Tesla TSL-HC-A310B User manual

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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.