Instruction Manual

Upper Arm Electronic

Blood Pressure Monitor
Model No.: FC-BP131

Manual Ver.: 1.0

Issuing Date: 01/11/2024

Please read this instruction manual carefully before

using your unit.
Please keep this instruction manual well for future use.
Thanks for choosing the Digital Blood Pressure Monitor.
The PATIENT is an intended OPERATOR.
 Contents
Contents...............................................................................2
1. Before Using the Unit.......................................................2
1.1 Introduction....................................................................2
1.2 Important safety notices...............................................3
1.3 Warning and safety notices.........................................4
2. Operating Instruction.....................................................6
2.1 Introduction of machine..............................................6
2.2 Battery Installation / Removal......................................7
2.3 Settings............................................................................8
2.4 Proper Use of the Arm Cuff...........................................9
2.5 Considerations for measurement...............................11
2.6 Function........................................................................12
2.7 Take a Measurement..................................................12
2.8 Use the Memory function...........................................13
2.9 About Blood Pressure..................................................15
3. Care and Maintenance...............................................17
3.1 Care and Maintenance.............................................18
3.2 Calibration and Service..............................................18
3.3 Error Indicators.............................................................18
3.4 Troubleshooting...........................................................18
3.5 Technical Data............................................................19
3.6 Technical description..................................................22
4. Warranty Information....................................................25
1. Before Using the Unit
1.1 Introduction

Thank you for purchasing the Upper Arm Electronic Blood Pressure
Monitor.

The unit utilizes the oscillometric method for blood pressure

measurement, detecting the movement of your blood through the
brachial artery and converting it into a digital reading. This method
eliminates the need for a stethoscope during monitoring, making the
unit easy to use.

The unit automatically stores 2*120 sets of measurement values.

You can conveniently review the stored data by pressing the
memory button.

The unit comes with the following components:

• Main Unit
• Arm Cuff
• Instruction Manual printed in English

SYMBOLS USED IN THIS INSTRUCTION MANUAL

Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may

result in minor or moderate injury to the user or patient or damage to
the equipment or other property.

Please read this instruction manual thoroughly before using the unit.
Please keep for future reference.
For specific information about your own blood pressure, CONSULT
YOUR DOCTOR.
Transport package shall Keep away Fragile, handle
be kept away from rain. from sunlight with care
EC REP AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
Refer to instruction UDI Unique device identifier
manual/booklet
MANUFACTURER Date of manufacture CHN Made in China
SN SERIAL NUMBER # Model number MD Medical device
Type BF applied part Importer CE mark

2
 The marking of electrical and electronics devices according to
Directive 2002/96/EC.
The device accessories and the packaging have to be disposed of
waste correctly at the end of the usage.
Please follow Local Ordinances or Regulations for disposal.

Device used within the Magnetic Resonance (MR) environment is

prohibited.

1.2 Important Safety Notices

To ensure the correct use of the product, basic safety measures
should always be followed, including the precautions listed below:

■ Please read all information in the instruction manual and any other
literature included in the box before using the unit.

■ Consult your physician for specific information about your blood

pressure. Self-diagnosis and treatment based on measurement results
can be dangerous. Follow the instructions of your healthcare provider.

■ Operate the unit only as intended. Do not use it for any other
purpose. The unit is intended for measuring blood pressure and pulse
rate in adults only. It is not recommended for use with neonatal babies
at home or in a medical center.

■ Avoid using a cellular phone near the unit, as it may result in

operational failure.

■ Refrain from using the unit in high-radiant areas to ensure accurate

measuring data.

■ Do not disassemble or attempt to repair the unit or its components.

Do not use the equipment in places with flammable gases (such as
anesthetic gas, oxygen, or hydrogen) or flammable liquids (such as
alcohol).

■ Avoid using a mobile phone or other devices that emit

electromagnetic fields near the unit, as this may result in incorrect
operation.

■ Note that too frequent measurements can cause injury to the

PATIENT due to blood flow interference.

■ Remove the batteries if the unit will not be used for three months
or more.
3
■ Please do not place the CUFF over a wound, as it can cause
further injury.

■ Be cautious about the effect of blood flow interference and the

potential harmful injury to the PATIENT caused by continuous CUFF
pressure due to connection tubing kinking.

■ Statement: Regarding the adapter requirements, it should meet the

following conditions: output voltage DC 5V, current 1000mA, and
comply with IEC 60601-1 and IEC 60601-1-11. Provide two MOPP
insulation layers between AC input and DC output.

■ Avoid installing the battery with the wrong polarity.

■ After the battery is exhausted, replace it with four new batteries.

■ If the device is not used for over three months, please remove the
battery to prevent leakage, overheating, rupture, and damage to
the blood pressure monitor body.

■ Intended Purpose: The Upper Arm Electronic Blood Pressure Monitor

is intended for measuring the systolic and diastolic blood pressure and
pulse rate of an adult individual using a non-invasive technique with
an inflatable cuff wrapped around the upper arm.

■ Indication: Intermittent measurement of human body blood pressure

from the upper arm.

Contraindications:
● The product should not be used for patients with arrhythmia.
● This product is not suitable for infants, neonates, or pregnancy.
● Individuals unable to express themselves should not use this product.

Intended Users: Professional medical staff and laypersons.

Patient Population: Adults.

Clinical Benefits: Measuring body blood pressure helps diagnose

human body conditions.

4
1.3 Warning and Safety Notices:
■ Exercise caution when applying the CUFF and pressurizing it on any
limb with vascular access, therapy, or an arteriovenous (A-V) shunt.
Temporary interference with blood flow could result in injury to the
PATIENT.

■ Be cautious when applying the CUFF and pressurizing it on the arm

on the side of a mastectomy.

■ Pressurizing the CUFF can temporarily cause loss of function in

simultaneously used monitoring ME EQUIPMENT on the same limb.

■ Ensure that the operation of the AUTOMATED Blood Pressure Monitor

does not result in prolonged impairment of the PATIENT's blood
circulation. Check, for example, by observing the concerned limb.

■ If the arm is oppressed by air pressure, loosen the CUFF or remove

batteries.

■ Avoid touching the patient and battery output simultaneously

during measurement.

■ Warning: Do not use lure connectors. If lure lock connectors are

used in tubing construction, there is a risk of inadvertent connection
to vascular fluid systems, allowing air to be pumped into a blood vessel.

■ Warning: Portable RF communications equipment, including

peripherals like antenna cables and external antennas, should be
used no closer than 30 cm (12 inches) to any part of the Blood
Pressure Monitor, including cables specified by the manufacturer.
Otherwise, equipment performance degradation may occur.

■ Warning: Place the Blood Pressure Monitor in a position inaccessible

to pets, pests, or children.

■ Warning: The neck of a child or animal can be strangled by a

too-long air hose, posing a threat to life, etc.

5
 ■ Warning: There is a hazard of accidental ingestion due to small
disassemblable parts (such as batteries, etc.) when touched by a child.

■ Keep the product out of reach of children; use it under adult

supervision.

■ Any serious incidents related to the device should be reported to

the manufacturer and the local competent authority of the user’s
location.

■ The Upper Arm Electronic Blood Pressure Monitor underwent clinical

investigation in accordance with the requirements of
ISO 81060-2:2018+A1:2020.

2. Operating Instruction
2.1 Introduction of machine
Body

Display

Battery
Air Socket MEM Button Compartment

START/STOP Button
SET Button USB Socket

Display

Systolic pressure Blood pressure

Classification

Diastolic pressure Sleeve with

Average icon self-check icon
Memory icon Sound icon(Optional)
Pulse detected
Irregular Body motion
HeartBeat (IRB) detection icon
Low battery
Pulse rate User number
6
Arm Cuff
Air Plug(Insert to Air Socket)
Fit for 8.7-16.5 inches
(22cm~42cm) range of
upper arm perimeter

Hose

Metal

If your arm cuff is broken or non-functional, please replace it with

a new cuff. Note that a new arm cuff does not come with an air
plug. Kindly continue using the old air plug with the new arm cuff.

Power
4 AAA Alkaline Batteries

Do not use rechargeable batteries.

Instruction Manual
● Please keep the instruction manual well after using.
2.2 Battery Installation / Removal
2.2.1Remove the battery cover from the battery compartment.
2.2.2 Install 4 “AAA” size batteries to match the + (positive) and -
(negative) polarities with the polarities of the battery compartment
as indicated.
2.2.3 Replace the battery cover.

7
 Caution!
● Be sure to replace the batteries if the low power battery symbol
appears on the display. Additionally, never leave low-power batteries
in the battery compartment, as they may leak and cause damage
to the unit.

2.3 Settings
2.3.1 To set unit
Long-press the "SET" button for 6 seconds when powered off to change
the previous unit (kPa or mmHg). The mark “ ” appears and flashes,
indicating the BPM is in mmHg status. Press the “MEM” button to
change it into “ ”, indicating the BPM is in kPa status. Press the
“ ” button to confirm the current setting.

2.3.2 To set user

Press the “SET” button when powered off, and then press the “SET”
button again to switch between User 1 or User 2.

8
2.4 Proper Use of the Arm Cuff
2.4.1 Ensure that the air plug is properly inserted into the main unit.

2.4.2 Take off all clothing from your upper arm to allow the cuff to fit
directly on the skin.

2.4.3 Sit in a chair with your feet flat on the floor. Position your arm on
a table to ensure that the cuff is level with your heart.

2.4.4 Thread the end of the cuff through the metal, ensuring that the
hose is facing outward.

9
2.4.5 Insert your arm through the loop and pull it up to the position
of your upper arm.

2.4.6 Allow the hose to run down the inside of your arm, and position
the bottom of the cuff approximately 0.8-1.2 inches (2~3cm) above
your elbow.
0.8-1.2 inches (2 ~ 3cm)

2.4.7. Securely wrap the cuff around your upper arm using the arm
band. Ensure there is a gap of 1-2 fingers between your arm and the
cuff. Remove any clothing that might restrict the arm.

2.4.8 Relax your arm, with the palm facing upward and fingers
naturally curved. Then, turn on the unit and begin the measurement.

10
2.5 Considerations for Measurement:

2.5.1 Correct Usage Method: Correct

(1) Ensure your elbow is on the

measurement
posture Take off the thick
clothes like sweater
table; sit comfortably with legs to measure

uncrossed and back and arm

Keep the
Keep the center of the
body straight
cuff and heart at the
supported. same height

(2) Maintain the center of the cuff

at the same height as the heart or
nipples. The ideal altitude difference

(3) Avoid putting clothes into the

between the desk and chair is
10-12 inches (25cm-30cm),
usually the altitude difference
cuff. in the house is 10-12 inches
(25cm-30cm)
(4) Keep palms up and the body
relaxed.
(5) Sit in a chair with your feet flat on the ground.

It is recommended that the PATIENT remain relaxed and refrain from

talking during the measurement PROCEDURE. Allow 5 minutes to
elapse before taking the first reading and avoid compressing or
restricting the connection tubing.

2.5.2 Ideal Environment for Measuring Blood Pressure:

(1) Measure in the morning when in a relaxed mood.
(2) Avoid consciousness of the need to use the toilet.
(3) Ensure the room temperature is around 20℃.
(4) Choose a quiet place with minimal surrounding noise.

2.5.3 Measure Blood Pressure at the Same Time Every Day:

Blood pressure is constantly changing, and a single measurement
may not accurately reflect the situation. It is more reliable to measure
repeatedly over time. Stick to measuring blood pressure every day,
preferably in a stable mood, such as early in the morning after waking
up. Aim to measure at the same time every day.

Note: Allow at least 2-3 minutes between two measurements.

Depending on individual physiological characteristics, a longer rest
time may be necessary.

Please have the cuff around your arm before starting the
measurement. Avoid measuring your blood pressure on the bus.

11
Care methods
* Clean the blood pressure monitor frequently;
* Use a soft dry cloth towel to clean this blood pressure monitor, if it is
very filthy you can wet thetowel with water or neutral detergent,
wring out it and wipe the monitor;
* Disinfection the cuff with moistened 75% alcohol cotton wool.

2.6 Function
2.6.1. The device has the WHO warning strip “ ” symbol display
function, with the blood pressure value change, the higher blood
pressure value “ ” symbol will appear relatively in the higher position
(refer to WHO definition of high blood pressure levels-reference table).
2.6.2. The device has the average of the last three display function
(press the memory key for the first time to display the value that is the
average of the last three measurements).
2.6.3. The device has a large screen display and value.
2.6.4. The device has kPa and mmHg display switching and
measurement functions.
2.6.5. The device has double memory lookup function and can store
120 sets of measurements for each person to remember the normal
status of your blood pressure.
2.6.6.Low power detection: detecting low power under any working
state, LED displays “ ” symbol indicates low power.
2.6.7. Overpressure protection function: when the pressure is more
than 300mmHg, the device cause automactic power consumption
fastly.
2.6.8. Automatic shutdown function: no operation for 2 minutes the
device will be shut down automatically.
2.6.9. Heartbeat prompting function.
2.6.10. Measurement completed prompting function.
2.6.11. Incorrect prompting function.

RATED ranges of the DETERMINATION

Cuff pressure: 0-299 mmHg
SYS: 45-255 mmHg
DIA: 24-222 mmHg

2.7 Take a Measurement

2.7.1 Press the “ ” button.
All display symbols appear on the screen. The cuff starts to
inflate automatically.
12
2.7.2 Measurement start. When pressurized to stop blood flow, the
Blood Pressure Monitor stops pressure before automatically leaking
air and measuring blood pressure.
The heartbeat symbol flashes when a pulse is detected.
When the heart beat symbol appears and flashes, the Blood
Pressure Monitor detects the pulse and begins to calculate the
pulse automatically.

2.7.3 The blood pressure and pulse rate are displayed when the
measurement completed.
The cuff is deflated automatically, and all of the measurement
results are stored in the memory.
The “ ” symbol will be displayed if irregular heartbeat is detected.

2.7.4 Press the “ ” button to turn off the unit.

The unit will be automatically turned off after two minutes if no
more operation.
NOTE: The inflation or measurement can be stopped by pressing
the “ ” button at any time.

13
2.8 Use the Memory function
The unit stores blood pressure and pulse rate in the memory mode
after completing each measurement. Automatically, 2x120 sets of
measurement values can be stored. The earliest record will be
deleted automatically to save the latest measurement value when
more than 2x120 sets are recorded.
The unit also calculates an average reading based on the values
of the latest 3 measurements.

2.8.1 To read the measurement value

Press the “MEM” button while the unit is off, the unit enters the memory
mode and the average value of the latest 3 times measurement values
of the current user will be displayed.
Press the “MEM” button once more, the latest measurement
values will be displayed, and then press the "MEM" button again to
check earlier measurement values.

2.8.2 To delete the memory value

■ In the memory mode, long press the “ MEM ” button, the unit
displays the following symbol to cancel all the memory records of
the current user.
■ Press the “ ” to cancel the memory records of the current user
if you are sure all the data of corresponding user can be deleted,
the unit will be turned off after deleting.
■ Please operate the delete memory function cautiously.

14
2.9 About Blood Pressure
2.9.1 Irregular Heartbeat Symbol IHB
When the unit detects an irregular rhythm two or more times during
the measurement, the irregular heartbeat Symbol will appear on the
display with the measurement values.
An irregular heartbeat rhythm is defined as a rhythm that is more
than 25% slower or 25% faster from the average rhythm which
detected while the monitor is measuring the systolic blood pressure
and the diastolic blood pressure.
If the Irregular Heartbeat Symbol ( ) displays your measurement
results, we recommend you consult your physician, and follow the
doctor’s directions.
Irregular Heartbeat
Normal Heartbeat Short Long
Pulse Pulse
Blood pressure Blood pressure

2.9.2 Blood Circulation

The blood circulation is responsible for supplying the body with
oxygen.
Blood pressure is the pressure exerted on the arteries.
The systolic blood pressure value (higher pressure or top value)
represents the blood pressure produced by contraction of the
heart muscle.
The diastolic blood pressure value (lower pressure or lower value)
represents the blood pressure produced by relaxation of the
heart muscle.

Systolic Blood Pressure Diastolic Blood Pressure

Contraction of Relaxation of
the heart muscle the heart muscle

Extrude blood Blood return heart

Pressure inreased Pressure decreased

to the blood vessel to the blood vessel

Higher pressure Lower pressure

15
2.9.3 Health and Blood Pressure
The incidence of hypertension increases with age. In addition, if lack
of exercise, excess body fat and high levels of cholesterol(LDL), would
sticks to the inside of blood vessels, which reduces elastictity of these
vessels. Hypertension accelerated arteriosclerosis which can lead to
serious conditions such as stroke and myocardial infarction. For these
reasons it is very important to know whether the blood pressure is
within a healthy range. Blood pressure fluctuates from minute to
minute, throughout the day. Therefore it is essential to take regular
measurements to help you identify an average blood pressure.
Upper curve: systolic blood pressure
Lower curve: diastolic blood pressure

Time of day

2.9.4 Classification of Blood Pressure

After each measurement is completed, the LED display will show your
position automatically on the six segments of the bar indicator which
corresponds to World Health Organization (WHO) Blood Pressure
Indicator.
Reference Material: Journal of Hypertension 1999, Vol 17 No.2

Diastolic Blood Pressure(mmHg)

Severe hypertension
110
Moderate hypertension
100
Mild hypertension
90
Normal systolic value
85
Normal blood pressure
80
Optimal blood
pressure
(target value)
120 130 140 160 180 Systolic Blood Pressure (mmHg)

*Note!
When a person’s systolic and diastolic pressures fall into different
categories, the higher category should apply.

16
2.9.5 Symptoms of High Blood Pressure
High blood pressure can go unnoticed for a long time, since it doesn’t
cause noticeable symptoms. The following are possible causes of
abnormally high blood pressure:
●Overweight;
●High cholesterol level;
●Smoking;
●Excessive alcohol consumption;
●Stress and emotional upset;
●Excessive consumption of salt;
●Lack of physical exercise;
●Genetic / hereditary predisposition;
●Underlying illnesses, such as kidney disorders or endocrine disturbance.

2.9.6 Treatment of High Blood Pressure:

If your blood pressure consistently reaches upper values of 140-160
mmHg and lower values of 90-95 mmHg over several days, it is advisable
to consult a doctor for a detailed medical examination. You can
support the treatment prescribed by your doctor in the following ways:
● Lose weight and lower your cholesterol level
●Reduce alcohol consumption
● Cut down on salt intake
● Quit smoking
● Engage in regular exercise
● Monitor your blood pressure regularly

3. Care and Maintenance

3.1 Cleaning/Disinfecting and Maintenance:
To maintain your blood pressure monitor in optimal condition and
protect it from damage, please adhere to the following guidelines:
3.1.1 Clean the blood pressure monitor regularly after each use by a
user. Avoid using abrasive or volatile cleaners, and never immerse the
unit or its components in water.
3.1.2 Use a soft dry cloth or towel to clean the blood pressure monitor.
If it is very dirty, you can dampen the towel with water or a neutral
detergent, wring it out, and wipe the monitor.
3.1.3 Disinfect the cuff with moistened 75% alcohol cotton wool.
3.1.4 Store the unit in a safe and dry location. Avoid folding the cuff
too tightly, and prevent exposure to extreme hot or cold temperatures,
humidity, and direct sunlight.
3.1.5 Avoid subjecting the unit to strong shocks, such as dropping it on
the floor.
3.1.6 Remove the batteries if the unit will not be used for three months
or longer. Always replace all batteries with new ones at the same time.
3.1.7 Use the unit following the instructions provided in this manual.
Only use authorized parts and accessories.

17
3.1.8 Do not attempt to repair or open the machine by yourself. In case
of a defect, please contact the local distributor for professional
assistance.
3.1.9 We will provide circuit diagrams, component part lists, descriptions,
calibration instructions, or other information to assist service personnel
who are trained by the manufacturer and possess the relevant
qualification certificate.

3.2 Calibration and Service

The accuracy of this blood pressure monitor has been carefully tested
and is designed for a long service life. It is generally suggested to
have the unit inspected every two years to ensure correct functioning
and accuracy. Please consult local authorized distributor or dealer.

3.3 Error Indicators

The following symbols will appear on the display when measuring
abnormally.
Symbol Cause Correction
The course of inflating Wrap the cuff correctly and tightly
appears error Inflate over again after ensuring
Do not move your arm
When measurement and body and keep quiet
fails Measure over again
according to correct way
When the batteries Replace all of the worn
power is too low batteries with new ones

3.4 Troubleshooting
Problem Causes and Solutions
Replace all of the worn batteries
No power
with new ones

No display appears on the Check the battery installation for

display screen proper placement of the
batteries polarities
Blood pressure varies constantly.
Many factors may effect your blood
Measurement values pressure, including stress, time of day,
appear too high or too low how you wrap the cuff. Review the
sections "Proper Way of
Measurement" and "Take a
Measurement"
18
3.5 Technical Data
3.5.1 Specifications
1 Model FC-BP131
2 Measurement
Oscillometric measurement method
Method
3 Display LED Digital Display
Blood Pressure range: 0~299mmHg
Measurement
4 (0 kPa - 39.9 kPa)
Range
Pulse: 40 to 180 beats/min
Accuracy of the Static Pressure: ±3mmHg(±0.4 kPa)
5
cuff pressure Pulse rate: Within ±5% of reading
6 Inflation Automatic inflation by pump
7 Deflation Automatic rapid deflation
8 Pressure Detection Semiconductor pressure sensor
9 Memory 2 Users * 120 memories
4 AAA alkaline batteries ( not included ),
10 Power supply DC6V
USB Type CDC5V1A
Approximately 300 measurements when
using alkaline batteries at the room
11 Battery life
temperature of 22°C and by using three
times a day and inflating to 170 mmHg
Temperature: -4°F to 140°F (-20°C to 55°C)
12 Storage Condition Humidity: 0 to 95% RH
Atmospheric pressure: 70 - 106kPa
Operating Temperature: 50°F to 104°F (10°C to 40°C)
13
Condition Humidity: 15 to 85% RH
Automatic
14 Within 2 Minutes
Power-OFF
Weight of Main
15 265g (exclude batteries)
Unit
External
16 110 X 140 X 67 mm
Dimensions
17 Cuff 8.7-16.5 inches (22-42cm)
Electric Shock
18 Internal power supply appliance type B
Protection

19
 Accessorial
19 Cuff, Instruction Manual
Components
20 Service Life 5 Years
To improve performance, these specifications are subject to change
without notice.
The device, accessories and the packaging have to disposed waste
correctly after the end of the usage, so that the risk of patient or user
can be lowered to acceptable level.

3.5.2 IEC 60601-1-2:2014/AMD1:2020 ME EQUIPMENT and ME SYSTEMS

identification, marking and documents for Class B product.

Instructions for use

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare
environments and so on.

Warning: Don’t near active HF surgical equipment and the RF shielded

room of an ME system for magnetic resonance imaging, where the
intensity of EM disturbances is high.

Warning: Use of this equipment adjacent to or stacked with other

equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.

Warning: Use of accessories, transducers and cables other than those

specified or provided by the manufacturer of this equipment could
result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.”

Warning: Portable RF communications equipment (including

peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the Upper Arm
Electronic Blood Pressure Monitor (model name: FC-BP131), including
cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.

20
If any: a list of all cables and maximum lengths of cables (if applicable),
transducers and other ACCESSORIES that are replaceable by the
RESPONSIBLE ORGANIZATION and that are likely to affect compliance of
the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7
(EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified
either generically (e.g. shielded cable, load impedance) or specifically
(e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).

If any: the performance of the ME EQUIPMENT or ME SYSTEM that was

determined to be ESSENTIAL PERFORMANCE and a description of what
the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or
degraded due to EM DISTURBANCES (the defined term “ESSENTIAL
PERFORMANCE” need not be used).

3.6 Technical description

1.all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL
PERFORMANCE with regard to electromagnetic disturbances for the
excepted service life.

2. Guidance and manufacturer’s declaration -electromagnetic

emissions and Immunity.

Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/ flicker emissions
Compliance
IEC 61000-3-3

21
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
IEC 60601-1-2
Immunity Test Compliance level
Test level
Electrostatic ±8 kV contact ±2 kV, ±8 kV contact
discharge (ESD) ±4 kV, ±8 kV, ±15 kV ±2 kV, ±4 kV, ±8 kV, ±15 kV
IEC 61000-4-2 air air
Electrical fast Power supply lines: Power supply lines: ±2 kV
transient/burst ±2 kV 100 kHz 100 kHz repetition
IEC 61000-4-4 repetition frequency frequency
Surge IEC 61000-4-5 line(s) to line(s): ±1 kV. line(s) to line(s)±1 kV.
0% UT 0.5 cycle
Voltage dips, short At 0º, 45 º, 90 º, 135 º, 0% UT 0.5 cycle
interruptions and 180 º, 225 º, 270 º and At 0º, 45 º, 90 º, 135 º, 180 º,
voltage variations on 315 º 0% UT 1 cycle 225 º, 270 º and 315 º 0% UT
power supply input And 70% UT 25/30 1 cycle And 70% UT 25/30
lines IEC 61000-4-11 cycles Single phase: cycles Single phase: at 0
at 0 0% UT 300 cycle 0% UT 300 cycle
Power frequency
30 A/m 30 A/m
magnetic field
50Hz/60Hz 50Hz/60Hz
IEC 61000-4-8
10 V/m 10 V/m
Radiated RF
80 MHz – 2,7 GHz 80 MHz – 2,7 GHz
IEC61000-4-3
80 % AM at 1 kHz 80 % AM at 1 kHz
30 kHz: 8A/m 30 kHz: 8A/m
Proximity magnetic
134.2 kHz: 65A/m 134.2 kHz: 65A/m
fields IEC 61000-4-39
13.56 MHz: 7.5A/m 13.56 MHz: 7.5A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.

22
Table 3
Guidance and manufacturer’s declaration - electromagnetic Immunity
IEC
Test Maxi- Comp-
Ban- Dista- 60601-1-2
Freque- Servi- Modulat- mum liance
d nce Test level
ncy ce ion Power level
(MHz) (m) (V/m)
(MHz) (W) (V/m)
Pulse
385 380– TETRA modulat- 1,8 0,3 27 27
390 400 ion 18 Hz
Radiated GMRS FM
RF 450 430– 460, ± 5 kHz 2 0,3 28 28
IEC 470 FRS deviation
61000-4-3 460 1 kHz sine
(Test 710 Pulse
LTE
specificat- 704– modulat-
745 Band 0,2 0,3 9 9
ions for 787 ion
780 13,17
ENCLOSU- 217 Hz
RE PORT GSM
IMMUNITY 800/
810
to 900,
RF wireless TETRA
communi- 800, Pulse
cations 800–
iDEN modulat- 2 0,3 28 28
equipment) 870 960
820, ion
CDMA 18 Hz
850,
LTE
Band
930
5

23
 GSM 1800;
1720
CDMA 1900;
GSM 1900; Pulse
1845 1700–
DECT; modulation 2 0,3 28 28
1990
LTE Band 1, 3, 217 Hz
1970 4, 25; UMTS
Bluetooth,
WLAN, Pulse
2400–
2450 802.11 b/g/n, modulation 2 0,3 28 28
2570
RFID 2450, 217 Hz
LTE Band 7
5240 Pulse
5100– WLAN 802.11
5500 modulation 0,2 0,3 9 9
5800 a/n
5785 217 Hz

Table 4
Guidance and manufacturer’s declaration - electromagnetic Immunity
Test frequency Modulation IMMUNITY TEST LEVEL (A/m)
30 kHz CW 8
Pulse modulation a b
134,2 kHz 65
2,1 kHz
Pulse modulation a b
13,56 MHz 7,5
50 kHz
a) The carrier shall be modulated using a 50% duty cycle square wave
signal.
b) r.m.s., before modulation is applied.

This device complies with part 15 of the FCC Rules.

Operation is subject to the following two conditions:
(1) This device may not cause harmful interference.
(2) this device must accept any interference received, including
interference that may cause undesired operation.

24
NOTE: This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee whether interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to remove the interference by
one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications to the product not explicitly approved by
the party responsible for compliance could void the user’s authority
to operate the equipment.

4. Warranty Information
■ The unit is guaranteed to be free of defects in workmanship and
materials when used as intended for a period of two years from the
date listed on the purchase record.

■ For repairs under this warranty, our authorized service agent must be
notified of the fault within the warranty period. This warranty covers
parts and labor only under normal operations. Any defects resulting
from natural causes, such as floods or hurricanes, are not covered by
this guarantee.

■ This guarantee does not cover damage incurred by not following the
instructions, accidental damage, or tampering/servicing by
unauthorized service agents. Any transportation or freight fees incurred
will be the owner's responsibility.

25
■ This guarantee specifically excludes expendables and consumables,
for example batteries.
All warranty claims must be directed to the distributor responsible for
the sale of the device.
The content of this warranty is subject to change without further notice.

■ Monitors subjected to misuse, abuse, and neglect of the manual

content are excluded from the warranty.

■ WARNING: No modification of this equipment is allowed.

26
U.S. Agent:
CTI U.S. Inc.
Suite 230,1455 Cti U.S. Inc.
Lincoln Parkway, Atlanta, Ga, 30346

EC REP RIOMAVIX S.L.

Calle de Almansa 55, 1D, Madrid, 28039 Spain
SRN: ES-AR-000001202

Manufacturer:
Shenzhen Finicare Co., Ltd
201, No.50, the 3rd Industrial Park, Houting Community,
Shajing Street, Bao'an District,
Shenzhen 518104 China

Made in China