microlife BP3GX1-5A User Manual

Important Product and Safety Information
Follow Instructions for Use. This document provides important product operation and safety information regarding this Blood Pressure Monitor. Please read this document thoroughly before using the device and keep for future reference.
This blood pressure monitor is an automatic digital blood pressure measur­ing device for use by adults on the upper arm at home or in the doctor’s office. It enables a very fast and reliable measurement of the systolic and diastolic blood pressure, as well as the pulse rate, by way of the oscillo­metric method. This device detects the appearance of irregular heartbeats during measurement and provides a warning signal when the irregular heartbeat is detected. The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software; the memory data can be transferred to the PC by connecting the monitor via cable with the PC.
This blood pressure monitor IS intended to be used:
• For self-measurement/monitoring of blood pressure and pulse in adults; whereas the person being measured may be the user/operator of the device.
• Within a home healthcare environment.
• With a cuff located upon the user’s upper arm; ½ inch above the elbow over the artery as indicated on the cuff.
This blood pressure monitor IS NOT intended for use with:
• Pregnancy
•Preeclampsia
• Children under 12
• Neonatal patients
WARNING – Potentially hazardous situation that if not avoided may result in serious injury or death.
• Self-measuring means monitoring, not diagnosis or treatment. Unusual values must always be discussed with your doctor. Under no circum­stances should you independently alter the dosages of any drugs prescribed by your physician.
• Consult your physician before using this device if any of the following or similar conditions are present: arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion,
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diabetes, age, pregnancy, preeclampsia, renal diseases. Motion during measurement, including trembling or shivering may affect the measurement.
• Though not for use with children under 12, ensure that any children around this device are supervised; some parts are small enough to be swallowed and any present tubes or cables may provide a risk of strangulation.
• Ensure the cuff tubing is not kinked during use as harmful injury may occur due to the effect of blood flow interference caused by high pressure in the cuff not releasing.
DO NOT:
Use this device if you think it is damaged or anything appears unusual
(e.g. sporadic operation, open packaging upon purchase).
Use the displayed pulse for checking the frequency of heart pacemakers
as this device is not suitable for this action.
Open/modify this device; inaccuracy and/or harmful injury may result.Conduct many frequent measurements as this may result in harmful
injury due to blood flow interference.
Place the Cuff over a wound as this may cause further injury.Place and pressurize the Cuff over/near any present intravascular access
or therapy, or arteriovenous shunt, as this may cause blood flow interfer­ence and result in harmful injury.
Place and pressurize the Cuff over a limb near the side of a mastectomy
as this may cause harmful injury.
Use the Blood Pressure Monitor on a limb simultaneously with other medical equipment
on the same limb due to possible interference with such
medical equipment.
Maintain pressure in the Cuff applied to the limb for a prolonged amount
of time. Ensure that circulation in the limb is not impaired by checking circulation if prolonged/repeated exposure to pressure occurs.
Service the device when being used or when power is supplied. When
the device is not in use and power is removed, cuff assembly, batteries and ac adapter (if applicable) may be replaced by the user with Microlife supplied replacements. No other parts/components are accessible.
CAUTION – Potentially hazardous situation that if not avoided may result in minor/moderate injury, property damage, and/or damage to the device
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This device contains sensitive electronics components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g., mobile telephones, microwave ovens). These can lead to temporary impair­ment of the measuring accuracy. Move the device to another location if interference is determined.
• When not using the Blood Pressure Monitor for extended lengths of time, remove the batteries to avoid potential battery leakage and damage to the monitor.
• When replacing the batteries, ensure all the batteries are replaced simultaneously to avoid battery damage and potential damage to the monitor. Microlife USA does not recommend using rechargeable batteries.
• To avoid inaccurate measurements and to lessen any discomfort from Cuff pressure, ensure the Cuff is placed correctly on the limb and fits correctly when snug (not tight), as indicated by markings with the Cuff.
• Consult your physician in cases of frequent irregular heartbeat detections.
• This Risk Indicator feature is provided in order to help you understand your potential blood pressure risk. However, this feature is neither a diagnosis nor a substitute for a medical examination. It is important to consult with your physician to determine your risk.
DO NOT:
Drop this device or expose it to strong vibrations; sensitive components
may be affected resulting in inaccuracies and/or operational issues.
Use the Blood Pressure Monitor outside of its specified operation
temperature and humidity rating, or if stored outside of its specified storage temperature and humidity rating. Avoid storage in direct sunlight.
Use this device in a moving vehicle; inaccurate measurements may result.Use third party accessories. Only use Microlife authorized accessories,
such as cuffs or AC adapters, as those not approved for use with the device may provide inaccurate measurements, injury, and/or damage the device.
STANDARDS:
This medical device is compliant with:
• Medical device and non-invasive blood pressure monitor standards IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and AAMI/ANSI/IEC 80601-2­30, and
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• Electromagnetic standards IEC 60601—1-2 along with FCC Part 15, and
• Clinical Testing per standard ISO 81060-2:2013 was conducted on blood pressure device using the same measurement technology.
Please note:According to international standards, your monitor should be checked for accuracy every 2 years.
TYPE:
IP20:Protected against solid foreign particles with a diameter of more than
12.5 mm, no protection against water. Keep Dry.
Type BF Applied Part Batteries and electronic instruments must be disposed of in accordance
with the locally applicable regulations, not with domestic waste.
Expected Life
Monitor: 5 Years Cuff: 2 Years
FCC:
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications to the product are not approved by Microlife USA and could void the user's authority to operate the equipment under FCC jurisdiction.
This equipment has been verified to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment on and off, the user is encouraged to try to correct the interference by increasing the distance between the product and the affected device; or if applicable, reorientation the receiving antenna, or moving the product’s power plug to another receptacle.
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ressure Monitor
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Instruction M
Introduction
1.
1.1. Y
1.2. G
How
2.
anual Table of Contents
our autom entle+ m
is blood pressure measured?
2.1. What is blood pressure, and w easurem
2.2. M
2.3. What can I do to change m
omponents of your blood pressure monitor
3. C
do I get started?
4. How
Blood P
atic blood pressure m
ent system
easurem
uidelines
ent G
y blood pressure?
onitor
hy does it fluctuate?
4.1. Inserting the batteries
4.2. Setting the date and tim
4.3. U
sing the A
C pow
4.4. Connecting the cuff and m
e
er adapter
onitor
4.5. Select the user
4.6. Select the measuring mode: standard or aging Mode
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4.7. Mic
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5.4.
Memory
5.5.
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5.6.
Hyper
5.7.
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5.8.
Battery change
5.9.
Software
6.
Installation and data transmission
6.1.
Error messages/troubleshooting
7.
Care and maintenance
8.
Limited warranty
9.
ake a measur
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10. Technical specifications
11. How to contact us
Microlife Averaging Mode
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1. Introduction
1.1. Your Automatic Blood Pressure Monitor
Your blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults on the upper arm at home or in your doctor’s office. It enables very fast and reliable measurement of the systolic and diastolic blood pressure as well as the pulse by way of the oscillometric method. This device offers clinically proven accuracy and has been designed to be user friendly.
Before using your blood pressure monitor, please read this instruction manual carefully and then keep it in a safe place for future reference. If you have additional questions regarding blood pressure measurements please contact your doctor.
1.2. Gentle+ Measurement System
Gentle+, our most advanced system to date, combines clinical accuracy and premium features including:
• A quieter, more comfortable measurement experience that reduces the amount of time your arm is under pressure. Less pressure = more comfort!
• An ergonomic cuff design that is easier to use and fits a wider range of arm sizes (for arms 8.7”-16.5”).
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2. How is blood pressure measured?
2.1. What is blood pressure, and why does it fluctuate?
Your level of blood pressure is determined in the circulatory center of the 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).
Blood pressure values must lie within certain normal ranges in order to prevent particular diseases.
--Blood pressure is too high if your systolic blood pressure is over 160 mmHg and/or your diastolic pressure is above 100 mmHg, while at rest. In this case, please consult your physician immediately. Long-term values at this level endanger your health due to continual damage to the blood vessels in your body.
If your systolic blood pressure values are between 140 mmHg and 159 mmHg and/or the diastolic blood pressure values are between 90 mmHg and 99 mmHg, consult your physician. Regular self-checks are necessary.
If you have blood pressure values that are too low (i.e., systolic values under 105 mmHg and/or diastolic values under 60 mmHg), consult your physician.
Even with normal blood pressure values, 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.
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2.2. Measurement Guidelines
The following standards for assessing high blood pressure (in adults) have been established by the National Institutes of Health JNC7, 2003.
Category Systolic Diastolic
(mmHg) (mmHg)
Normal <120 and <80 Pre-Hypertension 120-139 or 80-89
Hypertension
Stage 1 Hypertension 140-159 or 90-99 Stage 2 Hypertension
160 or 100
Additional 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 doctor.
• Correctly measured diastolic blood pressure values above 120 mmHg require immediate medical treatment.
2.3. What can I do to change my blood pressure?
a) Consult your doctor. b) Increased blood pressure values (various forms of hypertension) are
associated with considerable health risks over time. Arterial blood vessels in your body 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 result from arteriosclerosis. Furthermore, the heart will become structurally damaged with increased blood pressure values.
c) There are many different causes of high blood pressure. We differenti-
ate between the common primary (essential) hypertension and second­ary hypertension. The latter group can be ascribed to specific organ malfunctions. Please consult your doctor for information about the possible origins of your own increased blood pressure values.
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d)
There are measures which you can take to reduce and even prevent high blood pressure. These measures must be permanent lifestyle changes.
1) Eating habits
• Strive for a normal weight corresponding to your age. See your doctor for your ideal weight.
• Avoid excessive consumption of common salt.
• Avoid fatty foods.
2) Previous illnesses
• Consistently follow all medical instructions for treating illness such as:
• Diabetes (diabetes mellitus)
• Fat metabolism disorder
• Gout
3) Habits
• Give up smoking completely.
• Drink only moderate amounts of alcohol.
• Restrict your caffeine consumption (e.g., coffee).
4) Physical constitution
• After a preliminary medical examination, do regular 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 doctor before beginning your exercise routine. You must receive advice regarding the type and extent of exercise that is appropriate for you.
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3. Components of your blood pressure monitor a) Measuring unit
Cuff Socket
(blue)
Hypertension Risk Indicator
User Switch
Time/Date Button
Mode Switch
Select 1 or 3 Measurements (MAM)
Memory Recall Button
POWER Button
AC Adapter Port
USB Port
Date/Time
Systolic
Diastolic
Pulse
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User 1 & 2 Battery Indicator
Pause Heartbeat
Error 3 Error 2
Memory Irregular Heartbeat
MAM
b) Wide Range Cuff:
For arm circumference 22 cm - 42 cm (8.7” - 16.5 ”) If you ever need to buy a replacement cuff, call
us toll-free at 1-800-568-4147.
Please Note:
Arm circumference should be measured with a measuring tape in the middle of the relaxed upper arm. Do not force cuff connection into the opening. Make sure the cuff connection is not pushed into the AC adapter port. If the cuff is too small, call 1-800-568-4147 for additional information.
4. How do I get started?
4.1. Inserting the batteries
After you have unpacked your device, insert the batteries. The battery compartment is located on the bottom of the device.
a) Remove the battery cover. b) Insert the batteries (4 x size AA 1.5 V),
observing the indicated polarity.
c) If a battery warning appears in the
Low Battery Indicator
display, the batteries are discharged and must be replaced.
Attention!
• After the low battery indicator appears, the device won’t function until the batter­ies have been replaced.
Please use "AA" Long-Life or Alkaline
1.5 V
batteries and replace them all at
the same time.
• If the blood pressure monitor is not used for long periods, remove the batteries from the device.
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4.2. Setting the date and time
T
I
M
E
PM
1. After the new batteries are activated, the year number flashes in the display. You can advance the year by pressing the "M" button. To confirm and then set the month, press the TIME button.
2. You can now set the month using the "M" button. To confirm and then set the day, press the TIME button.
3. Please follow the instructions above to set the day, hour and minutes.
4. Once you have set the last minute and pressed the TIME button, the date and time are set and the time is displayed.
5. If you want to change the date and time, press and hold the TIME button down for approximately 3 seconds until the year number starts to flash. Now you can enter the new values as described above.
4.3. Using the AC power adapter
You may also operate this monitor using the included AC adapter.
Use only the included
AC adapter to avoid damaging the unit. a) Ensure that the AC adapter and cable are
not damaged.
b) Plug the adapter cable into the AC
adapter port on the right side of monitor.
c) Plug the AC adapter into a 110 V power
socket (U.S. or Canada).
d) Test that power is available by pressing
the POWER button.
Note:
• No power is taken from the batteries while the AC adapter is connected to the instrument.
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at
D
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i
T
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But
• If the power is interrupted during a measurement (e.g., by removal of the adapter from the wall socket), the instru­ment must be reset by removing the plug from the instrument.
If you have any questions regarding the AC adapter, call us at 1-800-568-4147.
4.4. Connecting the cuff and monitor
Insert the blue cuff tube connector into the blue socket on the left side of the instrument.
If your cuff connector is another color, please contact customer service as additional steps are needed to obtain an accurate reading.
4.5. 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.
• User 1: slide the user switch upwards to the User 1 icon
• User 2: slide the user switch downwards to the User 2 icon
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4.6. Select measuring mode: standard or
1 3
Microlife Averaging Mode (MAM)
This instrument enables you to select either standard (single measurement) or measurement a
veraging
mode (automatic triple measurement). a) To select Standard mode, push the switch on the
side of the instrument upward to Position "1."
b) To select Averaging mode, push the switch
downward to Position "3." Note the "MAM" icon will illuminate on the display.
If you select 1, then only one measurement will be taken. If you select 3, the unit will inflate and deflate three times resulting in one final average.
4.7. Microlife Averaging Mode (MAM)
• In Microlife Averaging Mode (MAM), three measurements are automatically taken in succes­sion and the result is then automatically analyzed and displayed. Because your blood pressure constantly fluctuates, a result determined in this way is more reliable than one produced by a single measurement.
• After pressing the POWER button the selected Microlife Averaging Mode appears in the display as the MAM symbol.
• The bottom, right-hand section of the display shows a 1, 2 or 3 to indicate which of the 3 measurements is currently being taken.
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5. How do I take a measurement? Please note: You should always be seated before and during measurement.
5.1. Preparing to take a measurement
• Avoid eating and smoking as well as all forms of exertion directly before measurement. These factors influence the measurement result. Find time to relax by sitting in an armchair in a quiet atmosphere for about 5 minutes before your measurement.
• Remove any garment that fits closely to your upper arm.
• Always measure on the same arm (normally left).
• Compare measurements at the same time of day, since blood pressure changes during the course of the day (as much as 20–40 mmHg).
5.2. Common errors
Note: Comparable blood pressure measurements always require the same conditions. Conditions should always be quiet.
• All efforts by the user to support the arm can increase blood pressure. Make sure you are in a comfortable, relaxed position and do not flex any of the muscles in the measurement arm during the measurement. Use a cushion for support if necessary.
• If the arm artery lies considerably lower or higher than the heart, an erroneously high or low blood pressure will be measured. Each 15 cm (6”) difference in height between your heart and the cuff results in a measurement error of 10 mmHg.
• Cuffs that are too narrow or too short result in false measurement values. Selecting the correct cuff is extremely important. Cuff size is dependent upon the circumference of the arm (measured in the center). The permissible range is printed on the cuff. If this is not suitable for your use, please call 1-800-568-4147.
• A loose cuff or a sideways protruding air pocket 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 a 1 minute pause or after your arm has been held up in order to allow the accumulated blood to flow away.
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5.3. Using the cuff
a) Pass the end of the cuff through the flat
metal ring so that a loop is formed. The hook and loop material must be facing outward. (Ignore this step if the cuff has already been prepared.)
Slide the cuff onto your upper left arm. The
b)
rubber tube should be on the inside of your arm extending downward to your hand. Make certain the cuff lies approximately 1/2” (1 to 2 cm) above the elbow.
IMPORTANT: The red strip on the edge the cuff (Artery Mark) must lie over the artery which runs down the inner side of the arm.
TIP: Align red artery mark to pinky finger.
c) To secure the cuff, wrap it around your
arm and press the hook and loop material together. Check the position of the green SIZING SEAM on the cuff. Ensure green sizing seam overlaps green size range bar.
8.7” - 16.5”
½
of
d) There should be little free space between
the arm and the cuff. You should be able to fit 2 fingers between your arm and the cuff. Clothing must not restrict the arm. Any piece of clothing which does must be removed. Cuffs that don’t fit properly result in false measurement values. Measure your arm circumference if you are not sure of proper fit.
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e) Lay your arm on a table so the cuff is at
the same height as your heart. Make sure the tube is not kinked.
Remain seated quietly for 5 minutes before
f)
you begin the measurement.
Comment If it is not possible to fit the cuff to your left arm, it
can also be placed on your 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 a reading).
Cuff on
right arm
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5.4. Taking a measurement
After the cuff has been appropriately positioned the measurement can begin. Remain still during your measurement, do not flex muscles.
a) Remain seated quietly for 5 minutes before you
begin the measurement.
b) Press the POWER button. After the system check,
the monitor displays OK and the pump begins to inflate the cuff. On the display, the increasing cuff pressure is continually shown.
c) After automatically reaching an individual
pressure, the pump stops and the pressure will release. The cuff pressure is displayed during the measurement.
d) When the device has detected your pulse, the
heart symbol in the display begins to blink.
e) When the measurement has been concluded, the
air will automatically release from the cuff. The measured systolic and diastolic blood pressure values, as well as the pulse, are now displayed.
f) The measurement results are displayed until you
switch the device off. If no button is pressed for 1 minute, the device switches off automatically.
g) When the unit is set to the MAM (Microlife
Averaging Mode) setting, 3 separate measure­ments will take place in succession, after which your result is calculated and displayed as a single, averaged measurement (individual results are not displayed). There is a 15 second resting time between each measurement. A count-down indicates the remaining time between measurements.
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.
Pumping Pressure
Measuring
Systolic
Diastolic
Pulse
Measurement
Complete
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