ADC 6015 Instruction manual

ADC 6015 Instruction manual
93-6016N-00 rev 1 IFU_93-6016N-00 rev 1 9/30/14 1:54 PM Page 1
Digital Wrist
Blood Pressure
Monitor
6015N, 6016N
Instruction Manual
marking applies to model 6015N only.
ONBO Electronic (Shenzhen) Co., Ltd.
No. 497, Ta Laneg Nan Road, Ta Laneg Street
Baoan District, Shenzhen, China
Medpack Swiss GmbH, Tramstrasse
16, CH-9442, Berneck, Switzerland
Read instructions carefully before
using this device
tel: 631-273-9600
toll free: 1-800-232-2670
fax: 631-273-9659
www.adctoday.com
Type BF applied part
IB p/n 93-6016N-00 rev 1
Dist. by: ADC®
Hauppauge, NY 11788
Inspected in the USA
Made in China
email: [email protected]
0044
6016N
PLEASE NOTE:
THIS MEDICAL INSTRUMENT MUST BE
USED ACCORDING TO INSTRUCTIONS
TO ENSURE ACCURATE READINGS.
Questions?
Call ADC toll free
at 1-800-232-2670
Printed in China
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Digital Wrist Blood Pressure Monitor
Table of Contents
16. HOW TO CONTACT US
I. A Special Thank You
4
1. INTRODUCTION AND INTENDED USE
4
To register your product and obtain further detailed user
information about our products and services visit us at:
2. WARNINGS AND PRECAUTIONS
5
www.adctoday.com
3. ABOUT BLOOD PRESSURE
6
and follow the links.
3.1. What is Blood Pressure?
3.2. What is a Normal Blood Pressure?
3.3. What Influences Blood Pressure?
3.4. Does Blood Pressure Vary?
3.5. What is Hypertension?
3.6. Can Hypertension be Controlled?
3.7. Why Measure Blood Pressure at Home?
3.8. How is Blood Pressure Measured?
3.9. How Should I Record My Blood Pressure?
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10
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4. COMPONENTS OF YOUR BLOOD PRESSURE MONITOR
11
5. SETTING UP YOUR BLOOD PRESSURE MONITOR
12
5.1. Inserting the Batteries
5.2. Setting the Time and Date
5.3. Select the User
5.4. Selecting the Measurement Mode
12
12
13
13
5.5. Using ADC® Average Mode Technology (6016N only)
14
6. MEASUREMENT PROCEDURE
15
6.1. Before Measurement
15
2
For questions, comments, or suggestions
call us toll free at:
1-800-232-2670
American Diagnostic Corporation
55 Commerce Drive, Hauppauge, New York 11788
Telephone: 631-273-9600 • Fax: 631-273-9659
Email: [email protected]
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13. WARRANTY
This blood pressure monitor is warranted for 5 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.
14. QUALITY STANDARDS
Device standard:
This device is manufactured to meet the European and United States
standards for non-invasive blood pressure monitors:
6.2. Common Sources of Error
6.3. Fitting the Cuff
6.4. Measurement Procedure
6.5. Discontinuing a Measurement
6.6. Reading Measurement Results
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16
16
17
17
7. SOFTWARE FUNCTIONS
18
7.1. PC Link Installation and Data Transmission (6016N only)
18
7.2. Installing and Using Microsoft® HealthVault™
22
8. IRREGULAR HEARTBEAT DETECTOR
20
8.1. Traffic Light Indicator (6016N only)
21
9. MEMORY FUNCTION
21
Electromagnetic compatibility:
Device fulfills the stipulations of the International standard IEC60601-1-2
9.1. Recall and Storage of Measurements
9.2. Delete Memory
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22
Clinical testing:
BHS A/A Rated. Clinical performance tests were carried out in the
U.K. “Association Protocol and British HTP Protocol.”
10. ERROR MESSAGES/TROUBLESHOOTING
22
11. CARE AND MAINTENANCE
24
15. SYMBOL DEFINITIONS
12. TECHNICAL SPECIFICATIONS
25
13. WARRANTY
26
Important Warning/Caution
Definition
Authorized European
Represenative’s Information
14. QUALITY STANDARDS
26
Latex-Free
Manufacturer’s Information
15. SYMBOL DEFINITIONS
26
16. HOW TO CONTACT US
27
EN1060-1 / 1995 • EN1060-3 / 1997 • EN1060-4 / 2004
Symbol
Definition
Circumference Size
Conforms to EU Standards
26
Symbol
°F
Temperature Limit
Humidity Limitation
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I. A SPECIAL THANK YOU
Congratulations on your purchase of an ADC® Advantage™ Automatic
Blood Pressure Monitor.
In hospitals and physician's 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 feature rich instrument was designed to
simplify the measurement of blood pressure and pulse rate at home
and deliver consistent, dependable results.
Read this booklet thoroughly before attempting to use your new
ADC® Advantage™ Automatic Blood Pressure Monitor.
12. TECHNICAL SPECIFICATIONS
Weight:
.35 lbs. (148 g) (with batteries + cuff)
Size:
3.75” x 4.25” x 4.25”
85mm x 77mm x 75mm (including cuff)
Storage temperature:
-20 − +55 °C / -4 − +131 °F
Humidity:
15 to 90% relative maximum humidity
Operation temperature:
50°F−104°F (10°C−40°C)
Display:
LCD (Liquid Crystal Display)
Measuring method:
Oscillometric
Pressure sensor:
Measuring range:
1. INTRODUCTION AND INTENDED USE
This manual is for Advantage™ 6015N and Advantage™ Ultra 6016N.
To find the model number of your device, look on the rating label
located on the cuff.
Your digital wrist blood pressure monitor with Irregular Heartbeat
Detection, ADC® Measurement Averaging Mode (6016N model only), and
PC Link Blood Pressure Analyzer Software (6016N model only) is a fully
automatic, digital blood pressure measuring device for use on the wrist.
This monitor enables very fast and reliable measurement of your systolic
and diastolic blood pressure as well as pulse by way of the oscillometric
method of measuring. This device offers a very high and clinically tested
measurement accuracy and is designed for maximum user-friendliness.
Capacitive
Rated range of the determined - Blood Pressure
SYS: 60-255mmHg
DIA: 40-200mmHg
40 - 200 beats per minute - pulse
Cuff pressure display range: 0-299 mmHg
Memory:
Automatically stores the last 99 measurements
for 2 users (198 total).
Measuring resolution:
1 mmHg
Accuracy:
Pressure within ± 3 mmHg or 2% of the reading
≥200mmHg Pulse ± 5 % of the reading
Power Source:
2 “AAA” batteries
Includes:
Automatic Blood Pressure Monitor with Cuff, 2
AAA batteries, Storage Case, Instruction Book,
and Record Book.
Before using, please read this instruction manual carefully and then
keep it in a safe place. Please contact your doctor for further
questions on the subject of blood pressure and its measurement.
To learn more, visit our website at: www.adctoday.com.
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Please remember that comparable blood pressure measurements
always require the same time and the same conditions! These are
normally quiet conditions. If you follow the procedure described earlier and
still get fluctuations of blood pressure of greater than 15 mmHg and/or
you repeatedly hear irregular pulse tones, consult your doctor.
Attention!
Should any technical malfunctions arise in the blood pressure monitor,
please contact the dealer where you bought the device or ADC. Never
attempt to repair the instrument yourself! Any unauthorized opening
of the instrument invalidates all warranty claims.
11. CARE AND MAINTENANCE
Do not expose the device to either extreme temperatures,
humidity, dust or direct sunlight.
Handle the cuff carefully and avoid all types of stress
through twisting or buckling in order not to damage the
sensitive air-tight bubble.
Clean the device with a soft, dry cloth. Do not use gas,
thinners or similar solvents. Spots on the cuff can be
removed carefully with a damp cloth and soapsuds. Do
not submerge the cuff in water!
Do not drop the monitor or treat it roughly in any way.
Never open the monitor!
This invalidates the manufacturer’s warranty.
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Remember…
• Only a healthcare professional is qualified to interpret blood
pressure measurements. This device is NOT intended to replace
regular medical checkups.
• It is recommended that your physician review your procedure for
using this device.
• Blood pressure readings obtained by this device should be verified
before prescribing or making adjustments to any medications used
to control hypertension. Under no circumstances should YOU alter
the dosages of any drugs prescribed by your doctor.
• This monitor is intended for use by adults only. Consult with a
physician before using this instrument on a child.
• In cases of irregular heartbeat (Arrhythmia), measurements made with this
instrument should only be evaluated after consultation with your doctor.
• Familiarize yourself with the section titled "About Blood Pressure".
It contains important information on the dynamics of blood
pressure readings and will help you to obtain the best results.
2. WARNINGS AND PRECAUTIONS
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.
Warning: This product may contain a chemical known to the state of
California to cause cancer, birth defects, or other reproductive harm.
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Caution: The standard material used is latex-free.
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
(10°C) to 104°F (40°C), with a 15-90% relative humidity.
3. ABOUT BLOOD PRESSURE
3.1. What is Blood Pressure?
Simply put, arterial blood pressure is the force of blood exerted against the
walls of the arteries. There are two components to blood pressure - systolic
and diastolic pressure. Systolic, the higher pressure, occurs during contraction
of the heart. Diastolic, the lower pressure, occurs when the heart is at "rest."
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 effected by fine muscles in the blood vessel walls.
Blood pressure is traditionally measured in millimeters of mercury (mmHg).
It is recorded as systolic/diastolic. For example a systolic of 120 and
diastolic of 80 would be recorded 120/80.
Blood pressure is a dynamic vital sign - one that changes constantly
throughout the day. A person's "resting" blood pressure is the pressure
6
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.
HI
The pressure in the cuff is too high (over 300mmHg). 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.
Other possible errors and their solutions
If problems occur when using this device, the following points should
be checked.
NOTE: Blood pressure is subject to fluctuations even in healthy people.
Malfunction
Remedy
The display remains blank when 1. Check battery installation/ polarity.
the device is switched on though 2. Remove the batteries and if the display is
the batteries are in place.
unusual, then exchange them for new ones.
The device frequently fails to
measure, or the values
measured are too low or high.
1. Fit the cuff correctly on the wrist.
2. Before starting measurement make sure
that clothing is not exerting pressure on the
arm. Take articles of clothing off if necessary.
Measure blood pressure again in complete
peace and quiet.
Every measurement results in
different values, although the
device functions normally and
normal values are displayed.
Refer to Section 6.2 Common
Blood pressure values differ from
those measured at the doctor’s.
Refer to Section 3.7. Why Measure
Blood Pressure at Home?
Sources of Error.
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Further information
Measurements should not occur immediately after each other;
otherwise, the results will be skewed. Wait for one minute in a
relaxed position, sitting or lying, before you repeat a measurement.
9.2. Delete Memory
Before you delete all memory readings stored, make sure you won’t
need to refer to them at a later date. Keeping a permanent record is
prudent and may provide additional information for your
doctor’s visit.
To delete stored memory readings, hold the «MEMORY»
button down until the LCD shows a flashing «CL». Release
the button. Press the «MEMORY» button while «CL» is
flashing to complete the operation. It is impossible to erase
the values individually.
Removing the batteries will also delete the memory.
10. ERROR MESSAGES/TROUBLESHOOTING
If an error occurs during a measurement, the measurement
is discontinued and a corresponding error code is displayed
(Example: Err 2).
Error No.
Pulse could not be detected. Please ensure the cuff is properly
placed on the inside of your wrist and repeat the measurement.
ERR 2
Unnatural pressure impulses influence the measurement
result. Reason: the arm was moved during the measurement.
ERR 3
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Possible Cause(s)/Solutions
ERR 1
If inflation of the cuff takes too long, the cuff is not correctly
seated. Reposition the cuff and repeat the measurement.
that exists first thing in the morning while a person is still at rest and
before consumption of food or drink.
3.2. What is a Normal Blood Pressure?
A systolic pressure of less than 120mmHg and a diastolic pressure of under
80mmHg are recognized as normal by the Joint National Committee on
Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, 2003.
NOTE: Blood pressure does increase with age, so you must check
with your doctor to find out what is “normal” for you! 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
doctor. Never use the results of your measurements to independently
alter the drug doses prescribed by your doctor.
3.3. What Influences Blood Pressure?
Blood pressure is influenced by many factors including age, weight,
physical conditioning, past illness, time of day, altitude, activity, and
climate, to name just a few. In general, blood pressure is lower in the
morning and increases throughout the day. It is lower in warm
weather, and higher in cold weather.
Physical activity can have a significant short term impact on blood
pressure. Work, exercise, smoking, eating, drinking - even talking,
laughing, or crying will all affect a person's blood pressure.
Your diet, including beverages containing caffeine or alcohol, may affect blood
pressure. Emotional stress can have a dramatic impact on your blood pressure.
Even repeated blood pressure measurements taken without adequate
rest between readings will alter your blood pressure as the vessels in
your arm engorge with blood. Many of these influences are only
temporary or short term, though chronic (long term) exposure to some
factors may result in permanently elevated blood pressure levels.
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3.4. Does Blood Pressure Vary?
Constantly. An individual's blood pressure varies greatly on a daily and seasonal
basis. It changes throughout one's lifetime. It is not uncommon for systolic
pressure to vary by 40mmHg or more throughout the course of a single day!
While generally not as volatile, diastolic pressure can still vary significantly. In
hypertensive individuals,
variations are even more
pronounced. Normally,
blood pressure is at its
lowest during sleep and
rises in the morning and
throughout the day. The
chart (left) illustrates the
fluctuations that could
occur in a typical day.
3.5. What is Hypertension?
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. The following
standards for assessment of high blood pressure in adults have been
established by the Joint National Committee, 2003.
Range
Classifications
Systolic
Blood Pressure
Diastolic
Blood Pressure
Precaution
Measures
Normal
<120
<80
Monitor regularly
Prehypertension
120 - 139
80 - 89
Contact your physician
––
H
Y
P
E
R T
E
N
S
I
O
N
––
Stage 1
(Moderate)
140 - 159
90 - 99
Contact your
physician Immediately
Stage 2
(Severe)
≥160
≥100
Contact your
physician URGENTLY
(JNC-7 report: Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure / 2003)
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6
0
1
6
N
M
o
d
e
l
O
n
l
y
8.1. Traffic Light Indicator (6016N only)
The bars on the left hand edge of the display show the range within
which the indicated blood pressure values lies. Depending on the
height of the bar, the readout value is either within the normal
(green), borderline (yellow), or danger (red) range. The classification is
based on standards
adopted from the
WHO (World Health
Organization). Refer to Indications of a Indications of a
Indications of
Indications of
“Normal”
“Pre-Hypertension” “Stage I Hypertension” “Stage 2 Hypertension”
Blood Pressure
Blood Pressure
Blood Pressure
Blood Pressure
the chart to the right
Red
Red
Red
Red
for details of the clas- Orange
Orange
Orange
Orange
sification.
Yellow
Yellow
Yellow
Yellow
Green
Green
Green
Green
Note: ESH/ESC guidelines may vary from those indicated. Consult
your physician for information relating to guidelines in your region.
9. MEMORY FUNCTION
9.1. Recall and Storage of Measurements
At the end of a measurement, this monitor automatically stores each result
with date and time. This unit stores 99 memories for each of 2 users.
Viewing the Stored Values
With the unit off, press the «MEMORY» button. The display first shows
"A", then shows the average of all measurements stored in the unit.
NOTE: Measurements for each user are averaged and stored
separately. Be certain that you are viewing the measurements for the
correct user (with no time and date shown).
Pressing the «MEMORY» button again displays the previous value. To
view a particular stored memory, press and hold the «MEMORY»
button to scroll to that stored reading.
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NOTE:
• You cannot run the PC Link software and HealthVault™ at the same
time. Be sure to completely remove the PC Link software before
installing HealthVault™.
• HealthVault™ has a mobile app available in both the Apple® App
Store and Microsoft® Windows® Phone marketplace.
8. IRREGULAR HEARTBEAT DETECTOR
This function indicates allorhythmic heartbeating. If the symbol of IHD
appears on the display that means that certain abnormalities in heartbeat
frequency were detected during the measurement. In this case, the result
may deviate from your normal blood pressure – repeat the measurement.
In most cases, this 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 tell your doctor. Please show your doctor the
following explanation:
Information for the doctor on frequent appearance of the Irregular
Heartbeat Detector
This instrument is an oscillometric blood pressure monitor that
also analyses pulse frequency during measurement. The
instrument is clinically tested. The symbol
is displayed
after the measurement, if pulse irregularities occur during
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. The instrument
does not replace a cardiac examination, but serves to detect
pulse irregularities at an early stage.
Remember, only a physician is qualified to interpret the readings
obtained from your blood pressure monitor. No attempt should ever
be made at self-diagnosis or treatment.
3.6. Can Hypertension be Controlled?
Although essential hypertension cannot be cured, it can usually be
controlled by altering lifestyle (including diet), adopting a program of
exercise, stress management and, where necessary, with medication
under a doctor's supervision.
To help reduce the risk of hypertension, or keep it under control, the
American Heart Association (AHA) recommends the following:
•
•
•
•
•
Don't smoke
Reduce salt and fat intake
Maintain proper weight
Exercise regularly
Have regular physical checkups
3.7. Why Measure Blood Pressure at Home?
Clinical studies have shown improved detection and treatment of
hypertension when regular home blood pressure monitoring is done in
consultation with a physician.
Blood pressure measured in a doctor's office or hospital setting may
cause anxiety and lead to an elevated reading—a condition referred to
as "white coat hypertension."
Home measurements generally reduce the "outside" influences on blood
pressure readings, and can provide a more comprehensive and
meaningful blood pressure history.
Note: While it is important to keep an accurate record of your blood
pressure measurements, don't be overly concerned by the results of any one
measurement. Individual results may be influenced by spiking of your
pressure due to diet, anxiety, or mis-measurement resulting from excessive
arm movement, or misapplication of the cuff. Many readings taken at the
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same time each day give a more comprehensive blood pressure history.
Always be sure to note the date and time when recording blood
pressure and pulse measurements. For best results, and with time
permitting, 3 successive measurements may be taken daily. Make sure to
allow at least 1 minute between measurements. Discard any reading that
appears suspect and record the average of the remaining readings.
7.2 Installing and Using Microsoft® Healthvault™ on your ADC®
Advantage™ Blood Pressure Monitor
The Advantage™ Ultra digital blood pressure monitors are compatible
with the Microsoft HealthVault™ software application. HealthVault™
allows you to easily store, use, and share your health information
online and on your mobile devices.
To use HealthVault™ with your unit, follow the steps below:
3.8. How is Blood Pressure Measured?
Healthcare professionals traditionally use a device known as a
sphygmomanometer along with a stethoscope - essentially a
professional version of the very same instrument you have purchased.
The sphygmomanometer is a system consisting of an inflatable bladder
contained within a cuff, inflation bulb with air control valve, and
pressure measuring manometer (gauge). The gauge may be mechanical,
electronic, or mercurial. The cuff is wrapped around the limb and inflated
to constrict blood flow to the artery. As pressure is released from the
cuff through the deflation valve, blood flow returns to the artery
producing pulse beats known as Korotkoff sounds, which are detected
with the stethoscope. Systolic pressure is recorded at the onset of these
sounds. Diastolic pressure is generally recorded when the sounds
disappear (when blood flow to the artery returns to normal).
3.9. How should I record my blood pressure?
Record your blood pressure by setting up a simple chart in a spiralbound notebook as shown below, or use the included record book.
Date
4/24
Time
7:50AM
Reading
128/83
Pulse
72
4/25
8:00AM
135/77
77
4/26
7:45AM
130/75
71
4/27
2:00PM
153/89
80
If you like you can add a column for comments about your condition at the
time of measurement, or a listing of any factors that may have influenced
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1. Create a user account at www.healthvault.com.
2. Once logged in, click on “Apps & Devices.”
3. Download the “HealthVault Connection Center” app and follow the
prompts on screen to guide you through installation.
4. Once installed, select “Select a Task -> Add Device” from within
the HealthVault application.
5. Plug in your ADC BP monitor to your computer using the supplied
USB cable. HealthVault™ will automatically install the device
drivers and associate your device to the HealthVault software.
At this point, you can start taking readings with your device. Once
you have collected a reading, you can now upload the data using the
“HealthVault Connection Center” app.
6. Click “Go online to HealthVault” and sign into your account.
7. Click the box of the user you would like to associate with this
device and click “Allow Access.”
8. Then, click “Upload Now.” Your readings will then upload from
your device to the HealthVault™ service.
9. You can the click “View Data in HealthVault” to see your readings.
Once you have approved a device, you will not need to perform these
actions again. You can just connect your device and start with step 11.
For more information on how to use HealthVault™, click “Help” at the top
right-hand corner of the page. There, you will find a detailed help document
as well as an FAQ section to help with any issues you may have.
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To prolong the batteries’ life the device switches off automatically if no
button is pressed for 2 minutes. Otherwise you can switch it off by
pressing the «ON/OFF» button.
7. SOFTWARE FUNCTIONS (6016N ONLY)
7.1. ADC® Advanced PC Link Software Installation and Data
Transmission (Software sold separately, Order Item #6023NPC)
This unit can be used in connection with your personal computer (PC)
running the ADC® Advanced PC Link Software. Your PC will allow a
capacity of monitoring 80 patients, each with 1000 records of data (Note:
Overuse will lower system efficiency). The memory data (except average
values) can be transferred to the PC by connecting the monitor via the
included USB cable with your PC. Note: The software does not work with
Mac computers.
a) Insert CD into CD ROM drive of your PC. The
installation will start automatically. If not, click
on SETUP.EXE.
b) Connect the monitor via USB cable with the PC.
Three horizontal bars will appear on the display
and last for 3 seconds.
c) The bars will then flash to
indicate that the connection
between computer and device
is successfully made. As long
as the cable is plugged, the
bars will keep flashing and
the buttons are disabled.
During the connection, the
device is completely
controlled by the computer.
Refer to the ‘Help’ file in the
software for detailed
Operating System:
Microsoft Window XP, Vista
instructions.
your readings (such as "had a cold", or "just returned from vacation").
For best results, and with time permitting, 3 successive
measurements may be taken daily. Make sure to allow at least a 1
minute interval between measurements. Discard any reading that
appears suspect and record the average of the remaining readings. If
this method is used, be sure to note that the readings are averaged.
On the Advantage™ Ultra (6016N) model, PC Link software is available.
Records can be automatically transferred to your Windows computer.
Many smart phone and tablet apps allow you to record, chart, and share
your BP measurements. ADC recommends Microsoft® Healthvault™.
4. COMPONENTS OF YOUR BLOOD PRESSURE MONITOR
The illustration shows your blood pressure monitor, consisting of:
Wrist monitor with attached cuff, storage case, and instruction
booklet.
- - -- - 1
18
1
For wrist circumference: 5.3−7.7” (13.5−19.5 cm)
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5. SETTING UP YOUR BLOOD PRESSURE MONITOR
5.1. Inserting the batteries
After you have unpacked your device, insert the batteries. The battery
compartment is located on the bottom of the device.
a) Push and lift to remove the battery cover.
b) Insert the batteries (2 x AAA, 1.5V), observing the indicated
polarity.
Attention!
• If a battery warning
appears in the display, the batteries are
almost discharged and must be replaced.
• After battery warning
appears, the device will
not work until the batteries have been replaced.
• If the blood pressure monitor is not used for long
periods, remove the batteries from the device.
• Use “AAA” Long-Life or Alkaline 1.5V batteries. Do
not use rechargeable batteries.
• Functional check: Press the «MEMORY» button down to test all the
display elements. When functioning correctly many icons will appear.
5.2. Setting the Time and Date
This blood-pressure monitor incorporates an integrated clock
with date display. After new batteries have been inserted, the
device will request the date and time to be reset.
Expanding the averaged measurement to see the three individual
readings: This function allows you to view the three individual
measurements used to calculate the ADC® Averaging Mode
Technology™ measurement. After taking an averaging mode
measurement turn unit off, hold the Memory button for 3 seconds
until you hear a short beep. (Do not hold the button longer than 7
seconds or you will delete all the readings in the memory!) Let go
of the button and watch the screen. It will automatically scroll
through the three measurements used in the measurement.
6.5. Discontinuing a Measurement
If it is necessary to interrupt a blood pressure measurement for any reason
(e.g. the patient feels unwell), the «ON/OFF» button can be pressed at any
time. The device immediately lowers the cuff pressure automatically.
6.6. Reading Measurement Results:
When the measurement has been concluded, a long beep tone
sounds. The measured systolic and diastolic blood pressure values, as
well as the pulse are now displayed.
1. After new batteries have been inserted, you will have
to set the year. The 4 characters (2014) on the screen
will flash. You can advance the year by pressing the
«MEMORY» button. To confirm and set the year,
press the «TIME» button.
2. To set the month, use the «MEMORY» button. To
confirm and set the month, press the «TIME» button.
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5. When the unit is set to the MAM setting, 3 separate measurements will
take place in succession after which your result is calculated and
displayed as a single, averaged measurement. There is a 15 second
resting time in-between each measurement. A countdown indicates the
remaining time.
NOTE: 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 an error code will be displayed.
Memory
Button
Time/Date
Button
PM
The appearance of this symbol
signifies that an irregular heartbeat
was detected. This indicator is only a caution. It is important that you be
relaxed, remain still and do not talk during measurements.
NOTE: We recommend contacting your physician if you see this
indicator frequently.
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93-6016N-00 rev 1 IFU_93-6016N-00 rev 1 9/30/14 1:54 PM Page 13
6.3. Fitting the Cuff
a) Remove all objects and jewelry (e.g. wristwatch) from the wrist in
use. Put the cuff over the wrist with the monitor face on the inside
of the wrist. The buttons should be on the bottom.
b) The distance between the cuff and the hand
should be approx. 10 mm (1/2").
c) Secure the cuff with the hook and loop
fastener, so that it lies comfortably and not too
tight. No space should remain between the
cuff and the wrist.
d) Lay your arm on a table, with the palm upwards.
Support the arm a little with a cushion, so that
the cuff rests at about the same height as the
heart. Remain still for 2 minutes, before
beginning the measurement. You can also use
the storage case as a support.
6.4. Measurement Procedure
After the cuff has been appropriately positioned, the measurement
can begin:
1. Press the «ON/OFF» button. The built-in pump begins to inflate the cuff.
In the display, the increasing cuff pressure is continually displayed.
2. After a suitable inflation pressure has been reached, the pump
stops and the pressure gradually falls, with cuff pressures being
displayed. If that inflation pressure is not sufficient, the monitor
automatically re-inflates.
3. When the measurement has been completed, the systolic, and
diastolic blood pressures and pulse rate now appear in the display.
4. The measurement readings remain on the display until you switch
off the instrument. If no button is pressed for a period of 2 minutes
the instrument switches itself off in order to preserve the batteries.
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3. To set the day, use the «MEMORY» button. Press the
«TIME» button to confirm. To set the hour, use the
«MEMORY» button. Press the «TIME» button to
confirm. To set the minutes, use the «MEMORY»
button. Press the «TIME» button to confirm.
4. Once you have set the minutes and pressed the
«TIME» button, the date and time are set and the
time is displayed.
NOTE
• If you want to change the date and time, press and hold the
«TIME» button down for approx. 3 seconds until the user icon
starts to flash. Press the «TIME» button again; now you can enter the
new values as described above.
• A single press of the «MEMORY» button or «TIME» button advances
one operation.
• Holding the button down speeds up the procedure.
5.3. 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.
a) With the unit off, press and hold the «TIME» button
to cycle between users ("1" and "2").
b) Press the «MEMORY» button to toggle between
users.
c) Press the «ON/OFF» button to make your selection.
5.4. Selecting the Measurement Mode (6016N only)
This instrument enables you to select either standard (single measurement)
or measurement averaging mode (automatic triple measurement).
a) To select Standard mode, push the switch on the side
of the instrument to Position "1."
1
3
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b) To select Averaging mode, push the switch to Position "3."
Note the MAM Advantage™ Averaging mode
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.
5.5. Using ADC Average Mode Technology (6016N only)
1. In MAM Advantage™ Averaging mode, three measurements
are automatically taken in succession and the result 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.
2. After pressing the «ON/OFF» button, the MAM Advantage™
Averaging mode
icon appears in the display.
3. 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.
4. There is a break of 15 seconds between the measurements (15
seconds are adequate according to “Blood Pressure
Monitoring, 2001, 6:145-147” for oscillometric instruments). A
countdown indicates the remaining time.
5. The individual results from measurements 1, 2 and 3 are not
initially displayed.
NOTE: If you want to see each of the individual readings
making up a triplicate reading, turn the unit off, then press
and hold the Memory button for 3 seconds, until you hear a
tone, immediately after a MAM Advantage™ Averaging
Mode measurement. Note: You can only see the individual
readings one time immediately following an Averaging
Mode measurement.
Do not remove the cuff between measurements.
14
6. MEASUREMENT PROCEDURE
6.1. Before 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 taking a measurement.
• Always measure on the same wrist (normally left).
• Always compare measurements taken at the same time of day,
since blood pressure changes during the course of the day, as
much as 20-40 mmHg.
6.2. Common sources of error:
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
15cm (6 inch) difference in height between your heart and the cuff
results in a measurement error of 10 mmHg!
• 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. If you
decide to take your Averaging Mode measurement again, be sure to
wait at least one minute beforehand.
15
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