Instruction Manual

Instruction Manual
Instruction Manual
Recommended by
Hypertension Canada
PRECISION 10.0
Blood Pressure Monitor
with Atrial Fibrillation
Screening
ELITE
Elite Blood Pressure Monitor
with Atrial Fibrillation Screening
Instruction Manual
Table of Contents
1.Introduction
1.1Features
1.2
Important Information
1.2A Safety Information
1.2B Care of the Device
1.3
About Blood Pressure
1.4
Normal Blood Pressure Values
1.5
Common Blood Pressure Questions and Answers
1.6
About MAM Technology
1.6A Why Use MAM?
1.6B Key Advantages
1.6C Medical Benefits
1.6D Measurement Sequence
1.7
Important Facts about Atrial Fibrillation (AFIB)
1.7A What is Atrial Fibrillation?
1.7B How Does AFIB Impact my Family or Me?
1.7C AFIB Detection Provides a Convenient Way to Screen for AFIB (only in MAM Mode)
1.7D Risk Factors you Can Control
2.
2.1
2.2
2.3
2.4
2.5
Getting Started
About the A6PC
About the LCD Screen
Inserting the Batteries
Using the AC Adapter
Storing the Cuff
3.
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
Using the Device
Setting the Time and Date
Measurement Mode Selection (MAM or Single)
Select the User
Obtaining Accurate Measurements
3.4A Before Measuring
3.4B Common Sources of Error
3.4C Fitting the Wide Range Cuff
Measuring your Blood Pressure
Appearance of the Atrial Fibrillation Indicator (only in MAM mode)
Hypertension Classification Indicator
Viewing Previously Recorded Values
Clearing All Values
Discontinuing a Measurement
4.
Software Functions
5.
Error Messages / Malfunctions
6.
Care and Maintenance
7.
Lifetime Guarantee
8.
Technical Specifications
1. Introduction
Thank you for purchasing the BIOS Diagnostics™ Elite Blood Pressure Monitor with Atrial Fibrillation Screening.
Designed for convenient and easy operation, this device provides a simple, yet accurate method to measure
your blood pressure.
Your blood pressure is an important parameter that can be used to monitor your health. This device enables you
to monitor your blood pressure regularly, and maintain a record of your blood pressure measurements. You can
then use this record to assist your physician in diagnosing and maintaining a healthy blood pressure level.
1.1 Features
The A6PC is a fully automatic, digital, blood pressure measuring device with a unique fuzzy logic technology as
well as patented MAM and AFIB technologies. It can store up to 198 blood pressure readings for two users.
It provides a fast and reliable measurement of systolic and diastolic blood pressure as well as heart rate using
the oscillometric measurement method.
AFIB detection is the world’s leading digital blood pressure measurement technology for the early detection
of atrial fibrillation (AFIB) and hypertension. These are the two top risk factors of heart disease and stroke
which increase the risk of getting a stroke or heart disease in the future. It is important to detect AFIB and
hypertension at an early stage, even though you may not experience any symptoms. Appropriate treatment can
reduce your risk of suffering a stroke. For this reason, it is recommended that you visit your doctor when the
device gives an AFIB signal during your blood pressure measurement. The AFIB algorithm has been clinically
investigated by several prominent clinical investigators and showed that the device detects patients with AFIB
at 97-100% certainty.
MAM - Averaging Mode technology used in the device provides accurate measurements. Using three
consecutive measurements, your result is calculated and displayed as a single averaged measurement
on the display screen.
AFIB -Atrial Fibrillation Detector technology icon is displayed when atrial fibrillation is detected
during a blood pressure reading.
•
Blood Pressure Analyzer Software allows you to download, record and chart your readings to
accurately monitor your daily readings. The Blood Pressure software can be downloaded for free from
www.biosmedical.com
This powerful medical tool automatically stores all your blood pressure readings. By clicking the viewing
options the user can review the readings in multiple forms including: by date, morning vs. evening
readings, isolated systolic or diastolic or pulse. The automatic graph clearly shows your blood pressure
history with highs and lows. Charts and graphs can even be printed or emailed to your doctor!
This device is easy to use and has been proven in clinical studies to provide excellent accuracy. Before using the
A6PC, read this instruction manual carefully and keep it in a safe place.
1.2 Important Information
Refer to the following sections to learn about important safety instructions and how to take care of the
BIOS Diagnostics™ Elite Blood Pressure Monitor with Atrial Fibrillation Screening.
1.2A Safety Information
• Self-measurement means control, not diagnosis or treatment. Your values must always be discussed with
your doctor or a physician who is familiar with your family history.
If you are undergoing medical treatment and receiving medication, consult your doctor to determine the
most appropriate time to measure your blood pressure. Never alter the dosages of any medication without
direction from your doctor.
• Your blood pressure depends on several factors, such as age, gender, weight, and physical condition. It
also depends on the environment and your state of mind at the time of measurement. In general, your
blood pressure is lower when you are asleep and higher when you are active. Your blood pressure may be
higher when recorded at a hospital or a clinic and may be lower when measured in the relaxing comfort of
your home. Due to these variations, we recommend that you record your blood pressure regularly at home
as well as at your doctor’s clinic.
• Try to record your blood pressure regularly at the same time of the day and under the same conditions.
This will help your physician detect any extreme variations in your blood pressure and thus treat you
accordingly.
• Morning Hypertension ( > 135 / 85 mm Hg): Recently, several studies have identified elevated
cardiovascular risks (heart failure, stroke, angina) associated with “morning hypertension”. There is a
typical rise in blood pressure during the physiological changes from sleep to arising for the day.
• The ideal time to measure your blood pressure is in the morning just after you wake up, before breakfast
and any physical activity, and in the absence of the urge to urinate. If this is not possible, try to take the
measurements later in the morning, before you start any physical activity. Relax for a few minutes before
you record your blood pressure.
• Your blood pressure increases or decreases under the following circumstances:
•
Blood pressure is higher than normal:
— when you are excited, nervous, or tense
— while taking a bath
— during and after exercise or strenuous physical activity
— when it is cold
— within one hour after meals
— after drinking tea, coffee, or other caffeinated drinks
— after smoking tobacco
— when your bladder is full
Blood pressure is lower than normal:
— after consuming alcohol
— after taking a bath
•
•
•
The pulse display is not suitable for checking the frequency of heart pacemakers.
If you have been diagnosed with a severe arrhythmia or irregular heartbeat, vascular constriction,
liver disorders, or diabetes, have a cardiac pacemaker, or are pregnant, measurements made with this
instrument should only be evaluated after consultation with your doctor.
Take care while handling the batteries in the device. Incorrect usage may cause battery fluid leakage.
To prevent such accidents, refer to the following instructions:
— Insert batteries with the correct polarity.
— Turn off power after use. Remove and store the batteries if you are not planning to use the device
for an extended period of time.
— Do not mix different types, brands, or size of batteries. This may cause damage to the product.
— Do not mix old and new batteries.
—
—
—
—
Remove batteries and dispose of them according to the proper regulations in your area.
Do not disassemble batteries or expose them to heat or fire.
Do not short-circuit the batteries.
Do not use rechargeable batteries.
1.2B Care of the Device
For prolonged life of your blood pressure monitor, note the following instructions:
• Do not drop or bang the unit. Prevent sudden jerks, jars, or shocks to the device to prevent damage.
• Do not insert any foreign objects in any device openings or vents.
• Do not disassemble the unit.
• If the unit has been stored at very low or freezing temperatures, allow to reach room temperature before
using it.
• Do not store the unit in direct sunlight, high humidity, or in places with a lot of dust.
• Clean the device with a soft dry cloth. Do not use gasoline, thinner or similar solvents. Carefully remove
spots on the cuff with a damp cloth and soap. Do not wash the cuff.
1.3 About Blood Pressure
Your blood pressure level is determined in the circulatory center of your brain. Your nervous system allows your
body to adapt or alter blood pressure in response to different situations. Your body alters your pulse or heart
rate and the width of blood vessels through changes in muscles in the walls of blood vessels.
Your blood pressure reading is highest when your heart pumps or ejects blood. This stage is called your systolic
blood pressure.
Your blood pressure is lowest when the heart rests (in-between beats). This is called your diastolic blood
pressure.
It is critical to maintain blood pressure values within a “normal” range in order to prevent cardiovascular
diseases. Increased blood pressure values (various forms of hypertension) have associated long and medium
term health risks. These risks concern the arterial blood vessels of your body, which are endangered due to
constriction caused by deposits in the vessel walls (arteriosclerosis). A deficient supply of blood to important
organs (heart, brain, muscles) can be the result. Furthermore, with long-term increased blood pressure values,
the heart will become structurally damaged.
There are many different causes of the appearance of high blood pressure. We differentiate between common
primary (essential) hypertension, and secondary hypertension. The latter group can be ascribed to specific
organic malfunctions. Please consult your doctor for information about the possible origins of your own
increased blood pressure values.
1.4 Normal Blood Pressure Values
Blood pressure is too high when, at rest, the diastolic pressure is above 90 mmHg or the systolic blood pressure
is over 140 mmHg.
If you obtain readings in this range, consult your doctor immediately. High blood pressure values over time can
damage blood vessels, vital organs such as the kidney, and your heart.
Should the systolic blood pressure values lie between 140 mmHg and 160 mmHg or the diastolic blood pressure
values lie between 90 mmHg and 95 mmHg, consult your doctor. Regular self-checks will be necessary.
With blood pressure values that are too low (i.e., systolic values under 105 mmHg or diastolic values under
60 mmHg), consult with your doctor.
Even with normal blood pressure values, a regular self-check with your blood pressure monitor is recommended.
This way you can detect possible changes in your values early and react appropriately.
Refer to the following table for classifying blood pressure values (units: mmHg) according to American Heart
Association (AHA) and European Society of Hypertension (ESH).
Category
Systolic Blood Pressure
Diastolic Blood Pressure
Too Low
< 100
< 60
Optimal
100 - 130
60 - 80
Elevated
130 - 135
80 - 85
Too High
135 - 160
85 - 100
> 160
> 100
Dangerously High
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”. In any case,
please discuss the values with your doctor.
Correctly measured diastolic blood-pressure values above 120 mmHg require immediate medical treatment.
1.5 Common Blood Pressure Questions and Answers
a) Why is my blood pressure reading always different?
Your blood pressure changes constantly. It is quite normal for blood pressure to fluctuate significantly (50 mmHg
to 60 mmHg) throughout the day. Blood pressure is normally lowest at night, but increases during waking hours
when the stress and activities of everyday life are highest.
mmHg
AM
Time
PM
Your blood pressure also increases and decreases under the following circumstances
Blood pressure is higher than normal:
• when you are excited, nervous, or tense
• while taking a bath
• during and after exercise or strenuous physical activity
• when it is cold
• within one hour after meals
• after drinking tea, coffee, or other caffeinated drinks
• after smoking tobacco
• when your bladder is full
Blood pressure is lower than normal:
• after consuming alcohol
• after taking a bath
b) Why is the doctor’s reading different from the reading taken at home?
Your blood pressure can vary due to the environment (temperature, nervous condition). When measuring blood pressure at the doctor’s office, it is possible for blood pressure to increase due to anxiety and tension.
c) Why should I monitor blood pressure at home?
One or two readings will not provide a true indication of your normal blood pressure. It is important to take
regular, daily measurements and to keep records over a period of time. This information can be used to
assist your physician in diagnosing and preventing potential health problems.
1.6 About MAM Technology
(Average Mode) technology is a new technology that enables optimum reliability in self-measurement
of blood pressure.
An advanced measurement accuracy is achieved by the automatic analysis of three successive measurements,
with short rest periods in between (see diagram 1).
This new technology provides reliable values for the doctor and can be used as the basis for reliable diagnostics
and medication therapy for high blood pressure.
•
•
•
Reliable patient self-measurement data for the doctor
Safe hypertension diagnostic tool
Reliable therapy control
1.6A Why Use MAM?
• Human blood pressure is not stable
1.6B Key Advantages
The technology provides reduction in:
• Device scattering
• Insufficient rest prior to measurement
• Movement effects (i.e. coughing, talking, movement)
• Cuff positioning influences
1.6C Medical Benefits
• Improved accuracy
1.6D Measurement Sequence
• Single results are not displayed
• Due to the “Data Analysis” result, a 4th or 5th measurement may be applied. The following illustration
provides a flow chart of the MAM Sequence
Diagram 1
1.7 Important Facts about Atrial Fibrillation (AFIB)
1.7A What is Atrial Fibrillation (AFIB)?
Normally, your heart contracts and relaxes to a regular beat. Certain cells in your heart produce electrical
signals that cause the heart to contract and pump blood. Atrial fibrillation occurs when rapid, disorganized
electrical signals are present in the heart’s two upper chambers, called the atria; causing them to contract
quickly and irregularly (this is called fibrillation). Atrial fibrillation is the most common form of heart arrhythmia
or irregular heart beat. You can live with atrial fibrillation, but it can lead to other rhythm problems, chronic
fatigue, heart failure and - worst of all - a stroke. You’ll need a doctor to help you control the problem.
1.7B How does AFIB impact my family or me?
One in every six strokes is AFIB-related. While individuals above the age of 65 are more likely to have AFIB,
individuals as young as 40 can exhibit AFIB. Early diagnosis followed by adequate treatment can help reduce
the risk of a stroke.
1.7C AFIB detection provides a convenient way to screen for AFIB (only in MAM mode)
Knowing your blood pressure and knowing whether or not you or your family members have AFIB can help
reduce the risk of stroke. AFIB detection provides a convenient way to screen for AFIB while taking your blood
pressure.
1.7D Risk factors you can control
High blood pressure and AFIB are both considered «controllable» risk factors for strokes. Knowing your blood
pressure and knowing whether or not you have AFIB is the first step in proactive stroke prevention.
2. Getting Started
2.1 About the A6PC
a) This section describes the various components of the Blood Pressure Monitor.
ST
AR
T
ST
OP
+ Button
3
1
1
Memory
Function
Cuff Connection
2
Start / Stop
Button
MAM Switch
Wide Range
Cuff
User Switch
- Button
Time
Button
Cuff Connection
6V
600
T
OP
ST
AR
ST
mA
DC
USB
Port
Adapter
Socket
Lock
Switch
Battery
Compartment
b) Upper arm cuff:
Wide range cuff for arm circumference 22 - 42 cm or 8.75” - 16.5”.
Cuff connection:
Insert the cuff tube into the opening provided on the left side of the monitor as shown in the diagram.
2.2 About the LCD Screen
The LCD screen displays the systolic and diastolic blood pressure measurements along with your heart rate.
It also displays previously recorded measurements and the date and time, when the appropriate button is
pressed.
TIME
MONTH-DAY
12:15
129
78
M
SYS
mmHg
DIA
mmHg
68
PULSE /min
1
2
Time and Date
Symbol Guide
Systolic Blood
Pressure (mmHg)
Atrial Fibrillation
MAM Averaging
Diastolic Blood
Pressure (mmHg)
Please wait in between measurements
Pulse Rate
(beats / min)
Heartbeat during measurement
Memory
user
Low battery
Cuff Check Indicator
START
STOP
M
Arm Movement Indicator
1
User Icon
2.3 Inserting the Batteries
Follow these steps to insert the four “AAA” batteries in the device.
1. Open the battery compartment cover in the direction shown.
2. Insert the four “AAA” batteries with the correct polarity as
indicated.
3. Replace the battery compartment cover.
Attention!
• After the battery warning appears, the
device is blocked until the batteries have been replaced.
• Please use “AAA” Long-Life or Alkaline 1.5V batteries.
• If the blood pressure monitor is left unused for long periods, please remove the
batteries from the device.
• Do not mix old and new batteries. Do not mix alkaline, standard (carbon-zinc) or
rechargeable batteries.
T
AR
ST
OP
ST
2.4 Using the AC Adapter
You may also operate this monitor using the
included AC adapter (output 6V DC/600 mA with
DIN plug). Use only the included AC adapter to
avoid damaging the unit.
1. Ensure that the AC adapter and cable are not
damaged.
2. Plug the adapter cable into the AC adapter
port on the blood pressure monitor.
3. Plug the adapter into your electrical outlet.
When the AC adapter is connected, no battery current is consumed. Note: No power is taken from the
batteries while the AC adapter is connected to the monitor. If electrical power is interrupted, (e.g., by
accidental removal of the AC adapter from the outlet) the monitor must be reset by removing the plug from
the socket and reinserting the AC adapter connection.
4. Slide the lock switch to the unlock position.
Functional check: Hold the
segments must appear.
DC
6V
600mA
button down to test all the display elements. When functioning correctly all
2.5 Storing the Cuff
The cuff used for measuring blood pressure is a delicate component of the device and should be stored carefully
when not in use. The A6PC is designed such that the cuff can be stored along with the blood pressure monitor.
Follow these steps to store the blood pressure cuff.
1. Roll up the upper arm cuff along with the inflating tube.
3
2. Push the folded cuff in the compartment on the back of the stand to
store it safely. Place the blood pressure monitor on the front of the
stand.
1
1
2
NOTE: The stand will not fit inside the included storage bag, with the
blood pressure monitor and cuff.
3.1 Setting the Time and Date
When you insert the batteries for the first time (see “Inserting the batteries”), the
monitor prompts you to set the current date and time. You can also adjust the date,
button for over 3
time and user at any time by pressing and holding down the
seconds. Follow these steps to set the date and time settings:
ST
AR
T
ST
OP
3. Using the Device
This section describes how to get the maximum benefit from your A6PC blood pressure monitor. Follow the
instructions carefully to get an accurate measurement of your blood pressure and pulse rate.
3
1
1
2
1. When you press the
button for over 3 seconds, the year will start flashing. Press
the or buttons to adjust the year and press the
button to confirm setting.
2. Next, the screen starts flashing the month setting. Press the or buttons
repeatedly to set the month and then press the
button to confirm the settings.
Follow the same steps to set the date setting.
3. Lastly, the screen starts flashing the hour values. Press the or buttons
repeatedly to set the hour and then press the
button to confirm the settings.
Follow the same steps to set the minute values.
MONTH-DATE
TIME
3.2 Measurement Mode Selection (MAM or single)
Clinical studies demonstrate taking multiple blood pressure readings and calculating
an “average” is more likely to determine your true blood pressure. Your premium blood
pressure unit allows you to switch the unit to an Average Mode setting that automatically takes multiple
readings!
Average Mode Slide Switch (MAM):
a) If you would like to take an Average Mode measurement, move the slide
switch to the right.
b) Average Mode takes 3 measurements in succession and calculates the result
and displays it as a single average measurement. A
symbol in the
display indicates that the unit is set to the Average Mode.
c) There will be 15 seconds resting time in-between each measurement. The unit will count down from
15 seconds. A beep will sound at the last 5 seconds to remind you that the unit is about to take another
measurement. If one of the measurements causes an error message, it will be repeated one more time. If any additional error
occurs the measurement will be discontinued and error code displayed.
Note: AFIB detection can only be done in MAM mode.
Single mode
a) If you would like to take a single mode measurement, please move the slide
switch to the left.
b) Single mode only has 1 measurement.
3.3 Select the User
This blood pressure monitor is designed to store 99 measurements for each of two users.
Before taking a measurement, be certain that the correct user has been selected.
ST
AR
T
ST
OP
1. Slide the user switch to toggle between User 1 and User 2.
3
1
1
2
3.4 Obtaining Accurate Measurements
Your blood pressure can vary based on numerous factors, physiological conditions, and your surroundings.
Follow these guidelines to obtain accurate and error-free measurements of your blood pressure and pulse rate.
3.4A Before Measuring
• Avoid eating, smoking as well as all forms of exertion directly before the measurement. All these factors
influence the measurement result. Relax by sitting in an armchair in a quiet atmosphere for about 5
minutes before the measurement.
• Always take measurements on the same arm (normally left) and in the same posture. Do not switch
between right and left arms while recording your blood pressure as there may be a difference of up to
10mmHg pressure between the two arms.
• Attempt to carry out the measurements regularly at the same time of day, since blood pressure changes
during the course of the day. The ideal time to measure your blood pressure is in the morning after you
wake up, before breakfast and physical activity, and in the absence of the urge to urinate.
• Rest for 5 minutes sitting quietly and release all the tension in your body — especially the arm muscles
— before beginning with the measurement. Remain calm and quiet when the measurement is in process.
Do not speak or move your arm (as well as other body) muscles during the process.
3.4B Common Sources of Error
All efforts by the patient to support the arm can increase the blood pressure. Make sure you are in a
comfortable, relaxed position and do not activate any of the muscles in the measurement arm during the
measurement. Use a cushion for support if necessary.
ATTENTION!
Comparable blood pressure measurements always require the same conditions with a peaceful
and calm environment. Ensure that you take measurements under the same conditions to obtain an
accurate estimate of blood pressure variation patterns.
•
•
•
If the arm artery lies considerably lower or higher than the heart, an erroneous value of blood pressure is
measured. Each 15 cm difference in height results in a measurement error of 10 mmHg.
A loose cuff causes false measurement values.
With repeated measurements, blood accumulates in the arm, which can lead to false results. Consecutive
blood pressure measurements should be repeated after at least a 15 second pause or after the arm has
been held up in order to allow the accumulated blood to flow away.
3.4C Fitting the Wide Range Cuff
a) Place the cuff around your arm. Make sure the bottom edge
of the cuff is about 1” above the elbow joint. Adjust the
cuff so that the rubber tubing under the cuff lies over the
brachial artery, which runs on the inside of the arm (see Fig.
B).
a)
b) Pull the cuff and tighten it by attaching the Velcro® fastener.
Normally, the left arm is used, unless there is a physical
reason for using the right arm.
b)
c) The cuff should fit snugly around the arm, but not too tight.
You should be able to fit two fingers under the cuff.
c)
d)
d) Place the arm on the table (palm facing upwards) so that the
cuff is at the same level as the heart. Make sure there is no
kink in the hose.
e) You can adjust the level of your arm by putting a cushion under
your arm.
e)
f) Remain seated in a comfortable room temperature for at least
5 minutes, then start the measurement.
f)
g) For those who cannot put the cuff on the left arm, put it on the
right arm as shown.
g)
h) Consecutive measurements will cause blood accumulation in the
lower arm which will affect the measuring results. To improve
reading accuracy, raise the arm being measured, squeeze and
relax your hand several times, then take another measurement.
Another option is to take the cuff off and wait at least 10 minutes
before repeating measurement.
h)
i) If this device was stored in low temperature, it is necessary to
leave it in room temperature for at least 1 hour, otherwise the
measurement can be inaccurate.
Comment:
If it is not possible to fit the cuff to your left arm, it can also be placed on the
right arm. However all measurements should be made using the same arm.
Comparable blood pressure measurements always require the same conditions
(Relax for several minutes before taking a measurement).
ATTENTION!: Do not use cuff other than the original cuff contained in this kit!
3.5 Measuring Your Blood Pressure
After following the guidelines described in the previous section and placing the cuff
around your upper arm, you are now ready to measure your blood pressure. Follow
these steps to record your measurement.
1. Press the Start/Stop button to turn on the device and start measurement.
The LCD screen is turned on. The cuff begins to inflate while the increasing
cuff pressure is displayed on the screen. After the suitable inflation pressure
is reached, the cuff stops inflating and the pressure gradually falls.During the
icon will flash on the display. When the measurement is
measurement the
completed, the systolic and diastolic blood pressure values along with the pulse
rate are displayed on the screen. The measurement is displayed for approximately
1 minute.
2. Switch off the device by pressing the Start/Stop button to preserve the batteries.
If no button is pressed for 1 minute, the instrument switches the display off.
TIME
MONTH-DAY
12:15
129
78
M
SYS
mmHg
DIA
mmHg
68
PULSE /min
1
2
user
START
STOP
M
NOTE: The time will continuously be displayed on the screen.
3.6 Appearance of the Atrial Fibrillation Indicator (only in MAM mode)
This symbol
indicates that atrial fibrillation was detected during the measurement. If AFIB is present
during blood pressure measurement, the
is displayed flashing at the end of the triple measurement.
In this case, the result may deviate from your normal blood pressure. It is highly recommended to take an
additional measurement an hour later to increase the specificity of the detection. In most cases, this is no cause
for concern. However, if the symbol appears on a regular basis (e.g. several times a week with measurements
taken daily) we advise you to visit your doctor. Please, provide the following explanation:
Information for the doctor on frequent appearance of the atrial fibrillation indicator
This instrument is an oscillometric blood pressure monitor that also analyses pulse frequency during
measurement. The instrument is clinically tested.
The
symbol is displayed after the measurement, if atrial fibrillation occurs during measurement. If the
symbol appears more frequently (e.g. several times per week on measurements performed daily) we recommend
the patient to seek medical advice. The instrument does not replace a cardiac examination, but serves to detect
atrial fibrillation at an early stage.
•
•
Sometimes the device will detect atrial fibrillation even when it is not there. This can happen if the arm
moves during the reading or another rhythm problem is present. Keep the arm still during the reading.
Visiting your doctor with this device may be necessary to check out any rhythm problems.
This device may not detect atrial fibrillation in people with pacemakers or defibrillators.
3.7 Hypertension Classification Indicator
The bars on the left hand side of the display show you the range within which the indicated blood pressure
values lies. Depending on the height of the bar, the readout value is either within the normal (green), borderline
(yellow/orange) or danger (red) range.
The classification is based on standards adopted from ESH (European Society of Hypertension), AHA (American
Heart Association) International Guidelines.
Refer to the chart below for details of the classification.
Red
Red
Orange
Yellow
Green
Green
SYS (mmHg) DIA
160
100
135-159
85-99
130-134
120-129
110-119
109
80-84
74-79
67-73
66
An arrow points to the indicator bar according to your measurement.
• If the arrow points to the first or second green bar, your measurement is in the green zone, or “Normal”
according to the ESH/AHA classification.
• If the arrow points to the third bar, it is still in the green zone, but is considered high normal according to the
ESH/AHA classification.
• If the arrow points to the fourth bar, it is in the yellow “Stage 1 Hypertension” zone.
• If the arrow points to the fifth bar, it is in the orange “Stage 2 Hypertension” zone.
• If the arrow points to the sixth bar, it is in the red “Stage 3 Hypertension” zone.
3.8 Viewing Previously Recorded Values
The blood pressure monitor automatically stores your measurements. It can store up to 99 measurements for
each of the 2 users. When more than 99 measurements are made, the oldest readings are deleted for that
particular user to make space for the new ones.
To view the previously stored values, press the
button. The display will show an average value of all stored
readings first, then press the button to view the last measurement. Press the button repeatedly to view
the all the measurements that are recorded on the device. The date and time of the measurement are also
displayed after the reading.
3.9 Clearing All Values
If you are sure that you want to permanently remove all stored values, select user 1 or user 2 then
button (the instrument must have been switched off before hand) until the “CL”
hold down the
appears and then release the button. If you do not want to clear the values, press the Start/Stop
button while “CL” is flashing. Individual
button. To permanently clear the memory, press the
values cannot be cleared.
3.10 Discontinuing a Measurement
If it is necessary to interrupt a blood pressure measurement for any reason (e.g. the patient feels unwell),
the Start/Stop button can be pressed at any time. The device then immediately lowers the cuff pressure
automatically.
4. Software Functions
This unit can be used in connection with your personal computer (PC) running the PC Link Blood Pressure
Analyzer Software. The software 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 USB cable with your PC.
NOTE: The software does not work with Mac Computers.
NOTE: The USB cable can be purchased at any electronics store. You will need USB cable Mini-B 5 pin. USB
versions 1.0 or 2.0 will work on this device.
System Requirements:
This software is compatible with Microsoft® Windows® XP / Vista / Windows 7 and supports 32 and 64 bit
operating systems.
To download the software go to www.biosmedical.com. There will be a link on the home page for “BPA
Software 3.2.5”. Follow the directions to download the software.
Once installation is complete connect the monitor via USB cable with the PC. Three horizontal bars will appear
on the display and last for 3 seconds.
The bars will then flash to indicate that the connection between computer and device is successfully made. As
long as the cable is plugged in, the bars will keep flashing and the buttons are disabled.
During the connection, the device is completely controlled by the computer. Please refer to the ‘help’ file in the
software for detailed instructions.
5. Error Messages / Malfunctions
If an error occurs during a measurement, a long beep followed by two short beeps is generated and the LCD
display the corresponding error code.
Error
Err 1
Possible Cause
No pulse has been detected.
Remedy
Ensure that the cuff is being worn correctly,
and that you have your arm at the heart level.
Err 2
Unnatural pressure impulses influence the
measurement result. Reason: The arm was
moved during the measurement.
The inflation of the cuff takes too long. The
cuff is not correctly seated.
Avoid unnecessary movement or talking.
Repeat the movement keeping your arm still.
Hi
Cuff pressure is over 300 mmHg or pulse is
over 200 beats per minute.
Lo
Pulse below 40 is detected.
Ensure that the cuff is worn correctly and
measure again. Avoid movement or talking
when the cuff is being inflated.
Ensure that the cuff is worn correctly.
Err 3
Err 5
Err 6
Ensure that the cuff is being worn correctly.
An adequate pressure cannot be generated
in the cuff. A leak may have occured. Check
the cuff is correctly connected and its not too
loose.
The difference between systolic pressure and Ensure that the cuff is being worn correctly
diastolic pressure is too far away from accept- and that you have been inactive for a sufable and reasonable range.
ficient time before making the measurement.
Avoid unnecessary movement and talking.
Due to unstable conditions during measurements, it is not possible to calculate an
average result in MAM mode.
Low battery
Replace batteries.
If problems occur when using the device the following points should be checked, and if necessary, the
corresponding measures should be taken.
Malfunction
Remedy
The display remains empty when the device is
switched on. The batteries are inserted.
1. Check batteries for correct polarity.
2. If the display is unusual, re-insert the batteries or
exchange them for new ones.
The pressure does not rise even though the pump is
running.
Check the connection of the cuff tube and connect
properly if necessary.
The device frequently fails to measure the blood
pressure values, or the values measured are too low
or too high.
1. Check the positioning of the cuff.
2. Measure the blood pressure again, ensuring that
you have remained motionless for a sufficient
amount of time to ensure an accurate reading.
Every measurement produces varying results
although the instrument functions normally and the
values displayed are normal.
Note that blood pressure fluctuates continuously;
therefore measurements will show some variability.
Blood pressure values measured differ from those
measured by the doctor.
Record the daily developement of the values and
consult your doctor.
Note: Individuals visiting their doctor frequently experience anxiety which can result in
a higher blood pressure reading than at home.
b) The cuff contains a sensitive air-tight bubble. Handle this carefully and avoid
all types of stress through twisting or buckling.
ST
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ST
OP
6. Care and Maintenance
a) Do not expose the device to either extreme temperatures, humidity, dust or
direct sunlight.
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2
c) Clean the device with a soft, dry cloth. Do not use gas, thinners or similar
solvents. Spots on the cuff can be removed carefully with a damp cloth
and soapsuds. The cuff with bladder must not be washed in a
dishwasher, clothes washer, or submerged in water.
d) Handle the tube carefully. Do not pull on it. Do not allow the tubing to kink and keep it away from sharp
edges.
e) Do not drop the monitor or treat it roughly in any way. Avoid strong vibrations.
RT
STA
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P
STO
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1
2
RT
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P
STO
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2
ST
ART
ST
OP
f) Never open the monitor. This invalidates the manufacturer’s warrantee.
3
1
1
2
g) Batteries and electronic instruments must be disposed of in accordance with
the locally applicable regulations, not with domestic waste.
7. Lifetime Guarantee
BIOS Diagnostics™ blood pressure monitors have a lifetime warranty to be free of manufacturing defects for the
life of the original owner. This warranty does not include the inflation system including the cuff and inflation
bladder. The cuff is warranted for two years. The warranty does not cover damage from misuse or tampering.
If you have questions regarding the operation of your monitor call the BIOS Diagnostics™ Blood Pressure
Hotline:
1-866-536-2289
Should repair be necessary, return the unit with all component pieces. Enclose proof of purchase and $5.00 for
return shipping and insurance. Ship the unit prepaid and insured (at owners option) to:
Thermor Ltd.
Repair Department
16975 Leslie Street
Newmarket, ON L3Y 9A1
www.biosmedical.com
[email protected]
Please include your name, return address, phone number, and email address. Thermor will repair or replace (at
Thermor’s option) free of charge any parts necessary to correct the defect in material or workmanship.
Please allow 10 days for repair and return shipping.
8. Technical Specifications
Operating temperature:
Storage temperature:
Weight:
Dimensions: Measuring procedure:
Measurement range: Cuff pressure display range: Resolution: Static accuracy: Pulse accuracy: Voltage source: Reference to standards:
10 to 40°C / 50 to 104°F
15-95% relative maximum humidity
-20 to 55°C / -4 to 131°F
15 to 95% relative maximum humidity
354 g (including batteries)
160 x 80 x 32 mm
oscillometric, corresponding to Korotkoff
method: Phase I systolic, Phase V diastolic
20 - 280 mmHg – blood pressure
40 - 200 beats per minute – pulse
0 - 299 mmHg
1 mmHg
pressure within ± 3 mmHg
or 2% of reading > 200mmHg
± 5 % of the readout value
• 4 x 1.5 V Batteries; size AAA
• Mains adapter DC 6V, 600 mA
ANSI/AAMI SP10; IEC 60601-1;
IEC 60601-1-2 (EMC)
Read the instructions carefully before using this device
Type BF applied part
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