MIO-CARE MiCor A100 User manual

User Manual
MiCor A100
Wearable ECG Recorder

1
Table of Contents
Important safety instructions ............................................................................................2
Overview............................................................................................................................7
Checking the package contents....................................................................................7
Getting to know your device ........................................................................................8
Charging the battery ....................................................................................................9
Getting started.................................................................................................................10
Activating the device..................................................................................................10
Putting on the device .................................................................................................10
Downloading the App.................................................................................................11
Setting the date and time...........................................................................................11
Operating basics ..............................................................................................................12
Changing the display mode ........................................................................................12
Recording ECG data....................................................................................................13
Connecting the device toyour phone ........................................................................14
Using the App...................................................................................................................15
Viewing ECG data .......................................................................................................15
Setting up the profile .................................................................................................19
Device settings ...........................................................................................................19
For more information ......................................................................................................20
Support..................................................................................................................... 20
Product Specifications
................................................................................................20
IP27 ............................................................................................................................21
Safety precautions .....................................................................................................22
Caring for your device ................................................................................................23
Federal Communication Commission Interference Statement..................................24
Guidance and manufacturer’s declaration.................................................................25

2
CAUTION: MiCor A100 is MR-unsafe! Do not expose the device to a magnetic resonance
(MR) environment. The device may present a risk of projectile injury due to the presence
of ferromagnetic materials which can be attracted by the MR magnet core.Thermal
injury and burns may occur due to the metal components of the device which can heat
during MR scanning. The device may generate artifacts in the MR image. The device may
not function properly due to the strong magnetic and radiofrequency fields generated by
the MR scanner.
Important safetyinstructions
Symbols and markings
This appendix provides information about the symbols that are used on the product, its
accessories or packing.
Follow instructions for use.
Type BF Applied Part - Electrically connected to patient.
Taiwan National Communications Commission (NCC) logo
Non-ionizing radiation
WEEE (Waste Electrical and Electronic Equipment). This product must not be
disposed of as normal household waste, in accordance with the EU directive for
waste electrical and electronic equipment (WEEE - 2002/96/EC). Instead, it should
be disposed of by returning it to the point of sale, or to a municipal recycling
collection point.
SN: WK0E6156789.The serial numberof this device.
Model: N507. The model number of this device.
Cautions

Caution! Federal law restricts this device to sale by or on the order of a physician.

CAUTION: MiCor A100 is MR-unsafe! Do not expose the device to a magnetic resonance
(MR) environment. The device may present a risk of projectile injury due to the presence
of ferromagnetic materials which can be attracted by the MR magnet core. Thermal
injury and burns may occur due to the metal components of the device which can heat
during MR scanning. The device may generate artifacts in the MR image. The device may
not function properly due to the strong magnetic and radiofrequency fields generated
by
the MR scanner

3
Please take off the device, clean and dry your device daily, particularly in areas in contact
with the skin. Use a clean, damp cloth.

Prolonged contact may contribute to skin irritation or allergies in some users. If you
notice any signs of skin redness, swelling, itchiness, or other skin irritation, please
discontinue. Continued use, even after symptoms subside, may result in renewed or
increased irritation. If symptoms persist, consult yourdoctor.

The device contains electrical equipment that could cause injury if not handled properly.

Consult your doctor before beginning or modifying any exercise program.

Consult your doctor before use if you have any pre-existing conditions that might be
affected by your use of thisdevice.

Do not check call notifications or other data on the device’s display while driving or in
other situations where distractions could be hazardous.

This device is not a toy. Do not allow children or pets to play with your device. The device
contains small components that can be choking hazard.

Please do not place the device in your bag or expose it to any external weight load, to
avoid exceeding the limit of bearable weight of this device.

The device is with water ingression grade IP27. It is water proof under 1-meter depth
of water but should not be worn while swimming and should not be submerged under
water.


Clean it only with a soft cloth slightly dampened with warm water or a mild soap. Do
not wash the device under afaucet.

Wear your device loosely enough to allow aircirculation.

Use skin care products sparingly on the areas of the skin covered by your device.

Take the device off from time to time to clean it and allow for your skin to be uncovered.

Do not open the enclosure or disassemble your device.

Do not use your device if the display iscracked.
Please take off the device, clean and dry your device daily, particularly in areas in contact
with the skin. Use a clean, dampcloth.

4

Substances in this device and its battery may harm the environment or cause injury if
handled and disposed of improperly.

Do not subject the device to excessive force, shock, dust, temperature changes, or
humidity. Do not expose the unit to strong shocks or vibrations.

Do not place your device in a dishwasher, washing machine, or dryer.

Do not expose your device to extremely high or low temperatures.

Do not use your device in a sauna or steamroom.

Do not leave your device in direct sunlight for an extended period of time.

Do not dispose of your device in a fire. The battery could explode.

Do not use abrasive cleaners to clean yourdevice.

Do not wear your device while chargingit.

Do not charge your device while it iswet.

Disperse any static electricity from your body before using the unit. To avoid static
electricity, use a small metal device (such as keys), cotton cloth, etc. to touch the door,
doorknobs, faucets, chair, bet rails, etc. to eliminate static electricity, and then hand
touch.

Remove your device if itfeels warm or hot.

Due to printing limitations, the displays shown in this manual may differ from the actual
display.

The contents of this user guide may not be reproduced without the permission of the
manufacturer.
Warning on heart rate measurement

Do not use with a defibrillator. Users do not apply to the use of regulator.

Do not use the unit in intensive care units or operating rooms.

Do not operate the device near strong electrostatic field, otherwise the device could be

5
damaged by the electrostatic.

Do not use in the presence of flammable anesthetics, drugs or pressurised oxygen (such
as in a hyperbaric chamber, ultraviolet steriliser or oxygen tent).

Do not take recordings in a location where the unit will be exposed to strong
electromagnetic forces, such as near an arc welder, high-power radio transmitter, etc.

Do not attempt self-diagnosis of the measurement results and analysis. Always consult
the doctor.

Do not take a recording if the electrodes are dirty. Clean them first.

Do not use for any purpose other than obtaining physiological information.

This device is not designed or intended for complete diagnosis of cardiac conditions.
This device should never be used as a basis for starting or modifying treatment without
independent confirmation by medical examination.

When using this unit in hospitals or other medical facilities, use the unit under the
supervision of your doctor.

The heart rate is calculated by using the auto-correlation method to calculate the
instant heart rate, and then get the average heart rate with all instant heart rates.

If no beats are detected in the interval of 2 seconds, the interval is defined as "PAUSE."
Built-in battery precautions information

Your device features a built-in battery, which is not user replaceable.

Tampering with your device, or attempting to open it, will void the warranty and can
result in a safety hazard. The main unit contains no user-serviceable parts.

Contact the manufacturer’s customer services if the device requires servicing.

Use only the charger cable that shipped with your device to charge the battery.

Charge the battery using a computer, powered hub, or power supply that is certified by a
recognized testing laboratory.

Charge the battery in accordance with the instructionssupplied.

6
Disposal and recyclinginformation
The symbol on the device or its packaging signifies that this device must be disposed of
separately from ordinary household wastes at its end of life. Please kindly be aware that it is
your responsibility to dispose of electronic equipment at recycling centres to help conserve
natural resources.
For information about your recycling drop off point, please contact your local related
electrical and electronic equipment waste management authority or the retailer where you
bought the device.

Do not dispose of your device with household waste.

Disposal of the packaging and your device should be done in accordance with local
regulations.

Batteries are not to be disposed of in the municipal waste stream and require separate
collection.
Intended Use
The device is intended for use by users who have transient symptoms that may suggest
cardiac conduction abnormalities or by users who wants to monitor the cardiac function at
home health care from Lead 1 ECG signal.
ECG acquisition and transmission is voluntary and mutually activated by the user. The
intend users are adult.
The device is design to let user wear on wrist and record ECG signal while user feel transient
cardiac abnormalities symptoms any time.
Users with implanted pacemaker are not recommended to use this device.

7
Overview
Thank you for purchasing a MioCARE product. This user manual guides you through the
successful setup of your device and familiarises you with the basic skills of using the device.
The device is the wristband as wearable style. It is smaller and light weight, dry electrode
and affordable ECG recording device. Its primary function is recording ECG signal of user/
patient with one finger press on top of ECG plate of device. The device will record the
user/patient ECG signal for 30 seconds and automatically store into build-in memory,
meanwhile, the device also display the real time heart rate. The device can store 30 sets of
ECG signal (30 seconds / set of data), then user can transfer ECG signal data from device to
APP of the iPhone via BLE. The APP can display ECG of each recording ECG signal. And user
can print the ECG and let his Cardiologist to refer and diagnose.
The device is build-in battery and for 15 days battery life and easy to know battery status as
press button, user will have nice experience to wear this device without oppress.
Checking the packagecontents
Check the items contained in the package carefully. You should have the following:

MiCor A100 Wearable ECGRecorder

Magnet type USB charging cable

Protection cover x 2

User manual

8
Getting to know your device
1
OLED screen
2
ECG sensor
3
MODE button
4
Charging connector
5
ECG sensor
6
Straps

9
2
1
3
*
NOTE: This device is intended to be supplied by a power unit that has output rated +5V dc/1.0A
(maximum).
Charging the battery
Your device has an internal battery that may not be fully charged when you purchase it. It is
recommended to charge the battery for about 1 hour before you start using the device for
the very first time. Follow the instructions below to charge the battery.
1. Remove the protection cover.
2. Connect the magnet type USB charging cable to the device's charging connector.
3. Connect the USB connector of the charger to the power supply*.
* The power supply accessories (not included) should be complied with IEC 60601-1 3.1.
4. During charging, the Battery icon ( ) on the screen indicates the battery charge
status:
5. The icon displays on the screen when the battery is fully charged. Remove the
magnet type USB charging cable and then replace the protection cover.

10
Getting started
Activating the device
Once the device is connected to the power supply after unpacking, the system activates
automatically.
Putting on thedevice
Putting on the device is like wearing a watch around your wrist. Follow the instructions
below to wrap the straps around your wrist and then secure it with the buckle.
The device comes with a set of detachable straps that should be properly assembled before
you use it. Follow the instructions below to detach/assemble the straps.

11
NOTE: MiCor A100 App supports the mobile device running iOS 8.0.
Downloading the App
MiCor A100 App is a free App on the Apple Store. After downloading and installing the
App on your phone, you can use it to change the device's settings, view the detailed
electrocardiogram, save and manage the ECG data and more functions via your phone.
Setting the date and time
To make sure that the date and time of your ECG recordings are correct, check the settings
before you begin recording.

Once the device is connected to your phone via the App, the date and time settings of
the device will be automatically synchronised with the connected phone.

You can set the displayed time format as 12-hour or 24-hour via the connected phone.

12
NOTE: The icon will display and flash on the screen while the ECG memory is full.
Operating basics
Changing the displaymode
Press the MODE button repeatedly to cycle through the display modes: Time & date > ECG
data amount > Battery status.

Time & date
Press the MODE button once to wake up the system and display the current time for 3
seconds and then the date for 2 seconds. The device will automatically enter Idle mode
after 5 seconds of inactivity in time & date displaymode.

ECG data amount
Time
(3 sec)
Date
(2 sec) Idle mode
Press the MODE button twice to display the amount of ECG data stored in the device.
The device will automatically enter Idle mode after 5 seconds of inactivity in ECG data
amount display mode.
ECG data amount

Battery status
Press the MODE button three times to display the battery status by the following icons.
The device will display the FCC ID after 3 seconds of inactivity in battery status display
mode, and then enter Idle mode.
10% - 25% 26% - 50% 51% - 75% 76% - 99% Battery full
NOTE: The icon will display and flash on the screen the battery power is less than 10%.
12
06/01
08:00

13
Recording ECG data
You can record and store up to 30 ECG data on the device. Follow the instructions to start
recording ECG data.
1. Wear the device on your wristproperly.
2. Press the MODE button to wake up the system from Idle mode.
3. Use your finger to touch the ECG sensor on the front panel for 2 seconds. After
displaying the ECG data amount and vibrating once, the system enters ECG recording
mode.
4. Wait for 3 seconds, and then the system will start recording ECG data.
Keep touching the ECG sensor for about 30 seconds and do not move until the
recording is completed. You can check the recording status from the screen.
5. When done, the device will vibrate once and display the complete status on the screen.
ECG data
Recording
(30 sec) Complete
Now, you can connect the device to your phone and start synchronization. Once
synchronized, the ECG data will be downloaded to your phone automatically.
72

14
NOTE: To obtain a correct ECG recording, please read the followings carefully and be sure that you
observe the points each time you take a measurement.
Ǧ ǀ
Ǧ ʬƽǀ
Ǧ ǀ
cotton swab.
Ǧ ǀǀ
Ǧ ʬ
measurement.
Ǧ ǀƽ
please contact your doctor for advice.
Connecting the device to your phone
Follow the instructions to connect the device to your phone via the App for the first time.
1. Download and install MiCor A100 App on your phone.
2. Make sure Bluetooth is activated and then launch the App.
3. Complete the initial settings including the profile and device settings.
- Profile: Enter your name, birthday and gender in the fields.
- Device settings: Select the time format.
4. Press the MODE button on the device so it will be discoverable for 5 seconds.
5. On you phone, select the device to pair and then enter the serial number (printed on
the back panel of the device).
6. Once the pairing is completed, the data will be synchronised automatically.

15
NOTE: The screenshots and other presentations shown in the following sections may differ from the
ones generated by the actual product.
Using the App
MiCor A100 App allows importing data from the device into your phone so that it can be
examined and printed. This App features useful functions, such as changing of the scale and
range of the ECG data, to better observe specific events which would be very helpful for
doctor's reference.
Viewing ECG data
After launching and synchronising, you can read the recorded ECG data by selecting the
item you wish to view from the ECG data list. The Details screen displays the detailed
information of the ECG data.
ECG data list Details screen

16
The ECG data list
The ECG data list provides the general information including the User Name (as shown on
the title bar) and recorded ECG data (sorted by date and time).
From the ECG data list, you can do one of the following:

To delete the record, slide the item to the left and then tap Delete.

Tap Edit to enter Edit mode, allowing you to:
- Select the desired records by checking the buttons in front of the items.
- Select all of the records by tapping All.
- Delete the selected records (or all records) by tapping Delete.

Tap Menu ( ) to display the menu screen, allowing you to:
- Select Sync now to start synchronization manually.
- Select Profile & Settings to display the Profile & Settingsscreen.
- Select Add new user to add a new user for the device.
The Details screen
The Details screen contains the detailed information of the ECG data, including the date/
time, the ECG waveform and the Notefield.

The waveform area contains the ECG trace, the speed/gain and the average heart rate.
- You can navigate the screen to view the 30-second ECG trace by dragging your
fingertip horizontally across the screen.

17
- While viewing the ECG trace, you can zoom in or out the waveform area by moving
your fingertips apart or together on the screen.
Spread tozoom in Pinch to zoom out

Tap on the Note filed to take notes for the ECG data.

Tap Edit to display the Edit list, allowing youto:

18
- Select Email to send the item by email.
- Select Print to print it out.
- Select Delete to delete the record.

19
Setting up theprofile
Adding a user
The App is designed for multiple users that means, for example, you can use the same App
to manage individual ECG data of the family members or multiple patients by a doctor.
1. From the ECG data list, tap Menu ( ) to display the menu screen.
2. Select Add new user.
3. Repeat the process of setting up the Profile and Device Settings.
4. Connect the device.
Now, you can choose the desired user from the User list after launching the App.
Connecting the otherdevices
You can use the same App to manage the ECG data from different devices.
1. From the ECG data list, tap Menu ( ) to display the menu screen.
2. Select Profile & Settings .
3. Tap Device SN to display the Device infoscreen.
4. Select Change device and then repeat the process of pairing a device.
Device settings
Setting the time format
You can set the displayed time format as 12-hour or 24-hour by disabling or enabling the 24
hour clock option.