IFU for Revlis ECG Monitor (CMP-121A)
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Table of contents
Introduction............................................................................................................................................. 3
Product Contents .................................................................................................................................. 4
Device Overview .................................................................................................................................... 5
Intended Use ........................................................................................................................................... 6
Indications For Use ............................................................................................................................... 6
Contraindications .................................................................................................................................. 6
Expected Service Life ........................................................................................................................... 6
Safe Disposal of the Device ............................................................................................................... 6
Operation Instruction .......................................................................................................................... 7
1. Installing the battery ....................................................................................... 7
2. First-time installation of the Fiona APP ............................................................. 8
3. Single-lead ECG (Lead I) Measurement ............................................................ 8
4. Device Operating Modes and LED Indicators .................................................... 9
Warnings and Precautions .............................................................................................................. 10
FCC compliance .................................................................................................................................. 12
Federal Communications Commission (FCC) Interference Statement .................................. 12
RF exposure statements ..................................................................................................... 12
Maintenance and Cleaning ............................................................................................................ 13
1. Service and repair ..........................................................................................13
2. Cleaning .......................................................................................................13
3. Exterior visual inspection ...............................................................................13
4. Battery replacement ......................................................................................13
Troubleshooting ................................................................................................................................. 14
Technical Specification ..................................................................................................................... 16
Symbols .................................................................................................................................................. 17
IFU for Revlis ECG Monitor (CMP-121A)
Proprietary and Copyright @ Revlis Biotech
6/8/2026 1:20 PM Page 3 of 17
Introduction
The Revlis ECG Monitor (the “Device”) is a personal electrocardiogram (ECG) monitoring
device intended to acquire and record a single-lead ECG (Lead I), providing a single-
channel view of the heart’s electrical activity. The ECG data are transmitted via Bluetooth
wireless technology to the Fiona Application (“Fiona App”) installed on a compatible
smartphone.
1. The top surface of the Device contains two electrodes intended for contact by the
user’s left and right fingers during ECG measurement.
2. The Device is powered by a coin cell battery.
3. The Device is intended for use with a compatible smartphone and the Fiona App. The
Fiona App is designed for offline operation and does not require an internet
connection during use. ECG data are stored locally on the smartphone and are not
transmitted to external cloud servers.
4. The Device firmware is validated prior to release, and firmware updates are not
required for normal operation.
5. The Device does not provide automated diagnostic interpretation and is not intended
to replace conventional diagnostic methods, clinical evaluation, or physician judgment.
6. ECG recordings should be reviewed and interpreted only by qualified healthcare
professionals.
7. The Device includes protective control features intended to reduce the risk of
unintended setting modifications.
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Product Contents
The product package includes:
⚫ One product package box
⚫ One Instructions for Use (IFU) manual
⚫ One Revlis ECG Monitor (the “Device”)
Note:
The Device requires one CR2032 coin cell battery for operation, the battery is not included
in the package.
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Device Overview
IFU for Revlis ECG Monitor (CMP-121A)
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Intended Use
The Revlis ECG Monitor is intended to acquire, display, store, and transmit single-lead
ECG (Lead I) signals and heart rate information for adult users in home environments.
Indications For Use
The Device is intended for use by lay users aged 22 years and older in home
environments to record, display, store, and transmit single-lead ECG (Lead I) data. ECG
recordings should not be used as the sole basis for diagnosis or treatment decisions, and
should be reviewed by qualified healthcare professionals.
Contraindications
This Device is not intended for use in patients with implanted cardiac pacemakers or other
implantable electronic devices. The Device is also not intended for use in pediatric
patients.
Expected Service Life
The expected service life of the Device is 2 years when used, stored, and maintained in
accordance with this Instructions for Use under normal operating conditions.
Safe Disposal of the Device
Do not dispose of the Device in household waste. Dispose of the Device in accordance
with applicable local, state, and national regulations for electronic waste and battery
disposal. Improper disposal may result in environmental contamination.
Do not cut, crush, incinerate, shred, or otherwise physically damage or dismantle the
Device.
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Operation Instruction
1. Installing the battery
（1） Open the product packaging and remove the Device.
（2） Use a coin (or a similar tool) to rotate the battery cover on the back of the Device
and open it.
（3） Insert one CR2032 coin cell battery with the positive (+) terminal facing outward.
Ensure the coin properly fits into the groove of the battery cover.
（4） Rotate the battery cover to close and secure it.
（5） After the battery is installed, the Device will enter standby mode, and the LED
indicator will remain off.
（6） When the battery is low, the LED indicator will flash in a different pattern (on for 0.5
seconds and off for 5 seconds). It is recommended to replace the CR2032 coin cell
battery as soon as possible.
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2. First-time installation of the Fiona APP
（1） Download the Fiona APP from the designated app store (App Store or Google
Play).
（2） Ensure that Bluetooth is enabled in your smartphone settings.
（3） This App is compatible with supported iOS and Android operating system versions.
3. Single-lead ECG (Lead I) Measurement
（1） Please sit comfortably in a stable position and rest quietly for at least 3 minutes
before measurement. If you have recently exercised or are feeling emotionally
stressed or excited, rest for at least 30 minutes and wait until your heart rate has
stabilized before taking the measurement.
（2） Open the Fiona APP and tap “Measurement.”
（3） Place both thumbs steadily on the electrode surfaces on both sides. Once the
device is activated, the LED indicator will light yellow-green for approximately 0.5
seconds and then turn off for about 2 seconds, indicating successful startup.
（4） After the device is powered on, the APP will automatically connect via Bluetooth.
Once the Bluetooth connection is successful, tap “Start.”
（5） After activation, keep both thumbs in contact with the electrodes on both sides while
maintaining a stable seated posture. Avoid applying excessive pressure and ensure
the device is held in the correct orientation. During measurement, the LED indicator
will continue flashing in a pattern of 0.5 seconds on and 2 seconds off, indicating
that recording is in progress. Do not remove your fingers before the measurement is
completed. Once the LED indicator turns off, you may remove both thumbs and wait
for the application results.
（6） Finally, the APP will display the recorded ECG waveform and calculated average
heart rate.
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4. Device Operating Modes and LED Indicators
Operating Mode
LED Indicator
Description
Standby Mode
Off
The Device is powered on but not in use.
Working Mode
(Activation)
On for 0.5 seconds →
Off for 2 seconds
The Device has been activated.
Measurement in
Progress
Continuous flashing
ECG is being recorded.
Measurement
Completed
Off
Measurement has been successfully
completed.
Low Battery
Warning
On for 0.5 seconds →
Off for 5 seconds
Battery level is low.
Measurement
Interruption
LED remains on
continuously
Measurement is interrupted due to loss of
finger contact with electrodes.
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Warnings and Precautions
1. Device limitations: The Device records single-lead ECG (Lead I) signals only. It does
not analyze or interpret ECG data, detect cardiac conditions, or provide a diagnosis.
2. Heart rate values are estimates derived from the recorded ECG signal and may be
affected by motion artifacts, poor electrode contact, or signal noise.
3. The Device is not intended for emergency or continuous cardiac monitoring.
4. The Device does not provide continuous real-time cardiac monitoring.
5. Do not use the Device output as the sole basis for medical diagnosis, treatment
decisions, medication use, or clinical decision-making. All recordings must be
reviewed by a qualified healthcare professional.
6. The Device may not detect all arrhythmias or cardiac conditions, including low-
amplitude signals or recordings affected by noise, motion artifacts, or poor contact.
7. Seek medical attention immediately if you experience chest pain, shortness of breath,
fainting or near-fainting, palpitations, or other concerning symptoms, regardless of
Device readings.
8. The Device is MR Unsafe and must not be used in MRI environments or in strong
electromagnetic fields (e.g., RF equipment).
9. Signal quality limitations: Improper electrode contact, excessive pressure, poor
posture, movement, sweating, or excessively dry/moist skin may result in degraded
signal quality or inaccurate recordings.
10. Performance may be affected when used near wireless communication equipment.
11. Ensure both thumbs maintain continuous contact with the electrodes during
measurement. Premature release may interrupt recording.
12. Do not use the Device outside the environmental conditions specified in this manual.
13. Do not use in wet environments, during thunderstorms, or where electrical hazards
may exist. Do not immerse the Device in liquids.
14. Replace the battery promptly when the low-battery indicator appears.
15. Coin cell batteries pose a choking hazard. During battery replacement, keep the
Device and batteries out of reach of infants and young children. If ingestion or
insertion is suspected, seek immediate medical attention, as it may cause serious
injury.
16. Do not replace the battery while the Device is in use or in contact with the user.
17. Keep the Device out of reach of children, pets, and pests to prevent damage or
IFU for Revlis ECG Monitor (CMP-121A)
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accidental ingestion.
18. Do not disassemble, modify, or repair the Device. Service should be performed only
by the manufacturer or authorized distributor.
19. Read and follow the Instructions for Use carefully. If in doubt, contact the
manufacturer or authorized distributor.
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FCC compliance
This device complies with Part 15 of the FCC Rules.
FCC ID: 2APXB-CMP-121A
Federal Communications Commission (FCC) Interference Statement
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.
Any changes or modifications not expressly approved by the party responsible for
compliance could void your authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
RF exposure statements
This product is based on SAR assessment and the user manual must have the following
warnings “This device meets the government’s requirements for exposure to radio waves.
This device is designed and manufactured not to exceed the emission limits for exposure
to radio frequency (RF) energy set by the Federal Communications Commission of the
U.S. Government. The exposure standard employs a unit of measurement known as the
Specific Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6 W/kg. Tests for SAR
are conducted using standard operating positions accepted by the FCC with the EUT
transmitting at the specified power level in different channels. The FCC has granted an
Equipment Authorization for this device with all reported SAR levels evaluated as in
compliance with the FCC RF exposure guidelines. SAR information on this device is on file
with the FCC and can be found under the Display Grant section of
www.fcc.gov/oet/ea/fccid.”
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Maintenance and Cleaning
Store the Device in a clean, dry environment within the specified storage and
environmental conditions described in this manual.
1. Service and repair
（1） No service or repair should be performed on the Device other than the maintenance
procedures described in this section.
（2） The Device contains no user-serviceable internal components.
（3） The Device does not require calibration during its service life, and contains no
operator-adjustable calibration controls.
2. Cleaning
（1） The Device is intended for single-patient use and for contact with intact skin only.
Routine cleaning is sufficient.
（2） Clean the electrodes using clean water and wipe with a clean, lint-free soft cloth as
needed.
（3） Do not use abrasive cleaners or abrasive materials.
（4） Do not immerse the Device in liquid or expose it to excessive moisture or fluids.
3. Exterior visual inspection
（1） Inspect the electrodes for deformation, surface damage, or corrosion.
（2） Inspect the device housing and external surfaces for cracks, deformation, or other
visible damage. If any damage is observed, discontinue use and contact the
manufacturer or authorized service provider.
4. Battery replacement
（1） Battery type: CR2032 coin cell battery compliant with IEC 60086-4.
（2） Insert the battery with correct orientation, ensuring the positive (+) terminal faces
upward.
（3） The battery cover requires a tool (e.g., a coin) for opening. A tool (e.g., a
screwdriver) is required for battery removal to reduce the risk of accidental
swallowing.
（4） Remove the battery if the Device will not be used for an extended period.
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Troubleshooting
If you experience difficulties using your Revlis ECG Monitor, refer to the troubleshooting
guide below.
If the problem persists after troubleshooting, discontinue use and contact customer support.
1. My Revlis ECG Monitor is not working
A. Verify Battery state
i. Use the correct CR2032 coin cell battery.
ii. Ensure the battery polarity matches the markings on the product when
inserting the battery.
iii. When the battery power is low, the LED indicator will flash in a different
pattern (on for 0.5 seconds and off for 5 seconds, with a longer off interval
compared to normal operation). Replace the CR2032 coin cell battery as
soon as possible.
B. Verify Device Activation
When holding the device and touching both electrodes with your thumbs, the central
LED indicator will illuminate yellow-green, indicating that the device has entered
operating mode.
C. Verify Smartphone Bluetooth Settings
i. Ensure that Bluetooth is enabled on your smartphone.
ii. For Android smartphones, ensure that Location Services are also enabled to
allow Bluetooth device detection and connection.
D. Verify App Connection
i. Ensure the Fiona App is installed and running on the smartphone.
ii. Keep the smartphone within the recommended Bluetooth communication
range during measurement.
2. I am having trouble getting a clear recording
A. Electrode and Skin Preparation
i. Clean the electrodes using a soft, damp cloth before use.
ii. Wash your hands with soap and water prior to recording.
iii. Slightly moisten the skin areas where your fingers contact the electrodes to
improve signal quality.
B. Reduce Muscle Noise During Recording
i. Relax your arms and hands during recording to minimize muscle noise and
motion artifacts.
ii. Rest your forearms and hands on a flat and stable surface while recording.
iii. Do not apply excessive pressure to the electrodes.
C. Reduce Electrical Interference
i. Avoid using the device near sources of electrical interference, such as
electronic devices, computers, chargers, wireless routers, or other electronic
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equipment.
ii. Hearing aids may introduce electrical interference during ECG recording. If
applicable, turn off hearing aids before recording.
3. Additional Troubleshooting Information
A. Measurement Interrupted
i. Bluetooth communication may be unstable. Move to an environment with
less wireless interference and try again.
ii. Battery power may be low. Verify the battery status of the device.
B. No ECG Waveform Displayed During Measurement
If no ECG waveform appears during measurement, the app may be connected to
another nearby device. Ensure that no other compatible devices are simultaneously
powered on nearby.
C. Device Damage
If the device appears damaged or is not functioning properly, discontinue use and
contact customer service or your authorized distributor.
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Technical Specification
Item
Specification
Function
Single-lead ECG (Lead I)
Dimension
W86mm*H8.6mm*D30mm
CPU
128 MHz Arm®Cortex®-M-33 processor
Memory
4Mb Flash memory
Interface
Bluetooth (BLE)
Sample rate
1,000Hz
Resolution
12 bit
Z_in
>10MΩ
CMRR
>60dB
FR
0.5Hz to 40Hz
Input dynamic range
±5mV offset ±300mV
NR
50Hz / 60Hz
Power
Sleep mode
3V/7uW
Operating mode
3V/7mW
Operating Temp.
5°C~ 40°C
Storage Temp.
-25°C~ 70°C
Transport Temp.
-25°C~ 70°C
Operating humidity
15%~90%
Storage humidity
15%~90%
Transport humidity
15%~90%
Weight
21g (w/o batteries and peripherals)
Measurement time
30 seconds
Power supply
CR2032*1
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Symbols
The packaging and labeling of the Device may include the following symbols:
Symbol
Interpretation
Symbol
Interpretation
Manufacturer
Temperature limit
Date of manufacture
Humidity limitation
Catalogue number
Consult instructions for use
Serial number
Caution
Unique device identifier(UDI)
Type BF Applied Part
Medical device
Do not cut, shred or attempt to
destroy device
Do not dispose with
household waste
Refer to instruction
manual/booklet
IP 22
WARNING
Projectile Hazard
