BRAUN BUA 5000 ExactFit 1 Blood Pressure Monitor User Manual

BRAUN BUA 5000 ExactFit 1 Blood Pressure Monitor

Intended use of Braun ExactFitTM 1

Braun ExactFit™ 1 is a blood pressure monitor that has been developed for easy and accurate blood pressure measurements from the upper arm. The measuring accuracy of Braun ExactFit™ 1 was tested at the time of manufacture and was proven by clinical research in accordance with ESH.†

What you should know about blood pressure
Blood pressure constantly changes throughout the day. It rises sharply in the early morning and declines during the late morning. Blood pressure rises again in the afternoon and finally drops to a low level at night. Also, it may vary in a short period of time. Therefore, readings from successive measurements can fluctuate.

Note: Blood pressure readings from a healthy 31-year-old male, measured at 5-minute intervals
Blood pressure measured in a doctor’s office only provides a momentary value. Repeated measurements at home better reflect one’s actual blood pressure values under everyday conditions.
Moreover, many people have a different blood pressure when they measure at home because they tend to be more relaxed than when in the doctor’s office.
Regular blood pressure measurements taken at home can provide your doctor with valuable information on your normal blood pressure values under actual everyday conditions.
The European Society of Hypertension (ESH) has set up the following standard blood pressure values when measured at resting pulse:

Safety information and important precautions

• To ensure accurate measuring results, carefully read the complete instructions for use.
• This product is intended for household use only. Keep products and batteries away from children.
• People suffering from cardiac arrhythmia, vascular constriction, arteriosclerosis in extremities, diabetes or users of cardiac pacemakers should consult their doctor before
• measuring their blood pressure themselves, since deviations in blood pressure values may occur in such cases.
• If you are under medical treatment or taking any medication, please consult your doctor first.
• The use of this blood pressure monitor is not intended as a substitute for consultation with your doctor.
• Protect from dust and from direct sunlight. Do not open or modify this equipment without authorization of the manufacturer.

Product Description

1. LCD display
2. Power (start/stop) button
3. Hose port
4. Battery compartment
5. Connector
6. Arm cuff
7. Air hose

Inserting batteries

Use alkaline batteries, type AA 1.5V as supplied with this product.
Remove the battery compartment cover and insert four batteries with correct polarity (see symbol in the battery compartment).
New batteries will provide approximately 400 measurements.

Key rules for accurate blood pressure measurement

• Always take readings at the same time of day, ideally in the morning, under the same conditions.
• Do not measure within 30 minutes after smoking, coffee or tea consumption or any form of exertion. These factors will influence the measurement results.
• Always measure on the same upper arm.
• Take off wrist watch and jewelry before fitting the cuff on the measuring arm.
• Wait approximately 3 minutes before repeating a measurement.
• Do not wrap the cuff over a jacket or sweater. This will affect the measurement.
• Remove tight-fitting clothing from your arm.

Applying the arm cuff

1. Plug the air hose into the connector (Fig. 1).

2.  The cuff is located correctly when the velcro is on the outside of the cuff and the metal ring does not touch the skin (Fig. 2).

3.  Put your arm through the cuff loop. The bottom of the cuff should be approximately 2-3 cm above elbow. The tube should lie over the brachial artery on the inside of the arm (Fig. 3).

4.  Pull the cuff so that the top and bottom edges are tightened around your arm (Fig. 4).

5.  When the cuff is positioned properly, press the Velcro firmly against the pile side of the cuff.

6.  This cuff is suitable for use if the arrow heads fall within the stripe pattern on the other side of the cuff when the cuff is tightened around your arm (Fig. 5).

7. Sit on a chair and place your arm on the table so that the cuff is at the same level as your heart (Fig. 6).
   Taking a measurement

8.  Sit on a chair with your feet flat on the floor.

9.  Wrap the cuff snugly around your arm (see “Applying the arm cuff” section above, Fig. 3-6).

10. Do not move the unit during measurement, or the proper measurement will not be achieved.

11. Press power button to begin. The measurement starts automatically. While measurement is in progress, do not move or speak.
    Note: If necessary to interrupt a measurement, press the power button at any time. The device immediately cancels the measurement, lowers cuff pressure and automatically turns off.

12.  The cuff will first inflate and then deflate. At the end of the measurement there are 2 final beep sounds and the reading is displayed:
    Upper (systolic) value Lower (diastolic) value Pulse

13. Press the power button to turn the product off. Otherwise the product will turn off automatically after 1 minute. If at any time you want to stop the measurement, press the power button .

14.  Test results will be saved into the memory automatically ( see memory function below).

Memory function

Your ExactFit™ 1 blood pressure monitor will automatically store the latest measurement. Storing is done automatically after the completed measurement.
To recall the reading, press and hold the power button for at least 2 seconds while the unit is switched off. When all the display elements are shown, release the power button and the screen will show the last reading with an symbol.

Battery charge indicator

Batteries almost discharged
When the batteries are approximately 75% used, a battery warning appears. This icon blinks 3 times first when the device is turned on, then goes to measuring mode. The monitor will continue to measure reliably, but new batteries should be obtained.

Batteries discharged—replacements required
When the batteries are fully discharged, the battery symbol will flash empty along with 3 short beep sounds as soon as the device is switched on. You cannot take any further measurement and must replace the batteries. Refer to the section called “Inserting batteries”.

Storage and cleaning

• Do not expose device to either extreme temperatures, humidity, dust or direct sunlight.
• The cuff contains a sensitive air-tight inflatable bladder. Handle this carefully and avoid all types of straining through twisting or buckling.
• Clean the product with a soft, slightly damp cloth. Stains on the cuff can be carefully removed with a damp cloth. Do not use gasoline, thinners or similar solvents. Do not
• wash or dry clean the cuff. Do not store the product in a place exposed to direct sunlight or high humidity.
• Do not drop the device or treat it roughly in any way. Avoid strong vibrations.
• NEVER open the device! This will make the manufacturer’s warranty invalid and could adversely affect the device’s accuracy!

Calibration
This product has been calibrated at the time of manufacture. If used according to the instructions for use, periodic recalibration is not required. If at any time you question the measuring accuracy, please contact our service representative (see last page for contact information).
What to do if …

Further information
Blood pressure is subject to fluctuations even in healthy people. Comparable measurements always require the same conditions (quiet conditions)!
In order to receive market clearance from governmental bodies, this device was subjected to strict clinical tests.

Readings from repeated measurements differ considerably.

| Blood pressure is a fluctuating value. For healthy adults, deviations of 10 to

20 mmHg are possible.

| Reminder: always use the same arm for measurements!
Cuff is not properly fitted.| Ensure that the cuff is fitted according to the“Applying the arm cuff” section.
Readings were not consistently taken at heart level.| For each measurement, make sure that the cuff is at heart level.
Talking, coughing, laughing, moving etc. when measuring will influence the reading.| While measuring, relax, keep still, do not move or speak.
Blood pressure values measured at your doctor’s office differ from your measurements.| Doctor visits can frequently cause anxiety.| Record the daily development of the measured values and consult your doctor.
Display remains blank, or is unusual, when instrument is switched on.| Batteries are not installed properly.| Check batteries for correct polarity.
Device frequently fails to measure blood pressure values, or values measured are too low (or too high).| Cuff may not be properly positioned.| Ensure that the cuff is fitted according to the“Applying the arm cuff” section.

Specifications

• Model:
• Operation principle: Display:
• Cuff pressure display range:
• Pulse measurement: Blood pressure measurement range: Laboratory accuracy:
• Clinical accuracy:
• Inflation:
• Power supply: Operating temperature/ atmospheric pressure/ humidity:
• Storage temperature/ atmospheric pressure/ humidity:
• Cuff:
• Clinical validation: Service life:
• Warranty:
• BUA5000
• Oscillometric method
• Liquid crystal display
• 0-299 mmHg
• 40-199 beats per minute
• 30-280 mmHg
• ±3 mmHg (cuff pressure)
• ±5% of reading (pulse rate)
• According to EN 1060-1/-3 and ISO 81060-2 with auscultatory reference:
• <5 mmHg systematic offset
• <8 mmHg standard deviation
• Automatic
• 4 batteries, type AA 1.5V
• 10 °C to 40 °C (50 ˚F to 104 ˚F)
• 860 to1060 hPa (0.849 to 1.046 atm)
• 15% to 90% relative humidity, non-condensing
• -20 °C to 55 °C (-1 ˚F to 131 ˚F)
• 860 to1060 hPa (0.849 to 1.046 atm)
• 15% to 90% relative humidity, non-condensing Universal cuff (22-42 cm)
• According to international protocol 2002 (ESH) 5 years
• 2 years

If device is not used within specified temperature and humidity ranges the technical accuracy cannot be ensured.

• Type BF applied parts
• Operating temperature
• See instructions for use
• Storage temperature
• Keep dry

Subject to change without notice. Internally powered equipment. Continuous operation.

• This device conforms to the following standards:
• EN 60601-1: Medical electrical equipment –
• Part 1: General requirements for safety
• EN 1060-1: AMD 1 Non-invasive sphygmomanometers –
• Part 1: General requirements
• EN 1060-3: Non-invasive sphygmomanometers –
• Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
• EN 60601-1-2: Medical electrical equipment –
• Part 1-2: General requirements for basic safety and essential performance –
• Collateral standard: Electromagnetic compatibility – Requirements and tests
• EN 60601-1-11: Medical electrical equipment –
• Part 1-11: General requirements for basic safety and essential performance –
• Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 0297
• This product conforms to the provisions of the EC directive 93/42/EEC (Medical Device Directive).
• This product carries the CE mark and is manufactured in conformity with the RoHS Directive 2011/65/EU.
• MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed description of EMC requirements please contact a service representative
• (see Package Insert or consult www.hot-europe.com). Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
• EQUIPMENT.
• This product contains batteries and recyclable electronic waste. To protect the environment, do not dispose of it in the household waste, but take it to appropriate local collection points.

Guarantee

Consumer Card available on our website at www.hot-europe.com/after-sales For support requests, please visit www.hot-europe.com/after-sales or find service contact information on the last page of this manual. The production date is given by the LOT located in the back of the device. The first 3 numeric digits after the LOT No represent the day of the year of manufacture. The next 2 numeric digits represent the last two numbers of the calendar year of manufacture and the letters at the end designate the manufacturer of the product. E.g. LOT 15614ABC: this product was made on day 156, year 2014 at the manufacturer with identifier ABC.

Guidance and manufacturer’s declaration – electromagnetic emissions

The BUA5000 is intended for use in the electromagnetic environment specified below.

The customer or the user of the BUA5000 should assure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment – guidance

RF emissions CISPR 11

|

Group 1

| The BUA5000 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

RF emissions CISPR 11|

Class B

|

Complies

Harmonic emissions IEC 61000-3-2|

Not applicable

|

The BUA5000 is solely battery powered.

Voltage fluctuations/ flicker emissions|

Not applicable

Non-life support equipment separation distance calculation (3Vrms / 3V/m compliance)

Rated maximum output power of transmitter (W)

| Separation distance according to frequency of transmitter (m)
150kHz to 80MHz in ISM bands

3,5

d = [     ] P V 1

| 80MHz to 800MHz

3,5

d = [E 1 ] P

| 800MHz to 2.5GHz

7

d = [E ] P

1

0.01| 0.12| 0.12| 0.23
0.1| 0.37| 0.37| 0.74
1| 1.17| 1.17| 2.33
10| 3.69| 3.69| 7.38
100| 11.67| 11.67| 23.33

References

• Andes Global Trading | Portal
• 龙8-long8-龙八(国际)官方网站
• 龙8-long8-龙八(国际)官方网站
• 龙8-long8-龙八(国际)官方网站
• 龙8-long8-龙八(国际)官方网站

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