smartheart 01-540 User manual

INSTRUCTION MANUAL
ENGLISH AND SPANISH
Automatic Digital
Wrist Blood Pressure Monitor
Model # 01-540
Please read this instruction manual
completely before operating this unit.
1-YEAR

STOP!
PLEASE ENSURE YOU HA E ALL OF THE
FOLLOWING COMPONENTS BEFORE USING
YOUR DIGITAL BLOOD PRESSURE MONITOR
IF YOU ARE MISSIN ANY PARTS, INCLUDIN INSERTS OR
INSTRUCTION MANUALS, DO NOT RETURN TO PLACE OF
PURCHASE. CONTACT CUSTOMER CARE AT 866-326-1313.
Digital Monitor 2 AAA Batteries Storage Case
Instruction Manual
Quick Start uide
Blood Pressure Reading Tracking Log
FAQ Information Sheet
2 • ENGLISH

ENGLISH • 3
INDEX
Care & Safety Information...................................................4-5
Introduction..........................................................................6
Digital Blood Pressure Monitor Features...................................7
etting Started.....................................................................8
Battery Installation ...............................................................9
Setting Date and Time .........................................................10
Applying Your Blood Pressure Cuff........................................11
Taking Your Blood Pressure Reading .................................12-13
Interpreting your Results ..................................................14-15
Memory Functions .............................................................13
Care and Maintenance .......................................................16
Device and Label Symbols ...................................................18
Display Symbols .................................................................19
Error codes and troubleshooting ...........................................20
FCC Statement ...................................................................21
Electromagnetic Compatibility..........................................22-25
Specications.....................................................................26
Warranty...........................................................................27
Instrucciones en Español .................................................28- 55
Toll-Free Customer Care Help Line: 1-866-326-1313
Monday – Friday 8:30 a.m. – 4:30 p.m. CST
SmartHeart™
Manufactured for
Veridian Healthcare
1175 Lakeside Drive
urnee, IL 60031
Made in China
#93-1081 07/14
©2014 Veridian Healthcare, LLC

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.
GENE AL CAUTIONS AND WA NINGS
• 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
• Do not use this device with other diagonstic monitoring equipment
• Do not share this device with infected persons where there may be a risk of cross-
contamination

ENGLISH • 5
• Consult with your physician before use if any of the following conditions are present:
arrhythmia, inammatory diseases, intravascular therapy, arterio-venous shunts or if
a mastectomy has been performed.
OPE ATING CAUTIONS AND WA NINGS
• 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: 41°F – 104°F (5°C –
40°C); Humidity: ≤90% RH
• Never use this unit while operating a vehicle or in the bathtub or shower
STO AGE CAUTIONS AND WA NINGS
• Storage outside of stated storage temperature may result in measurement error or
device malfunction; storage environment temperature is: -4°F – 131°F (-20°C –
55°C); Humidity: ≤90% RH
• 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 WA NINGS
• 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
• Follow the ‘Cleaning and Maintenance’ portion of this manual before sharing with
other persons
CARE & SAFETY INFORMATION

6 • ENGLISH
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.
INTRODUCTION
PLEASE EAD THIS INST UCTION MANUAL
COMPLETELY BEFO E OPE ATING THIS UNIT.

ENGLISH • 7
DETAILS OF THE DISPLAY AND INTE P ETATION OF THE SYMBOLS A E
INCLUDED TH OUGHOUT THIS MANUAL.
BLOOD PRESSURE MONITOR FEATURES
Wrist Cuff
Digital Display
MEMORY
Recall
Button
START/POWER
Button (on/off)
Battery Compartment
(underside)

8 • ENGLISH
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.
GETTING STARTED

ENGLISH • 9
This unit comes complete with 2 AAA batteries.
2
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 START button
is pressed.
1. Press down and lift the cover.
2. Insert or replace 2 AAA 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.
BATTERY INSTALATION
MEM

10 • ENGLISH
SETTING DATE/TIME
The date/time feature is on the bottom left of the
display screen, Fig 1. The date and time will alternate
every four seconds regardless of the operating mode.
1. When the unit is off, press and hold the START and
MEM button at the same time. The unit will beep
once and the month will begin to ash, Fig. 2.
2. Press the MEM button to change until the desired number
appears. To scroll through the numbers quicker, hold down
the MEM button as the numbers advance.
3. Press the START button to conrm the month entry.
4. Next, the date will blink. Repeat steps 2 and 3 to set the
date, then hours, then minutes. This unit does not track the
year.
5. After setting the minutes, the unit will automatically exit out
of the date/time setting mode.
IT IS NECESSA Y TO SET THE DATE AND TIME FO THE UNIT EVE Y
TIME BATTE IES A E INITIALLY INSTALLED O EPLACED.
DATE AND TIME WILL DEFAULT TO FACTO Y SETTINGS, 12:00 A.M. /
1(M)-1(D), IF YOU DO NOT CHOOSE TO SET THE CO ECT DATA.
MILITARY TIME = RE ULAR TIME
1:00 = 1am 7:00 = 7am 13:00 = 1pm 19:00 = 7pm
2:00 = 2am 8:00 = 8am 14:00 = 2pm 20:00 = 8pm
3:00 = 3am 9:00 = 9am 15:00 = 3pm 21:00 = 9pm
4:00 = 4am 10:00 = 10am 16:00 = 4pm 22:00 = 10pm
5:00 = 5am 11:00 = 11am 17:00 = 5pm 23:00 = 11pm
6:00 = 6am 12:00 = 12pm 18:00 = 6pm 24:00 = 12am
Fig. 1
12
Fig. 2
When the monitor is off, the date and time will still appear on the display.
T ime is displayed in 24hr Military Time. This chart explains the time conversion.

ENGLISH • 11
Before applying your blood pressure cuff, be sure your wrist
is within the appropriate cuff range: Wrist Circumference
Range Suitable for 5-1/2” – 7-5/8” (14 – 19.5 cm)
Reminder, it is important to avoid smoking, eating, taking
medication, alcohol consumption or physical activity 30
minutes prior to taking a reading.
If for any reason you are unable to or should not use your left
wrist, please modify the instructions for cuff application to
your right wrist. Your physician can help you identify which
wrist is best for you to take measurements from.
1. Remove any constrictive clothing or jewelry that may
interfere with cuff placement.
2. Be seated at a table or desk with your feet at on the oor
and your legs uncrossed.
3. Hold your left arm in front of you with your palm facing
upward.
4. Apply the preformed cuff to your left wrist so that the digital
display face is positioned on the inside area of your wrist
facing you, Fig. 1.
5. Adjust the cuff 1/4” - 1/2” from the edge of the head of the ulna bone, Fig. 2.
6. The cuff should t comfortably, yet snugly around your wrist.
APPLYING YOUR CUFF
P OPE CUFF FIT AND PLACEMENT IS C ITICAL IN OBTAINING
ACCU ATE BLOOD P ESSU E MEASU EMENTS. PLEASE EAD THESE
INST UCTIONS CA EFULLY AND CONSIDE CONSULTING WITH YOU
PHYSICIAN FO FU THE DI ECTION.
Fig. 1
Fig. 2
If you are not comfortable with applying your cuff, please seek the assistance of
another member of your household or work with your physician to practice the cuff
application. Incorrectly applied cuffs may result in inaccurate readings.

12 • ENGLISH
TAKING YOUR MEASUREMENTS
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. 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. Be certain that
cuff is elevated to the proper level; you may choose
to support your hand with a folded towel or book.
Relax your left hand.
2. Press the START button to turn the unit on; the unit
will run a self-test, Fig 2.
3. The display will briey show a ashing arrow
and ‘0’ before the measurement begins, Fig 3.
4. The cuff will automatically inate to approximately
190mmHg or 40 mmHg higher than the last systolic
pressure reading stored in memory.
5. 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.
Fig. 1
MEM
Fig. 2
Fig. 3
YOU CAN STOP THE INFLATION O DEFLATION P OCESS AT ANY TIME
BY P ESSING THE STA T/POWE BUTTON.

ENGLISH • 13
TAKING YOUR MEASUREMENTS
6. When the measurement is complete, your blood
pressure measurement and pulse will display
separately on the screen alternating repeatedly every
2-3 seconds, Fig 4. The systolic and diastolic
readings will display at the same time.
7. The Hypertension Indicator will indicate your reading
range in the right side of the display, Fig 5. See page
12 for a chart interpreting the Hypertension Indicator
results.
8. If an irregular heartbeat was detected during the
reading, the Irregular Heartbeat Detector icon
will appear ashing on the display for both the
measurement results and pulse results screens, Fig 6.
See page 12 for more information on the Irregular
Heartbeat Detector feature.
9. The reading will automatically be stored in memory,
up to 60 readings.
10.Select START to turn the unit off and conserve energy
and battery life. The unit will automatically shut-off
and revert to time/date mode after approximately 1
minute.
Systolic/Diastolic Results
Pulse Results
Fig. 4
Fig. 5
Fig. 6

INTERPRETING YOUR RESULTS
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 icon 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.
14 • ENGLISH
Pulse
Pulse
Blood
Pressure
Blood
Pressure
Normal Heartbeat
Irregular Heartbeat
Shor
Bea
Long
Bea

INTERPRETING YOUR RESULTS
The Hypertension
Indicator is located
on the right side of
the display window
Stage 3 Hypertension
Systolic pressure: ≥180 mmHg
or
Diastolic pressure: ≥110 mmHg
Stage 2 Hypertension
Systolic pressure: ≥160-179 mmHg
or
Diastolic pressure: ≥100-109 mmHg
Stage 1 Hypertension
Systolic pressure: ≥140-159 mmHg
or
Diastolic pressure: ≥90-99 mmHg
High Normal
Systolic pressure: ≥130-139 mmHg
or
Diastolic pressure: ≥85-89 mmHg
Normal
Systolic pressure: ≥ 120-129 mmHg
or
Diastolic pressure: ≥ 80-84 mmHg
Optimal
Systolic pressure: <120 mmHg
or
Diastolic pressure: <80 mmHg
Hypertension Indicator
This unit features our unique Hypertension Indicator. The World Health
Organization has established globally accepted standards for the assessment of
high or low blood pressure readings
This chart can help you identify where a given blood pressure measurement falls
according to World Health Organization standards. This chart should only be
considered as a guideline; always consult with your physician to interpret your
individual results. Never adjust your medication(s) dosage, or severely alter your
diet or exercise routine without consulting with your physician.
ENGLISH • 15

MEMORY FUNCTIONS
ecalling Measurements in Memory
You can recall up to 60 total measurements in memory. These measurements can
be shared with your physician or trained healthcare professional.
1. Press and release the MEM button. The unit will show how
many measurements are stored within the bank, Fig 1.
2. Press the MEM button again to scroll through the saved
measurements. Measurements will appear on the display
from oldest to most current.
All results for a given measurement will display, including
measurement results, pulse rate, Hypertension Indicator,
Irregular Heartbeat alert (if applicable), and date/time
stamp, Fig 2. The measurement results and pulse results will
alternate, ashing between measurement and pulse every
2-3 seconds.
3. When the number of readings exceeds 60, the oldest data
will be replaced with the new record.
4. Press START to turn the monitor OFF at any time during
review of the stored measurements.
Clearing Measurements from Memory
1. Press and release the MEM button. The unit will display
how many measurements are stored within the bank.
2. Press and hold down the MEM button until four horizontal
lines ash, Fig. 3. This indicates that all measurements
have been erased.
MEM
Fig. 1
MEM
Fig. 2
MEM
Fig. 3
16 • ENGLISH

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: -4°F – 131°F (-20°C –
55°C); Humidity: ≤90% RH
• Avoid high temperatures and direct sunlight
• 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
• To disinfect the cuff, wipe the inside (skin contact side) of the cuff using a soft cloth
slightly moistened with 75-90% ethyl rubbing alcohol and allow to air dry; it is
suggested to disinfect the cuff frequently when used in clinical settings or if the cuff is
contaminated in any way
• 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
ENGLISH • 17

DEVICE AND LABEL SYMBOLS
18 • ENGLISH
Read This Manual—All included manuals should be read prior to first use
Warning—Symbol indicates a warning, prohibition or mandatory action that
mitigates a risk that is not necessarily obvious to the device operator
Typ e 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; in the case of this
device the cuff is the Type BF Applied Part
Environment Protection—dispose of this product properly; consult with your
local recycling ordinances for proper recycling and disposal
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 Meaning

2012

2012
These symbols may appear on your device, instructions or packaging and may
vary by make and model.

DISPLAY SYMBOLS
ENGLISH • 19
Meaning
MEM
Symbol
SYS
DIA
mmHg
Pul/min
MEM
MEM
Systolic Blood Pressure– The ‘top’ blood pressure result
Diastolic Blood Pressure– The ‘bottom’ blood pressure result
Milligrams of Mercury– Unit of blood pressure measurement for this device
Pulse Rate– Pulse rate per minute during the measurement
Low Battery– Battery life indicator
Ready to Inate Indicator– The cuff is not properly wrapped or has too much air left in
it. The arrow will stop ashing when the unit is ready to use
Irregular Heartbeat Icon– An irregular heartbeat was detected during the measurement
Memory– The measurement displayed is from the memory bank
Average– The measurement displayed is average of the last three measurements taken
User– Indicates which user the measurement will be stored for
Error– An error has occurred during the measurement

20 • ENGLISH
Display shows an
abnormal result
Display is blank
when power is on
Problem
Cuff position was not correct or
was not tight enough
Body posture was not correct
during measurement
Speaking, excessive movement,
angry, excited or nervous anxiety
during measurement
Batteries may be expired or
installed improperly
Apply the cuff properly and attempt a
new measurement
Review the ‘Taking a Measurement’
portion of this manual and attempt a new
measurement
Wait a period of time and attempt a new
measurement after calm has returned; do
not speak or move during measurement
Check the polarity of the batteries and
reinstall if necessary; replace batteries
with new batteries
Possible Cause Solution
ERROR CODES & TROUBLESHOOTING
Display Shows Er 1
Display Shows Er 0
Display Shows Er 2
Display Shows Er 3
Display Shows Er 4
Display Shows Er 5
Display Shows Er 6
Display Shows Er 7
Display Shows Er 8
Display Shows Er A
If your error persists or is not remedied, please contact Customer Care at 866-326-1313
Review the ‘Taking a Measurement’
portion of the manual, wait a minimum of
5 minutes and attempt a new
measurement.
Review the Applying Cuff portion of this
manual; re-apply the cuff, wait a minimum
of 5 minutes and attempt a new
measurement.
Check that the cuff is applied properly,
wait a minimum of 5 minutes and attempt
a new measurement. If the monitor still
does not perform or performs abnormally,
contact Customer Care
Pressure system is unstable before
measurement
Failed to detect systolic pressure
Failed to detect diastolic pressure
Pneumatic system blocked or cuff
is too tight during ination
Pneumatic system leakage or cuff
is too loose during ination
Cuff pressure above 300 mmHg
Cuff pressure above 15 mmHg for
more than 3 minutes
EEPROM accessing error
Device parameter checking error
Pressure sensor parameter error