Diagnostic PRO Afib User manual

0197
5128
INSTRUCTION MANUAL
AUTOMATIC UPPER-ARM BLOOD PRESSURE AND PULSE
MONITOR WITH ATRIAL FIBRILLATION DETECTION
Diagnosis S.A.
ul. Gen. W. Andersa 38A,
15-113 Białystok, Poland
tel./fax 85 732 46 22, 732 40 99
www.diagnosis.pl

CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Device features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Important information on self-monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2. IMPORTANT INFORMATION ON BLOOD PRESSURE AND ITS MEASUREMENT . . . . . . 2
2.1 How is hypertension / hypotension developed? . . . . . . . . . . . . . . . . . . . . . . 2
2.2 What is the correct pressure value?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
3. Important Facts about Atrial Fibrillation (AFIB) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.1 Harmful impact of atrial fibrillation for me and my family. . . . . . . . . . . . . . 3
4. PRESSURE MONITOR DESIGN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5. STARTING THE DEVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.1 Installing battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2 Battery life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.3 Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.4 User selection and setting date and time. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6. TAKING MEASUREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.1 Before measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.2 Most frequent errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3 Wrapping the cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
6.4 Body posture during measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7. Measuring procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.1 STANDARD measuring mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2 AFIB measuring mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8. MEMORY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8.1 Deleting all measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
9.SYMBOL INDICATING ARRHYTHMIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10. SYMBOL INDICATING ATRIAL FIBRILLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11. ERROR MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
12. MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
13. WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
14. SAFETY AND DISPOSAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
15. SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
16. TECHNICAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

PAGE 1
Thank you for buying the blood pressure and pulse monitor Diagnostic PRO Afib. The model can be
used with irregular pulse and atrial fibrillation. If the device detects irregular pulse, the symbol .
appears on the display. If the device detects atrial fibrillation, the symbol . appears on the
display. In such a case, it is advisable to consult your physician.
Please carefully read this user manual before the first use of the device.Please keep the user
manual. The information contained herein may be needed in the future.
1. INTRODUCTION
1.1. Device features
The Diagnostic PRO Afib pressure monitor is a fully automatic digital device for measuring blood
pressure on the upper arm, which allows to take quick and reliable readings of systolic and
diastolic pressure and pulse rate, using the oscillometric method . The device provides a very high
accuracy of measurement and was designed to be as user-friendly as possible. The device is
intended for taking blood pressure measurements at home. For more information on blood
pressure and its measurement, please contact your doctor.
1.2 important information on self-measurement
lUsing a cuff other than the recommended one may result in measuring error.
lDo not use the device for measuring blood pressure in infants.
lDo not use the device in pregnant patients in pre-eclampsia.
lPay attention not to entangle the tubing because this may result in a serious injury of the
patient or disturbances in blood pressure measurement.
lToo frequent measurements may cause trauma to the patient due to impaired blood flow.
lWrapping the cuff on a wound may lead to a deterioration of its condition.
lApplication of the cuff on the treated arm may lead to injury as a result of temporary
obstruction of blood flow during pressure increase.
lDo not put on and inflate the cuff, on the side where the mastectomy procedure has been
performed.
lInflation of the cuff may cause temporary stoppage of equipment monitoring vital
functions used on the same arm.
lPressure measurement using the automatic device for measuring blood pressure does
not cause long-term impairment of the patient's circulation.
lThe device is not suitable for simultaneous monitoring with high-frequency
electrosurgical apparatus.
Self-measurement means control and not diagnosis and treatment .Unusual values should
always be consulted with your doctor. You should under no circumstances change the doses
of medications prescribed by a doctor.
lThe displayed pulse rate is not suitable for controlling the operating frequency of a
pacemaker!
lIn the case of arrhythmias, the measurement made using the device should be consulted
with a doctor.
Electromagnetic interference
The device contains sensitive electronic components, therefore, one should avoid strong
electrical or electromagnetic fields (e.g., nearby cellular phones, microwave ovens). Otherwise,
there may be a temporary deterioration in the accuracy measurements.

PAGE 2
2. IMPORTANT INFORMATION ON BLOOD PRESSURE AND ITS
MEASUREMENT
2.1 How is hypertension / hypotension developed?
The level of blood pressure is regulated in the brain, in the circulatory center and adapted to the
current conditions based on feedback involving the nervous system. To adjust the blood pressure,
the frequency and the strength of heart contractions and the diameter of blood vessels (the degree
of contraction of smooth muscle of blood vessel walls). The level of blood pressure changes
periodically in the cardiac cycle: during the contraction the value is the highest (systolic) and at the
end of the diastole the value is the lowest (diastolic pressure). In order to prevent the development
of dangerous diseases, the blood pressure values should be correct.
2.2 What is the correct pressure value?
The value of blood pressure is too high if the diastolic pressure at rest is above 90 mmHg or the
systolic pressure is over 160 mmHg. In such a case, you should immediately consult your doctor.
Long-term persistence of pressure on such a level endangers human health due to the increased
damage to bloodvessels.
If systolic pressure is within the range of 140 to 160 mmHg or the diastolic pressure is between 90 to
100 mmHg, consult your doctor. Subsequently, regular self-measurement will be necessary. In the
case of values that are too low, that is the systolic pressure is below 100 mmHg or the diastolic
pressure falls below 60 mmHg, you should also consult your doctor. Even in the case of pressure
values in the normal range, it is recommended to perform regular blood pressure self-
measurements. This allows for detecting any changes in the value of blood pressure at an early
stage and respond accordingly. If the patient is undergoing treatment for hypertension/hypotension,
regular measurements should be taken at a specific time of day and the results recorded, and then
presented to the doctor.
Never use the obtained results to individually change dosage of medications
prescribed by your doctor.
Table of blood pressure value classification (unit: mmHg) according to the World Health Organization
(WHO):
Range Systolic Diastolic Remedial
pressure pressure measures
Hypotension below 100 below 60 Consult your doctor
Optimal blood pressure from 100 to 120 from 60 to 80 Self-measurement
Normal blood pressure from 120 to 130 from 80 to 85 Self-measurement
Slightly elevated from 130 to 140 from 85 to 90 Consult your doctor
blood pressure
Too high from 140 to 160 from 90 to 100 Imperative contact
blood pressure your doctor
Significantly elevated from 160 to 180 from 100 to 110 Imperative contact
blood pressure your doctor
Dangerously high Above 180 Above 110 Immediately contact
blood pressure your doctor
lIf the values of your blood pressure at rest are usually normal, but elevated during stress,
you may suffer from labile (latent) hypertension. If you suspect that this might be
possible, contact your doctor.
lCorrectly measured diastolic pressure above 120 mmHg requires immediate medical
treatment.

3. IMPORTANT FACTS ABOUT ATRIAL FIBRILLATION (AFIB)
Normally, your heart contracts and relaxes to a regular beat. Certain cells located in a specially
dedicated areas of the heart tissue form system which produce electrical signals responsible for
heart contracting and pumping blood. Atrial fibrillation occurs when rapid and uncoordinated
electrical signals are present in the heart's two upper chambers, (called the atria). These signals
cause the heart muscle to contract irregularly (this is called fibrillation). Atrial fibrillation is the
most common form of heart arrhythmia or irregular heart beat which often causes no symptoms,
yet it significantly increases your risk of stroke. In such case, medical attention is required.
3.1 Harmful impact of atrial fibrillation for me and my family.
People with atrial fibrillation have a five-fold higher risk of getting stroke. Since the chance of having
a stroke increases with age, atrial fibrillation screening is recommended for people over 65 years
and older. However, for people from the age of 50 years with high blood pressure (hypertension),
diabetes, coronary heart failure or have had a previous stroke atrial fibrillation screening is also
recommended. Early diagnosis of atrial fibrillation followed by adequate treatment can significantly
reduce the risk of getting stroke. In young people AFIB screening is not recommended as it could
generate false positive results and unnecessary anxiety. In addition, young individuals with atrial
fibrillation have a relatively low risk of getting stroke as compared to elder people.
For more information please visit our website: www.diagnosis.pl .
Pro Afib detection provides a convenient way to screen for AFIB. Knowing your blood pressure and
knowing whether you or your family members have atrial fibrillation can help reduce the risk of
stroke. Pro Afib detection provides a convenient way to screen for atrial fibrillation whilst taking your
blood pressure. Risk factors you can control high blood pressure and atrial fibrillation are both
considered controllable risk factors for strokes. Knowing your blood pressure and knowing whether
you have atrial fibrillation is the first step in proactive stroke prevention.
PAGE 3

PAGE 4
4. PRESSURE MONITOR DESIGN
START/STOP
button
STANDARD mode
START/STOP
button
AFIB mode
pulse
symbol
matching
cuff
symbol of the movement
of the arm during the
measurement
pressure
measurement
Afib mode
symbol of atrial
fibrillation
users / groups
memory symbol
x2
DISPLAY
ELEMENTS
LCD display
MEMORY
button
power supply
socket
TIME
button
air tube
connector
diastolic
pressure
systolic
pressure
date / time
exhausted
battery
symbol
blood pressure classification
indicator according to the World
Health Organization (WHO)
irregular heart rate symbol
number of the stored measurement
CUFF
(Applied part type BF)
Arm circumference range:
22-42 cm
plug connecting the air tube with the
blood pressure monitor (insert in the
air tube connector)
air tube
metal buckle

PAGE 5
5.STARTING THE DEVICE
5.1 Installing battery
1. Remove the battery cover.
2. Insert 4 standard AA alkaline batteries..
l Use batteries of the same brand.
l Note that all the batteries are properly installed, observing polarity.
3. Reinstall the battery cover.
4. If the battery icon is displayed on the screen , it means that there is 20% power left
until the battery is drained completely.
5. If the battery icon is displayed on the screen, it indicates low batteries . Batteries must
be replaced, otherwise the device may fail to operate properly.
lAfter replacing batteries, you must reset the time and date..
lAfter the battery warning icon is displayed, the device will not turn on until the battery is
replaced.
lUse batteries of AA Long-Life type or alkaline 1.5 V. It is not recommended to use 1.2 V
rechargeable batteries.
lDIf the pressure monitor is left without use for an extended period of time, you should
remove the batteries.
5.2 BATTERY LIFE
Four new LR6 (AA) batteries last for approximately 200 measurements (1 per day, at room
temperature 23°C), battery life varies depending on the temperature in which they are used, and
may be shorter at lower temperatures.
If the low battery symbol , is displayed, they should be replaced with new ones.
5.3 Power adapter
1. Connect the plug of the power cord into the power supply connector.
2. Plug the power adapter unit into electrical outlet.
lUse power adapter suitable for local mains voltage.
lPower adapter specification: 100~240 V, 50/60Hz; output: 6V, min. 600mA
l We recommend using only the power adapter supplied by the manufacturer, model
Diagnostic ZID 6-1 (100~240 V, 50/60Hz, 6 V, 1000 mA (1 A))
lIf the device is defective, unplug the power supply or the power cord.
lDo not touch the power adapter with a wet hand.
lDo not tangle the wires during usage.
lThe power adaptor is added to the set.
5.4 User selection and setting date and time
User selection: The blood pressure monitor allows you to track blood
pressure readings of 2 users.
a) Before starting the measurement, make sure that the appropriate user is set. The device can
track the results of up to 2 users (user 1, user 2).
b) Hold down the TIME button for at least 3 seconds. The screen will display a blinking user
icon. Change the user by pressing the memory button (M). To confirm user selection, press
the START/STOP button.
c) We recommend that the first person who takes measurement is user 1.
power
supply

PAGE 6
5.5.Time and date settings
The device has an integrated clock and displays the date. This permits saving not only the result of
blood pressure measurement, but also the exact date and time of taking the reading. After inserting
the new batteries, the CLOCK will be set to 12:00 and the DATE to 1-01. You must then set the correct
time and date. For this purpose, please do the following.
1. Hold down the TIME button for at least 3 seconds. The user icon starts blinking. Next, press
the TIME button again to display the year (4 characters flashing).
2. Enter the year by pressing the MEMORY button.
3. Press the TIME button again. Now the date with the flashing month icon appears on the
screen.
4. Set the month using the MEMORY button.
5. Press the TIME button again. Now the last two characters will flash (day).
6. Set the day using the MEMORY button.
7. Press the TIME button again. Now the system switches to time settings; the hours character
will flash.
8. Set the hour using the MEMORY button.
9. Press the TIME button again. Now the last two characters will flash (minutes).
10. Set the exact time, i.e. minutes, using the MEMORY button.
11. Press the TIME button: the measurement unit will start flashing.
12. Press the MEMORY button to set the unit of measurement (mmHg or kPa).
13. After completing the settings, press TIME. Now the settings are confirmed and the timer
starts running.
14. After completing all the settings, press the TIME button once again.
The device will briefly display the date and time. Now the entered settings are confirmed and the
clock starts running After pressing the TIME and MEMORY buttons, data is entered (e.g. switching
from hours to minutes or changing the value by +1). After pressing and holding the button, the
switching is much quicker.
6. TAKING MEASUREMENTS
6.1 Prior to measurement
lDirectly prior to measurement one should not: eat, smoke and avoid physical effort
because all these activities have an impact on measurement results. Prior to
measurement you should relax,
lsitting on a chair in a quiet environment for approximately 10 minutes.
lMeasurements should always be taken on the same arm.
lTake measurements on a regular basis, every day at the same time, because blood
pressure varies throughout the day.
6.2 Most frequent errors
For blood pressure measurements to be comparable, the same measurement conditions are
necessary! (these conditions always include peaceful surroundings).
lAll the patient's efforts to support the arm may result in increased blood pressure. Select
a comfortable and relaxed position. During the measurement, do not stretch any muscles
of the arm on which the cuff is wrapped. If necessary, use a pillow as a support.
lThe operation of the pressure monitor may be disturbed by extreme temperatures,
humidity and taking measurements at high altitudes.
lPay attention not to pinch or bend the tubes.
lA loosely fitting cuff will cause incorrect measurement results. In the case of repeated
measurements there is a build-up of blood in the arm, leading to incorrect results. For
this reason, the correct blood pressure measurement should be carried out after a 5
minute break.

6.3 Wrapping the cuff
1. Insert the tip of the air duct firmly in the opening on the left side of the unit (air tube
socket) Page 4.
2. Insert the end of the cuff under the metal buckle, with the velcrofacing out.
3. Wrap the cuff approximately 2-3 cm above the elbow. For
best results, wrap the cuff on bare skin, at heart level.
4. The compression of arm caused by tucked up sleeve
may prevent accurate reading.
5. The cuff should be wrapped easily on the shoulder
and the Velcro should fasten easily.
6. After wrapping the cuff, make sure that there is
sufficient space under the cuff to fit a finger.
7. If the cuff does not fit on the arm, the accuracy of measurements may be incorrect.
8. Your feet should not be crossed and rest flat on the floor; shoulders and arms should be
supported.
lDo not fold the cuff or the air tube.
lTo disconnect the cuff, remove the air tube plug from the device.
lMeasurement can be started only after wrapping the cuff properly.
lThe cuff must be replaced if there is a leak or when the cuff is not operating properly.
lIn order to ensure the accuracy of readings, you should only use the
lcuff supplied by the manufacturer.
6.4 Body posture during measurement
Relax, rest the elbow on the table with palm facing up; the cuff
should be at heart level. Accuracy of readings may be reduced
if the cuff is not wrapped properly. The arm should be at the
same height as the heart. If the arm is too low, the reading
results will be too high. If the arm is too high, the reading
results will be too low.
7. MEASUREMENT PROCEDURE
7.1. Measurement STANDARD mode (one measurement mode)
In standard measuring mode it is possible to detect arrhythmia, but it is impossible to detect atrial
fibrillation (AFIB).
After wrapping the cuff properly, you can start taking the measurement:
a) Press the button, the cuff will start inflating. The increasing cuff
pressure is displayed continuously.
b) Cuff indicator: if the cuff does not fit correctly, the symbol will
be displayed with flash during taking the measurement. The symbol
indicates well-fitted cuff. (Fig.1)
c) Movement Error Indicator: the symbol appears if the arm
movement is detected. This, in fact may compromise the accuracy of
the measurement. In the case of the slighest arm movement the
measurement can be continued. In the case of the significant arm
movement, the measurement will not be continued, the symbol "Err2"
will be dispalyed (Fig.2)
The arm should be
positioned at the same
height as the heart.
PAGE 7
Fig. 1
Fig. 2
The air hose should
be placed in the
center of the arm
Palm facing up
2-3 cm

PAGE 8
d) When the appropriate pressure of the cuff is reached, the pump stops
and pressure starts to slowly decrease. During the measurement,
pressure of the cuff is displayed (capital digits). When the pulse is
detected, the heart icon will start blinking on the screen.
e) After completing the measurement, the values of systolic and
diastolic pressure and the pulse rate appear on the screen (FIG. 3)
The results of the measurement will be displayed until the device is turned off. If no button is
pressed within 3 minutes, the unit will automatically turn off to save battery power.
7.2 AFIB measuring mode (two measurements mode)
In AFIB measuring mode, the device takes two subsequent measurements and the result is
automatically analysed and displayed. Blood pressure varies constantly, which is why the result
based on two measurements is more reliable than in case of one measurement.
lPress the button , the symbol will appear on the screen.
lOn the bottom left-hand side of the screen, digits "1" or "2" of the measurement
performed are displayed (first or second measurement).
lThere is 15-seconds interval between measurements. (In order to perform next
measurement, a 15-second interval between blood pressure readings is accurate, in
accordance with "Blood Pressure Monitoring, 2001, 6:145-147"). A timer counts down
showing how much time remains for starting a new measurement.
lThe device does not display separate results. The values of blood pressure appear on the
screen only after two measurements were performed.
NOTICE
lDo not remove the cuff between measurements.
lIf one of the measurement results is doubtful , the device will
automatically take the third one.
Measuring procedure: The pressure of the cuff is displayed during
the measurement is performed. When pulse rate is detected, the heart
symbol will start blinking on the screen.
Measurement results: The values of systolic and diastolic pressure
and the pulse rate will appear on the screen.
EXAMPLE 4 Systolic pressure 128, diastolic pressure 86, pulse 68, arrhythmia is detected.
Arrhythmia and atrial fibrillation symbols are displayed on the screen .. The arm movement
is detected, too loosely fitting cuff.
x2
EXAMPLE 4
Fig.3
Example 1
Systolic pressure 120, diastolic
pressure 80, pulse 70.
Arrhythmia is detected, too
loosely fitting cuff.
Example 2
Systolic pressure 127,
diastolic pressure 82, pulse
74. Arrhythmia is detected,
cuff is wrapped correctly.
Example 3
Systolic pressure 128, diastolic
pressure 86, pulse 68. Arm
movement is detected, cuff is
wrapped correctly.

8. MEMORY
Internal memory stores 120 of measurement results.
After pressing the MEMORY button, the device will display the average score of 3 most recent
measurements, also the last measurement and further 120 measurements (Mr119, Mr118,...,MR1)
one by one.
8.1 Deleting all measurements
NOTICE
Before deleting all the results stored in the memory, make sure that they
will not be needed in the future. It is prudent to conduct a measurement
log, which allows to provide more information during a visit to the doctor's
office. To remove all stored results, press and hold the MEMORY button for
at least 5 seconds. Release the button when the screen displays "CL". To
permanently delete the entire memory, press the MEMORY button while
the "CL" is flashing.
PAGE 9
EXAMPLE 5:
Systolic pressure 128, diastolic pressure 86, pulse 68, arrhythmia is
detected, but atrial fibrillation is not detected. The arm movement is
detected; the cuff is wrapped correctly.
The results of the measurement will be displayed until the device is turned
off. If no button is pressed within 3 minutes, the unit will automatically turn
off to save battery power.x2
EXAMPLE 5
x2 x2
AFIB measuring mode
the measurement result no. 9
AFIB measuring mode
the measurement result no. 8
STANDARD measuring mode
the measurement result no. 3
Symbol "A" indicates the average score of 3
most recent measurements

9. SYMBOL INDICATING ARRHYTHMIA
Pro Afib pressure monitor is a fully automatic digital device that also analyses pulse
rate during blood pressure measurement. If an irregular pulse (arrhythmia) is
detected during measurement, the symbol () is displayed after completion of the
measurement (when the measurement results are displayed). In most cases, this
does not give cause for concern. However, if this symbol appears frequently (e.g.
several times per week on measurements performed daily), we recommend you to
inform your doctor. This device does not replace heart diseases diagnostics, but
serves as a device to detect arrhythmia at an early stage.
10. SYMBOL INDICATING ATRIAL FIBRILLATION
The device detects atrial fibrillation. If atrial fibrillation is detected during the
measurement, the symbol is displayed after completion of the measurement
(when the measurement results are displayed). If this symbol is displayed after
having performed a full measurement (two-fold measurement), we advise you to
wait one hour and retake your measurement. If the atrial fibrillation symbol is
displayed again, we recommend you to inform your doctor.
If after repeated measurement, the symbol does not appear there is no cause for
concern. In that case, it is advisable to take another measurement again the next day.
The device may not detect atrial fibrillation for patients with pacemakers and
defibrillators.
11. ERROR MESSAGES
If an error occurs during the measurement, the reading will be interrupted and an error code
displayed.
PAGE 10
Error code Possible cause ERR
ERR 1 No pulse detected.
ERR 2 Measurement results affected by interference.
Cause: there was an arm movement during measurement.
ERR 3 Inflation of the cuff has taken too long. The cuff has not been wrapped properly.
ERR 5 Measurement has indicated unacceptable difference between the systolic and
diastolic pressure values. Perform another measurement carefully following the
instructions. If unusual results persist, contact your doctor.
Further information. Blood pressure varies even in healthy people, that is why it is important to
always take measurements under the same conditions (peaceful environment). If, despite
following these principles, the fluctuations will be higher than 15 mmHg and irregular pulse rate
occurs repeatedly, consult your doctor. In the event of problems, you should consult with
Diagnosis S.A.
YOU SHOULD NEVER ATTEMPT TO REPAIR THE DEVICE YOURSELF! ALL UNAUTHORIZED
ATTEMPTS AT OPENING THE DEVICE WILL VOID THE WARRANTY!
If, during the use of the device, a problem occurs, please check the following items and undertake
the listed remedial measures.

PAGE 11
12. MAINTENANCE
lDo not expose the device to extreme temperatures, humidity, dust or direct sunlight.
lWhen wrapping the cuff, be careful and avoid deformation by twisting or bending.
lClean the device with a soft and dry cloth. Do not use gasoline, thinners or similar
solvents. Stains on the cuff should be removed with care using a damp cloth and suds.
Do not wash the cuff!
lBe careful not to drop the device and handle it with care. Avoid strong vibrations.
lDo not open the device.
Periodic inspections
lThe measuring device requires regular inspections.
lFor that reason, we recommend to carry out periodic inspections of the pressure monitor
every 2 years.
More information will be provided by Diagnosis .
13. WARRANTY
The Diagnostic PRO Afib blood pressure monitor is covered by a 2-year warranty starting from the
purchase date. The warranty does not cover damage due to improper handling, accidents, non-
compliance with the user manual, or changes made in the device by third parties. The warranty is
only valid on presentation of the warranty card.
14. SAFETY AND DISPOSAL
lThe device may be used only for its intended purpose as described in the user manual.
The manufacturer is not liable for damage caused by incorrect use of the device.
lThe device has sensitive elements and must be handled with care. It is necessary to
follow the conditions of storage and use (technical data).
lProtect the device from water and moisture, extreme temperatures, impact, dropping,
dust, direct sunlight, heat and cold.
lInflate the cuff only after it has been properly wrapped
lThe device is not intedud for usa in the electromagnetic enviranment generated by all
phones or radio.
lDo not use the device if it is damaged.
lIf the device is not used for an extended period of time, remove the batteries.
lTake care to prevent children from using the device without supervision; some parts of
the device are small and may be swallowed.
lUse only original elements supplied by the manufacturer. The use of other elements may
reduce the level of safety.
FAULT
The screen remains dark despite
turning off the device and inserting
new batteries.
The device is frequently unable to
measure the pressure or
measurement results are too low (or
too high).
The results of each measurement are
different, despite the fact that the
device is working correctly, and the
values are also displayed correctly.
The result of blood pressure
measurement is different from the
one that has been taken by
the doctor.
REMEDIAL MEASURES
1. Check if batteries are arranged correctly (polarity) and, if necessary, correct
their positioning.
2. If the display is incorrect, reinstall the batteries or replace them
1. Check positioning of the cuff.
2. Take another blood pressure measurement in a quiet and peaceful
environment, following the instructions for use.
1. Read the following information and the information included in "Most frequent
errors". Repeat the measurement. Please remember: Blood pressure varies constantly,
which is why subsequent measurements will be characterized by some variability.
1. Take daily notes of measurement results and consult them with your doctor.
Please remember: during a visit to the doctor some people feel nervous, which
can raise blood pressure (relative to the readings taken at home).

15. SYMBOLE
Rev.
SYMBOL SYMBOL
FUNCTION/MEANING FUNKCJA/ZNACZENIE
0197 SN
IPX0
PAGE 12
Date of the last revision
Application part type BF
Systolic blood pressure in mmHg
Manufacturer
Diastolic blood pressure in mmHg
Product catalog number
Pulse. Number of beats per minute.
Irregular pulse symbol
Atrial Fibrillation Indicator Symbol
Symbol attesting compliance with the European
Union Directive 93/42/ECC for medical devices
Indication of battery polarity
Serial number
Manufacturing date
Direct curret
Protect against moisture
Keep away from sunlight
Read the user manual before use Protection against ingress of water
Warnings
The worn out product should be taken to a waste collection facility. Contains components that are dangerous for
the environment. The correct disposal of the device allows to preserve valuable resources and avoid negative
effects on health and the environment, which may be threatened by inappropriate handling of waste. If you are in
doubt where to return the used appliance, contact Diagnosis. Free infoline 800 70 30 11
Measurement
Display method
Measurement range
Measurement accuracy
Inflating
Deflating
Memory function
Power supply
Conditions of use
Transportation and storage
Dimensions
Weight
Protection against electric shock
Safety classification
Operation
Protection against ingress of water
Accessories
Oscillometric Digital
LCD display
Pressure 30 to 280 mmHg (± 1 mmHg)
Pulse: 40 do 200 beats per minute
Pressure: ±3mmHg
Pulse: ±5% reading
Automatic pumping device
Automatically through air valve
2 x 120 measurements with date and time
4 x AA alkaline batteries
or power adapter DC 6.0 V, min. 600 mA (optional)
5~40°C, 15%~85% relative humidity
-10~55°C, 10%~95% relative humidity
135×115×72±1.0 mm
540 g±5g
Internally powered equipment
Type BF
Continuous mode
IPX0
Cuff sized M/L (22-42 cm), 4x batteries AA, adaptor
Diagnostic ZID 6-1 (100-240 V, 50/60 Hz, 6 V, 1000 mA
(1 A)), user manual, carrying case
12. TECHNICAL DATA

PAGE 13
Guidelines and manufacturer's declaration - electromagnetic emissions
The devices are intended for use in the electromagnetic environment as described below.
The customer or the user of the device should assure that the device is used in such an environment
Emission test
The emission of radio
frequency waves; CISPR
standard
The device uses radio-frequency energy only for its internal
functions. Therefore, these emissions are very low and should
not cause interference in nearby electronic equipment
Group 1
The emission of radio
frequency waves; CISPR
standard
The device can be used in all buildings, including residential
buildings, and those that are directly connected to the public
low-voltage network, supplying power to buildings intended for
residential purposes.
Group B
Harmonic emissions
IEC 61000-3-2 non applicable
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Fulfillment
of requirements Guidelines regarding electromagnetic environment
Guidelines and manufacturer's declaration regarding electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the DEVICE
should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
Fast transient/burst IEC
61000-4-4
Surges IEC 61000-4-5
Voltage dips, short
interruptions and
voltage changes on
power supply inlets
IEC 61000-4-11
Magnetic field of the power
supply frequency (50/60 Hz)
IEC 61000-4-8
Test level, IEC 60601
standard
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for
± 1 kV differential mode
± 2 kV common mode
<5 % UT (>95 % clip in UT) for 0,5 cycle
40 % UT (60 % clip in UT) for 5 cycle
70 % UT (30 % clip in UT) for 25 cycle
<5 % UT (>95 % dip de UT) dla 5 s
3 A/m
Compatibility
± 6 kV contact
± 8 kV air
Non applicable
Non applicable
Non applicable
3 A/m
Electromagnetic environment - guidelines
Floors should be wooden, concrete or made of ceramic
tiles. If floors are covered with synthetic materials, the
relative humidity should be at least 30%. If ESD interferes
with the device, you should consider the use of
compensatory elements i.e. wrist strap, grounding.
The quality of power supply should be adequate for typical
commercial installation or hospital environment.
The quality of power supply should be adequate for typical
commercial installation or hospital environment.
The quality of power supply should be adequate for typical
commercial installation or hospital environment. If the user
[of the device or system] requires continuous use even
during power interruptions, it is recommended to connect
the device or system to emergency power supply.
The level of magnetic fields of power sources should be
within the limits applicable for typical commercial
installations or hospital environment.
Note UT is the alternating voltage (AC) of the power grid prior to the application of the test level.
RF - frequency of the electromagnetic spectrum section, which is between the low range of long-wave radio frequencies
and the infrared range; frequency useful for radio transmission. 9 kHz and 3 000 GHz are generally accepted as limits
RF - frequency of the electromagnetic spectrum section, which is between the low range of long-wave radio frequencies
and the infrared range; frequency useful for radio transmission. 9 kHz and 3 000 GHz are generally accepted as limits.

PAGE 14
0,01
0,1
1
10
100
150 kHz do 80 MHz
d = 1,16
0,12
0,38
1,2
3,8
12
80 MHz do 800 MHz
d = 1,16
0,12
0,38
1,2
3,8
12
800 MHz do2.5 GHz
d = 2,33
0,23
0,73
2,3
7,3
23
GUIDELINES AND MANUFACTURER'S DECLARATION REGARDING ELECTROMAGNETIC IMMUNITY
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the DEVICE
should assure that it is used in such an environment.
Immunity test Test level, IEC 60601
standard
Compatibility
level
Electromagnetic environment - guidelines
3V Portable and mobile radio communication measures should be used
at a distance from any of the elements [of the DEVICE or system],
including cables, which is not lower than the recommended distance
calculated from the transmitter frequency equation.
Recommended distance d = 1.2
d = 1.2 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.5 GHz
where P is the maximum power rating of the transmitter in watts
(W) as specified by the manufacturer, and (d) is the recommended
distance in meters (m).
Field strengths from fixed RF transmitters, as determined in field
measurements of electromagnetic fields, should be lower than the
compatibility level for each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
Recommended distance
d = 1.2
3V/m
3 Vrms
150 kHz do 80 MHz
3 V/m
80 MHz do 2,5 GHz
Conducted radio-
frequency signal
IEC 61000-4-6
Emitted radio-
frequency signal
IEC 61000-4-3
Note 1: For 80 MHz and 800 MHz, the higher frequency range is assumed.
Note 2: The provided information does not apply in every situation. The propagation of electromagnetic waves is affected by the absorption and
reflection from the surfaces, objects, and people.
(a) Field power from certain transmitters, such as mobile communication base stations, radio transmitters, amateur radio, AM and FM radio
transmission and TV transmission cannot be predicted theoretically with accuracy. To assess the electromagnetic environment, tests of
local conditions should be considered. If the measured field strength in the location where the DEVICE operates exceeds the appropriate
level of compliance, normal operation of the DEVICE should be checked. If improper operation is observed, it may be necessary to take
appropriate preventive steps such as moving or relocating the DEVICE.
(b) For frequencies outside the range of 150 kHz to 80 MHz, the field strength should not be higher than 3 V/m.
RF - frequency of the electromagnetic spectrum section, which is between the low range of long-wave radio frequencies and the infrared range;
frequency useful for radio transmission. 9 kHz and 3 000 GHz are generally accepted as limits
Recommended distance between portable and mobile radio communication equipment and the DEVICE
The [DEVICE or SYSTEM] is intended for use in the electromagnetic environment in which the interference caused by the emission of radio waves is
controlled. The buyer or the user of the [DEVICE or SYSTEM] can help prevent electromagnetic interference by keeping a minimum distance between
portable and mobile radio communication equipment (transmitters) and the [DEVICE or SYSTEM], as recommended below, according to the
maximum output power of the communication equipment.
For transmitters assessed at the maximum output power not listed below, the recommended distance d in meters (m) can be estimated using the
equation corresponding to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts according to
the transmitter manufacturer.
NOTE 1 at 80 MHz and 800 MHz, the distance for the higher frequency range applies.
NOTE 2: these guidelines do not apply in all situations. The propagation of electromagnetic waves is affected by the absorption and reflection from
the buildings, objects and people.
Maximum rated
power of the
transmitter
W
Distance according to frequency of the transmitter m

1. Diagnosis S.A. grants a warranty:
l24 months for DIAGNOSTIC blood pressure monitors and cuffs (excluding pump
assembly)
Hardware defects revealed during the warranty period will be rectified free of charge within 21
days. The term runs from the date of delivery of the equipment to the service center.
2. The purchaser shall be entitled to replace the equipment for a new one, free of defects,
when:
lthe repair has not been made within the time limit set in item 1
lan authorized service center found an irreparable manufacturing defect
lduring the warranty period, 4 repairs were effected, and the equipment still shows
defects that prevent its use in accordance with its intended purpose.
lThe concept of repair shall not include operations related to equipment check and
cleaning.
3. The warranty shall not cover: batteries, products with illegible or damaged serial number,
damage due to the operation and storage inconsistent with the user manual, ingress of
liquids or foreign bodies, overvoltage of mains, repairs by unauthorized persons and random
events.
4. Faulty equipment should be delivered by the buyer to the address of the main service
center or one of the Authorized Service Centers (listed in the appendix).
5. The warranty for the sold consumer goods shall not exclude, restrict, or suspend the
powers of the buyer resulting from non-conformity of the goods with the contract.
6. The only basis for the warranty rights shall be the warranty card with the date of sale,
stamp and signature of the salesperson. If the card is not completed, filled in wrongly, with
traces of corrections and entries made by unauthorized persons, illegible as a result of
damage - it shall be invalid.
WARRANTY CARD
store stamp and signature of salesperson
DEVICE NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MODEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SERIAL NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATE OF SALE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WARRANTY TERMS
Diagnosis S.A.
ul. Gen. W. Andersa 38A, 15-113 Białystok, Poland
Free infoline 800 70 30 11
tel./fax 85 732 46 22, 732 40 99
www.diagnosis.pl
MAIN SERVICE CENTER
ul. Przemysłowa 8,
16-010 Wasilków, Polska
tel. 85 874 60 45

MAIN SERVICE CENTER
ul. Przemysłowa 8,
16-010 Wasilków, Polska
tel. 85 874 60 45
Diagnosis S.A.
ul. Gen. W. Andersa 38A,
15-113 Białystok, Poland
Free infoline 800 70 30 11
tel./fax 85 732 46 22, 732 40 99
www.diagnosis.pl
Rev. 2016.09.30
Angielski - na podstawie polskiej
wersji z dnia 2016.09.21
Table of contents
Other Diagnostic Blood Pressure Monitor manuals