Wellue Checkme Plus Health Monitor User Guide

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Health Monitor
Quick Guide Model: Checkme Plus

The Basics

This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
1.1 Safety
Warnings and Cautionary Advice

• Before using the device, please ensure that you have read this manual thoroughly and fully understand corresponding precautions and risks.
• This device has been designed for practical use, but is not a substitute for a visit to the doctor.
• The data and results displayed on the device are for reference only and cannot be directly used for diagnostic interpretation or treatment.
• We recommend not to use this device if you have a pacemaker or other implanted devices. Follow the advice given by your doctor, if applicable.
• Do not use this device with a defibrillator.
• Do not use this device during MRI examination.
• Do not use the device in a combustible environment (i.e., oxygen-enriched environment).
•  Never submerge the device in water or other liquids. Do not clean the device with acetone or other volatile solutions.
• Do not drop this device or subject it to strong impact.
• Do not place this device in pressure vessels or gas sterilization device.
• Do not dismantle the device, as this could cause damage or malfunctions or impede the operation of the device.
• This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device. Children should be supervised around the device to ensure they do not play with it.
• Do not allow the electrodes of the device to come into contact with other conductive parts (including earth).
• Do not use the device with persons with sensitive skin or allergies.
• Do not store the device in the following locations: locations in which the device is exposed to direct sunlight, high temperatures or levels of moisture, or heavy contamination; locations near to sources of water or fire; or locations that are subject to strong electromagnetic influences.
• Do not swing the device with the strip, which may result in injury.
• This device displays changes in the heart rhythm and blood oxygenation etc. which may have various different causes. These may be harmless, but may also be triggered by illnesses or diseases of differing degree of severity. Please consult a medical specialist if you believe you may have an illness or disease.
• Vital signs measurements, such as those taken with this device, cannot identify all diseases. Regardless of the measurement taken using this device, you should consult your doctor immediately if you experience symptoms that could indicate acute disease.
• Do not self-diagnose or self-medicate on the basis of this device without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
• This device is not a substitute for a medical examination or your heart or other organ function, or for medical electrocardiogram recordings, which require more complex measurements.
• It is not possible to use this device to diagnose illness or diseases. This is exclusively the responsibility of your doctor.
• We recommend that you record the ECG curves and other measurements and provide them to your doctor if required.

Intended Use

The health monitor is intended to be used for measuring, displaying, reviewing and storing ECG in home or healthcare facilities environment.
The data and results provided by this device are for precheck screening purpose only and cannot be directly used for diagnostic or treatment.

Unpacking

Main Unit; Quick Guide; Charging / Data Cable; ECG Cable; Reusable ECG Electrodes; Carry Case; Neck Strap
Warnings and Cautionary Advice

• Use accessories specified in this chapter. Using other accessories may cause damage to the device or not meet the claimed specifications.

About the Main Unit

ViHealth App

You can use ViHealth app to synchronize and share your data. Use your mobile phone to search for ViHealth in the App Store or Google Play.
Download and install the ViHealth mobile app.
Caution:
Uninstalling the app will delete all data!
If you need to reinstall the app, please install the new version directly, it will automatically update the old version.

Desktop Software

Use the desktop software to download your data onto
Windows or Mac.
Download this software from our support page:
www.getwellue.com
Menu: FAQ & Download->PC Software & Mac App

Set Up

7.1 Charging
Connect the device to a standard USB charging adapter with the provided charging cable.
7.2 Powering On/Off
Press and hold the home button for 1 second to power on, and 3 seconds to power off. It will turn off automatically if it is not measuring or operating.
7.3 Initial Settings
When the device is powered on for the first time, please set the current date and time. 7.4 First Check

1. On the homepage, touch the Heart Check icon, then choose an ECG Type Lead II (Read notes).
2. Hold the device as shown in the device display.
3. Remain still and relaxed while taking measurements until complete. Next, the results will be displayed.

Note:

• Moisten skin (the area that the electrode touches) may help to get a better waveform.
• You can get different signal amplitudes from Lead I, Lead II, or Chest Lead. Usually, the signals from Lead II and Chest Lead are stronger
• For Lead I, rest your hands on a table or thigh to help you keep relax throughout the check. If your hand is trembling, try your left wrist or bicep instead of your left hand.
• Touching the rectangular electrode on the back of the device has little influence.

7.5 View Results
There are 6 kinds of measurement results, Touch the ” ” icon to view the specific definitions
Touch the “ ” icon to replay the ECG waveform.
Touch the “ ” icon to take new measurements.
You can use the home button at any time to return to the homepage or cancel taking measurements.
7.6 Reviewing Records
On the homepage, touch the History icon to review your history results.
You can choose a record to review the results and touch “ ” icon to replay the recorded ECG waveform.
Touch” ” icon to delete the current record.
7.7 Syncing Data to ViHealth App
Search for ViHealth in the App Store or Google Play.
Download and install the ViHealth mobile app.

1. On the homepage, choose Settings->Bluetooth to turn on the device’s Bluetooth.
2. Switch on Bluetooth on your mobile phone.
3. Run ViHealth on your mobile phone. (Please Always Allow location and storage permissions for the Bluetooth connection and data storage.)
4. Add a new device: The app will automatically search for devices and display them on the screen. Choose Checkme Plus and wait for the data to download.
5. Review report: Choose a single record, and you can enter a detailed report.
6. Share report: On the report details page, tap the share button in the upper right corner to share your report.
7. Delete a record: Choose a single record, swipe left to delete it.
   Note: This operation will only delete the records in the app, not the records on the device.

7.8 Using the PC Software
Download the latest version from: www.getwellue.com
Menu: FAQ & Download->PC Software & Mac App
Note:

1. If you have downloaded the software before, please update it to the latest version.
2. Occasionally, firewall or anti-virus software may block “Pulsebit Browser”. Allow it.
3. Please check the help document in the software for more information.

Download and Install Pulsebit Browser Pro on your computer.
To export data:

1. Connect the device to the PC with the provided cable
2. On the device, enter Settings->To PC
3. Run the software, click the Download Button to export the data on the device

With the software, you can view and print reports, which can also be exported as PDF files.

Exploring More Features

8.1 Choosing Different ECG Types
Before taking measurements, you can choose different ECG types (Leads). Any results will be marked with the corresponding type. 8.2 Using the ECG cable for Heart Checks

1. Touch to start taking measurements; touch the icon at the bottom to switch to External mode.
2. Insert the ECG cable into the Micro D port, adhere the reusable electrodes onto your body as shown below.

• Tips:

• Use Lead II if signal is too low in Lead I
• Moisten skin (area that touch electrodes) if too dry
• Rest hands on table or thigh and keep relax
• Use the cable when you have difficulty to get stable ECG without cable

8.3 About Reusable Electrodes
Please cover the white protective paperback and seal the electrode pads in the plastic bag after each use. We recommend replacing the electrodes after 50 uses. Electrode performance will decrease after excessive use. You can purchase more electrodes on  Amazon or our website getwellue.com
8.4 Understanding the Results

Heart Rate| The number of times your heart beats per minute calculated from the ECG.
The reference range for adults is 50-100 beats per minute in a relaxed state and higher when stimulated. Control your maximum heart rate during fitness or exercise to avoid overstressing the heart.
---|---
ECG| An electrocardiogram (ECG) is a test that records the heart’s electrical activity.
Regular heartbeat – the recorded ECG shows a usual and regular pattern.
Irregular heartbeat – the recorded ECG shows an erratic pattern. It may be caused by overstressing the heart or other conditions.
Poor signal| Low signal amplitude or noise. Changing to Mode II may help.
Unable to analyze| ECG recording is incomplete.

8.5 Settings
User Mode: Settings->User Mode->touch to choose One- User/Two-User modes
When you switch to Dual User mode, the homepage will show User A and User B icons. Choose a user to start taking measurements, and the results will be marked A or B. In single user mode, the results are not marked.
ECG Length: Settings->ECG Length, for 30s/60s/5 minutes Note: only measurements through cables are supported in 5minute mode
Brightness: Settings-> Touch the brightness meter to adjust the brightness
Voice: Settings->Touch the Voice switch to turn the heartbeat voice on and off. Other settings: Date& Time, Erase Data, Factory Reset, About.

Maintenance

9.1 Care and Cleaning
Warnings and Cautionary Advice
Have the device repaired by authorized service centers only, otherwise its warranty is invalid.
Clean the device per week, carefully swabbing the device surface with a soft cloth or cotton swab with rubbing alcohol. Do not pour alcohol directly on or into the device.
9.2 Troubleshooting

try again.
The device might be damaged| Please contact your local distributor.
Low battery indicator is blinking| The battery is low.| Charge the battery and try again.
The ECG waveform amplitude is small| The Lead you have chosen is not suitable.| Swap with another Lead and try again.
ECG waveform drifts or disappears and “Check Contact” displays.| The pressure exerted on the electrode is not stable or too great.| Hold the device so that it is stable.
Hand or body may be moving.| Try to keep perfectly still and retest.

Specifications

Classifications

EC Directive| MDD, 93/42/EEC
R&TTE, 1999/5/EC
ROHS 2.0, 2011/65/EU
Degree protection against electrical shock| Type BF
Environmental
Item| Operating| Storage
Temperature| 5 to 45°C| -25 to 70°C
Relative humidity (noncondensing)| 10% to 95%| 10% to 95%
Barometric| 700 to 1060 hPa| 700 to 1060 hPa
Degree of dust & water resistance| IP22
Physical
Size| 88x56x13 mm
Weight| 64 g (main unit)
Display| 2.4″ touch screen, color, backlit
Connector| Micro-D connector
Power Supply
Battery type| Rechargeable lithium-polymer battery
Battery run time| Heart check: > 800 times
Charge time| I Less than 2 hours to 90%
ECG
Lead type| Integrated ECG electrodes
Lead set| Lead I, lead II
Record length| 30s, 60s, 5min
Sampling| 500 Hz / 16 bit
Display Gain| 1.25 mm/mV, 2.5 mm/mV, 5 mm/mV 10 mm/mV, 20 mm/mV
Sweep speed| 25 mm/s
Bandwidth| 0.67 to 40Hz
Electrode offset potential tolerance| ±300 mV
HR measurement range| 30 to 250 bpm
Accuracy| ±2 bpm or ±2%, whichever is greater
Heart rate is calculated based on average of every 5 to 30 QRS complex.
Measurement summary| Heart rate, Rhythm analysis (Regular ECG Rhythm, Fast Heart Rate, Slow Heart Rate, Irregular ECG Rhythm, Unable to analyze)
Standards| Meet standards of ISO 80601-2-61
Review
Waveform review| Full disclosure waveform
Storage| 100 pcs of records, 30s per record

Symbols

municipal waste.
| Follow Instructions for Use.
**| Type BF Applied Part
| MRI unsafe. Presents hazards in all MR environments as device contains strongly ferromagnetic materials.
IP22| Resistant to liquid ingress
| CE marking
| Authorized representative in the European community
**| UKCA marking
| Authorized Representative in the United Kingdom
| This product complies with the rules and regulations of the Federal Communication Commission.
| Non-ionizing radiation
| Our products and packaging can be recycled, don’t throw them away!
Find where to drop them off on the
www.quefairedemesdechets.fr site (Only applicable for French market).
| This product complies with verpackG.

Electromagnetic Compatibility

The device meets the requirements of EN 60601-1-2. All the accessories also meet the requirements of EN 60601-1-2 when in use with this device.
Warnings and Cautionary Advice
Using accessories other than those specified in this manual may result in increased electromagnetic emission or decreased electromagnetic immunity of the equipment.
The device or its components should not be used adjacent to or stacked with other equipment.
The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.
Other devices may interfere with this device even though they meet the requirements of CISPR.
When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result.
Portable and mobile communication equipment may affect the performance of this device.
Other devices that have RF transmitter or source may affect this device (e.g. cell phones, PDAs, and PCs with wireless function).

Guidance and Declaration – Electromagnetic Emissions

The Health Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Emission tests| Compliance| Electromagnetic environment -guidance
RF emissions CISPR 11| Group 1| The device 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 device 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 IEC61000-3-2| Class A
Voltage
Fluctuations / Flicker Emissions IEC 61000-3-3| Complies
Guidance and Declaration – Electromagnetic Immunity

The Health Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Health Monitor should  assure that it is used in such an environment.
Immunity test| IEC60601 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
± 1 kV for input/output lines| ± 2 kV for power supply lines ± 1 kV for input/output
lines typical| Mains power quality should be that of a
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
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) for 5 s| <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) for 5 s| Mains power quality should be that of a
typical commercial or hospital environment. If the user of our product
Power frequency (50/60 HZ) 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.

Guidance and Declaration – Electromagnetic Immunity
The Health Monitor is intended for use in the specified electromagnetic environment. The customer or the user of the Health Monitor should assure that it is used in such an environment as described below.

Immunity test| IEC60601 test level| Compliance level|  Electromagnetic environment – guidance
---|---|---|---
Conduced RF IEC61000-4- 6| 3 Vrms 150 kHz to 80 MHz

outside ISM bands

| 3 Vrms 150 kHz to 80 MHz
outside ISM bands| Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.
Recommended separation distances:
Radiated RF IEC61000-4- 3| 3 V/m 80 MHz to 2.5 GHz| 3 V/m 80 MHz to 2.5 GHz|

Recommended separation distances:
80 MHz～800 MHz:
800MHz-2.5GHz:
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 meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b.Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz to 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.
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 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 may be necessary, such as re-orienting or relocating the device.
b Over frequency range 150kHz to 80MHz. For Resp field strength should be less than 1V/m.
Recommended separation distances between portable and mobile RF communications equipment and the device
The Health Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Health Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the monitor as recommended below, according to the maximum output power of the communications equipment.

Rated max. output power of transmitter (W)| Separation distance according to frequency of thetransmitter (m)
---|---
150 kHz – 80 MHz
| 80 MHz – 800 MHz| 800 MHz – 2.5 GHz
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
100| 12| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.

References

• Wellue - Innovative Technology Powers Your Health
• Wellue - Innovative Technology Powers Your Health
• Wellue - Innovative Technology Powers Your Health
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