smartheart 01-563 User manual

Automatic Digital
Blood Pressure Arm Monitor
Model # 01-563
INSTRUCTION MANUAL
ENGLISH AND SPANISH
Please read this instruction manual
completely before operating this unit.

2 • ENGLISH
Digital Monitor Wide-Range Cuff
Instruction Manual
Quick Start Guide
Blood Pressure Reading Tracking Log
FAQ Information Sheet
Replacement Parts Order Form
STOP!
PLEASE ENSURE YOU HAVE ALL OF THE
FOLLOWING COMPONENTS BEFORE USING
YOUR DIGITAL BLOOD PRESSURE MONITOR
IF YOU ARE MISSING ANY PARTS, INCLUDING INSERTS OR
INSTRUCTION MANUALS, DO NOT RETURN TO PLACE OF
PURCHASE. CONTACT CUSTOMER CARE AT 866-326-1313.
4 AA
Batteries

ENGLISH • 3
INDEX
SmartHeart™
Manufactured for
Veridian Healthcare
1175 Lakeside Drive
Gurnee, IL 60031
Made in China
#93-1562 10/22
©2022 Veridian Healthcare, LLC
Toll-Free Customer Care Help Line: 1-866-326-1313
Monday – Friday 8:30 a.m. – 4:30 p.m. CST
Care & Safety Information.............................................................4-8
Introduction & Indications for Use..................................................... 9
Blood Pressure Monitor Features ................................................10-11
Getting Started ............................................................................ 12
Battery Installation ....................................................................... 13
Setting Date & Time..................................................................14-15
Fitting & Applying Your Cuff ......................................................16-17
Taking Your Blood Pressure Reading ...........................................18-19
Interpreting Your Results ............................................................20-21
Memory Function .....................................................................22-23
Care & Maintenance................................................................24-25
Device & Label Symbols................................................................ 26
Display Symbols .......................................................................... 27
Troubleshooting ........................................................................... 28
Error Codes................................................................................. 29
FCC Statement............................................................................. 30
Electromagnetic Compatibility....................................................31-34
Specications .............................................................................. 35
Warranty .................................................................................... 36
Instrucciones en Español ...........................................................37-72

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CARE & SAFETY INFORMATION
NOTE: Read all instructions carefully before use. The following basic precautions are
needed when using an electrical product.
CAUTION: Failure to read and observe all precautions could result in personal
injury or equipment damage.
Improper care or use of your blood pressure monitor may result in injury, damage
to the unit or ineffective treatment. Following these instructions will ensure the blood
pressure monitor’s efcacy and long life.
WARNINGS
• In order to ensure comparable values, always measure your blood pressure at
the same time of day.
• Before every measurement, relax for about ve minutes.
• If you want to perform several measurements on the same person, wait ve
minutes between each measurement.
• Do not take a measurement within 30 minutes of eating, drinking, smoking or
exercising.
• Repeat the measurement if you are unsure of the measured value.
• The measured values taken by you are for your information only – they are no
substitute for a medical examination. Discuss the measured values with your
doctor and never base any medical decisions on them (e.g. medicines and their
dosages).
• Using the blood pressure monitor outside your home environment or whilst
on the move (e.g. whilst travelling in a car, ambulance or helicopter, or
whilst undertaking physical activity such as playing sport) can inuence the
measurement accuracy and cause incorrect measurements.
• Do not use the blood pressure monitor on newborns or patients with pre-
eclampsia. We recommend consulting a doctor before using the blood pressure
monitor during pregnancy.
• Cardiovascular diseases may lead to incorrect measurements or have a
detrimental effect on measurement accuracy. The same also applies to very low
CARE & SAFETY INFORMATION

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CARE & SAFETY INFORMATION
blood pressure, diabetes, circulatory disorders and arrhythmias as well as chills
or shaking.
• This device is not intended for use by people (including children) with restricted
physical, sensory or mental skills or a lack of experience and/or a lack of
knowledge, unless they are supervised by a person who is responsible for their
safety or are instructed by such a person in how to use the device. Supervise
children around the device to ensure they do not play with it.
• The blood pressure monitor must not be used in connection with a high-
frequency surgical unit.
• Only use the device on people who have the specied upper arm
measurement for the device.
• Please note that when inating, the functions of the limb in question may be
impaired.
• During the blood pressure measurement, the blood circulation must not be
stopped for an unnecessarily long time. If the device malfunctions, remove the
cuff from the arm.
• Avoid any mechanical restriction, compression or bending of the cuff line.
• Do not allow sustained pressure in the cuff or frequent measurements. The
resulting restriction of the blood ow may cause injury.
• Make sure that the cuff is not placed on an arm in which the arteries or veins
are undergoing medical treatment, e.g. intravascular access or therapy, or an
arteriovenous (AV) shunt.
• Do not use the cuff on people who have undergone a mastectomy.
• Do not place the cuff over wounds as this may cause further injury.
• Place the cuff on your upper arm only. Do not place the cuff on other parts of
the body.
CAUTIONS
• You can either use the blood pressure monitor with batteries or with a mains

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part. Please note that data transfer and data storage is only possible when
your blood pressure monitor is supplied with power. As soon as the batteries
are empty or the mains part is disconnected from the power supply, the blood
pressure monitor loses the date and time.
• To conserve the batteries, the blood pressure monitor switches off automatically
if no buttons are pressed for one minute.
• The device is only intended for the purpose described in these instructions
for use. The manufacturer is not liable for damage resulting from improper or
careless use.
• The blood pressure monitor is made from precision and electronic components.
The accuracy of the measured values and service life of the device depend on
its careful handling:
– Protect the device from impacts, humidity, dirt, marked temperature
uctuations and direct sunlight.
– Do not drop the device.
– Do not use the device in the vicinity of strong electromagnetic elds and
keep it away from radio systems or mobile telephones.
– Only use the cuff included with the delivery or original replacement cuffs.
Otherwise incorrect measured values will be recorded.
• We recommend that the batteries be removed if the device will not be used for
a prolonged period of time.
WARNING ON HANDLING BATTERIES
• If your skin or eyes come into contact with battery uid, rinse the affected
areas with water and seek medical assistance.
• Choking hazard! Small children may swallow and choke on batteries.
Store batteries out of the reach of small children.
• Observe the plus (+) and minus (-) polarity signs while inserting the batteries in
the battery housing.
CARE & SAFETY INFORMATION

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CARE & SAFETY INFORMATION
• If a battery has leaked, put on protective gloves and clean the battery
compartment with a dry cloth.
• Protect batteries from excessive heat.
• Risk of explosion! Do not throw batteries into a re.
• Do not charge or short-circuit batteries.
• If the device will not be used for some time, take the batteries out of the battery
compartment.
• Use identical or equivalent battery types only.
• Always replace all batteries at the same time.
• Do not use rechargeable batteries!
• Do not disassemble, open or crush the batteries.
INSTRUCTIONS FOR REPAIRS AND DISPOSAL
• Batteries do not belong in household waste. Please dispose of empty batteries
at the collection points intended for this purpose.
• Do not open the device. Failure to comply will invalidate the warranty.
• Do not repair or adjust the device yourself. Proper operation can no longer be
guaranteed in this case.
• Repairs must only be carried out by Customer Services or authorized retailers.
Before making a claim, please check the batteries rst and replace them if
necessary.
• For environmental reasons, do not dispose of the device in the household
waste at the end of its useful life. Dispose of the device at a suitable
local collection or recycling point in your country. Dispose of the device
in accordance with local Legislation on Waste Electrical and Electronic
Equipment. If you have any questions, please contact the local authorities
responsible for waste disposal.

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NOTES ON ELECTROMAGNETIC COMPATIBILITY
• The device is suitable for use in all environments listed in these instructions for
use, including domestic environments.
• The use of the device may be limited in the presence of electromagnetic
disturbances. This could result in issues such as error messages or the failure of
the display/device.
• Avoid using this device directly next to other devices or stacked on top of other
devices, as this could lead to faulty operation. If, however, it is necessary to
use the device in the manner stated, this device as well as the other devices
must be monitored to ensure they are working properly.
• The use of accessories other than those specied or provided by the
manufacturer of this device can lead to an increase in electromagnetic
emissions or a decrease in the device’s electromagnetic immunity; this can
result in faulty operation.
• Failure to comply with the above can impair the performance of the device.
CARE & SAFETY INFORMATION

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INTRODUCTION & INDICATIONS FOR USE
It is recommended that you rst seek the advice and recommendation of your
physician or healthcare professional when using home diagnostic devices,
including blood pressure monitors.
Automatic digital blood pressure monitors use the oscillometric method to
electronically measure your blood pressure. The monitor detects your blood’s
movement through the artery in your arm and converts the movements into a
digital reading. The oscillometric method does not require a stethoscope, making
the monitor ideal for home use.
Blood pressure readings determined with this device are equivalent to
measurements obtained by a trained healthcare professional using the cuff/
stethoscope auscultation method, within the limits prescribed by the American
National Standard for Electronic or Automated Sphygmomanometers.
Thank you for purchasing an Automatic Digital Blood Pressure Monitor. With
proper care and use, your monitor will provide you with many years of reliable
readings.
PLEASE READ THIS INSTRUCTION MANUAL
COMPLETELY BEFORE OPERATING THIS UNIT.

10 • ENGLISH
BLOOD PRESSURE MONITOR FEATURES
Arm Cuff
Battery
Compartment
(underside)
Digital Display
POWER
Button Memory 2 Button
Memory 1
Button

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BLOOD PRESSURE MONITOR FEATURES
DETAILS OF THE DIGITAL DISPLAY SCREEN AND INTERPRETATION OF
THE SYMBOLS ARE INCLUDED THROUGHOUT THIS MANUAL.
WHO Indicator
Irregular
Heartbeat
Heart
Rate Detected
Cuff
Position Control
Memory Mode
Memory Count
Date & Time
Systolic Pressure
Diastolic Pressure
Pulse Rate
Low Battery
User Icons

12 • ENGLISH
GETTING STARTED
Before Taking a Measurement
1. Your readings should only be interpreted by your physician or healthcare
professional with access to your individual medical history. Regular use of a
home blood pressure monitor will allow you to track and record your readings
for discussion with your physician.
2. Conduct your measurement in a quiet place while seated in a relaxed position.
Rest for 15 minutes before taking your reading. If an error occurs or you desire
to take a second reading, allow 15 minutes between readings for your blood
vessels to return to normal.
3. Avoid smoking, eating, taking medication, alcohol, physical activity or any
other stressful activity for 30 minutes prior to taking a reading.
4. Always remove any jewelry or constrictive clothing that may interfere with the
cuff placement.
5. Keep yourself and the monitor still during measuring; do not talk during the
reading.
6. It is recommended that you take your readings at the same time each day to
better monitor any indications in your results.
7. Record your daily measurement on the included chart or some other written
document to share with your physician.

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BATTERY INSTALLATION
This unit requires 4 AA batteries.
It is necessary to replace the batteries when the “Low
Battery” symbol appears on the display or when the display
does not turn on after the POWER button is pressed.
The battery compartment is located on the underside of this
monitor.
1. Depress the clip on the battery
compartment and remove the
cover.
2. Insert or replace 4 AA
batteries into the battery
compartment, ensuring to
match the indicated polarity
symbols. Always use new
batteries.
3. Replace the battery cover.
4. Dispose of batteries according
to local disposal and recycling
regulations.
It is recommended to remove the
batteries if the unit will not be used
for an extended period of time.
The ‘Low Battery’
symbol will appear
on the upper left
of the display.

14 • ENGLISH
SETTING DATE/TIME
IT IS NECESSARY TO SET THE DATE AND TIME FOR THE
UNIT EVERY TIME BATTERIES ARE INITIALLY INSTALLED OR
REPLACED
It is essential to set the date and time correctly. Otherwise, you will not be able to
save your measured values correctly with a date and time and access them again
later
The M1, M2 and POWER buttons are
located below the display.
1. When the batteries are rst installed, the device will automatically prompt you to set the
Date/Time feature.*
*NOTE: If the batteries have already been installed—when the unit is o (a blank
display screen), press and hold the POWER button for 5-7 seconds to make the unit go
into clock setting mode.
2. Military/ Standard Clock- When you rst enter into the clock setting mode you have
the option to choose between a 24 or 12 hour clock. Press the M1 button to toggle
between the two settings. Once a selection is made press the POWER button to advance
to the next step.
3. YEAR—next the year will ash on the display. Press the Mbutton to advance the display
to the desired year, press the POWER button to conrm your selection and advance to
the date settings.

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4. MONTH/DATE—repeat the same sequence of step 2 to conrm the MONTH and DATE
setting.
5. HOURS/MINUTES—repeat the same sequence of step 2 to conrm the HOUR and
MINUTE setting.
6. After the Date/Time setting function is complete, the monitor is ready for use.
SETTING DATE/TIME

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FITTING & APPLYING YOUR CUFF
PROPER CUFF FIT AND PLACEMENT IS CRITICAL IN OBTAINING
ACCURATE BLOOD PRESSURE MEASUREMENTS. PLEASE READ THESE
INSTRUCTIONS CAREFULLY AND CONSIDER CONSULTING WITH
YOUR PHYSICIAN FOR FURTHER DIRECTION.
Before applying your blood pressure cuff, be sure you have
selected the appropriate size cuff.
To determine the proper cuff size, measure the circumference
of your left upper arm at the point midway between inside
bend of your elbow and your shoulder.
Wide-Range Adult Cuff ts arm circumference 8.6”—16.5” (22—42 cm)
If for any reason you are unable to or should not use your left arm, please modify
the instructions for cuff application to your right arm. Your physician can help you
identify which arm is best for you to take measurements from.
Assembling Your Cuff
Your cuff may need to be ‘threaded’ through the metal bar
to form the cuff cylinder for your arm.
1. Lay the open cuff hook and loop side down, size/
instruction wording side up on a at surface.
2. Keeping the words on the inside of the cuff, thread the
end of the cuff through the metal bar, Fig 1. The end
of the cuff should be able to fold over onto itself for
securing via the hook and loop closure, Fig 2.
Fig. 1
Fig. 2

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FITTING & APPLYING YOUR CUFF
Applying Your Cuff
Be seated at a table or desk with your feet at on the
oor. To avoid accidentally pulling on or dropping your
monitor, the cuff should not be plugged into the monitor
until after the cuff is applied to your arm.
The cuff is printed with a useful guide for applying the
cuff; please consult the following steps for additional
direction.
1. Remove any constrictive clothing or jewelry that may
interfere with cuff placement.
2. Slide the cuff cylinder onto your left arm and align the
artery mark over the brachial artery on the inside of
your arm, Fig 3.
The tube should follow the inside length of the arm,
Fig 4.
3. The bottom edge of the cuff should be positioned
approximately 0.5” above the elbow joint, Fig 5.
4. When the cuff is closed around the arm, the triangle
guide imprint should be within the OK range bar
marking; if the triangle is outside of the range, a
different sized cuff is needed.
5. The cuff should t comfortably, yet snugly around your
arm, Fig 6. You should be able to insert one nger
easily between your arm and the cuff.
6. During use, avoid compression or squeezing of the
air hose/tube, as this may cause ination error or
injury due to excessive cuff pressure.
Fig. 3
Fig. 5
Fig. 4
Fig. 6
~0.5/1-2cm

18 • ENGLISH
TAKING YOUR BLOOD PRESSURE READING
Please read the preceding portions of this
manual prior to taking your rst reading.
Reminder, it is important to avoid smoking,
eating, taking medication, alcohol consumption
or physical activity 30 minutes prior to taking a
reading.
1. Position the monitor on a at, stable surface
with the digital display in view. Be seated
with your feet at on the oor and legs
uncrossed.
2. After applying the cuff insert the cuff tubing
connector into the port on the left side of your
monitor.
3. Rest your elbow on a solid surface with your
palm facing upward. Elevate your arm so that
the cuff is at the same level as your heart, Fig
1. Relax your left hand.
4. Press and release the POWER button to turn
the unit on; the unit will briey ash a self-test,
Fig 2.
5. The cuff will automatically inate; you will see
the numbers increase on the display screen
and feel the cuff inate.
Fig. 2
PROPER CUFF PLACEMENT ICON
After a few moments, the screen will show the OK Cuff symbol,
indicating that the cuff is applied properly. If this icon does not show,
the measurement will hault and the error E3 will show on the display. If
an error occurs, wait a few minutes, reapply the cuff and attempt a new
measurement.
Fig. 1

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TAKING YOUR BLOOD PRESSURE READING
6. When the measurement is complete, the cuff will
automatically deate, then your blood pressure
measurement and pulse reading results will
show on the display screen at the same time,
Fig 3.
7. The measurement results will default to the
memory bank in use. To select a memory bank,
while the results show on the display, press M1
or M2 to store the results.
8. The Hypertension Indicator will indicate your
reading range on the left display in comparison
to the color bars on the face of the monitor, Fig
4. For more information see Interpreting Your
Results.
9. If an irregular heartbeat was detected during
the reading, the Irregular Heartbeat Detection
indicator will appear on the display, Fig 5. For
more information see Interpreting Your Results.
10. The reading will automatically be stored in
memory, up to 60 readings per user bank.
11. Select POWER to turn the unit off and conserve
energy and battery life.
12. The unit will automatically shut-off approximately
1 minute after use.
13. Disconnect the tubing prior to storage.
YOU CAN STOP THE INFLATION OR DEFLATION PROCESS AT ANY
TIME BY PRESSING THE POWER BUTTON.
Fig. 3
Fig. 5
Fig. 6

20 • ENGLISH
Irregular Heartbeat Indicator
An irregular heartbeat is dened as a heartbeat rhythm that is more than 25%
slower or 25% faster than the average measurement detected while the monitor is
conducting the measurement. When this device detects an irregular rhythm two or
more times during the reading, the IHB symbol will appear on the display.
This monitor will operate if the icon appears, but the results may be compromised,
especially if this symbol appears often. Please consult with your physician or
trained healthcare professional for further information regarding an irregular
heartbeat and if this symbol appears frequently.
INTERPRETING YOUR RESULTS
Pulse
Pulse
Irregular Heartbeat
Normal Heartbeat
Blood
Pressure
Blood
Pressure
Short
Beat Long Beat