nubeca BA2318 Instruction Manual

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Model: BA2318

Arm Automatic

Blood Pressure Monitor

Instruction Manual

Table of Contents

1. Safety Information................................................................1

1.1 Warning............................................................................1

1.2 Contraindications..............................................................3

1.3 Care and maintenance.......................................................3

2. Product Feature.....................................................................4

3. Pre Measurement..................................................................7

3.1 Battery .............................................................................7

3.2 Setting...............................................................................8

4. Take a measurement............................................................10

4.1 Important Noted...............................................................10

10................................................................ ffuc eht gnittiF 2.4

4.3 Body posture during measurement ................................11

4.4 Take Measurement.........................................................12

4.5 Memory..........................................................................15

5. Error Indication..................................................................15

6. Trouble Shooting................................................................16

7. Specification.......................................................................17

8.About Blood Pressure..........................................................22

8.1 What is Blood Pressure? ................................................22

8.2 What is high blood pressure?..........................................22

8.3 What is morning hypertension (morning surge)?...........24

Reference Standard.................................................................25

Explanation of Symbols............................................................26

Guarantee Card..............................................................................26

After-Sale Service.........................................................................27

Rev：A1

Self diagnosis and treatment which use measured results

may be dangerous. Follow the instructions of your physicia

or licensed healthcare provider.

Only take measurement with the manufacturer supplied cuff

or else it will lead to inaccurate results.

Do not use the blood pressure monitor when you are close

proximity to strong static electricity or electromagnetic fields

and avoid using the mobile during measurement.

.1 Warning

1. Safety Information

Do not use in combination with a hyperbaric oxygen therapy device, or in an environment where combustible gas may be generated.

Do not install the unit in the following locations:

- Locations subject to vibration such as ambulances and emergency helicopters.

- A location where there is gas or flame.

- A location where there is water or steam.

- A location where chemicals are stored.

- A location where the unit may easily fall.

If cuff inflation doesn’t stop, remove the cuff or power off the unit, otherwise, it may result in a hazard condition.

Measurements or stores need to take into account environment variables, or else it would lead to the inaccurate measurement.

When using or replacing the batteries, the operator not to touch those parts and the patient simultaneously.

Rev：A1

The battery has positive/negative polarity. If the battery does not connect well to the unit, do not forcibly connect it. Do not use Luer lock. If Luer lock connectors are used in the

This product is suitable for use to self- monitoring of blood pressure in home or used by the licensed healthcare per sonnel in hospital.

construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.

Blood pressure measurements determined with the device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limit prescribed by the American National Standard, Manual, electronic or automated sphygmomanometers. Keep out of reach of infants, small children, and compromised

Children must be supervised to ensure that they are not play with the device.

Use only manufacturer authorized parts and accessories. Parts and accessories not approved for use with the device may damage the unit.

Be careful not to rest your arm on the air tube. This will restrict the flow of air to the cuff.

people who cannot express their consent. Playing the air tube may result in suffocate children, and Children may swallow small parts and lead to suffocation.

1.2 Contraindications

1.3 Care and maintenance

• Do not apply the cuff over a wound or inflamed area.

Rev：A1

Operation of the device does not result in prolonged impairment of the circulation of the blood of the patient.

Direct plug is considered as disconnect device, please do not place the equipment in a difficultly operation position.

When using the device, the patient is an intended operator. Do not serviced or maintained while in use with the patient. The patient can perform the maintenance of changing batteries.

Those who have arrhythmia, diabetes, blood circulation or apoplexy problem, please use under the physician’s instruction.

Clinical testing has not been conducted on newborn infants and pregnant women. Do not use in infants and pregnant women.

Do not use the blood pressure monitor for any other purpose except measuring the blood pressure of human body.

The common arrhythmia such as atria premature beats, premature ventricular and atrial fibrillation will lead to inaccurate results or error.

Do not attempt to disassemble, repair or modify the blood pressure monitor or hand cuff.

Do not measurement too frequent, or else it may result in bruising where the cuff is applied.

The application of the cuff and its pressurization on the arm can cause temporary interference to blood flow, but it would not result in injury to the patient.

Do not wet or cleaning the cuff with water.

Clean the body with soft dry cloth dipped in a concentration of 75% medical alcohol.

Precaution！Please read the enclosed instruction.

. Product Feature

Indications for use：Measurement of Human Blood Pressure and Pulse Rate for adults in home or used by the licensed healthcare personnel in hospital.

Rev：A1

Avoid high temperature, moisture, dust and direct sunlight.

Clean the cuff with soft dry cloth after measurement.

Do not drop or expose the device to heavy shock.

Remove the batteries if the unit will not use for a long time.

Do not disassemble or modify the structure of the unit and damage the safety performance. If you need service, please contact the manufacturer, the maintenance should be done by authorized persons of manufacturer. Maintenance of the necessary technical document, including the schematics, key components list and etc., will provided by the manufacturer for maintenance personnel.

The blood pressure monitor has gone through several trials of testing to ensure the measurement accuracy. The end user should conduct a manufacturer recommended inspection and calibration annually.

Do not use the unit near large equipment that uses a switching relay for power ON/OFF.

Do not use at extremely high temperature, high humidity, or high altitude. Use only within the required ambient conditions.

Body

Fig 1

Rev：A1

uff (Type BF Applied Part)

odel：BC1000

Applicable Arm Circumference: 220 mm to 360 mm

Cuff

Air Tube

Air Tube Connector

LCD Display

Air socket

SET MemoryON/OFF

Cuff label

Fig 2

ote:

ymbol for TYPE BF APPLIED PART

Rev：A1

isplay

Fig 3

Systolic

Diastolic

Pulse Rate

Blood Pressure Level Indicator

Date and Time

Battery Symbol

Memory1 Memory2

Unit of Pressure

Heart Mark

Irregular Heat Rate Symbol

Mean Symbol

2~3cm

Model：BC1000

3. Pre Measurement

3.1 Battery

3.1.1 Installation and replacement

）Remove battery cover

）

Please use the same brand battery and aware of battery polarity during installation

Fig 4

Load 4 standard AAA alkaline battery as indicated in figure below

4 x AAA

Rev：A1

3）Install back the battery cover 4

）Replace the battery if low battery icon is displayed

If the low battery symbol is display, replace with

new batteries, otherwise the unit will not function properly.

Use 4 same brand 1.5 Volt A alkaline batteries.

AA Do not mix the new and old batteries. Remove the battery if the unit is to remain unused for an

extended period.

Reset the time and date after battery replacement.

3.1.2 Battery Life

Four new LR03 (AAA) batteries will last for approximately 200 measurements, if measurements are taken once a day at room temperature (23°C).

The batteries enclosed in the package are used for demonstration

purpose. It is possible that these batteries will therefore not last for 200 measurements. The battery life can be confirmed in the bottom left of the display. If the low battery symbol is display, remaining power is low, replace with new batteries.

Rev：A1

3.2.1 Setting

3.2

Setting

1）With monitor power off 2）Hold the【Set】button for 3 seconds, Year digits blinking

a) Change number

i Press the

【】

button to

advance one number

ii Hold down the button the number will

change rapidly

b) Enter the two digit of the year number. c) Press the 【Set】 button will proceed to month setting.

Press the 【Set】 button will proceed to set time mode.

Complete setting time mode, Press the【Set】button will proceed to set hour.

Repeat step a) to c) to set hour and minutes.

epeat step a）to c）to set month, day.

Press the 【M】 button will automatically change the unit conversion as shown on Fig 7 or Fig 8.

）Unit Conversion (mmHg to kPa)

Rev：A1

The blood pressure monitor is capable to hold 2 sets of memory data. Prior using the blood pressure monitor, select the correct memory data.

Memory data conversion: With monitor power off, hold the

【ON/OFF】

button until

the selected Memory displayed.

The machine is complete setting, ready to use.

Press the

【ON/OFF】

button will automatically change the

memory data conversion either from Memory 1 or Memory 2.

3.2.2 Memory Data Conversion

Complete setting, press 【ON/OFF】 button to exit.

Fig 5 Fig 6 Fig 7 Fig 8

Take a measurement

.1 Important Noted

on't eat, drink alcohol, smoke, take a shower or exercise

or at least 30 minutes before you take your blood pressure

nd don't use any medicines that can raise blood pressure.

Try not to take your blood pressure if you are nervous or upset. If we are nervous, anxious, or agitated our blood pressure will rise. Rest for 5～10 minutes before taking a reading. Sit in a comfortable, relaxed position. Don't move around or talk while taking the blood pressure. Leave your legs in one position, breath freely and calmly. The blood pressure cuff should fit over about 3/4 of your upper arm. It should easily go around the arm and the Velcro should close tightly. If you can, use the same arm for every reading. Measuring blood pressure at the same time on different days should give about the same reading (excluding outside influences like exercise).

Rev：A1

Changes in medication or nutritional supplement can alter your result. Please consult your doctor before taking or stopping medications or supplement.

.2 Fitting the cuff

pproximately 2～3cm ( 1～2 inches) above the elbow. (Fig 9）

）Plug in the air tube connector into the main unit

2）Wrap the cuff around the upper left arm or upper right arm

）

Tighten the cuff around the arm, make sure the cuff is

2 cm～3 cm

Palm face up

Air tube bladder locates in the center of the arm.

Fig 9

4 ) Make sure cuff air tube outlet is facing your finger. Do not over tighten. Approximate one finger should be able to fit underneath the cuff after tightening. 5 ) Relax, place the elbow on the desk with palm facing up; the cuff should be level with your heart. If the cuff doesn’t fit your arm, the reading accuracy may be affected.

Do not bend with the cuff or the air tube. To detach the cuff, unplug the air tube connector from the

main unit

Do not inflate prior fitting the cuff.

Rev：A1

Change the cuff, if it there is a leakage or if the cuff is not working properly.

Only use the manufacturer cuff provide ensure the measurement

accuracy.

4.3 Body posture during measurement

Relax, place the elbow on the desk with palm facing up; cuff

should be at the heart level (Fig 10). The reading accuracy may be affected if the cuff is not fitted properly. The arm should be at the same level of your heart. If your arm is too low, your reading will be too high. If your arm is too high, your reading will be too low.

Arm should be at the same level of your heart.

Fig 10

4.4 Take Measurement

After installing the batteries and wearing the cuff, the unit is ready for measurement: 1 ) For the most accurate result please relax, do not smoke, take deep breath, speak loudly or move around during the measurement. 2 ) Turn on the 【ON/OFF】 button; display will lit-up for 1 second as shown on Fig 11.

Rev：A1

3 )

Then the display on switch to Fig 12, a beep sound indicates the monitor has begun taking the measurement. 4 ) When the device detects a pulse, the heart symbol will flash as shown on Fig 13. The cuff inflates, and your pulse and blood pressure measurement is taken. 5 )

the blood pressure, the blood pressure level classification and definition as show in Fig 15.

When completing the test, the cuff will automatically deflate and the test result will display on the screen as shown on Fig 14. And the pillar in the left of the display will indicate the level of

9) In the end of measurement, “ ” will display on the screen

Fig10

Fig11 Fig13Fig12

6) You may turn off the unit or compare with the previous results

7) Automatic shut off in 3 minutes.

8) If a problem occur during the test, “Err ” will display on the screen.

when irregular pulse is detected.

Rev：A1

The blood pressure level classification and definition (Fig 15)

Rev：A1

Notes:

Do not self-diagnosis according to measurement results. Follow the instructions of your physician or licensed healthcare provider. The pillar in the left of the display and the segment color in the unit will indicate the level of the blood pressure, the blood pressure level classification and definition as show in Fig 15.

If the device cause any discomfort during measurement or fail to perform as indicated, turn off the power or discontinue use. The time of the pressure reduced from 260mmHg (34.67kPa)

Fig 15

When holding the

4.5 Memory

The Memory 1 and Memory 2 can hold up to 60 reading each.

1）Memory Review

a） With monitor power off, hold the 【M】button to enter the memory mode.

b）The unit will display the most recent 3 set of data average. . c

）

d ) If the user need to display the other set of memory data please refer to section 3.2.2 e ) If the data in memory displays the heart mark, it prompts when measurement the irregular pulse is detected.

button the user can view the data

from the most recent date to the oldest date. When holding the

button the user can view vice versa.

2）Delete memory data

a）

b）

Press and hold the memory button until the “---” displayed,

to 15mmHg (2kPa) does not exceed 10s. If cuff inflated up to 300 mmHg (40 kPa) doesn’t stop, please remove the cuff or power off the unit

Rev：A1

c）The unit will only delete the present set of memory data;

d） The device is not capable of deleting a single data. e）Press the 【ON/OFF】 button e

xit the memory mode and

turn off.

5. Error Indication

List of Error code.

Caution: Continuous holding the button will delete all the memory.

【】

Set

【】

Enter into the memory mode refer to section 3.2.2

all the memory data will be deleted.

the other set of memory data will not be affected.

Error

Cause

How to correct

Power on, cuff inflation rate is too

low or main unit does not connect with the cuff.

（

）

Reconnect the air tube connector

with the main unit

（2） Cuff or bladder leakage, if

necessary purchased a new one.

（3） Confirm the cuff is wrapped up

correctly (ref 4), retake the

measurement

Er 230

Weak Signal or cuff is too loose

Cuff too loose，Confirm the cuff is

wrapped up correctly（ref 4.2）retake the

measurement

Er 3

Calculation error，heavy shock,

assembly or hardware error

Remain still, retake the measurement (ref

4.1）

Er 5

Bad Signal，moving or talking

during the measurement

Remain still, retake the measurement (ref

4.1）

Er7

Measurement abnormal

Please retake the measurement

Low battery power, cannot inflate

Change battery（ref 3.1）

6. Trouble Shooting

When the unit encounters malfunction during the use, refer to table below:

Rev：A1

Abnormal How to correct

After batteries installation, power on, no display.

（1）

Check batteries polarity。

（2） If still cannot power on, reinstall the batteries or change

new batteries

Measured value are abnormally high or low

（

1） Confirm the cuff is wrapped up correctly。

（2） If the user clothing restricts the normal flow, please remove

the obstructing clothing and retake the measurement

（3） Relax, place the elbow on the desk with palm facing up;

cuff should align with heart level. Retake the

measurement

Cuff inflation rate is too low or does not inflate

（

）

Reconnect the air tube connector with the main unit

（2） Cuff or bladder leakage, if necessary purchased a new

one.

Cuff deflates too quickly.

（1） Cuff too loose，confirm the cuff is wrapped up correctly。

Measure value is different from the hospital or the value is inconsistent

（

1） Blood pressure value is varied during the day which also

will affect by the human emotional and physical condition

（

2） Record the variance and consult to the doctor

Rev：A1

7. Specification

Description

Arm automatic blood pressure monitor

Model

Display LCD Digital Display

Measuring

principle

Oscillometric Method

Measurement Range

Pressure: 0mmHg~280mmHg

（0kPa~37.3kPa） Pulse: 40 pulse/min ~180 pulse/min

Accuracy

Pressure : ±3mmHg （±0.4kPa

）

Pulse: ±5%

Memory

Automatic

power off

Unattended 3 minutes

Power source

4 AAA Alkaline battery

Battery Life

Approx 200 measurements

Protection

against electric shock

TInternally powered ;

ype BF

IP classification

IP21

Operating Environment

Temperature：+5℃～+40℃；

Humidity：15%-93% Pressure: 70.0kPa～106.0kPa Altitude: ≤ 3 000 m

Storage and transport Environment

Temperature：-25℃～+70℃； Humidity：10%～95% Pressure:50.0kPa～106.0kPa

Weight

280g（Without batteries）

Size

188mm× 87 mm×58mm

if t e

L e im

(B dy)

Body

five years or 10000

times

Contents

·Cuff(Applicable arm circumference: 220mm to 360mm)

·4 AAA alkaline batteries

·Storage case (Optional)

·Instruction Manual

Cuff 10000 times

BA2318

Continuous

Mode of operation

Applied part

Cuff

*If the above suggestion doesn’t remediable, please dial Service Hotline 86-4006 755 009 for consultant.

2 Memory sets, 60 reading each set.

This product must not be disposed together with the domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner. Please remove the battery before disposing of the equipment. Do not dispose of old batteries with your household waste, but dispose of them at a battery collection station at a recyclingsite or in a shop. Consult your municipal authority or your dealer for information about disposal.

Rev：A1

Disposal

This unit is intended for home use and the specification may be changed without prior notice.

Rev：A1

Important information regarding Electro Magnetic Compatibility (EMC) With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. In order to re

gulate the requirements for EMC (Electro Magnetic Compatibility) with

the aim to prevent unsafe product situation, the IEC60601 -1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices. This medical device conforms to this IEC60601-1-2:2007 standard for both immunity

and

emissions

Nevertheless, special precautions need to be observed:

· Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic fields, near the medical device. This may result in incorrect operation of the unit and create a potentially unsafe situation. Recommendation is to keep a minimum distance of 7 m. Verify correct operation of the device

in case the distance is shorter.

Guidance and manufacturer’s declaration

Guidance and manufacturer’s declaration – electromagnetic emissions

The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure that

it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The [EQUIPMENT or SYSTEM] uses RF energy

only for its internal function. Therefore, its RF emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage

fluctuations/flicker emissions

IEC 61000-3-3

Not applicable

Guidance and manufacturer’s declaration – electromagnetic immunity

The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified

below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure that it is used

in such an environment.

Immunity

test

IEC 60601 test

level

Compliance

level

Electromagnetic environment -

guidance

Electrostatic

discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. If ESD interfere with the operation of equipment, counter measurements such as wrist strap,

grounding shall be considered.

Electrical fast

transient/burst

IEC

61000-4-4

2 kV for power

supply lines ± 1 kV for

input/output lines

Not applicable

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

1 kV

differential mode ± 2 kV common

mode

Not applicable

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips,

short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5% UT

(>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (>95% dip in UT)

for 5 sec

Not applicable

Mains power quality should be that of a typical commercial or hospital environment. If the user of the [equipment or system] requires continued operation during power mains interruptions, it is recommended that the [equipment or system] be powered from an uninterruptible power supply or a battery.

Power

frequency (50/60 Hz) magnetic

field IEC

61000-4-8

3 A/m 3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Rev：A1

Guidance and manufacturer’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE – SUPPORTING

Guidance and manufacturer’s declaration – electromagnetic immunity

The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure that

it is used in such an environment.

Immunity test

IEC 60601 test

level

Compliance

level

Electromagnetic environment -

guidance

Conducted RF

IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3V/m

Portable and mobile RF

communications equipment should be used no closer to any part of the [EQUIPMENT or SYSTEM], including cables, than the recommended separation distance calculated from the equation applicable to the frequency or the transmitter. Recommended separation distance

d = 1.2

80 MHz to 800 MHz

d = 2.3

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of

equipment marked with the following

symbol:

Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – For EQUIPMENT and SYSTEMS that are not LIFE – SUPPORTING

Rev：A1

Recommended separation distances between portable and mobile RF communications equipment and the [EQUIPMENT or SYSTEM]

The [EQUIPMENT or SYSTEM] is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the [EQUIPMENT or SYSTEM] can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the [EQUIPMENT or SYSTEM] as recommended below, according to the maximum output power of the

communications equipment.

Rated maximum

output power of

transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

d = 1.16

80 MHz to 800 MHz

d = 1.16

800 MHz to2.5 GHz

d = 2.33

0.01 0.12 0.12 0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended separation

distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propag

ation is affected

by absorption and reflection from structures, objects and people.

8．About Blood Pressure

8.1 What is Blood Pressure?

Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels, and is one of the principal vital signs.

Two pressures are measured for a blood pressure reading:

• Systolic blood pressure is a measure of blood pressure while

the heart is beating.

• Diastolic pressure is a measure of blood pressure while the

heart is relaxed.

8.2 What is high blood pressure?

High blood pressure, also known as HBP or hypertension, is a widely misunderstood medical condition. Some people think

Rev：A1

that those with hypertension are tense, nervous or hyperactive, but hypertension has nothing to do with personality traits. The truth is, you can be a calm, relaxed person and still have HBP. Let's look at the facts about blood pressure so you can better understand how your body works and why it is smart to start protecting yourself now, no matter what your blood pressure numbers are. By keeping your blood pressure in the healthy range, you are:

•

Reducing your risk of your vascular walls becoming overstretched

and injured

• Reducing your risk of your heart having to pump harder to

compensate for blockages

•Protecting your entire body so that your tissue receives regular supplies of blood that is rich in the oxygen it needs

nubeca BA2318 Instruction Manual

Specifications and Main Features

Frequently Asked Questions

User Manual