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

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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.

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
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

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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.

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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.

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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.