TESLA Smart Oximeter Measures Hemoglobin Saturation User Manual

TESLA Smart Oximeter Measures Hemoglobin Saturation

THIS MEDICAL INSTRUMENT MUST BE USED ACCORDING TO INSTRUCTIONS TO ENSURE ACCURATE READINGS

OVERVIEW

1. Power button
2. Display
3. SpO2 data
4. Bluetooth/Battery indicator
5. Pulse Rate data
6. Plethysmogram
7. Battery cover

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 condition 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) measurements 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:
• High-frequency electrosurgical equipment.
• Placement of the sensor on an extremity 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.

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 communication 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 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, appropriate 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 electromagnetic 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 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.

• 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 Tesla Smart Oximeter, including cables specified by the manufacturer. Otherwise, it may result 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 maximum 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 (immunity). accessories may be specified 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 performance” 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.

• 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.

INTRODUCTION

Intended use

The Tesla Smart Oximeter is a non-invasive 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.

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 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.

Product Features

• Lightweight for easy carrying and use.

• Manually adjust the direction of interface. · Color OLED display, simultaneous display for testing value and plethy-s mography.

• Visual & Sound reminder function. Real-time spot-checks. · Wireless Bluetooth for data transmission.

• Low Battery voltage indicator. · Automatic switch-off. · Includes two standard AAA 1.5V alkaline batteries.
  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 conjunction 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 blood samples with a laboratory COoximeter. 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 COoximeter. 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.
  Expected Service Life Is dependent on:

• The expected service life of the medical electronic equipment;

• The expected service life of parts or accessories shipped with the medical electronic equipment;

• Where the shelf life is less than the expected service life, the shelf life of parts or accessories shipped with the medical electronic equipment;

INSTALLATION, SETUP AND OPERATION

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.

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 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.

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).

Operation

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.
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.
Read data from display screen

|

1. When the battery power is at its lowest level, the battery symbol will be shown, reminding users to replace the batteries.
2. The plethymogram can been considered accurate if the wave symbol is fluctuating regularly.

APP OPERATION

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.
  

Connect  the device

• Open Tesla Smart app and click “+” sign to Add new device · Select Health care – Tesla Smart Oximeter
• Please follow the instructions to add the Tesla Smart Oximeter step by step on your phone 4.3 Control device · Control oximeter with APP

CLEANING AND DISINFECTION

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.

Disinfection

multiple patients use the machine, e.g., in a hospital. Use 75% medical alcohol to clean the surface that was in contact with the patient. CAUTION: Do not use strong solvent, e.g., acetone. CAUTION: Never use an abrasive such as steel wool or metal polish. CAUTION: Do not allow any liquid to enter the product and do not immerse any part of the device in liquid. CAUTION: Avoid pouring liquid on the device while cleaning. CAUTION: Do not leave cleaning solution on the surface of the device. 6

TROUBLESHOOTING AND MAINTENANCE

Maintenance

Replace the batteries in a timely  manner, if the battery indication is low. Clean the surface of the oximeter before it is used for diagnosis of patients. Remove the batteries from the battery compartment if the oximeter will not be operated for a long time. It is best to store the product where the ambient temperature is between -25°C and 55°C and humidity is 15% to 93%. Regular inspection is recommended in order to make sure that no obvious damage is present that may affect the safety and performance of the device. Do not expose the device to flammable substances, high or low temperatures or humidity levels outside those in the operation conditions.

1. Finger is not inserted correctly.
2. Patient’s perfusion is too low to be measured.

|

1. Retry by inserting the finger thoroughly.
2. Try a few more times to make sure there is no problem with the product itself. Otherwise seek medical help for exact diagnos

Oxyhemoglobin or heart rate is unstable|

1. Finger might not be inserted correctly.
2. Finger is trembling, or patient‘s body is moving

|

1. Retry by inserting the finger thoroughly.
2. Try to help the patient keep calm and still.

Oxyhemoglobin or heart rate is outside of the standard range|

1. Finger might not be inserted correctly.
2. Patient’s SPO2 & PR is abnormal.

|

1. Retry by inserting the finger thoroughly.
2.  Seek medical help for further examination.

The oximeter cannot be turned on.|

1. Batteries may need replacement.
2. Batteries might be installed incorrectly
3. The oximeter might be damaged.

|

1.  Please replace batteries.
2. Please reinstall the batteries.
3. Please contact your point of purchase.

The screen suddenly turns off.|

1. The device automatically turns off, if there is no signal detected for more than 16 seconds.
2. Batteries may need replacement.

|

1. This is a normal process.
2. Replace the batteries.

SPECIFICATION

Device Name: Tesla Smart Oximeter Dimension (L×W×H): (62 × 34 × 31) mm Anti-electric Shock Type: Internally powered equipment Anti-electric Shock Equipment
Degree: Type BF EMC type: Group I Class B Enclosure
Degree of ingress protection: IP22 Internal Power: 2×AAA, 1,5V alkaline batteries Power consumption: Below 45mA Screen: 0.96′ OLED SpO2 Display: 35-100% Pulse rate
Display: 30-250 BPM Resolution: SpO2: 1 %
Heart rate: 1 BPM Measure
Accuracy: SpO2: ±3% (70%-100%);
Unspecified ( <70%) PR: ±2BPM Data averaging and other signal processing: 8s Data Update Period: 1s Operating
Environment: Temperature: +5°C to +40°C Humidity:15% to 93%, non- condensing
Air Pressure: 70Kpa-106Kpa
Storage & Transport Environment:
Temperature: -25C to +55C
Humidity: 15% to 93% non-condensing
Air Pressure: 70Kpa-106Kpa

CLINICAL SPO2 ACCURACY

The below table shows statistic distribution of an invasive controlled desaturation study, which guided by ISO80601-2-61, Annex EE, Guideline for evaluating and documenting SpO2 Accuracy in human subjects. The statistic distribution displayed the accuracy distribution between the range of 70% ~ 100%, which may be helpful to user.

Electromagnetic emissions

Emissions test| Compliance
RF emissions -CISPR 11| Group 1
RF emissions -CISPR 11| Class B
Harmonic emissions -IEC 61000-3-2| Not application
Voltage fluctuations/ flicker emissions -IEC 61000-3-3| Not application

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, ±8kV,  ±15 kV air
Electrical fast transient/burst IEC 61000-4-4| Power supply lines ±2 kVinput/ output lines ±1 kV| Not applicable
Surge IEC 61000-4-5| line(s) to line(s)±1 kV.; line(s) to earth±2 kV. 100 kHz repetition frequency| Not applicable
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11| 0% 0.5 cycle; At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º 0% 1 cycle; And 70% 25/30 cycles Single phase: at 0; 0% 300 cycles| Not applicable
Power frequency magnetic field IEC 61000-4-8| 30 A/m 50Hz/60Hz| 30 A/m

50Hz/60Hz

Conduced RF IEC61000-4-6| 150KHz to 80MHz: 3Vrms, 6Vrms (in ISM and amateur radio bands); 80% Am at 1kHz| Not applicable
Radiated RF -IEC61000-4-3| 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
Guidance and manufacturer’s declaration Electromagnetic Immunity

Radiated RF

IEC 61000-

4-3

(Test specifications for ENCLO- SURE PORT IMMUNI-

TY to RF wireless communications equip- ment)

| Test Frequency   (MHz)| Band (MHz)| Service| Modulation| Mo- dulati- on (W)| Dis- tan- ce (m)| Im- muni- ty test Level (V/m)
385| 380- 390| TETRA 400| Pulse Modulotion

18 Hz

| 1,8| 0.3| 27
450| 430- 470| GMRS 460, FRS 460|  FM ±5kHz deviation

1 kHz sine

| 2| 0.3| 28
710 745 780| 704- 787| LTE Band 13, 17| Pulse modulation 217 Hz| 0,2| 0.3| 9
810 870 930| 800-

960

| GSM 800/ 900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5| Pulse modula- tion 217 Hz| 2| 0.3| 28
1720 1845 1970| 1700 – 1990| GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band1,3,4, 25; UMTS| Pulse modula- tion 217 Hz| 2| 0.3| 28
2450| 2400 -2570| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450,

LTE Band 7

| Pulse modula- tion 217 Hz| 2| 0.3| 28
5240 5240 5785| 5100- 5800| WLAN 802.11 a/n| Pulse modulation 217 Hz| 0,2| 0.3| 9

MANUFACTURER’S EMC DECLARATION

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the expected service life. 2) Guidance and manufacturer’s declaration -Electromagnetic Emissions and Immunity.

INFORMATION ABOUT DISPOSAL AND RECYCLING

This product is marked with the symbol for separate collection. The product must be disposed of in accordance with the regulations for disposal of electrical and electronic equipment (Directive 2012/19/EU on waste electrical and electronic equipment). Disposal together with regular municipal waste is prohibited. Dispose of all electrical and electronic products in accordance with all local and European regulations at the designated collection points which hold the appropriate authorization and certification in line with the local and legislative regulations. Correct disposal and recycling help to minimize impacts on the environment and human health. Further information regarding disposal can be obtained from the vendor, authorised service center or local authorities.

EU DECLARATION OF CONFORMITY

Hereby, Tesla Global Limited declares that the radio equipment type A310B is in compliance with 2014/53/UE directives. The full text of the EU declaration of conformity is available at the following internet address: tsl.sh/doc
Connectivity: Bluetooth
Frequency band: 2.412 – 2.472 MHz
Max. radio-frequency power (EIRP): < 20 dBm

Shenzhen Aeon Technology Co., Ltd .
RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong, No.133
ofYiY.uan road, Nantou Street, Nanshan District, 518052, Shenzhen,
PEOPLE’S REPUBLIC OF CHINA
I EC I REP I Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Manufactured for:
Tesla Global Limited
www.teslasmart.com

References

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