Gima ARMFIT+ BLOOD PRESSURE MONITOR, ARMFIT+ MONITOR MISURATORE DI PRESSIONE CON ECG User guide

Automatic Upper Arm

Model BP2/BP2A

Blood Pressure Monitor

User Manual

English|Deutsche|Italiano|Español|Français

Contents

User Manual
Benutzerhandbuch
Manuale d'uso
Manual de usuario
Manuel de l'utilisateu

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English 1-20

Deutsch 21-43

Italiano 44-65

Español 66-87

Français 88-109

1

User Manual

Contents

1. The Basics..................................................................

1.1 Safety............................................................. 2

2. Introduction...............................................................

2.1 Intended Use..................................................

2.2 Contraindications...........................................

2.3 About the Product.........................................

2.4 Unpacking......................................................

2.5 Symbols..........................................................

3. Using the Monitor................................................... 10

3.1 Charging the Battery....................................

3.2 Blood Pressure Measurement.....................

3.3 Recording ECG..............................................

3.4 Reviewing History Records..........................

3.5 Connecting with the App.............................

4.Troubleshooting........................................................

5. Maintenance...........................................................

5.1 Maintenance................................................

5.2 Cleaning.......................................................

5.3 Storage.........................................................

10
10
12
14
15
15
17
17
17
17

6. Specifications.......................................................... 18

7. Electromagnetic Compatibility................................

20

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6
6
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7
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8

2

1. The Basics

This manual contains the instructions necessary to operate
the product safely and in accordance with its function and
intended use. Observing this manual is a prerequisite for
proper product performance and correct operations, which
ensures patient and operator safety.

1.1 Safety

Warnings and Tips

 Before using the device, please ensure that you have

read this manual thoroughly and fully understand the
corresponding precautions and risks.

 This device has been designed for practical use but is

not a substitute for visiting 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 using this device if you have a

pacemaker or other implanted devices. Follow your
doctor’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 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 impacts.

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 Do not place this device in pressure vessels or gas
 sterilization devices.
 Do not dismantle the device because this could cause

damage or malfunctions or impede device operations.

 This device is not intended for use by people (including

children) with restricted physical, sensory, or mental
acumen or a lack of experience and/or a lack of
knowledge unless they are supervised by someone
responsible 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 to come into contact with

other conductive parts (including the ground).

 Do not use the device on anyone 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 sources of water
or fire; or locations that are subject to strong
electromagnetic influences.

 Do not swing the device with the strap, which may

result in injury.

 This device displays changes in heart beat, blood

oxygenation, etc. which may have varying causes.
These may be harmless, but may also be triggered by
illnesses or diseases of differing degrees of severity.
Please consult a medical specialist if you believe you
may have an illness or disease.

 Vital sign measurements, such as those taken with this

device, cannot identify all diseases. Regardless of the
measurements taken using this device, you should

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consult your doctor immediately if you experience
symptoms that could indicate a serious disease.

 Do not self-diagnose or self-medicate based on 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 for your heart or other organ functions, or
for medical electrocardiogram recordings, which
require more complex measurements.

 It is not possible to use this device to diagnose illnesses

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.

 Clean the device and cuffs with a dry, soft cloth or a

cloth moistened with water and a neutral detergent.
Never use alcohol, benzene, thinners, or other harsh
chemicals to clean the device or cuffs.

 Avoid tightly folding the cuffs or wrapping the hoses for

long periods, to avoid shortening the component use
period.

 The device and cuffs are not water-resistant. Keep rain,

sweat and water from getting on the device and cuffs.

 Measurements may be distorted if the device is used

close to televisions, microwave ovens, mobiles phones,
X-rays, or other devices with strong electrical fields.

 Do not modify the device. It may cause damage to the

device.

 To measure blood pressure, the arm must be squeezed

by the cuff hard enough to temporarily stop blood flow

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through the artery. This may cause pain, numbness, or
a temporary red mark on the arm. This condition will
appear especially when measurements are repeatedly
taken. Any pain, numbness, or red marks will disappear
with time.

 Do not apply the cuff on an arm with another

electronic medical device. The equipment may not
function properly.

 People who have a severe circulatory deficiency in their

arm must consult a doctor before using the device, to
avoid medical problems.

 Do not self-diagnose the measurement results and

start treatment on your own. Always consult your
doctor to evaluate the results and subsequent
treatment.

 Do not apply the cuff on an arm with an unhealed

wound.

 Do not apply the cuff on an arm receiving an

intravenous drip or blood transfusion. It may cause
injury or accidents.

 Do not use the device where flammable gases, such as

anesthetic gases are present. It may cause an
explosion.

 Do not use the device in highly concentrated oxygen

environments, such as a high-pressure oxygen chamber
or an oxygen tent. It may cause a fire or explosion.

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2. Introduction

Model

Blood Pressure
Measurement

ECG
Measurement

BP2√√

BP2A

√

2.1 Intended Use

The product is intended to be used for measuring, displaying,
reviewing, and storing ECG and blood pressure variations in
the home or healthcare facilities.
ECG and Blood pressure variation is intended for use with
adult.
The data and results provided by this device are for precheck
screening purposes only and cannot be directly used for
diagnosis or treatments.

Product Features

2.2 Contraindications

 This device is contraindicated for use in ambulatory

environments.

 This device is contraindicated for use on aircraft.

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2.3 About the Product

1. Start/Stop button

 Power On/Off
 Press to Start/Stop measuring blood pressure.

2. Function button

 Press to start the ECG measurement.
 Press and hold for 2 seconds to review historical data.

3. Display screen

4. LED indicator

 Blue light is on: the battery is charging.
 Blue light is off: the battery is fully charged.

5. ECG electrodes
Press and hold them while taking ECG measurements.

6. Cable connector
Connect with the charging cable.

2.4 Unpacking

Main Unit; Charging Cable; User Manual; Quick Guide

8

2.5 Symbols

Symbol

Description

Manufacturer

Date of manufacture

SN

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

9

This product complies with the
rules and regulations of the
Federal Communication
Commission.

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.

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3. Using the Monitor

3.1 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 2 hours to fully
charge. 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.

3.2 Blood Pressure Measurement

3.2.1 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.

3.2.2 Applying the Arm Cuff

1. Wrap the cuff around the upper arm, about 1 to 2 cm

above the elbow joint, as shown.

2. Place the cuff directly against the skin, as clothing may

cause a faint pulse and result in measurement errors.

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3. Constriction of the upper arm, caused by rolling up a

shirtsleeve, may prevent accurate readings.

4. Confirm that the artery position mark is lined up with

the artery.

Note：Keep the host wear position aligned with the middle
finger.

3.2.3 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.

3.2.4 Measuring Blood Pressure

1. Power on the blood pressure monitor.

2. Press the Start/Stop button to start taking blood pressure
measurements.

4. The monitor will automatically deflate the cuff slowly
while taking measurements. A typical measurement

takes about 30s.

4. The readings will be displayed when the measurement is

finished.

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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.

3.2.5 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 2 minutes after
taking measurements.

3.3 Recording ECG

3.3.1 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 them using 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

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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.

3.3.2. 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:

1. Put your right palm on the right side electrodes of the

monitor.

2. Place the left side electrodes to the body position that

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you desired to measure.

default

3. Once the body parts are placed on the electrodes, press

the Function button to start EKG recording.

4. 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.

3.3.3. 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.

3.4 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 to enter the History
screen. The last measurement results will be displayed by

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

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To view the next records, press the NEXT button.

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

To exit the History screen, press the HOME button.

3.5 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.

4.Troubleshooting

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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
service.

The device has
malfunctioned.

Contact
customer
service.

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.

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5. Maintenance

5.1 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 inaccurate
blood pressure readings and/or EKG recordings.

5.2 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 cotton

swab 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.

5.3 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.

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6. 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

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

Wireless connectivity

Built-in Bluetooth 4.0 BLE

Power Supply

Charge input

Micro USB, DC5V

Battery type

Rechargeable lithium-polymer battery

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Battery run time

500 measurements

Charge time

2 hours

Blood Pressure Measurements

Technology

Oscillometric Method

Pressure measurement
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

20

7. Electromagnetic Compatibility

The device meets the requirements of EN 60601-1-2.

Warnings and Tips

 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

PN：255-02716-00 Version: B Sept. 2021

Shenzhen Viatom Technology Co., Ltd.

4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road,
Block 67, Xin'an Street, Baoan District, Shenzhen, 518101,
Guangdong, China

Well Kang Limited

The Black Church, St. Mary's Place,Dublin 7, D07 P4AX,Ireland
Tel 1: [phone]
Tel 2: [phone]
Fax: [phone]
Email:[e-mail]

Wellkang Ltd (www.UKCA-marking.com)

16 Castle St., Dover,CT16 1PW, England
Tel 1: [phone]
Tel 2: [phone]
Fax: [phone]
Email:[e-mail]