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Text - Dr Trust USA Afib Talk - Atrial Fibrillation BP Monitor

Measurement Principle- MDI Technology

Dr Trust BP Check with MDI is a BP monitor with Measurement During Inflation (MDI) technology. MDI is a new technology which is faster and gives extra comfort to the arm of the patient.  This product uses the Oscillometric Measuring method to detect  blood pressure during inflation and hardly creates any pressure on the arm. It allows accurate consecutive blood pressure measurements on the upper arm with minimal deviation. Better accuracy is ensured in case of repeated measurements. It measures diastolic blood pressure first during inflation and gives instant result without deflating. It classifies measurements according to the WHO evaluation system using Traffic-Light Colour scale. Also, allows for immediate repeat measurement for comparison with least difference.

Key Features of Dr Trust BP Checkwith MDI

  • The device is intended for self-use in
  • The device offers very high and clinical tested measurement accuracy.It has been designed to provide a maximum of user-friendliness.
  • BP measurement can be performed using either the right or left arm.
  • The arm cuff is inflated around the arm by pressing the START/STOP button and deflationspeed is automatically controlled.
  • Easy to operate as no special adjustment is required.
  • Justinsert your arm into the arm insertion section to the shoulder and press the START/STOP button. The rest of the procedure is done automatically for a quick and easy measurement of blood 
  • It is a fully automatic, digital, blood pressure measuring device with MDItechnology and a large LCD screen.
  • It provides a fast and reliable measurement of systolic and diastolic blood pressure as well as heart rate usingthe oscillometric measurement method.
  • It displays pulse irregularities measuredduring a blood pressure reading. However, if the irregularity appears several times a week with measurement taken daily, we advise you to consult your doctor.
  • Hypertension Classification Indicator displays the range between which your blood pressurevalues lie.
  • Memory feature allows to store 2 users, 112blood pressure readings with time and date.

1.3. Important Information About Self-Measurement

  • Substitution of a different component might result in measurement error.
  • Cuffis replaceable only by an
  • Do not use with neonatal patients.
  • Do not intend to use with pregnant or pre-eclamptic patients
  • It will cause harmful injury to the patient or affectthe blood pressure due to connection tubing kinking.
  • Too frequent measurements can cause injury to the patient due to blood flow interference.
  • The application of the cuff over a wound can cause further injury.
  • The application of the cuff and its pressurization on any limb where intravascular access or therapy, or an arteriovenous (A-V) shunt, is present because of temporary interference to blood flowand could result in injury to the patient.
  • Do not let the cuffpressure you on the arm which is on the side of a mastectomy.
  • Pressurization of the cuffcan temporarily cause loss of function of simultaneously used monitoring ME equipment on the same limb.
  • You need to check theoperation of the automated sphygmomanometer does not result in prolonged impairment of patient blood circulation.
  • Not intended to be used together with HF surgical equipment.

Attention! 

Points To Be Noted 

  • Self-measurement means control, not diagnosis or treatment.
  • Unusual values must always be discussed with your doctor.  
  • The pulse display is not suitable for checking the frequency of heart pacemakers.
  • In cases of cardiac irregularity (Arrhythmia), measurements made with this instrument should only be evaluated after consultation with the doctor.
  • For further questions on the subject of blood-pressure and its measurement, please contact your doctor.

Electromagnetic Interference

The device contains sensitive electronic components (Microcomputer). Therefore, avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave cookers). These can lead to temporary impairment of the measuring accuracy.

  1. IMPORTANT INFORMATION ON THE SUBJECT OF BLOOD-PRESSURE AND ITS MEASUREMENT

2.1. What Causes High Blood Pressure?

While the cause of high blood pressure in most people remains unclear, inactivity, poor diet, obesity, older age, and genetics -- can all contribute to the development of hypertension.

2.2. How does high/low blood-pressure problem arise?

The level of blood-pressure is determined in a part of the brain, the so-called circulatory centre, and adapted to the respective situation by way of feedback via the nervous system. To adjust the blood-pressure, the strength and frequency of the heart (Pulse), as well as the width of circulatory blood vessels is altered. The latter is effected by way of fine muscles in the blood-vessel walls. The level of arterial blood-pressure changes periodically during the heart activity: During the «blood ejection» (Systole) the value is maximal (systolic blood-pressure value), at the end of the heart’s «rest period» (Diastole) minimal (diastolic blood-pressure value). The blood-pressure values must lie within certain normal ranges in order to prevent particular diseases. 

2.3. What Is Systolic and Diastolic Blood Pressure?

The blood pressure reading is measured in millimeters of mercury (mmHg) and is written as systolic pressure, the force of the blood against the artery walls as your heart beats, over diastolic pressure, the blood pressure between heartbeats. For example, a blood pressure reading is written as 120/80 mmHg, or "120 over 80". The systolic pressure is 120 and the diastolic pressure is 80.

2.4. What Health Problems Are Associated With High Blood Pressure?

Hypertension contributes to several serious health conditions. Atherosclerosis, Heart Diseases or Heart Failure, Stroke, Kidney Disease and Eye Disease are few among several potentially serious health conditions which are linked to high BP.

2.5. Which values are normal? 

Blood pressure is too high if at rest, the diastolic pressure is above 90 mmHg and/or the systolic blood-pressure is over 160 mmHg. In this case, please consult your doctor immediately. Long-term values at this level endanger your health due to the associated advancing damage to the blood vessels in your body. If the systolic blood-pressure values lie between 140 mmHg and 160 mmHg and/or the diastolic blood-pressure values lie between 90 mmHg and 100 mmHg, likewise, you need to consult your doctor. Furthermore, regular self-checks will be necessary.

With blood-pressure values that are too low, i.e. systolic values under 100 mmHg and/or diastolic values under 60 mmHg, likewise, please consult your doctor. Even with normal blood-pressure values, a regular self-check with your blood-pressure monitor is recommended. In this way you can detect possible changes in your values early and react appropriately. If you are undergoing medical treatment to control your blood pressure, please keep a record of the level of your blood pressure by carrying out regular self-measurements at specific times of the day. Show these values to your doctor.

 

Table for classifying blood-pressure values (unit: mmHg) according to World Health Organization:

Range & broadcasting

Systolic Blood-pressure

DiastolicBlood-pressure

Measures

Hypotension

lower than 100

lower than 60

Consult your doctor

Optimal BP

between 100 and 120

between 60 and 80

Self-check

Normal BP

between 120 and 130

between 80 and 85

Self-check

High To Normal BP

between 130 and 140

between 85and 90

Consult your doctor

Slight Hypertension

between 140 and 160

Between90and 100

Seek medical advice

Medium Hypertension

between 160 and 180

Between100and 110

Seek medical advice

Strong Hypertension

Higher than 180

Higher than 110

Urgently seek medical advice!

 

Further Information

  • If your values are mostly standard under resting conditions but exceptionally high under conditions of physical or psychological stress, it is possible that you are suffering from so-called «labile hypertension». Please consult your doctor if you suspect that this might be the case.
  • Correctly measured diastolic blood-pressure values above 120mmHg require immediate medical treatment.

Attention!

To BE Noted

Never use the results of your measurements to alter independently the drug doses prescribed by your doctor.

  1. THE VARIOUS COMPONENTS OF THE BLOOD-PRESSURE MONITOR
  1. PUTTING THE BLOOD-PRESSURE MONITOR INTO OPERATION

4.1 Inserting the batteries

  1. a) Insert the batteries (4 x size AA 1.5V), afterobserving the indicated polarity.
    b) This is lowbattery  icon. It is warning symbol that appears in the display when the batteries remain 20%.
  2. c) If the battery warningicon appears in the display, it means the batteries are empty and must be replaced by new ones.

Attention!

To be Noted

  • After the battery warningicon appears, the device is blocked until the batteries have been replaced.
  • Please use «AA»Long-Life or Alkaline1.5V Batteries.
  • The use of 1.2V Accumulators is not recommended.
  • If the blood-pressure monitor is left unused for a long period, please remove the batteries from the device.

4.2 Reading The Set Date

Please press the TIME button and the date will be shown in the display.

4.2 User Selection And Setting The Time / Date

User selection: This advanced blood pressure monitor allows you to track blood pressure readings for 2 individuals independently. 

  1. Before measurement, make sure you set the unit for the intended user. The unit can track results for 2 individuals.
  2. b) Press the TIME button for at least 3 seconds. The display now indicates the set user, during which the set user blink, to confirm, press ON/OFFbutton
  3. c) Click the MEMORY button to select User

Setting The Time & Date

This blood-pressure monitor incorporates an integrated clock with date display. This has the advantage, that at each measurement procedure, not only the blood-pressure values are stored, but also the exact moment of the measurement. After new batteries have been inserted, the clock originally displays DATE as 1-01 and TIME as 12:00. You must then re-enter the date and current time. For this, please proceed as follows.

  1. Firstly, press the TIME button for at least 3 seconds then, user icon will blink. Then press TIME button again the display now indicates the set year, during which the four characters blink.
  2. The correct year can be entered by pressing the MEMORY button.
  3. Press the TIME button again. The display now switches to the current date, during which the first character (month) blinks.
  4. The corresponding month can now be entered by pressing the MEMORY button.
  5. Press the TIME button again. The last two characters (day) are now blinking
  6. The corresponding day can now be entered by pressing the MEMORY button.
  7. Press the TIME button again. The display now switches to the current time, during which the first character (Hour) blinks
  8. The corresponding hour can now be entered by pressing the MEMORY button.
  9. Press the TIME button again. The last two characters (Minutes) now blink.
  10. The exact time can now be entered by pressing the MEMORY button
  11. Press TIME button (or TIME / DATE or TIME): the unit of measurement will flash.  
  12. Press the "MEMORY to set the unit of measurement (mmHg or kPa)   
  13. Once you have made your settings, press the TIME button (or TIME / DATE or TIME). The setting is confirmed and the clock starts running.
  14. Now after all settings have been made, press the TIME button once again. The date is briefly displayed and then the time. The input is now confirmed and the clock begins to work.

Attention!  

To Be Noted

With each press of the button (TIME, MEMORY) one input is made (e.g. switching over from hours to minutes mode, or altering the value by +1). However, if you keep the respective button pressed, you can switch more quickly to find the desired value respectively.

  1. CARRYING OUT A MEASUREMENT
  • Before the Measurement

To ensure a reliable reading follow these recommendations:

  • Avoid eating, drinking alcohol, bathing, smoking as well as all forms of exertion directly beforetaking the measurement as all these factors influence the measurement result.
  • Try to rest for 15-30 minutes by sitting in an armchair in a quite atmosphereprior to taking a measurement.
  • Always take measurements in a quiet place.
  • Stress raises blood pressure. So don’t takemeasurements during stressful times.
  • Measure always on the same arm (preferably left).
  • Attempt to carry out the measurements regularly at the same time of day, since the blood-pressure changes during the course of the day.
  • Avoid wearing tightclothing on your arm.
  • Do not talk, just remain still during the measurement.
  • Thecuff (arm) should be at the same level as your heart.

Attention!

To Be Noted

Comparable blood-pressure measurements always require the same conditions! These are normally always quiet conditions.

Common Sources Of Error

  • All efforts by the patient to support the arm can increase the blood-pressure. Make sure you are in a comfortable, relaxed position and do not activate any of the muscles of the measurement arm during the measurement. Use a cushion for support,if necessary.
  • The performance of the automated sphygmomanometercan be affected by extremes of temperature, humidity and altitude.
  • Avoid compression or restriction of the connection tubing.
  • A loose cuff causes false measurement values.
  • With repeated measurements, blood accumulates in the respective arm, which can lead to false results. Correctly executed blood-pressure measurements should therefore first be repeated after a 5 minute pause or after the arm has been held up in order to allow the accumulated blood to flow away (after at least 3 minutes).

4.2. Fitting the cuff

Insert air connector into air outlet shown in left photo and  make sure the air connector is fitted properly to avoid air leakage. 

Positioning the Cuff on The Arm Correctly

  1. The distance between the edge of cuff and the elbow should be approx 2~3cm. 
  1. Secure the cuff with the Velcro fastener, so that it lies comfortably and not too tight. Ensure that no space should remain between the cuff and the arm.

C)Lay the arm on a table, with the palm upwards. Support the arm a little with a rest (cushion), so that the cuff rests at about the same height as the heart. Take care, that the cuff lies free. Sit quietly in the same position for 2 minutes after beginning with the measurement.

 d) Let legs be uncrossed, feet flat on the floor, back and arm supported.

4.3. Start Taking BP Measurement

After the cuff has been appropriately positioned, the measurement can be started:

  1. Press the ON/OFF button, the pump begins to inflate the cuff. In the display, the increasing cuff-pressure is continually displayed.
  2. b) As the cuff inflates, the monitor automatically determines your ideal inflation level. This monitor detects your blood pressure and pulse rate during inflation. The Heartbeat Symbol l ()flashes with every heartbeat.
  3. When the measurement has been concluded. The measured systolic and diastolic blood-pressure values as well as the pulse frequency are now displayed.

Example (Fig.): Systole 118, Diastole 73, Pulse 75

The measurement results are displayed, until you switch the device off. If no button is pressed for 3 minutes, the device switches automatically off, to save the batteries.

 

4.4. Discontinuing a Measurement

If it is necessary to interrupt a blood pressure measurement for any reason (e.g. the patient feels unwell), the “ON/OFF” power button can be pressed at any time. The device then immediately lowers the cuff-pressure automatically.

4.5. Memory-Storage And Recall Of The Measurements

The blood-pressure monitor automatically stores each of the last 120 measurement values with user identity. By pressing the MEMORY button, an average value of the last 3 measurements as well as the last measurement and the further last 120 measurements (MR119,MR118,…,MR1) can be displayed one after the other.

(MR1: Values of the last measurement) (MR2-MR120: Values of the measurement before MR1) 

4.6. Memory– Cancellation Of All Measurements 

Before you delete all readings stored in the memory, make sure you will not need \refer to the readings at a later date. Keeping a written record is prudent and may provide additional information for your doctor’s visit. In order to delete all stored readings, press the MEMORY button for at least 5 seconds, the display will show the symbol «CL» and then release the button. To clear the memory permanently, press the MEMORY button while «CL» is flashing to indicate deletion of stored data. 

4.7. Memory full

Pay attention that the maximum memory capacity is not exceeded. When the memory is full, the old values are automatically

Overwritten with new ones. When memory is full , the display shown 1 second as follows to remind you “ memory full”

 

4.8. Memory– Cancellation Of All Measurements 

Before you delete all readings stored in the memory, make sure you don’t need \refer them for future reference. Keeping a written record is prudent and may provide additional information for your doctor’s visit.

In order to delete all stored readings, press the MEMORY button for at least 5 seconds, the display will show the symbol «CL» and then release the button. To clear the memory permanently, press the MEMORY button while «CL» is flashing to indicate deletion of stored data.

  1. APPEARANCE OF THE PULSE ARRHYTHMIA INDICATOR FOR EARLY DETECTION

The  symbol indicates that certain pulse irregularities were detected during the measurement. In this case, the result may deviate from your normal blood pressure-repeat the measurement. In most cases, this is no cause for concern. However, if the symbol appears on a regular basis (e.g. several times in a week with measurements taken daily) we advise you to tell your doctor.

  1. ERROR MESSAGES /MALFUNCTIONS

If an error occurs during a measurement, the measurement is discontinued and a corresponding error code is displayed.

 

Error No.

Possible cause(s)

ERR 1

No pulse has been detected.

ERR 2

Unnatural pressure impulses influence the measurement result.

Reason: The arm was moved during the Measurement (Artefact).

ERR 3

The inflation of the cuff takes too long. The cuff is not correctly seated.

ERR 5

The measured readings indicated an unacceptable difference between systolic and diastolic pressures. Take other reading following directions carefully. Contact you doctor if you continue to get unusual readings.

Err8

The pressure in the cuff is too high (over 290 mmHg)

 

Further Information - The level of blood-pressure is subject to fluctuations even with healthy people. Important thereby is, that comparable measurements always require the same conditions (Quiet conditions)! If, in spite of fulfilling all these factors, the fluctuations are larger than 15mmHg, and/or you hear irregular pulse tones on several occasions, please consult your doctor.

 

Other Possible Malfunctions And Their Elimination

If problems occur when using the device, the following points should be checked and if necessary, the corresponding measures are to be taken:

 

Malfunction

Remedy

The display remains empty when the instrument is switched on although the batteries are in place.

1. Check batteries for correct polarity and if necessary insert correctly.

2. If the display is unusual, re-insert batteries or exchange them.

The device frequently fails to measure the blood pressure values, or the values measured are too low (too high).

1. Check the positioning of the cuff.

2. Measure the blood-pressure again in peace and quiet under observance of the details made under point 5.

Every measurement produces a different value although the instrument functions normally and the values displayed are normal

1. Please read the following information and the points listed under «Common sources of error». Repeat the measurement.

Please Note: Blood pressure fluctuates continually so successive measurements will show some variability.

Blood pressure measured differs from those values measured by the doctor.

1. Record the daily development of the values and consult your doctor. 

 

Please Note: Individuals visiting their doctor frequently experience anxiety which can result in a higher reading at the doctor than obtained at home under resting conditions.

 

TO BE NOTED

For licensing, the device has been subjected to strict clinical tests, by which the computer program used to measure the blood-pressure values was tested by experienced specialist doctors in Germany. The same computer program is used in every individual device, and has thus also been clinically tested. The manufacture of the devices takes place according to the terms of the European standard for blood-pressure measuring devices (see technical data) you must consult your specialist dealer or chemist if there are technical problems with the blood-pressure instrument. Never attempt to repair the instrument yourself! Any unauthorized opening of the instrument invalidates all warrantee claims!

 

  1. CARE AND MAINTENANCE, RE-CALIBRATION
  1. a) Do not expose the device to extreme temperatures, humidity, dust or direct sunlight.
  2. b) The cuff contains a sensitive air-tight bubble. Handle this carefully and avoid all types of straining through twisting or buckling.
  3. c) Clean the device with a soft, dry cloth. Do not use petrol, thinners or similar solvent. Spots on the cuff can be removed carefullywith a damp cloth and soapsuds. The cuff must not bewashed!
  4. d) Do not drop the instrument or treat it roughly in any way. Avoid strong vibrations.
  5. e) Never open the device! Otherwise the manufacturer calibration becomes invalid!

Periodical Re -calibration

Sensitive measuring devices must be checked time to time for accuracy. We therefore recommend a periodical inspection of the static pressure display every 2 years.

  1. BATTERY LIFE

1000 times measurement with 4- size “AA”alkaline Batteries

  1. SAFETY, CARE AND DISPOSAL

Safety & Protection

  • This instrument may be used only for the purpose described in this booklet. The manufacturer will not be responsiblefor the damage caused by incorrect application.
  • This instrument comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the “Technical specifications” section!
  • Protect it from water and moisture, extreme temperatures, impact and dropping, contamination and dust, direct sunlight, heat and cold.
  • The cuffs are sensitive and must be handled with care.
  • Only pump up the cuff once fitted.
  • Do not use the instrument close to strong electromagnetic fields such as mobile telephones or radio installations.
  • Do not use the instrument if you think it is damaged or notice anything unusual.
  • If the instrument is not going to be used fora prolonged period the batteries should be removed.
  • Read the additional safety instructions in the individual sections of this booklet. Ensure that children do not use the instrument unsupervised: some parts are small enough to be swallowed.
  • Must use the recognized accessories, detachable parts and materials, if the use of other parts or materials can degrade minimum safety.
  • A warning to remove primary batteries if the instruments is not likely to be used for sometime

Attention

To be Noted

  • Always clean the instrument only with a softand dry cloth.
  • Do not submerge the device or any of the components in water.
  • Do not allow the BP monitor to strong shocks, such as dropping the unit on the floor.
  • Store the device and the components in a clean, safe location.
  • Do not disassemble or attempt to repair the unit or components as it will void the user warranty.

Disposal

Batteries and electronic instruments must be disposed off in accordance with the locally applicable regulations, not with domestics waste.

    1. REFERENCE TO STANDARDS

     

    Device standard: Device corresponds to the requirements of

    the European standard for non-invasive blood pressure monitor 

    IEC60601-1-6:2010+A1:2013/ EN60601-1-6:2010+A1:2015

    IEC60601-1:2005+A1:2012/EN60601-1:2006+A11:2011+A1:2013+A12:2014

    IEC60601-1-2:2014/ EN60601-1-2:2015

    IEC/EN60601-1-11:2015

    IEC80601-2-30:2009+A1:2013/EN80601-2-30:2010+A1:2015

     

    The stipulations of the EU-Guidelines 93/42/EEC for Medical Products Class IIa have been fulfilled.

  1. REMARK

 

Some electrical and electrical equipments forbid to abandon and disposal at will

 

TUV NO.

 

Manufacturer’s  name and address

 

Reading Instruction Book before use

 

Inapplicable baby

 

Type B equipment

 

Cuff  Connector

Protection against ingress of water:

IP22

 

Attention consult accompanying documents

 

Wellkang Tech  Consulting Suite B ,29 Harley Street, LONDON W1G 9QR ,United  Kingdom

 

  1. Technical Specifications

Measurement Procedure:

Oscillometric, Corresponding to Korotkoff Method: Phase I : systolic , Phase V : diastolic

Display:

Digital Display

Measuring range:

Pressure: 30 to 280 mmHg (in 1 mmHg increment)

Pulse: 40 to 199 beat/minute

Static accuracy:

Pressure: ±3mmHg / Pulse: ±5% of reading

Measuring resolution :

1mmHg

Inflation:

Automatic inflation by internal pump

Memory function:

2 x 120 memories for 2 users (SYS, DIA, Pulse)

Decompression:

Constant exhaust valve system

Power source:

4- size “AA” alkaline Batteries

( adapter: micro USB DC5.0V / 1.0A ) optional

Operation temperature:

5~40°C/41~104°F

Operation humidity:

15%~85%RH maximum

Storage temperature:

-10~55°C/14~131°F

Storage humidity:

10%~95%RH maximum

Dimensions :

135×112×71±1.0 mm

Weight :

510 g±5g (including batteries and cuff)

Cuff pressure display range:

0~299mmHg/0~39.9kPa

Electrical shock protection:

Internal power unit

Safety classifications:

Type B equipment

Mode of operation:

Continuous operation

Protection against ingress of water:

IP22

Accessories:

M-size Cuff , 4 “AA” batteries,  instruction manual

 

Please note it down, the power adapter (micro USB DC5.0V / 1.0A ) is not supplied from the origin ,users can buy the adapter in the market which must comply to EN60601-1, EN60601-1-2.

  1. MANUFACTURER’S DECLARATION 

Dr Trust BP Check with MDI is intended for use in the electromagnetic environment specified below. The customer or the user of Dr Trust BP Check with MDI should assure that it is used in such an environment.

 

Electromagnetic Emissions: (IEC60601-1-2)

Emission Test

Compliance

Electromagnetic Environment

RF emission CISPR 11

Group 1

Dr Trust BP Check with MDI uses RF energy only for internal functions. Therefore, this RF emission is extremely weak and there is little chance of it creating any kind of interference whatsoever with nearby electronic equipment.

RF emissions CISPR 11

Class B

Dr Trust BP Check with MDI  is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations/flicker IEC 61000-3-3

Not applicable

 

Electromagnetic Immunity: (IEC60601-1-2)

Immunity test

IEC60601-1-2 test level

Compliance level

Electromagnetic environment -guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electric fast transient/ burst IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

Not applicable

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

Not applicable

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT(95% dip inUT.) for 0.5 cycle

40 % UT(60% dip in UT )for 5 cycles

70 % UT(30% dip inUT) for 25 cycles

<5 % UT(95% dip inUT)for 5 sec.

Not applicable

Mains power quality should be that of a typical commercial or hospital environment. If the user of the upper arm style requires continued operation during power mains interruptions, it is recommended that Dr Trust BP Check with MDI be powered from an uninterruptible power supply or a battery.

Power frequency  (50/ 60 Hz) magnetic field IEC 61000-4-8

3 A/m

Not applicable

Not applicable

Note: UT is the a.c. mains voltage prior to application of the test level.

Immunity test

IEC60601-1-2 test level

IEC60601-1-2 test level

Electromagnetic environment - guidance

 

 

 

 

 

 

 

Conducted RF IEC 61000-4-6

 

 

Radiated RF IEC 61000-4-3

 

 

 

 

 

 

 

3 Vrms 150 kHz to 80 MHz 80% AM (2Hz)

 

 

3 Vrms 80 MHz to 2.5 GHz 80% AM (2Hz)

 

 

 

 

 

 

 

 

3 Vrms

 

 

 

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of Dr Trust BP Check with MDI , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommend separation distance

3V

d = 1.2×p1/2  80Mhz to 800 MHz

d = 2.3×p1/2MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to he transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

 

Note1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless)telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Dr Trust BP Check with MDI is used exceeds the applicable RF compliance level above, Dr Trust BP Check with MDI should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating Dr Trust BP Check with MDI .

bOver the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.

 

Recommended Separation Distances: 

Recommended separation distance between portable and mobile RF communications equipment and Dr Trust BP Check with MDI .

Dr Trust BP Check with MDI is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Dr Trust BP Check with MDI can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Dr Trust BP Check with MDI as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

d = 1.2×p1/2

80 MHz to 800 MHz

d = 1.2×p1/2

800 MHz to 2.5 GHz

d = 2.3×p1/2

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note1:At 80MHz and 800MHz, the separation distance for the higher frequency range applies

Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

 

About Dr Trust

Driven by the passion for innovation, we at Dr Trust endeavour to provide our customers with the latest medical inventions with an objective to promote good health and wellness all around the world. All the medical devices and health monitors provided by Dr Trust are supported by accurate, latest and ground breaking technologies, innovated at our headquarters in NY, USA. All our products adhere to the most stringent CE and FDA guidelines and are strongly recommended by doctors and health practitioners. Our products are designed in the utmost exemplary ways to ensure that their accuracy and convenience are unrivalled. The ease of their use and operation makes them even more suitable for users of all age groups. 

Dr Trust strives to enhance the quality of lifestyle by providing with the most trusted and innovative health care and wellness products. Being a renowned global leader in health care products, Dr Trust ensures that our technically efficient team works dynamically and tirelessly to provide the best of the medical devices to our clients. The products that we have to offer are suitably designed for use at homes, laboratories and hospitals.

Our ground breaking solutions allow you to monitor your health in the easiest ways possible. In today’s era when all of our lives are too hassled to handle, it becomes a bit difficult to pay attention to our health. But it has now become easier with the coming of the monitoring devices which can be conveniently used at homes and even on the go.

We bring to you a variety of best self monitoring devices, trusted and used by Doctors, medical professionals and home users all over the world.

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