microlife BPB3 Comfort PC Blood Pressure and Pulse Rate Measuring Device Instruction Manual

microlife BPB3 Comfort PC Blood Pressure and Pulse Rate Measuring Device Instruction Manual

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 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.

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 MAM button 4.
2. Press the M-button to set the month. Press the MAM 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 MAM 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 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 centre of the upper arm).

• Contact your local Microlife Service if the enclosed cuff  10  does not fit.

• If you buy a spare  Microlife cuff, please remove the cuff connector  11  from the cuff tube  12 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).
  nnect the cuff to the device by inserting the cuff connector  11  into the cuff socket  6  as far as it will go.

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, press the MAM button  **4**  until the MAM-symbol  **16**  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 the 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. Select standard (single measurement) or MAM mode (automatic triple measurement): see details in chapter «1.».
2. Press the ON/OFF button  1  to start the measurement.
3. 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.
4. The cuff fit check  18  on the display indicates that the cuff is perfectly placed. If the icon  18-A  appears, the cuff is fitted sub optimally, but it is still ok to measure.
5. The measurement is performed during the inflation. The inflation speed may vary, this is a normal occurence.
6. During the measurement, the pulse indicator  23 flashes in the display
7. The result, comprising the systolic  13  and the diastolic  14  blood pressure and the pulse rate  15  is 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. (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»  25  is flashing. Confirm to delete the reading by pressing the MAM button  4.

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

How do I evaluate my blood pressure?
The triangle on the left-hand edge of the display  22 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.

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».

Appearance of the Irregular Heartbeat (IHB) Symbol
This symbol  20  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 stored values
Press the M-button  3  briefly, when the device is switched off. The display first shows  «M» 25  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 100th 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  17  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  17  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  9  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 1.».
   • The memory retains all values although date and time must be reset – the year number therefore flashes automatically after the batteries are replaced.

fety, 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.

Protect it from:

• water and moisture

• extreme temperatures

• impact and dropping

• contamination and dust

• direct sunlight

• heat and cold

• The cuffs are sensitive and must be handled with care.

• Do not exchange or use any other kind of cuff or cuff connector for measuring with this device.

• Only pump up the cuff once fitted.

• Do not use this device close to strong electromagnetic fields such as mobile telephones or radio installations. Keep a minimum distance of 3.3 m from such devices when using this device.

• Do not use this device if you think it is damaged or notice anything unusual.

• Never open this device.

• If the device is not going to be used for a prolonged period the batteries should be removed.

• Read the additional safety information provided within the individual sections of this instruction manual.  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 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.

• 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 him/her if you have noticed anything unusual or feel unsure. Never rely on single blood pressure readings.

• Under no circumstances should you alter the dosages of drugs or initiate a treatment without consulting your doctor.

• 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.

• 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.

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.

Microlife BP B3 Comfort PC Overview

1. ON/OFF button
2. Display
3. M-button (memory)
4. MAM button
5. User Button
6. Cuff Socket
7. Mains Adapter Socket
8. USB Port
9. Battery Compartment
10. Cuff
11. Cuff Connector
12. Cuff Tube
13. Systolic Value
14. Diastolic Value
15. Pulse Rate
16. MAM Mode
17. Battery Display
18. Cuff Fit Check
    • -A:  Suboptimal Cuff Fit
    • -B:  Arm Movement Indicator «Err 2»
    • -C: Cuff Pressure Check «Err 3»
    • Cuff Signal Indicator «Err 1»
19. Irregular Heartbeat (IHB) Symbol
20. MAM Interval Time
21. Traffic Light Indicator
22. Pulse Indicator
23. User Indicator
24. Stored Value
25. Date/Time

•  Read the instructions carefully before using this device.
•  Type BF applied part
•  Keep dry

Intended use:
This oscilloscope 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 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

Preparation

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

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.
   

Before each measurement

1. Avoid eating, bathing, smoking or caffeine (approx. 30 min).
   

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

Micro life BP B3 Comfort PC EN

1. ON/OFF button

2. Display

3. M-button (memory)

4. MAM button

5. User Button

6. Cuff socket

7. Mains Adapter Socket

8. USB Port

9. Battery compartment

10. AT Cuff

11. AK Cuff connector

12. AL Cuff tube
    Display

13. Systolic value

14. AN Diastolic value

15. AO Pulse rate

16. AP MAM Mode

17. AQ Battery display

18. AR Cuff fit check

    • A: Suboptimal cuff fit
    • B: Arm movement indicator «Err 2»
    • C: Cuff pressure check «Err 3»

19. AS Cuff signal indicator «Err 1»

20. BT Irregular heartbeat (IHB) symbol

21. BK MAM Interval time

22. BL Traffic light indicator

23. BM Pulse indicator

24. N User indicator

25. BO Stored value

26. BP Date/Time

Read the instructions carefully before using
this device.
Caution
Type BF applied part
Keep dry
Type approval of measuring device
Unified sign of circulation of products on the market of the member states of the Eurasian Customs Union
Serial number
(YYYY-MM-DD-SSSSS;
year-month-day-serial number)
Catalogue number
Manufacturer
Class II equipment
Temperature limitation
Keep away from sunlight
Recycling
CE Marking of Conformity
Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not with domestic waste.
Please immediately consult your doctor, if this or any other problem occurs repeatedly.
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 AK from the cuff tube AL 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.

• 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 conditions:
  10 – 40 °C / 50 – 104 °F
  15 – 95 % relative maximum humidity

• Storage conditions:
  -20 – +55 °C / -4 – +131 °F
  15 – 95 % relative maximum humidity

• Weight:  402 g (including batteries)

• Dimensions:  138 x 94.5 x 62.5 mm

• 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:  pressure 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:  IP20

• 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
  • Accessories:  2 years

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

Guarantee Card

Name of Purchaser : ____
Serial Number: ____
Date of Purchase : __
Specialist Dealer :___
  Microlife AG
Espenstrasse 139
9443 Widnau / Switzerland
www.microlife.com
  Microlife UAB
P. Lukšio g. 32,
08222 Vilnius
Lithuania

References

• Hypertension and Fever Management - Microlife AG
• Hypertension and Fever Management - Microlife AG
• Support - Microlife AG

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