BP A3L Comfort - Blood pressure monitor MICROLIFE - Free user manual and instructions

USER MANUAL BP A3L Comfort MICROLIFE

Display Intended use: This oscillometric blood pressure monitor is intended for measuring non-invasive blood pressure in people aged 12 years or older. Dear Customer, 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 Microlife BP A3L Comfort

1 ON/OFF button 2 Display 3 Cuff socket 4 Battery compartment 5 Mains Adapter Socket 6 Cuff 7 Cuff connector 8 USB Port 9 MAM Switch AT User switch AK M-button (memory) AL Time button AM User indicator AN Battery display AO Date/Time AP Systolic value AQ Diastolic value AR Pulse rate AS Traffic light indicator BT MAM Interval time BK Pulse indicator BL Cuff check indicator BM MAM Mode BN Irregular heartbeat (IHB) symbol BO Arm movement indicator BP Stored value Read the important information in these instructions for use before using this device. Follow the instructions for use for your safety and keep it for future reference. 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 Catalogue number Serial number (YYYY-MM-DD-SSSSS; year-month-day-serial number) Caution Humidity limitation Temperature limitation Medical device Keep away from children of age 0 - 3 CE Marking of Conformity

dealer in your country. Alternatively, visit the internet at www.microlife.com where you will find a wealth of invaluable infor- mation on our products. Stay healthy – Microlife AG!

• This device is tested according to the ESH protocol and ISO81060-2:2013. Table of contents

1. Important facts about blood pressure and

self-measurement How do I evaluate my blood pressure

2. Using the device for the first time

Inserting the batteries Setting the date and time Selecting the correct cuff Selecting the user Selecting standard or MAM mode MAM mode (highly recommended)

3. Taking a blood pressure measurement

Checklist for taking a reliable measurement How not to store a reading

4. Appearance of the irregular heartbeat (IHB) symbol

Installation and data transmission

8. Battery indicator and battery change

Low battery Flat battery - replacement Which batteries and which procedure? Using rechargeable batteries

11. Safety, care, accuracy test and disposal

Device care Cleaning the cuff Accuracy test Disposal

1. Important facts about blood pressure and

self-measurement Blood pressure is the pressure of the blood flowing in the arteries generated by the pumping of the heart. Two values, the systolic (upper) value and the diastolic (lower) value, are always measured. The device indicates the pulse rate (the number of times the heart beats in a minute). Permanently high blood pressure values can damage your health and must be treated by your doctor! Always discuss your values with your doctor and tell them if you have noticed anything unusual or feel unsure. Never rely on single blood pressure readings. There are several causes of excessively high blood pressure values. Your doctor will explain them in more detail and offer treatment where appropriate. Under no circumstances should you alter the dosages of drugs or initiate a treatment without consulting your doctor. Depending on physical exertion and condition, blood pressure is subject to wide fluctuations as the day progresses. You should therefore take your measurements in the same quiet conditions and when you feel relaxed! Take at least two readings every time (in the morning: before taking medica- tions and eating / in the evening: before going to bed, bathing or taking medication) and average the measurements. It is quite normal for two measurements taken in quick succes- sion to produce significantly different results. Deviations between measurements taken by your doctor or in the pharmacy and those taken at home are quite normal, as these situations are completely different. Several measurements provide much more reliable informa- tion about your blood pressure than just one single measure- ment. Leave a small break of 5 minutes between two measurements. If you suffer from a cardiac arrhythmia consult with your doctor before using the device. See also chapter «Appearance of the irregular heartbeat (IHB) symbol» of this user manual. The pulse display is not suitable for checking the frequency of heart pacemakers! If you are pregnant, you should monitor your blood pressure regularly as it can change drastically during this time.3Microlife BP A3L Comfort

How do I evaluate my blood pressure Table for classifying home blood pressure values in adults in accordance with the international Guidelines (ESH, ESC, JSH). Data in mmHg. The higher value is the one that determines the evaluation. Example: a blood pressure value of 140/80 mmHg or a value of 130/90 mmHg indicates «blood pressure too high».

2. Using the device for the first time

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

1. After the new batteries are fitted, the year number flashes in the

display. You can set the year by pressing the M-button AK. To confirm and then set the month, press the time button 9.

2. Press the M-button to set the month. Press the time button to

confirm and then set the day.

3. Follow the instructions above to set the day, hour and minutes.

4. Once you have set the minutes and pressed the time button, the

date and time are set and the time is displayed.

5. If you want to change the date and time, press and hold the time

button for approx. 7-8 seconds until the year number starts to flash. Now you can enter the new values as described above. 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).

Contact your local Microlife Service if the enclosed cuff 6 does not fit.

Connect the cuff to the device by inserting the cuff connector 7 into the cuff socket 3 as far as it will go. Selecting the user This device allows to store the results for 2 individual users.

Before each measurement, set the user switch AT for the intended user: user 1 or user 2.

User 1: slide the user switch AT upwards to the user 1 icon.

User 2: slide the user switch AT downwards to the user 2 icon. Selecting standard or MAM mode This device enables you to select either standard (standard single measurement) or MAM mode (automatic triple measurement). To select standard mode, slide the MAM switch 9 on the side of the device downwards to position «1» and to select MAM mode, slide this switch upwards to position «3».

This monitor is specially tested for use in pregnancy and pre-eclampsia. When you detect unusual high readings in pregnancy, you should measure after a short while again (eg. 4 hour). If the reading is still too high, consult your doctor or gynecologist. Range Systolic Diastolic Recommendation

normal < 120 < 74 Self-check

130 - 134 80 - 84 Self-check

dangerously high ≥ 160 ≥ 100 Urgently seek medical advice! Cuff size for circumference of upper arm M 22 - 32 cm M - L 22 - 42 cm L 32 - 42 cm

Pre-shaped cuffs are optionally available.

If you buy a spare Microlife cuff (size S, 17-22 cm), please remove the cuff connector from the cuff tube from the cuff supplied with the original device and insert this cuff connector into the tube of the spare cuff (only valid for cuff size S).

The first person to measure should select user 1.4 MAM mode (highly recommended) In MAM mode, 3 measurements are automatically taken in succession and the result is then automatically analysed and displayed. Because the blood pressure constantly fluctuates, a result determined in this way is more reliable than one produced by a single measurement. When you select the 3 measurements, the MAM-symbol BM appears in the display. The bottom, right hand section of the display shows a 1, 2 or 3 to indicate which of the 3 measurements is currently being taken. There is a break of 15 seconds between the measurements. A count down indicates the remaining time. The individual results are not displayed. Your blood pressure will only be displayed after all 3 measurements are taken. Do not remove the cuff between measurements. If one of the individual measurements was questionable, a fourth one is automatically taken.

3. Taking a blood pressure measurement

Checklist for taking a reliable measurement

1. Avoid activity, eating or smoking immediately before the

2. 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.

3. Always measure on the same arm (normally left). It is recom-

mended 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.

4. 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.

5. 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.

6. Press the ON/OFF button 1 to start the measurement.

7. 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.

8. When the correct pressure is reached, the pumping stops and

the pressure falls gradually. If the required pressure was not reached, the device will automatically pump some more air into the cuff.

9. During the measurement, the pulse indicator BK flashes in the

display. 10.The result, comprising the systolic AP and the diastolic AQ blood pressure and the pulse rate AR are displayed. Note also the explanations on further display symbols in this booklet. 11.When the device has finished measuring, remove the cuff. 12.Switch off the device. (The monitor does switch off automati- cally after approx. 1 min.). How not to store a reading As soon as the reading is displayed press and hold the ON/OFF button 1 until «M» BP is flashing. Confirm to delete the reading by pressing the M-button AK.

4. Appearance of the irregular heartbeat (IHB) symbol

This symbol BN 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.

5. Traffic light indicator in the display

The bars on the left-hand edge of the display AS show you the range within which the indicated blood pressure value lies. Depending on the height of the bar, the readout value is either within the optimum (green), elevated (yellow), too high (orange) or

You can stop the measurement at any time by pressing the ON/OFF button or open the cuff (e.g. if you feel uneasy or an unpleasant pressure sensation). 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.5Microlife BP A3L Comfort

dangerously high (red) range. The classification corresponds to the 4 ranges in the table as defined by the international guidelines (ESH, ESC, JSH), as described in «Section 1.».

6. PC-Link functions

This device can be used in conjunction with a personal computer (PC) running the Microlife Blood Pressure Analyzer+ (BPA+) soft- ware. The memory data can be transferred to the PC by connecting the monitor via a cable. If no download-voucher and cable is included download the BPA+ software from www.microlife.com/software and use a USB cable with a Mini-B 5 pin connector. Installation and data transmission

1. Connect the monitor via the cable to the PC; there is no need to

switch the device on. 3 horizontal bars will appear on the display and last for 3 seconds.

2. The bars will then flash to indicate that the connection between

PC and device is successful. As long as the cable is plugged in, the bars will keep flashing and the buttons are disabled.

This device automatically stores up to 99 measurement values for each of the 2 users. Viewing the stored values Select either user 1 or 2 with the user switch AT. Press the M-button AK briefly, when the device is switched off. The display first shows «M» BP, and «28A»which stands for the average of all stored values. Pressing the M-button again displays the previous value. Pressing the M-button repeatedly enables you to move from one stored value to another. Memory full Clearing all values Make sure the correct user is activated.

1. Select either user 1 or 2 with the user switch AT, when the

device is switched off.

2. Hold down the M-button AK until «CL» appears and then

3. Press the M-button while «CL» is flashing to permanently clear

all values of the selected user.

8. Battery indicator and battery change

Low battery When the batteries are approximately ¾ empty the battery symbol AN 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 AN 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 4 on the bottom of the device.

2. Replace the batteries – ensure correct polarity as shown by the

symbols in the compartment.

3. To set date and time, follow the procedure described in Section

«2. Using the device for the first time». Which batteries and which procedure?

During the connection, the device is completely controlled by the computer.

Pay attention that the maximum memory capacity of 99 memories per user is not exceeded. When the 99 memory is full, the oldest value is automatically overwritten with the 100th value. Values should be evaluated by a doctor before the memory capacity is reached – otherwise data will be lost.

Individual values cannot be cleared.

The memory retains all values although date and time must be reset – the year number therefore flashes automatically after the batteries are replaced.

The memory retains all values although date and time must be reset – the year number therefore flashes automatically after the batteries are replaced.

Do not use batteries beyond their date of expiry.

Remove batteries if the device is not going to be used for a prolonged period.6 Using rechargeable batteries You can also operate this device using rechargeable batteries.

9. Using a mains adapter

You can operate this device using the Microlife mains adapter (DC 6V, 600 mA).

1. Plug the adapter cable into the mains adapter socket 5 in the

blood pressure monitor.

2. Plug the adapter plug into the wall socket.

When the mains adapter is connected, no battery current is consumed. 10.Error Messages If an error occurs during the measurement, the measurement is interrupted and an error message, e.g. «Err 3», is displayed.

• Please immediately consult your doctor, if this or any other problem occurs repeatedly. 11.Safety, care, accuracy test and disposal Follow instructions for use. This document provides important product operation and safety information regarding this device. Please read this document thoroughly before using the device and keep for future reference.

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.

Only use the Microlife mains adapter available as an orig- inal accessory appropriate for your supply voltage.

Ensure that neither the mains adapter nor the cable are damaged. Error Description Potential cause and remedy «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 your 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 neces- sary. Repeat the measurement. «Err 5» Abnormal result The measuring signals are inaccurate and no result can therefore be displayed. Read through the checklist for taking a reliable measurement and then repeat the measurement.* «Err 6» MAM Mode There were too many errors during the measurement in MAM mode, making it impossible to obtain a final result. Read through the checklist for taking a reli- able measurement and then repeat the measurement.* «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 measure- ment.*

If you think the results are unusual, please read through the information in «Section 1.» carefully. Safety and protection Error Description Potential cause and remedy7Microlife BP A3L Comfort

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 condi- tions described in the «Technical Specifications» section. 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. Read the additional safety information provided within the indi- vidual sections of this instruction manual. The measurement results given by this device is not a diag- nosis. It is not replacing the need for the consultation of a physi- cian, 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. Do not use this device if the patient’s condition meets the following contra-indications, 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 intrave- nous drip) making it unsuitable for surface contact or pressur- ization, 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 pres- sure. 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 mastec- tomy or lymph node clearance. Do not use this device in a moving vehicle (for example in a car or on an aircraft). 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 medica- tion changes should be prescribed only by a medical profes- sional. Inspect the device, cuff, and other parts for damage. DO NOT USE the device, cuff or parts if they appear damaged or oper- ating abnormally. Blood flow of the arm is temporarily interrupted during measure- ment. Extended interruption of blood flow reduces peripheral circulation and may cause tissue injury. Beware of signs (for example tissue discoloration) of impeded peripheral circulation 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. 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. Contra-indications WARNING8 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. 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) equip- ment 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) equip- ment, 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 This device has 2 user settings. Please ensure it is cleaned and disinfected between users to prevent any cross contamination. 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 Carefully remove spots on the cuff with a damp cloth and soap- suds. 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 (see foreword). Disposal 12.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 guarantee: CAUTION

WARNING: Do not wash the cuff in a washing machine or

WARNING: Do not dry the cuff cover in a tumble dryer!

WARNING: Under no circumstances may you wash the

inner bladder! Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not with domestic waste.9Microlife BP A3L Comfort

Transport costs 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. 13.Technical Specifications This device complies with the requirements of the Medical Device Directive 93/42/EEC. Technical alterations reserved. Operating conditions:

Storage conditions: -20 - +55 °C / -4 - +131 °F Weight: Dimensions: Cuff size: Measuring procedure:

385 g (including batteries) 143 x 85 x 58 mm from 22 - 42 cm according to the cuff sizes (see «Selecting the correct cuff») oscillometric, corresponding to Korotkoff method: Phase I systolic, Phase V diastolic Measurement range: 20 - 280 mmHg – blood pressure