Becken BBPM-3007W Medidor tensao pulso Manual do proprietário

INSTRUCTIONS MANUAL

MANUAL DE INSTRUCCIONES

MANUAL DE INSTRUÇÕES

Wrist Blood

Pressure Monitor

Monitor de Presión Sanguínea para Muñeca

Medidor da Pressão Arterial para Pulso

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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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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

INDEX

1. SAFETY INSTRUCTIONS 4

1.1. Humidity and Water 6

1.2. Cleaning 6

1.3. General Precautions 6

2. OPERATING INSTRUCTIONS 10

2.1. Blood Pressure Classification Chart 10

2.2. Product Description 12

2.3. Set-up 14

2.4. Troubleshooting 25

3. TECHNICAL SPECIFICATIONS 29

4. AFTERSALE SERVICE 31

5. ENVIRONMENTAL PROTECTION 31

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1. SAFETY INSTRUCTIONS

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.

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.

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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

To avoid hazards or deterioration of your appliance through incorrect use

it is advisable to read these instructions thoroughly.

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

Do not clean the unit with alcohol or other corrosive liquids.

Do not wet or clean the cu with water.

Clean the cu with soft dry cloth after measurement.

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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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

• 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 will lead to inaccurate results or

errors.

• Please take into account environmental variables, otherwise they may

lead to inaccurate measurement.

• When using or replacing the 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

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.

Precaution

• 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.

• Do not drop the device or expose to heavy shocks.

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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 newborns 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.

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC’s and mobile

(cellular) telephones, medical devices experience interference which may

result in incorrect operation of the medical device and create a potentially

unsafe situation.

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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

In order to regulate the requirements for EMC (Electro Magnetic

Compatibility) with the aim to prevent any 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

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2. OPERATING INSTRUCTIONS

2.1. Blood Pressure Classification Chart

Consider the blood pressure level classification and definition 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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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

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

• IEC 80601-2-30:2009+A1:2013 Medical electrical equipment -Part 2-30:

Particular requirements for the basic safety and essential performance

of automated non-invasive sphygmomanometers.

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

Part 2: Clinical validation of automated measurement type

Explanation of Symbols

LOT Symbol for “batch code”

Symbol of “manufacturer”

Symbol for “CE Conformity marking”

Symbol for “Follow operating instructions”

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IP22

Symbol for “the IP classification”

Symbol for “electrical and electronic equipment”

EC REP

Symbol for “AUTHORISED REPRESENTATIVE IN THE

EUROPEAN COMMUNITY”

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

LCD DISPLAY

SET

BATTERY COVER MEMORY

ON/OFF

Fig 1

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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

Cu Label (Type BF Applied Part)

Applicable Wrist Circumference: 135 mm to 215 mm

(135 - 215) mm

(10 - 15) mm

Fig 2

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Display

Blood Pressure Level Indicator

Heart Mark

Time

Pulse Rate

Low Battery

Memory

Memory 2

Memory 1

Pressure Unit

Diastolic

Systolic

Mean

Fig 3

2.3. Using the Product

Battery

Installation and Replacement

1) Remove battery cover.

2) Insert 2 standard AAA alkaline batteries.

3) Place back the battery cover.

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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

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 2 same brand 1.5 V AAA alkaline batteries and aware of the

polarity of batteries during installation.

• Do not mix the new and old batteries.

• Remove the batteries if the unit is to remain unused for an extended

period.

• Reset the time and date after battery replacement.

Fig 4

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Battery Life

• Two new LR03 (AAA) batteries will last for approximately 200

measurements, if measurements are taken once a day at room

temperature (23°C).

• The 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.

2.3.1. Set-up

1) With monitor power o, hold the [S] button for more than 1 second to

enter the “Year” setting, “Year” digits will start blinking; Press the [M]

button to modify;

2) Press the [M] memory button to advance one number; Hold down the

[M] memory button to change the number rapidly;

3) Enter the two digits of the year number; Press the [S] button to

confirm and enter the next setting;

4) Repeat step (2) to (3) to set month, day, hour and minutes; Press the

[S] button to confirm and enter the unit setting;

5) Press the [M] memory button to switch the unit (mmHg/kPa) as

shown on Fig 5 or Fig 6; Press the [S] button to confirm the unit;

6) Complete setting the unit, press [ON/OFF] button to exit.

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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

mmHg

0

20:00

kPa

0.0

20:00

Fig 5 Fig 6

2.3.2. Memory Data Conversion

The blood pressure monitor is capable of holding 2 sets of memory data.

Prior to using the blood pressure monitor, select the correct memory data.

Memory data conversion:

• With monitor power o, hold the [ON/OFF] button until the selected

Memory is displayed.

• Press the [ON/OFF] button to automatically change the memory data

conversion either from Memory 1 or Memory 2.

• The setting is completed, the machine is ready to use.

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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 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 to 10 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 wrist. It should easily

go around the wrist and the Velcro should close tightly.

• If possible, use the same wrist 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. Applying the wrist cu

1) Roll up your sleeve. Make sure your sleeve is not rolled up too tightly on

your arm. This may constrict the flow of blood in your arm.

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Wrist Blood Pressure Monitor | Monitor de Presión Sanguínea para Muñeca | Medidor da Pressão Arterial para Pulso

2) Wrap the cu directly against your skin. Do not apply the cu over

clothing. Place the cu over your left wrist with your left thumb facing

upward.

3) Position the cu leaving a clearance of approximately 10 to 15mm

between the cu and the bottom of your palm (Fig 7).

4) Hold the bottom part of the cu and wrap it around the wrist so it fits

comfortably and securely around your wrist (Fig 8).

5) Fold the remaining part of the wrist cu back out of the way.

6) If you cannot apply the cu on the left wrist, you also can take a

measurement using the right wrist position.

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(135 - 215) mm

(10 - 15) mm

Fig 7 Fig 8

2.3.5. Body posture during measurement

• Hold your wrist at the same level as your

heart as show on Fig 9. If your arm is too low, your

reading will be too high. If your arm is too high,

your reading will be too low.

• Keep your elbow firm to avoid body movement.

Sit still and do not talk or move during the

measurement.

• Do not use force on your fingers during the

measurement. Do not bend your wrist up or down

during measurement and do not clench your fist. Fig 9

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