microlife BPB2 Easy Blood Pressure Monitor Instruction Manual

microlife BPB2 Easy Blood Pressure Monitor

Preparation

Sit on a back-supported chair and keep your legs uncrossed.

Avoid thick or close-fitting garments on the upper arm.

Place the artery-mark on the cuff over your artery.

Fill the cuff closely, but not too tight.

Position the cuff 1-2 cm above your elbow

Microlife BP B2 Easy Package inside and parts overview

1. ON/OFF button
2. Display
3. Cuff socket
4. Mains Adapter Socket
5. Battery compartment
6. Cuff
7. Cuff tube
8. Cuff connector
9. Systolic value
10. Diastolic value
11. Pulse rate
12. Battery display
13. Cuff signal indicator «ERR 1
14. Irregular heartbeat (IHB) symbol
15. Traffic light indicator
16. Stored valu
17. Pulse indicator
18. Cuff fit chec
19. A:Suboptimal cuff fit
20. B:Arm movement indicator «ERR 2»
21. C:Cuff pressure check «ERR 3»

Before each measurement

Avoid eating, bathing, smoking or caffeine approx. 30 min. Avoid activity and relax for 5-10 min Measure before medication intake.

SYMBOLS

Read the important information in theseMinstructions for use before using this device. Type BF applied part Keep dry

Manufacturer

Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not with domestic waste.

Authorized representative in the European Community.

Serial number YYYY-MM-DD-SSSSS; year month dayserial number.

Caution

Humidity limitation

Temperature limitation

Medical device

Keep away from children of age 0 – 3

Intended use

This oscillometric blood pressure monitor is intended for  measuring non- invasive blood pressure in people aged 12 years or older. It is clinically validated in patients with hypertension, hypotension, diabetes, pregnancy, preeclampsia, atherosclerosis, end stage renal disease, obesity and the elderly. This device was developed in collaboration with physicians and clinical tests carried out prove its measurement accuracy to be of a very high standard. If you have any questions, problems or want to order spare parts please contact your local Microlife-Customer Service. Your dealer or pharmacy will be able to give you the address of the Microlife dealer in your country. Alternatively, visit the internet at www.microlife.com where you will find a wealth of invaluable information on our products.

Stay healthy Microlife AG
This device uses the same measuring technology as the award winning «BP 3BTO-A» model tested according to the British and Irish Hypertension Society (BIHS) protocol.

Using the device for the first time

Inserting the batteries

After you have unpacked your device, first insert the batteries. The battery compartment 5 is on the bottom of the device. Insert the batteries (4 x 1.5 V, size AA), thereby observing the indicated polarity.

Selecting the correct cuff

Microlife offers different cuff sizes. Select the cuff size to match the circumference of your upper arms (measured by close fitting in the centre of the upper arm.

Pre shaped cuffs are optionally available.

• Only use Microlife cuffs.
• Contact your local Microlife Service if the enclosed cuff 6 does not fit.
• Connect the cuff to the device by inserting the cuff connector 8 into the cuff socket 3 as far as it will go.

Checklist for taking a reliable measurement

• Avoid activity, eating or smoking immediately before the measurement.
• Sit down on a back-supported chair and relax for 5 minutes.
• Keep your feet flat on the floor and do not cross your legs.
• Always measure on the same arm normally left.
• It is recommended that doctors perform double arm measurements on a patients first visit in order to determine which arm to measure in the future.
• The arm with the higher blood pressure should be measured.
• Remove close-fitting garments from the upper arm.
• To avoid constriction, shirt sleeves should not be rolled up they do not interfere with the cuff if they are laid flat.
• Always ensure that the correct cuff size is used marking on the cuff.
• Fit the cuff closely, but not too tight.
• Make sure that the cuff is positioned 1-2 cm above the elbow.
• The artery mark on the cuff ca.3 cm long bar) must lie over the artery which runs down the inner side of the arm.
• Support your arm so it is relaxed.
• Ensure that the cuff is at the same height as your heart.

Taking a blood pressure measurement

1. Press the ON/OFF button 1 to start the measurement.
2. The cuff will now pump up automatically. Relax, do not move and do not tense your arm muscles until the measurement result is displayed. Breathe normally and do not talk.
3. The cuff fit check AR on the display indicates that the cuff is perfectly placed. If the icon AR A appears, the cuff is fitte suboptimally, but it is still ok to measure.
4. When the correct pressure is reached, the pumping stops and the pressure falls gradually.
5. If the required pressure was not reached, the device will automatically pump some more air into the cuff.
6. During the measurement, the pulse indicator AQ flashes in the display.
7. The result, comprising the systolic 9 and the diastolic AT blood pressure and the pulse rate AK are displayed. Note also the explanations on further display symbols in this booklet.
8. When the device has finished measuring, remove the cuff.
9. Switch off the device.
10. The monitor does switch off automatically after approx. 1 min.
11. You can stop the measurement at any time by pressing the ON/OFF button e.g. if you feel uneasy or an unpleasant pressure sensation.
12. This monitor is specially tested for use in pregnancy and pre eclampsia.
13. When you detect unusual high readings inpregnancy, you should measure after a short while again eg. 1 hour.
14. If the reading is still too high, consult your doctor or gynecologist.

Manual inflation

In case of high systolic blood pressure e.g. above 135 mmHg it can be an advantage to set the pressure individually.

• Press the ON/OFF button after the monitor has been pumped up to a level of approx. 30 mmHg shown on the display.
• Keep the button pressed until the pressure is about 40 mmHg above the expected systolic value – then release the button.
• How do I evaluate my blood pressure
• The triangle on the left-hand edge of the display AO points at the range within which the measured blood pressure value lies. The value is either within the optimum white, elevated (hatched gray) or high (black) range. The classification corresponds to the following ranges defined by international guidelines ESH, ESC, JSH.
• Data in mmHg

How do I evaluate my blood pressure

The triangle on the left-hand edge of the display AO points at the range within which the measured blood pressure value lies. The value is either within the optimum  white, elevated hatched gray or high (black) range. The classification corresponds to the following ranges defined by international guidelines (ESH, ESC, JSH). Data in mmHg

The higher value is the one that determines the evaluation.

Example
Ablood pressure value of 140/80 mmHg or a value of 130/90 mmHg indicates «blood pressure too high».

Appearance of the irregular heartbeat (IHB) symbol

This symbol AN indicates that an irregular heartbeat was detected. In this case, the measured blood pressure may deviate from your actual blood pressure values. It is recommended to repeat the measurement.

Information for the doctor in case of repeated appearance of the IHB symbol
This device is an oscillometric blood pressure monitor that also measures the pulse during blood pressure measurement and indicates when the heart rate is irregular.

Data memory

This device always stores the last result at the end of the measurement. To recall the reading, press and hold the ON/OFF button 1 while the device is switched off. Release the button as soon as all display elements are shown. The stored result will then be shown indicated with the letter M AP.

Battery indicator and battery change

Low battery

When the batteries are approximately ¾ empty the battery symbol AL will flash as soon as the device is switched on partly filled battery displayed. Although the device will continue to measure reliably, you should obtain replacement batteries.

Flat battery replacement

When the batteries are flat, the battery symbol AL will flash as soon as the device is switched on flat battery displayed. You cannot take any further measurements and must replace the batteries.

1. Open the battery compartment 5 at the back of the device.
2. Replace the batteries  ensure correct polarity as shown by the symbols in the compartment.

Which batteries and which procedure?

• Use 4 new, long-life 1.5 V, size AA alkaline batteries.
• Do not use batteries beyond their date of expiry.
• Remove batteries if the device is not going to be used for a prolonged period.

Using rechargeable batteries

You can also operate this device using rechargeable batteries.

• Only use «NiMH» type reusable batteries.
• Batteries must be removed and recharged when the flat battery symbol appears. They should not remain inside the device as they may become damaged (total discharge as a result of low use of the device, even when switched off.
• Always remove the rechargeable batteries if you do not intend to use the device for a week or more.
• Batteries cannot be charged in the blood pressure monitor.
• Recharge batteries in an external charger and observe the information regarding charging, care and durability.

Using a mains adapter

You can operate this device using the Microlife mains adapter DC 6V, 600 mA. Only use the Microlife mains adapter available as an original accessory appropriate for your supply voltage. Ensure that neither the mains adapter nor the cable are damaged.

1. Plug the adapter cable into the mains adapter socket 4 in the blood pressure monitor.
2. Plug the adapter plug into the wall socket.
3. When the mains adapter is connected, no battery current is consumed.

Error messages

If an error occurs during the measurement, the measurement is interrupted and an error message, e.g. ERR 3, is displayed

ERR 1

AM

| Signal too weak| The pulse signals on the cuff are too weak. Reposition the cuff and repeat the measurement.

ERR 2

AR-B

| Error signal| During the measurement, error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping your arm still.
ERR 3

AR-C

| Abnormal cuff pressure| 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 neces- sary. Repeat the measurement.
ERR 5| Abnormal result| The measuring signals are inaccurate and no result can therefore be displayed.
HI| Pulse or cuff pressure too high| The pressure in the cuff is too high over 299 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.

Please immediately consult your doctor, if this or any other problem occurs repeatedly.

Safety, care, accuracy test and disposal

Safety and protection

Follow instructions for use. This document provides important product operation and safety information regarding this device.

• This device may only be used for the purposes described in these instructions.
• The manufacturer cannot be held liable for damage caused by incorrect application.
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions.
• The cuffs are sensitive and must be handled with care.
• Only pump up the cuff once fitted.
• Do not use this device if you think it is damaged or notice anything unusual.
• Never open this device.
• The measurement results given by this device is not a diagnosis.
• It is not replacing the need for the consultation of a physician, especially if not matching the patient’s symptoms. Do not rely on the measurement result only, always consider other potentially occurring symptoms and the patient’s feedback.
• Calling a doctor or an ambulance is advised if needed.
• Ensure that children do not use this device unsupervised; some parts are small enough to be swallowed.
• Be aware of the risk of strangulation in case this device is supplied with cables or tubes.

Contraindications

• Do not use this device if the patient’s condition meets the following contraindications, to avoid inaccurate measurements or injuries.
• The device is not intended for measuring blood pressure in pediatric patients of age younger than 12 years old children, infant, or neonates.
• Presence of significant cardiac arrhythmia during measurement may interfere with blood pressure measurement and affect the reliability of blood pressure readings. Consult with your doctor about whether the device is suitable for use in this case.
• The device measures blood pressure using a pressured cuff. If the measuring limb suffers from injuries for example open wounds or under conditions or treatments for example intravenous drip making it unsuitable for surface contact or pressurization, do not use the device, to avoid worsening of the injuries or conditions.
• Patient motions during measurement may interfere with the measurement process and influence results.
• Avoid taking measurements of patients with conditions, diseases, and susceptible to environment conditions that lead to incontrollable motions (e.g. trembling or shivering) and inability to communicate clearly for example children and unconscious patients.
• The device uses oscillometric method to determine blood pressure.
• The arm being measure should have normal perfusion.
• The device is not intended to be used on a limb with restricted or impaired blood circulation.
• If you suffer with perfusion or blood disorders, consult your doctor before using the device.
• Avoid taking measurement on the arm on the side of a mastectomy or lymph node clearance.
• Do not use this device in a moving vehicle for example in a car or on an aircraft.

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

• This device may only be used for the intended uses described in this Instructions for Use.
• The manufacturer cannot be held liable for damage caused by incorrect application.
• Do not change the patient medication and treatment based the result of one or multiple measurements.
• Treatment and medication changes should be prescribed only by a medical professional.
• Inspect the device, cuff, and other parts for damage.
• DO NOT USE the device, cuff or parts if they appear damaged or operating abnormally.
• Blood flow of the arm is temporarily interrupted during measurement.
• Extended interruption of blood flow reduces peripheral circulation and may cause tissue injury.
• Beware of signs for example tissue discoloration of impeded peripheral circulatio if taking measurements continuously or for an extended period of time.
• Prolonged exposure to cuff pressure will reduce peripheral perfusion and may lead to injury.
• Avoid situations of extended cuff pressurization beyond normal measurements.
• In the case of abnormally long pressurization, abort the measurement or loose the cuff to depressurize the cuff.
• Do not use this device in oxygen rich environment or near flammable gas.
• The device is not water resistant or water proof. Do not spill or immerse the device in water or other liquids.
• Do not dissemble or attempt to service the device, accessory and parts, during use or in storage.
• Access to the device internal hardware and software is prohibited.
• Unauthorized access and servicing of the device, during use or in storage, may compromise the safety and performance of the device.
• Keep the device away from children and people incapable of operating the device. Beware of the risks of accidental ingestion of small parts and of strangulation with the cables and tubes of this device and accessories.

CAUTION
Indicates a potentially hazardous situation which, if not avoided may result in minor or moderate injury to the user or patient, or cause damage to the device or other property.

• The device is intended only for measuring blood pressure at upper arm.
• Do not measure other sites because the reading does not reflect your blood pressure accurately.
• After a measurement is completed, loosen the cuff and rest for > 5 minutes to restore limb perfusion, before taking another measurement.
• Do not use this device with other medical electrical ME equipment simultaneously.
• This may cause device malfunction or measurement inaccuracies.
• Do not use this device in proximity of high frequency HF surgical equipment, magnetic resonance imaging MRI equipment, and computerized tomography CT scanners.
• This may cause device malfunction and measurement inaccuracies.
• Use and store the device, cuff and parts in temperature and humidity conditions specified in the «Technical specifications».
• Usage and storage of the device, cuff and parts in conditions outside ranges given in the «Technical specifications» may results in device malfunction and the safety of usage.
• Protect the device and accessories from the following to avoid damaging the device water, other liquids, and moisture extreme temperatures impacts and vibrations direct sunlight contamination and dust.
• Stop using this device and cuff and consult with your doctor if you experience skin irritation or discomfort.

Electromagnetic Compatibility Information
This device is compliant with EN60601-1-2: 2015 Electromagnetic Disturbances standard. This device is not certified to be used in vicinity of High Frequency (HF) medical equipment.Do not use this device close to strong electromagnetic fields and portable radio frequency communication devices (for example microwave oven and mobile devices). Keep a minimum distance of 0.3 m from such devices when using this device.

Device care

Clean the device only with a soft, dry cloth.

Cleaning the cuff

The cuff delivered with this device is washable.

1. Remove the cuff connector 8 from the cuff tube 7 and carefully pull the bladder through the opening at the edge of the cuff cover.
2. Hand wash the cuff cover in soapsuds: not hotter than 30 °C.
3. Completely dry the cuff cover by linen drying.
4. Loop the cuff tube back through its opening and carefully place the bladder flat in the cuff cover.
5. Reattach the cuff connector on the cuff tube.
6. The bladder must lay straight in the cuff cover, not folded.
7. Do not use fabric softener.

WARNING
Do not wash the cuff in a washing machine or dishwasher. Do not dry the cuff cover in a tumble dryer! Under no circumstances may you wash the
inner bladder

Accuracy test
We recommend this device is tested for accuracy every 2 years or after mechanical impact e.g. being dropped. Please contact your local Microlife- Service to arrange the test

Disposal
Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not with domestic waste.

Guarantee
This device is covered by a 5 year guarantee from the date of purchase. During this guarantee period, at our discretion, Microlife will repair or replace the defective product free of charge. Opening or altering the device invalidates the guarantee. The following items are excluded from the guaranteeTraonsport csts and risks of transport.

• Damage caused by incorrect application or non-compliance with the instructions for use.
• Damage caused by leaking batteries.
• Damage caused by accident or misuse.
• Packaging/storage material and instructions for use.
• Regular checks and maintenance (calibration).
• Accessories and wearing parts: Batteries, power adapter optional.

The cuff is covered by a functional guarantee (bladder tightness) for 2 years. Should guarantee service be required, please contact the dealer from where the product was purchased, or your local Microlife service. You may contact your local Microlife service through our website: www.microlife.com/support. Compensation is limited to the value of the product. The guarantee will be granted if the complete product is returned with the original invoice. Repair or replacement within guarantee does not prolong
or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

Technical specifications

• Operating conditions:10 – 40 °C / 50 – 104 °F 15-90 % relative maximum humidity
• Storage conditions: -20 – +55 °C / -4 – +131 °F 15-90 % relative maximum humidity
• Weight:277 g (including batteries)
• Dimensions:  131 x 90 x 60.5 mm
• Cuff size: from 17-52 cm according to the cuff sizes
• Measuring procedure:oscillometric, corresponding to Korotkoff method: Phase I systolic, Phase V diastolic
• Measurement range: 20 – 280 mmHg – blood pressure 40-200 beats per minute pulse
• Cuff pressure display range:0 – 299 mmHg
• Resolution:1 mmHg
• Static accuracy:within ± 3 mmHg
• Pulse accuracy: ± 5 % of the readout value
• Voltage source: 4 x 1.5 V alkaline batteries; size AA
• Mains adapter DC 6V, 600 mA (optional)
• Battery lifetime: approx. 920 measurements (using new batteries)
• IP Class: IP 20
• Reference to standards: EN 1060-1 /-3 /-4; IEC 60601-1; IEC 60601-1-2 (EMC); IEC 60601-1-11
• Expected service life: Device: 5 years or 10000 measurements, whichever comes first Accessories 2 years or 5000 measurements, whichever comes first

This device complies with the requirements of the Medical Device Directive 93/42/EEC. Technical alterations reserved.

References

• The Most Iconic Photographs of All Time - LIFE
• Hypertension and Fever Management - Microlife AG
• Hypertension and Fever Management - Microlife AG
• Support - Microlife AG
• Preventief je gezondheid managen - Microlife Nederland - Microlife AG
• Advies of hulp nodig? | Microlife - Microlife AG

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