Checkme BP2 Automatic Upper Arm Blood Pressure Monitor User Manual

: June 15, 2024
: Checkme

Checkme BP2 Automatic Upper Arm Blood Pressure Monitor

The Basics

This manual contains the instructions necessarytooperatethe product safely and in accordance withits functionandintended use. Observing this manual is a prerequisiteforproper product performance and correct operations, whichensures patient and operator safety

Safety

Warnings and Tips

Before using the device, please ensure that youhaveread this manual thoroughly and fully understandthecorresponding precautions and risks.
This device has been designed for practical usebutisnot a substitute for visiting the doctor.
The data and results displayed on the deviceareforreference only and cannot be directly usedfordiagnostic interpretation or treatment.
We recommend not using this device if youhaveapacemaker or other implanted devices. Followyourdoctor’s advice, if applicable.
Do not use this device with a defibrillator.
Do not use this device during an MRI exam.
Do not use the device in a combustibleenvironment(i.e., oxygen-enriched environment).
Never submerge the device in water or other liquids.Do not clean the device with acetone or othervolatilesolutions.
Do not drop this device or subject it tostrongimpacts.
Do not place this device in pressure vessels orgas
sterilization devices.
Do not dismantle the device because this couldcausedamage or malfunctions or impede deviceoperations.
This device is not intended for use by people(includingchildren) with restricted physical, sensory, or mentalacumen or a lack of experience and/or alackof knowledge unless they are supervisedbysomeoneresponsible for their safety, or they receiveinstructionsfrom this person on how to use the device. Childrenshould be supervised around the devicetoensuretheydo not play with it.
Do not allow the electrodes to come intocontactwithother conductive parts (including the ground).
Do not use the device on anyone withsensitiveskinorallergies.
Do not store the device in the following locations:locations in which the device is exposedtodirectsunlight, high temperatures or levels of moisture, orheavy contamination; locations near sourcesof wateror fire; or locations that are subject tostrongelectromagnetic influences.
Do not swing the device with the strap, whichmayresult in injury.
This device displays changes in heart beat, bloodoxygenation, etc. which may have varyingcauses. These may be harmless, but may alsobetriggeredbyillnesses or diseases of differing degrees of severity.Please consult a medical specialist if youbelieveyoumay have an illness or disease.
Vital sign measurements, such as thosetakenwiththisdevice, cannot identify all diseases. Regardlessofthemeasurements taken using this device, youshould
consult your doctor immediately if youexperiencesymptoms that could indicate a serious disease.
Do not self-diagnose or self-medicate basedonthisdevice without consulting your doctor. Inparticular,donot start taking any new medication or changethetypeand/or dosage of any existing medicationwithoutpriorapproval.
This device is not a substitute for a medical examination for your heart or other organfunctions,orfor medical electrocardiogramrecordings, whichrequire more complex measurements.
It is not possible to use this device to diagnoseillnessesor diseases. This is exclusively the responsibilityofyourdoctor.
We recommend that you record the ECGcurvesandother measurements and provide themtoyourdoctorif required.
Clean the device and cuffs with a dry, soft clothoracloth moistened with water and a neutral detergent.Never use alcohol, benzene, thinners, or otherharshchemicals to clean the device or cuffs.
Avoid tightly folding the cuffs or wrappingthehosesforlong periods, to avoid shortening the componentuseperiod.
The device and cuffs are not water-resistant. Keeprain,sweat and water from getting on the deviceandcuffs.
Measurements may be distorted if the deviceisusedclose to televisions, microwave ovens, mobilesphones,X-rays, or other devices with strong electrical fields.
Do not modify the device. It may causedamagetothedevice.
To measure blood pressure, the armmust besqueezedby the cuff hard enough to temporarily stopbloodflow through the artery. This may cause pain, numbness,ora temporary red mark on the arm. This conditionwillappear especially when measurements arerepeatedlytaken. Any pain, numbness, or red marks will disappearwith time.
Do not apply the cuff on an armwith another electronic medical device. The equipment maynotfunction properly.
People who have a severe circulatory deficiencyintheirarm must consult a doctor before using thedevice,toavoid medical problems.
Do not self-diagnose the measurement resultsandstart treatment on your own. Always consult yourdoctor to evaluate the results and subsequent treatment.
Do not apply the cuff on an armwith anunhealedwound.
Do not apply the cuff on an armreceivinganintravenous drip or blood transfusion. It maycauseinjury or accidents.
Do not use the device where flammablegases, suchasanesthetic gases are present. It may causeanexplosion.
Do not use the device in highly concentratedoxygenenvironments, such as a high-pressure oxygenchamberor an oxygen tent. It may cause a fire or explosion.

Introduction

Intended Use

The product is intended to be used for measuring, displaying,reviewing, and storing ECG and blood pressurevariationsinthe home or healthcare facilities. ECG and Blood pressure variation is intendedforusewithadult. The data and results provided by this deviceareforprecheckscreening purposes only and cannot be directlyusedfordiagnosis or treatments.

Product Features

Model| Blood Pressure Measurement| ECG

Measurement

---|---|---
BP2| √| √
BP2A| √|

Contraindications

This device is contraindicated for use inambulatoryenvironments.
This device is contraindicated for use onaircraft.

About the Product

Start/Stop button
- Power On/Off
- Press to Start/Stop measuring blood pressure.
Function button
- Press to start the ECG measurement.
- Press and hold for 2 seconds to reviewhistorical data.
Display screen
LED indicator
- Blue light is on: the battery is charging.
- Blue light is off: the battery is fully charged.
ECG electrodes Press and hold them while taking ECG measurements.
Cable connector Connect with the charging cable.

Unpacking

Main Unit; Charging Cable; User Manual; QuickGuide

Symbols

Symbol	Description
****	Manufacturer
Date of manufacture
Serial number
****	Indicates a medical device that is not to be disposed of as unsorted

municipal waste.
| Follow Instructions for Use.
| Type BF Applied Part
| No alarm system
| 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).

| Heartbeat symbol
| Battery symbol
| Bluetooth symbol
| Data transmission symbol
| ECG waveform
| ECG measurement progress bar
| Press to display next record
| Press to return to home screen
| Current record / Total records
| Low signal amplitude or noise
---|---
| Lead off when ECG is measuring
| The recorded ECG satisfies a common regular pattern.
****| The recorded ECG is erratic. It may be caused by heart issues or other conditions.

Using the Monitor

Charging the Battery

Use the USB cable to charge the monitor. Connect the USB cable to a USB charger or to the PC. It takes 2hourstofullycharge. When the battery is fully charged, the indicator will be off. The monitor works on very low power consumption, and a full charge usually lasts for months. A battery symbol, which indicates the battery status is displayed on the screen.
Note: The device cannot be used while charging.

Blood Pressure Measurement

Before Taking Measurements

To help ensure accurate measurements, follow these directions:

Rest for at least 5 minutes before taking measurements.
Stress raises blood pressure. Avoid taking measurements when stressed.
Remove any tight-fitting clothing from your arm.
A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several results over a period of time.
Try to measure your blood pressure at the same time each day to maintain consistency

Applying the Arm Cuff

Wrap the cuff around the upper arm, about 1to2cmabove the elbow joint, as shown.
Place the cuff directly against the skin, as clothing may cause a faint pulse and result in measurement errors.
Constriction of the upper arm, caused by rolling up a shirt sleeve, may prevent accurate readings.
Confirm that the artery position mark is lined up with the artery.

Note: Keep the host wear position aligned with them iddle finger.

Sitting Correctly

To take measurements, you need to be relaxed and comfortably seated. Sit in a chair with your legs uncrossed and your feet flat on the floor. Place your arm on a table, so that the cuff is level with your heart.

Measuring Blood Pressure

Power on the blood pressure monitor.
Press the Start/Stop button to start taking blood pressure measurements.
The monitor will automatically deflate the cuff slowly while taking measurements. A typical measurement takes about 30s.
The readings will be displayed when the measurement is finished.
You can press Start/Stop button again to stop the blood pressure measurement.
Note: While taking measurements, you should remain still and not squeeze the cuff.

After Taking Measurements

The monitor will automatically release the gas in the cuff once finished taking measurements. Press the button to turn the power off after taking measurements. Remove the cuff.
Note: The device has an automatic power shut-off function, which turns off the power automatically 2minutesaftertaking measurements.

Recording ECG

Before Taking Measurements

To help ensure accurate measurements, follow these directions:

Before using the ECG function, pay attention to the following points to obtain precise measurements.
The ECG electrode must be positioned directly against the skin.
If your skin or hands are dry, moisten the musing a damp cloth before taking measurements.
If the ECG electrodes are dirty, remove the dirt using a soft cloth or cotton swap dampened with disinfection alcohol.
While taking measurements, do not touch your body with the hand with which you are taking measurements.
Please note that there must be no skin to skin contact between your right and left hand. Otherwise, the measurements cannot be taken correctly.
Stay still while taking measurements, do not speak and hold the device still. Movements of any kind will falsify measurements.
If possible, take measurements when sitting and not when standing.
Follow the text and voice guides on your phone to finish taking measurements.

Recording ECG without the Cable

There are four methods to record ECG without the cable.

A. Right hand to left Leg

B. Hand to hand

C. Right hand to abdomen

D. Right hand to chest

To start an ECG Recording:

Put your right palm on the right side electrodes of the monitor.
Place the left side electrodes to the body position that you desired to measure.
Once the body parts are placed on the electrodes, press the Function button to start EKG recording.
Wait for 30 seconds, the result readings will be displayed.

To start recording ECG again, press the Start/Stop button to return to the Home screen, then press the Function button.
Note:

The recording must take at least 30 seconds to complete, and to be analyzed by the detectors
You can get different signal amplitudes from different methods. Use Lead II mode if the signal is too low in Lead I mode

Turn on/off Heartbeat Sound

The buzzer beeps when a heartbeat is detected while recording ECG. You can turn on/off the heartbeat sound on the App.

Reviewing History Records

You can review the history results and replay the recorded ECG waveform on the History screen. Hold the Function button for 2 seconds toenter theHistoryscreen. The last measurement results will be displayed by default

For ECG recordings, the Heart Rate will be displayed first and then replayed over the 30-second ECG wave form.

To view the next records, press the NEXT button. To exit the History screen, press the HOME button.

Connecting with the App

App name: ViHealth iOS: App Store Android: Google Play

|

The monitor has built-in Bluetooth wireless connectivity, which enables exporting measurement records to mobile phones and tablets running iOS or Android. Hold the function button and Start/Stop button simultaneously to enable Bluetooth and start pairing it to your smart device.

Troubleshooting

Problem	Possible Cause	Solution
No power. No display appears on the device.	Battery is depleted	Recharge the

battery
Blood pressure readings appear too high or too low| Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the arm cuff, may affect your blood pressure.| Hold still for a moment and try again
Error 1 Apply the arm cuff tighter.| Arm cuff is applied too loosely| Tighten the arm cuff and try again.
Error 2

Do not move or talk, remain still.

| Moving or talking while taking measurements, and the pressure of the cuff is interfered with.| Remain still and do not talk while taking measurements
Error 3 Remove any clothing interfering with the cuff.| The signal is poor while measuring blood pressure.| Take blood pressure on a bare arm.
Error x (x>4) Contact customer| The device has malfunctioned.| Contact customer service.
service.| |
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Check the connection| The ECG cable is off, or the body parts are not placed on the electrodes closely enough.| Check the ECG cable, or place the electrodes closer to your body part.
ECG waveform drifts| The pressure exerted on the electrode is not stable or too much.| Hold the device stably and gently.
Hand or body may be moving.| Try to keep perfectly still and test again.
The ECG waveform amplitude is small| The measurement method you chose is not suitable for you.| Change another lead and try again.

Maintenance

To protect your monitor from damage, store the monitor and the components in a clean, safe location. Caution: DO NOT disassemble or attempt to repair this monitor or other components. This may cause in accurate blood pressure readings and/or EKG recordings.

Cleaning

Do not use any abrasive or volatile cleaners.
Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and the arm cuff and then wipe them with a dry cloth.
When electrodes are dirty, use a soft cloth or cottons wab moistened with an alcohol-based sanitizer to
clean the electrodes.
Do not use gasoline, thinners, or similar solvents to clean your monitor and arm cuff or other components.

Storage

Keep your monitor and other components in the storage case when not in use.

Store your monitor and other components in a clean, safe location.
Do not store your monitor and other components in locations exposed to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors, such as bleach.

Specifications

Classifications

EC Directive| MDD, 93/42/EEC
RED, 2014/53/EU
ROHS 2.0, 2011/65/EU
Degree of protection against electrical shock| Type BF
Environmental
Item| Operating| Storage
Temperature| 5 to 40°C| -25 to 70°C
Relative humidity (non-condensing)| 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
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Physical
Size (main unit)| 135mm(L)×45mm(W)×20mm(H)
Weight (main unit)| 240 g
**** Cuff size| Adult cuff: 22-42cm

Small adult cuff (optional): 17-22cm Adult cuff (optional): 22-32cm

range

| 0 – 300mmHg
Pressure measurement accuracy| ±3mmHg
Pulse rate range| 40 to 200 /min
Pulse rate accuracy| ±2 /min
Clinical accuracy| Meet IEC80601-2-30
ECG Recording
Lead type| Integrated ECG electrodes
Lead set| Lead I, Lead II, Chest Lead
ECG length| 30s
Heart rate range| 30 – 250/min
---|---
Heart rate accuracy| ±2 /min or ±2%, whichever is greater
Storage
Blood pressure records| 50
ECG records| 10
Bluetooth RF
Frequency range| 2.402 – 2.480 GHz
Max RF power| -10 dBm

Electromagnetic Compatibility

The device meets the requirements of EN60601-1-2.

Warnings and Tip

Using accessories other than those specified in this manual may result in increased electromagnetic emissions or decreased electromagnetic immunity for the device.
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 CISPR requirements.
When the inputted signal is below the minimum amplitude provided in the technical specifications, erroneous measurements could result.
Portable and mobile communication equipment may affect device performance.
Other devices that have RF transmitters or sources may affect this device (e.g. cell phones, PDAs, and PCs with wireless functionality). The EMC table information is listed on our website: http://api.viatomtech.com.cn/documents/2017/emc_en.pdf