average HR ≥130 bpm). Relax, stay still and record again with cable
electrodes. Please consult a doctor if you have chest pain or discomfort.
4
Bradycardia suspected (average HR = 41 –50 bpm). Relax, stay still and record again with cable
electrodes. Please consult a doctor if you have chest pain or discomfort.
5
Bradycardia suspected (average HR ≤40 bpm). Relax, stay still and record again with cable electrodes.
Please consult a doctor if you have chest pain or discomfort.
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Premature ventricular contractions suspected. Relax, stay still and record again with cable electrodes.
Please consult a doctor if you have chest pain or discomfort.
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Arrythmia suspected. Relax, stay still and record again with cable electrodes. Please consult a doctor if
you have chest pain or discomfort.
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Too much noise or signal is too weak. Unable to analyze. Please operate finger electrodes according to
the instruction manual, or relax, stay still and recheck with cable electrodes.
Note: “No abnormal waveforms detected” indicates that no abnormalities are found of the issues this
device is designed to detect.
Calculation of heart rate (HR):
Real-time HR:
 


Average HR:
 
    


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7. Product Specifications
Product Model
Q21
Product
Wireless Bluetooth ECG Recorder (wireless Bluetooth 4.1)
Leads
Single-lead, Lead I: finger electrodes, Lead II: cable electrodes
Product Size
1. Main unit: 66 mm (L) x 40 mm (W) x 12 mm (H)
2. Main unit with storage case: 90 mm (L) x 90 mm (W) x 25 mm
(H)
Weight
1. Main unit: 37 g  3 g
2. Main unit with storage case: 116 g  5 g
Power Supply
1. Lithium battery (500mAh)
2. Power adapter (5V 1.2A DC, Micro USB)
Model: EDAC POWER Electronics
EM1005AVUS (optional purchase)
Input Power
1. Power adapter input power supply: 100–240V
Input current: 0.6A (max) @ 115V～ 0.3A (max) @ 230V
Output voltage/current: 5V/1.2A
2. Device input voltage/current: 5V/225 mA
Recording Tools
1. Finger electrodes
2. Cable electrodes
Number of Readings
Saved in Cellphone
Up to 10 most recent readings (default setting)
Device Memory
Capacity
1. Storage space: 4GB. Can save up to 720 hours of ambulatory
recording data.
2. When the storage space is full, any untransferred data will be
replaced by new data.
Data Transfer
1. Low-power Bluetooth wireless transfer
2. Wi-Fi: 802.11 b/g/n (large data size transfer)
Recording Time
Recording time can be set in the Chiline app
1. Resting mode: supports 30 or 60 seconds recording
2. Ambulatory mode: supports 1 minute to 24 hours recording
Sampling Rate
500 Hz
Sensitivity
10 mm/mV
Paper Speed
25 mm/s
Dynamic Range
403 mV
Gain Setting
6
Accuracy
0.2% (FS)
Frequency Response
0.067–131 Hz
Input Impedance
>10 M Ohm
Common Mode
Rejection Ratio
≥ 105 dB
Storage/Delivery
Conditions
Temperature: -25°C–60°C
Humidity: 10%–95%
Operation Conditions
Temperature: 10°C–45°C
Humidity: 10%–95%
Resting Mode Result
Range
1. Average heart rate: 30–250 bpm
2. ST range: -3 to +3 mm
3. QRS interval: <0.20 sec
Ambulatory Mode
Result Range
Average heart rate: 45–180 bpm
Filter Frequency Range
0.5–40 Hz
Resting Mode Result
Error
Heart rate: 2 bpm
Power Supply Standard
Class II

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Shelf Life
2 years
Note: Please use a charger that meets the requirements.
This product uses built-in lithium battery. Users cannot replace the battery on their own.
Please recycle batteries
1. Device Notifications and Solutions
1.1 Indication light
The indication light provides three colors for indication: orange, blue and green.
Status
Indication Light
27. Device is on
Green light remains on.
28. Device turning off
Orange light remains on for 2 seconds then switches off.
29. Charging
Orange light flashes (on for 0.5 second, off for 1 second).
30. Fully charged
Orange light remains on.
31. Bluetooth connection
1. When Bluetooth connection is on, blue light remains on.
2. When data is being synced, blue light flashes twice every
second.
32. Discomfort marking during ambulatory
recording
Orange light remains on for 1 second then switches off.
33. ECG recording in progress
Green light flashes (on for 0.5 second, off for 3 seconds).
1.2 Alarm
Status
Alarm
Disconnection during offline recording
1. The alarm will go off three times, each for one second.
2. If disconnection continues, the alarm will go off every
minute for three times.
8.3 Troubleshooting
Please follow the below solutions for each problem.
Displayed message and solutions
Causes
No device found. Please ensure the device is
turned on.
(If this error persists, please read the manual
or contact customer service.)
1. Device is off.
2. Device has been inactive for more than 3 minutes.
3. The distance between device and cellphone is out of
range of connection.
4. Bluetooth is off.
Unable to connect to the device
(If this error persists, please read the manual
or contact customer service.)
The device has been disconnected.
(If this error persists, please read the manual
or contact customer service.)
The device is currently in use by another
person offline in ambulatory mode. If you wish
to record, please restart the device.
The device is in use by another person offline in ambulatory
mode.
Recording cannot be done while the device is
being charged. Please remove the charger and
record again.
Concurrent use of ECG recorder and charger.
Your selected type of electrodes is different
from that detected by the system.
Recording tool used is different from the tool selected in the
app.
Unable to detect ECG signal. Please confirm
Disconnection (lead-off) of finger or cable electrodes when

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connectivity of cable electrodes or finger
electrodes.
recording in resting mode.
Unable to detect ECG signal. Please confirm
connectivity of cable electrodes.
Disconnection (lead-off) of cable electrodes or heart rate
detected is 0 when recording in ambulatory mode.
Less than 20% storage space left. A data
transfer is recommended to avoid data loss.
Less than 20% storage space left in the device.
Too much noise or signal is too weak. Unable
to analyze. Please operate finger electrodes
according to the instruction manual, or relax,
stay still and recheck with cable electrodes.
Unable to analyze due to noise or weak signal when recording
in resting mode. Possible reasons include:
1. Dry or oily skin. Use soap and water to remove oil or
use alcohol to clean the skin.
2. Dirt on finger electrodes and electrode pads. Clean
the finger electrodes and replace electrode pads.
Follow the instructions under “9. Others” to clean.
3. Cable electrodes improperly connected to the device.
4. Muscle too tense. During recording, keep the arms
relaxed and place the side of the forearms on the
table.
5. Intense exercise carried out during recording. Please
stay still and avoid intense exercise.
6. Electromagnetic interference. Stay away from source
of interference.
Too much noise or signal is too weak. Unable
to analyze. Please operate cable electrodes
according to the instruction manual and
recheck.
Unable to analyze due to noise or weak signal when recording
in ambulatory mode. Possible reasons include:
1. Dry or oily skin. Use soap and water to remove oil or
use alcohol to clean the skin.
2. Dirt on electrode pads. Replace electrode pads.
3. Cable electrodes improperly connected to the device.
4. Electromagnetic interference. Stay away from source
of interference.
8.4 Technical issues
Please follow the below solutions for each technical issue.
Displayed message and solution
Cause
Error:
E1 Device error. Contact customer service.
Storage device error. Data cannot be saved.
Error:
E2 Device error. Contact customer service.
Persistent issue with detecting the recording tool, or constant
disconnection with finger or cable electrodes.
8.5 Reset
When there is a malfunction and the above solutions do not work, press the power button for 10
seconds to reset. The LED light will first disappear, then turn on again. If the problem persists after
resetting, please contact customer service. Do not disassemble the device on your own. The warranty is
void if the device has been disassembled.
8Others
9.1 Cable electrodes:
Cable electrodes must be used with electrode pads, which are purchased separately. It is advised to
purchase electrode pads that meet the following specifications:
1) The snap (male) must be able to fit with a 4.0 mm (diameter) female snap connector.
2) Electrode pads should not exceed 50 mm (diameter).
3) Electrode pads must have a medical device certification.
4) Electrode pads are for single use only. Use a new set of pads for each recording.

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5) Clean the area of skin that will have contact with the electrode pads.
6) Stop using the product if allergic reactions or inflammation of the skin occurs.
7) Avoid placing the electrode pads on wounded skin.
8) Ensure that the electrode pads are not expired.
9.2 Device care
Part
Device care
Chiline ECG Recorder
Wipe the product surface with dry cloth or 75% alcohol.
Storage case
Wipe the product surface with dry cloth or 75% alcohol.
Cable electrodes
Wipe the product surface with dry cloth or 75% alcohol.
Finger electrodes
Regularly wipe the surface of the finger electrodes with 75% alcohol.
Protective case
Clean with damp, soft cloth.
Carrying case
Gently clean the surface with soft dusting brush (with or without water). Do not
rub.
9.3 Symbols:
Symbol
Description
Carefully read the instruction manual before using the product.
The product must be connected to the user to use. But it cannot be placed directly
on the heart.
In compliance with the National Communications Commission (NCC) regulations.
Recycling information. This product contains electronics and electronic components
that may harm the environment. Do not dispose of the product with other general
waste. Recycle the product following applicable local laws and regulations.
Radiofrequency radiation hazard warning symbol
Serial number
Direct current
Manufacturing date
Manufacturer
9.4 Battery
9.4.1 This product has an inbuilt, non-removable lithium battery. Do not replace or repair it on your own, as doing
so will void the warranty and may cause other safety concerns.
9.4.1.1 Do not open, break, hit or throw the battery into fire or water as the battery will break, explode, or leak
dangerous chemicals.
9.4.1.2 When the battery is not being charged properly, gives a foul odor, or has a change in shape, stop using
the battery and return the device to the manufacturer. Only authorized engineers are permitted to disassemble
the device. Rechargeable lithium battery with the same model as the one provided by the original manufacturer
must be used.
9.4.2 It takes about three hours to charge the battery from 0% to 90%.
9.4.3 When the device is fully charged, the battery can last for one day with ambulatory recording. If Wi-Fi is used
to download recorded data, the battery can last for about 2.5 hours.
9.5 ECG waveform explained

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9.6 Manufacturer’s declarations
9.6.1 Guidance and manufacturer’s declaration—electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The user must ensure
that the device is used in such environment.
Emission test
Compliance
Electromagnetic environment—
guidance
Radiofrequency emissions CISPR
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Group 1
The device uses radiofrequency (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.
Radiofrequency emissions CISPR
11
Class B
The device is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
network that supplies buildings used
for domestic purposes.
Harmonic emissions IEC 61000-
3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
N/A
9.6.2 Recommended distance between portable/mobile RF communications equipment and Chiline’s ECG
Recorder
Chiline’s ECG Recorder is intended for use in an environment in which radiated RF disturbances are
controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance
between portable/mobile RF communications equipment and the ECG Recorder as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Distance according to frequency of transmitter (m)
150 kHz–80 MHz
d = 1.2
P
80 MHz–800 MHz
d = 1.2
800 MHz–2.5 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
2.3
10
3.8
3.8
7.3
P
P

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100
12
12
23
For transmitters rated at a maximum not listed, the recommended distance d in meters (m) can be
determined 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.
Note:
•At 80 MHz and 800 MHz, the distance for the higher frequency range applies.
•These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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9.6.3 Guidance and manufacturer’s declaration—electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The user must
ensure that the device is used in such environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic
environment—guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact
15 kV air
8 kV contact
15 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%. Try to use the
device in the environment
specified. If the condition
of the environment cannot
be determined, other
preventive measures must
be taken, such as using an
antistatic device,
discharging static electricity
from the body or wearing
antistatic clothing.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV
1 kV for input/output
2 kV
1 kV for input/output
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common mode
1 kV differential
mode
2 kV common mode
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95% dip in UT)
for 0.5 cycle
40 % UT
(60% dip in UT)
for 5 cycles
70 % UT
(30% dip in UT)
for 25 cycles
<5 % UT
(>95% dip in UT)
<5 % UT
(>95% dip in UT)
for 0.5 cycle
40 % UT
(60% dip in UT)
for 5 cycles
70 % UT
(30% dip in UT)
for 25 cycles
<5 % UT
(>95% dip in UT)
Mains power quality should
be that of a typical
commercial or hospital
environment.
If the user of the device
requires continued
operation during power
interruption, it is
recommended that the
device is powered by an
uninterruptible power
source.

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for 5 sec
for 5 sec
Power frequency
(50/60 Hertz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the AC mains voltage prior to application of the test level.

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9.6.4 Guidance and manufacturer’s declaration—electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The user must ensure
that the device is used in such environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment—guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz–80 MHz
10 V/m
80 MHz–2.7 GHz
3 Vrms
10 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including cables,
than the recommended distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended distance:
d = 1.2
d = 1.2
P
, 80 MHz to 800 MHz
d = 2.3 , 800 MHz to 2.5 GHz
Where Pis the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer, and dis the recommended
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,ashould be less than the
compliance level in each frequency
range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
P
P

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Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Notes 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio and AM and FM radio broadcast, cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment from fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the device is used exceeds the applicable RF compliance level above, the device should be observed to
verify normal operation. If abnormal performance is observed, additional measures are required, such as
reorienting or relocating the device.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
System Requirements
This product supports low-power Bluetooth data transfer. Compatible cellphone models include:
Apple iOS system
iPhone XS Max
iPhone XS
iPhone 8
iPhone 7
iPhone 6S
The iOS version must be iOS 9.3.2 or later.
Android system
Samsung S10
Samsung Galaxy A30
Samsung Note9
ASUS ZenFone Max Pro(M2)
Sony Xperia 10
Xiaomi Redmi Note7
OPPO R17
OPPO R11s
The Android version must be Android 5.0 or later.
Visit Chiline’s website (www.easydr.com.tw) for a complete list of compatible cellphone models.