microlife PF 200 Asthma Monitor Instruction Manual

microlife PF 200 Asthma Monitor

Specifications

• Manufacturer: Microlife AG, SHC Technology, ONBO Electronic
• Model: PF 200
• Intended Use: Peak Expiratory Flow (PEF) and Forced Expiratory Volume in 1-second (FEV1) measurement
• Environment of Use: Home setting
• Country of Origin: Switzerland, Kazakhstan, China

Product Usage Instructions

Introduction

Intended Use: The Microlife Peak Flow Meter is designed for measuring PEF and FEV1 in both pediatric and adult patients to monitor respiratory conditions like asthma and COPD.

Environment of Use

The device is intended for home use. Refer to the Technical Specifications for detailed operating and storage conditions.

Preparation for your first measurement

1. Inserting the Batteries: Follow the instructions in the manual to insert batteries properly.
2. Setting Date and Time: Set the date and time on the device as per the manual guidance.

Carrying out a Measurement
Follow the steps provided in the manual to perform PEF and FEV1 measurements accurately.

Self-Assessment with the Traffic Light Scheme
Utilize the traffic light scheme on the device to assess your measurements effectively.

Cleaning and Disinfecting

• Cleaning / Disinfecting the Mouthpiece: Use recommended methods to clean and disinfect the mouthpiece.
• Cleaning / Disinfecting the Measuring Tube: Clean and disinfect the measuring tube following the provided instructions.
• Cleaning the Main Unit: Keep the main unit clean by following the cleaning guidelines.

Memory Handling
Learn how to manage and review data stored in the device’s memory for future reference.

Technical Specifications
Refer to the technical specifications section for detailed information on the device’s capabilities, operating conditions, and more.

FAQ

Q: Can children use the Microlife Peak Flow Meter unsupervised?
A: Children should not use the device unsupervised due to small parts that could be swallowed.

Q: How should I dispose of batteries and electronic devices?
A: Dispose of batteries and electronic devices according to locally applicable regulations, not with domestic waste.

Important Safety Instructions

Introduction

Intended Use
Microlife Peak Flow Meter is a medical device intended for measuring Peak Expiratory Flow (PEF) and Forced Expiratory Volume in 1-second (FEV1). The device can be used by patients to take PEF and FEV1 measurements in both pediatric and adult patients.

• Peak Expiratory Flow (PEF) is the fasted speed air can be blown out of the lungs after a full inhalation.
• Forced Expiratory Volume in 1-second (FEV1) is the volume of air from exhalation in 1-second after a full inhalation.

Peak Expiratory Flow (PEF) and Forced Expiratory Volume in 1-second (FEV1) are pulmonary function measurements indicative of the amount of airflow coming out of a patient’s airway during forced exhalation, which are used to track airway functions and to detect airway obstructions. These metrics are useful for monitoring respiratory conditions and airway, including asthma and chronic obstructive pulmonary diseases (COPD).

Environment of Use
Microlife Peak Flow Meter is designed for home use, by patients (self- measurement or use under supervision) in a home setting. Please refer to the Technical Specification section for details about operating conditions and storage conditions

Contraindications
This device is not suitable for self-measurement by patients who are unable to conduct the measurements correctly, for example:

• Patients unconscious or in disabling conditions that does not allow correct self measurement operating conditions.
• Bedridden patients unable to stand or sit upright as required for correct measurement.
• Patients whose mouth cannot cover the mouthpiece as required for correct measurement, for instance very young children.

Important Information for Measurement and Control of your values

• It is necessary to keep regular control of your peak flow values.Doctors generally recommend taking one measurement in the morning and one in the evening, every day, normally before inhaling your prescribed medication. Carry out additional measurements whenever you feel unwell or perceive shortness of breath.

• Your doctor is only interested in the highest peak flow value that you can achieve during a measurement session. Please repeat the measurements until you feel you have got the best possible result for the moment.
  Take care to have sufficient relaxation between measurements. In case of poorer results at each successive measurement session talk to your doctor.
  It may be a sign of unstable asthma.

• Please note that asthma attacks are indicated in advance by low peak flow values before you feel it! Please contact your doctor in cases such as these. Also do so if you have signs and symptoms such as chest tightness, shortness of breath coughing or wheezing.

• Self-measurement means control, not diagnosis or treatment. In any event, please be sure to discuss your measured values with your doctor.
  Your doctor will also explain which values are normal for you.

• You should never alter the dosages of any medication without talking to your doctor.

• Please note that the device stores up to 240 measured values with date and time.
  When the memory is full, the oldest values are automatically erased!
  Make sure you visit your doctor in time to analyse your data.

• Please confirm that date and time settings are correct at all times.

• The performance of the monitor can be affected by extremes of temperature and humidity. Please refer to Technical Specifications for details.

• Please conduct measurements per instructions provided in this user manual. Conducting measurements incorrectly, for instance when the patient is lying down or with mouth far away from the device mouth piece will affect measurement accuracy.

• The device can be used to measure PEF and FEV1 of both children and adults. Use by children under 12 years old should be carried out under the supervision of an adult.

• Measurement of PEF and FEV1 is susceptible to influences of local air flow conditions; please ensure the measurement is conducted in an indoor environment without exposure to strong wind or other air flow conditions, such as near electric fan or air conditioning outlet. Only operate the device within specified operating conditions.

• If the device is used by more than one patient, please ensure the mouth piece and turbine is cleaned and disinfected before use.

Important Safety & Device Care Information

• Do not expose the device to extreme temperatures, humidity, dust or direct sunlight.

• Clean the device with a soft, dry cloth. Do not use gasoline, thinners or similar solvents. The measuring tube should not be washed in a dishwasher!

• Do not drop the instrument or treat it roughly in any way. Avoid strong vibrations.

• Never attempt to repair the instrument yourself.
  Any unauthorised opening of the instrument invalidates all guarantee claims!

• If the device gives surprising results, is dropped or knocked, if you notice any malfunction or damage, it should be checked by the Microlife service representative in your country.

• Do not use this device if you think it is damaged or notice anything unusual.

• The function of this device may be compromised when used close to strong electromagnetic fields such as mobile phones or radio installations and we recommend a distance of at least 1 m. In cases where you suspect this to be unavoidable, please verify if the device is working properly before use.

Your Microlife Asthma Monitor

Preparation for your first Measurement

Before your first use we recommend that you disinfect the mouthpiece as explained in this manual.

Inserting the Batteries

1. Please open the Battery Compartment from underneath and insert the two batteries (1.5V,size AAA).
2. Please watch the polarity as indicated by the symbols in the compartment.

Setting Date and Time
The monitor automatically records the time and date of each measurement. After new batteries have been inserted, the time/date display shows the following setting: year: 2002; day 01, month 01 and time 00:00 o’clock.
You must then re-enter the date and current time.
To do this, proceed as follows (Example: Entering 15th June 2002, 09:50 o’clock):

1. Please open the Data Compartment from underneath at the position of the data symbol indication.

2. Press the small time switch next to the clock symbol with a pen and «2002» starts blinking; release the switch.

3. Using the two arrow keys on the front of the monitor you can decrease (left arrow button) or increase (right arrow button) the number.
   Release the arrow button when the correct number is reached.

4. Press the time switch again to confirm the year setting and move to the month setting.
   The month digits blink.

5. The current month can now be entered by pressing the arrow button. (Example: pressing 5 times the right arrow button advances to 06 for June)

6. Press the time switch again to confirm the month setting and move to the day setting.
   The day digits blink.

7. The current day can now be entered by pressing the arrow button. (Example: pressing 14 times the right arrow button advances to 15 for 15th June)

8. Press the time switch again to confirm the day setting and move to the hour setting. The hour digits blink.

9. The current hour can now be entered by the arrow button. (Example: pressing 9 times the right arrow button moves to 09 for 09 o’clock)

10. Press the time switch again to confirm the hour setting and move to the minute setting.
    The minute digits will now blink.

11. The current minutes can now be entered by pressing the arrow button. (Example: pressing 9 times on the left arrow button moves to 50 for 09:50 o’clock).

12. Press the time switch again to confirm all settings. Date and time are now stored, the clock starts running and the monitor switches to «ready» state.

13. Close the data compartment.

Please note:

• If you hold down the arrow key for more than 2 seconds it speeds up.
• Date /time can also be set easily from computer when you run the Microlife Asthma Analyser Software.

Carrying out a Measurement

• When different people use this meter their individual readings cannot be assigned to different users when the data is stored.
• If time/date is not set, measurements can not be performed.
• If another person intends to use the device permanently, all data from the previous user should be erased as explained in this manual.
• In case another user has already used the monitor, we recommend disinfecting the measuring tube as explained in this manual. In this case we also recommend that each user uses a new mouthpiece. Extra mouthpieces can be ordered through your Microlife dealer.

1. Press the ON/OFF button to turn the monitor on. At first, the last result of the memory is shown («0» if there is no data) and then the device indicates «READY» for a measurement by two short beeps and blinking arrows.
2. You can perform the measurement while standing or sitting upright. For better comparison of your data you should always perform the measurement in a similar position.
3. Hold the monitor with both hands on the two rubber areas (compartments).
4. Inhale completely and hold your breath for a moment.
5. Cover the mouthpiece tightly with your lips.
6. Blow into the measuring tube as hard and as fast as you can.
7. A long beep confirms that the result is recorded. The peak flow value is displayed for about 3 seconds, then the FEV1 is shown. Afterwards the monitor is ready for a new measurement which is indicated by two short beeps.
8. It is recommended to perform three or more measurements sequentially. Please note that the monitor only saves the highest reading from switching the device on until switching it off.
9. After each measurement, at first the actual reading is shown in the display and then it switches automatically to the highest reading of your current measurement session.
10. Press the ON/OFF button to switch the monitor off. Before the monitor switches off, the highest value and its related memory position «MR xx» is displayed.
11. Store the monitor in a clean and dust free place.

Traffic light indicator on the device
After the measurement, a small arrow in the display will indicate if the reading is in the green, yellow or red range.

500 l/min is defined as reference value.
If a reading is above 80% (> 400 l/min) of the reference value, it will be indicated in the green range. A reading in the yellow range indicates a reading between 60% and 80% (300 l/min – 400 l/min) of the reference value. A reading in the red range indicates a reading below 60% (< 300 l/min) of the reference value.

It would be best to determine the area limits together with your physician and when required these ranges can be set manually within the software.

Self-Assessment with the Traffic Light Scheme

The so-called «traffic light scheme» allows you to self-assess your measured values and the course of your condition. This leads to an independent assessment of your symptoms with adjustment of your medication. If you or your physician wish to make use of this scheme, an asthma control card is enclosed with the device, on which a green, a yellow, and a red area are marked. The area limits should best be determined together with your physician and entered into the card.

Significance of the Traffic Light Scheme

• Green area – OK
  The lung disease is well under control. A higher medication dosage is not required.

• Yellow area – Caution
  Should your measured values frequently be located in this area, increase your medication dosage as discussed with your physician.

• Red area – Danger
  It is dangerous if your measured values are in this area! Act as discussed with your physician or seek emergency medical treatment.

Cleaning and Disinfection

Cleaning / Disinfecting the Mouthpiece
We recommend disinfecting the mouthpiece before your first use and at least once a week using the following procedure:

1. Disconnect the mouthpiece from the measuring tube and put it in hot water (temperature approx. 66°C / 155°F) for at least 10 minutes.
2. Afterwards, put the mouthpiece on a fresh paper towel and let it air dry.
3. Reassemble the mouthpiece on the measuring tube.
   • Alternatively, you can disinfect the mouthpiece by putting it into commonly available disinfecting solutions. Please carefully follow the instructions for the disinfecting solution! Make sure that it is suitable for a mouthpiece.

Cleaning / Disinfecting the Measuring Tube

• The performance of the monitor can be affected by spitting or coughing into the measuring tube.
  In this case please rinse the tube with distilled water (available at a pharmacy or drugstore).

Please do not use tapwater.

1. Disconnect the measuring tube from the main unit by moving it in a forward direction.
2. Disconnect the mouthpiece from the measuring tube.
3. Rinse the tube in distilled water, afterwards please shake off the water and put it on a fresh paper towel for complete drying.

In case another user has already used the monitor the measuring tube should be disinfected:

1. Disconnect the tube as explained above and put it into a commonly available disinfecting solution. Please carefully follow the instructions for the disinfecting solution!

2. Never put the measuring tube into boiling water!
   The measuring tube material cannot withstand boiling temperature.

3. Reconnect the mouthpiece to the measuring tube and reassemble it back to the main unit as shown. Make sure that the tube finally «clicks» into the fixed position.

4. Please make sure that the measurement tube and the device stay together by confirming that the identification on tube and device is the same.

Cleaning the Main Unit
Clean the main unit once a day with a clean damp cloth. Never put the main unit into water!

Memory Handling

The 240 measuring data can be reviewed on the display:

1. Switch the monitor on and press the memory scroll buttons.

2. By pressing the «<» button, you can see the latest value stored in the memory with date and time; pressing this button once at a time shows all stored data. If you keep pressing the button you can move quickly through the memory.

3. The «>» button works in the opposite direction.

   • Memory Capacity Low
     When the memory covers 230 or more data, «MR XX» blinks after the monitor is switched on to indicate that the remaining memory capacity is low.

   • Memory Full
     When the memory is full with 240 data, the monitor gives a warning «beep» when switching on and «MR 240» blinks. From now on, data is still memorised but the oldest values are automatically erased!

   • Memory Clear
     Please note: the memory is automatically cleared after data transfer to computer.
     Clearing all data from the memory manually should be done when you intend to give the monitor to another person. To clear all data press the «<» and the «>» buttons simultaneously for 5 seconds, and then release the buttons. «clr» starts blinking in the display for about 3 seconds. If you really want to erase all data from memory you need to press the ON/OFF button during these seconds.
     Otherwise the monitor moves back to normal operation and the data remains.

   • Clear the last measurement
     You can erase the last memory reading by pressing both memory scroll buttons simultaneously for 5 seconds. After releasing the buttons «clr» will flash on the screen for 3 seconds. To erase the last reading you need to press both buttons again while the screen is flashing.

Analyse Data by Computer

The monitor can be connected via a USB connection port with a computer and all memory data can be analysed by the Microlife Asthma Monitor software program.

Please contact your Microlife dealer.

Note: Please always use the latest version of the Analyzer to ensure up- to-date performance and security. Remember to check the Microlife website or your Microlife dealer for updates of the Analyzer software.

Warning!: To use the Microlfe Asthma Monitor software on your Windows personal computer (PC), please make sure the Windows operating system is up- to-date, with firewall and anti-virus software installed, to ensure the secure operation of the software.

Warning!: Do not use the device if the QA sticker inside the battery compartment is missing or damaged, as the device maybe susceptible to unauthorized disassembly or tampering.

Messages / Malfunctions / Errors

If an error occurs one of the following listed error codes is displayed

and computer does not work.

| Check the cable connection

between device and computer.

no| There is no data stored in the monitor.|
Hi| The result is higher than 900 ml/min.| This is a very good result.

Other possible malfunctions
If problems occur when using the device, the following points should be checked:

Batteries have been

installed.

| 2. If the display is erratic or unusual, remove the

batteries and re-install new batteries.

The instrument frequently

fails to measure or the values measured are wrong.

| 1.  Ensure that the measuring tube is connected correctly.

2.  Check if when blowing into the tube, the wing wheel is rotating. Any objects, dust liquids or mucous may interfere with the rotation of the wing wheel. In this case clean the tube as explained.

3.  Discuss the values with your doctor.

If you have any questions regarding the use of this device, please ask your dealer or pharmacist for the Microlife Service representative in your country. The Microlife service team will be happy to help you.

Battery Replacement

When the battery low symbol appears in the display, the device is blocked until the batteries have been replaced. Please use 1.5 V «Long-Life» or «Alkaline» batteries,size «AAA». The use of 1.2 V Accumulator batteries is NOT recommended. If the monitor is left unused for longer periods, please remove the batteries. Please note that during battery exchange the data stored in the memory of the monitor is well protected and will NOT be lost.
After battery change (or when the unit has been disconnected from any power supply) time/date needs to be entered, again! Otherwise data can not be memorised.

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, mouthpiece, measuring tube.

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 Specification

Measuring range:| PEF from 50 – 900 l/min

FEV1 from 0.01 – 9.99 litres

---|---
Measuring method:| Rotating wing wheel
Accuracy:| PEF ± 20 l/min or 10% of the reading, whichever is

greater.

FEV1 ± 0.1 l or ± 5% of the reading, whichever is greater.

Measuring resolution:| PEF 1 l/min; FEV1 0.01 l
Data safety:| Data rememorised by EEPROM
Memory:| 240 measurements with date/time
Size:| 77 (W) x 144 (L) x 48 (H) mm
Weight:| 150g (with batteries)
Storage conditions:| -5 – +50 °C / 23 – 122 °F,

10 – 90% relative maximum humidity

Operation conditions:| 10 – 40 °C / 50 – 104 °F,

10 – 85% relative maximum humidity

Power source:| 2 batteries of 1.5 V, size AAA
Battery lifetime:| Approximately 1000 measurements
IP Class:| IP20
Reference to standards:| CE (EU Guidelines 93/42/EEC) EN60601-1, EN60601-

1-2, EN ISO 23747, IEC60601-1-11, ATS standard

1994 update

System requirements:| Microsoft® Vista, 7, 8, 550 MHz CPU,

500 MB free hard disk, 256 MB RAM, 800 x 600 pixel resolution, 256 colour, CD- ROM drive or internet access for online download, one free USB port

Expected service life:| 5 years or 10000 measurements

Technical modifications reserved!

www.microlife.com
Detailed user information about our products and services can be found at www.microlife.com

References

• Microlife
• Support - Microlife AG
• Официальный поставщик лабораторного оборудования по Казахастану - VISTA MED

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