nu-beca BW2119 Blood Pressure Monitor User Manual


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nu-beca BW2119 Blood Pressure Monitor User Manual | Manualzz

Instruction Manual

BW2119

Table of Contents

Before Using the Monitor

Introduction................................................................................................1

Symbols Use..............................................................................................2

Important Safety Notes..............................................................................3

Konw Your Unit.......................................................................................4-5

IHB Introduction.........................................................................................6

Before Taking A Measurement...................................................................7

Operating Instructions

Battery lnstallation/Replacement............................................................8-9

Adjusting Settings

1. To set year ......................................................................................10

2. To set date and time ...................................................................11-12

3. To set positioning sensor ................................................................12

4. To set displaying of the date and time ........................................13-14

5. To set unit ........................................................................................15

6. To set Volume...................................................................................16

7. To set user .......................................................................................17

Proper Way of Measurement ...................................................................18

Take a Measurement ..........................................................................19-21

Use the Memory Function

To read the average value ...................................................................22

To read the measurement value ..........................................................23

Model No.: BW2119

Thanks for choosing the Digital Blood Pressure Monitor

Please read this instruction manual before using your unit.

Please keep this instruction manual safe for future use.

Table of Contents

To delete the memory value .................................................................24

About Blood Pressure

Blood Circulation ..................................................................................25

Health and Blood Pressure ..................................................................26

Classification of Blood Pressure .....................................................27-28

Care and Maintenance

Exceptional Situations

Error Indicators ....................................................................................29

Eliminate Fault .....................................................................................30

Care and Maintenance

Care .....................................................................................................31

Maintenance ........................................................................................32

Specifications .....................................................................................33-34

Statement ................................................................................................35

Warranty Information ..........................................................................36-44

Introduction

Thank you for purchasing Fully Automatic Wrist Style Digital Blood Pressure

Monitor.

The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.

The unit stores automatically 180(2*90) sets of measurement values with the measuring date and time. You can read the stored data conveniently by pressing the memory button.

The unit comes with the following components:

• Main Unit

• Storage Case

• Instruction Manual printed in English

The unit have the following advanced functions:

• Back Light

• Voice Function

• Positioning Sensor

• Displaying of the date and time

1

Important Safety Notes

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

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

Contact your physician for specific information about your blood pressure.

Self-diagnosis and treatment using measured results may be dangerous.Follow the instructions of your healthcare provider.

Operate the unit only as intended. Don't use for any other purpose.

The unit is intended to use in measuring blood pressure and pulse rate for adult only, not recommended for neonatal baby at home or medical centre.

Do not use a cellular phone near the unit. It may result in operational failure.

Please avoid using in high radiant area in order to make your measuring data correctly.

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

Do not use the equipment where flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (such as alcohol) are present.

3

Symbols Use

SYMBOLS USED IN THIS INSTRUCTION MANUAL

WARNING which, if not

CAUTION

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.

Type BF applied part

AUTHORISED REPRESENTATIVE IN THE

EUROPEAN COMMUNITY

Refer to instruction manual/booklet

MANUFACTURER

SERIAL NUMBER

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.

2

Know Your Unit

Body & Cuff

Back Light

START/STOP Button

Memory Button

Setting Button

Display

BW2119

Voice

Battery Compartment

Wrist Cuf f

4

Know Your Unit

Display

User Symbol

Inflation/Deflation Symbol

or WHO Indication

Heartbeat Symbol

Position Symbol

Memory & Times

Irregular Heartbeat

Symbol

Date/Time

Systolic Blood

Pressure

Diastolic Blood

Pressure

Unit lndication

Average Value Symbol

Pulse

Low Battery Symbol

Power

2 AAA Alkaline

Batteries

Storage Case

5

Before Taking A Measurement

1.Avoid eating,drinking alcohol, smoking, exercising and bathing for

30 minutes before taking a measurement.

2.Stress raises blood pressure.Avoid taking measurements during

stressful times.

3.The cuff can be applied to your left or right wrist.Always measure

your blood pressure on the same wrist.

4.Measurements should be taken in a quiet place.

5.Position the unit at heart level throughout the measurement.

6.Remain still and do not talk during the measurement.

7.Keep a record of your blood pressure and pulse readings for your

physician.A single measurement does not provide an accurate

indication of your true blood pressure.You need to take and record

several readings over a period of time.Try to measure your blood

pressure at the same time each day for consistency.

8.Wait 30~60 seconds between measurements.The wait time allows

the arteries to return to the condition prior to taking the blood

pressure measurement.You may need to increase the wait time

depending on your individual physiological characteristics.

7

IHB Introduction

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.

Normal Heartbeat

Pulse

An irregular heartbeat rhythm is defined as a rhythm that varies by less than 25% from the average rhythm or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.

Pulse

Irregular Heartbeat

Short Long

If the Irregular Heartbeat Symbol ( ) displays with your measurement results, we recommend you consult your physician.

Follow the directions of your doctor.

6

Battery Installation / Replacement

1

Remove the battery cover from the battery compartment.

BW2119

2

Install 2 “AAA” size batteries so the + (positive) and - (negative) polarities match the polarities of the battery compartment as indicated.

BW2119

8

3

Battery Installation / Replacement

Replace the battery cover.

BW2119

Caution!

Use two identical 1.5V alkaline batteries type

AAA/LR03.

Do not use rechargeable batteries.

Replace both of the batteries if the symbol of low battery appears on the display.

Never leave any low battery in the battery compartment since they may leak and cause damage to the unit.

9

Adjusting Settings

2. To set date and time

Press the “MEM” button to change the month and press the “SET” button and continue with next step. Then set the day, the time system conversion, the hour and the minute by using the same way. Continue with step 3.

Month Setting Day Setting

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BW2119 time system conversion

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Hour Setting

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11

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Adjusting Settings

1. To set year

1.1 All information will appear on the display when the batteries are installed

at the first time. After 2 seconds the year flashes on the display. Finally,

press the “SET” button and continue with step 2.

1.2 The mark of year appears and flashes after press the “SET” button

for 3~4 seconds, while the unit is off.Finally, press the “SET” button

again and continue with step 2.

Then press the “MEM” button one time for increasing one year, twice for

two years, so on and so forth. Long press the “MEM” button and the

value quickly increases.

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The year can be set between 2011 and 2030, and it will return to 2011 when the display of year up to 2030.

10

Adjusting Settings

Minute Setting

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3. To set positioning sensor

The Positioning Sensor symbol “ ” will appear.

Press the “MEM” button to change the current setting.

If the positioning system is turned on, the LCD will display " ".

If the positioning system is turned off, the LCD will display " ".

Press the “SET” button and continue with step 4.

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12

BW2119

“mmHg” display

Adjusting Settings

4. To set displaying of the date and time

Press the “MEM” button and confirm whether the unit displays the date and time after turning off.

Then press the “SET” button and continue with step 5.

BW2119

BW2119

When the display function of the date and time is ON, the LCD will display " " .

When the display function of the date and time is OFF, the LCD will display " " .

13

Adjusting Settings

5. To set unit

Then press the “MEM” button to change the current unit. (kPa or mmHg)

Then press the “SET” button and continue with step 6.

15

BW2119

“kPa” display

Adjusting Settings

If select to display the date and time, the current date and time will display when turned off.

12 Hour System

Conversion

24 Hour System

Conversion

BW2119

Hour Display

Minute Display

Second Display

Date Display

BW2119

Hour Display

Minute Display

Second Display

Date Display

14

Adjusting Settings

6. To set Volume

Press the “MEM” button and the volume change one-way circularly from level 0 to level 7. Press the “SET” button and return to the step 1.

Press the “ START/STOP ” button to save the current setting and turn off.

Voice ON/OFF

......

BW2119 BW2119 BW2119

Volume Level 7 Volume Level 0 Volume Level 1

When the volume is level 0, the LCD will display “ ” and the voice function is OFF.

When the volume can be set between level 1 and level 7, the LCD will display “ ” and the voice function is ON.

16

Adjusting Settings

7. To set user

Press the “SET” button and the mark of a user will appear when turned off or the display function of the date and time is ON. Then press the “MEM” button to change the current user.

Finally, press the “START/STOP” button to confirm user and turn off.

Proper Way of Measurement

1

Remove all clothes from your arm allowing the cuff to fit directly on the skin.

2

Wrap the cuff tightly around your wrist by using the Velcro strip.

1cm

(0.4'')

3

Sit in a chair with your feet flat on the floor.

BW2119

You can stop the setting anytime when you press the “START/STOP” button to save the current setting and turn off.

If select to display the date and time, the current date and time will display when turned off.

17

Take a Measurement

1

Press the “

START/STOP

” button.

All display symbols appear. If the positioning system is turned on, when the unit detects your arm is not in proper position, it will remind you according to the “Bi-Bi” voice to heighten or lower the cuff. Then the mark of arrowhead flashes, until the mark of arrowhead disappear and the “ ” symbol display.

Bi--Bi Bi Bi

Bi...Bi...Bi

Too Iow

Bi Bi Bi Bi

Bi Bi Bi Bi

Iow

Bi...Bi...Bi

OK

BW2119

High

Too High

19

18

Take a Measurement

2

When your arm is in proper position and the mark of heartbeat disappears, it will automatically start to inflate and measure.

The hearbeat symbol “ ” flashes once a pulse is detected.

Start to inflate Inflating Heartbeat appear Continue Inflating To a fit pressure

3

The blood pressure and pulse rate are displayed when the measurement completed.

The cuff is deflated automatically, and the measurement results are stored in memory with date and time.

The “ ” symbol will be displayed if irregular heartbeat deteced.

“kPa”display

OR

“mmHg”display

OR

“ ”display

20

Take a Measurement

4

Press the “START/STOP” button to turn off the unit.

The unit will automatically turn off after two minutes if you have forgotten to turn it off.

If select to display the date and time, the current date and time will display when turned off.

OR

BW2115 BW2115

NOTE:

To stop the inflation or measurement, press the “START/STOP” button in anytime. The unit will stop inflating and then release and turn off.

21

Use the Memory Function

To read the measurement value

..............................................

Press the “MEM” button to display the set of measurement values with the measuring date from the most recent to the oldest.

Press the “SET” button to display the next set of measurement values with the measuring date from the oldest to the most recent.

Alternating

display

The 1st latest measurement value

The 2nd latest measurement value

Forward

Backward

The 90th latest measurement value

BW2119

23

Use the Memory Function

The unit stores the blood pressure and pulse rate in the memory after completing a measurement every time. It can automatically store180 sets measurement values for 2 users(2*90). The earliest record is deleted to save the latest measurement value when any one user more than 90 sets.

The unit also calculates an average reading based on the values of the latest 3 times measurement taken.

To read the average value

...................................

Press the “MEM” button, the average value of the latest 3 times measurement taken of the current user will display with the average reading.

Turn to next

BW2119

22

the average value of the latest

3 times measurement taken

Use the Memory Function

To delete the memory value..............................................

In the memory reading mode, press the “SET” button for 4-6 seconds, the unit will display “ ”.

Press the “MEM” button and confirm “ ” or “ ”.

If you are sure all the data of corresponding user can be deleted, press the

“START/STOP” button, all the corresponding user’s data will be deleted and the unit will turn off.

BW2119

Note: If you have set “ ”, but do not press a button for 2 minutes, the unit will

turn off automatically, but the corresponding user’s blood pressure data will not

be deleted. The delete operation must be confirmed by user.

After the measurement finished and when reading the memory values, the backlight is on about 10 seconds.

24

About Blood Pressure

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

Contraction of the heart muscle

Extrude blood

Pressure increased to the blood vessel

Higher pressure

Diastolic Blood Pressure

Relaxation of the heart muscle

Blood return heart

Pressure decreased to the blood vessel

Lower pressure

25

About Blood Pressure

Classification of Blood Pressure

After each measurement is completed, the LCD 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 Pressur (mmHg)

Severe hypertension

110

Moderate hypertension

100

Mild hypertension

90

Normal systolic value

85

80

Normal blood pressure

Optimal blood pressure

(target value)

WHO

Red

Yellow

Green

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.

27

About Blood Pressure

The incidence of hypertension increases with age. In addition, a lack of exercise, excess body fat and high levels of cholesterol (LDL), which sticks to the inside in blood vessels, reduces elasticity of these vessels. Hypertension accelerates arterial sclerosis which can lead to very 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.

26

About Blood Pressure

Classification of Blood Pressure

High blood pressure can go unnoticed for a long time, since it doesn’t cause noticeable symptoms. The following are all 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.

28

If your blood pressure reaches upper values of 140~160 mmHg and lower values of 90~95 mmHg in repeated measurements over several days, you should consult your doctor for detailed medical examination. You can assist the treatment prescribed by your doctor in the following ways:

Loose weight and lower your

cholesterol level;

Reduce the consumption of alcohol;

Reduce the intake of salt;

Stop smoking;

Take regular exercise;

Monitor your blood pressure.

Exceptional Situations

Error Indicators

The following symbol will appear on the display when measuring abnormally.

Symbol Cause Correction

Wrap the cuff correctly and tightly.

The course of inflating appears error.

Inflate over again after ensuring.

When measurement fails.

Do not move your arm and body, and keep quiet.

Measure over again according to correct way.

When the batteries power are too low.

Replace both of the worn batteries with two new ones.

29

Care and Maintenance

Care

Keep the unit in the storage case when not in use.

Clean the unit with a soft dry cloth.

Do not use any abrasive or volatile cleaners.

Never immerse the unit or any components in water.

BW2119

Avoid subjecting the monitor to strong shocks or vibrations, such as dropping the nuit on the floor.

Use the unit consistent with the instructions provided in this manual.

Use only authorized parts and accessories.

31

Exceptional Situations

Eliminate Fault

Problem

No power.

No display appears on the display screen.

Measurement values appear too high or too low.

Causes and Solutions

Replace both of the worn batteries with two new ones.

Check the battery installation for proper placement of the batteries polarities.

Blood pressure varies constantly. Many factors including stress, time of day, how you wrap the cuff, may affect your blood pressure. Review the sections "Proper

Way of Measurement" and "Take a

Measurement".

30

Care and Maintenance

Maintenance

Do not clean the body and cuff with naphtha, thinner or gasoline etc.

Do not wet the cuff or attempt to clean the cuff with water.

thinner gasoline

Store the unit in a clean and dry location. Do not subject the unit to extreme hot or cold temperature, humidity and direct sunlight.

BW2119

Remove the batteries if the unit will not be used for 3 monthes or longer.

Always replace both of the batteries with new ones at the same time.

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32

Model No.

Display

Measuring Principle

Measurable

Circumference of Wrist

Electric Shock Protection

Back Light

Measurement

Range

Pressure

Accuracy

Pulse

Pressure

Pulse

LCD

Indication

Pressure

Pulse

Symbol

Specifications

BW2119

LCD Digital Display

Oscillometric Method

13.5~21.5cm (5.3''~8.5'')

Internal power supply appliance type B

White

0 to 299 mmHg (0~39.9 kPa)

40 to180 Pulses/min

3 mmHg (0.4kPa)

5% of reading

3 Digits Display of mmHg or kPa

3 Digits Display

Memory/IHB/Heartbeat/Low Battery,etc.

33

Statement

The intended use: The unit is intended to be used by adults at home or medical centre to measure blood pressure and pulse rate.

The unit satisfies the requirements of IEC60601-1 Medical electrical equipment,

EN1060-1: Non-invasive sphygmomanometer, EN1060-3: Non-invasive sphygmomanometer,IEC80601-2-30: Medical electrical equipment.

The unit has passed the EMC Test.

Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard,

Manual, electronic, or automated sphygmomanometers.

The risk of patient and user can be lowered to acceptable level.

Substitution of a cuff different from that supplied might result in measurement error.

Please contact us if you need the circuit diagrams, component part lists etc.

Specifications are subject to change without notice due to improvements in performance.

35

Specifications

Inflation

Rapid Air Release

Memory Function

Power Source

Automatic Power-Off

Dimensions

Gross Weight

Automatic by Internal Pump

Automatic by Air Valve

Memory 180 (2*90) Sets Measurement Values

2 AAA Alkaline Batteries

In 2 Minutes

Approx. 87*84*36mm

Approx. 160g (Batteries not included)

Operating

Environment

Transport and

Storage

Environment

Temperature

Humidity

Barometric Pressure

Temperature

Humidity

34

10 ~ 40 C (50 ~ 104 F)

15 ~ 90%RH (Noncondensing)

80~105 kPa

-20 ~ 60 C (-4 ~ 140 F)

10 ~ 95%RH (Noncondensing)

Warranty Information

Federal law restricts this device to sale by or on the order of a physician.

The unit, excluding the unit cuff, is guaranteed to be free of defects in workmanship and materials for a period of two years from the date listed on the purchase record, when used in accordance with the instructions provided with the unit.The unit cuff is warranted to be free from defects in materials and workmanship appearing within one year from the date listed on the purchase record when the unit is used in accordance with the instructions provided with the unit.

For repair under this warranty.Our authorized service agent must be advised of the fault within the period of the warranty.This warranty covers parts and labor only under normal operations.A transportation fee or freight fee that may be incurred will be the owner’s responsibility.Any defect resulting from natural causes, e.g.,flood,hurricane etc., is not within this guarantee.

This guarantee does not cover damage incurred by use of the unit not in accordance with the instructions, accidental damage, or being tampered with or serviced by unauthorized service agents.

Unit subjected to misuse, abuse, and neglect of these manual contents, non-instructional purposes;unauthorized repair or modifications will be excluded from this warranty. 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.

36

Warranty Information

Periodical check:

Sensitive measuring devices must be checked from time to time for accuracy and leakage, we therefore recommend that the performance should be checked every 2 years and after maintenance and repair.

Please contact the local distributor for details.

Clean the cuff with a soft dry cloth.

The unit satisfies the requirements of EN60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance; EN60601-1-2: Medical electrical equipment Part 1-2:General requirements for basic safety and essential performance – Collateral standard:

Electromagnetic compatibility – Requirements and tests;

EN1060-1:Non-invasive sphygmomanometers – Part 1: General requirements;

EN1060-3: Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring system.

EN1060-4:Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers.

37

Warranty Information

Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

*MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding

EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS.

*Portable and mobile RF communications equipment can affect MEDICAL

ELECTRICAL EQUIPMENT.

* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.

Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!

WARNING:

The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the COMPRESSOR NEBULIZER as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.

39

Warranty Information

Warning: Do not use luer lock connector in the 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.

It can’t be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

It can’t be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

Applied parts contains cuff.

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.

Protection Class: Internally powered equipment

Applied Part Type: Type B

Moisture Protection: IPX0, continue operation

WARNING: No modification of this equipment is allowed.

Manufacturer will make available on request circuit diagrams, component part lists etc for the service personnel in parts repair.

38

Warranty Information

Guidance and manufacture’s declaration

Guidance and manufacture’s declaration – electromagnetic emission

The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the Digital Blood Pressure Monitor should assure that it is used in such an environment.

Emission test

RF emissions

CISPR 11

Compliance

Group 1

Electromagnetic environment – guidance

The Digital Blood Pressure Monitor use 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 emission

CISPR 11

Harmonic emissions

IEC 61000-3-2

Class B

Not applicable

The Digital Blood Pressure Monitor is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Not applicable

40

Warranty Information

Guidance and manufacture’s declaration – electromagnetic immunity

The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Digital Blood Pressure Monitor should assure that it is used in such an environment.

Immunity test

IEC 60601 test Compliance level level

Electromagnetic environment - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

Power frequency

(50Hz/60Hz) magnetic field IEC

61000-4-8

±6 kV contact

±8 kV air

3A/m

±6 kV contact

±8 kV air

3A/m

Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.

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

NOTE UT is the a.c. mains voltage prior to application of the test level.

41

Warranty Information

Immunity test

Radiated RF

IEC 61000-4-3

IEC 60601 test Compliance level level

3A/m

80 MHz to 2.5

GHz

3A/m

Electromagnetic environment - guidance survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Digital Blood Pressure

Monitor is used exceeds the applicable RF compliance level above, the Digital Blood

Pressure Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the

Digital Blood Pressure Monitor.

43

Warranty Information

Guidance and manufacture’s declaration – electromagnetic immunity

The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Digital Blood Pressure Monitor should assure that it is used in such an environment.

Immunity test

IEC 60601 test Compliance level level

Electromagnetic environment - guidance

Radiated RF

IEC 61000-4-3

3A/m

80 MHz to 2.5

GHz

3A/m

Portable and mobile RF communications equipment should be used no closer to any part of the Digital Blood Pressure Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

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 metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site

42

Warranty Information

Recommended separation distances between portable and mobile RF communications equipment and the Digital Blood Pressure Monitor.

Pressure Monitor is intended for use in an electromagnetic environment in which radiated

RF disturbances are controlled. The customer or the user of the Digital Blood Pressure

Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Digital

Blood Pressure Monitor as recommended below, according to the maximum output power of the communications equipment.

output power of transmitter

Separation distance according to frequency of transmitter

(m)

80 MHz to 800 MHz

80 MHz to 800 MHz

0.01

0.1

1

0.117

0.369

1.167

0.233

0.738

2.333

10

100

3.689

11.667

7.379

23.333

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.

44

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