Beurer BC 58 User Manual [en, es]

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BC 58

ENGLISH

ESPANOL

Blood pressure monitor
Instruction manual .....................	2
Tensiómetro
Manual de instrucciones .........	27

READ THIS MANUAL COMPLETELY AND

CAREFULLY BEFORE USING THIS PRODUCT

Keep this manual in a safe location for future reference

LEA TODO ESTE MANUAL CON ATENCIÓN ANTES DE USAR ESTE PRODUCTO

Conserve este manual en un lugar seguro para consultarlo en el futuro

Beurer North America LP

Hallandale Beach, FL 33009

www.beurer.com

ENGLISH

IMPORTANT SAFETY NOTES

Signs and symbols

The following signs appear in the Safety Section (pages 2, 3, 4, 5, 6, 7) and in this manual on pages 11, 12, 13, 14, 17, 18, 20, 21.

READ THIS ENTIRE MANUAL, THE SAFETY SECTION AND ALL INSTRUCTIONS AND WARNINGS COMPLETELY AND CAREFULLY BEFORE USING THIS PRODUCT. FOLLOW ALL SAFETY INSTRUCTIONS AND WARNINGS TO AVOID HAZARDOUS SITUATIONS AND TO MAKE CORRECT USE OF THIS PRODUCT.

WARNING WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE NOTICE addresses practices not related to personal injury, such as product and/or property damage.

WARNING:

•Consult your physician before starting to measure your blood pressure.

•Read and understand all instructions and warnings before using this device.

•Like any oscillometric blood pressure measurement devices, certain medical conditions can affect the measurement accuracy, among others:

–disorder of the cardiac rhythm

–very low blood pressure

–patients in shock

–patients with very low blood perfusion

–diabetes

–vessel anomalities

–people with electrical implants, such as a cardiac pacemaker

–women who are pregnant.

Due to their condition the oscillometric measurement method can produce incorrect readings. This represents a risk for your health, since values may be interpreted incorrectly. Always consult your physician to determine what will be suitable for you.

•Never try to adapt or plug this device to the AC line. This device is battery powered.

•This product does not and is not intended to provide a medical diagnosis. Measurements results are for reference only. Self-diagnosis and treatment, e.g. regarding medication, using measured results represent a risk for your health. Always consult with a licensed physician for determination of appropriate medication and dosage thereof. Follow the instructions of your physician or licensed healthcare provider. If you have or suspect

that you have a medical problem, promptly consult your physician. If you have an emergency please call 911 immediately.

•Only a physician or a trained health care professional who is familiar with your medical history is able to accurately interpret your blood pressure measurements. Consult your physician before starting blood pressure monitoring.

•This product is not intended to serve as a substitute for the advice of a physician or medical professional. This product is not intended to substitute for regular medical checkups. Contact your physician for specific information about your blood pressure.

•Please note that technically related measuring tolerances are possible. Please see section “12. Technical Specifications” for details.

•Any cuff related blood pressure measurement in high repetition rates, can lead to severe measurement side effects, e.g.

–a nerval compression with temporary arm/hand paralysis

–the release of an arterial or venous thrombus, which can cause a life threatening situation.

Please contact your physician about the specific risks of cuff pressure in your specific case.

WARNING:

•The ‘irregular heartbeat’ function does not replace a cardiac examination, but may help to detect potential pulse irregularities at an early stage. Always consult your physician to determine what will be suitable for you.

•The ‘irregular heartbeat’ function is not designed for diagnosing or treating an arrhythmic disorder. Arrhythmia can only be ascertained by a licensed physician.

•The WHO chart is not intended to replace a medical diagnosis. This chart is only a reference for different classifications of blood pressure.

•If you notice abnormal or suspicious variations in blood pressure measurements, consult your physician immediately.

•Prior to use, you have to ensure that the blood pressure monitor is free of damage. If in doubt, do not use the unit and contact customer service. Please see warranty for service contact.

•This device is intended only for personal, non-commer- cial, adult use in measuring blood pressure and pulse rate. Do not use the product for any other purpose. This product is not intended for use in a hospital, physician’s office, or any other health care facility.

•The unit must be used in accordance to the specified ambient conditions, otherwise the accuracy of readings

might be affected. See section “9. Care, maintenance and storing the instrument” and section “12. Technical Specifications” for details.

•Do not wrap the cuff around body parts other than your left wrist. Misuse represents a risk to your health.

•Use this monitor only on humans.

•Swallowing batteries and/or battery fluid can be extremely dangerous. Keep the batteries and the unit out of the reach of children and disabled persons. Should any person swallow a battery and/or battery fluid, please call 911 immediately.

•Batteries should not be charged or reactivated by any other means. The batteries may explode.

•Batteries should not be taken apart, thrown in the fire or short circuited. The batteries may explode.

•Should battery fluid leak and come into contact with your eyes or skin immediately rinse with plenty of clean water. Please call 911 immediately.

•This product is not intended for use by or on children, toddlers and infants or on persons who cannot express their consent, e.g. persons with mental disorders or the like. Consult your physician for alternative methods of measuring a child’s blood pressure.

•This product is not a toy. Keep it out of reach of children, toddlers, and infants.

•Keep the product out of the reach of pets.

•Do not drop this monitor or subject it to strong impact.

•Packaging materials are a deadly hazard for children and can cause suffocation. Remove all packaging materials immediately and keep them away from children at all times.

•This product contains small parts that may present a choking hazard to children. Keep the unit and all parts out of reach of children. NEVER LEAVE CHILDREN OR THOSE WHO REQUIRE CLOSE SUPERVISION UNATTENDED WITH THIS DEVICE.

•People with disabilities, activity limitations, or who are physically frail, should be assisted by another person when using this unit.

•Proper cuff size is important for accurate measurements. Only use the device on adults who have the right wrist circumference for this instrument. See section “12. Technical Specifications” for suitable wrist circumferences.

•Do not use any accessories other than those explicitly recommended by “Beurer North America” for use with this product. Parts and accessories not approved for use with the device may cause damage to your health and to the product.

To prevent such interference, use the unit at a sufficient distance from such devices or turn the devices off.

•Do not measure your blood pressure while operating a vehicle or in any situation which requires your full attention.

CAUTION:

•The device should not be used when your arm/wrist has been wounded/injuried or when a catheter has been inserted. Such use may result in injury.

•Remove any kind of wrist jewelry or the like before taking a measurement. This could cause bruises.

•Do not place the wrist cuff over heavy clothing (e.g. a jacket or sweater sleeve) as the blood pressure monitor will not be able to take a proper measurement and there is an elevated danger of acquiring hematoma or skin marks during the course of the measurement.

•In case the cuff does not stop inflating, interrupt the measurement by pressing the START/STOP button and open the cuff at once.

•If a battery has leaked do not touch the battery fluid. Avoid skin contact (e.g. put on protective gloves) and clean the battery compartment with a dry cloth.

•Do not disassemble the unit, it may result in injuries.

CAUTION:

•Blood pressure measurements can lead to temporary marks on the skin at the site of the cuff placement. This is especially the case in high repetition rates, in hypertonic patients and in patients with weak pulses. In rare cases a mark may persist for a couple of days. Please contact your physician about these specific risks of cuff pressure in your specific case.

•For hygienic reasons the cuff is intended only for the use by one person.

NOTICE:

•The blood pressure monitor is made up of precision electronic components. Accuracy of readings and the instrument’s service life depend on careful handling. Protect the unit against hard knocks (e.g. dropping the unit), moisture, water, dirt, dust, chemicals, extreme hot or cold temperatures, major temperature fluctuations, direct exposure to sunlight and heat sources which are too close (e.g. stoves, heating radiators). This may damage the unit. The device must be stored in the specified ambient conditions. Please see section “9. Care, maintenance and storing the instrument” and section “12. Technical Specifications” for details.

•Do not use any aggressive solvents, cleaning agents, detergents or any other strong chemicals to clean the device.

•Never immerse and or spill water or any other liquid onto the monitor or any components, otherwise liquid will enter it and cause damage.

•Do not wash the unit in a washing machine, dish washer or tumble dryer.

•Observe the local regulations for material disposal. Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.

•Batteries can contain toxins that are harmful to the environment. Always dispose of batteries in accordance with applicable local regulations. Do not dispose of batteries with normal household waste.

•Always use the size and type of battery indicated. The use of other batteries will damage the device.

•Never use different types of batteries, battery brands or batteries with different capacities. This may damage the unit. You should preferably use alkaline batteries.

•Never use rechargeable batteries. This may damage the unit.

•Always replace all batteries at the same time and use batteries of the same type.

•Remove the batteries if the monitor will not be used for a month or more to avoid damage of battery leakage.

•Replace weak batteries before they discharge complete-

ly. When appears in the display please change the batteries.

•Leaking batteries may damage the device. If you do not intend to use the unit for longer periods, remove the batteries from the battery compartment before placing the device in storage.

•Never attempt to repair, open and/or disassemble the unit (including cuff and optional accessory) or adjust it yourself. This may damage the unit and impair the functions. If you need to have the unit repaired, please contact our customer service. Please see warranty for service contact. Before submitting any complaint, first check the batteries and replace them if necessary.

•Changes or modifications to the device will nullify the user warranty.

•Do not drop or insert any object into any opening. This may damage the unit.

•Do not press the buttons with excessive force or with pointed objects.

•This blood pressure monitor is verified by auscultatory method. It is recommended that you check annex B of ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for details of verification method if you need.

•Blood pressure measurements determined by this monitor are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard Institute, Electronic or automated sphygmomanometers.

Contents

IMPORTANT SAFETY NOTES...............................................			2
	WARNING ........................................................................		2
	CAUTION .........................................................................		5
	NOTICE ............................................................................		6
1.	Getting to know your instrument...................................		8
2.	Important information.....................................................		8
3. Package Contents...........................................................			9
4.	Unit description/Icons in the display............................		9
5.	Inserting/Replacing batteries .....................................		11
6.	Measuring blood pressure ...........................................		12
	6.1	Positioning cuff .........................................................	14
	6.2	Correct posture.........................................................	15
	6.3	General Notes ...........................................................	15
	6.4	Taking Measurement.................................................	16
7.	Evaluating results..........................................................		17
	7.1	Irregular heartbeat symbol........................................	17
	7.2	WHO (World Health Organization) ............................	18
8.	Saving, retrieving and deleting results........................		19
9.	Care, maintenance and storing the instrument .........		20
10.	Alarm/error messages/troubleshooting....................		21
11. FCC Statement ..............................................................			22
12.	Technical Specifications...............................................		23
13.	Glossary .........................................................................		24
14.	Warranty.........................................................................		24

SAVE THESE INSTRUCTIONS FOR FUTURE REFERENCE

If the instruction manual is damaged or if you no longer have the instruction manual in your possession, please contact customer service at 1-800-536-0366 or at info@beurer.com

Dear Customer,

Thank you for choosing this Beurer product. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage and air.

Please read and understand these instructions completely and carefully before using this product and keep them for later reference. Be sure to make them accessible to other users and observe the information they contain.

With best regards,

Your Beurer Team

1. Getting to know your instrument

The wrist blood pressure monitor is used for non-invasive measurement and monitoring of adults’ arterial blood pressure. This allows you to quickly and easily measure your blood pressure and to display the last recorded measurement. The values determined are classified and graphically evaluated according to WHO guidelines.

2. Important information

Signs and symbols

The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and accessories:

Caution

Note

Note on important information

Follow instructions for use

Type BF applied part (cuff)

Direct current

				Disposal in accordance with EC Directive
				Disposal in accordance with EC Directive
				2002/96/EC – WEEE (Waste Electrical and
				Electronic Equipment).


				Manufacturer

			55°C	Temperature limitation
-20°C

				Permissible storage humidity
	RH ≤95%			Permissible storage humidity
	RH ≤95%

				Keep dry

		SN		Serial number
				The CE labelling certifies that the product
				complies with the essential requirements of
0483				complies with the essential requirements of
0483				Directive 93/42/EEC on medical products.

3. Package Contents

•Wrist Blood Pressure monitor BC 58

•Instruction manual

•Storage box

•2 x 1.5V AAA alkaline batteries

•USB-Cable

4. Unit description/Icons in the display

	1	1.	Display
6	2	1.	Display
6	2	2.	Memory button MEM
		2.	Memory button MEM
		3. START/STOP button


		3 4.	USB interface
		5.	Touch screen activation
			switch
		6.	Battery cover
	5
	4

Touch screen activation switch

The device features a touch screen display. To prevent the screen from being activated accidentally, keep the touch screen activation switch set to OFF when the device is not in use. To operate the device, move the touch screen activation switch to ON. When the touch screen display is touched (START/STOP buttonor MEM button), a beep is output.

Tip: You can switch off the device at any time by setting the touch screen activation switch to the OFF position.

1.Time and date

2.WHO classification

3.Systolic pressure

4.Diastolic pressure

5.Measured pulse

6.“Change battery” icon

7.Pump up, release air (arrow)

8.Memory display ( ), average value ( ), morning ( ), evening ( )

9.Cardiac arrhythmia icon

9		1
9
	AM
8	PM
8	M	2
8		2
8		3
7		3
7
6
5		4
	NOPUL /min

For product information, questions or customer service call toll free 1-800-536-0366 or e-mail info@beurer.com.

Beurer blood pressure monitors also allow you to transfer your measured values to the PC.

To do this you require a USB cable (included in delivery) and the Beurer “Health Manager”.

You can download the “Health Manager” program free of charge from www.beurer.com/service/download.

System requirements for the Beurer Health Manager PC Software:

1.Supported operating systems:

• Windows XP SP3

• Windows Vista SP1 or later

• Windows 7

• Windows 7 SP1

2.Supported architectures:

•x86 (32 bit)

•x64 (64 bit)

3. Hardware requirements:

•Recommended: at least Pentium 1 GHz or faster with at least 1 GB RAM

•Free memory on the primary partition of at least:

–x86 – 600 MB

–x64 – 1.5 GB

•Graphic resolution from: 1024 x 768 pixels

•USB port 1.0 or later

5. Inserting/Replacing batteries

WARNING:

•Batteries should not be charged or reactivated by any other means. The batteries may explode.

•Batteries should not be taken apart, thrown in the fire or short circuited. The batteries may explode.

•Should battery fluid leak and come into contact with your eyes or skin immediately rinse with plenty of clean water. Please call 911 immediately.

CAUTION:

•If a battery has leaked do not touch the battery fluid. Avoid skin contact (e.g. put on protective gloves) and clean the battery compartment with a dry cloth.

NOTICE:

•Always use the size and type of battery indicated. The use of other batteries will damage the device.

•Never use different types of batteries, battery brands or batteries with different capacities. This may damage the unit. You should preferably use alkaline batteries.

•Never use rechargeable batteries. This may damage the unit.

•Always replace all batteries at the same time and use batteries of the same type.

•Replace weak batteries before they discharge com-

pletely. When appears in the display please change the batteries.

•Leaking batteries may damage the device. If you do not intend to use the unit for longer periods, remove the batteries from the battery compartment before placing the device in storage.

Note: To conserve the batteries, the monitor switches off automatically if you do not press any buttons for 1 minute.

Inserting battery

•Open the battery compartment lid.

•Use exclusively brand-name batteries of the type: 2x1.5V AAA (Alkaline Type LR03). Making absolutely sure

that you insert them with the correct polarity as marked. Do not use re- chargeable batteries.

• Replace the battery cover carefully.

If the battery change is continuously illuminated, measurement is no longer possible and you must replace all the batteries. Once batteries have been removed from the device, the time must be reset.

Setting date and time

You should set the date and time without fail. Otherwise, you will not be able to save your measured values correctly with a date and time and to access them again later.

The time can be shown in 12-hour AM/PM or 24-hour universal clock.

Tip: If you press and hold the MEM button, you can set the values more quickly.

To set the date and time, proceed as follows:

•Move the touch screen activation switch to the ON position.

•Press the START/STOPand MEM buttons simultaneously.

•24 h is displayed. Press the MEM button to choose the 12-hour AM/PM or 24-hour universal clock. Confirm your

selection with START/STOP .

Note:

– If you select 24-hour time format date will be displayed Day/Month. – If you select 12-hour time format date will be displayed Month/Day.

• The year display will start to flash. Set the year with the MEM button and confirm with START/STOP .

• Then set the month, day, hour and minutes and confirm each setting with START/STOP .

•Pressing the START/STOP buttonagain will switch the display off.

6. Measuring blood pressure

WARNING:

•Consult your physician before starting to measure your blood pressure.

•Read and understand all instructions and warnings before using this device.

•Like any oscillometric blood pressure measurement devices, certain medical conditions can affect the measurement accuracy, among others:

–disorder of the cardiac rhythm

–very low blood pressure

–patients in shock

–patients with very low blood perfusion

–diabetes

–vessel anomalities

–people with electrical implants, such as a cardiac pacemaker

–women who are pregnant.

•Never try to adapt or plug this device to the AC line. This device is battery powered.

•Prior to use, you have to ensure that the blood pressure monitor is free of damage. If in doubt, do not use the unit and contact customer service. Please see warranty for service contact.

•The unit must be used in accordance to the specified ambient conditions, otherwise the accuracy of readings might be affected. See section “9. Care, maintenance and storing the instrument” and section “12. Technical Specifications” for details.

•Do not wrap the cuff around body parts other than your left wrist. Misuse represents a risk to your health.

•Use this monitor only on humans.

•People with disabilities, activity limitations, or who are physically frail, should be assisted by another person when using this unit.

WARNING:

•Electromagnetic interference: Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave ovens) while it is in operation, as inaccurate measurements may result. To prevent such interference, use the unit at a sufficient distance from such devices or turn the devices off.

•Do not measure your blood pressure while operating a vehicle or in any situation which requires your full attention.

CAUTION:

•The device should not be used when your arm/wrist has been wounded/injuried or when a catheter has been inserted. Such use may result in injury.

•Remove any kind of wrist jewelry or the like before taking a measurement. This could cause bruises.

•In case the cuff does not stop inflating, interrupt the measurement by pressing the START/STOP button and open the cuff at once.

•For hygienic reasons the cuff is intended only for the use by one person.

6.1 Positioning cuff

Note: Always properly position the Arm Cuff on your wrist, according to the following instructions.

1	2	”	3
		.4
		cm/01cm
		1

•Bare your left wrist, making sure that the circulation in the arm is not restricted by tight clothing or other objects that are too tight. Position the cuff on the inside of your wrist. Do not place the wrist cuff over heavy clothing (e.g. a jacket or sweater sleeve) as the blood pressure monitor will not be able to take a proper mea-

surement.

• • • • • • • • • • • • •

•Fasten the cuff with the Velcro fastening so that the upper edge of the monitor is positioned approx. 0.4” (1 cm) below the ball of your thumb.

•The cuff has to be fitted tightly around the wrist but should not constrict it.

6.2 Correct posture

•Rest at least for 5 minutes before each measurement. Otherwise there may be erroneous results.

•You can perform the measurement either sitting or lying down. Always

make sure that the cuff is on a level with your heart. Otherwise there may be serious divergences. Relax your arm and the palms of your hands.

•In order not to distort the result, it is important to keep still during the measurement and not talk. The most precise measurement results are obtained if you strive for a relaxed measurement situation. You may close your eyes and breathe calmly during the measurement.

•Please note that any muscle movement during inflation or deflation can cause measurement error.

6.3 General Notes

•For reliable monitoring and reference of blood pressure, keeping long-term records is recommended.

•Always measure on the same wrist.

•Do not share the cuff with other infecitve person to avoid cross-infection.

•To minimize measurement variations due to physical activity, rest at least 5 minutes before measuring your blood pressure (or 15 minutes after strenuous activity). You should not be physically tired or exhausted while taking measurement.

•In order to obtain a resting condition blood pressure, avoid eating, drinking alcohol and caffeinated beverages, smoking, exercising, and bathing for at least 30 minutes before taking a measurement.

•Stress raises blood pressure.

•Perform measurements in a quiet and relaxed environment at room temperature.

•Always wait at least 5 minutes between measurements to allow the blood circulation in your arm to return to normal. Prolonged over-inflation of the bladder may cause ecchymoma of your arm. You may need to increase the wait time depending on your individual physiological characteristics. Because of normal physiologic changes and the many external factors influencing blood pressure, it is unusual to obtain identical blood pressure measurements, even when taken a few minutes apart. Speak with your physician to determine what is affecting your blood pressure and which variation may be seen as normal in your case.

•The accuracy of any blood pressure measurement with this device can be affected by a multitude of causes. Some can be avoided some have to be accepted at the time of measurement. Speak with your physician about possible causes affecting your blood pressure.

•Do not inflate the cuff unless wrapped around wrist.

•If no button is pressed for approx. 1 minute the automatic shut off function shuts off the unit in order to preserve the batteries.

•Do not touch the unit and cuff and/or press any buttons when measurement is in progress, except for stopping the measurement. Doing so may cause incorrect readings.

6.4 Taking Measurement NOTE:

If you are using the unit for the first time, please remove the protective film from the display.

•Move the touch screen activation switch to the ON position.

•Switch on the blood pressure monitor with the START/

STOP button . After the full-screen display, the most recently used user memory appears ( or ). To change the user memory, press the MEM button and confirm your selection with the START/STOP button

. If no button is pressed, the most recently used user memory is automatically used after 5 seconds.

•Before the measurement, the last saved test result is briefly displayed. If there is no measurement in the memory, the instrument always displays the value 0.

•The cuff is pumped up first time to 190 mmHg. Cuff air pressure is released slowly.

If a tendency towards high blood pressure is already detectable, the cuff is pumped up again and cuff pressure

increased further. As soon as a heart rate is detected, the heart rate symbolis displayed.

•After the pressure has been completely reduced, the systolic pressure, diastolic pressure and pulse readings are displayed.

•You can cancel the measurement at any time by pressing the START/STOP buttonor by pushing the touch screen activation button to OFF.

•Er appears if it has not been possible to perform the measurement properly. Observe the section in these instructions on error messages/troubleshooting and repeat the measurement.

•The test result is saved automatically.

•To switch off the device, press the START/STOP button

or push the touch screen activation switch to OFF. If you forget to switch off the device, it switches off automatically after approx. 1 minute.

Wait at least 5 minutes before taking another measurement.

7. Evaluating results

WARNING:

•Please note that technically related measuring tolerances are possible. Please see section “12. Technical Specifications” for details.

•If you notice abnormal or suspicious variations in blood pressure measurements, consult your physician immediately.

•If Irregular Heartbeat (IHB) brought by common arrhyt-

mias is detected in the procedure of blood pressure measurement, a signal ofwill be displayed. Under

this condition, the Electronic Sphygmomanometer can keep function, but the results may not be accurate, it´s suggested that you consult with your physician for accurate assessment. There are 2 conditions under which the signal of IHB will be displayed:

1)The coefficient of variation (CV) of pulse period >25%.

2)The difference of adjacent pulse period ≥0.14s, and the number of such pulse takes more than 53 per-

centage of the total number of pulse.

Note: A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency.

7.1 Irregular heartbeat symbol

WARNING:

•The ‘irregular heartbeat’ function is not designed for diagnosing or treating an arrhythmic disorder. Arrhythmia can only be ascertained by a licensed physician.

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