microlife V4-IT 1024 MAM Wrist Blood Pressure Monitor Instruction Manual

microlife V4-IT 1024 MAM Wrist Blood Pressure Monitor

Product Information

Specifications

• Manufacturer: Microlife
• Model: BP MAM Wrist
• Intended Use: Measuring non-invasive blood pressure in people aged 12 years or older
• Technology: MAM (Microlife Average Mode)
• Power Source: Batteries

Product Usage Instructions

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 also indicates the pulse rate.

• To begin using the device, select between standard mode or MAM mode. MAM mode, which stands for Microlife Average Mode, is recommended for more accurate readings.
• Sit in a comfortable position with your arm at heart level.
• Ensure the cuff is positioned correctly on your wrist.
• Press the ON/OFF button to start the measurement.
• Remain still and avoid talking during the measurement.
• Record your systolic, diastolic, and pulse rate values.
• The device will display an irregular heartbeat symbol if detected. It also has a data memory function to store past measurements for future reference.
• Monitor the battery indicator on the display to know when to change the batteries. To change batteries, follow the instructions provided in the manual.

FAQ

• Q: What should I do if I see an irregular heartbeat symbol on the device?
• A: If you see the irregular heartbeat symbol, consult with your healthcare provider for further evaluation.
• Q: How often should I replace the batteries in the device?
• A: Replace the batteries when the battery indicator on the display indicates low battery levels or when the device fails to power on.

Guarantee Card

OVERVIEW

1. ON/OFF button

2. Display

3. 1/3 button (MAM)

4. Battery compartment

5. Cuff
   Display

6. Systolic value

7. Diastolic value

8. Pulse rate

9. Stored value

10. MAM Mode

11. Irregular heartbeat (HB) symbol

12. Battery display

13. Pulse

SYMBOLS

• 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 under the locally applicable regulations, not with domestic waste.
• Authorized representative in the European Community
• Model number
• Catalogue number
• Serial number (YYYY-MM-DD-SSSSS; year-month-day-serial number)
• Caution
• Temperature limitation for operating or storage
• Humidity limitation for operating and storage
• Medical device
• Keep away from children of age 0 – 3
• CE Marking of Conformity

Intended use

This oscillometric blood pressure monitor is intended for measuring non- invasive blood pressure in people aged 12 years or older.
Dear Customer,
Your new Microlife blood pressure monitor is a reliable medical device for taking measurements on the wrist. It is simple to use, accurate and comes highly recommended for blood pressure monitoring in your home. This device was developed in collaboration with physicians and clinical tests prove its measurement accuracy to be very high.*
If you have any questions, or 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 clinically tested according to the British and Irish
  Hypertension Society (BIHS) protocol. Highest possible grading for Systolic (A) and Diastolic (A) measurement accuracy.

Important facts about blood pressure and self-measurement

• 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 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.
• 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 suffer from an irregular heartbeat AK (arrhythmia, see Section «Appearance of the irregular heartbeat (IHB) symbol»), 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.
• Several factors can affect the accuracy of measurements taken on the wrist. In some cases, the result may differ from the measurement taken on the upper arm. We therefore advise you to compare these values with those produced by the upper arm measurement and discuss them with your doctor.

How do I evaluate my blood pressure?
Table for classifying blood pressure values in adults under the World Health Organisation (WHO) in 2003. Data in mmHg.

your doctor
Range| Systolic| Diastolic| Recommendation
---|---|---|---
4.| blood pressure too high| 140 – 159| 90 – 99| Seek medical advice
5.| blood pressure far too high| 160 – 179| 100 – 109| Seek medical advice
6.| blood pressure dangerously high| ≥180| ≥110| Urgently seek medical advice!

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».

Using the device for the first time

Selecting standard or MAM mode
This device enables you to select either standard (standard single measurement) or MAM mode (automatic triple measurement). To select standard mode, press the MAM button 3 for 3 seconds while the device is switched off until «ON» starts flashing. Press the ON/ OFF button 1 to switch from «ON» to «OFF». The device is now set to standard mode (single measurement). The device then automatically turns off. To select MAM mode, repeat the sequence above until «ON» and the MAM symbol appear in the display. The MAM symbol is permanently displayed and the device is now set to MAM mode (automatic triple measurement).

MAM-Mode

• In MAM mode, 3 measurements are automatically taken in succession and the result is then automatically analyzed and displayed. Because blood pressure constantly fluctuates, a result determined in this way is more reliable than one produced by a single measurement.
• After pressing the ON/OFF button 1, the MAM-symbol AT appears in the display.
• 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 (15 seconds are adequate according to «Blood Pressure Monitoring, 2001, 6:145-147» for oscillometric instruments). A countdown indicates the remaining time and a beep will sound 5 seconds before the 2nd and 3rd readings will begin.
• 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.

Taking a blood pressure measurement

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 according to the information in the «Technical specifications».
7. Support your arm in a relaxed position and ensure that the device is at the same height as your heart.
8. Press the ON/OFF button 1 to start the measurement.
9. 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.
10. 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.
11. During the measurement, the heart symbol AM flashes in the display and a beep sounds every time a heartbeat is detected.
12. The result, comprising the systolic 6 and the diastolic 7 blood pressure and the pulse rate 8 is displayed and a long beep is heard. Note also the explanations on further display symbols in this booklet.
13. 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).

Appearance of the irregular heartbeat (IHB) symbol

• This symbol AK 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 always stores the last result at the end of the measurement.
• To recall the reading, press and hold the ON/OFF button 1 while the device is switched off. All display elements are shown now.
• Release the button when the stored result with the letter «M» 9 is displayed.

Battery indicator and battery change

Low battery
When the batteries are approximately ¾ empty the battery symbol AL 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 AL 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 4 by pulling off the cap.
2. Replace the batteries – ensure correct polarity as shown by the symbols in the compartment.

• 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.

weak. Re-position the cuff and repeat the measurement.*

«ERR 2»| 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»| 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.

If the 2-year warranty period has expired, it is recommended to replace it with a new Microlife cuff available at your pharmacy.

«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.*

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.

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 does not replace the need for the consultation of a physician, especially if not match 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 environmental conditions that lead to uncontrollable 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 incorrect application.
• DO NOT change the patient’s 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.
• 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 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

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 the 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 result 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 the 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

• 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: 130 g (including batteries)
• Dimensions: 80 x 70 x 70 mm
• Cuff size: 13.5 – 21.5 cm (5.25 – 8.5 inches)
• Measuring procedure: oscillometric, corresponding to Korotkoff method: Phase I systolic, Phase V diastolic
• Measurement range: SYS: 60 ~ 255 mmHg DIA: 40 ~ 200 mmHg Pulse: 40 – 200 beats per minute

Cuff pressure display

• range: 0 – 299 mmHg
• Resolution: 1 mmHg
• Static accuracy: within ± 3 mmHg
• Pulse accuracy: ± 5 % of the readout value
• Voltage source:   2 x 1.5 V alkaline batteries; size AAA
• Battery lifetime : approx. 460 measurements (using new batteries)
• IP Class: IP 20
• Reference to standards: IEC 80601-2-30; IEC 60601-1; IEC 60601-1-2 (EMC); IEC 60601-1-11
• Expected service life: Device: 5 years or 10000 measurements, whichever comes first Accessories: 2 years or 5000 measurements, whichever comes first

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

CONTACT

Microlife Corporation

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

References

• Aerosol, termometri, repellenti antizanzare - Colpharma
• Microlife
• Support - Microlife AG

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