ExactFit 3 - Blood pressure monitor BRAUN - Free user manual and instructions

USER MANUAL ExactFit 3 BRAUN

• To ensure accurate measuring results, carefully read the complete use instructions.

• This product is intended for household use only. Keep product and batteries away from children.

• People suering 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 rst.

• The use of this blood pressure monitor is not intended as a substitute for consultation with your doctor. Product description (See page 2-3, Fig. 1)

12. Battery compartment cover (4 X 1.5V type AA (LR6) batteries)

Inserting batteries (See Fig. 2-3)

• Remove the battery compartment cover at the bottom of the unit and insert 4 AA LR6 alkaline batteries with correct polarity (see symbol in the battery compartment).

• Note: always re-set date and time after replacing new batteries to make sure the measurement results are stored with correct date and time. Only discard empty batteries. They should not be disposed of in the household waste, but at appropriate collection sites or at your retailer. Key rules for accurate blood pressure measurement

• Always take readings at the same time of day, ideally in the morning and evening, under the same conditions.

• Do not measure within 30 minutes after smoking or consuming coee or tea.

• Take o wrist watch and jewelry before tting the cu on the measuring arm.

• While taking a measurement, sit down, relax, keep still, and do not move or speak.

• Wrap the cu snugly around your arm. The cu must be at heart level.

• Do not vibrate the unit during measurement, or the proper measurement will not be achieved.

• Perform measurement quietly in a relaxed position.

• Sit in a chair with your feet at on the oor.

• Do not wrap the cu over jacket or sweater sleeve or measurement cannot be done.

• Remove tight-tting clothing from your left arm.

English Intended use of Braun ExactFit 3 and ExactFit 5 Braun upper arm blood pressure monitor has been developed for accurate and comfortable blood pressure measurements. The measuring accuracy of Braun’s upper arm blood pressure monitor 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 nally drops to a low level at night. Also, it may vary in a short period of time. Therefore, readings from successive measurements can uctuate. Blood pressure readings taken from a healthy 31-year -old male, measured at 5-minute intervals Blood pressure measured in a doctor’s oce only provides a momentary value. Repeated measurements at home better reect one’s actual blood pressure values under everyday conditions. Moreover, many people have a dierent blood pressure when they measure at home, because they tend to be more relaxed than when in the doctor’s oce. 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 World Health Organisation (WHO) has set up the following standard blood pressure values when measured at resting pulse. Blood pressure Normal Mild Severe (mmHg) values hypertension hypertension SYS = systole (upper value) up to 140 140-180 over 180 DIA = diastole (lower value) up to 90 90-110 over 1106

• For BP6200 only Note: On BP6200, the backlight goes on when the unit is turned on and it will remain on until the device will be switched o.

• Do not inate the monitor’s cu when it is not wrapped around the arm.

• Do not attempt to disassemble or change any parts of the monitor including the cu.

• Do not drop the product or put it through strong impact.

• The device is not supposed to be used if your arm has any wound or injury. Choosing the right cu For accurate measurement, it is important to choose the correct size cu which best ts your upper arm. Choose the cu size according to your arm circumference and make sure the bottom of the cu is 2~3cm above your elbow.

1. Slide the end of arm cu furthest from the tube through the metal ring to a loop.

The smooth cloth should be on the inside of the cu. Fig. 4 Fig. 6

2. Plug the air hose into the connector (Fig. 4).

3. If the cu is located correctly, the velcro will be on the outside of the cu and the metal ring will

not touch the skin (Fig. 5).

4. Put your left arm through the cu loop. The bottom of the cu should be approximately (2~3 cm)

above elbow. The tube should lie over the brachial artery on the inside of the arm (Fig. 6). Fig. 7 Fig. 9 Fig. 8 Adult cu 22~32 cm / 32~42 cm OKOKIndex

5. Pull the cu so that the top and bottom edges are tightened around your arm (Fig. 7).

7. When the cu is positioned properly, press the Velcro rmly against the pile side of the cu.

7. This cu is suitable for use if the <<index>> mark falls within the <<ok range>> marked by two

arrows when the cu is tightened around your arm (Fig. 8).

8. Sit on a chair and place your arm on the table so that the cu is at the same level as your heart

6. LCD Display will show the results and WHO indicator arrow after measurement.

After taking blood pressure measurement, turn o the device by pressing the start button (1) or automatically after 1 minute. Memory function Your blood pressure monitor can store the latest 40 readings for both users each for the BP6000, 50 readings for both users each for the BP6100 and 60 readings for both users each for the BP6200. Storing measurement data After each blood pressure measurement, the Systolic pressure, diastolic pressure, pulse rate and the time & date of specic day will be automatically stored. Memory #01 is always the most recent one. Once the memory is full, the oldest values will be overwritten. Press memory button

(2) to review the stored data. The last memory data (sys/dia/pul) with measurement date/time, IHB (for BP6200 only) and WHO indicator will show on LCD. Press memory button

(2) again to show the previous data. Be aware that the correct user A or B is chosen. Average function for BP6000 Press the average button (5) to show last 3 readings average on LCD. Press average button again to clear LCD for 0.5 seconds, then results will be shown again. Average function for BP6100 Press the average button (5) to show the full day average of past 7 days on LCD. Press average button again to clear LCD for 0.5 seconds, then results will be shown again. Average function for BP6200 Press the average button (5) to show the full day average of past 7 days on LCD. Press the average button second to show the morning average of past 7 days on LCD. If the result is with morning hypertension, the morning hypertension icon will be shown. Press the average button third time to show the evening average of past 7 days on LCD. Press the average button fourth time to show the full day average of past 7 days again. A A

Select mode How to select user A /user B

• Make sure the Product is in power o mode.

• Slide the user switch to user A or user B, the current user mode will ash on the LCD display. The WHO/ESH indicator to evaluate blood pressure data This device has a blood pressure level indicator established according to WHO and the European Hypertension Society Guidelines (ESH) in 2007. For every measurement displayed on the screen, the cursor will indicate the blood pressure level with the corresponding color code, from green to red. You can use this classication daily to guide you to understand your blood pressure level. If you are really concerned by the classication level, you should consult your doctor. Setting month, date and time a. Switch o the device for the date/time setting. b. User press set button (4) to start the year setting, then the “year” will blink display, user can press adjust (3) to adjust year by increase step “1”. c. User press set button (4) to start the month setting, then the “month” will blink display, user can press adjust (3) to adjust month by increase step “1”. d. User press set button (4) to start the day setting, then the “day” will blink display, user can press adjust (3) to adjust day by increase step “1”. e. User press set button (4) to start the hour setting, then the “hour” will blink display, user can press adjust (3) to adjust hour by increase step “1”. f. User press set button (4) to start the minute setting, then the “minute” will blink display, user can press adjust (3) to adjust minute by increase step “1”. g. User press set button (4) to end all the date/time setting, all the blink are stopped. Note: Holding the adjust button will scroll the value. Taking a measurement Wrap the cu around the arm (see “applying the arm cu” section above).

1. Sit upright on the chair to have a correct posture.

2. Press and release start button

(1), date/time and current user will be displayed.

3. Set user A/B switch (6) to A for user A or B for user B, LCD display will show user A or B symbol.

4. Press and release the start button

(1), all icons on display will be shown for 2 seconds. The device will adjust to zero automatically. The measuring blood pressure symbol will then ash on the display and the air pressure will automatically pump up to certain pressure level and start measurement. Do not move or talk in the midst of taking blood pressure measurement.

5. After the air pressure has increased, the pulse is detected, the heart rate symbol

will start ashing. RED > GREEN >

What to do if ….. Problem Reason Solution Heart rate symbol Appears in the measurement condition and ashes when pulse is detected.

• Measurement in progress, remain quiet. Low battery indicator Appears when the battery voltage is excessively low or the positions of the batteries are incorrect.

• Replace all four batteries with new ones. Insert the batteries in the correct positions. Be aware of +/- positions. Measuring error Appears when the accurate blood pressure and pulse could not be obtained.

• Press “start/stop” button again and remeasure.

• Check if cu is wrapped according to instructions.

• Check that there are no kinks in tube.

• Check palm if exerting eort.

• Check if talking or moving during measurement.

• Check if posture is correct. E1 shows The cu is not secure • Refasten the cu and then measure again. E2 shows The cu is very tight • Refasten the cu and then measure again. E 10 or E 11 shows The monitor detected motion, talking or the pulse is too poor while measuring.

• Relax for a moment and then measure again. E 20 shows The measurement process does not detect the pulse signal.

• Loosen the clothing on the arm and then measure again. E 21 shows Measure incorrectly • Relax for a moment and then measure again. EE 3 - EE15 Error while measuring • Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions. Erasing data Press and hold memory button

(2) for more than 5 seconds, LCD will blink display “dEL ALL”(if the “slide switch is in User A side, the user A icon will show ”) or “dEL ALL”(if slide switch is in User B side, the user B icon will show). Press memory button

(2) again, LCD will display “---” to mean all the stored data of corresponding user have been deleted. Irregular heart beat detector (for BP6200 only) The appearance of this symbol signies that a certain pulse irregularity was detected during the measurement. Talking, moving, shaking or an irregular pulse during the measurement can result in the appearance of this icon. Usually this is not a cause for concern, however if the symbol appears often, we recommend you seek medical advice. The device does not replace a cardiac examination, but serve to detect pulse irregularities at an early stage. Low battery indicator When the low battery indicator ashes on the display, it means the battery is low and the four batteries need to be replaced with alkaline LR6 (AA) batteries. ** After replacing batteries, BPM will go into time-setting mode automatically and show the last measurement time on screen. Please set the current date / time before taking the next measurement to get correct average result. 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 -20°C) or high (more than 60°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 cu when it is dirty.

• Do not use any strong cleansers to clean it.

• 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 make the manufacturer’s warranty invalid. 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) or visit www.hot-europe.com/support. 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. Production date is given by the LOT located in the back of the device. The rst 3 numeric digits after 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 15614VTN this product was made on the day 156, year 2014 at manufacturer identier VTN.

This product conforms to the provisions of the EC directive 93/42/EEC (Medical Device Directive). This device conforms to the following standards:

• EN 60601-1: 2006 + AC:2010: - General requirements for basic safety and essential performance

• EN 60601-1-2:2007 - Electromagnetic compatibility requirements and tests

• EN 60601-1-11:2010 - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

• EN 1060-1:1995 + A2:2009 – Non-invasive sphygmomanometers - general requirements

• EN 1060-3:1997 + A2:2009 - Non-invasive sphygmomanometers - Supplementary requirements for electro-mechanical blood pressure measuring systems.

• EN 1060-4:2004 - Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed description of EMC requirements please contact an authorized local Service Centre (see guarantee). Portable and mobile RF communications equipment can aect 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. Guarantee Consumer Card available on our website at www.hot-europe.com/support Please see last page of this manual to nd the Support contact numbers in your country. The LOT and SN of your device are printed on the rating label in the back of the product. UK only: This guarantee in no way aects your rights under statutory law. Specications Method of measurement Oscillometric Model number BP6000, BP6100, BP6200 Range of measurement Pressure 0~300 mmHg Pulse 40~199 beats/minute Accuracy Pressure +/- 3 mmHg Pulse +/- 5 % Max. Ination Deluxe automatic Display Liquid crystal display – systolic, diastolic, pulse rate Backlight Display for BP6200 Sets of memory BP6000: 40 sets per user BP6100: 50 sets per user BP6200: 60 sets per user Cu size Small cu = 22-32cm arm circumference Large cu = 32-42cm arm circumference Operating temperature +10 °C ~ + 40 °C, less than 85 % R.H. Storage temperature -20 °C ~ +60 °C, less than 85 % R.H. Operating atmospheric pressure 860-1060 hPa Unit weight Approximately 500gr (without batteries) Power supply Alkaline battery: 4 x AA (LR6) 1.5V Battery life 300 times measurement Auto power o Whenever not used for 1 minute Accessories 4 batteries, 2 arm cus with tube, instruction manual, pouch, travel bag Service life: 5 years. IMPORTANT Read the operating instructions. If device is not used within specied temperature, humidity and atmospheric pressure ranges, the technical accuracy of the measurement cannot be guaranteed. Classication:

• Internally powered equipment

• IP22: Protected against solid foreign objects of 12.5 mm diameter and greater. Protected against vertically falling water drops when the device is tilted up to 15°

• Not suitable for use in the presence of ammable anesthetic mixture with air, oxygen or nitrous oxide

• Continuous operation with short-time loading Operating temperature Storage temperature Storage humidity Subject to change without notice.14

Guidance and manufacturer’s declaration – electromagnetic emissions The ME equipment is intended for use in the electromagnetic environment specied below. The customer or the user of the ME equipment should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment – guidance RF Emissions CISPR 11 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 CISPR 11 Class B Complies Harmonic emissions

Not Applicable The ME equipment is solely battery powered. Voltage uctuations/ icker 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) 150 kHz to 80 MHz in ISM bands 80 MHz to 800 MHz 800 MHz to

Guidance and manufacturer’s declaration – electromagnetic immunity The ME is intended for use in the electromagnetic environment specied below. The customer or the user of the ME should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment– guidance Electrostatic discharge (ESD)

±6kV Contact ±8kV Air Complies Floors should be wood, concrete, or ceramic tile. If oors are covered with synthetic mate- rial, the relative humidity should be at least 30% Radiated RF

3 V/m 80MHz to 2.5GHz Complies Field strengths outside the shielded location from xed RF transmitters, as determined by an electromagnetic site survey, should be less than 3 V/m. Interference may occur in the vicinity of equip- ment marked with the following symbol: Separation distance calculation provided above. If a known trans- mitter is present the specic distance can be calculated using the equations. Conducted RF

±2kV power line ±1kV I/O lines Not Applicable The ME equipment is solely battery powered. Surge

±1kV dierential ±2kV common Not Applicable Power frequency magnetic eld

3 A/m Complies Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines

>95% dip 0.5 cycle 60% dip 5 cycles 70% dip 25 cycles 95% dip 5 sec. Not Applicable The ME equipment is solely battery powered. d = [ 3,5 ] P

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Mwww.hot-europe.com This product is manufactured under license to the ‘Braun’ trademark. ‘Braun’ is a registered trademark of Braun GmbH, Kronberg , Germany. Kaz Europe Sàrl Place Chauderon 18 CH-1003 Lausanne Switzerland Made and printed in China © 2016 All rights reserved.