BRAUN BUA5000 ExactFit 1 Upper Arm Blood Pressure Monitor User Manual

: June 10, 2024
: Braun

BRAUN BUA5000 ExactFit 1 Upper Arm Blood Pressure Monitor

Product Description

LCD display
Power (start/stop) button
Hose port
Battery compartment
Connector
Arm cuff
Air hose

Indications For Use

This device is a digital blood pressure monitor intended for measuring the blood pressure and pulse rate of adults.
The Braun ExactFit 1 Upper arm blood pressure monitor has been developed for accurate and comfortable blood pressure measurements.
The measuring accuracy was tested at the time of manufacture and was proven by clinical research in accordance with the ESH IP-2002 and ANSI / AAMI SP-10-2002.

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.
This device will display your blood pressure reading referring to two values: systolic and diastolic. The systolic blood pressure (the upper number) indicates how much pressure your blood is exerting against your artery walls when the heart beats. The diastolic blood pressure (the lower number) indicates how much pressure your blood is exerting against your artery walls while the heart is resting between beats. The pulse value is also displayed after each measurement.
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 AHA (American Heart Association) have set up the following standard blood pressure values when measured with a resting pulse at home:

Blood pressure (mmHg)| Normal| Elevated| High Blood Pressure Stage 1| High Blood Pressure Stage 2| Hypertensive Crisis
---|---|---|---|---|---
SYS = systole (upper value)| Less than 120| 120-129| 130-139| 140-180| higher than 180
| and| and| or| or| and/or
DIA = diastole (lower value)| Less than 80| Less than 80| 80-89| 90-120| higher than 120

If you are under medical treatment or taking any medication, please consult your doctor first. DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your doctor. Only a doctor is qualified to diagnose and treat high blood pressure.

Safety Information And Important Precautions

To ensure accurate measuring results, read the complete instructions for use carefully. People suffering from renal diseases, cardiac arrhythmia, vascular constriction, arteriosclerosis in the extremities, diabetes or users of cardiac pacemakers should consult their doctor before measuring their blood pressure themselves. Deviations in blood pressure values may occur in such cases. If your blood pressure reading is in the hypertensive crisis range with a systolic blood pressure value higher than 180 mmHg and / or a diastolic blood pressure value higher than 120 mmHg and you find you have one or two readings in this range – please see your doctor immediately.

The use of this blood pressure monitor is not intended as a substitute for a consultation with your doctor.
Avoid compression or restriction of the connection tubing. Continuous cuff pressure due to the connection tubing kinking can affect blood flow and cause possible injury to the user.
DO NOT use this device on the arm of the same side of the body on which the user had a mastectomy.
Measuring blood pressure too frequently can cause injury to the user due to blood flow interference.
DO NOT apply the cuff to a limb on which there is intravascular access or on which an arterio-venous (A-V) shunt is present. This can cause temporary interference of blood flow and potential injury to the user.
DO NOT apply the cuff over a wound as this can cause further injury.
DO NOT use the device while simultaneously using other medical electrical (ME) equipment.
DO NOT use this device on neonatal and infant subjects, pregnant, including pre-eclamptic, subjects, or persons who cannot express their intentions.

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).

Batteries should not be disposed of in the household waste, but at appropriate collection sites or at your retailer.
Do not mix alkaline, standard, or rechargeable batteries

Key Rules For Accurate Blood Pressure Measurement

ALWAYS take readings at the same time of day, under the same conditions.
DO NOT take a measurement within 30 minutes of smoking, drinking coffee or tea or any form of exertion. These factors will influence the measurement.
ALWAYS measure on the same arm. The left arm is recommended. DO NOT move or speak. Keep your legs uncrossed and feet flat on the floor.
Place the cuff in direct contact with the skin. DO NOT wrap the cuff over a jacket, sweater or shirt.
If you want to take multiple measurements, wait approximately 3 minutes before repeating a measurement.

Applying The Arm Cuff

Plug the air hose into the connector (Fig. 1).
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).
Put your arm through the cuff loop. The bottom of the cuff should be approximately 0.8″–1.2″ above elbow (Fig. 3). The tube should lie over the brachial artery on the inside of the arm (Fig. 4).
Pull the cuff so that the top and bottom edges are tightened around your arm.
When the cuff is positioned properly, press the Velcro firmly against the pile side of the cuff.
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).
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

Sit on a chair with your feet flat on the floor.
Wrap the cuff snugly around your arm (see “Applying the arm cuff” section above, Fig. 3-6).
Do not move the unit during measurement, or the proper measurement will not be achieved.
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.
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
Press the power button to turn the product off. Otherwise the product will turn off automatically after 1 minute.
Test results will be saved into the memory automatically ( see memory function below).

This device is not intended as a substitute for regular check-ups by your doctor, please continue to visit your doctor on a regular basis for a professional reading.

Memory Function

Your ExactFit™ 1 Upper arm 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 4 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 M 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

ALWAYS keep the unit in the carrying case after its use.
DO NOT put the item directly under the sunlight, in high temperature or humid and dusty places.
DO NOT store in extremely low (less than -4°F (-20°C)) or high (more than 131°F (55°C)) temperature.
Use a piece of cloth with water or mild cleansing agent to clean the case and then use a piece of dry cloth to wipe it dry. Use a piece of dry cloth to wipe the cuff when it is dirty.
NEVER use abrasive cleaning agents, thinners, or benzene for cleaning, and NEVER immerse the unit in water or other cleaning liquids.
When the unit is not to be used for a long time, remove the batteries. (Batteries may leak or cause harm).
DO NOT modify the device. NEVER open the device! This will void the manufacturer’s warranty.
DO NOT use this device close to strong electromagnetic fields such as mobile telephones or radio installations. Maintain a minimum distance of 3.3m from such devices when using this unit.

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.

What to do if …

Error	Description	Potential cause and remedy

| Batteries are low| Get ready to replace batteries soon with new ones.
| Batteries are fully discharged| Insert new batteries or check that batteries are correctly inserted.

«Err 1»

| Signal too weak| The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement.

«Err 2»

| Error signal| During the measurement, error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping the arm still.

«Err 3»

| No pressure in the cuff| An adequate pressure cannot be generated in the cuff. A leak may have occurred. Check that the cuff is correctly connected and is not too loose. Replace the batteries if necessary. Repeat the measurement.

«Err 5»

| Abnormal result| The measuring signals are inaccurate and no result can therefore be displayed. Read through the checklist for performing reliable measurements and then repeat the measurement.

«HI»

| Pulse or cuff pressure too high| The pressure in the cuff is too high (over 300 mmHg) OR the pulse is too high (over 200 beats per minute). Relax for 5 minutes and repeat the measurement.

«Lo»

| Pulse too low| The pulse is too low (less than 40 beats per minute). Repeat the measurement.
G ui d an ce a n d m a nu facture r ‘s de cl a r a ti o n – e l ectromagnetic i mm uni ty

The BUASOOO i sintended for use in the electromagneticenvironment speci fied below.

The customer or the user ofthe BUASOOOshould ensure thatit is used in such an environment.

Phenomenon| Basic EMC standard or test method| I MM UN I TY TEST LEVELS
HOMEHEALTHCARE ENVIRONMENT
ELECTROSTATIC DISCHARGE| IEC 61000 -4-2| ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,± 15 kV air
Radiated RF EM fie l ds a)| IEC 61000-4-3| 10 V/m 1)
80 MHz – 2,7 GHz b)
80 % AM at 1 kHz c)
Pro ximity fields from RF wireless communications equipment| IEC 61000-4-3| See RF w ireless communication equipment immunit y table below
RATED power frequency magnetic fields dJ e)| I EC 61000-4 -8| 30 Alm g)
50 Hz or 60 Hz
a) The interfa ce between the PATIENT ph ysiological signal simulation, if used, and the ME EQUIPMENT or ME SYSTEM sh all be located within 0,1 m of the vertical plane of the uniform field area in one ori entation of the ME EQUIPMENT or ME SYSTEM.

b) ME EQUIPMENT and ME SYSTEMSthat intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of receptiorn. Testing may be performed at other modulation frequencies identified by the RI SKMANAGEMENTPROCES.SThis test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve normal reception during the test.

c) Testing may be performed at other modulation frequencies identified by the RISKMANAGEMENT PROCES.S

d) Applies only to ME EQUIPMENTand ME SYSTEMS wi th m agnetic all y sensitive components or circuitry.

e) During the test . the ME EQUIPMENT or ME SYSTEM may be powered at any NOMINAL input voltage, but with the same frequency as the test signal (see Table 1).

f) Before modulation is applied.

g) This test level assumes a minimum distance between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic fiel d of at least 15 cm. If the RISK ANALYSI S shows that the ME EQUIPMENT or ME SYSTEM will be used closer than 15cm to sou rces of p ower frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance .

Guidance and manufacturer’sdecla r ati on – electromagnetic emissions

The BUAS000 equipment is intend ed for use in the electromagnetic environment specified below. The customer or the user of the BUAS000 shou ld ensure that it is used in such an environment.
Emissions Test| Compliance| Electromagnetic environment- guidance
RF Emissions CISPR11| Group 1| The ME equipment 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 CISPR11| Class B| Com plies
Harmonic emissions IEC61000-3-2| Not Appl icable| The ME equipment is solely battery powered.
Voltage fluctuations/ flicker emissions| Not Applicable
Gu i dance and manufacturer ‘ s declaration – RF wireless commun i cation equipment immunity

Test frequency
(MHz)| Band • >
(MHz)| Service• >| Modulation b )| Maximum pow e r
(W)| Distance
(m)| IMMU N I TY TEST LEVEL
(Vim)
385| 380 – 390| TETRA 400| Pulse modulation bJ 18 Hz| 1,8| 0,3| 27
450| 4 30 – 47 0| GMRS 460,
FRS 460| FM 0)
± 5 kHz deviation
1 kHz sine| 2| 0,3| 28
710| 704 – 787| LTE Band 13,
17| Pulse modulation b) 217 Hz| 0,2| 0,3| 9
745
780
810| 800 – 960| GSM 800/90,0 TETRA 800,
iDEN 820,
COMA 850,
LTE Band 5| Pulse modulationb ) 18 Hz| 2| 0,3| 28
870
930
1 720| 1 700 –
1 990| GSM 1800;
COMA 1900;
GSM 1900; OECT;
LTE Band 1, 3,
4, 25; UMTS| Pulse modulationb ) 217 Hz| 2| 0,3| 28
1 845
1 970
2 450| 2 400 –
2 570| Bluetooth, WLAN,

802.11 b/9/n , RFIO 2450, LTE Band 7

| Pulse modulationb ) 217 Hz| 2| 0,3| 28
5 240| 5 100 – 5 800| WLAN 802.11 a/n| Pulse modulationb ) 217 Hz| 0 , 2| 0 ,3| 9
5 500
5 785
a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.

c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while ii does not represent actual modulation, it would be worst case.

Specifications

Model : BUA5000
Operation principle : Oscillometric method
Display : Liquid crystal display
Range of measurement : Pressure 30~280 mmHg Pulse 40~199 beats/minute
Laboratory accuracy : ±3 mmHg (cuff pressure) ±5% of reading (pulse rate)
Clinical accuracy : <5 mmHg systematic offset <8 mmHg standard deviation
Battery life : 400 measurements
Auto power off : Whenever not used for 1 minute
Accessories : 4 batteries, 1 arm cuff with tube, instruction manual
Inflation : Automatic
Power supply : 4 batteries, type AA 1.5V
Operating temperature / 10 °C to 40 °C (50 ˚F to 104 ˚F)
atmospheric pressure / 860 to1060 hPa (0.849 to 1.046 atm)
humidity : 15% to 90% relative humidity, non-condensing
Storage temperature / -20 °C to 55 °C (-4 ˚F to 131 ˚F)
atmospheric pressure / 860 to1060 hPa (0.849 to 1.046 atm)
humidity : 15% to 90% relative humidity, non-condensing
Cuff : Universal cuff (22-42 cm)
Service life : 5 years
Warranty : 2 years

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

Type BF applied parts
See instructions for use
Keep dry
Operating temperature
Storage temperature
Storage humidity/ operating humidity

Subject to change without notice.
Internally powered equipment.
Continuous operation.
Protected against solid foreign particles with a diameter of more than 12.5 mm, no protection against liquid.

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 visit www.hot- europe.com/support. Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.

Please do not dispose of the product in the household waste at the end of its useful life. Disposal can take place at your local retailer or at appropriate collection points provided in your country.

Warranty

Please read all instructions before attempting to use this device. Please retain the receipt as proof of and date of purchase. The receipt must be presented when making any claim within the relevant warranty period.
Any claim under the warranty will not be valid without a proof of purchase.
Your device is warrantied for two years (2 years) from date of purchase.
This warranty covers defects in materials or workmanship that occur under normal use; defective devices meeting these criteria will be replaced free of charge.
The warranty DOES NOT cover defects or damage resulting from abuse or failure to follow the user instructions. The warranty becomes void if the device is opened, tampered with, or used with non-Braun branded parts or accessories, or if repairs are undertaken by unauthorised persons.
Accessories and consumables are excluded from any warranty.
For support requests, please visit www.hot-europe.com/support or find service contact information at the end of this owner’s manual.
This warranty is applicable to Europe, Middle East and Africa only.
UK Only: This does not affect your consumer statutory rights.
The LOT and SN of your device are printed on the rating label on the back of the product. The first 3 numeric digits of the LOT No. represents 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 15614onb, this product was made on day 156, year 2014, at manufacturer identifier onb.

Contact Us

Questions or Comments?
Call us toll-free at: 1-800-327-7226
Visit: www.BraunHealthcare.com/contact-us
www.BraunHealthcare.com/support
Please be sure to specify the model number.
Certain trademarks used under license from
The Procter & Gamble Company or its affiliates.