microlife BP AG1-20 Aneroid Blood Pressure Kit Instruction Manual

microlife BP AG1-20 Aneroid Blood Pressure Kit Instruction Manual

Name of Purchaser

1. Manometer
2. Cuff
3. Pump ball
4. Adjustable deflation valve
5. Stethoscope
6. Chest piece
7. Ear piece

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

Authorized representative in the European Community Catalogue number

Serial number (YYYY-MM-DD-SSSSS; year-month-day-serial number)

Caution

Humidity limitation

Temperature limitation

Medical device

Keep away from children of age 0 – 3

CE Marking of Conformity

Dear Customer,
This aneroid blood pressure kit is a mechanical blood pressure measuring device for use on the upper arm and ensures you a precise and consistent measurement.
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 or problems 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!

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.
• 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.
• 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.

How do I evaluate my blood pressure
Table for classifying home blood pressure values in adults in accordance with the international Guidelines (ESH, ESC, JSH).
Data in mmHg.

advice
5.| 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».

Using the device for the first time

Selecting the correct cuff
When choosing the correct size cuff the arm circumference should be measured at the centre of the upper arm. 22-32 cm (8.75-12.5 inches) should be the correct size for the majority of people.

Only use Microlife cuffs.

• Contact your local Microlife Service if the enclosed cuff 2 does not fit.

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 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).

   • 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.

6. Proper deflation rate is essential for an accurate reading. Practice and master a recommended deflation rate of 2-3 mmHg per second or a drop of 1-2 marks on the manometer 1 for each heartbeat

Measuring procedure

1. Place the chest piece 6 underneath the cuff 2 or 1-2 cm below it. Make sure the chest piece is in contact with the skin and lies on the brachial artery.
2. Plug in the ear piece 7 and check, if the chest piece is placed correctly, so that the Korotkoff sounds appear the loudest.
3. Close the valve 4 on the pump ball 3 by turning the screw clockwise. Do not over-tighten.
4. Take the pump ball 3 in your free hand (the arm you are not using to measure) and pump up the cuff. Watch the pressure indicator on the manometer 1 and pump up to approx. 40 mmHg higher than the expected systolic value (the upper value).
   • Inflate to 200 mmHg if you are not sure about the expected value.
5. Open the valve 4 slowly by turning the screw counter clockwise whilst holding the stethoscope chest piece 6 on the brachial artery. Listen carefully as the cuff begins to deflate. Note the reading on the manometer 1 as soon as you hear a faint, rhythmic tapping or thumping sounds. This is the systolic blood pressure reading.
6. Allow the pressure to continue dropping at the same deflation rate. Note the reading on the manometer 1 as soon as the thumping sound stops. This is the diastolic blood pressure reading.
7. Deflate the cuff completely.
8. Repeat the measurement at least two further times and record your values, date and time immediately after finishing the measurements.
9. Remove the cuff and the stethoscope.

Malfunction / Troubleshooting

If problems occur when using the device, the following points should be checked and if necessary, the corresponding measures are to be taken:

• Check the ear pieces if they are dirty or cracked. If not, make sure you wear them properly.
• Check the tube if it is broken or twisted.
• Check the chest piece if there is any damage.
• Make sure the chest piece is in contact with the skin and lies on the brachial artery. Clean or replace any defective parts if found to avoid inac- curate reading.

The pressure does notrise although the pump ball ➂ is pumping.|

• Make sure that the valve is closed.
• Make sure the cuff is properly connected to bulb and manometer.
• Check if the cuff, tube and/or bulb is leaking. Replace the defective parts if any.

The deflation rate can not be set to 2-3 mmHg/sec. by adjusting the valve ➃.| Disassemble the valve from pump ball to check if there is any blockage in the airway of the valve. Clean the blockage and try again. If it still does not work, replace it to avoid inaccurate readings.
The manometerneedle is not at 0 ± 3 mmHg at rest.|

• Make sure that the valve is completely open for zero check.
• If still more than 3 mmHg deviation, contact your dealer to recalibrate the manometer.

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.
• Never inflate beyond 300 mmHg.
• Always deflate the cuff completely before storage.
• Do not use this device if you think it is damaged or notice anything unusual.
• 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.

• Do not use this device in a moving vehicle (for example in a car or on an aircraft).
• Contraindicated for neonate use. Do not use with neonatal cuffs or neonate patients.
• The aneroid sphygmomanometer requires frequent recalibration (at least every 6 months).
• Expertise and retraining required to avoid observer error.
• It helps the user detect the Korotkoff sounds through a stethoscope for auscultation. The measurements and readings might be interfered by the noise around.
• Requires manual dexterity to ensure proper cuff deflation rate.
• Excellent hearing and vision are required for accurate measuments.

Side effects
Use of the device may be accompanied by minor side effects.

• A device can lose calibration (become inaccurate) when it is jostled or bumped, leading to false readings.
• Observers might have bias and terminal digit preference which lead to inaccurate readings.

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 two years or after mechanical impact (e.g. being dropped). Please contact your local Microlife- Service to arrange the test.

Guarantee

This device is covered by a 2 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

Weight: ≤ 540 g g (including batteries)
Dimensions: 185 x 75 x 110 mm / ± 1 mm
Storage conditions: -20 ~ +70 °C (-4 ~ 158 °F) 15~85 % relative maximum humidity
Operating conditions: 10 – 40 °C / 50 – 104 °F
Measurement range: 0 – 300 mmHg – blood pressure
Resolution: 2 mmHg
Static accuracy: within ± 3 mmHg
Pressure reduction rate: 2-3 mmHg/sec.
Air leakage: < ± 4 mmHg/min
Included accessories: M-cuff (22-32 cm), pump ball, valve, stethoscope, softbag
Reference to standards: EN ISO 81060-1 ANSI / AAMI SP09

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

References

• Hypertension and Fever Management - Microlife AG
• Support - Microlife AG
• Verenpainemittaus ja kuumemittaus - Microlife AG
• Microlife - Hipertenzijos ir karščiavimo kontrolė - Microlife AG
• Mājaslapa - Microlife AG

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