N1 Basic - Blood pressure monitor MICROLIFE - Free user manual and instructions

USER MANUAL N1 Basic MICROLIFE

9443 Widnau / Switzerland

www.microlife.com

C€0044

microlife®

Digital blood pressure monitor with measurement markings and a wristwatch (no visible text or symbols on device body)

Microlife BP N1 Basic BP N1 Basic Guarantee Card

microlife

① ON/OFF button
② Display
③ M-button (memory)
④ Pump Ball Pin
⑤ Cuff Pin
⑥ Battery Compartment
⑦ Cuff
⑧ Quick-acting Discharge Valve
⑨ Pump ball

Display

⑩ Systolic Value
⑪ Diastolic Value
⑫ Pulse and Hypertension Indicator
⑬ Pulse Arrhythmia Indicator (PAD)
⑭ Air Pump-up
⑮ Battery Display
⑯ Stored Value
⑰ Air Discharge
⑱ Pulse Rate
⑲ Memory Number

Dear Customer,

Your new Microlife blood pressure monitor is a reliable medical device for taking measurements on the upper arm. 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 carried out prove its measurement accuracy to be of a very high standard.*

Please read through these instructions carefully so that you understand all functions and safety information. We want you to be happy with your Microlife product. 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 uses the same measuring technology as the «BP 3BTO-H» model tested according to the protocol of the European Society for Hypertension (ESH).

Table of Contents

1. Explanation of symbols

2. Important Facts about Blood Pressure and Self-Measurement

• How do I evaluate my blood pressure?

1. Using the Device for the First Time

2. Inserting the batteries

3. Selecting the correct cuff

4. Connecting the pump ball

5. Taking a Blood Pressure Measurement using this Device

• How not to store a reading

1. Appearance of the Heart Arrhythmia Indicator for early Detection
2. Appearance of the Hypertension Indicator

3. Data Memory

4. Viewing the stored values

5. Memory full

6. Clearing all values

7. Battery Indicator and Battery change

8. Low battery

9. Flat battery – replacement

10. Which batteries and which procedure?
    • Using rechargeable batteries

11. Error Messages

12. Safety, Care, Accuracy Test and Disposal

13. Safety and protection

14. Device care
15. Cleaning the cuff
16. Accuracy test

17. Disposal

18. Guarantee

19. Technical Specifications Guarantee Card

1. Explanation of symbols

Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not with domestic waste.

Read the instructions carefully before using this device.

Type BF applied part

Keep dry

Conformity mark

Type approval of measuring device

Eurasian Conformity mark

Serial number

Reference number

Manufacturer

Class II equipment

Operating temperature restriction 10 - 40 °C

Operating

Storage

C€0044

Storage temperature restriction -20 - +55 °C

CE Marking of Conformity

2. 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 him/her 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. Besides medication, weight loss and exercise can also lower your blood pressure.

- Under no circumstances should you alter the dosages of any drugs prescribed by 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 and in the evening) 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 at least 15 seconds between two measurements.

- If you suffer from an irregular heartbeat (arrhythmia, see «Section 5.»), 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 very closely as it can change drastically during this time!

This monitor is specially tested for use in pregnancy and pre-eclampsia. When you detect unusual high readings in pregnancy, you should measure again after 4 hours. If the reading is still too high, consult your doctor or gynecologist.

How do I evaluate my blood pressure?

Table for classifying home blood pressure values in adults in accordance with the international Guidelines (ESH, AHA, JSH). Data in mmHg.

Range Systolic Diastolic Recommendation
	blood pressure too low	↓ 100	↓ 60	Consult your doctor
1.	blood pressure optimum	100 - 130	60 - 80 Self-check
2.	blood pressure elevated	130 - 135	80 - 85 Self-check
3.	blood pressure too high	135 - 160	85 - 100 Seek medical advice
4.	blood pressure dangerously high	160 ↑	100 ↑ 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».

3. 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 at the back of the device. Insert the batteries (2 x 1.5 V, size AAA), thereby observing the indicated polarity.

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).

Cuff size for circumference of upper arm
S 17 - 22 cm
M	22 - 32 cm
L	32 - 42 cm

Only use Microlife cuffs.

When using an L cuff with this device, be sure to only use it with the corresponding black deflation valve.

• Contact your local Microlife Service if the enclosed cuff ⑦ does not fit.
  Connect the cuff tube to the cuff pin ⑤ as far as it will go.

Connecting the pump ball

Connect the tube of the pump ball ⑨ to the pump ball pin ④.

The pump ball and cuff can be placed on either pin ④ or ⑤.

4. Taking a Blood Pressure Measurement using this Device

Checklist for taking a reliable measurement

1. Avoid activity, eating or smoking immediately before the measurement.
2. Sit down for at least 5 minutes before the measurement and relax.
3. 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.
4. 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.
5. Always ensure that the correct cuff size is used (marking on the cuff).
6. Fit the cuff closely, but not too tight.
7. Make sure that the cuff is positioned 2 cm above the elbow.
8. 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.
9. Ensure that the cuff is at the same height as your heart.
10. Switch on the device and wait until «0» appears in the display and the arrow «▲» ⑭ starts to flash.
11. Take the pump ball in your free hand (the arm you are not measuring from) and pump up the cuff. Watch the pressure indication in the display and pump approx. 40 mmHg higher than the expected systolic value (the upper value). If you have not pumped enough, a flashing arrow «▲» ^14 will appear telling you to pump higher.
12. After pumping, the measurement is taken automatically. Relax, do not move and do not tense your arm muscles until the measurement result is displayed. Breathe normally and do not talk.
13. During the measurement, the pulse indicator ⑫ flashes in the display.
14. The result, comprising the systolic ⑩ and the diastolic ⑪ blood pressure and the pulse rate ⑱ is displayed. Note also the explanations on further display symbols in this booklet.
15. When the measurement has finished, press the quick-acting discharge valve ⑧ in order to release any remaining air in the cuff. Remove the cuff.
16. Switch off the device with ON/OFF button ①. (The monitor does switch off automatically after approx. 1 min.).

How not to store a reading

As soon as the reading is displayed press and hold the ON/OFF button ① until «M» ⑯ is flashing. Confirm to delete the reading by pressing the M-button ③.

You can interrupt the measurement at any time by pressing the quick-acting discharge valve ⑧ (e.g. if you feel uneasy or notice an unpleasant pressure sensation).

5. Appearance of the Heart Arrhythmia Indicator for early Detection

This symbol ⑬ indicates that certain pulse irregularities were detected during the measurement. In this case, the result may deviate from your normal blood pressure – repeat the measurement. In most cases, this is no cause for concern. However, if the symbol appears on a regular basis (e.g. several times a week with measurements taken daily) we advise you to tell your doctor.

Please show your doctor the following explanation:

Information for the doctor on frequent appearance of the Arrhythmia indicator

This device is an oscillometric blood pressure monitor that also analyses pulse frequency during measurement. The device is clinically tested.

The arrhythmia symbol is displayed after the measurement, if pulse irregularities occur during measurement. If the symbol appears more frequently (e.g. several times per week on measurements performed daily) we recommend the patient to seek medical advice.

This device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

6. Appearance of the Hypertension Indicator

This symbol ⑫ flashes at the end of the measurement, if either your systolic or diastolic blood pressure is higher than the recommended values in accordance with the international guidelines (ESH, AHA, JSH).

Systolic blood pressure: > 135 mmHg

Diastolic blood pressure: > 85 mmHg

7. 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 the last stored result.

Pressing the M-button again displays the previous value. Pressing the M-button repeatedly enables you to move from one stored value to another.

Memory full

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 31st value. Values should be evaluated by a doctor before the memory capacity is reached – otherwise data will be lost.

Clearing all values

All memory data are cleared when batteries are taken out of the device.

8. Battery Indicator and Battery change

Low battery

When the batteries are approximately 34 empty the battery symbol ^15 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 ⑮ 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 ⑥ at the back of the device.

2. Replace the batteries – ensure correct polarity as shown by the symbols in the compartment.

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.

9. Error Messages

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

Error Description Potential cause and remedy
«ERR 1»	Signal too weak	The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement.*
«ERR 2»	Error signal D	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»	No pressure in the cuff	An adequate pressure cannot be generated in the cuff. A leak may have occurred. Check that cuff and pump ball are correctly connected and that the cuff is not fitted too loosely. 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 measurements 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.*

* Please 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 2.» carefully.

10. 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.

• 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 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.
• 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.

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 soapsuds.

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). The verification time period is 2 years. Checking of blood pressure monitors is performed according to the document P 50.2.032-2004 «Recommendations about metrology. GSI. Measuring instruments of arterial pressure non-invasive. Checking technique». Confirmation of primary checking – You can find the electronic version of the certificate on the website www.alpha-medica.ru according to the name, model and serial number of the device. The original certificate is in Alpha-Medica.

Disposal

When the disposal of this device is required please contact a specialized organization, authorized to provide utilization according to the legislation of the Russian Federation.

11. Guarantee

This device is covered by a 5 year guarantee from the date of purchase. The guarantee is valid only on presentation of the guarantee card completed by the dealer (see back) confirming date of purchase or the receipt.

• Batteries and parts that become worn with use are not included.
• Opening or altering the device invalidates the guarantee.
• The guarantee does not cover damage caused by improper handling, discharged batteries, accidents or non-compliance with the operating instructions.
• The cuff has a functional guarantee (bladder tightness) for 2 years.

Please contact your local Microlife-Service (see foreword).

12. 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: 106 g (including batteries)

Dimensions:	115 x 59 x 30 mm
Measuring procedure:	oscillometric, corresponding to Korotkoff method: Phase I systolic, Phase V diastolic
Measurement range:	20 - 280 mmHg – blood pressure40 - 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:	2 x 1.5 V alkaline batteries; size AAA
Battery lifetime:	approx. 780 measurements(using new batteries)
Included accessories:	blood pressure monitor, cuff, pump ball with valve, 2 x AAA batteries, instruction manual, guarantee card
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 measurementsAccessories: 2 years
This device complies with the requirements of the Medical Device Directive 93/42/EEC.
Technical alterations reserved.

Date of production: first four digits of the serial number of the device. First and second digit – the week of the year / third and fourth digit – the year of production.

Microlife BP N1 Basic

RU