TrueScan BPW4100 - Blood pressure monitor BRAUN - Free user manual and instructions

USER MANUAL TrueScan BPW4100 BRAUN

www.kaz-europe.com This product is manufactured by Kaz Europe SA under a license to the ‘Braun’ trade- mark. ‘Braun’ is a trademark of Braun GmbH, Kronberg , Germany. Kaz Europe SA Place Chauderon 18 CH-1003 Lausanne Switzerland ©2010 Kaz Europe SA3

Intended use of Braun TrueScan Braun TrueScan is a blood pressure monitor that has been developed for easy and ac-curate blood pressure measurements from the wrist. The measuring accuracy of Braun TrueScan was tested at the time of manufacture and was proven by clinical research. Blood pressure readings 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. Re-peated 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) and the ESH have set up the following standard blood pressure values when measured at resting pulse. (mmHg)

English5 What you should know about this blood pressure monitor For accurate measurements, all wrist blood pressure monitors must be positioned at heart level. Example: If the monitor is positioned 20 cm below heart level as shown on the left (e.g. by putting the arm on a table), the reading you will obtain is approximately 15 mmHg too high. Therefore, the Braun TrueScan has an easy positioning system (A): it guides you to hold your measuring arm in the right posi- tion at heart level and gives you conrmation of correct arm position before measurement is taken. Safety Information and Important Precautions

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

• Operate the unit only as intended. Do not use for any other purposes.

• 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 be- fore 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 consulta- tion with your doctor.

• Do not disassemble or attempt to repair the unit or components

• Do not use equipment where ammable gas (such as anesthetic gas, oxygen or hydrogen) or ammable liquid (such as alcohol) are present.

• The unit is intended to use in measuring blood pressure and pulse rate for adult only, not recommended for neonatal baby.

• Do not use a cellular phone near the unit. It may result in operational failure.

• Please avoid using in high radiant area in order to makeyour measuring data cor- rectly.

• Substitution ofa cu dierent from that supplied might result in measurement error for more information regarding the Safety Information and Important Precautions, contact your local Service Center. 20 cm6 Product description A Easy Positioning system B User button C On/o button D Memory/Average Function button E Battery compartment F Time and date setting button G Adjust Button H Cu I Velcro Strap J User icon Inserting batteries

• Use alkaline batteries, 2 type LR 03 (AAA) (e.g. Energizer) as supplied with this product.

• Warning: do not use rechargeable batteries.

• Remove the battery compartment cover and insert two batteries with correct polarity (see symbol in the battery compartment (E)).

• New batteries (Energizer) will provide approximately 300 measurements.

• Only discard empty batteries. They should not be disposed of in the household waste, but at appropriate collection sites or at your dealer. Key rules for accurate blood pressure measurements Correct handling is key for obtaining accurate measuring results!

• 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, coee or tea consumption.

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

• While taking a measurement, sit down, relax, keep still, especially the hand and ngers of the measuring arm, do not move or speak. K Systolic pressure L Diastolic pressure M WHO/ESH indicator N Pulse rate O Heart rate indicator P Low battery indicator Q Irregular heartbeat R Time S Month and day7

• Hold the appliance at heart level during the measurement.

• Wait approximately 3 minutes before repeating a measure- ment. Taking a measurement For a reliable blood pressure measurement, please follow the in- structions below. Apply the cu on your right wrist , when taking a measurement. The device can also be used on your left wrist.

1. Place the monitor housing on the slim side of your bare

forearm with the monitor facing up. Keep the required 2 cm distance to your palm line.

2. Fasten the cu on your wrist. Make sure that the cu ts

4. Put the hand with the appliance on the other upper arm as

shown. Slowly move the hand upward along the upper arm. Watch the positioning system (A) and move your hand up or down according to the direction of the arrow shown.

5. If your wrist position is accurate the the green arm icon on

the device will appear with a black outline and the device will sound “BEEP BEEP BEEP BEEP”. Directly following the the four beeps the device will automatically inate and begin taking the user’s reading. When the measurement is complete the reading is displayed on the LCD.

BOTTOM: PULSE If the measuring position is incorrect, the measurement can’t start, so there is no possibility to obtain a wrong or inaccurate measurement. The device will beep rapidly if the positioning system is incor- rect. You have to move your arm up or down according to the arrow indication on the LCD screen. If your wrist position is at the correct level with your heart, the LCD will display and the measurement will start. Measuring arm: If your wrist position is lower than your heart, the LCD will display as shown and will beep as “BEEP BEEP BEEP BEEP”. If your wrist position is higher than your heart, the LCD will display as shown and will beep as ” BEEP BEEP BEEP BEEP”. If the positioning system has been deactivated, you will have no indication before processing the measurement. Please note:

• In case of system errors or handling mistakes, the display will show an error code, instead of giving you inaccurate results (for details, please see section «What to do if…»).

Turning off Press the on/o button to turn the product o, otherwise the product will turn o automatically after 2 minutes. Memory Mode Your blood pressure monitor can store the readings of 80 (2x40) measurements. Storing is done automatically after each com- pleted measurement. The memory is non-volatile. This means that you will not lose stored data when changing batteries. Once the memory is full, the oldest values will be overwritten. How to review the memory

• Make sure the product is in power o mode.

• Press the Memory/Average Function button. The LCD will display the past 7 days average of blood pressure rst.

• Press the Memory/Average Function button again and the lat- est reading will display.

• Press it again and the next reading will display. Average Function: 7 Day Average

• Press the Memory/Average Function button once, and the “7 Day Average” result will show on LCD.

• Make sure the DATE / TIME is correct when taking a measure- ment, so you will get the correct 7 Day Average result.

• If there is no data in memory within past 7 days, “ ” will show on LCD. How to delete the memory data

• Make sure the product is in power o mode.

• Press the Memory/Average Function button for at least 10 seconds.

• LCD will display “del no” as shown.

• Press the Memory/Average Function button again. LCD will display “del yes”.

• If you are sure all the data of corresponding user can be deleted, press “power” button, all the corresponding user’s data will be deleted and the device will shut down. Note: if you have set “delete yes”, but do not press a button for 2 minutes, the product will shut o automatically, but the cor-10 responding user’s blood pressure data will not be deleted. The delete operation must be conrmed by user. Select mode How to select user1/user2

• Make sure the product is in power o mode.

• Press the “user” button, and the current user mode will ash on the LCD display.

• Press the “user” button again, it will change to another user mode.

• When you have set the correct user mode, press the “power” button to save the user mode and exit this setting.

• If you have selected the correct user mode and do not press a button for 2 minutes, the product will shut o and save the user mode you have selected automatically. How to set date and time

• First turn o the product. Press the “set” button, and the “month” will ash.

• Press the “adjust” button to change the current month. (It can only be increased.)

• When the month is correct, press the “set” button again.

• Next the “date” will ash.

• Follow the same operation process to adjust the “date”, “hour” and “minute”.

• When you nish the date/time setting, you can press the “power” button to shut o the product or if you do not press a button for 2 minutes, the product will shut o and save the user mode you have selected automatically. How to set positioning system ON/OFF Should you wish to deactivate the positioning system proceed as follows:

• First turn o the product.

• Press the “user” button and hold it for 5 seconds.

• If the “position system” is turned ON, the LCD will display “on”. If the “position system” is turned OFF, the LCD will display “o”.

• Press the “user” button again, the state of “position system” will be changed.

• When the “position system” has been set to your liking, you can11 press “power” button to shut o the product and the “position system” state will be saved. The WHO/ESH indicator to evaluate blood pressure data This device has a Blood Pressure Level Indicator (M) 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. Irregular Heart Beat Detector The appearance of this symbol signies that a certain pulse irregularity was detected during the measurement. Talking, mov- ing, 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 recom- mend you seek medical advice. The device does not replace a cardiac examination, but service to detect pulse irregularities at an early stage. Calibration This product has been calibrated at the time of manufacture. If used according to the Instructions of use, periodic recalibra- tion is not required. If at any time, you question the measuring accuracy, maintenence and repair, please contact an authorized Kaz Customer Service Centre. Manufacturing date is given by the LOT number on the back of the product. The three numbers after LOT represents the day of the year of manufacture. The two last digits of the year of manu- facture. An example: LOT 25010KYD – this product has been manufactured on the 250th day of the year 2010. RED > GREEN >12 Storage and cleaning Keep the unit in the storage case when not in use. Clean the product with a soft, slightly damp cloth. Do not wet the cu or attempt to clean the cu with water. Do not wash or dry clean the cu. Do not store the product in a place exposed to direct sunlight or high humidity. Remove the batteries if the unit will not be used for 3 months or longer. Always replace all of the batteries with new ones at the same time. If needed, please use ultraviolet radiation for if disinfection. Specifications Model: BPW4100 Operation principle: Oscillometric method Display: Liquid Crystal Display Measuring range: 0-280mmHg (cu pressure) Blood pressure measurement: Systolic pressure: 60-280mmHg Diastolic pressure: 30-250mmHg Pulse rate: 40-180/min Laboratory accuracy: Cu pressure: ±3mmHg Pulse rate: ±5% Ination: Automatic, soft adapted to blood pressure Power supply: 2 batteries, type LR03(AAA) Electric Shock Protection: Internal power supply appliance type BF Operating Environment: Temperature +10 C / +40 C Humidity 15 ~ 85%RH (Noncondensing) Atmospheric Pressure 105 kPa ~ 80 kPa Transport and Temperature -20C / +60C Storage Environment Humidity 15 ~ 85%RH (Noncondensing) Atmospheric Pressure 105 kPa ~ 80 kPa Cu: Suitable for wrist circumference of 13.5 to 21.5cm Accessory: Batteries(2*AAA) If device is not used within specied temperature and humidity ranges the technical accuracy can not be ensured.13 What to do if… Problem Reason Solution Battery Icon is ashing • Batteries are at.

• Memory readings can be called up, but measure- ments are not possible. Insert new batteries. Err 1 Cu is not wrapped on the wrist well (too loose). Rewrap the cu tighter on the wrist. Err 2 • Arm moved during ination measurement.

• Systolic pressure is above 280mmHg Please do not move arm or speak when you take a measurement. No display No information on the display screen. Check the battery instal- lation for proper instal- lation of the batteries’ polarities Measurements appear too high or too low Blood pressure varies constantly during the day. Many factors such as stress, time of day, talking, coughing, laugh- ing, moving etc. when measuring will inuence the reading. Please read “Key rules for accurate blood pressure measurements” and “Taking a measurement” Prior to measurement, the positioning system (A) on the display does not work. Positioning system (A) is deactivated. Refer to the chapter «Select mode» to activate the positioning system (A).14 Type BF equipment Portable and mobile RF communications equipment can aect MEDICAL ELECTRICAL EQUIPMENT. MANUFACTURER 10°- 40°C. Temperature Limitation IP4X: International Protection rating 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. SYMBOL FOR THE MARKING OF ELECTRICAL AND ELECTRONIC DEVICES ACCORDING TO DIRECTIVE 2002/96/EC. Subject to change without notice.

Part 1: General requirements.

EN 1060-3/A1 1997 Non-invasive sphygmomanometers —

Part 3: Supplementary requirements for electro-

mechanical blood pressure measuring systems. EN 1060-4/A1 2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated noninvasive sphygmomanometers EN 60601-1/A2 1995 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN 60601-1-2 2007 Medical electrical equipment – part 1-2: General requirements for basic safety and essential performance – Collateral standard: electromagnetic compatibility – Requirements and tests EN ISO 14971 2007 Medical devices – Application of risk management to medical devices. EN ISO 10993-1 2003 Biological evaluation of medical devices –

Part 1: Evaluation and Testing.