Checkme Pro Health Monitor
User’s Manual………………….…….English 1-27
Manuel de l'utilisateur……..…Français 28-52
Benutzerhandbuch …………...Deutsch 53-76
Manuale d’uso……………………Italiano 77-99
Manual de usuario……………………Español 100-140
Contents
1. Introduction ............................................................................................ 2
2. Using Checkme ........................................................................................ 6
3. Settings .................................................................................................. 17
4. Review ................................................................................................... 19
5. Maintenance ......................................................................................... 20
6. Accessories ............................................................................................ 21
7. Specifications ........................................................................................ 21
8. Electromagnetic Compatibility .............................................................. 24
1. Introduction .......................................................................................... 29
2. Utiliser Checkme ................................................................................... 33
3. Réglages ................................................................................................ 44
4. Revoir .................................................................................................... 47
5. Maintenance ......................................................................................... 48
6. Accessoires ............................................................................................ 49
7. Spécifications ........................................................................................ 49
1. Einleitung .............................................................................................. 54
2. Checkme - so wird das Gerät verwendet ............................................... 58
3. Einstellungen ......................................................................................... 69
4. Auswertung ........................................................................................... 71
5. Wartung ................................................................................................ 72
6. Zubehör ................................................................................................. 73
7. Technische Angaben .............................................................................. 74
1. Introduzione .......................................................................................... 78
2. Usare Checkme ..................................................................................... 82
3. Impostazioni .......................................................................................... 92
4. Controllo dati ........................................................................................ 95
5. Manutenzione ....................................................................................... 95
6. Accessori ............................................................................................... 96
7. Specifiche .............................................................................................. 97
1
1. Introduction
1.1 Safety
Warnings and Cautionary Advices
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).
Do not place this device in pressure vessels or gas sterilization 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.
Do not allow the electrodes of the device to come into contact with other
conductive parts (including earth).
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.
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.
The device has no alarms and will not sound if the measurement reading is too
low or too high.
Check the SpO2 sensor application site every 6-8 hours to determine the
positioning of the sensor and the circulation and skin sensitivity of the patient.
Patient sensitivity varies depending on medical status or skin condition. For
patients with poor peripheral blood circulation or sensitive skin, inspect the
sensor site more frequently.
Do not use the Oximeter on the same hand/arm when using a blood pressure cuff
2
or monitor.
5 6 7
2 1 3
4
1.2 Intended Use
The Checkme Pro health monitor is intended to be used for measuring, displaying,
reviewing and storing of multiple physiological parameters including ECG, pulse oxygen
saturation (SpO
2), pulse rate, temperature and blood pressure variation in home or
healthcare facilities environment.
ECG and Blood pressure variation is intended for use with adult.
The data and results provided by this device are for pre-check screening purpose only
and cannot be directly used for diagnostic or treatment.
1.3 About Checkme
1. Touch Screen
2. Infrared temperature sensor
3. Internal SpO
2 sensor
4. LED indicator
Off: the monitor is turned off or working in Standby Mode;
Green: the monitor is turned on, and working normally; or when the
battery is fully charged;
Blue: the battery is being charged;
Red: the battery is low;
5. Multi-functional connector
It connects with external SpO
6. Home, Power On/Off
When the monitor is off, press this button to power it on.
When the monitor is on, press and hold it for 2 seconds to turn it off.
During operation, press this button will switch to Main Screen, or Calendar
Screen, or return to upper menu.
7. ECG right electrode
Use right thumb to press on it.
2 cable, ECG cable, or charging cable.
3
8. Speaker
9
11 8 10 1 2
3
4 6 7
5
9. ECG left electrode
Put it to your left palm, left abdomen or left knee.
10. Neck stripe hole
11. ECG back electrode
Use right forefinger or middle finger to press on it.
1.4 Main Screen
The Main Screen is shown as below. Slipping your finger from right to left can switch to
the second page, and vice versa.
*Minimonitor and ECG Holter are optional function.
1.5 Calendar Screen / Standby Mode
The device will enter Calendar Screen / Standby Mode when:
No operation is detected for 120 seconds in other screen interface, the device will
automatically switch to the Calendar Screen.
Pressing the Home button in the Main Screen.
4
1. Current time
1 2 3
4
2. Current date
When a reminder event happens, this area displays the event name, e.g. “Daily
Check”.
You are allowed to change the current time and date when the device is powered on at
the first time. Or you can also go to the Setting menu to change it.
3. This arrow indicates users to press the Home button to exit the Calendar Screen /
Standby Mode.
4. Battery indicator
5. If you failed to respond to the previous reminder event, then that event will be
shown in this area.
6. This icon appears when <Quick ECG> is enabled.
7. This icon appears if you have set reminder event.
1.6 Result Screen
For each measurement, a Result report will be provided after the measurement is
finished. An example is shown as below.
1. Measured parameters and readings
2. A summary of this measurement
3. A graphic indicator about the health status
: All measured parameters are within the reference range;
: One or more than one measured parameter(s) is (are) out of reference
range. When the icon appears, it is suggested to test again, and consult
your doctor for help.
4. Buttons
Select button to start a measurement again.
Press and hold the button to add voice memo. Voice memo is only
available for Daily Check and ECG Recorder measurements.
Select button to review previous results.
Press button to open the help information.
5
1.7 Symbols
Symbol
Meaning
In conformity with Directive 93/42/EEC
Symbol for “ENVIRONMENT PROTECTION – Waste electrical
retailer for recycling advice”.
dripping(15° tilted)
Application part type BF
Manufacturer
CE0197
European Representative
products should not be disposed of with household waste. Please
recycle where facilities exist. Check with your local authority or
IP22
Against ingress of solid foreign objects ≥12.5mm diameter, Against
Follow operating instructions
No alarm system.
2. Using Checkme
2.1 Prior to Use
Charge the Battery
To charge the battery,
1. Connect the smaller end of the USB charging cable to the multi-functional
connector
2. Connect the other end of the USB charging cable to the USB charging port.
3. When the LED turns to green, it means the battery is fully charged.
Warnings and Cautionary Advices
The device cannot be used for any measurement during charging.
Use charging adapter provided by manufacturer, or USB charging devices which
comply with the standard of IEC 60950.
Power On/Off
Press the Power On/Off button to power on the device. Press and hold Power On/Off
button for 2 seconds to power off the device.
6
2.2 Daily Check
(1)
(2)
(3)
(4)
About Daily Check
Daily Check measurement is a function that combines the measuring of ECG
(Electrocardiograph), SpO
20 seconds to collect your vital signs before giving you vital signs readings and your
health evaluation.
Using Daily Check
To start a Daily Check, follow the steps as below.
1. If you have not created user, then please follow the instruction in [Settings
Section] to add your user account.
2. Tap the <Daily Check> icon in the middle of the screen.
3. Choose the right user.
4. Hold the device according to the instruction, keep the device at the same level as
your heart, and keep stable posture and stay calm. Don’t exert too much pressure
on the ECG electrode, which may result in EMG (electromyograph) interference.
Just hold gently and ensure good contact with the ECG electrode. Do not exert
pressure on the finger that put in the SpO
ensure good blood perfusion.
2 (blood oxygenation) and systolic blood pressure. It takes only
2 sensor. Just fit it inside but gently to
(1) Put the right forefinger into the built-in SpO
squeeze the edge of the SpO
2 sensor cover, then move in upward to the left
2 sensor. Use the finger nail to
to raise it up as shown below.
(2) Press the right thumb on the right electrode.
(3) Press the right middle finger on the back
electrode.
(4) Press the left electrode to the left palm.
5. Once the device detects stable waveform, it will
automatically start the measurement. The
countdown bar moves from left to right.
6. When the bar is fully filled, the device will analysis your data, and then show the
measurement result.
7
Daily Check provides the trending graph of heart rate, SpO
the trend, tap the button, then select one record, and then tap the button.
2 and blood pressure. To view
BP Calibration
Warnings and Cautionary Advices
For a given user, it is suggested to make BP calibration every three months.
To get blood pressure readings, this device should be calibrated by a doctor with a
traditional cuff blood pressure (BP) meter. Because of individual differences, each user
must make his/her own calibration before using Daily Check to measure or track the
blood pressure. The calibration should be performed when the user is under calm
status.
To calibrate with a cuff BP meter, follow the steps as below.
1. Select the <Settings> icon, select <BP Calibration>, and then choose the right
user.
2. Ensure that the cuff and the Checkme monitor are at the same level as your heart.
Then start the blood pressure measurement from the cuff BP meter.
3. Press the button on the Checkme screen, and start the DailyCheck
measurement.
4. When the blood pressure measurement is finished, manually input the readings
of systolic pressure reading in the Checkme.
5. Repeat the calibration once again by following the above steps.
2.3 ECG Recorder
About ECG Recorder
The ECG recorder offers four different methods to measuring ECG. Tap the icon to
switch between two pages.
As shown above, from left to right, there are:
Method A: Lead I, right hand to left hand
Method B: Lead II, right hand to left abdomen
Method C: Lead I, left wrist to right wrist
8
Method D: Lead II, right wrist to left lower abdomen
ST segment analysis is performed on selected LEAD.
Method A and B offer maximum comfort, than method C and D, but no ST segment
value. No matter which method you choose to measure ECG, please keep stable
posture and stay calm during the measurement.
Measuring without Cable
To start an ECG Recorder measurement without cable,
1. Choose the method A or B.
2. Follow the instruction according to the mode you selected.
Press the right thumb on the right electrode;
Press the right forefinger on the back electrode;
For method A, press the left electrode to the left palm;
For method B, press the left electrode to the left lower abdomen;
Do not press the device too firmly against your skin, which may result in EMG
(electromyograph) interference. After you finish the above steps, hold the device
stably and stay calm.
3. Once the device detects stable waveform, it will automatically start the
measurement. The countdown bar moves from left to right.
4. When the bar if fully filled, the device will analysis your data, and then show the
measurement result.
Measuring with Cable
To start an ECG Recorder measurement with cable,
1. Choose the method C or D.
2. Follow the instructions to connect the ECG cable and place the ECG electrodes.
9
Sit down or stand, stay calm;
Palms facing up, place an electrode in the middle of right wrist;
For method C, place another electrode in the middle of left wrist;
For method D, place another electrode in the left lower abdomen;
3. The display will then show your ECG waveform.
The device will monitor your ECG continuously, however no data will be saved
until you press the button.
4. Press the button to start collecting your ECG data. The countdown bar moves
from left to right.
5. When the bar is fully filled, the device will analysis your data, and then show the
measurement result.
Quick ECG
If the <Quick ECG> function is enabled, then you can start an ECG measurement very
quickly by picking up the device and hold it according to method A. This saves time and
is much easier for use.
In the Settings menu and tap <Quick ECG> to enable or disable this function.
2.4 Temperature
About thermometer
Warnings and Cautionary Advices
The thermometer is only designed for the measuring area on the human body
stated in this manual.
The device needs to be in the room which the measurement is taken for at least
10
10 minutes before use.
Physical activity, increased perspiration on the forehead, taking vasoconstictive
medication and skin irritations can distort the result.
The forehead (temples) must be free from perspiration and cosmetics.
Influences on forehead temperature include but not limited to
A person’s individual metabolism;
Age; Forehead temperature is higher in babies and infants than in adults.
Greater temperature fluctuations occur faster and more often in children.
Normal forehead temperature decreases with age.
Environmental temperature;
Time of day; Forehead temperature is lower in the morning and increases
throughout the day towards evening.
Activities; Physical and, to the lesser extent, mental activities increases forehead
temperature.
Taking Temperature Measurement
To start a temperature measurement,
1. In the Main Screen, select <Thermometer>.
2. Put the thermometer sensor on your temple.
3. Press the Home button once, you will hear “Bi-Bi” beep, which indicates the
measurement starts. Then move the thermometer around the temple for around
3 seconds until you hear a long “Bi” beep, which indicates the measurement is
finished.
4. Take down the device, and the screen shows the measurement result.
In the Settings menu, tap the <Thermometer> area to change between Celsius degree
(°C) and Fahrenheit degree (°F).
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2.5 Oximeter
Finger nail position
About Oximeter
The Checkme Health Monitor measures the amount of oxygen in your blood, your
pulse rate and pulse index. The oxygen saturation (SpO
percentage of full capacity.
Measuring without Cable
To start a Oximeter measurement without cable,
1. In the Main Screen, tap the <Pulse Oximeter> icon.
2. Insert the forefinger into the built-in SpO
2) is measured and displayed as a
2 sensor as shown below.
Relax your forefinger and do exert pressure.
3. When the device detects stable waveform, it will automatically start the
measurement. The countdown bar moves from left to right.
4. When the bar is fully filled, the device will analysis your data, and then show the
measurement result.
Measuring with Cable
1. Connect the external SpO2 sensor to the multi-functional connector.
2. Put your index finger or middle finger into the external SpO
2 sensor. Make sure
the cable is positioned along the top of the hand, and the finger nail is in the
position as shown below.
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3. Tap the <Pulse Oximeter> icon.
4. The display will then show your PLETH waveform, SpO
2 and pulse rate.
The device will monitor continuously, however no data will be saved until you
press the button.
5. Press the button to start collecting your SpO
2 data. The countdown bar moves
from left to right.
6. When the bar is fully filled, the device will analysis your data, and then show the
measurement result.
2.6 Sleep Monitor
Checkme offers a non-invasive method to monitor sleep status for adult users who
have sleep problem, sleep related breathing disorders and obstructive sleep apnea.
Warnings and Cautionary Advices
Before using as a sleep monitor, please ensure the battery is fully charged.
To start a sleep monitor measurement,
1. Tie the wristband on one of your left hand.
2. Insert the SpO
connector.
3. Put one of your finger into the sensor. Forefinger or
middle finger is suggested. If needed, remove the
colored nail polish from the finger. Make sure that
the sensor is correctly placed so that the cable goes
above your hand back.
4. Press the Home button to enter the Main Screen. Then Tap the Sleep Monitor
icon to enter the screen as below.
2 cable into the multi-functional
5. Tap the button to start the sleep monitoring. During monitoring, a countdown
timer is always displayed at the lower left part.
6. You can press Home button to lock the screen, as shown below. The device will
work in a very low power consumption mode.
7. Insert the device into the wrist band cover, and then begin to sleep.
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8. When you get up, or when you want to stop monitoring, you can press the Home
button again to unlock the screen, and then tap icon to stop sleep
monitoring.
9. You can tap button to view the SpO
button and return to the Main Screen.
2 trending during your sleep, or tap “Close”
2.7 NIBP（Optional）
Checkme can work with the NIBP unit (optional accessory) to
measure blood pressure.
1. In the Checkme Main Screen, select <NIBP>, choose the
right user.
2. Turn on the NIBP unit to connect it via Bluetooth.
3. Sit correctly. Place the cuff on the left upper arm. Press the <start>.
4. Following the instruction on Checkme, pump to the target pressure then keep
still until the results.
5. Deflate the cuff.
2.8 Minimonitor (Optional)
About Minimonitor
The Minimonitor function is able to continuously monitor and display patient's ECG and
SpO
2. Real-time waveform and readings can be sent and displayed on a tablet or phone.
Before using this function, please search and download "Check Trace" from APP store
or Google Play to your tablet or phone.
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Using Minimonitor
To start a Minimonitor function, follow the steps as below.
1. In the Checkme Main Screen, select <Minimonitor>
2. Correctly connect the "Minimonitor adaptor", SpO
device.
3. Put finger into the external SpO
belo w.
4. Turn on the Bluetooth on your pad and open “Check Trace “app. The app will
search the device through Bluetooth.
5. Choose the device you’re monitoring via SN.
6. When the devices are connected successfully, you can see the waveform and
measurement data on both Checkme and app. Please see below the displaying
screen on app.
2 sensor. Place the ECG electrodes as shown
2 cable and ECG cable with the
7. When you finish measuring, press the Home button to stop monitoring.
2.9 ECG Holter (optional)
2.9.1 Choose Holter Lead
Choose the proper ECG lead in the setting menu.
There are 4 options: LEAD II; CC5; CM5; User defined.
2.9.2 Meaurement
1. In the Main sceen, tap the ECG Holter icon.
2. Choose the right user, enter the guidance screen.
3. Plug ECG cable and place eletrodes on the right postions as guided.
4. The display will show ECG waveform, press the button to start recording. (The
recording will start to record 1 minutes later automatically without pressing the
15
button)
5. Wear the Holter Belt around your waist
6. Put Checkme in the pocket of the Belt, then close the pocket.
Keep recording for 24 hours or less. During this process, the device will beep if the
cable or any electrode is off.
2.9.3 Report on PC
Checkme Holter Browser is a PC software to check and print the report.
1. Connect device and PC by USB cable.
2. Operation on device:
Settings->To PC; or Review-> Holter icon->To PC icon
3. Operation on PC:
Open the software, press the button in the leftup corner to download the data
from device. Then you can check the report.
2.10 Pedometer
To start a Pedometer measurement,
1. In the Main Screen, select <Pedometer> icon. If you have not created user, then
please add your user account.
2. Select a user to enter the screen as below.
3. Tap the button to set your target, if needed.
4. Tap the button to start calculating steps.
5. Place the device into your pocket.
6. When you finished calculating steps, press the Home button to stop the
pedometer.
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7. Press Home button again to exit pedometer function.
2.11 Reminder
Up to 6 reminder events can be set by user. You can add, edit and delete reminder
events.
3. Settings
3.1 Changing Sound Volume
In the Settings menu, tap the <Volume> area to change volume directly. “X” means the
volume is turned off.
3.2 Enabling/Disabling Voice Guide
In the Settings menu, tap the <Voice Guide> to enable or disable this function.
3.3 User Management
To use the Daily Check measurement, you must create your account. If the Daily Check
measurement is used by more than one user, then each user must create his/her own
account.
To create a user account:
1. In the Settings menu, choose <User Management>.
2. Tap a “+” button to open the menu below.
3. Tap each button to edit corresponding information.
4. Tap to return the < User Management > menu.
To edit the information of a user:
1. In the Settings menu, choose <User Management>.
2. Choose the user that you want to edit.
3. Tap the information that you want to edit, and then modify.
4. Tap <OK> and to return the < User Management > menu.
To delete a user:
1. In the Settings menu, choose <User Management>.
2. Choose the user that you want to delete.
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3. Tap the button.
4. Choose <Yes > to confirm.
3.4 Setting Date & Time
1. In the Settings menu, choose <Date & Time>
2. Tap “+” or “-” button to change the date, then tap .
3. Tap “+” or “-” button to change the time.
4. Tap to finish the setting.
3.5 Choosing Language
1. In the Settings menu, choose <Language>.
2. Choose the language from the list.
3.6 Changing ECG waveform length
To change the length of ECG waveform saved for each ECG Recorder measurement:
1. In the Settings menu, choose<ECG Length>.
2. Then choose among <30s>, <60s>. And tap <OK> to enable the change.
3.7 Setting ECG Bandwidth
In the Setting menu and choose <ECG bandwidth> to change between <Normal> and
<Wide>.
3.8 Changing Holter ECG Lead
To change the lead of ECG Holter for ECG Holter measurement:
1. In the Settings menu, tap <Holter Lead>.
2. choose among <LEAD II>, <CC5>,<CM5> and <User-defined>
3. Tap <YES> to enable the change.
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3.9 Erasing Data
In the Setting menu, Tap <Erase All Data>, and then <Yes>.
All measurements saved in the device will be deleted.
3.10 Factory Reset
In the Setting menu, Tap <Factory Reset>, then tap <Yes>.
All measurements, user information and other settings saved in the device will be
deleted, and the device will be restored to the factory default settings.
4. Review
4.1 Reviewing Daily Check
To review Daily Check records,
1. In the <Review> menu, select <DailyCheck>.
2. Choose the right user to open the list as below, then select one record to review
more information as below.
In this menu, you can:
Select to delete this measurement
Select to replay the ECG waveform as shown below.
When the ECG waveform is being replayed, you can
Select to change the waveform amplitude.
Select to pause it.
Select to return Daily Check list.
Select to view the trend of heart rate, SpO
Select to return to the Daily Check list.
2 and blood pressure
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5. Maintenance
Problem
Possible Cause
Solution
The device does
1. The battery may be low.
1. Charge the battery and
your local distributor.
amplitude is small
suitable for you.
try again.
ECG waveform
1. The pressure exerted on the
moving.
1. Hold the device stably
fluctuates
moving.
still and test again.
The app cannot
The Bluetooth may not be
Turn on the Bluetooth on
Screen.
local distributor.
BP calibration
1. Wrong height.
calibrations is too large.
1. Reconfirm your height.
still and calibrate again.
measurement.
Temperature value
1. The measurement area is
2. The thermometer sensor is
1. Remove hair from the
2. Keep the sensor
5.1 Care and Cleaning
Clean the device per week, carefully swabbing the device surface with a soft cloth or
cotton swab with rubbing alcohol.
5.2 Trouble Shooting
not turn on.
The ECG waveform
drifts
SpO2 or pulse rate
shows no value, or
the number
find the device.
“System Error ”
occurred.
failed.
No voice during
ECG and SpO
2
2. The device might be
damaged
The lead you choose is not
electrode is not stable or too
much.
2. Hand or body may be
1. Finger may not be inserted
co rre ctly.
2. Finger or hand may be
turned on.
Software or hardware failure. Restart the device and
2. The difference between two
The speaker is muted. Unmuted the speaker in
try again.
2. Please contact with
Change another lead and
and gently.
2. Try to keep perfectly
still and test again.
1. Remove finger and
reinsert, as directed.
2. Try to keep perfectly
the second page of Main
measure again.If the
error persists, mark
down the error number
and contact with your
2. Try to keep perfectly
the Settings menu.
is too low.
covered by hair.
measurement area.
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too far away from your skin.
dirty.
a soft cloth or cotton.
Part Number
Description
540-00192-00
ECG cable with 2 leadwires, snap
540-00193-00
SpO2 finger sensor, 25 cm, FP-10
540-00194-00
USB charging cable, micro D
560-00198-00
ECG electrode, 10 pcs
540-00354-00
Minimonitor adaptor
Classifications
MDD, 93/42/EEC
R&TTE, 1999/5/EC
ROHS 2.0, 2011/65/EU
shock
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
Drop test
1.0 m
Physical
Size
88×56×13 mm
Packing size
178*123*75 mm
Weight
Less than 80 g (main unit)
Display
2.7” touch screen, HD
Connector
Micro D connector
Wireless connectivity
Built-in Bluetooth dual mode, support 4.0 BLE
Power Supply
Battery type
Rechargeable lithium-polymer battery
3. The thermometer sensor is
contact with your skin.
3. Clean the sensor with
6. Accessories
Warnings and Cautionary Advices
Use accessories specified in this chapter. Using other accessories may cause
damage to the device or not meet the claimed specifications.
Depending on the configuration, May not all the accessories are included in your
package.
7. Specifications
EC Dire ctive
Degree protection against electrical
Type BF
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Battery run time Only daily check: > 1000 times
Pure standby calendar mode: > 3 months
Charge time
Less than 2 hours to 90%
ECG
External ECG cable and electrodes
Lead set
Lead I, lead II
Measurement mode
Episode, continuous
Sampling rate
500 Hz
Sampling accuracy
16 bit
10 mm/mV, 20 mm/mV
Sweep speed
25 mm/s
Bandwidth*
0.05 to 40 Hz
potential tolerance
range
Accuracy
±2 bpm or ±2%, whichever is greater
range
Unable to analyze)
SpO2
Standards
Meet standards of ISO 80601-2-61
measurements.
SpO2 range
70% to 100%
SpO
Accuracy (Arms)
80-100%:±2%, 70-79%:±3%
PR range
30 to 250 bpm
PR accuracy
±2 bpm or ±2%，whichever is greater
PI range
0.5-15
summary
Unable to analyze)
Continuous sleep monitoring: > 12 hours
Lead type
Display Gain
Electrode offset
HR measurement
ST measurement
Integrated ECG electrodes
1.25 mm/mV, 2.5 mm/mV, 5 mm/mV
±300 mV
30 to 250 bpm
-0.5 to +0.5 mV
Heart rate**, QRS duration, ST segment***,QT /QTc Rhythm analysis
Measurement
summary
(Regular ECG Rhythm, High Heart Rate, Low Heart Rate, High QRS
Value, High ST Value***, Low ST Value***, Irregular ECG Rhythm,
Measurement accuracy verification: The SpO2 accuracy has been verified in human experiments
by comparing with arterial blood sample reference measured with a CO-oximeter. Pulse
oximeter measurement are statistically distributed and about two-thirds of the measurements
are expected to come within the specified accuracy range compared to CO-oximeter
2
Measurement
SpO2, PR, PI, Summary (Normal Blood Oxygen, Low Blood Oxygen,
22
Blood Pressure Variation
Measurement method
Cuff-free non-invasive technology
Measurement
summary
Thermometer
Technique
Infrared body temperature
temperature
Measurement site
Tem pl e
Measurement time
3s
Measureme nt range
34.0 to 42.2 °C (94.0 to 108.0 °F)
Accuracy
±0.2°C or ±0.4°F
Sleep Monitor
Monitoring time
Up to 10 hours
Data storage
Store SpO2 and pulse rate
Unable to analyze)
Pedometer
Range
0 to 99999 steps
Distance
0.00 to 999.99 km
Timer
0 to 1999 minutes
Calories
0.00 to 9999.99 kcal
Fat
0.00 to 199.99 g
Reminder
No. of reminder
6
Reminder event
Wake up, Check me, Medicine, Self-define
Review
Data review
Graphic trend, list trend
Waveform review
Full disclosure waveform
Daily check
100 pcs of records without audio memo
ECG recorder
100 pcs of records without audio memo
Oximeter
100 pcs of records
Thermometer
100 pcs of records
Sleep record review
5 pcs of records, 10 hours each record
Mobile APP
Operating system
IOS 7.0 or above, Android 4.4 or above
launched subsequently;
Android Capabilit y
Mobile phone or tablet with Bluetooth 2.1 or above
Systolic pressure based on individual calibration coefficient
Environment
Measurement
summary
16.0 to 40.0 °C
Total duration, <90% STAT, Average saturation, Lowest saturation,
Summary(No abnormal detected, blood oxygen drop detected,
IOS Capability iPhone 4s and models launched subsequently; iPad 3 and models
23
Functionality
Data export, data review, waveform replay, trend review, data sharing
* : External ECG cable, bandwidth mode set to wide
Guidance and Declaration - Electromagnetic Emissions
Emission tests
Compliance
Electromagnetic environment - guidance
to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions
IEC61000-3-2
Emissions IEC 61000-3-3
Guidance and Declaration - Electromagnetic Immunity
user of the Health Monitor should assure that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic
**: Heart rate is calculated based on average of every 5 to 30 QRS complex.
***: Only for measurement with external ECG cable, bandwidth mode set to wide
8. 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 Advices
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).
The Health Monitor is intended for use i n the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used i n such an environment.
RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
Class A
Voltage Fluctuations / Flicker
The Heal th Monitor is intended for use in the electromagnetic environment specified below. The customer or the
Complies
Therefore, its RF emissions are very low and are not likely
The device is suitable for use in all establishments,
including domestic establishments and those di rectly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
24
environment - guidance
Electrostatic discharge
Floors should be wood,
covered with synthetic
rical fast
lines
lines
be that of a typi cal
commercial or hospital
Interruptions and
power supply input
for 5 s
for 5 s
be that of a typi cal
commercial or hospital
our product requires
Power frequency
characteristic of a typical
location in a typical
commercial or hospital
Note: UT is the AC mains voltage prior to application of the test level.
the Health Monitor should assure that it is used i n such an environment as described below.
kHz to
kHz to
should be used no closer to any par t of the system,
(ESD) IEC 61000-4-2
Elect
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
Voltage variations on
lines
IEC 61000-4-11
(50/60 HZ) magnetic
field IEC 61000-4-8
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/output
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<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)
3 A/m 3 A/m Power frequency magnetic
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/output
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<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)
concrete
or ceramic tile. If floors are
material,
the relative humidity should
be at
least 30 %.
Mains power quality should
environment.
Mains power quality should
environment. If the user of
continued operation during
power mains interruptions, it
is recommended that our
product be powered from an
uninterruptible power supply
or a battery.
fields should be at levels
environment.
Guidance and Declaration - Electromagnetic Immunity
The Health Monitor is intended for use in the spe cified electromagnetic environment. The customer or the user of
Immunity
test
Conduced RF
IEC60601 test
level
3 Vrms 150
Compliance
level
3 Vrms 150
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
25
IEC61000-4-6 80 MHz
outside ISM
outside ISM
distances:
Pd 2.1=
3 V/m 80
Pd 2.1=
Pd 3.2=
reflection from structures, objects and people.
Recommended separation distances between portable and mobile RF communications equipment and the device
power of
Separation distance according to frequency of the transmitter (m)
0.01
0.12
0.12
0.23
1
1.20
1.20
2.30
100
12.00
12.00
23.00
Pd 2
.1=
P
d 2.1=
Pd 3.2
=
bands
80 MHz
bands
including cables, than the recommended separation
distance calculated from the equation appropriate for the
frequency of the transmitter. Recommended separation
Radiated RF
IEC61000-4-3
Note 1: At 80 MHz to 800 MHz, the separation distance for the higher frequency rang e applies.
Note 2: These guidelines may not appl y in all situations. Electromagnetic propagation is affected by absorption and
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 b roadcast 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 fiel d strength in the location in which the dev ice 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 neces sary, such as re-orienting or relocating the device.
b
Over frequency range 150kHz to 80MHz. For Resp field strength should be les s than 1V/m.
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 equi pment.
Rated max. output
transmitte r (W)
MHz to
2.5 GHz
3 V/m 80 MHz
to
2.5 GHz
150 kHz - 80 MHz
Recommended separation distances:
80 MHz～800 MHz:
800MHz-2.5GHz:
Where, P is the maximum output powe r rating of the
transmitter in wa tts (W) according to the transmi tter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey
the compliance level in each frequency range
Interference may occur in the vicini ty of equipment
marked with the following sym bol:
80 MHz - 800 MHz 800 MHz - 2.5 GHz
a
, should be less than
b
.
0.1 0.38 0.38 0.73
10 3.80 3.80 7.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
26
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
reflection from structures, objects and people.
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 highe r frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
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