Tesla 1890095 Používateľská príručka

1

USER MANUAL

TESLA SMART BLOOD

PRESSURE MONITOR

EN

CZ

SK

PL

HU

SL

DE

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Please read the manual carefully before you use the unit and

keep the manual well after using.

SAFETY INFORMATION

• Your new digital blood pressure monitor uses the oscillometric

method of blood pressure measurement. This means the monitor

detects your blood´s movement through your brachial artery and

converts the movements into a digital Reading. An oscillometric

monitor does not need a stethoscope, so the monitor is simple

to use.

• Intelligent inflation will reduce the uncomfortable feeling by

incorrect inflation, and shorten the measurement time, prolong

the cuff ‘s usage lifetime.

• 2x199 sets memory function each measurement result will

be displayed on the screen and automatically stored. This unit

has blood classification index, could easy to check your blood

pressure.

• This automatic blood pressure monitor could measure the

systolic pressure diastolic pressure and pulse, the components

are included the body, cuff and printed instruction manual. This

unit is intended for adult use.

INTENDED USE

The automatic blood pressure monitor intended to measure

the systolic pressure, diastolic pressure, and pulse rate through

upper arm. They are expect used in the home, and hospital,

intended for over 12 years old adult using.

Contraindication

This product can‘t be used in patients who is with severe heart

insufficiency to avoid suffocation and death. This product is not

suitable for infants and children.

• To assure the correct use at the product, basic safety measures

should always be followed including the warning and the caution

listed in the instruction manual:

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WARNING: This alert identities hazards that may cause

serious personal injury or death.

CAUTION: This alert identities hazards that may cause

minor personal injury. product damage, or property damage.

Those who have arrhythmia, diabetes, blood circulation or

apoplexy problem please use under the physician‘s instruction.

Contact your physician for speciﬁc information about your

blood pressure. Self-diagnosis and Treatment which use mea-

sured results may be dangerous. Follow The instructions of your

physician or licensed healthcare provider.

Please place on a high place where it can’t be touched by

children.

No modification of this equipment is allowed.

Do not modify This equipment without authorization of the

manufacturer.

If this equipment is modified, appropriate inspection and

testing must be conducted to ensure continued safe use of

equipment.

The cuff hose around the neck may cause the suffocation.

The swallowing of small part like packing bag, battery,

battery cover and so on may cause the suffocation.

Please don’t use a dilution agent, alcohol or, petrol to clean

the unit. Please don’t hit heavily or fall down the product from a

high place. Use The right cuff, otherwise, it cannot work.

Never leave any low battery in the battery compartment

since they may leak and cause damage To The unit.

Please take off the battery if you won’t use device in 3

months.

Replace The new batteries if the unit displays a low battery

symbol.

Do not mix the old and new batteries.

Please avoid using in a high radiant area to make your

measuring data correctly.

SAFETY INFORMATION

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Do not use the equipment where flammable gas (such as

anesthetic gas, oxygen, or hydrogen) or flammable liquid (such

as alcohol) is present.

Do not touch the output of the AC adapter and the patient

simultaneously.

Do not touch the live end of battery and the patient simulta-

neously when changing the batteries.

WARNING

Do not dispose at electrical appliances as unsorted municipal

waste, use separate collection facilities. Contact your local

government for information regarding the collection systems

available. If electrical appliances are disposed at in landﬁlls or

dumps, hazardous substances can leak into the groundwater and

get into the food chain, damaging your health and well-being.

1. Internally powered equipment;

2. Type BF applied part;

3. Protection against ingress of water or Particulate matter: IP21;

4. Not category AP /APG equipment;

5. Mode of operation: Intermittent operation;

The user must check that the equipment functions safely and

see that it is in proper working condition before being used.

CLASSIFICATION

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Body

Display

Wide range Cuff

Cuff Connector

Air Socket for

Cuff Connector

User button

Memory button

Setting button

Start/Stop button

Type-C

PRODUCT STRUCTURE

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The accessories cuff is L size, for upper-arm circumference 22-

42cm use. The cuff is treated as the applied part.

Insert the connector with cuff tube into the hole which is on the

left side of the device as picture. (Only provided cuff can be

used, cannot change to any other branded cuff.)

Remove the battery cover from the battery compartment and

insert the battery.

a) Remove the battery cover as picture showed.

b) Insert 4 AAA powerful batteries into the compartment and

ensure each battery is in the proper direction.

BATTERY INSTALLATION

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Low battery and replacement

When power on an the low battery symbol “ ” will display

you must replace old batteries with new batteries, otherwise the

unit can‘t work.

Battery type and replacement

Please use 4pcs AAA identical 1.5V alkaline batteries. Do Not

use the batteries beyond their expiry date. Please remove the

batteries if you do not need to use device for a long Time.

WARNING

Dispose of the battery in accordance with all federal, state and

local laws. To avoid tire and explosion hazards, do Not burn or

incinerate the battery.

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Adapter technical features:

Output voltage: Type-C 5V±5%

Output current: At least 600 mA

Note:

-When use USB adapter, the power of battery won‘t be consu-

med.

-When suddenly stop during measurement (like the plug off from

the outlet by carelessness), it must be reinserted the plug into the

unit, and restart the measurement.

User setting

Press button when power off, the screen will display or,

press button, it will be changed between “ ” and “ ”,

press button START/STOP when you confirm the user.

Unit setting

Press button SET when power on, the screen will display 0 or

0.0, then press button MEM, it will be changed between kPa or

mmHg. Press button SET when you conﬁrm the unit.

SETTING MODE

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PROPER USE OF THE UNIT

Measurement

Pre-measurement

• Relax for about five to ten minutes prior to the measurement

Avoid eating, drinking alcohol, smoking, exercising, and bathing

for 30 minutes before taking a measurement.

All these factors will influence the measurement result.

• Remove any garment that tits closely to your upper arm.

• Always measure on the same arm (normally left).

• Take measurement regularly at the same time of every day, as

blood pressure changes even during the day.

Common factors of wrong measurement

• All efforts by the patient to support their arm can increase

blood pressure.

• Make sure you are in a comfortable, relax position and do

not activate any of the muscles in the measurement arm during

measurement. Use a cushion for support if necessary.

• It the arm artery lies lower or higher than the heart, a false

reading will be obtained.

Note

• Only use clinically approved cuffs!

• A loose cuff or an exposed bladder causes a false reading.

• With repeated measurements, blood accumulates in the arm

which can lead to false reading,

Consecutive blood pressure measurements should be repeated

after a 1-minute pause or after the arm has been held up to allow

the accumulated blood to flow away.

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Fitting the CUFF

1). Put the cuff on a table flatly with the velcro side

down. Pass The end of the cuff Through The metal

loop so that a circle is formed. The velcro closer will

now be facing outwards (ignore

this step if the cuff has already been prepared).

2). Push The cuff over the left upper arm so that the

tube points in the direction of the lower arm.

3). Wrap The cuff on the arm as illustrated. Make cer-

tain that the lower edge of the cuff lies approximately

2 To 3cm above the elbow and the rubber tube leaves

the cuff on the inner side of the arm.

4). Tighten The free end of the cuff and close the cuff

by affixing the velcro.

5). The cuff should be snug on your upper arm so that

you can fit 2 fingers between the cuff and your upper

arm. Any piece of clothing restricts the arm which must

be taken off.

6). Secure The cuff with the velcro closer in such a

way that it lies comfortably and not too tight. Lay your

arm on a table (palm upwards) so that the cuff is at the

same height as the heart. Do not bend the tube.

Note

If it is not possible to fit the cuff to your left arm, it can also be

placed on the right hand. However, all measurements should be

made using the same arm.

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Measuring procedure:

After the cuff has been appropriately positioned, the measure-

ment can begin:

1). Press the START/STOP button, all symbols appear on the dis-

play, then the pump begins to inflate the cuff, the rising pressure

in the cuff is shown on the display.

2). Atter the suitable pressure has been reached, the pump stops,

and the pressure gradually falls. The cuff pressure is displayed. ln

base that the inflation is net sufficient, the device automatically

re—inflates to a higher pressure.

3) When the device detects the signal, the heart symbol on the

display starts to ﬂash.

4). The measurement readings remain on the display until you

switch off the device. If no button is pressed for a period of 3

minutes, the device switches off itself to save the power.

Note

the symbol ” ” is displayed with the reading only if an irregu-

lar heartbeat is detected during the measurement.

Discontinuing a measurement

If it is necessary to interrupt a blood pressure measurement for

any reason (e.g., the patient feels unwell), the START/STOP

button can be pressed at any time. The device immediately

decreases the cuff pressure automatically.

Memory-recall of measurements

This blood pressure monitor automatically stores 2x199 sets

measurements value, the oldest record will be replaced by the

latest measurement value when more than 199 sets each user.

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Read memory record

Press the button MEM when power Off, the latest 3 times

average value will be shown, press the button MEM again, the

Iast measurement value will be shown, as well as subsequent

measurements can be displayed one after the other by pressing

the button MEM each time.

Memory -clear of measurements

lf you are sure that you want to permanently remove all stored

memories. Press the button SET for 2 times until CL appears

when power off, press the START/STOP button, CL will ﬂash for

4 times to clear all the memories. After this press button MEM,

and “no“ will be shown on the display which means that no

memory in-store.

1 Preparation for use

• Tesla Smart is available for both iOS and Android OS. Search

the name ‚Tesla Smart‘ in App Store or Android Market or scan

the QR-Code to download the App and register or login your

account.

• Make sure that the smartphone is connected to the 2.4Ghz

network and have Bluetooth & GPS location turned on.

APP OPERATION

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2 Connect the device

• Open Tesla Smart app and click “+” sign to Add new device

• Select Health care - Tesla Smart Blood Pressure monitor

• Please follow the instructions to add the Tesla Smart Blood

Pressure monitor step by step on your phone

• Long press the „SET“ button of the blood pressure monitor, the

monitor will display the word „bt“ and enter the Bluetooth pairing

mode

3 Control the device

• Control blood pressure monitor with APP

4 Settings of users

• Device support Settings of 2 users.

• The ability to switch between user1/user2 and view the corre-

sponding user data are shown directly in the main APP interface.

• You can switch users both on the device and in the app

• When you are connected to the Tesla Smart app, after the

blood pressure monitor has finished measuring, the app switch

users automatically and the monitor will follow to synchronize

the app‘s user settings.

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ABOUT BLOOD PRESSURE

Blood pressure is the pressure exerted the arteries,

The systolic blood pressure value represents the blood pressure

produced by contraction of the heart muscle.

The diastolic blood pressure value represents the blood pressure

produced by relaxation of the heart muscle.

• According to the blood pressure classification by the WHO/ISH.

• SYS lower than 100 mmHg (13.3kPa) is considered as hypotension.

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EXCEPTIONAL SITUATION

Trouble removal

Error indicators

The following symbol will appear on the display when measuring

abnormal.

Please contact the distributor if you can‘t solve the problem, do not disassemble

the unit by yourself!

Symbol Cause Correction

Weak signal or pres-

sure change suddenly

Wrap the cuff properly.

Remeasure with correct way.

Weak signal or pres-

sure change suddenly

When near cell phone or other high

radiant devices the measurement will

be failed.

Keep quiet and no chatting when

measure.

It appears error during

the

process of inflating

Wrap the cuff properly.

Make sure that the air plug is properly

inserted in the unit.

Remeasure.

Abnormal blood

pressure

Repeat the measurement after relaxing

for 30 mins, if get unusual readings for 3

times please contact your doctor.

Low battery Replace all the worn batteries with new

ones.

Problems Check Cause and solutions

No power Wrap the cuff properly. Replace a new one

Check the polarity position Installation for proper placement

of the battery’s polarities

No inflation Whether the plug insert Insert into the air socket tightly

Whether move the arm when

inflating Change a cuff

Err and stop

working

Check if chatting when

measured Keep the body peaceful

Whether the cuff wrap too

loose Keep quiet when measuring

Cuff leak Whether the cuff broken Wrap the cuff tightly

Replace all the worn batteries

with new ones. Change a new cuff

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CARE AND MAINTENANCE

Care for the main unit and blood pressure monitor cuff

• Keep the unit in the storage case when no use.

• Clean the unit with soft dry cloth.

• Do not use any abrasive or volatile cleaners.

• Never immerse the unit or any component in water.

• Make sure the monitor is off prior to cleaning, a mixture of

distilled water and 10 percent bleach could be used.

• Using a spray bottle, moisten a soft cloth towel with the bleach

or detergent mix until it is fully saturated. Squeeze any excess

moisture from the cloth to avoid any dripping or potential over

saturation of the cuff.

• Wipe all surfaces at the blood pressure monitor cuff thorou-

ghly, making sure to clean the inside and outside of the cuff. Be

cautious not to get any moisture in the main unit.

• Using a dry cloth, gently wipe away any excess moisture that

may remain on the blood pressure cuff. Lay the cuff flat in an

unrolled position and allow the cuff to air dry.

• 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

• Store the unit in a clean and dry location.

• Do not subject the unit to extreme hot or cold temperature,

humidity, and direct sunlight

• Remove the batteries it the unit will not be used in 3 months or

longer.

Maintenance

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Description: Automatic upper arm blood pressure monitor

Display: LED digital display

Measuring principle: Oscillometric method

Measuring location: Upper arm

Measurement range:

Pressure: O~299mmHg

Pulse: 40~199 pulses/mm

Accuracy: Pressure: ±3mmHg

Pulse: ±5% of reading

LED indication: Pressure: 3 digits display of mmHg

Pulse: 3 digits display

Symbol: Memory/Heartbeat/low battery

Memory function: 2x199 sets memory of measurement values

Power source: 4pcs AAA alkaline battery/Type-C 5V

Automatic power off: in 3 minutes

Main unit weight: Approx.260g (batteries not included)

Main unit size: 138mm x 100mm x 62mm

Main unit lifetime: 10 000 times under normal use

Battery life: Could be used for 300 times for normal

condition

Accessories: Cuff, instruction manual

Operating environment: Temperature: 5°C~40°C

Humidity: 15%~93%RH

Air pressure: 86kPa~106kPa;

Storage environment: Air pressure: 86kPa~106kPa;

Temperature:-20°C~55°C; Humidity:

10%~93%RH;

avoid crash, sun burn or rain during trans-

portation

Expected service life 5 years

SPECIFICATION

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EMC Declaration

IEC 60601 -1 -2:2014 Tesla Smart Blood Pressure Monitor: iden-

tification, marking and documents for Class B product

Instructions for use

The Tesla Smart Blood Pressure Monitor is suitable for home

healthcare environments and so on.

Warning: Don‘t hear active HF surgical equipment and the RF

shielded room of a system for magnetic resonance imaging,

where the intensity of EM disturbances is high.

Warning: Use of this equipment adjacent to or stacked with

other equipment should be avoided because it could result in

improper operation. If such use is necessary, this equipment and

the other equipment should be observed to verify that they are

operating normally,

Warning: Use of accessories, transducers and cables other

than those specified or provided by the manufacturer of this

equipment could result in increased electromagnetic emissions

or decreased electromagnetic immunity of this equipment and

result in improper operation.

Warning: Portable RF Communications equipment (including

peripherals such as antenna cables and external antennas)

should be used no closer than 30 cm (12 inches) to any part of

the blood pressure monitor, including cables specified by the

manufacturer. Otherwise, degradation of the performance of this

equipment could result.

If any: a list of all cables and maximum lengths of cables (if appli-

cable), transducers and other accessories that are replaceable

by the responsible organization and that are likely to affect Tesla

Smart Blood Pressure Monitor with the requirements of Clause

7 (EMISSIONS) and Clause 8 (IMMUNITY). Accessories may

be specified generically (e.g., Shielded cable, load impedance)

or specifically (e.g., by manufacturer and equipment or type

reference].

If any: the performance of Tesla Smart Blood Pressure Monitor

that was determined to be essential performance and a descrip-

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tion of what the operator can expect if the essential performance

is lost or degraded due to EM disturbances (the defined term

“essential performance „ need not be used).

Technical description

1. AII necessary instructions for maintaining basic safety and

essential performance regarding to electromagnetic disturban-

ces for the excepted service life.

2. Guidance and manufacturer’s declaration - electromagnetic

emissions and immunity.

Guidance and manufacturer’s declaration -

electromagnetic emissions

Emissions test Compliance

RF emissions CISPR 11 Group 1

RF emissions CISPR 11 Class B

Harmonic emissions IEC

61000-3-2

Class A

Voltage fluctuations/ ﬂicker

emissions IEC 61000-3—3

Compliance

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Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity Test IEC 60601-1-2 Test level Compliance level

Electrostatic discharge

(ESD) IEC 61000-4-2

±8 kV contact, ±2 kV, ±4

kV, ±8 kV, ±15 kV air

±8 kV contact ±2

kV, ±4 kV, ±8 kV,

±15 kV air

Electrical fast transient/

burst IEC 61000-4-4

Power supply lines:

±2kV 100 KHZ repetition

frequency

Power supply

lines ±2kV 100

kHz repetition

frequency

Surge IEC 61000-4-5 line[s] to line ±1 kHz line(s) to line(s)

±1 kV

Voltage dips, short

interruptions and voltage

variations on power supply

input lines IEC 31000-4-11

0% 0.5 cycle at 0°, 45°,

90°, 135°, 180°, 225°, 270°

315° 0% 1 cycle and 70%

25/30 cycles single phase:

at 0 0% 300 cycles

0% 0.5 cycle at

0°, 45°, 90°, 135°,

180°, 225°, 270°

315° 0% 1 cycle

and 70% 25/30

cycles single

phase: at 0 0%

300 cycle

Power frequency magnetic

field IEC 61000-4-8

30 A/m, 50Hz/60Hz 30 A/m,

50Hz/60Hz

Conduced RF IEC 61000-

4-6

150 kHz 80 MHz 3Vrms

6Vrms (in ISM and amateur

[ln ISM and amateur radio

bands) 80% Am at 1kHz

150 kHz 80 MHz

3Vrms 6Vrms (in

ISM and amateur

[ln ISM and ama-

teur radio bands)

80% Am at 1kHz

Radiated RF IEC 61000-

4-3

10 V/m 80 MHz-2,7 GHz

80% AM at 1 kHz

10 V/m 80 MHz-

2,7 GHz 80% AM

at 1 kHz

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Tesla 1890095 Používateľská príručka

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