Dr Trust 1201 Portable ECG Smart Connect User Manual

Dr Trust
Portable ECG Smart Connect -1201
QUICK START GUIDE

1201 Portable ECG Smart Connect

(There are three different methods -A “right index finger chest, B “left index finger chest”, and C left-hand right hand” of taking the measurement.)

Without Bluetooth

Press the On/Off button to turn the device on and the device shows the full display.
Choose the method and put the Dr Trust Portable ECG Smart Connect on your body part accordingly to start measurement.
The result will be shown on the LCD after 30 seconds automatically.
With Bluetooth

Download Dr Trust 360 App from the Play Store/App store to connect to your smartphone or tablet with Bluetooth.
Enable Internet, GPS & Bluetooth for completing registration.
You rdata is automatically synchronized with the App for evaluation and easy sharing with your doctor in real-time.

DR TRUST 360 APP DOWNLOAD
System Requirements: Smartphones or Tablets with Bluetooth Connectivity
Please scan the QR code to enter Dr Trust 360 App web page.

https://link.drtrust360.com/3wSZPux

Follow the instructions to register and use the app.

GENERAL NOTES

• This is an Electrocardiogram (ECG) device that provides referential data that could be taken into consideration by medical professionals.
• The applied part is ECG
• Self diagnosis or treatment is dangerous behavior. Please don’t use the cardiogram or data generated by the device to diagnose yourself.
• Consult with medical professionals if you notice any change in your condition, regardless of the measurement results.
• The measurement results produced by the device only reflect the measurement taken at the moment.
•  The cardiogram cannot show all variations and symptoms of the heart disease, please consult with medical professionals when feeling discomfort with your heart.

IMPORTANT SAFETY NOTES

• It is not recommended to use the device with a cardiac pacemaker or other implanted devices. Be sure to follow your doctor’s instruction if necessary.
• Do not use this device during an MRI scan.
• Do not use this device with a defibrillator.
• Do not submerge (or immerse) the device in water or liquid. Do not clean the device with acetone, or other volatile solutions. Clean the unit with a cloth dampened with water or mild detergent. Then wipe it dry with a dry cloth.
• Do not put the device in autoclaves, or gas sterilization devices.
• Avoid hitting, dropping, stamping, shaking of the device.
• Do not disassemble the device that may result in damage, malfunction, or abnormal operation.
• Do not use this device on people with sensitive skin or allergies.
• This device is not approved for use on children weighing less than 10 kg.
• Do not store/expose the device in the following environments: Locations exposed to direct sunshine, high temperature or humidity, heavy dirt, near water or fire, and under high electro- magnetic influence.
• Store the device in safe place to avoid small parts swallowed by children under any circumstances.

*Static electricity may cause damage to the electronic components, to prevent electrostatic damage to the device, grounding yourself to discharge the static electricity from the body is required before handling the device. Increasing humidity, moisturizing skin can effectively reduce the accumulation of body surface electrostatic charge.

PRODUCT DESCRIPTION

3.1 Main Features

• Dr Trust Portable ECG Smart Connect- 1201 can complete your cardiogram measurement in about 30 seconds.
• Your Dr Trust Portable ECG Smart Connect- 1201 will automatically analyze and provide referential results using measurement data.
• Dr Trust Portable ECG Smart Connect- 1201 can take up to 500+ measurements with two new coin-typed batteries and keep records of 36 measurements.
• The APP can assist you to:
  – Download ECG data.
  – Configure your Dr Trust Portable ECG Smart Connect- 1201 .
  – Store measurement records in chronicle order.
  – Display ECG waveforms for reference to medical professionals .

3.2 Package Contents
Your package should include the following items

 Two coin – typed batteries (trial batteries)

3.3 Components

3.4 LCD Display

1. Heartbeat Indicator: Flashes in sync with the heartbeat during measurement.

2. Heart Rate: Shows average heart rate of recording.

3. Battery Level Indicator: Shows current battery level.

4. Digits Display:
   a. Shows the sequence number of the measurement results stored in memory.
   b. Shows the 30 second count down during measurement.

5. Time: Shows date and time.

6. Bluetooth Connection: Displays the status of Bluetooth connection.

PREPARATION BEFORE TAKING MEASUREMENT

4.1 Battery Installation

To charge your Dr Trust Portable ECG Smart Connect- 1201, please follow the steps below:

• Remove the battery cover by inserting the tip of your finger into the opening of the cover.
• Follow the +(positive) and -(negativep ol a rities indi cat edon the battery compartment.
• Slide the battery cover until it clicks into place.

4.2 Things to know Before taking Measurement
To assure accurate measurement, please observe the following:

• Make sure that electrodes are directly in contact with your skin.
• If your skin or hands are dry, moisten your skin with damp cloth before taking measurement.
•  If the electrodes are dirty, use a soft cloth or a cotton swab moistened with disinfectant alcohol to clean dirt from the surface.
•  During the measurement, do not touch your body with the hand with which you are taking the measurement.
• Make sure there is no skin contact between your right and left hand (measuring method C), or between your hand and chest (measuring methods A/B). Otherwise, the measurement cannot be taken correctly.
• Ideally perform the measurement either sitting down or lying down. Do not stand up.
• Do not move or talk during the measurement and hold the device still. Movements of any kind will falsify the measurements.

TAKING MEASUREMENT

5.1 Operation Procedure

There are three different methods of taking the measurement. Start with measurement method A, “right index finger-chest.” If this method does not deliver measurements, or delivers only unstable measurements (“EE” is frequently displayed), switch to method B “left index finger-chest” and, if necessary, to method C”left hand-right hand.”
The most suitable method/ procedure depends on the heart configuration (shape of the heart) of each individual user. If it is not possible to take stable measurements using a given measurement method, this could have a harmless cause such as the shape of the
heart. However, the cause may also be an illness or disease.
Measurement method C offers maximum comfort, but offers a much lower measurement stability than methods A or B.
Press the on/ off button for about three seconds to turn the device on. The device shows the full display.
ATTENTION
If segments are missing, stop using the device and immediately contact customer services.
To test whether the full display is completely displayed, hold the On/Off button when switching on the device.
5.2 Measurement Methods

Measurement Method A| “right index finger-chest” (approximately corresponds to “lead 2”)
---|---
| Place your right index finger on the two upper electrodes on the device and hold the device.
| Place the bottom electrode of the Dr Trust Portable ECG Smart Connect-1201 on bare skin about 5 centimeters (2 inches) below your left nipple supported by the ribcage, and press it GENTLY until you hear the click sound.

Lightly press the electrode against your chest until you hear or feel a click.
Important: Do not exert excessive pressure on the electrodes with your fingers.

Measurement Method A|  “left index finger-chest” (approximately corresponds to “lead 3”)
---|---
| Place your left index finger on the two upper electrodes on the device and hold the device vertically in your hand.
| Place the bottom electrode of the Dr Trust Portable ECG Smart Connect-1201 on bare skin about 5 centimeters (2 inches) below your left nipple supported by the ribcage, and press it GENTLY until you hear the click sound.

Lightly press the electrode against your chest until you hear or feel a click.
Important: Do not exert excessive pressure on the electrodes with your fingers.

Measurement Method C| “left hand – right hand” (approximately corresponds to “lead 1)
---|---
| Place your right index finger on the two upper electrodes on the device. Place a  finger of your left hand on the lower
electrode.

Press the lower electrode until you hear or feel a click.
Important: Do not press the device too firmly against your skin.
CAUTION
Please note that there must be no skin contact between your right and left hand (measurement method C) or hand and chest (measurement methods A/B). Otherwise, the measurement cannot be taken correctly. Do not move during the measurement, do not speak and hold the device still. Movements of any kind will falsify the measurements.

1. The device will start beeping (if the beep is enabled) and the number indicator will flash for a few seconds. This indicates that the measurement is about to begin.
2.  The measurement is completed, and the results are displayed at the end of the 30-second countdown.

Note: If the bottom electrode is removed within the space of three seconds after the measurement starts, the measurement will be displayed as EE.
5.3 Common Wrong Operations
Please avoid the following operations:
Finger not touching the electrodes tight enough.
Measuring over/through clothing.

Holding Dr Trust Portable ECG Smart Connect in the wrong direction.

Holding Dr Trust Portable ECG Smart Connect with left hand.

RESULT DISPLAY

6.1 Measurement Results
The possible results are shown below.

| : Normal Result
---|---
|  : Slow Heart Rate (<60 bpm)
| : Fast Heart Rate (>100 bpm)
|  : Paused Heart beat (pause>2 s)
|   (Disrupted Rhythm) : Irregular Rhythm
|  : Abnormal Waveform (Altered Waveform)

Please note that if the displayed heart rate is flashing, it indicates ECG signals are unstable or weak. Please retake the measurement.
6.2 Reviewing results on Dr Trust Portable ECG Smart Connect- 1201

1. Press the button for 3 seconds to turn on your Dr Trust Portable ECG Smart Connect- 1201. The LCD shows the total number of records stored.

2. The button again, and the LCD shows the average heart rate of the latest measurement and the Digits Display shows the sequence number of stored records.

3. By pressing the button repeatedly, the result will be shown in a cyclic order.

CLEANING AND MAINTENANCE

Please clean the surface of the Dr Trust Portable ECG Smart Connect – 1201 with a soft cloth dampened with water.
If the electrodes are dirty, please use a soft cloth or a cotton swab moistened with disinfectant alcohol to clean dirt from the surface.

MESSAGES & TROUBLE SHOOTING

Measurement result shows flashing Heart
Rate.| Unstable or weak ECG signals.| Please retake the measurement following the manual’s instruction.
Measurement result shows
EE.| Failure analysis resulted from either low contact pressure or high noise level during measurement.| Please retake the measurement following the manual’s
instruction.
Problem|          Possible Cause|   Suggestion
---|---|---
Power does not come on after pressing the
power button for 3 seconds.| 1. Battery power is low.
2. Batteries are installed with     wrong direction.| 1. Replace with new batteries.
2. Make sure the polarities of batteries are matched with the ones indicated on the battery compartment.
Electrode touching skin, but measurement
does not start.| Pressing too lightly.| Make sure to press the bottom electrode down enough.
Measurement records disappear from the
device.| Old records are overwritten by new ones due to storage overload.| Download data periodically to your computer for record keeping.
Bluetooth connection failed.| Basic communication problem between the device and Smartphone/Pad.| Please turn off the device, “Dr Trust iBP Monitor” APP
and Bluetooth function of Smartphone/Pad, then follow the instructions mentioned above to reconnect again.
Device ID is not displayed on the box in the “Setting” function of “iBP Monitor APP.| Problems of data exchanging for the first time connection.| If the device is discovered successfully, there will be a blank on the box, then click on the blank to manually link the device with APP and display the device ID.

SPECIFICATIONS

Dr Trust Portable ECG Smart Connect- 1201

Model| Smart Portable ECG Pen
Induction System| single channel, bipolar
Bandwidth| 0.05 40 Hz
Sampling Rate| 256 Hz
Heart Rate Range| 5 199 beats/min
Memory| 36 measurements
Power Supply| two coin-typed batteries
Battery life| 500+ measurements with two new coin-typed batteries
Transportation Environment Storage Environment| -20 60°C, 10 95% RH
-20 60°C, 10 95% RH
Operating Environment| 5 40°C, 30 85% RH
Weight| 30 g (without batteries)
Dimensions| 93 x 38 x 11 mm
Air Pressure| 700-1060hPa

EMC INFORMATION

Guidance and manufacturer’s declaration – electromagnetic emissions

The Dr Trust Portable ECG Smart Connect- 1201 is intended for use in the electromagnetic environment specified below. The customer or the user of the Dr Trust Portable ECG Smart Connect-1201 should assure that it is used in such an environment.
Emissions| Compliance| Electromagnetic environment– guidance
RF emissions CISPR 11| Group 1| The Dr.Trust ECG Pen 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 Dr.Trust ECG Pen 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| Complies
Guidance and manufacturer’s declaration – electromagnetic immunity

The Dr Trust Portable ECG Smart Connect- 1201 is intended for use in the electromagnetic environment specified below. The customer or the user of the Dr Trust Portable ECGSmartConnect-1201should assure that it is used in such an environment.
Immunity test| EN 60601 test level| Compliance level| Electromagnetic environment –guidance
Electrostatic discharge (ESD) IEC 61000-4-2| ±6 kV contact ±8 kV air| ±6 kV contact ±8 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 %.
Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines| ±2 kV for power supply lines| Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5| ±1 kV line(s) to line(s)
±2 kV line(s) to earth| ±1 kV line(s) to line(s)
±2 kV line(s) to earth| Mains power quality should be that of a typical commercial or hospital environment.

user
voltage variations| 40 % UT| 40 % UT| of the Dr.Trust ECG Pen requires
on power supply| (60 % dip in UT)| (60 % dip in UT)| continued operation during
input lines| for 5 cycles| for 5 cycles| power mains interruptions, it is
IEC 61000-4-11| 70 % UT| 70 % UT| recommended that the
| (30 % dip in UT) for 25 cycles| (30 % dip in UT) for 25 cycles| 870E be powered from
<5 % UT| <5 % UT| an uninterruptitie power supply or
(>95 % dip in UT)| (>95 % dip in UT)|
for 5s| for 5s| a battery.
Power frequency| 3 A/m| Not applicable| Not applicable
(50/60 Hz) magnetic field| | |
NOTE Ur is the a.c. mains voltage prior to application of the test level
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3| 3 Vrrns 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 Vrms
3 V/m| Portable and mobile RF communications equipment should be used no closer to any part of the 870E , including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter. Recommended separation distance
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).
---|---|---
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Dr trust Portable ECG Smart Connect – 1201 is used exceeds the applicable RF compliance level above, the Dr trust Portable ECG Smart Connect- 1201 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Dr trust Portable ECG Smart Connect-
1201. Recommended separation distances between portable and mobile RF communications equipment and the Dr Trust Portable ECG Smart Connect- 1201.
Dr trust Portable ECG Smart Connect- 1201 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Dr trust Portable ECG Smart Connect- 1201 can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Dr trust Portable ECG Smart Connect- 1201 as recommended below, according to the maximum output power of the communications equipment.

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.
NOTE 1 : At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

SYMBOL DEFINITIONS

| Type CF applied part| | The product is with Bluetooth function
---|---|---|---
| ATTENTION, should read the Instruction for Use| | Protection against solid foreign objects of 125 mm 0 and greater and against vertically falling water drops when enclosure tilted up to 15°
| CE Mark ( made in compliance with Directive 93/42/EEC on Class Ila medical devices)
| Consult Instruction for Use| | This way up
| Manufacturer| | Fragile

| Date of manufacture| | Keep dry
Reference number| | Keep away from sunlight
| Serial number| | Permissible operating temperature and humidity
| Batch number| | Permissible storage/transport temperature and humidity

CONTACT US

CONTACT ADDRESS
USA
Nureca INC.USA
276 5th Avenue, Suite 704-397,
New York (NY) – 10001, USA
INDIA
Corporate Office (Mumbai)
Nureca Limited
128 Gala Number Udyog Bhavan,
1st Floor Sonawala Lane, Goregaon East
Mumbai City Maharashtra 400063
Contact us
India: +91-7527013265 /+91-9356658436
Website: www.drtrust.in
Corp Website:
www.nureca.com
Customer Care Executive Email:
customercare@nureca.com
Connect with us on social networks
Facebook: @drtrust
Instagram: @drtrustisin
Youtube: NurecaUsa
COPYRIGHT © 2021 NURECA LTD ALL RIGHTS RESERVED
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References

• Dr Trust - India's Most Trusted Healthcare & Wellness brand | Dr Trust
• Nureca Limited - Specialists in Health and wellness products

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