ADC 6012N Digital Blood Pressure Monitor Instruction Manual
- June 21, 2024
- ADC
Table of Contents
6012N Digital Blood Pressure Monitor
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Product Information
Technical Specifications
-
Display: LCD (Liquid Crystal Display)
-
Weight: .96 lbs. (436 g) with batteries and
cuff -
Dimensions: 3.75 (W) x 4.25 (L) x 5.5 (H)
(77mm x 85mm x 140mm) Including cuff -
Operating conditions:
-
Storage conditions:
-
Measuring procedure: Oscillometric,
corresponding to Korotkoff method: Phase I systolic, Phase V
diastolic -
Measurement range: Sys: 60 – 225 mmHg Dia: 40
– 200 mmHg Pulse 40-200 beats per minute -
Memory: Automatically stores the last
measurement -
Cuff pressure display range: 0 – 299 mmHg
-
Measuring resolution: 1 mmHg
-
Static accuracy:
-
Pulse accuracy:
-
Power source: 4 AA batteries
-
Additional cuff sizes:
- Item No. Size 850-6012N Adult Range 8.7 – 12.6 (22-32 cm)
- Item No. Size 850-6022NX Lg. Adult Range 12.5 – 20.4 (32-52
cm)
Product Usage Instructions
Operating Conditions
To ensure accurate readings, operate the blood pressure monitor
within the following conditions:
- Temperature: [Insert temperature range]
- Humidity: [Insert humidity range]
Storage Conditions
When not in use, store the blood pressure monitor in a cool, dry
place away from direct sunlight.
Measuring Procedure
Follow these steps for accurate measurements:
-
Sit comfortably with your back supported and feet flat on the
floor. -
Place the cuff on your upper arm at heart level.
-
Press the start button to begin the measurement.
-
Remain still and silent during the measurement process.
-
Record the systolic, diastolic, and pulse readings
displayed.
Battery Replacement
If the battery indicator shows low power, replace the four AA
batteries following the manufacturer’s instructions.
Frequently Asked Questions (FAQ)
Q: How often should I calibrate my blood pressure monitor?
A: According to international standards, your monitor should be
checked for calibration every two years. Contact ADC for an
accuracy check.
Q: Can I use the blood pressure monitor if I have a
pacemaker?
A: This device is contraindicated for any person who is
connected to a wearable or implantable electronic device or
instrument, such as a pacemaker or defibrillator. Consult your
physician for alternative monitoring options.
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Instructions for Use Model 6012N
Onbo Electronic (Shenzhen) Co., Ltd. No. 138 Huasheng Road Langkou Community,
Dalang Street Longhua District, Shenzhen, China
Microlife UAB P. Luksio g. 32 08222 Vilnius, Lithuania
Distributed by: ADC 55 Commerce Drive Hauppauge, NY 11788
U.S.A.
Inspected in the U.S.A. Made in China
tel: 631-273-9600,
1-800-232-2670 fax:
631-273-9659
www.adctoday.com
email: info@adctoday.com
IB p/n 93-6012N-00 rev 4 (10/03/2023)
0044
Printed in China
This medical instrument must be used according to instructions to ensure
accurate readings.
Questions? Call ADC at 1-800-232-2670
Table of Contents
A Special Thank You …………………………………………………………………….3 Introduction and Intended
Use……………………………………………………….3 Contraindications …………………………………………………………………………4
Symbol Definitions ……………………………………………………………………….4 Warnings and Precautions
…………………………………………………………….5 What’s in the Box…………………………………………………………………………6
Display Icons……………………………………………………………………………….7 Setting Up Your
Monitor………………………………………………………………..8
Insert the Batteries …………………………………………………………………….8 Assemble the Bulb and
Valve…………………………………………………….8-9 Connect the Cuff ……………………………………………………………………….9
Preparing for a Measurement …………………………………………………..9-10 Fitting the D-Bar Cuff
……………………………………………………………….10 Taking a Measurement…………………………………………………………..11-14
Inflating Further……………………………………………………………………….14 Stopping a
Measurement…………………………………………………………..14 Last-Reading
Memory…………………………………………………………………15 Irregular Heartbeat Detector
………………………………………………………..16 Understanding Blood Pressure
Readings……………………………………….17 Performing Reliable Measurements
…………………………………………18-19 Error Messages and Troubleshooting……………………………………….19-20
Care and Maintenance ………………………………………………………………..21 Technical Specifications
……………………………………………………………..22 Warranty……………………………………………………………………………………23 Quality
Standards……………………………………………………………………….23 How to Contact Us
……………………………………………………………………..23
Warranty
This blood pressure monitor is warranted for five years from date of purchase.
This warranty includes the instrument and the cuff. The warranty does not
apply to damage caused by improper handling, accidents, improper use, or
alterations made to the instrument by third parties. The warranty is only
valid after the product is registered online at
www.adctoday.com/support/warrantyregistration.
Quality Standards
Device standard: This device is manufactured to meet the European and United
States standards for non-invasive blood pressure monitors: EN 1060-1/-3/-4
Electromagnetic compatibility: Device fulfills the stipulations of the
International standard IEC60601-1-2
How to Contact Us
1-800-ADC-2670 Email: info@adctoday.com
www.adctoday.com
Technical Specifications
Display:
LCD (Liquid Crystal Display)
Weight:
.96 lbs. (436 g) with batteries and cuff
Dimensions:
3.75″ (W) x 4.25″ (L) x 5.5″ (H) (77mm x 85mm x 140mm) Including cuff
Operating conditions:
50°F to 104°F (10°C to 40°C) 15 to 90% relative maximum humidity
Storage conditions:
-4°F to 131°F (-20°C to 55°C)
Measuring procedure:
Oscillometric, corresponding to Korotkoff method: Phase I systolic, Phase V diastolic
Measurement range:
Sys: 60 – 225 mmHg Dia: 40 – 200 mmHg Pulse 40-200 beats per minute
Memory:
Automatically stores the last measurement
Cuff pressure display range: 0 – 299 mmHg
Measuring resolution:
1 mmHg
Static accuracy:
Pressure within ±3 mmHg or 2% of reading >=200 mmHg
Pulse accuracy:
±5% of the read-out value
Power source:
4 AA batteries
Additional cuff sizes are also available for the device:
Item No. Size 850-6012N Adult 850-6022NX Lg. Adult
Range 8.7″ – 12.6″ (22-32 cm) 12.5″ – 20.4″ (32-52 cm)
NOTE: According to international standards, your monitor should be checked for calibration every two years. Contact ADC for an accuracy check.
A Special Thank You
Thank you for purchasing an ADC AdvantageTM semi-automatic home blood pressure
monitor.
In hospitals and physician offices throughout the world, where accuracy and
dependability are critical, ADC professional diagnostic products are the
instruments of choice. Now you, too, can enjoy the benefits of ADC engineering
and quality in the home.
This instrument was designed to simplify the measurement of blood pressure and
pulse rate at home and deliver consistent, dependable results.
©2023 AMERICAN DIAGNOSTIC CORP.
Introduction and Intended Use
This manual covers the AdvantageTM 6012N semi-automatic digital upper-arm
blood pressure monitor. To find the model number of your device, see the
rating label located on the bottom of the unit. Your unit uses the
oscillometric method to provide systolic pressure, diastolic pressure, and
pulse rate. It’s semi-automatic, relying on manual cuff inflation. Other
features include an easy-to-read LCD display, irregular heartbeat detection,
and last-reading memory. Before getting started, please read this instruction
manual carefully and then keep it in a safe place. Additional documentation is
available at www.adctoday.com/ADCatHome. Please contact your doctor if you
have further questions about blood pressure and its measurement.
Contraindications
This device is contraindicated for any person who is connected to a wearable
or implantable electronic device or instrument, such as a pacemaker or
defibrillator.
This blood pressure monitor is not intended to be a diagnostic device. Contact
your physician if hypertensive values are indicated.
WARNING: The device is not suitable for use on: pregnant women; users with
implanted electric devices; users with preeclampsia, premature ventricular
beats, atrial fibrillation, or peripheral arterial disease; users undergoing
intravascular therapy or arteriovenous shunt; or people who received a
mastectomy. Consult with your physician prior to using this unit if you suffer
from any of these illnesses or conditions.
Symbol Definitions
Care and Maintenance
Clean Use a
the monitor only when necessary. soft, dry cloth with a 70% isopropyl
alcohol solution.
Spots on the cuff can be removed carefully
with a damp cloth and soapsuds.
Do not drop the monitor.
Do not clean with gas, thinners, or similar
solvents.
The following symbols are associated with your monitor.
Symbol Definition
Symbol Definition
Important Warning/Caution
Read operating instructions
Avoid stress when handling the cuff and tubing.
Twisting or buckling can damage the sensitive
air-tight bubble. Keep away from sharp edges.
Relative humidity limits Lot code
UDI number Medical device
Do not expose to extreme temperatures,
humidity, dust, or direct sunlight.
Not made with natural rubber latex
Serial Number
Phthalate free Keep dry
Temperature limits Product identifier
Never open the monitor! This invalidates the
manufacturer’s warranty.
Type BF applied part
Manufacturer’s information
Dispose in accordance with regulations
IP20
Protected against solid foreign particles with a diameter of more than 12.5 mm, no protection against water
Limb circumference (Minimum/Maximum)
Authorized European representative’s information
Meets essential requirements of European Medical Device Directive 0044
93/42/EEC
Do not submerge any parts in water.
Handle the tubing carefully!
Keep the tube away from sharp edges.
Other possible errors and their solutions
If problems occur when using the device, the following points should be
checked:
Malfunction
Remedy
The display remains blank when the device is switched on although the batteries are in place.
1. Check battery installation/polarity. 2. Remove the batteries and if the
display is
unusual, then exchange them for new ones. Check polarity.
The pressure does not rise although the inflation bulb is being pumped.
Check the connection of the cuff tube and connect properly.
The device frequently fails to measure, or the values measured are too low or high.
1. Fit the cuff correctly on the arm. 2. Confirm proper measuring technique
as
described Preparing for a Measurement (page 9) and Performing Reliable
Measurements (page 18).
Every measurement results in different values.
Blood pressure values differ from those measured at the doctor.
1. Confirm proper measuring technique as described in Preparing for a
Measurement (page 9) and Taking a Measurement (page 11).
2. Consult our informational document About Blood Pressure, at
www.adctoday.com/ADCatHome.
i Blood pressure is subject to fluctuations even in healthy people. Please
remember that comparable blood pressure measurements always require the same
time and the same conditions!
i If your blood pressure readings regularly fluctuate more than 15 mmHg,
or if you repeatedly see the irregular heartbeat icon, consult your doctor.
If you experience technical malfunctions with the monitor, contact the dealer where you bought the device or ADC. Never attempt to repair the instrument yourself! Unauthorized opening invalidates the warranty.
Warnings and Precautions
A warning statement in this manual identifies a condition or practice which,
if not corrected or discontinued immediately, could lead to patient injury,
illness or death.
WARNING: The device contains sensitive electronic 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.
WARNING: Use of this instrument on patients under dialysis therapy or on
anticoagulant, antiplatelets, or steroids could cause internal bleeding.
WARNING: Do not use cuffs or batteries other than those included with this
product or replacement parts supplied by the manufacturer.
WARNING: This system may fail to yield specified measurement accuracy if
operated or stored in temperature or humidity conditions outside the limits
stated in the specifications section of this manual.
ATTENTION: Self-measurement means control, not diagnosis or treatment. Unusual
values must always be discussed with your doctor. Under no circumstances
should you alter the dosages of any drugs prescribed by your doctor.
ATTENTION: The pulse display is not suitable for checking the frequency of
heart pacemakers!
ATTENTION: In cases of irregular heartbeat, measurements made with this
instrument should only be evaluated after consultation with your doctor.
NOTE: To obtain the greatest accuracy from your blood pressure instrument, it
is recommended that the instrument be used within a temperature range of 50°F
to 104°F (10°C to 40°C), with a 15-90% relative humidity.
What’s in the Box
Quick Release Valve
Blood Pressure Monitor Tubing
Connector Port
Bulb
LCD Display
On/Off Button
Connector
Blood Pressure Cuff The 6012N includes a soft, nylon, self-adjusting D-bar
cuff,
with inflation bulb and quick-release valve.
Cuff Size
Adult (#850-6012N)
Fits Arm Circumference
22 cm – 32 cm (8.7 in – 12.6 in)
Instructions for Use
4 AA Batteries
–
–
–
Batteries are
packaged with the cuff.
Battery
Compartment
i A loose cuff or a sideways protruding air pocket causes false
measurements. Ensure that cuff is properly applied.
i With repeated measurements, blood accumulates in the arm,
which can lead to false results.
i To learn more about blood pressure, see our informational document
About Blood Pressure, at www.adctoday.com/ADCatHome.
Error Messages and Troubleshooting
If an error occurs during a measurement, the measurement is interrupted and a corresponding error code is displayed, example <Err 2>.
Error No.
Possible Cause(s)/Solutions
ERR 1
The systolic pressure was determined, but then the pressure in the cuff went down to less than 20 mmHg (diastolic blood pressure can’t be measured). The tube may have loosened after the systolic pressure has been determined. Further possible reason: pulse could not be detected.
ERR 2
Unnatural pressure impulses influence the measurement result. Reason: the arm was moved during the measurement.
ERR 3 ERR 5
The difference between systolic and diastolic is excessive. Measure again
carefully following proper procedures. Consult your doctor if you still get
unusual results of measurements.
The measuring signals are inaccurate and no result can be displayed. Read
through the checklist for performing reliable measurements and then repeat the
measurement.
HI
The pressure in the cuff is too high (over 300mmHg) or the pulse
is too high (over 200 beats per minute). Relax for 5 minutes and
repeat the measurement.
LO
The pulse is too low (less than 40 beats per minute). Relax for
5 minutes and repeat the measurement.
Performing Reliable Measurements
i When taking blood pressure, ensure all steps involved in the process
are properly observed. Small variations in technique can cause large variances
in measurements. Comparable blood pressure measurements require the same
conditions.
i 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.
i If the arm artery lies considerably lower or higher than the heart, blood
pressure may read erroneously higher or lower. Each 15 cm (6 inch) difference
in height between your heart and the cuff results in a measurement error of 10
mmHg.
i 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). Each
model has its own cuff:
Model
Cuff Size
Fits Arm Circumference
6012N
Adult (#850-6012N)
22 cm – 32 cm (8.7 in – 12.6 in)
i If the cuff provided with your unit is too small), please call
1-800-232-2670,
or consult the cuff sizes chart on page 22. Only use approved ADC cuffs.
i ADC cuffs have specially designed markings to promote the precise
and accurate determination of blood pressure. Please review the section on
fitting your cuff on page 10.
Display Icons: 6012N
Systolic Value
Pulse Indicator
Irregular Heartbeat Detection
M
Low Battery Indicator
Stored Value/ Memory
Deflation Indicator
Inflation Indicator
Diastolic Value
Pulse Rate
Setting Up Your Monitor
Insert the Batteries
Batteries are packaged with the cuff. The battery compartment is on the bottom
of the device.
Remove cover,
1
insert batteries,
and replace cover
–
–
–
–
4 x AA, 1.5V
All icons will
2
Press and hold for g
M
flash on screen
about five seconds to
perform a function check
Low Battery Warning
Expired Battery Warning
i Use AA long-life or alkaline 1.5V batteries. Do not use rechargeable
batteries. Remove batteries if monitor will not be used for long periods.
Assemble the Bulb and Valve
If your unit is new, you’ll need to assemble the bulb and valve.
Insert quick-release
valve stem into the
1
tube end leading
from the cuff
Understanding Blood Pressure Readings
The current blood pressure scale and classifications (see chart below) were
established by the American Heart Association and American College of
Cardiology in 2017.
Under these guidelines, a systolic pressure of less than 120mmHg and a
diastolic pressure of under 80mmHg are recognized as normal.
Hypertension (high blood pressure) is elevated systolic or diastolic levels.
In 90 to 95 percent of the diagnosed cases, the specific causes are unknown,
although the condition is often linked with family history and lifestyle. This
is referred to as essential hypertension. In the remaining cases, high blood
pressure is a symptom of an underlying, often treatable condition, which if
corrected, may normalize blood pressure. This less common type is known as
secondary hypertension. Hypertension, if left untreated, may contribute to
kidney disease, heart attack, stroke, or other debilitating illnesses.
Blood Pressure Category
HYPERTENSIVE CRISIS Consult your doctor immediately
HIGH BLOOD PRESSURE HYPERTENSION Stage 2
HIGH BLOOD PRESSURE HYPERTENSION Stage 1
ELEVATED NORMAL
Systolic mm Hg
Diastolic mm Hg
(upper number) and/or (lower number)
Higher Than 180 and/or Higher Than 120
140 or Higher
or
90 or Higher
130 – 139
or
80 – 89
120 – 129
and
Less than 80)
Less Than 120
and
Less than 80
i Only a physician is qualified to interpret the readings obtained from
blood pressure monitor. No attempt should ever be made at self-diagnosis or
treatment.
i Readings below 90 (sys) and/or 60 (dia) may be considered hypotensive.
Consult your physician.
Irregular Heartbeat Detector
The appearance of this icon means allorhythmia, or irregular, heartbeat was
detected. If the symbol appears, then certain abnormalities in heartbeat
frequency were detected during the measurement. This indicator is only a
caution.
i It is important that you are relaxed, remain still, and do not talk during
measurement.
In most cases, the appearance of an irregular heartbeat 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 speak with your
doctor.
Information for the doctor on frequent appearance of the Irregular Heartbeat
Detector: This device is an oscillometric blood pressure monitor that also
analyzes pulse irregularity during measurement. The device is clinically
tested. The arrhythmia symbol is displayed after the 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. This device
does not replace a cardiac examination but serves to detect pulse
irregularities at an early stage.
2
Push until fully seated
Connect the Cuff
Insert the cuff
1
connector into
the port on the
left side of
the unit
i Make sure cuff connector is fully inserted before taking a reading.
Preparing for a Measurement
Find time to relax by sitting in an armchair in a quiet atmosphere for about
ten minutes before taking a measurement. Avoid eating and smoking as well as
all forms of exertion directly before measurement.
o3 Measure on a bare arm, if possible. o3 Always measure on the same arm
(normally left). o3 Try to take measurements around the same time each day.
i For additional tips and information on obtaining accurate readings, see page
17.
Fitting the D-Bar Cuff
1
Loop cuff
through ring
2
Position cuff over left arm
Hook-and-loop facing outward
3/4″ to 1″ above elbow Artery Mark over artery
Tube toward lower arm
3
Tighten cuff
Pull end and close
hook-and-loop
The white
triangle on
4
Verify fit
the cuff should fall between
Test fit by sliding two fingers the range lines
between arm and cuff
i If the cuff provided with your unit is too small, please call
1-800-232-2670 or
consult the cuff sizes chart on page 22. Only use approved ADC cuffs.
Last-Reading Memory
M The monitor automatically stores the last reading in memory.
1
g
With the unit off,
press and hold for
about five seconds
M
Values from the last reading will appear
i The irregular heartbeat icon will appear if it was detected during that reading.
Inflating Further
If cuff inflation is not high enough for an accurate reading, the measurement
will pause and the inflation indicator will flash on the display.
Pump the bulb
1
again to inflate at least 20 mmHg
higher
g
i The instruction to inflate further can appear several times.
Repeat, if necessary, until pressure is sufficient for measurement.
Stopping a Measurement
You can stop a measurement at any time.
1
g
Press and hold the quick-release valve
Cuff will deflate
i If you experience any discomfort, such as pain in the arm, stop the
measurement immediately and remove the cuff.
Taking a Measurement
Lay your arm on a table, palm up, so the cuff is at the same height as your
heart. Make sure the tube is not kinked.
g
1
Press and release
g
The unit will turn on and you’ll see
a 0 on the display
Three beeps will sound and the inflation indicator will begin flashing
Grasp the bulb
2
with your free g hand and begin
pumping
Keep pumping until the
3
cuff is inflated to a
pressure that’s about 30 mmHg higher than g
your typical systolic
pressure
i If you don’t know your typical systolic value, inflate to around 160-180 mmHg.
i If you stop pumping the bulb for more than a few seconds, some air may start
releasing through the connector.
When a pulse is
detected, a heart
symbol will start to
g
flash and a beep will
sound for each
heartbeat
i If measurement does not begin or if the inflation indicator reappears,
pump the bulb again to inflate to a higher pressure.
i If the cuff is inflated over 300 mmHg, a warning beep will sound and HI
will appear on the display. Use the quick-release valve on the bulb to deflate
cuff pressure, then start the reading again.
Set the bulb down
4
and remain seated in a quiet and
g
relaxed position
g
g
Press and hold the
5
quick-release valve until cuff is fully deflated
g
The measurement proceeds on its own, automatically
A long beep sounds when measurement is
complete and the systolic pressure, diastolic pressure, and pulse rate are
displayed
The deflation indicator will begin flashing to signal that remaining cuff
pressure can be released
6
Press and release to turn off
i If no button is pressed for 90 seconds the instrument will turn itself off.
References
- American Diagnostic Corporation - Core Medical Device Manufacturer. Stethoscopes, Blood Pressure, Thermometry, and EENT
- ADCatHomenew | American Diagnostic Corporation