microlife BPB3 Comfort PC Blood Pressure Monitor Instruction Manual

: June 9, 2024
: microlife

microlife BPB3 Comfort PC Blood Pressure Monitor

microlife-BPB3-Comfort-PC-Blood-Pressure-Monitor-product-
image

Microlife Corporation
9F, 431, RuiGuang Road, NeiHu
Taipei 11492, Taiwan, China
www.microlife.com

microlife-BPB3-Comfort-PC-Blood-Pressure-Monitor-15 Microlife UAB
P. Lukšio g. 32
08222 Vilnius
Lithuania

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.
Fit the cuff closely, but not too tight.
Position the cuff 1-2 cm above your elbow.
Keep your arm still and do not speak during the measurement.

Microlife BP B3 Comfort PC

Before each measurement

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

Guarantee Card

Name of Purchaser
Date of Purchase
Specialist Dealer

ON/OFF button
Display
M-button (memory)
MAM button
User Button
Cuff socket
Mains Adapter Socket
USB Port
Battery compartment
Cuff
Cuff connector
Cuff tube
Display
Systolic value
Diastolic value
Pulse rate
MAM Mode
Battery display
Cuff fit check
- A: Suboptimal cuff fit
- B: Arm movement indicator «Err 2»
- C: Cuff pressure check «Err 3»
Cuff signal indicator «Err 1»
Irregular heartbeat (IHB) symbol
MAM Interval time
Traffic light indicator
Pulse indicator
User indicator
Stored value
Date/Time

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

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 Microlite-Customer Service. Your dealer or pharmacy will be able to give you the address of the Microlite 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 is tested according to the ESH protocol and ISO81060-2:2013.
1. 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
2. Checklist for taking a reliable measurement
3. Taking a blood pressure measurement
  How not to store a reading
  How do I evaluate my blood pressure Appearance of the irregular heartbeat (IHB) symbol
4. Data memory
  Viewing the stored values
  Clearing all values
5. Battery indicator and battery change Low battery
  Flat battery – replacement
  Which batteries and which procedures
  Using rechargeable batteries
6. Using a mains adapter
7. PC-Link functions
8. Error Messages
9. 9. Safety, care, accuracy test and disposal Device care
  Cleaning the cuff
  Accuracy test
  Disposal
10. Guarantee
11. Technical Specifications

Using the device for the first time

Inserting the batteries
After you have unpacked your device, first insert the batteries.
The battery compartment 9 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

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 MAM button 4.
Press the M-button to set the month. Press the MAM button to confirm and then set the day.
Follow the instructions above to set the day, hour and minutes.
Once you have set the minutes and pressed the MAM button, the date and time are set and the time is displayed.
If you want to change the date and time, press and hold the MAM button for approx. 3 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 center of the upper arm).

Cuff size	for circumference of upper arm
S	17 – 22 cm
M	22 – 32 cm
M – L	22 – 42 cm
L	32 – 42 cm
L – XL	32 – 52 cm

Pre-shaped cuffs are optionally available.
Only use Microlife cuffs.
- Contact your local Microlife Service if the enclosed cuff AT does not fit.
- Connect the cuff to the device by inserting the cuff connector AK into the cuff socket 6 as far as it will go.
if you buy a spare Microlife cuff, please remove the cuff connector (1) from the cuff tube 12 from the cuff supplied with the original device and insert this cuff connector into he 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 BN) 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 analyzed 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, press the MAM button 4 until the MAM-symbol AP appears on the display. To change to standard mode (single measurement), press the MAM-button again, until the MAM-symbol disappears.
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.

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 (automatic triple measurement): see details in chapter 1.»
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 AR on the display indicates that the cuff is perfectly placed. If the icon AR-A appears, the cuff is fitted sub optimally, but it is still ok to measure.
The measurement is performed during the inflation. The inflation speed may vary, this is a normal occurrence.
During the measurement, the pulse indicator BM flashes in the display.
The result, comprising the systolic AM and the diastolic AN blood pressure and the pulse rate AO 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 automatically after approx. 1 min.).

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).

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

«CL» is displayed when the reading is deleted from the

How do I evaluate my blood pressure
The triangle on the left-hand edge of the display BL points at the range within which the measured blood pressure value 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.

Range	Systolic	Diastolic	Recommendation
1.	blood pressure too high	≥135	≥85
2.	blood pressure elevated	130 – 134	80 – 84
3.	blood pressure normal	< 130	< 80

How do I evaluate my blood pressure
The triangle on the left-hand edge of the display BL points at the range within which the measured blood pressure value 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.

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 stored values
Press the M-button 3 briefly, when the device is switched off.
The display first shows «M» BO, and «A» 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.

Blood pressure readings with suboptimal cuff fit AR-A are not considered in the average value.
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 MAM 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 AQ 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 AQ will flash as soon as the device is switched on (flat battery displayed). You cannot take any further measurements and must replace the batteries.

Open the battery compartment 9 at the back of the device.
Replace the batteries – ensure correct polarity as shown by the symbols in the compartment.
To set date and time, follow the procedure described in Section «1. 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.

Plug the adapter cable into the mains adapter socket 7 in the blood pressure monitor.
Plug the adapter plug into the wall socket.

When the mains adapter is connected, no battery current is consumed.

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 Micro-USB cable.
Microlife BP B3 Comfort PC

Error Messages

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

Error	Description	Potential cause and remedy
«Err 1» AS	Signal too weak	The pulse signals on the cuff are too weak.

Re-position 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 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 measure- ment.

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
The cuff delivered with this device is washable.

Remove the cuff connector AK from the cuff tube AL and care-fully pull the bladder through the opening at the edge of the cuff cover.
Hand wash the cuff cover in soapsuds: not hotter than 30 °C.
Completely dry the cuff cover by linen drying.
Loop the cuff tube back through its opening and carefully place the bladder flat in the cuff cover.
Reattach the cuff connector on the cuff tube.
- The bladder must lay straight in the cuff cover, not folded.
- Do not use fabric softener.

WARNING: Do not wash the cuff in a washing machine or dishwasher!
WARNING: Do not dry the cuff cover in a tumble dryer!
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

Operating
10 – 40 °C / 50 – 104 °F
conditions:
15-90 % relative maximum humidity
Storage conditions:
-20 – +55 °C / -4 – +131 °F
15-90 % relative maximum humidity
Weight:
402 g (including batteries)
Dimensions:
138 x 94.5 x 62.5 mm
Cuff size:
from 17-52 cm according to the cuff sizes
(see «Selecting the correct cuff»)
Measuring procedure:
oscillometric, corresponding to Korotkoff method: Phase I systolic, Phase V diastolic
Measurement range:
20 – 280 mmHg – blood pressure
40-199 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. 580 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