MICROLIFE BP Blood Classic Pressure Monitor User Manual

MICROLIFE BP Blood Classic Pressure Monitor

Important facts about blood pressure

• 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 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 medication 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 succession 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 information about your blood pressure than just one single measurement.
• Leave a small break of 5 minutes between two measurements.
• If you are pregnant, you should monitor your blood pressure regularly as it can change drastically during this time.
• If you suffer from 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!

PRODUCT DESCRIPTION

1. ON/OFF button

2. Display

3. M-button (memory)

4. Time button

5. Cuff socket

6. Battery compartment

7. Cuff

8. Cuff connector

9. Cuff tube
   Display

10. Systolic value

11. Diastolic value

12. Pulse rate

13. Battery display

14. Traffic light indicator

15. Stored value

16. Pulse indicator

17. Cuff fit check

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

18. AR Cuff signal indicator «ERR 1»

19. Irregular heartbeat (IHB) symbol

20. Date/Time

Using the device for the first time

Inserting the batteries
After you have unpacked your device, first insert the batteries. The battery compartment 6 is on the bottom of the device. Insert the batteries (4 x 1.5 V, size AAA), 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 time button 4.
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. 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).

• Pre-shaped cuffs are optionally available.
• Only use Microlife cuffs.
• This device is not compatible with other Microlife cuff sizes except M and M-L.
  • Contact your local Microlife Service if the enclosed cuff 7 does not fit.
  • Connect the cuff to the device by inserting the cuff connector 8 into the cuff socket 5 as far as it will go.

3. 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 must lie over the artery which runs down the inner side of the arm.
  • Support your arm so it is relaxed.
  • Ensure that the cuff is at the same height as your heart.

Taking a blood pressure measurement

1. Press the ON/OFF button 1 to start the measurement.
2. The cuff will now pump up automatically. Relax, do not move and do not tense your arm muscles until the measurement result is displayed. Breathe normally and do not talk.
3. The cuff fit check AQ on the display indicates that the cuff is perfectly placed. If the icon AQ-A appears, the cuff is fitted suboptimally, but it is still ok to measure.
4. 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.
5. During the measurement, the pulse indicator AP flashes in the display.
6. The result, comprising the systolic AT and the diastolic AK blood pressure and the pulse rate AL are displayed. Note also the explanations on further display symbols in this booklet.
7. When the device has finished measuring, remove the cuff.
8. 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 or open the cuff (e.g. if you feel uneasy or an unpleasant pressure sensation).

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» AO is flashing. Confirm to delete the reading by pressing the time 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 AN points at the range within which the measured blood pressure value lies. The value is either within the optimum (white), elevated (hatched gray) or high (black) range. The classification corresponds to the following ranges defined by international guidelines (ESH, ESC, JSH). Data in mmHg.

The higher value is the one that determines the evaluation. Example: 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 AS indicates that an irregular heartbeat was detected. In this case, the measured blood pressure may deviate from your
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 the last 30 measurement values.

Viewing the stored values
Press the M-button 3 briefly, when the device is switched off. The display first shows «M» AO, 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 AQ-A are Pay attention that the maximum memory capacity of 30 memories is not exceeded. When the 30 memory is full, the oldest value is automatically overwritten with the 31 value. Values should be evaluated by a doctor before the memory capacity is reached – otherwise data will be lost.

Clearing all values
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 time button while «CL ALL» is flashing. Individual values cannot be cleared.
Cancel deletion: press ON/OFF button 1 while «CL

Battery indicator and battery change

Low battery
When the batteries are approximately ¾ empty the battery symbol AM 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 AM 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 battery compartment 6 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 «2. Using the device for the first time».
   The measurements stored in the memory are deleted whe the batteries are removed from the battery compartment (e.g. when replacing batteries).

Which batteries and which procedure?

• Use 4 new, long-life 1.5 V, size AAA 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.

Error messages

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

«ERR 1»

AR

| Signal too weak| The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measure- ment.*
«ERR 2»

AQ-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.
Error| Description| Potential cause and remedy
---|---|---
«ERR 3»

AQ-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 performing reliable measure- ments 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.*

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 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 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 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. .

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 intrave-nous 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 environmental 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 an oscillometric method to determine blood pressure. The arm being measured 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 measurements 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 the 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 waterproof. Do not spill or immerse the device in water or other liquids.

• Do not disassemble 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

• 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

•  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 3.3 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.
WARNING: Do not wash the cuff in a washing machine or dishwasher!

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.
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.

Technical specifications

• Operating conditions: 10 – 40 °C / 50 – 104 °F 15-90 % relative maximum humidity
• Storage conditions: -20 – +55 °C / -4 – +131 °F 15-90 % relative maximum humidity
• Weight: 251 g (including batteries)
• Dimensions: 124 x 92 x 61 mm
• Cuff size: 22 – 42 cm
• Measuring procedure: oscillometric, corresponding to Korotkoff
• method: Phase I systolic, Phase V diastolic
• Measurement range: 20 – 280 mmHg – blood pressure 40 – 200 beats per minute – pulse Cuff pressure display
• range: 0 – 299 mmHg
• Resolution: 1 mmHg
• Static accuracy: within ± 3 mmHg
• Pulse accuracy: ± 5 % of the readout value
• Voltage source: 4 x 1.5 V alkaline batteries; size AAA Mains adapter DC 6V, 600 mA (optional)
• Battery lifetime: approx. 400 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

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: Battery.

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.

References

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

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