Tesla Smart Oximeter Instrukcja obsługi

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USER MANUAL

TESLA SMART

OXIMETER

EN

CZ

SK

PL

HU

SL

DE

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THIS MEDICAL INSTRUMENT

MUST BE USED ACCORDING TO

INSTRUCTIONS TO ENSURE

ACCURATE READINGS

1. Power button

2. Display

3. SpO2 data

4. Bluetooth/Battery indicator

5. Pulse Rate data

6. Plethysmogram

7. Battery cover

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5

3

2

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1 SAFETY

1.1 Instructions for the Safe

Operation and Use of the

Tesla Smart Oximeter

• Do not attempt to service the Tesla

Smart Oximeter. Only qualiﬁed service

personnel should attempt any needed

internal servicing.

• Prolonged use or the patient’s condi-

tion may require changing the sensor

placement periodically. Change the

sensor placement and check sensor is

in contact with exposed skin, circulatory

status, and correct alignment at least

every 2 hours.

• Oxygen saturation (SpO2) measu-

rements may be adversely aﬀected in

the presence of high ambient light. The

sensor area should be shielded with a

surgical towel, plaster, or bandage if

necessary.

• The following factors may cause

interference to the testing accuracy of

the Tesla Smart Oximeter:

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• High-frequency electrosurgical

equipment.

• Placement of the sensor on an extre-

mity with a blood pressure impacted by

arterial catheter, or intravascular line.

• If the patient has severe hypotension,

vasoconstriction, severe anemia, or

hypothermia.

• If the patient is in cardiac arrest or

in shock.

• Fingernail polish or false ﬁngernails

may cause inaccurate SpO2 readings.

• The device should be given at least

10 minutes to come to normal working

temperature if stored in a hot or cold

environment.

• The device is non-sterile and not

intended to be sterilized.

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1.2 Warning

The MEDICAL ELECTRONIC

EQUIPMENT is suitable for home

healthcare environments:

• Although the medical electronic

equipment conforms to the intent of the

standard EN 60601-1-2 in relation to

electromagnetic compatibility, electrical

equipment may produce interference.

If interference is suspected, move the

equipment away from the sensitive

device.

• Portable and mobile RF commu-

nication equipment can aﬀect this

instrument’s normal operation.

• Explosion hazard -Do not use the

Tesla Smart Oximeter in a ﬂammable

atmosphere where concentrations

of ﬂammable anesthetics or other

materials may occur.

• Do not throw batteries in ﬁre as this

may cause them to explode.

• Do not attempt to recharge normal

dry-cell batteries, they may leak and

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may cause a ﬁre or even explode.

• Do not use the Tesla Smart Oximeter

in an MRI or CT environment.

• Do not modify this equipment without

the authorization of the manufacturer.

• If this equipment is modiﬁed, appro-

priate inspection and testing must be

conducted to ensure continued safe use

of equipment.

• Do not use near active high frequency

surgical equipment and the RF shielded

room of an medical electronic equip-

ment system for magnetic resonance

imaging, where the intensity of electro-

magnetic disturbances is high.

• 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.

•Use of accessories, transducers, and

cables other than those speciﬁed or

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provided by the manufacturer of this

equipment could result in increased

electromagnetic emissions or decreased

electromagnetic immunity of this equip-

ment and result in improper operation.

• Portable RF communications equi-

pment (including peripherals such as

antenna cables and external antennas)

should be used no closer than 30 cm

(12 inches) to any part of the Tesla Smart

Oximeter, including cables speciﬁed by

the manufacturer. Otherwise, it may re-

sult in a degradation of the performance

of this equipment.

• High-pressure sterilization cannot be

used on the device.

• IF ANY: a list of all cables and maxi-

mum lengths of cables (if applicable),

transducers and other accessories that

are replaceable by the responsible

organization and that are likely to aﬀect

compliance with the requirements of

clause 7 (emissions) and clause 8 (im-

munity). accessories may be speciﬁed

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either generically (e.g., shielded cable,

load impedance) or speciﬁcally (e.g., by

manufacturer and equipment or type

reference).

• IF ANY: the performance that was

determined to be essential performance

and a description of what the operator

can expect if the essential performance

is lost or degraded due to disturbances

(the deﬁned term “essential performan-

ce” need not be used).

Cautions:

• Keep the operating environment

free of dust, vibrations, corrosive, or

ﬂammable materials, and extremes of

temperature and humidity.

• Do not operate the unit, if it is damp or

wet because of condensation or spills.

Avoid using the equipment immediately

to a warm, humid location.

• Never use sharp or pointed objects to

operate the front-panel switches.

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• The batteries must be taken out from

the battery compartment if the device

will not be used for a long time.

• The device shall only be used with the

battery cover closed.

• The batteries must be disposed of

properly, according to local regulation

aer their use.

• Keep the device away from children

and pets to avoid swallowing.

2 INTRODUCTION

2.1 Intended use

The Tesla Smart Oximeter is a non-inva-

sive device intended for spot checking

of functional oxygen saturation of

arterial hemoglobin (SpO2) and pulse

rate (PR). This portable device is suitable

for non-professional adult patients of

any color in clinical institutions and

home environments.

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2.2 Brief Device Description

The Tesla Smart Oximeter is based

on digital technology. The device is

intended for non-invasive spot-check

measurement of functional oxygen

saturation of arterial hemoglobin

(SpO2). Advanced DSP algorithm can

minimize the inﬂuence of motion artifact

and improve measurement accuracy of

low perfusion.

The Tesla Smart Oximeter can be used

to measure human SpO2 and pulse

rate through the ﬁnger. The product is

suitable for private home-use, hospitals

(including clinical use in internist/

surgery, anesthesia, pediatrics etc.),

social medical organizations, physical

care in sports etc.

Note:

• DSP algorithm: Digital signal processor

algorithm.

• Low Perfusion: In physiology,

perfusion is the process of a body

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delivering blood to a capillary bed in its

biological tissue. Under the condition

of low perfusion, the measurement of

non-invasive saturation of pulse-blood

oxygen is not accurate.

2.3 Product Features

• Lightweight for easy carrying and use.

• Manually adjust the direction of

interface.

• Color OLED display, simultaneous

display for testing value and plethys-

mography.

• Visual & Sound reminder function.

Real-time spot-checks.

• Wireless Bluetooth for data trans-

mission.

• Low Battery voltage indicator.

• Automatic switch-oﬀ.

• Includes two standard AAA 1.5V

alkaline batteries.

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Note:

• Plethysmograph: is an instrument for

measuring changes in volume within an

organ or whole body (usually resulting

from ﬂuctuations in the amount of

blood or air it contains).

CAUTION: The device must not be

used on children below 3 years of age,

as it cannot be guaranteed to provide

accurate results.

CAUTION: The Tesla Smart Oximeter

is intended only as an adjunct in patient

assessment. It must be used in conjun-

ction with other methods of assessing

clinical signs and symptoms.

CAUTION: A function tester cannot be

used to assess the accuracy of the Tesla

Smart Oximeter monitor or sensor.

Clinical testing is used to establish the

SpO2 accuracy. The measured arterial

SpO2 value (SpO2) of the sensor is

compared to arterial hemoglobin

oxygen (SaO2) value, determined from

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blood samples with a laboratory CO-

oximeter. The accuracy of the sensors in

comparison to the CO-oximeter samples

measured over the SpO2 range of 70-100%.

Accuracy data is calculated using the root-

mean-square (Arms value) for all subjects.

Only about two--thirds of pulse oximeter

measurements can be expected to fall within

±Arms of the value measured by a CO-

oximeter. A pulse simulator shall be used to

assess pulse rate accuracy. The measured

pul-se rate is compared to the preset pulse

rate value in the simulator. Accuracy data is

calculated using the root-mean--square

(Arms value) for all subjects.

2.4 Expected Service Life

Is dependent on:

• The expected service life of the medical

electronic equipment;

• The expected service life of parts or acce-

ssories shipped with the medical electronic

equipment;

• Where the shelf life is less than the expect-

ed service life, the shelf life of parts or acce-

ssories shipped with the medical electronic

equipment;

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3 INSTALLATION, SETUP

AND OPERATION

3.1 OLED display parameter setting

When the device is in the measuring

interface, press the direction button for 1

second in order to enter the menu page

(ﬁgure 3.1.1 and ﬁgure 3.1.2). There are

two sub-menus.

3.1.1 Reminder Setup

Press the direction button for 1 second

and enter the Reminder Setup. User

can adjust the setting through moving

the “*” symbol to the Sound Reminder,

Beep, Restore or Brightness.

• Sound reminder

Press the direction button for 1 second,

move the “*” symbol to the “Sound

Reminder”, long press the direction

button to turn the alarm sound on/

oﬀ. If the measured value exceeds the

maximum or minimum value of SPO2 or

PR, there will be an alarm sound, if this

function is turned on.

• Beep

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Press the direction button for 1 second,

move the “*” symbol to the back of

“Beep”, long press the direction button

to turn the beep sound on/oﬀ. When

the beep is turned on, the sound

emitted during the test indicates the

pulse rate.

• Bluetooth

Press the direction button for 1 second,

move the “*” symbol to the back of

Bluetooth, long press the direction

button to turn it on/oﬀ.

• Restore

With the “*” symbol next to “Restore”,

long press the direction button. This

will change to “OK”, which restores the

device to factory settings.

• Brightness

With the “*” symbol next to “Brightness”,

long press the direction button to

change the Brightness value on a scale

from 1 to 5.

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3.1.2 Limit Value Setting

With the “ * ” symbol next to “Reminder

Setup”, long press the direction button

until the “Limit Setup” menu appears.

You can then press the direction button

to select the items. Press the direction

button for 1 second to change to the

data you need.

On the “Limit Setup” menu page, with

the “*” symbol next to “+/-”, press the

direction button for 1 second to change

the “+” to “-” or change the “-” to “+”.

When “+” shows on the right side,

by pressing the direction button for

1 second and moving the “ * ” next to

the Spo2 Hi or PR Hi setting, you can

increase the value to a higher value

(until it reaches the maximum).

When “-” shows on the right side, by

press the direction button for 1 second

and moving the “ * ” next to the Spo2

Lo or PR Lo value setting, you can

reduce the value to a lower value (until it

reaches the minimum).

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3.2 Operation

3.2.1 Installing batteries

Place two AAA batteries into the battery

compartment taking care to align the

polarities, then close the cover.

WARNING: Do not attempt to recharge

normal alkaline batteries, as they may

leak and may cause a ﬁre or even

explode.

3.2.2 Turning on and applying the

Tesla Smart Oximeter

Put one of your ﬁngers into the rubber

opening of the Tesla Smart Oximeter

with nail facing upward, then release the

clamp. Press the power button to turn the

Tesla Smart Oximeter on. The oximeter

will automatically turn oﬀ, if there is no

ﬁnger in the device for more than 16±2

seconds.

3.2.3 Read data from display screen

Display Description Show Note

OLED

Screen

The screen

display can

scroll

through

four

directions

with six

diﬀerent

display

modes by

pressing the

power

button.

1. When the

battery power

is at its lowest

level, the

battery symbol

will be shown,

reminding

users to

replace the

batteries.

2. The plethy-

mogram can

been

considered

accurate if the

wave symbol

is ﬂuctuating

regularly.

SpO2%

PR bpm

98

65

5.5

SpO2%

PR bpm

98

65

5.5

%SpO2

PR bpm

98

65

5.5

%SpO2

PR bpm

98

65

5.5

%SpO2

PR bpm

98

65

5.5

98

65

%SpO2

PR bpm

5.5

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4 APP OPERATION

4.1 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 co-

nnected to the 2.4Ghz network and have

Bluetooth & GPS location turned on.

4.2 Connect the device

• Open Tesla Smart app and click “+”

sign to Add new device

• Select Health care - Tesla Smart

Oximeter

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• Please follow the instructions to add

the Tesla Smart Oximeter step by step

on your phone

4.3 Control device

• Control oximeter with APP

5 CLEANING AND DISINFECTION

5.1 Cleaning

Switch oﬀ the power and take out the

batteries before cleaning. Keep the

exterior surface of the device clean and

free of dust and dirt. Clean the exterior

surface (display screen included) of

the unit with a so dry cloth. Use 75%

medical alcohol to clean the surface by

applying a small amount with a dry cloth

to avoid the alcohol entering the device.

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