Тонометр nissei ds 500 инструкция

DIGITAL BLOOD PRESSURE MONITOR

DS-500

INSTRUCTIONS

is manual is intended to assist the user in the safe and e cient operation of

Digital Blood Pressure Monitor DS-500.

accordance with the procedures contained in this manual and must not be

used for purposes other than those described herein. It is important to read

and understand the entire manual. In particular, please read carefully and

become familiar with the section entitled «TIPS ON TAKING YOUR BLOOD

PRESSURE».

PRECAUTIONS FOR USE

BASIC PRODUCT INFORMATION

INSTALLING BATTERIES AND SETTING THE CLOCK

TIPS ON TAKING YOUR BLOOD PRESSURE

CORRECT MEASURING POSTURE

WRAPPING THE CUFF

MEASUREMENT PROCEDURES

MEMORY FUNCTION

ERROR DISPLAYS AND TROUBLESHOOTING

TECHNICAL DESCRIPTION

WARRANTY

is equipment is guaranteed for the period of 2 years a er the date of purchase against

manufacturing defects when returned along with the proof of date of purchase to the

dealer from whom the purchase was made. During this period, the unit will be repaired or

replaced free of charge if the failure is attributable to faulty design or manufacture.

warranty does not cover damage or malfunctions caused by improper handling or use

contrary to the instructions in this manual. Please contact your dealer for additional

warranty provisions which may remain e ective a er the manufacturer’s warranty period

has expired.

Manufacturer:

NIHON SEIMITSU SOKKI CO., LTD. 2508-13 Nakago Shibukawa Gunma 377-0293 Japan

EC-Representative: Nissei Healthcare (UK)LTD. Hen eld, BN5 9SJ UK

A116558-1-D

PRECAUTIONS FOR USE

Do not use this instrument without consultation with your doctor

if you are under dialysis therapy or on anticoagulants,

antiplatelets or steroids. Use of this instrument under such

conditions could cause internal bleeding.

For speci c information on your blood pressure, contact your

physician. Never make any judgment on your own regarding

measurement results.

The material used for the cu bladder is natural rubber latex and it

could cause allergic reactions.

Do not use cu s other than the original cu included with this

product.

To avoid any possibility of accidental strangulation, keep this unit

away from children and do not drape AIR TUBE around your

neck.

Use of this device in areas near portable phones, microwave ovens

or other devices with strong electromagnetic

malfunctions.

The system may fail to yield speci ed measurement accuracy if

operated or stored in temperature or humidity conditions outside

the limits stated in the speci cations section of this manual.

Because the unit includes precision parts, care should be taken to

avoid extreme temperature variations, humidity, shock, dust, and

direct sunlight. Do not drop or strike the unit. Make sure not to

expose the unit to moisture. This unit is not water resistant.

Do not disassemble or modify the unit.

Do not in ate the cu when it is not wrapped around your arm.

ENGLISH

e product must be used in

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web site http://www.nisseihealthcare.com

eld may cause

BASIC PRODUCT INFORMATION

INDICATIONS FOR USE

e DS-500 system is intended for the non-invasive measurement of systolic

and diastolic blood pressure and determination of pulse rate in adults, i.e., age

12 and above; this unit is not designed for neonatal use. Also, an inaccurate

reading may result if this instrument is used on a child’s arm. Consult your

physician if you wish to take a child’s blood pressure.

recommended for use by patients with labile blood pressure or known

hypertension in a home care environment as an adjunct to medical

management.

approximately 22 to 32 centimeters. Pressure is measured over a range of 0 to

300 mmHg and pulse rate over a range of 40 to 160 beats/minute.

METHOD OF MEASUREMENT

… 2

is product employs the oscillometric method for measurement of blood

pressure and pulse rate.

….. 2

around the arm. Circuits within the cu sense the small oscillations in pressure

against the cu produced by the expansion and contraction of the arteries in

the arm in response to each heart beat.

measured, converted to millimeters of mercury, and displayed on the LCD as a

digital value. If the pulse rhythm detected during measurment was irregular,

irregular pulse rate rhythm indication be displayed. A memory circuit stores

the 30 most recent measurement results with date and time for comparison

and computes the average value of stored data.

…. 4

PARTS NAMES AND PRODUCT COMPONENTS

is

AIR CONNECTOR

4 AA BATTERIES

PRODUCT SPECIFICATIONS

Model

Operating Principle

Indicator

Pressure Indicating Range : 0 to 300 mmHg (Cu pressure)

Measuring Range

Accuracy

In ation

De ation

Exhaust

Power Supply

Power Consumption

Memory

Operating Environment

Storage Environment

Cu

Main Unit

Key to symbols

is device complies with EMC (IEC60601-1-2), EN1060-1 and EN1060-3.

CARE AND MAINTENANCE

Use only a so , dry cloth to clean the unit. Do not use gasoline, paint thinner,

or other strong solvents on the unit. Since the cu may absorb perspiration

and other uids, inspect it for stain and discoloration a er each use. When

cleaning the cu , do not machine wash or scrub it. Use a synthetic detergent

and gently rub the surface. Air dry thoroughly. Make sure uid never gets in

AIR HOSE.

When storing the unit, do not place heavy objects on it and do not coil AIR

HOSE too tightly. When the unit has been stored at a temperature below the

freezing point, keep it for at least 1 hour in a warm place before using. Remove

the batteries if the instrument is to be stored for an extended period of time.

Keep the batteries out of reach of children.

We suggest that you have your blood pressure monitor checked every 2 years.

is operation may only be performed by the manufacturer or by rms

authorized by the manufacturer.

e cu will accommodate an upper arm circumference range of

e cu is connected to the main unit and wrapped

e amplitude of each pressure waves is

M1 BUTTON

M2 BUTTON

POWER BUTTON

MAIN UNIT

CARRYING BAG

: DS-500

: Oscillometric method

: 13 digits liquid crystal display

: 50 to 250 mmHg (systolic)

40 to 140 mmHg (diastolic)

40 to 160 bpm (pulse rate)

: ±3 mmHg (Cu pressure)

±5% of reading (pulse rate)

: Automatic in ation

: Automatic (electric control valve)

: Automatic exhaust valve

: 4 pcs. 1.5 volt «AA» (LR6) type batteries

: 4W (max.)

: 30 measurements x 2 and averages

: +10˚C to +40˚C, 85% relative humidity or below

: -5˚C to +50˚C, 85% relative humidity or below

: Coverage arm circumference ; 22 to 32cm

: Weight ; Approx. 255g (without batteries)

Size ; 152 x 100 x 60 mm (W x D x H)

: Type BF equipment

: Important ; Read operating instructions

Speci cations are subject to change without notice due to improvements in performance.

e product is

D RING

TUBE PLUG

CUFF

AIR TUBE

INSTRUCTIONS

Производство приборов сертифицировано по международным стандартам ISO 9001, ISO 13485, EN 46001.
Модель DS-500 соответствует стандарту EMC (IEC60601-1-2), EN1060-1, EN1060-3, требованиям ГОСТ Р 50444-92, ГОСТ 28703-90, ГОСТ Р 50267.0.2-95 (МЭК 601-1-2-93), ГОСТ Р 51959.1-2002 (ЕН 1060-1-96), ГОСТ Р 51952.3-2002 (ЕН 1060-3-97), ГОСТ Р 50267.0-92 (МЭК 601-1-88).
Источник электропитания модель LD-N057 соответсвует международному стандарту EN 55022 Class A, соответствует требованиям ГОСТ Р 502067.0-92 (МЭК 601-1-88), ГОСТ Р 50267.0.2-95, ГОСТ Р 51318.14.1-99 Госстандарта России, тип и степень защиты от поражения электротоком: класс II, тип В.
Государственный реестр средств измерений Российской Федерации № 35497-07.
Росздравнадзор регистрационное удостоверение ФС № 2006/2040 выдано 18 декабря 2006 г.

MEMORY FUNCTION

Measured result is stored in either M1 or M2. Each of two memory banks can hold up to 30 results and their average. When the number of

measurements exceeds 30, the oldest data will be deleted to record new data. You may decide which bank to store your measurement results to

avoid data mixture with someone else’s, or may use two banks to save data measured in the morning and evening separately.

RECALLING STORED DATA

Press POWER BUTTON once while measurement result is being displayed a er a measurement.

NUMBER OF

STORED DATA

DATE

MEMORY

DATA

TIME

NUMBER

ERROR DISPLAYS AND TROUBLESHOOTING

ERROR SYMBOL /

CAUSE / CHECK POINT

SYMPTOM

OVER-PRESSURIZATION;

e cu was in ated to the maximum

pressure because of movement of body

etc.

MEASUREMENT ERROR;

Measurement could not be made

because of moving or talking during

measurement.

INFLATION ERROR;

TUBE PLUG is not correctly inserted.

e cu is not properly applied.

DEFLATION ERROR;

Measurement could not be made

because of moving or talking during

measurement.

NO POWER;

Batteries are exhausted.

Have the batteries polarities been

positioned incorrectly?

Are the battery terminals clean?

LOW BATTERY;

Battery is weak.

If you cannot get correct measurement with the methods above, do not tamper with the internal mechanism. Contact your dealer. If the unit malfunctions, please return it to the dealer or an authorized

service representative for service according to the warranty.

TECHNICAL DESCRIPTION

DS-500 complies with the EMC, electromagnetic compatibility, standard, IEC60601-1-2.

Refer to the tables below for speci c information regarding compliance to the standard.

DS-500, as a medical electrical equipment, needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information

provided below.

Portable and mobile RF communications equipments can a ect the device.

e use of accessories other than those speci ed in this manual may result in increased emissions or decreased immunity of the device.

DS-500 should not be used adjacent to or stacked with other equipment.

Table 201 — Guidance and manufacturer’s declaration — electromagnetic emissions —

DS-500 is intended for use in the electromagnetic environment speci ed below.

Emissions test

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

N/A

Voltage uctuations/ icker emissions IEC 61000-3-3

N/A

Table 202 — Guidance and manufacturer’s declaration — electromagnetic immunity —

DS-500 is intended for use in the electromagnetic environment speci ed below.

Immunity test

IEC 60601 test level

Electrostatic discharge (ESD)

±6 kV contact

IEC 61000-4-2

±8 kV air

Electrical fast transient/burst

±2 kV for power supply lines

IEC 61000-4-4

±1 kV for input/output lines

Surge IEC 61000-4-5

±1 kV di erential mode

±2 kV common mode

Voltage dips, short interruptions

<5% U

(>95% dip in U

) for 0,5 cycle

T

T

and voltage variations on power

40% U

(60% dip in U

) for 5 cycles

T

T

supply input lines IEC 61000-4-11

70% U

(30% dip in U

) for 25 cycles

T

T

<5% U

(>95% dip in U

) for 5 sec

T

T

Power frequency (50/ 60 Hz)

3 A/m

magnetic eld IEC 61000-4-8

NOTE

U

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

T

page4

Press memory M1 BUTTON or memory

M2 BUTTON to see stored data.

The average of the stored result in the

selected bank is displayed.

: average

e latest result stored is displayed when there is

only a single result and the clock display remains

: latest data

when there are no results stored.

e memory data is displayed for approximately 30

day/month

seconds. Approximately 30 seconds a er memory

button is released, the apparatus will turn o .

Press memory button to move to next data.

e indication at the top of the display alternately

changes from memory data number to date and to

time.

e memory data number 1 is the latest among the

stored data in the selected memory bank.

Every depression of memory button

switches among the memory data.

As memory button is pressed, the memory data

number increases; the bigger the number, the older

the result.

REMEDY

Do not move during measurement.

Remain still and quiet during

measurement.

Reinsert TUBE PLUG and make

sure that it is securely inserted.

Properly apply the cu .

Remain still and quiet during

measurement.

Replace all batteries with new ones.

Reinsert the batteries in the

correct position.

Clean with a dry cloth.

Replace all batteries with new

ones.

e customer or the user of DS-500 should assure that it is used in such an environment.

Electromagnetic environment — guidance

DS-500 uses RF energy only for its internal function.

erefore, its RF emissions are very low

and are not likely to cause any interference in nearby electronic equipment.

DS-500 is suitable for use in all establishments, including domestic establishments and those

directly connected to the public low-voltage power supply network that supplies buildings used

for domestic purposes.

e customer or the user of DS-500 should assure that it is used in such an environment.

Compliance level

Electromagnetic environment — guidance

±6 kV contact

Floors should be wood, concrete or ceramic tile. If oors are covered

±8 kV air

with synthetic material, the relative humidity should be at least 30 %.

N/A

N/A

N/A

N/A

N/A

N/A

3 A/m

Power frequency magnetic elds should be at levels characteristic of a

typical location in a typical commercial or hospital environment.

DELETING STORED DATA

Show the individual result to be erased or

the average of a memory bank to clear all

the memory bank data.

Press and hold down either one of memory

buttons: M1 button to erase speci ed data

in memory bank M1, and M2 button to

erase speci ed data in memory bank M2.

e displayed data starts ashing.

Hold down the button until nothing but the

memory bank number is displayed.

ERROR SYMBOL /

CAUSE / CHECK POINT

SYMPTOM

IMPROPER OPERATION;

POWER BUTTON was accidentally

pressed during battery replacement.

Measurement

is

When noise is detected or diastolic

interrupted

once

blood pressure is low, the cu

and cu is de ated

de ated and in ated again.

and in ated again.

Did you move during measurement?

Cannot

complete

Have the batteries run down?

the measurement.

Blood pressure is

Are you measuring with correct posture?

di erent each time.

e

Blood pressure readings constantly vary

reading is extremely

with time of measurement and nervous

low (or high).

condition.

Pulse rate is too low

Did you move during measurement?

(or too high).

Did

you

take

immediately a er exercise?

Measurement result

Is it the right memory bank?

is not stored.

Did you select correct memory bank

number a er the measurement?

Have you le the instrument untouched

e

power

is

a er the measurement?

automatically turned

o .

Table 204 — Guidance and manufacturer’s declaration — electromagnetic immunity —

DS-500 is intended for use in the electromagnetic environment speci ed below.

Immunity test

IEC 60601 test level

Compliance level

Conducted RF IEC 61000-4-6

3 Vrms, 150 kHz to 80 MHz

N/A

Radiated RF IEC 61000-4-3

3 V/m, 80 MHz to 2,5 GHz

3 V/m

NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE2

ese guidelines may not apply in all situations. Electromagnetic propagation is a ected by absorption and re ection from structures, objects and people.

a Field strength from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radios broadcast

and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site

survey should be considered. If the measured eld strength in the location in which DS-500 is used exceeds the applicable RF compliance level above, DS-500 should

be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating DS-500.

b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [V1] V/m.

Table 206 — Recommended separation distances between portable and mobile RF communications equipment and DS-500 —

DS-500 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and DS-500 as

recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

Rated maximum output power of

transmitter W

150 kHz to 80 MHz N/A

0,01

N/A

0,1

N/A

1

N/A

10

N/A

100

N/A

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.

NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE2

ese guidelines may not apply in all situations. Electromagnetic propagation is a ected by absorption and re ection from structures, objects and people.

30

REMEDY

Press POWER BUTTON to turn

o the power once and press it

again to start a measurement.

is does not indicate a problem.

is

Do not move during measurement.

Replace all batteries with new ones.

Measure with the correct posture.

See TIPS ON TAKING YOUR

BLOOD PRESSURE.

Remain still during measurement.

measurement

Measure again a er resting for

more than 5 minutes.

Con rm the memory bank number.

Make sure desired memory bank

is selected before turning o the

monitor a er a measurement.

is does not indicate a problem.

e instrument automatically turns

o 3 minutes a er a measurement

or 30 seconds a er memory display.

e customer or the user of DS-500 should assure that it is used in such an environment.

Electromagnetic environment — guidance

Portable and mobile RF communications equipment should be used no closer to any

part of DS-500, including cables, than the recommended separation distance calculated

from the equation applicable to the frequency of the transmitter.

Recommended separation distance

N/A

d=1,2√P, 80 MHz to 800 MHz

d=2,3√P, 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 xed RF transmitters, as determined by an electromagnetic site

survey,

a

should be less than the compliance level in each frequency range.

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

e customer or the user of DS-500 can help prevent

m

80 MHz to 800 MHz d=1,2√P

800 MHz to 2,5 GHz d=2,3√P

0,12

0,23

0,38

0,73

1,2

2,3

3,8

7,3

12

23

30

b