microlife BPW3 Comfort Wrist Blood Pressure Monitor User Manual

BPW3 Comfort Wrist Blood Pressure Monitor
User Manual BP W3 Comfort

BPW3 Comfort Wrist Blood Pressure Monitor

Microlife BP W3 Comfort

Guarantee Card
Name of Purchaser ………………………….
Serial Number……………………………………
Date of Purchase ………………………………..
Specialist Dealer ………………………………….

Microlife BP W3 Comfort

1. ON/OFF button

2. Display

3. M-button (memory)

4. Time button

5. Battery compartment

6. Cuff
   Display

7. Systolic value

8. Diastolic value

9. Pulse rate

10. Date/Time

11. Stored value

12. Traffic light indicator

13. Irregular heartbeat (IHB) symbol

14. Cuff signal indicator «ERR 1»

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

16. Pulse indicator

17. Battery display

| Read the important information in these instructions for use before using this device. Follow the  instructions for use for your  afety 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.
| Conformity mark
| Type approval of measuring device
| Unified sign of circulation of products on the market of the member states of the EurasianCustoms Union.
| Model number
| Catalogue number
| Serial number (YYYY-MM-DD-SSSSS; year-month-day-serial number)
| Caution
| Temperature limitation
| Humidity limitation
| Medical device
IP22| Protected against solid foreign objects of 12.5
mm Ø and greater. Protected against vertically
falling water drops when enclosure tilted up to
15°.
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| Keep away from children of age 0 – 3
0044| 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 Microlife-Customer Service. Your dealer or pharmacy will  beable 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 ISO810602:2013.

Important facts about blood pressure and selfmeasurement

• Blood pressure is the pressure of the blood flowing in the arteries generated by the pumping of the heart. Two values, the systolic (upper) value and the diastolic (lower)  value, are always measured.

• The device indicates the pulse rate (the number of times the heart beats in a minute).

• Permanently high blood pressure values can damage your health and must be treated by your doctor!

• Always discuss your values with your doctor and tell them if you have noticed anything unusual or feel unsure. Never rely on single blood pressure readings.

• There are several causes of excessively high blood pressure values. Your doctor will explain them in more detail and offer treatment where appropriate.

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

• Depending on physical exertion and condition, blood pressure is subject to wide fluctuations as the day progresses. You should therefore take your measurements in the same quiet conditions and when you feel relaxed! Take at least two readings every time (in the morning: before taking medications 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. Therefore we recommend using the MAM technology.

• 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.
  Therefore we recommend using the MAM technology.

• Leave a small break of at least 15 seconds between two measurements.

• If you suffer from an irregular heartbeat, measurements taken with this device should be evaluated with your doctor.

• 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.
  This monitor is specially tested for use in pregnancy and preeclampsia. 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.

Using the device for the first time

Inserting the batteries
After you have unpacked your device, first insert the batteries. The battery compartment 5 is on the bottom of the device. Insert the batteries (2 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.

Checklist for taking a reliable measurement

1.  Avoid activity, eating or smoking immediately before the measurement.
2. Sit down on a back-supported chair and relax for 5 minutes. Keep your feet flat on the floor and do not cross your legs.
3. Always measure in a sitting position and on the same wrist. Use the wrist which usually shows higher blood pressure values.
4. Remove any items of clothing and your watch, for example, so that your wrist is free.
5. Always ensure that the cuff is positioned correctly, as shown in the pictures illustrated on the short instruction card.
6. Fit the cuff comfortably but not too tight. The cuff will cover a wrist circumference of 13.5 – 23 cm (5.25 – 9.05 inches).
7. Support your arm in a relaxed position and ensure that the device 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 fit check AO on the display indicates that the cuff is perfectly placed. If the icon AO-A appears, the cuff is fitted suboptimally, but it is still ok to measure.
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 measurement is performed during the inflation. The inflation speed may vary, this is a normal occurence.
5. During the measurement, the pulse indicator AP flashes in the display.
6. The result, comprising the systolic 7 and the diastolic 8 blood pressure and the pulse rate 9 are displayed. Note also the explanations on further display symbols in this booklet.
7. Remove and switch off the monitor and enter the result in the enclosed blood pressure pass. (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).

How not to store a reading
As soon as the reading is displayed press and hold the ON/OFF button 1 until «M» AK 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 AL 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 AM 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  onitor 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» AK, 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 AO-A are not considered in the average value.
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» appears and  then release the  button. To permanently clear the memory, press the M-button while
«CL» 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 5 by pulling off the cap.
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 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 2 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.
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.

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 15-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 15-C| No pressure in the cuff| An adequate pressure cannot be generated in the cuff. A leak may have occurred. Check that the cuff is correctly connected and is not too loose. Replace the batteries if necessary. Repeat the measurement.
«ERR 5| Abnormalresult| 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.
«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 beatsper minute). Repeat the measurement.

• Please immediately consult your doctor, if this or any other problem occurs repeatedly.
  If you think the results are unusual, please read through the information in «Section 1.» carefully.

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 pressuriza tion, 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 wrist. 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 any marks on the cuff with a damp cloth and mild detergent.
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.

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

humidity
Weight:| 112 g (including batteries)
Dimensions:| 81 x 65 x 21 mm
Cuff size:| 13.5 – 23 cm (5.25 – 9.05 inches) oscillometric, corresponding to Korotkoff
Measuring| 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:| 2 x 1.5 V alkaline batteries; size AAA
Battery lifetime:| approx. 320 measurements (using new batteries)
IP Class:| IP 22
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

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

Microlife AG
Espenstrasse 139
9443 Widnau / Switzerland
www.microlife.com
**** 0044

References

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

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