Becken BBPM-3008A medidor tensao de braco Manual do proprietário

INSTRUCTIONS MANUAL

MANUAL DE INSTRUCCIONES

MANUAL DE INSTRUÇÕES

Arm Blood

Pressure Monitor

Monitor de Presión Sanguínea para Brazo

Medidor da Pressão Arterial de Braço

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Dear client,

Thank you for purchasing this product.

The quality of this appliance has been certified by several

laboratory tests. This instructions manual is provided to

simplify the use of the appliance as well as to guarantee

a safe use.

Please read carefully the instructions and safety measures

described in this manual.

We sincerely hope you will be satisfied when using your new

appliance.

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

INDEX

1. SAFETY INSTRUCTIONS 4

1.1. Humidity and Water 6

1.2. Cleaning 6

1.3. General Precautions 6

2. OPERATING INSTRUCTIONS 11

2.1. Blood Pressure Classification Chart 11

2.2. Product Description 12

2.3. Product Operation 14

2.4. Troubleshooting 24

3. TECHNICAL SPECIFICATIONS 26

4. AFTERSALE SERVICE 27

5. ENVIRONMENTAL PROTECTION 28

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1. SAFETY INSTRUCTIONS

WARNING

RISK OF ELECTRIC SHOCK

DO NOT OPEN

Warning: to avoid the risk of electric shock, do not

remove the cover. The interior does not contain any parts

that can be repaired by the user. Ask for assistance from

qualified personnel.

Important Warnings

Before using your appliance read this instructions manual

carefully and keep it in a safe place as you may need to

consult it in the future.

Before turning on your appliance, and to ensure a safe and

correct operation, do not use if:

• It has fallen to the ground;

• You notice any evidence of damage;

• Any anomaly occurs during its operation.

To avoid hazards or deterioration of your appliance through

incorrect use it is advisable to read these instructions

thoroughly.

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

Your appliance may not be used for other purposes than the

ones intended and solely for household use. Any damage

resulting from using the appliance outside this scope, any

incorrect use, as well as any manual modifications to the

product will not be covered and automatically voids the

warranty.

Assistance

In case of malfunction, take your appliance to a qualified

technician for assistance.

This appliance can be used by children from the age of 8

and by people with reduced physical, sensorial or mental

capabilities and/or lack of experience and knowledge if they

have been given instructions on using the appliance safely

and if they understand the hazards involved. Children may

not play with the appliance. Cleaning and maintenance must

not be carried out by children without supervision.

These instructions are also available at www.suporteworten.pt

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1.1. Humidity and Water

Do not use your appliance in humid places. Do not allow the

appliance to become wet under any circumstances as this

may be dangerous. To avoid fire hazard or electric shock do

not expose your appliance to humidity or water. Furthermore,

do not place your appliance under water (e.g. for cleaning).

1.2. Cleaning

Clean the body with soft dry cloth dipped in a concentration

of 75% medical alcohol.

Do not wet or clean the cu with water.

Clean the cu with soft dry cloth after measurement.

To clean the exterior of the product, use a dry soft cloth only.

1.3. General Precautions

• Self-diagnosis and treatment using measured results may

be dangerous. Follow the instructions of your physician or

licensed healthcare provider.

• Those who suer from arrhythmia, diabetes, blood

circulation problems or apoplexy problems, please use as

instructed by your physician.

• If cu inflation doesn’t stop, remove the cu or power o

the unit, otherwise it may result in a hazardous situation.

• Do not use in combination with a hyperbaric oxygen

therapy device, or in an environment where combustible

gas may be generated.

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

• Do not install the unit in the following locations:

- Locations subject to vibration such as ambulances and

emergency helicopters.

- Locations where there is gas or a flame.

- Locations where there is water or steam.

- Locations where chemicals are stored.

- Locations where the unit may easily fall.

• Common arrhythmias such as atrial premature beats,

premature ventriculars and atrial fibrillations may lead to

inaccurate results or errors.

• Please take into account environmental variables,

otherwise they may lead to inaccurate measurement.

• When using or replacing the AC adapter and batteries the

operator should not touch these parts simultaneously with

the patient.

• Do not use Luer lock. If Luer lock connectors are used in

the tubing construction, there is a possibility that they

might be inadvertently connected to intravascular fluid

systems, allowing air to be pumped into a blood vessel.

• Avoid high temperatures, moisture, dust and direct sunlight.

• Do not use at extremely high temperatures in high

humidity or at high altitudes. Use only within the required

ambient conditions.

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• Do not use the unit near large equipment which uses a

switching relay for power ON/OFF.

• Remove the batteries if the unit will not be used for a long

time.

• Clinical testing has not been conducted on new-borns and

pregnant women. Do not use on new-borns and pregnant

women.

• The blood pressure monitor has gone through several

trials of testing to ensure measurement accuracy. If used

according to the operation instructions, it does not require

periodic re-adjustments.

• Blood pressure measurements determined with the

device are equivalent to those obtained by a trained

observer using the cu/stethoscope auscultatory method,

manual, electronic or automated sphygmomanometers.

• Keep out of reach of infants, small children, and

compromised people who cannot express their consent.

• This product is suitable for the self-monitoring of blood

pressure at home or to be used by licensed healthcare

personnel in hospitals.

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

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 regulate the requirements for EMC (Electro

Magnetic Compatibility) with the aim to prevent an 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 7m. Verify correct operation of the device in case the

distance is shorter. Further documentation in accordance

with IEC60601-1-2:2007 is available at pump at the address

mentioned in this user manual.

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Reference Standard

• IEC 60601-1: 2005 Medical electrical equipment - Part:

General requirements for safety and essential performance.

• IEC 60601-1-2:2007 Medical electrical equipment - Part

1-2: General requirements for basic safety and essential

performance - Collateral standard: Electromagnetic

compatibility - Requirements and tests

• EN 1060-1:1995+A2:2009 Non-invasive

sphygmomanometers - parts1: General requirements

• EN 1060-3:1997+A2:2009 Non-invasive

sphygmomanometers - parts3: Supplementary

requirements for electro-mechanical blood pressure

measuring systems.

• ANSI/AAMI SP-10:2002+A1:2003+A2: 2006/(R)2008

Manual, electronic, or automated sphygmomanometers

• ANSI/AAMI/ISO 81060-2-2009 Non-invasive

sphygmomanometers

Explanation of Symbols

LOT Symbol for “batch code”

Symbol of “manufacturer”

“CE Conformity marking”

Symbol for “Follow operating instructions”

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

IP22 Symbol for “the IP classification”

Symbol for “electrical and electronic equipment”

EC REP

Symbol for “AUTHORISED REPRESENTATIVE

IN THE EUROPEAN COMMUNITY”

2. OPERATING INSTRUCTIONS

2.1. Blood Pressure Classification Chart

According to World Health organization standard, the blood

pressure level classifications and definitions are as following:

Category Systolic (mmHg) Diastolic (mmHg)

Desirable <120 and <80

Normal 120-129 and/or 80-84

Pre-hypertension 130-139 and/or 85-89

Hypertension >140 and/or >90

Stage 1 Hypertension 140-159 and/or 90-99

Stage 2

Hypertension 160-179 and/or 100-109

Hypertensive Crisis >180 and/or >110

These categories were defined by the American Heart

Association. This chart applies to adults age 20 and older.

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2.2. Product Description

Indications for use: Measurement of Human Blood Pressure

and Pulse Rate for adults at home or to be used by licensed

healthcare personnel in hospitals.

Body

ACM Adapter

connector Air socket

Set

ON/OFF

Memory

LCD Display

Fig 1

Cu Label (Type BF Applied Part)

Applicable Arm Circumference: 220 mm to 360 mm

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

Cu Air tube

Air tube Connector

Cu label

2~3cm

Fig 2

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Display

Diastolic

Unit of Presure

Battery Symbol

Time

Pulse Rate

Heart Mark

Blood Pressure

Level Indicator

Memory Symbol

Mean Symbol

Systolic

Fig 3

2.3. Using the Product

2.3.1. Battery

Installation and replacement

1) Remove battery cover.

2) Insert 4 standard AA alkaline batteries as indicated on

figure.

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

A(AA) Alkaline Battery

Battery Cover

Fig 4 Fig 5

Please use the same brand of batteries and be aware of

battery polarity during installation

3) Place back the battery cover.

4) Replace the battery if low battery icon is displayed.

• If the low battery symbol is displayed, replace with

new batteries, otherwise the unit may not function

properly.

• Use 4 same brand 1.5 Volt AA alkaline batteries.

• 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.

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Battery Life

• Four new LR6 (AA) batteries will last for approximately

200 measurements, if measurements are taken once a day

at room temperature (23°C).

• Battery life can be confirmed on the bottom right of

the display. If the low battery symbol is displayed

remaining power is low, replace with new batteries.

2.3.2. Set-up

1) With monitor power o

2) Hold the [Set] button for 3 seconds until year digits blink.

a) Changing the number:

i) Press the [M] button to advance one number.

ii) Hold down the [M] button to change the number

rapidly.

b) Enter the two digits of the year number.

c) Press the [Set] button to proceed to month setting.

d) Repeat step a) to c) to set month, day, hour and

minutes.

3) Unit Conversion (mmHg to kPa):

a) Press the [M] memory button to automatically change

the unit conversion as shown on Fig 6 or Fig 7.

4) Unit with Broadcast.

a) To continue the broadcast setting, press the [M] button

to automatically turn on or o the broadcast system as

shown on Fig 8 or Fig 9.

b) To complete the setting, press the [ON/OFF] button to

exit.

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

Fig 6 Fig 7 Fig 8 Fig 9

2.3.3. Taking measurement

Important Notes

• Don’t eat, drink alcohol, smoke, take a shower or exercise

for at least 30 minutes before you take your blood pressure

and don’t use any medicines which could raise your blood

pressure.

• Try not to take your blood pressure if you are nervous

or upset. When nervous, anxious, or agitated your blood

pressure may rise.

• Rest for 5 to10 minutes before taking a reading. Sit in a

comfortable, relaxed position. Don’t move around or talk

while taking your blood pressure. Leave your legs in one

position, breathe freely and calmly.

• The blood pressure cu should fit over about 3/4 of your

upper arm. It should easily go around the arm and the

Velcro should close tightly.

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• If possible, use the same arm for every reading.

• Measuring blood pressure at the same time on dierent

days should give similar readings (disregarding outside

influences like exercise).

• Changes in medication or nutritional supplement can alter

your result. Please consult your doctor before taking or

stopping medications or supplements.

2.3.4. Fitting the cu

1) Plug in the air tube connector into the main unit

2) Wrap the cu around the upper left or right arm.

3) Tighten the cu around the arm, make sure the cu is

approximately 2 to 3cm (1 to 2 inches) above the elbow.

(Fig 10)

2~3cm

Air lube bladder located at the centre of the arm

Palm face up

Fig 10

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EN

Arm Blood Pressure Monitor

Monitor de Presión Sanguínea para Brazo | Medidor da Pressão Arterial de Braço

4) Make sure the cu’s air tube outlet is facing your finger.

Do not over tighten. Approximately one finger should be

able to fit underneath the cu after tightening.

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

the cu should be level with your heart. If the cu doesn’t

fit your arm, the reading accuracy may be aected.

• Do not bend with the cu or the air tube on.

• To detach the cu, unplug the air tube connector from the

main unit.

• Do not inflate prior to fitting the cu.

• Change the cu if it there is a leakage or if the cu is not

working properly.

• Only use the manufacturer cu provided to ensure the

measurement accuracy.

2.3.5. Body posture during measurement

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

cu should be at heart level (Fig 11). The reading accuracy

may be aected if the cu is not fitted properly. The arm

should be at the same level as 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.

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Arm should be at the same level as your heart

Fig 11

2.3.6. Taking Measurement

After installing the batteries and fitting the cu, the unit is

ready for measurement:

1) For the most accurate results please relax, do not smoke,

take a deep breath, speak loudly or move around during

the measurement.

2) Press the [ON/OFF] button; the display will light-up for 1

second as shown on Fig 12.

3) Then the display switches on as shown on Fig 13, 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 14. The cu inflates, and your pulse

and blood pressure measurement is taken.

5) When the test is completed, the cu will automatically

deflate and the test result will be displayed on the screen

as shown on fig 15 and the device will broadcast the result.

The pillar on the right side of the display will indicate

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