smartheart 01-521 User manual

Talking
Blood Pressure Monitor
Model # 01-521
INSTRUCTION MANUAL
ENGLISH, ESPAÑOL AND LE FRANÇAIS
Please read this instruction manual
completely before operating this unit.

2 • ENGLISH
Digital Monitor Wide-Range
Arm Cuff Storage Case
4 AA Batteries
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.

ENGLISH • 3
INDEX
SmartHeart™
Manufactured for
Veridian Healthcare
1175 Lakeside Drive
Gurnee, IL 60031
Made in China
#93-1398 02/18
©2018 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.............................................................4-5
Introduction & Indications for Use..................................................... 6
Digital Blood Pressure Monitor Features ............................................ 7
Getting Started .............................................................................. 8
Battery Installation ......................................................................... 9
Setting Memory Bank / User ........................................................ 10
Setting Date and Time................................................................... 10
Setting Language and Volume........................................................ 11
Applying Your Blood Pressure Cuff .............................................12-13
Taking Your Blood Pressure Reading ...........................................14-15
Interpreting your Results ............................................................16-17
Memory Functions........................................................................ 18
Care and Maintenance................................................................. 19
Device and Label Symbols............................................................. 20
Description of Display Symbols...................................................... 21
Troubleshooting ........................................................................... 22
FCC Statement............................................................................. 23
Electromagnetic Compatibility....................................................24-27
Specications .............................................................................. 28
Warranty .................................................................................... 29
Instrucciones en Español ...........................................................31-60
Instructions en Français.............................................................61-92

4 • ENGLISH
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.
GENERAL CAUTIONS AND WARNINGS
• Measurement results should be discussed with your physician or healthcare
professional; never self-diagnose or attempt treatment as this may be
dangerous
• Intended for adult use only; this device is not approved for infant or child use
• Keep out of reach of children
• Do not use the unit if it has any damaged parts (including power cord or plug
and cuff), if it has been submersed in water or dropped
• If any abnormality occurs, discontinue use until the unit has been examined
and repaired
• Only use included attachments and parts; do not use attachments from other
brands or models as these may not be properly calibrated for use with this
device and may result in measurement error
• Do not disassemble the unit or attempt to repair it; substitution of a component
different from that supplied may result in measurement error and will void
manufacturer warranty
• Always follow local regulations for proper disposal of the monitor, cuff and
batteries

ENGLISH • 5
CARE & SAFETY INFORMATION
OPERATING CAUTIONS AND WARNINGS
• Prolonged overination may cause congestion, swelling or bruising in some
people
• If you experience any discomfort or an abnormality occurs, stop using the
device immediately; to stop the device during operation, press the START/
STOP button and the cuff will automatically deate
• Operation outside of stated operating temperature may result in measurement
error or device malfunction; operation environment temperature is: 50°F –
104°F (10°C – 40°C); Humidity: 15% – 93% RH max
• Never use this unit while operating a vehicle or in the bathtub or shower
STORAGE CAUTIONS AND WARNINGS
• Storage outside of stated storage temperature may result in measurement error
or device malfunction; storage environment temperature is: -13°F – 158°F
(-25°C – 70°C); Humidity: ≤93%
• Keep the unit out of reach of small children
• Always keep the unit unplugged while not in use; remove the batteries if the
unit will not be used for an extended period of time
CLEANING CAUTIONS AND WARNINGS
• Never immerse the unit in water to clean as it may damage the unit
• Follow the ‘Cleaning and Maintenance’ portion of this manual for instruction
on how to clean and care for your monitor

6 • ENGLISH
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 a SmartHeart 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.

ENGLISH • 7
BLOOD PRESSURE MONITOR FEATURES
DETAILS OF THE DIGITAL DISPLAY SCREEN AND INTERPRETATION OF
THE SYMBOLS ARE INCLUDED THROUGHOUT THIS MANUAL.
Cuff
Connector
Battery
Compartment
(underside)
Digital Display
MEMORY
Recall
Button
SET
Button
START/STOP
Button
(power on/off)

8 • 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 as 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.

ENGLISH • 9
BATTERY INSTALLATION
This unit comes complete with 4 AA
batteries.
It is necessary to replace the batteries when the
Low Battery symbol appears on the display, Fig
1, or when the display does not turn on after the
START/STOP button is pressed.
The battery compartment is located on the
underside of this monitor.
1. Depress the clip in the
battery compartment
cover and remove the
cover.
2. Insert or replace 4
AA batteries into the
battery compartment,
ensuring to match
the indicated polarity
symbols, Fig 2. 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
corner of the display.
Fig. 1
Fig. 2

10 • ENGLISH
SETTING MEMORY BANK / USER
IT IS NECESSARY TO SET THE DATE AND TIME FOR THE UNIT EVERY TIME
BATTERIES ARE INITIALLY INSTALLED OR REPLACED.
IF YOU CHOOSE NOT TO SET THE DATE AND TIME, YOU MAY PRESS THE
START/STOP BUTTON TO FORWARD THROUGH THE TIME AND DATE
FEATURE WITHOUT SETTING A PREFERENCE.
After setting the Memory Bank, the screen will advance to
setting the Date and Time.
1. The month will blink on the lower left of the display; press
Mto advance to the desired Month. Press SET to conrm.
2. Repeat Step 1 to conrm the Day, Hour and then Minutes.
3. After selection, press START/STOP to exit set-up, or
press SET to conrm and move to the Language Selection
feature.
This unit offers 4 memory banks, allowing for tracking of multiple
user results in the household with the same monitor.
1. With power off, press SET button to enter the system set-up
functions.
2. The User / Memory Bank in use will show on the upper
right of the display screen.
3. Press the Mbutton to scroll through the users until the desire
user is shown, 1, 2, 3, or 4. The User selected will default
to the selected user every time the device is powered on
until a new user is selected.
4. After selection, press START/STOP to exit set-up, or press SET to conrm
and move to the Date and Time setting feature.
SETTING DATE AND TIME
M
D

ENGLISH • 11
SETTING LANGUAGE AND VOLUME
This unit offers 3 language settings for audio prompts and reading results - English,
Spanish, or French - with volume control, or the audio option can be turned
completely OFF.
After setting the Date and Time, the screen will advance to setting the Language
and Volume.
LANGUAGE:
1. The display will show L1 and announce ‘English’.
2. Press the Mbutton to scroll through the options until the
desired language is shown, L1 (English), L2 (Spanish),
L3 (French), or OFF.
NOTE: The language selected will default to the selected
language every time the device is powered on until a new
language is selected.
3. Press SET to conrm the selected language. Proceed to
setting the volume.
VOLUME:
4. The volume level bars will show on the left side of the
display.
5. Press the Mbutton to increase the volume; you will hear an
audio prompt for each level. Continue to press Muntil the
desired volume is reached.
6. After selection, press SET to conrm and then START/
STOP to exit set-up and prepare for your measurement.

12 • ENGLISH
FITTING AND 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 Cuff ts arm circumference 8.6”—16.5” (22—42 cm)
Additional cuff sizes are available for order on the enclosed order form.
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

ENGLISH • 13
FITTING AND APPLYING YOUR CUFF
Applying Your Cuff
Be seated at a table or desk with your feet at on the
oor. To avoid accidently pulling on or dropping your
monitor, the cuff should not be plugged into the monitor
until after the cuff is applied to your arm.
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
air hose over the main artery on the inside of your
arm, Fig 3. For proper positioning, the tube should
follow the inside length of the arm, Fig 4.
3. The bottom edge of the cuff should be positioned
approximately one inch above the elbow joint, Fig 5.
4. The INDEX mark arrow should be within the range
bar marking as shown, Fig 6; if the INDEX arrow is
outside of the range, a different sized cuff is needed.
The cuff should t comfortably, yet snugly around your
arm. You should be able to insert one nger easily
between your arm and the cuff.
Fig. 3
Fig. 5
Fig. 4
Fig. 6
0.8-1.2”/2-3cm

14 • ENGLISH
TAKING YOUR BLOOD PRESSURE READING
Getting Started
1. Position the monitor on a at, stable surface with the
digital display in view.
2. 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 the START/STOP button to turn the unit on; the
unit will briey ash a self-test, Fig 2. A voice tone will
indicate when the unit is ready for testing.
NOTE: Unit will not fuction if residual air from previous
testing is present in cuff. The LCD may ash until pressure
is stabilized.
5. The cuff will automatically inate to approximately
180mmHg; you will see the numbers go up on the
display screen and the heart icon may ash, Fig 3.
Fig. 1
Fig. 2
Fig. 3
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.
mmHg kPa
M
D
No
AVG
(
( )
)
mmHg
M
D

ENGLISH • 15
TAKING YOUR BLOOD PRESSURE READING
6. When the ination has reached optimum level,
the display will begin to show the decreasing
pressure while you feel the pressure of the cuff
decrease.
7. When the measurement is complete, your blood
pressure measurement and pulse will display
simultaneously on the screen with a voice
broadcast.
8. The Hypertension Indicator will indicate your
reading range in the left side of the display,
Fig 4. See page 16 for a chart interpreting the
Hypertension Indicator results.
9. If an irregular heartbeat was detected during the
reading, the Irregular Heartbeat Detector indicator
will appear on the display, Fig 5. See page 15
for more information on the Irregular Heartbeat
Detector feature.
10. The reading will automatically be stored in
memory bank seelcted prior to the reading, up to
99 readings.
11. Select START/STOP to turn the unit off and
conserve energy and battery life. The unit will
automatically shut-off after 3-minutes.
12. Disconnect the cuff and tubing prior to storage.
YOU CAN STOP THE INFLATION OR DEFLATION PROCESS AT ANY
TIME BY PRESSING THE START/STOP BUTTON.
Fig. 4
Fig. 5
mmHg
M
D
mmHg
M
D
(
( )
)

16 • ENGLISH
Irregular Heartbeat Detector
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 screen.
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 BLOOD PRESSURE READING
Pulse
Pulse
Irregular Heartbeat
Normal Heartbeat
Blood
Pressure
Blood
Pressure
Short
Beat Long Beat
(
( )
)

ENGLISH • 17
INTERPRETING YOUR BLOOD PRESSURE READING
Hypertension Indicator
This unit features our unique
Hypertension Indicator. The color
bars on the left side of the monitor
display correspond with an icon on the
digital display, indicating where the
measurement results fall
within the World Health Organization
standards.
The World Health Organization has established globally accepted standards for
the assessment of high or low blood pressure readings. The below chart should be
considered only as a guideline, always consult with your physician or health care
professional to interpret your individual results. Never adjust your medication(s)
dosage, or severely alter your diet or exercise routine without consulting with your
physician.
Stage 3 Hypertension
Systolic pressure: ≥180 mmHg
or
Diastolic pressure: ≥110 mmHg
High Normal
Systolic pressure: ≥130-139 mmHg
or
Diastolic pressure: ≥85-89 mmHg
Stage 2 Hypertension
Systolic pressure: ≥160-179 mmHg
or
Diastolic pressure: ≥100-109 mmHg
Normal
Systolic pressure: ≥120-129 mmHg
or
Diastolic pressure: ≥80-84 mmHg
Stage 1 Hypertension
Systolic pressure: ≥140-159 mmHg
or
Diastolic pressure: ≥90-99 mmHg
Optimal
Systolic pressure: < 120 mmHg
or
Diastolic pressure: < 80 mmHg

18 • ENGLISH
MEMORY FUNCTIONS
Recalling Measurements in Memory
This monitor stores and recalls up to 99 measurements, plus
an average of the last three measurements in each memory
bank / per user.
Select the user to review; see page 10 for instructions on how
to change the User.
All results will be announced aloud in the selected memory
bank if the voice feature is On.
1. Press and release the Mbutton. The unit will rst display
the average of the last three measurements, Fig 1.
2. Press the Mbutton again to begin scrolling through the
saved measurements. Measurements will appear on the
display from most current to oldest; the memory number
will appear on the lower right corner of the display, Fig 2.
Press M again to proceed to the result, Fig 3.
3. Press the START/STOP button to turn the unit off.
Clearing Measurements from Memory
Memory for a specic bank may be entirely deleted while in
Memory Recall mode.
1. Press and hold the SET button for approximately 3
seconds to delete all memory records from the selected
group with voice broadcast “Memory Clear” and then
transfer into testing mode, Fig. 3.
2. Press the START/STOP button to turn the unit off.
NOTE: Memory can not be recovered once it has been
deleted.
Fig. 1
mmHg
M
D
AVG
Fig. 2
M
D
No
Fig. 3
mmHg
M
D

ENGLISH • 19
CARE AND MAINTENANCE
Proper care and maintenance of your blood pressure monitor will help ensure long
life for the product; improper use of the monitor may void the included warranty.
Always disconnect the cuff and tubing from the monitor prior to cleaning and
storage.
Monitor Care and Maintenance
• Do not use any liquids on the monitor; use a soft, dry cloth to clean the monitor
as needed
• Storage outside of stated storage temperature may result in measurement error
or device malfunction; storage environment temperature is: --13°F – 158°F
(-25°C – 70°C); Humidity: ≤93%
• Always keep the unit unplugged while not in use; remove the batteries if the
unit will not be used for an extended period of time
• Do not attempt to disassemble your monitor; disassembling your monitor may
void the manufacturers warranty
• Do not subject the monitor to strong shocks; take care not to drop the monitor
Cuff Care and Maintenance
• The cuff should not be submerged or washed in a washing machine, but may
be spot cleaned with a mild-detergent as needed
• Never attempt to iron or dry the cuff; if the cuff becomes wet, allow the cuff to
air dry completely before use or storage
• Do not attempt to remove the tube and bladder from the nylon cuff as this may
damage the cuff
• Take care not to forcefully bend or kink the tubing during storage

20 • ENGLISH
DEVICE & LABEL SYMBOLS
These symbols may appear on your device, instructions or packaging and
may vary by make and model.
Read This Manual—All
included manuals should
be read prior to rst use
Warning—Symbol
indicates a warning,
prohibition or mandatory
action that mitigates a
risk that is not necessarily
obvious to the device
operator
Type BF Applied Parts—
Indicates that a part of
this unit comes in contact
with the patient in order
to carry out it’s intended
function
Environment Protection—
dispose of this product
properly; consult with
your local recycling
ordinances for proper
recycling and disposal
Serial Number
Symbol Meaning Symbol Meaning

Keep Dry—This device
should be kept dry;
never submerge the unit
or cuff. Consult with the
Care and Maintenance
section of this manual for
information on cleaning
your monitor
Symbol for
“MANUFACTURE DATE”
Symbol for
“MANUFACTURER”
Keep off Sunlight
Prohibited
The product conforms
to the requirements of
the EC Directive MDD
(93/42/EEC) on medical
deices.
0197