microlife S-V11 2024 Bluetooth Blood Pressure Monitor User Guide

BPB6 Connect
Bluetooth® Blood Pressure Monitor
User Guide

S-V11 2024 Bluetooth Blood Pressure Monitor

Preparation

1| | Sit on a back-supported chair and keep your legs uncrossed.
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2| | Avoid thick or close-fitting garments on the upper arm.
3| | Place the artery-mark on the cuff over your artery.
4| | Fit the cuff closely, but not too tight.
5| | Position the cuff 1–2 cm above your elbow.
6| | Keep your arm still and do not speak during the measurement.

Microlife BP B6 Connect

Microlife BP B6 Connect

1 ON/OFF button
2 Display
3 M-button (memory)
4 Bluetooth/Time Button
5 User Button
6 Cuff socket
7 MAM Switch
8 Traffic light indicator
9 USB Port
10 Mains Adapter Socket
11 Battery compartment
12 Cuff| 13 Cuff tube
14 Cuff connector
Display
15 Active Bluetooth®
16 Systolic value
17 Diastolic value
18 Pulse rate
19 Battery display
20 Cuff fit check
-A: Suboptimal cuff fit
-B: Arm movement indicator «Err 2»
-C: Cuff pressure check «Err 3»| 21 Cuff signal indicator «Err 1»
22 Irregular heartbeat (IHB) symbol
23 Atrial Fibrillation Indicator (AFIB)
24 User indicator
25 MAM Mode
26 Stored value
27 Clinical Blood Pressure Average «MyBP»
28 Date/Time
29 Pulse indicator
30Average Indicator «MyCheck»
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Before each measurement

1| | Avoid eating, bathing, smoking or caffeine (approx. 30 min).
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2| | Avoid activity and relax for 5 –10 min.
3| | Measure before medication intake.

Guarantee Card

Name of Purchaser ————–
Serial Number ——————-
Date of Purchase —————–
Specialist Dealer ——————

| 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.
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| 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 for operating and storage
| Temperature limitation for operating or storage
| Medical device
| Keep away from children of age 0 – 3
| CE Marking of Conformity

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, pre-eclampsia, atherosclerosis, end-stage renal disease, obesity and the elderly.
The device can detect an irregular pulse suggestive of Atrial Fibril-lation (AF). Please note that the device is not intended to diagnose AF. A diagnosis of AF can only be confirmed by ECG. The patient is advised to see a physician.

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.*
Microlife AFIBsens is the world’s leading digital blood pressure measurement technology for the detection of atrial fibrillation (AF) and arterial hypertension. These are the two top risk factors of getting a stroke or heart disease. It is important to detect AF and hypertension at an early stage, even though you may not experience any symptoms. AF screening in general and thus also with the Microlife AFIB algorithm, is recommended for people of 65 years and older.
The AFIB algorithm indicates that atrial fibrillation may be present.
For this reason, it is recommended that you visit your doctor when the device gives an AFIB signal during your blood pressure measurement. The AFIB algorithm of Microlife has been clinically investigated by several prominent clinical investigators and showed that the device detects patients with AFIB at a certainty of 97–100%. 1,2
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 Corporation!

• 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.

¹Kearley K, Selwood M, Van den Bruel A, Thompson M, Mant D, Hobbs FR et al.: Triage tests for identifying atrial fibrillation in primary care: a diagnostic accuracy study comparing single-lead ECG and modified BP monitors. BMJ Open 2014; 4:e004565.
²Wiesel J, Arbesfeld B, Schechter D: Comparison of the Microlife blood pressure monitor with the Omron blood pressure monitor for detecting atrial fibrillation. Am J Cardiol 2014; 114:1046-1048.

Appearance of the Atrial Fibrillation Indicator for early Detection

(Active only in MAM mode)

This device is able to detect atrial fibrillation (AF). This symbol 23 indicates that atrial fibrillation was detected during the measurement. Please refer to the next paragraph for information regarding the consultation with your doctor.

Information for the doctor on frequent appearance of the atrial fibrillation indicator
This device is an oscillometric blood pressure monitor that also analyses pulse irregularity during measurement. The device is clinically tested.
The AFIB symbol is displayed after the measurement, if atrial fibrillation occurred during measuring. If the AFIB symbol appears after having performed a full blood pressure measurement episode (triplicate measurements), the patient is advised to perform another measurement episode (triplicate measurements). If the AFIB symbol appears again, we recommend the patient to seek medical advice.
If the AFIB-symbol appears on the screen of the blood pressure monitor, it indicates the possible presence of atrial fibrillation.
The atrial fibrillation diagnosis however, must be made by a cardiologist based on ECG interpretation.

Keep the arm still during measuring to avoid false readings.
This device may not or wrongly detect atrial fibrillation in people with pacemakers or defibrillators.
In the presence of atrial fibrillation the diastolic blood pressure value may not be accurate.
In the presence of atrial fibrillation using MAM-mode is recommended for more reliable blood pressure measurement.

What is Atrial Fibrillation (AF)?
Normally, your heart contracts and relaxes to a regular beat.
Certain cells in your heart produce electrical signals that cause the heart to contract and pump blood. Atrial fibrillation occurs when rapid, disorganized electrical signals are present in the heart’s two upper chambers, called the atria; causing them to contract irregularly (this is called fibrillation). Atrial fibrillation is the most common form of heart arrhythmia. It often causes no symptoms, yet it significantly increases your risk of stroke. You’ll need a doctor to help you control the problem.

Who should be screened for Atrial Fibrillation?
AF screening is recommended for people over 65 years of age, since the chance of having a stroke increases with age. AF screening is also recommended for people from the age of 50 years who have high blood pressure (e.g. SYS higher than 159 or DIA higher than 99) as well as those with diabetes, coronary heart failure or for those who have previously had a stroke.
In young people or in pregnancy AF screening is not recommended as it could generate false results and unnecessary anxiety. In addition, young individuals with AF have a low risk of getting stroke as compared to elder people.

Risk factors you can control
Early diagnosis of AF followed by adequate treatment can significantly reduce the risk of getting stroke. Knowing your blood pressure and knowing whether you have AF is the first step in proactive stroke prevention.
For more information visit our website: www.microlife.com/afib.

Using the device for the first time

Inserting the batteries
After you have unpacked your device, first insert the batteries. The battery compartment 11 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 ③. To confirm and then set the month, press the Bluetooth/Time button ④.
2. Press the M-button to set the month. Press the Bluetooth/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 Bluetooth/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 Bluetooth/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).

Only use Microlife cuffs.

▶ Contact your local Microlife Service if the enclosed cuff 12 does not fit.
▶ Connect the cuff to the device by inserting the cuff connector 14 into the cuff socket 6 as far as it will go.

If you buy a spare Microlife cuff, please remove the cuff connector 14 from the cuff tube 13 from the cuff supplied with the original device and insert this cuff connector into the tube of the spare cuff (valid for all cuff sizes).

Selecting the user
This device allows to store the results for 2 individual users.
▶ Select the intended user (user 1 or user 2 24 ) by pressing the user button 5.

Before each measurement, ensure that the correct user is selected.

Selecting standard or MAM mode
Before each measurement, select standard (single measurement) or MAM mode (automatic triple measurement). 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 obtained in this way is more reliable than when a single measurement is performed.

• To select MAM mode, slide the MAM switch 7 upwards to position «3» until the MAM symbol 25 appears on the display. To change to standard mode (single measurement), slide the MAM switch downwards to position «1».
• 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.

AF detection is only activated in MAM mode.

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

▶ Select standard (single measurement) or MAM mode (auto-matic triple measurement): see details in chapter «Using the device for the first time»
▶ Press the ON/OFF button 1 to start the measurement.
▶ 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.
▶ The cuff fit check 20 on the display indicates that the cuff is perfectly placed. If the icon 20 -A appears, the cuff is fitted suboptimally, but it is still ok to measure.
▶ 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.
▶ During the measurement, the pulse indicator 29 flashes in the display.
▶ The result, comprising the systolic 16 and the diastolic 17 blood pressure and the pulse rate 18 are displayed. Note also the explanations on further display symbols in this booklet.
▶ When the device has finished measuring, remove the cuff.
▶ Switch off the device. (The monitor does switch off automati-cally after approx. 1 min.).

AF detection is only activated in MAM mode.
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).
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. 1 hour). If the reading is still too high, consult your doctor or gynecologist.
In pregnancy the AFIB symbol can be ignored.

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 not to store a reading
As soon as the reading is displayed press and hold the ON/OFF button 1 until «M» 26 is flashing. Confirm to delete the reading by pressing the Bluetooth/Time button 4.

«CL» is displayed when the reading is deleted from the memory successfully.

How do I evaluate my blood pressure
The LED traffic light indicator on the left-hand side of the display 8 indicates within which range the measured blood pressure lies. The value is either within the optimum (green), elevated (yellow) or high (red) 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: a blood pressure value of 140/80 mmHg or a value of 130/90 mmHg indicates «blood pressure too high».

Average Indicator «MyCheck»
This symbol 30 indicates after each measurement, if the most recent measured value lies below, above or on the same level as your stored average value (see also chapter «5. Data memory»).

If the measured Systole or Diastole is more than 5mmHg higher than the stored average, the arrow shows upwards.
If the measured Systole or Diastole is more than 5mmHg lower than the stored average, the arrow shows downwards.
If the measured Systole and Diastole do not differ by more than 5mmHg from the stored average, the arrow shows straight on.
If the measured systole and diastole differ in different directions from the stored average, this is indicated first with the systole figure flashing, together with the up or down arrow for two seconds. Thereafter, the diastole figure flashes with the arrow pointing up or down for two seconds.

Appearance of the irregular heartbeat (IHB) symbol
This symbol 22 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 automatically stores up to 99 measurement values for each of the 2 users.
Select either user 1 or 2 by pressing the user button 5.

Viewing the average of the last 28 days
Press the M-button 3 again. The display first shows «M» 26 and «28A», which stands for the average measurement values of the last 28 days.

Blood pressure readings with suboptimal cuff fit 20 -A are not considered in the average value.

Viewing the clinical blood pressure average «MyBP»
Pressing the M-button 3 briefly when the device is switched off, allows you to see the average clinically relevant blood pressure «MyBP». The display first shows «M» 26 and «MyBP» 27. This average is only shown when 12 clinically relevant measurement values in the last 28 days have been performed.

Only measurements that were performed in the morning between 05:00–10:59 or in the evening between 17:00–22:59 are considered.
A maximum of 4 readings per day are considered (2 from the morning and 2 from the evening).
Measurements performed in standard mode and in MAM-mode are considered in the average, when they have been performed during the right time of the day.
Measurements performed in MAM-mode or single standard mode are both classed as single measurements for working out the «MyBP average».
Blood pressure readings with suboptimal cuff fit 20 -A are not considered in the average value.

Viewing the stored single values
Pressing the M-button again, allows you to see the last performed measurement. The display first shows «M» 26 and a value, e.g. «M17». This means that there are 17 single values in the memory. Pressing the M-button again displays the previous value. Pressing
the M-button repeatedly enables you to move from one stored value to another.

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

Clearing all values
Make sure the correct user is activated.
If you are sure that you want to permanently remove all stored values, hold down the M-button (the device must have been switched off beforehand) until «CL ALL» appears and then release the button. To permanently clear the memory, press the Blutetooth/Time button while «CL ALL» is flashing. Individual values cannot be cleared.

Cancel deletion: press ON/OFF button 1 while «CL ALL» is flashing.

Battery indicator and battery change

Low battery
When the batteries are approximately ¾ empty the battery symbol 19 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 19 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 11 at the back 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 «Using the device for the first time».

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

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 10 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.

Bluetooth® Function

Use the Bluetooth® function to transfer data to «Microlife Connected Health+» App on a smartphone (Android OS or iOS).
Information available on: www.microlife.com/technologies/connect

Bluetooth® operations

• Manually turn on Bluetooth®: Press Bluetooth/Time button 4 to activate Bluetooth®, Bluetooth® symbol 15 on display will blink.
• Automatically turn on Bluetooth®: Bluetooth® will activate automatically after a measurement. Bluetooth® symbol 15 on display will blink.
• Manually turn off Bluetooth®: Press ON/OFF button 1 to turn off Bluetooth®.
• Automatically turn off Bluetooth®: Bluetooth® will turn off automatically after 2 minutes if a smartphone does not connect to the device.

Bluetooth® pairing & app setup

1. Open «Microlife Connected Health+» App on the smartphone (Make sure the app is running in the foreground, not in the back- ground.)
2. Turn on Bluetooth® manually to connect device to smartphone.
3. When smartphone finds the device, the smartphone will show a message to pair with the device. Confirm on smartphone to complete pairing. Cancel to abort pairing.
4. After pairing, the app will show a message to setup the device user selection (1 or 2) to the app user profile. Confirm to proceed with setup. Cancel to abort setup (if user selection is incorrect).
5. After setup, the device will automatically exchange measurement data and date/time settings with the app. Bluetooth® turns off automatically after data exchange.

Bluetooth® status

• Bluetooth® symbol 15 blinking slowly: Bluetooth® is activated and waiting for connection.
• Bluetooth® symbol 15 not blinking: Bluetooth® connection established.
• Bluetooth® symbol 15 blinking rapidly: Bluetooth® connection error.

In case of Bluetooth® connection error, turn off device Bluetooth®, wait for a minute, then re-try Bluetooth® connection. Refer to chapter «10. Error messages» for details.

PC-Link functions

This device can be used in conjunction with a personal computer (PC) running the Microlife Blood Pressure Analyzer+ (BPA+) software. 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 Micro-USB cable.

Error messages

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

Re-position the cuff and repeat the measurement.
«Err 2» 20 – 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» 20 – 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 necessary. 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 reliable 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 measurement.*
| Bluetooth® symbol 15 blinks rapidly| Bluetooth® connection error. Turn off the device Bluetooth® and close the app on the smartphone. Wait for 1 minute, open the app on the smartphone and manually activate Bluetooth® on the device, to re-try Bluetooth® connection and data transfer.
«Err bt»| Bluetooth® self check error| Bluetooth® is malfunctioning. Contact your local Microlife distributor.

• 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.
  Please read this document thoroughly before using the device and keep for future reference.

• 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 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 individual sections of this instruction manual.

• 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.

Contra-indications
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 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 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.
• 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

• 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 soapsuds.

WARNING: 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 (see foreword).

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 guarantee:

• 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.

Technical specifications

15 – 90 % relative maximum humidity
Weight:| 415 g (including batteries)
Dimensions:| 157.5 x 105 x 61.5 mm
Measuring procedure:| oscillometric, corresponding to Korotkoff method: Phase I systolic, Phase V diastolic
Measurement range:| SYS: 60 – 255 mmHg
DIA: 40 – 200 mmHg
Pulse: 40 – 199 beats per minute
Cuff pressure display range:| 0 – 299 mmHg
Resolution:| 1 mmHg
Static accuracy:| within ± 3 mmHg
Pulse accuracy:| ± 5 % of the readout value
Wireless Communication:| Bluetooth® Low Energy
Compatibility:| iOS: iOS 15.0 or newer
Android: Android 11 or newer
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:| IEC 80601-2-30; 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 measure-ments, whichever comes first

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

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Microlife Corp. is under license. Other trademarks and trade names are those of their respective owners.

Microlife Corporation
9F, 431, RuiGuang Road, NeiHu
Taipei 11492, Taiwan, China
www.microlife.com
Microlife UAB
P. Lukšio g. 32
08222 Vilnius
Lithuania Microlife AG
Espenstrasse 139
9443 Widnau
Switzerland

References

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

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