Microlife BP3AX1-4U User manual

3AX1-4U-LF-JUL06-FDA-2

PLEASE NOTE:
THIS MEDICAL INSTRUMENT MUST BE USED ACCORDING TO
INSTRUCTIONS TOENSURE ACCURATE READINGS.
Questions? Preguntas?
Call Toll Free: 1-866-464-6184
Model # BP3AX1-4U
ID # 3AX1-4U-LF (344536)
Instruction Manual
Premium Wrist
Blood Pressure
Monitor
Premium Wrist
Blood Pressure
Monitor

Premium Wrist Blood Pressure Monitor
Instruction Manual
Model #BP3AX1-4U
ID#3AX1-4U-LF (344536)
Table of Contents
1. Introduction
1.1. Features of your blood pressure monitor
1.2. Important information about self-measurement
2. Important Information about Blood Pressure and its Measurement
2.1. How does high/low blood pressure arise?
2.2. Which values are normal?
2.3. How can you treat high blood pressure?
2.4. Benefits of Life Fitness AveragingMode Technology™
3. The Components of Your Blood Pressure Monitor
4. Using Your Blood Pressure Monitor
4.1. Inserting the batteries
4.2. Initial setup
4.3. Setting alarm times
4.4. Sleep mode
5. Taking a Measurement
5.1. Before the measurement
5.2. Common sources of error
5.3. Fitting the cuff
5.4. Measurement mode selection (LifeFitness Averaging Mode Technology™
feature)
5.5. Measurement procedure
5.6. Discontinuing a measurement

6. Memory Recall and User Setting
6.1. Viewing measurements saved in memory
6.2. How to use the individual memory feature
6.3. Clearing the memory
7. Software Functions
7.1. Installation of software and downloading readings
8. Adjusting the Display Contrast
9. Error Messages / Malfunctions
10. Care and Maintenance
11. Warranty
12. What U.S. and International Standards is this device
manufactured to meet?
13. Technical Specifications
14. How to Contact Us
1

1. Introduction
1.1. Features of your Premium Blood Pressure Monitor, ID # 3AX1-4U-LF
The blood pressure monitor is a fully automatic, digital blood pressure measuring
device for use on the wrist. This enables very fast and reliable measurement of
systolic and diastolic blood pressures as well as the pulse through the
oscillometric measuring method. The device offers excellent accuracy proven in
clinical studies and has been designed for ease of use.
Before using, please read this instruction manual carefully and then keep it in a
safe place. For further questions on the subject of blood pressure and its
measurement, please contact your doctor.
Caution!
1.2. Important information about self-measurement
•Self-measurement means knowledge, not diagnosis or treatment. Unusual
values must always be discussed with your doctor.You should never alter
the dosages of any drugs prescribed by your doctor.
• The pulse reading is not suitable for checking the frequency of heart
pacemakers!
• Clinical trials have shown that wrist measurements can reach similar
accuracy to upper arm measurements. However, some individuals may get a
different result between both methods. Therefore, we generally recommend
to compare the readings of this device to data obtained by your doctor.
• Make sure you keep the device at heart level during measurement to avoid a
user accuracy error.
Electromagnetic interference
The device contains sensitive electronic components. Therefore, avoid strong
electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile
telephones, microwave cookers). These can lead to temporaryimpairment of the
measuring accuracy.
2

2. Important information about blood pressure and its measurement
2.1 How does high or low blood pressure arise?
Your level of blood pressure is determined in the circulatory center of your brain
and adjusts to a variety of situations through feedback from the nervous system.
To adjust blood pressure, the strength and frequency of the heart (Pulse), as well as
the width of circulatory blood vessels is altered. Blood vessel width is affected by fine
muscles in the blood vessel walls. Your level of arterial blood pressure changes
periodically during heart activity. During the "blood ejection" (Systole), the value is
highest (systolic blood pressure value). At the end of the heart’s "rest period" (Diastole)
pressure is lowest (diastolic blood pressure value). Your blood pressure values should lie
within certain normal ranges in order to prevent particular diseases.
2.2 Which values are normal?
Blood pressure is dangerously high if your diastolic pressure is above 90 mmHg and/or
your systolic blood pressure is over 160 mmHg, while at rest. In this case, please
consult your physician immediately. Long-term values at this level endanger your health
through continual damage to the blood vessels in you body.If your systolic blood
pressure values lie between 140 mmHg and 160mmHg and/or your diastolic blood
pressure values lie between 90 mmHg and 95mmHg consult your physician. Regular
self-checks will be necessary. If you have blood pressure values that are too low, (i.e.,
systolic values under 105mmHg and/or diastolic values under 60 mmHg), consult your
physician. Even with normal blood pressurevalues, a regular self-check with your blood
pressure monitor is recommended. You can detect possible changes in your values early
and react appropriately. If you are undergoing medical treatment to control your blood
pressure, keep a record of values along with time of day and date. Show these values
to your physician. Never use the results of your measurements to independently
alter the drug doses prescribed by your physician.
3

The following standards for assessing high blood pressure (without regard to age) have
been established by the U.S. National Institutes of Health JNC7, 2003.
☞Further information
•If your values are mostly normal under resting conditions but exceptionally high
under conditions of physical or psychological stress, it is possible that you are
suffering from so-called "labile hypertension." Consult your physician.
•Correctly measured diastolic blood pressure values above 120mmHg require
immediate medical treatment.
2.3 What can be done if regular high or low values are obtained?
a) Consult your physician.
b) Increased blood pressurevalues (various forms of hypertension) are associated with
considerable health risks over time. Arterial blood vessels in your body may be
endangered due to narrowing caused by deposits in the vessel walls
(Arteriosclerosis). A deficient supply of blood to important organs (heart, brain,
muscles) can result. Furthermore, the heart will become structurally damaged with
increased blood pressure values.
c) There are many different causes of high blood pressure. We differentiate between
common primary(essential) hypertension, and secondaryhypertension. Secondary
hypertension can be ascribed to specific organ malfunctions. Please consult your
physician for information about the possible origins of your own high blood pressure.
d) There are measures you can take to reduce and even prevent high blood
pressure. These measures should include permanent lifestyle changes.
4
Category Systolic Diastolic
(mmHg) (mmHg)
Normal <120 <80
Self-Check
Pre-Hypertension 120 - 139 80 - 89
Stage 1 140 - 159 90 - 99
Hypertension
Stage 2 >160 >100
Hypertension

1) Eating habits:
•Strive for a normal weight corresponding to your age. See your doctor for your
ideal weight.
•Avoid excessive consumption of salt.
•Avoid fatty and fried foods.
2) Previous illnesses
•Consistently follow all medical instructions for treating illness such as:
diabetes (diabetes mellitus or sugar diabetes), fat metabolism disorder, and
gout.
3) Habits
•Give up smoking completely.
•Drink only moderate amounts of alcohol.
•Restrict your caffeine consumption (coffee, tea and chocolate).
4) Your physical condition
•After a medical examination, and with your doctor’s approval and direction,
exercise.
•Choose sports which require stamina and avoid those which require strength.
•Avoid reaching the limit of your performance.
•With previous illnesses and/or an age of over 40 years, please
consult your physician before beginning your exercise routine. You must
receive advice regarding the type and extent of exercise that is
appropriate for you.
2.4 Life Fitness AveragingMode Technology™
Life Fitness AveragingMode Technology™ is a new concept for optimum reliability in
measurement of blood pressure. A single measurement is rarely your real result. An
average of three readings is medically demonstrated to provide the most accurate
result. With the push of a single button, the Life Fitness AveragingMode Technology™
blood pressure monitor takes three consecutive measurements and calculates the
average.
5

3. Components of your blood pressure monitor
The illustration below shows your blood pressure monitors key features:
This wrist cufffits wrist circumference of 5.3” to 7.67” (13.5cm to 19.5 cm).
4. Using the blood pressure monitor
4.1. Inserting the batteries
After you have unpacked your device, insertthe
batteries.
1. Remove the cover as illustrated (A).
2. Lay the clear plastic strip (B)inside the battery
compartment, and insert 2 x size AAA 1.5V
batteries (C), observing the indicated polarity
according to the markings on the cuff (D).
Caution!
• After the low batterywarning appears, the device
is disabled until the batteries have been replaced.
• If the battery warning appears in the display, the
batteries are discharged and must be replaced by
new ones.
• Use AAA Long-Life or Alkaline 1.5V Batteries. The
use of rechargeable batteries is not recommended.
• If the blood pressure monitor is left unused for long
periods, remove the batteries from the device.
6
Scroll Buttons
M=OK/Mode Button
Cuff
Display
Battery Cover
ON/OFF/START
Button
SYS
DIA
PUL
120
mmHg
80
mmHg
68
/min
11:31 am
No. 10
4/11
1
ON/OFF/START
M
A
B
C
D

4.2. Initial Setup
When the batteries are installed, the display shows
the language selection screen.
Press ▲or ▼to select the display language. Press
OK (M) to confirm the selection. The default language
is English.
The device prompts you to set the time and date. The
year blinks highlighting the first field to change.
Press ▲or ▼to change the year. Press OK (M) to
confirm the date. The month, day, hour, and minute
are all consecutively highlighted. Press ▲or ▼to
change these fields and press OK (M) to confirm. You
are then prompted to set the alarms.
4.3. Setting Alarm Times
After you have set the time, you can set one or two
alarms to alert you to take your blood pressure
measurements. An alarm icon appears in the display.
Press ▲or ▼to set the hour and minute for Alarm1.
Press OK (M) to confirmeach setting.
When the alarm icon is highlighted, press ▲or ▼to
enable or disable Alarm 1. Press OK to confirm.
You are then prompted to set Alarm 2. Follow the
instructions for Alarm 1 to set this alarm.
After setting the alarms, press OK to exit the Time and
Date Setup. An alarm icon appears in the display to
indicate that the alarm is activated.
Attention!
The time display is set on a 24-hour clock.
Language
➤English
Deutsch
Francais
Russian
Espanol
Jan 1 2006
0:00
Display
Off
7
Feb 24 2006
8:15
Display
Off
Feb 24 2006
8:15
Display
Off
Feb 24 2006
10:30
Display
Off

When the final field (DISPLAY OFF) is highlighted, press
▲or ▼to select whether you want the time and date
display to remain on when the device is switched off.
Press OK to confirm the settings and exit the time
setup screen.
4.4. Sleep Mode
The device is designed to stay
in sleep mode as batteries are
loaded. The illustration shows
the display elements, when the
BPM is in sleep mode, and the
DISPLAY OFF feature is disabled
(see Section 4.2).
5. Taking a measurement
5.1. Before the measurement
• Avoid eating, smoking as well as all forms of exertion directly before the
measurement. All these factors influence the measurement result. Try to find
time to relax by sitting in an armchair in a quiet atmospherefor about ten
minutes beforemeasurement on the left wrist.
• If you compare readings note the time of day as blood pressure fluctuates
throughout the day.
5.2. Common sources of error:
Note: Comparable blood-pressure measurements always require the
same conditions! Quiet conditions are always required for your
optimal measurement.
• All efforts by the patient to support the arm can increase the blood pressure.
Make sureyou are in a comfortable, relaxed position and do not flex any of
the muscles in the measurement armduring the measurement. Use a cushion
8
Apr 17 2006
JOHN MAM
Date
Time (Military Time
24-hour format)
Life Fitness
AveragingMode™
Current user (#1)
15:31
Alarm active

for support if necessary.
• If the wrist artery lies considerably lower or higher than the heart, an
erroneously higher or lower blood pressure will be measured! (Each 15cm or
5.9” difference in height results in a measurement error of 10mmHg!)
• A loose cuff causes false measurement values.
• With repeated measurements, blood can accumulate in the respective arm,
which can lead to false results. Correctly executed blood pressure
measurements should therefore first be repeated after a 1 minute pause or
after the arm has been held up in order to allow
the accumulated blood to flow away. (Does not
apply to a Life Fitness AveragingMode™
measurement.)
5.3. Fitting the cuff
a) Remove all objects and jewelry (e.g. wristwatch)
from the wrist in use. Put the cuff over the wrist
with the monitor face on the inside of the wrist.
b) The distance between the cuff and the hand should
be approx. 1/2” (10 mm).
c) Secure the cuff with the Velcro™ fastener, so that
it lies comfortably and not too tight. No space
should remain between the cuff and the wrist.
d) Lay your armon a table, with your palm upwards.
Support your arm with a cushion, so that the cuff
rests at about the same height as your heart. Do
not hold or support the cuff with your free hand.
Remain still for 5 minutes before beginning a
measurement.
9

5.4. Measurement Mode Selection
Choose which measurement mode you want to use before taking a blood pressure
reading. Press OK (M) to enter the menus, press ▲or ▼to select Measuring
mode, and press OK (M) to enter the submenu Select , «1» or «3/MAM» for Life
Fitness AveragingMode Technology™ with the scroll buttons and confirm your
selection by «OK».
Life Fitness AveragingMode Technology™
In average mode, the unit takes 3 continuous
measurements, and afterwards calculates the
result based on an average using Life Fitness
AveragingMode Technology™ (see Section 2.4).
Thereis a 15-second rest time between
measurements; the unit beeps during the last 5
seconds to remind you of the upcoming
measurement.
Single Mode
In single mode «1», only one measurement is taken.
5.5. Measurement Procedure
After the cuffand armhave been appropriately
positioned and the measurement mode is set, the
measurement can be taken as follows. Press the
ON/OFF/START button. The Life Fitness Welcome
screen appears, and is followed by a screen which
shows you how to properly hold your arms. If the
display offfunction is enabled, the Sleep Mode
screen appears for two seconds
before measurements are taken.
The pump begins to inflate the
cuffand the increasing cuff
pressureis displayed.
10
MEASURING MODE
[▼][▲]
1 3/MAM
Numeric pressure
Graphical pressure
Hold left wrist at heartlevel
and remain still during
measurement.

After the suitable inflation pressure has been reached, the pump stops, the
measurement signals are displayed and the heart icon flashes.
This curve shows each heart beat activity. Movement artifacts (excessive
movement) would become visible by large deviations within the curve.
Along beep sounds when the measurement has
been completed. The systolic and diastolic blood
pressureand pulse rate appear in the display.
The measurement reading remains on the display
for approximately 30 seconds. If no button is
pressed during the 30-second period the
instrument switches itself offin order to preserve
the batteries.
When the unit is set to MAM, it means the Life
Fitness AveragingMode Technology™
has been engaged and three separate
measurements take place as
explained under section 5.4.
11
User #1 Icon
Relative amplitude
Hearticon
Pressure
3/03 15:48
sys
124 mmHg
dia
73 mmhg
pul
77 /min.
22
Countdown
timer
Measurement
number
MAM
Life Fitness
AveragingMode
Technology™ icon

5.6. Discontinuing a measurement
If it is necessary to interrupt a blood pressure measurement for any reason, for
example, if the patient feels ill, press the ON/OFF/START button. The device
immediately lowers the cuff pressure and enters into sleep mode.
6. Memory handling and user setting
6.1 Viewing Measurements Saved in
Memory
This blood pressure monitor automatically
stores each of the last 30 measurement
values. To view the stored measurements
for a user, press or in sleep mode. The
last measurement taken for the user is
displayed.
The user,measurement sequence number,
date, and time aredisplayed on the top.
Data obtained in Life Fitness
AveragingMode Technology™ are indicated
by a MAM symbol in the upper right corner.
•Press or to scroll through the list items.
•The first item in the list is the average of all
stored data.
• Press OK and the display shows table of all
data.
• The first entry is the average. Data obtained in
Life Fitness AveragingMode Technology™ is
indicated by an «A» symbol at the veryright.
•Press or to scroll through the list.
12
9MAM
3/06 15:48
sys
124 mmHg
dia
73 mmhg
pul
77 /min.
Measurement
number
Life Fitness
AveragingMode
Technology™
3/06 15:48
No. sys dia pul
avg. 149 110 85
1 145 109 83
2 119 71 74 A
3 124 73 79
4 130 80 77 A

Press OK and the display shows graph of
all data.The lines indicate the Systolic (top
end) and Diastolic (bottom end) values.
Press or to move the cursor between
measurements. The currently selected
measurement is indicated by a blinking line.
Press ON/OFF/START to exit this mode.
6.2. Setting the User
This monitor allows you to track readings
for two individuals independently. Scroll to
User and press OK to enter the submenu.
Press or to make your selection. Select
to set the device to not save readings.
Select to select user 1. Any readings
made when user 1 is selected will be
stored only in memory 1.
Select
when user 2 is selected will be stored only
in memory 2.
Note: There is a User 0, which does not store
memories. If your unit is on the User 0 setting,
no readings will be stored in memory.
After selecting user 1 or user 2 you are
prompted to enter the user name. You can
use up to six characters.
Tokeep the default name «User_1», press
ON/OFF/START. To enter a different name,
follow these instructions:
Press or to scroll through the
alphanumeric characters A ~ Z and 0 ~ 9.
There is also one underscore and one space
13
No.7 3/06 15:48
200
150
100
50
SYS
145
DIA
85
PUL
98
4/17 - 4/18 AVG MAM
USER
USER_1
EXIT=[ON/OFF/START]
*A friend can measure their blood
pressure without saving it in
memory by setting the user to the
symbol (User 0).

character.
Press OK (M) to accept the character and
move to the next space.
After you have finished entering the name,
press OK to exit the user setup menu. The
user name is displayed on the screen.
6.3. Clearing the Memory
This item enables you to clear readings for
user 1 or user 2. You can erase single
readings, or erase all readings at once.
Select user 1 or user 2 as explained under
section 6.2. Scroll to Clear Memory and
press OK.The user you selected is shown
in the upper left corner.
Clear Single Readings
Select «SINGLE» by the selection buttons
and press OK to erase single readings.
Press or to select a reading from the
list. An arrow highlights the selected
reading. Press OK to erase the selected
reading.
Clear All Readings
Select «All» by the selection buttons and
press OK to erase all readings of the
selected user. You areprompted to confirm
the action. Press OK to erase all readings
of the selected user. Press the
0N/OFF/START
button to cancel deletion of all readings.
14
JAMES MAM
15:31
ALL
SINGLE
CLEAR MEMORY
Apr 17 2006
CLEAR MEMORY
3/06 15:48
No. SYS DIA PUL
1 124 84 76
2 139 95 74
3 139 98 80
4 146 106 72
CLEAR MEMORY
CLEAR ALL?
YES=[M]
NO=[ON/OFF/START]

15
7. Software Functions
(For more detailed information, see instructions included on the CD)
Measurements stored in your wrist unit can be downloaded to your PC using the
enclosed software. Your PC will allow a capacity of monitoring 80 patients, each
with 1000 data (note: overuse will lower system efficiency). The memory data can be
transferred to the PC by connecting the monitor via the USB cable. Important: your
wrist blood pressure monitor must be set to PC LINK mode whenever the
unit is in contact with your computer.When the software prompts you to make
the connection to your blood pressure monitor, your monitor must be in the PC LINK
mode. Push the M Button and choose PC LINK then push the M Button again to
select it. You must set your wrist blood pressure monitor to PC LINK mode to install
the software and every time you want to download your measurements to your PC.
When the unit is in PC LINK mode you will see a series of curved lines that pulsate
from a stationary dot. Note: Software does not work with MAC computers!
7.1. Installation and Data Transmission
a) Insert CD into CD ROM drive of your PC. The installation will start automatically (If
not, click on SETUP.EXE). The software will prompt you to connect your unit to the
computer via the USB cable. The wrist unit must be in PC LINK mode.
b) To transmit data you must have stored data in the memory first. To download
memories from User 1, you must set the blood pressure monitor to User 1 prior to
downloading. To download memories from User 2, you must set the monitor to User
2. Thereis a User 0, which does not storememories. If your unit is on the User 0
setting, no readings will be downloaded. Remember to make sure your wrist unit is
in PC LINK mode prior to connecting to your computer.
c) You cannot take a blood pressure measurement while the unit is in PC LINK mode.
During the PC connection, the device is completely controlled by the computer. Please
refer to the ‘help’ file for softwareinstructions.
Note: For problems with installation, go to Error Messages/Troubleshooting in

16
Section 9.
8. Adjusting the Display Contrast
This item enables you to adjust the contrast. Scroll to Contrast and
press OK to enter the submenu. Press to increase the display
contrast. Press to decrease the display contrast. After you have
adjusted the contrast, press OK to confirm the setting.
Note: Do not set the contrast to the lowest setting. It will
appear blank and remain that way next time you turn it on,
rendering it impossible to see. Make only minor contrast
adjustments.
9. Error messages / malfunctions
If an error occurs during
ameasurement, the
measurement is dis-
continued and a
corresponding error
code is displayed
(Example: Error No. 2).
Error No. Possible cause(s)
ERR 1 No pulse was detected.
ERR 2 Unnatural pressure impulses influence the measurement
result.
Reason: Your arm was moved during the measurement
(Referred to as an “artifact”).
ERR 3 Inflation of the cufftakes too long. The cuffis not
correctly seated.
ERR 5 The measured readings indicated an unacceptable
difference between systolic and diastolic pressures. Take
another reading following directions carefully. Contact your
doctor if you continue to get unusual readings.
ERR 6 Single data differ too much during Life Fitness
AveragingMode™ (MAM) even after 3 cycles. No average
result can be displayed.
CONTRAST

Other possible malfunctions and their elimination
If problems occur when using the device, the following points should be checked
and if necessary, the corresponding measures are to be taken:
Malfunction
The display remains blank when the
instrument is switched on although the
batteries are in place.
The device frequently fails to measure
the blood pressure values, or the values
measured are too low (too high).
Every measurement produces a different
value although the instrument functions
normally and the values displayed are
normal
Blood pressure measured differs from
those values measured by the doctor.
Trouble downloading measurements
to my PC
17
Remedy
1. Check batteries for correct polarity and if
necessary insert correctly.
2. If the display is unusual, re-insert batteries
or exchange them.
3. Be sure contrast is not turned too far down.
1. Check the positioning of the cuff.
2. Measure the blood pressure again in peace
and quiet. See section 5, Taking a
Measurement
1. Please read the following information and
the points listed under «Common sources of
error». Repeat the measurement.
Please note: Blood pressure fluctuates
continually so successive measurements
will show some variability.
1. Recordthe daily development of the values
and consult your doctor.
Please note: Individuals visiting their
doctor frequently experience anxiety
which can result in a higher reading at
the doctor’s office than at home under
resting conditions.
Uninstall the software using uninstall feature
from the cd. Take the cd out. Restart PC.
Reinstall software. Turn on your wrist monitor
and put into PC Link mode. Make sure you have
measurements stored in User 1 or User 2 then
set on appropriate user (Not User 0). Attach
wrist monitor to computer via supplied USB
cable and click OK on computer screen.