TESLA 1890095 Smart Blood Pressure Monitor User Manual

TESLA 1890095 Smart Blood Pressure Monitor

SAFETY INFORMATION

Please read the manual carefully before you use the unit and keep the manual well after using.

• 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.
• 2×199 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:

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 measured 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.

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 simultaneously 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.

CLASSIFICATION

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.

PRODUCT STRUCTURE

• Body
  

• Display
  

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.)

BATTERY INSTALLATION

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.

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.

• Adapter technical features:
  Output voltage: Type-C 5V±5%
  Output current: At least 600 mA
  

SETTING MODE

Note :

• When use USB adapter, the power of battery won‘t be consumed.
• 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.

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.

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 certain 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.

Measuring procedure

After the cuff has been appropriately positioned, the measurement can begin:

1. Press the START/STOP button, all symbols appear on the display, 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 irregular 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 2×199 sets measurements value, the oldest record will be replaced by the latest measurement value when more than 199 sets each user.

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 last 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
if 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.

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 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

Control the device

• Control blood pressure monitor with APP

Settings of users

• Device support Settings of 2 users.
• The ability to switch between user1/user2 and view the corresponding 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.

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.

• Systolic blood pressure
  

• Diastolic blood pressure
  

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

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

EXCEPTIONAL SITUATION

Error indicators
The following symbol will appear on the display when measuring abnormal.

Remeasure with correct way.
| Weak signal or pressure 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.

Trouble removal

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

Please contact the distributor if you can‘t solve the problem, do not disassemble the unit by yourself!

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 thoroughly, 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.

Maintenance

• 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.

SPECIFICATION

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:| 2×199 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

EMC Declaration

IEC 60601 -1 -2:2014 Tesla Smart Blood Pressure Monitor: identification, 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 applicable), 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 description 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. All necessary instructions for maintaining basic safety and essential performance regarding to electromagnetic disturbances 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
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 amateur 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
Guidance and manufacturer’s declaration – electromagnetic immunity

Radiated RF IEC61000- 4-3 (Test specifications for enclosure port immunity to RF wireless communications equipment)| Test Frequency (Mhz)| Band (MHz)| Service| Modulation| Mo- dula- tion (W)| Dis- tan- ce (m)| Im- muni- ty test level

(V/m)

385| 380-390| TETRA 400| Pulse modulation 18 Hz| 1.8| 0.3| 27
450| 430-470| GMRS 460
FRS 460| FM ±5 kHz
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 modulation 18 Hz| 2| 0.3| 28
1920
1845
1970| 1700-1990| GSM 1800/1900
1, 3, 4, 25; UMTS| Pulse modulation 217 Hz| 2| 0.3| 28
2450| 2400
2570| Bluetooth, WLAN, 802.11
b/g/n, RFID 2450, LTE
Band 7| Pulse modulation 217 Hz| 0.2| 0.3| 28
5240
5500
5785| 5100-
5800| WLAN
802.11 a/n| Pulse modulation 217 Hz| 0.2| 0.3| 9

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 authorisation and certification in line with the local and legislative regulations. Correct disposal and recycling help to minimise impacts on the environment and human health. Further information regarding disposal can be obtained from the vendor, authorised service centre or local authorities.

EU DECLARATION OF CONFORMITY
Hereby, Shenzen Urion Technology declares that the radio equipment type U82RH is in compliance with 2014/53/EU 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 Urion Technology Co.,Ltd.
Floor 4-6th of Building D , Jiale Science&Technology Industrial Zone, No.3
, ChuangWei Road ,Heshuikou Community,MaTian Street,GuangMing New District, 518106 Shenzhen, PEOPLE‘S REPUBLIC OF CHINA
Tel:（86 -755-29231308 E-mail:urion@urion.com.cn MADE IN CHINA

Customer Support

Eu representative
Shanghai International Holding Corp. GmbH
(Europe) Eiffestrasse 80, 20537 Hamburg,Germany
Tel:+49-40-2513175
Made for: Tesla Global Limited
www.teslasmart.com

References

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