Biocare 3160A-3 User manual
Blood Pressure Monitoring System
Owner’s Manual
Model : 3160A-3
Blood Pressure Owner’s Manual Blood Pressure Owner’s Manual Blood Pressure Owner’s Manual Blood Pressure Owner’s Manual
Dear 3160 System Owner :
Thank you for purchasing the Blood Pressure Monitoring System. This system is a fully
automatic, digital blood-pressure measuring d evice for use on the upper arm, it enables
very fast and reliable measurement of the systolic and diastolic blood-pressure as well as
the pulse frequency by way of the oscillo metric method of measuring.
This manual provides impo rtant information to h elp you operate this system correctly.
Before using this product, please read the following contents thoroughly and carefully.
With the compact size and easy operation of this Blood Pressure Monitoring System, you
can easily monitor your blo od pressure by yourself at any time or place. In addition, this
system can help you and your h ealthcare professionals to monitor and adjust your
treatment plans, and keep your blood pressure under control.
If you have other questions regarding this product, please contac t the place of purchase.
Type BF applied p art. Read the instructions carefully b efore using this device.
IMPORTANT SAFETY PRECAUTIONS
READ THI S BEFORE USE
1. Use this device ONLY for the intende d use described in this manual.
2. Do NOT use accessories which are not specied by the manufacturer.
3. Do NOT use the device if it is not working properly or damaged.
4. Do NOT use the e quipment where aerosol sprays are being used, or wh ere oxygen is
being administered.
5. Do NOT use under any circumstances on newborns.
6.This device does NOT serve as a cure for any symptoms or diseases. The data measured
are for reference only. Always consult your doc tor to have the results interpreted.
7.Keep the equipment and its exible cord away from hot surfaces.
8.Do NOT apply the cu to areas other than the p lace directed.
9.Do NOT remove plastic wrapping membrane to ensure the waterpro of function.
10.Proper maintenance and periodically calibration are essential to the longevity of
your device. If you are concerned about your accuracy of measurement, please
contact local customer service for help.
KEEP TH ESE INSTRUCTIO NS
BEFORE YOU BEGIN
INTENDED USE
The 3160A-3 system is a system designed to measure the systolic and diastolic bl ood
pressure and p ulse rate by using a non-invasive technique in which an inatable cu is
wrapped on the upper ar m. It is intended for individuals age 18 and above for use at home
and in clinical settings. The device is not to be used for the diagnosis of hypertension or for
testing on newborns.
TEST PRINCIPLE
Blood pressure is measure d non-invasively at the upper arm based on oscillometric
method. If you have been diagnosed with a severe arrhy thmia or irregular heartbeat, atrial
or ventricular premature beats or atrial brillation, measurements made with this
instrument should only be evaluated after consultation with the doctor or your healthcare
professionals.
Electromagnetic interference
The device contains sensitive electronic components. Avoid strong electromagnetic elds
in the direc t vicinity of the device (e.g. mobile phones, microwave ovens. Elec trical
interference can lead to temporar y impairment of the measuring accuracy).
MONITOR OVERVIEW
Device
3160 oers a wide range fan-type cu, measuring size :
22~38cm, suitable for most of ar m circumferences;
Large cu (measuring range 32~42cm) is available as
special accessories.
Do not use accessories or equipment which are
not certied by manufacturer, they might increase
emissions or decrease immunity of this s ystem.
DISPLAY SCREEN
ADVANTAGES OF AUTOMATIC BLOOD PRESSURE
MONITOR
Blood Pressure Rate Indicator.
Blood pressure rate indicator is located along the left side in the display. The classication
corresponds to ESH (European Society of Hyper tension) ranges describ ed in the table of
the section «7.1.re ference values».
After the measurement, there appears the color bars in the lef t part of the display: green
zone - optimal blood pressure, yellow - elevated, orange - too high, re d – dangerously
high. This function helps you to self- orient in the measurement results.
CAM technology – Clinically Accurate Measurement
CAM Technology - Clinically Accurate Measurement - provides you with the maximally
accurate results of blood pressure measurement at home. Cardiologists recommend
always take several repeated measurements and calculate their average values. The device
in the CAM mo de automatically takes 2 measurement s in succession, analyzes the results
and displays the ready values.
Irregular Heartbeat Detection Advanced
IHB advanced is an oscillometric waveform technolo gy which is more sensitive, but not
specic, to identif y varying rhythm symptom such as skipped heartbeats, abnormally
rapid (Tachycardia), or slow (Bradycardia) pulse and Atrial Fibrillation occurring during the
measurement, while regular IHB (Irregular Hear t Beat) feature in the market is to detect a
condition where the hear tbeat rhythm varies by more than cer tain percentage fro m the
average hear tbeat detected during the measurement, If th e symbol of IHB advanced
appears on the display that means that certain abnormality in heart beat frequency was
detecte d during the measurement. In this case, the result may deviate from your normal
blood pressure – repeat the measurement. In most cas es, this is no cause for concern.
However, if the symbol appears on a regular basis (e.g. several times a week with
measurements taken dail y) we advise you to tell your doc tor.
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 10
advice. The instrument does not replace a cardiac examination, but serves to detect
pulse irregularities at an early stage.
SETTING THE MONITOR
Before using your monitor for the rst time, check and update these settings. Make sure
you complete the steps below and save the desired settings.
INSERT BATTERIES
After you have unpacked your device, rst insert the at tached
batteries (4 x size AAA 1.5V ) with the indicated polarity. The battery
compartment is locate d at the bottom side of the d evice (see
illustration).
NOTE
• After the warning appears, device is blocked till the batteries have been rep laced.
• Please use «AAA» 1.5V Batteries.
• If the bloo d-pressure monitor is left unused for long periods, pl ease remove the batteries.
USE A MAINS ADAPTOR
The 3160 Series Blood Pressure Monitor can be op erated with a mains adapter (output 5 V
DC / 600 mA).
a. Connec t the micro plug to the socket at the device right side.
b. Plug the mains adapter (output 5 V D C / 600 mA) to a 100-240V electr ical power socket.
ENTER THE SETTING MODE
Insert batteries or press the O/I but ton at the back
side of the dev ice, then touch and hold M/SET
button for 3 seconds until the “2013” ashes on
the upper right corner.
SETTING THE DATE AND TIME
a. When the year ashes, press M/SET but ton until the
correct year appears .Press CAM button to conrm
and change to Month setting.
b. When the month ashes, press M/SET button until
the correc t month appears. Press CAM button to
conrm and change to date setting.
c. Set the day, hour and minute in the same way as
described above.
SETTING THE ALARM
This 3160 Series upper arm blood pressure monitor allows you to set
2 alarm clocks as a reminder to take medication or measurements.
a. Device in standby status, hold M/SE T then hold CAM button. Release
both buttons, “1” ashes on the screen, press M/SET button to toggle
between alarm “1” and “2”.
b. Touch CAM button, hour ashes, touch M/SE T button to set the
desired hours and touch CAM button for the next minute setting.
c. At the time of alarm, the mete r beeps automatically. You can touch
any button to silence it immediately.
How to switch o the alarm permanently : hold CAM button when the
alarm number “1” or “2” is ashing, release as “On” is changed to “OFF”
on the display
NOTE : The alarm times must b e re-entered each time the batteries are
replaced.
USER NUMBER SELECTION.
This 3160 Series system suppor ts measurement for two users. Be fore
measurement, make sure you set the unit for th e intended user: device
in standby status, hold START then M/SET button, till user icon switches
to another one.
TESTING YOUR BLOOD PRESSURE
BEFORE MEASUREMENT
• Avoid caffeine, tea, alcohol and tobacco for at least 30 minutes b efore measurement.
• Wait 30 minutes af ter exercising or bathing before measurement.
• Sit or lie down for at least 10 minutes b efore measurement.
• Do not measure when feeling anxious or tense.
• Take a 5-10 minutes break between measurem ents. This break can be longer if necessary,
depending on your physical condition
• Keep the records for your doctor as reference.
• Blood pressure naturally varies between each arm. Always measure your bloo d pressure
on the same up per arm.
FITTING THE CUFF PROPERLY
a. Plug the cu connector to the cu socket on the device left side.
b. Assemble the cu as shown below. The smooth surface should be inside of the cu loop
and the metal D-ring should not touch your skin.
c. Stretch your left (right) arm in front of you with your
palm facing up. Slide and place the cu onto your
arm to let the air tube and artery mark region toward
the lower arm. Wrap and tighten the cu above your
elbow. The ar tery mark on the edge of the cu should
be approx. 0.8" to 1.2" (2 cm to 3 cm) above your elbow.
Align the tube over the main ar teries on the inside.
d.Leave a lit tle free space between the arm and the cu :
you should be able to t two n gers between them.
Remove all clothing covering or constricting the
measurement arm.
e. Press the hook material rmly against the pile material.
The top and bottom edges of the cu should be
tightened evenly around your upper arm.
PROPER MEASUREMENT POSITION
Sit down for at least 10 minutes before measuring.
a. Place your elbow on a at surface. Relax your hand with
the palm facing up.
b. Make sure the cu is about the same height as the location
of your hear t.
c. Press the O/I button to switch on the monitor.
d. Remain still and do not talk or move during the measurement.
WARNING If the cu is relatively lower (higher) than the hear t, the obtained blood pressure
value could b e higher (lower) than the actual value. A 15 cm dierence in height may result
in an error around 10 mmHg.
TAKING MEASUREMENTS
TAKING A SINGLE MEASUREMENT
Always apply the pressure cu before turning on the monitor.
a. Turn on the monitor by pressing the O/I button at the back side.
❶O/I button
❷Cuff socket
❸M/SET Button
❹CAM Button
❺Start Button
❻Battery Compartment
❼DC Jack
❽LCD Display
❾Air Tube
❿Air Plug
Cuff
1.Time Date
2. Alarm Clock
3. Systolic Pressure
4. Diastolic Pressure
5. Low battery Icon
6. Pulse Rate
7. AF Icon
8. CAM Mode
9. Heartbeat Icon
10. Irregular Heartbeat Detector
11. Memory Set
12. Memory Icon
13. Night Time Icon
14. Day Time Icon
15. Traffic Light Indicator
16. User Icon
Blood Pressure Owner’s Manual
Shanghai International Trading Corp.
GmbH(Hamburg)
Eiffestrasse 80, 20537 Hamburg, Germany
TEL:+49‐40‐2513175
FAX:+49‐40‐255726
Biocare Asia Co., LTD
No.260,Mayun Road, New District Suzhou,
Jiangsu,215129,P.R.C
TEL:+86‐512‐68091772
FAX:+86‐512‐68097761
www.bca-medical.com
Blood Pressure Owner’s Manual Blood Pressure Owner’s Manual Blood Pressure Owner’s Manual Blood Pressure Owner’s ManualBlood Pressure Owner’s Manual
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b. Touch START button, pump begins to inate the cu. The rising
pressure in the cu is shown on th e display.
NOTE
In case the ination pressure is not sucient to determine m easurement
result, the monitor automatically re-inates to a higher level.
c. Pressure in cu increases to working pressure. Then pump stops
and pressure falls.
d. The hear t symbol “ ” starts to ash every h eart beat once pulse is
detected.
e. fter the measurement, systolic pressure, diastolic pressure, pulse rate
and color bars classied from ESH (European Societ y of Hypertension)
standards shows on the display.
f. If irregular heartbeat was detected during the measurement, LCD
displays the “ ” icon to remind users of heartbeat irregularity. Please
consult your do ctor if it appears of ten.
CAM MODE
(CLINICALLY ACCURATE MEASUREMENT)
Always apply the pressure cu before turning on the monitor.
In CAM mode, 2 measurements (at 20 sec break) are automatically taken
in succession and the result is then automatically analyzed and displayed.
Because people’s blood pressure constantly uc tuates, a result
determined in this way is more reliable than the one produced by a single
measurement.
a. Turn on the device by p ressing the O/I button at the back side of the
monitor.
b. Touch CAM button, pump begins to inate the cu. LCD display shows
CAM icon and the rising pressure in the cu.
c. Pressure in cu increases to working pressure. Then pump stops and
pressure falls.
NOTE
In case the ination pressure is not sucient to determine m easurement
result, the monitor automatically re-inates to a higher level.
d. The hear t symbol “ ” starts to ash every h eart beat once pulse is
detected.
e. After the 1st measurement, the monitor automatically starts the 2nd
measurement after 20 sec countdown.
f. After the 2nd m easurement, the device analyzes the1st and 2nd
measurement values: if sys BP1- sys BP 2 >/= 15 mmHg, dia BP1 - dia BP2
>/= 10 mmHg, CAM mode will automatically start the 3rd measurement
after another 20 sec countdown.
NOTE
In case the 1st and/or 2nd pulse rate </= 60, device willautomatically take
4 times measurement in succession.
g. The CAM measured sys tolic pressure, diastolic pressure, pulse rate and
color bars classied from ESH( European Society of Hyper tension)
standards show on the display.
h. If irregular heartbeat was detected during the measurement, LCD
displays the “ ” icon to remind users of hear tbeat irregularit y.
Please consult your doctor if it appears often.
i. If LCD displays th e “ ” icon quite often, please consult your doctor
to check what k ind of arrhythmias you may have. It is impor tant for
early diagnostic of atrial brillation.
MONITOR MEMORY
Press O/I button at the back sid e of the device, the monitor is turned
on and stays standby.
AVERAGE OF ALL STORED MEMORIES
Touch M/SET but ton, LCD shows a set of values averaged from all the
stored memories of the selected user, accompanied by an icon “A”.
AVERAGE OF ALL STORED DAY-TIME MEMORIES
Press M/SET b utton again, LCD shows another set of values averaged
from all the stored day-time (4:00~9:59) taken measurements,
accompanie d by an icon “A” and .
NOTE
Heart at tack and stoke occurs mo re frequently in the morning. This
feature averages the morning readings between 4:00 and 9:59AM to
ident i t y morning hypertensions.
AVERAGE OF ALL STORED NIGHT-TIME MEMORIES
Press M/SET b utton once more, LCD shows the other set of values
averaged from all the stored night-time (17:00~1:59) taken
measurements, accompanied by an icon “A” and .
MEMORY RECALL
The device stores 90 most recent blood pressure test results along with
respective dates and tim es in the monitor memor y for each of two users.
Reviewing Test Results
a. Touch M/SET button again af ter you see the average of
all stored night-time memories, the single memor y
reading appears.
b. Per the setting, the rst reading you see is the last blood
pressure result. Touch M/SET button again, the next
measurement eg. M89, as well as th e previous 88
measurements (M88, M87… M1) can be displayed
one after the other.
NOTE : CAM icon will show on LCD if the measurement is taken under C AM mode.
DELETE ALL STORED MEMORIES.
With device in standby status, hold down M/SET but ton for 14 seconds
until “CL” ashes on LCD, press M/SE T button again, all the s tored
memories inside is removed.
Before you delete all the readings stored in the memory, please make
sure you will not need to use them any more at a later time.
DOWNLOADING RESULTS ONTO A COMPUTER
This device is able to be used with a personal computer running URIGHT
Health Care Management System. All stored memor y readings can be
transferred to your computer via the attached micro USB cable.
a. Soft ware installation Download the software from website, then click
setup for installation of BioCare corproation.
b. Data Transmission Connect the monitor to your co mputer via micro
USB cable, LCD immediately displays three lines to indicate successful
connection and data transmission is now available.
NOTE
During the whole process of USB connection, the monitor is completely controlled by the
software system.
MAINTENANCE
CARING FOR YOUR MONITOR
To avoid the monitor at tracting dirt, dust or other contaminants, wash and dry your hands
thoroughly before use.
Cleaning
• To clean the monitor e xterior, wipe it with a cloth moistene d with tap water or a mild
cleaning agent, then dr y the device with a soft dry cloth. D o NOT ush with water.
• Do NOT use organic solvents to clean the monitor.
• Do NOT wash the pressure cuff.
• Do NOT iron the pressure cuff.
Monitor Storage
• Storage condition: -20°C to 55°C (-4°F to 131°F), below 95% relative humidity.
• Always store o r transport the monitor in its original storage case.
• Avoid dropping or heavy imp act.
• Avoid direct sunlight and high humidity.
DETAILED INFORMATION
Reference Values
Clinical studies show that adult diabetes is often accompanied by elevated blood pressure.
People with diabetes can reduce their heart risk by managing their blood pressure along
with diabetes treatment*4.
Monitoring your routine blood pressure trend helps you to know your body condition.
Human blood pressure naturally increases after reaching middle age. This symptom is a
result of continuous ageing of the blood vessels. Further causes include obesity, lack of
exercise and cholesterol (LDL) adhering to the blood vessels. Rising blood pressure
accelerates hardening of the arteries, and the body becomes more susceptible to apoplexy
and coronary infarction. The recommended blood pressure range is as below :
Isolated systolic hypertension should be graded (1, 2, 3) according to systolic blood pressure values in the ranges indicated, provided
that diastolic values are < 90mmHg.
Source: The European Society of Hypertension and European Society of Cardiology TaskForce Members. 2007 ESH-ESC Practice
Guidelines for the Management of Arterial Hypertension. J Hypertens 2007; 25: 1751-1762.
*1 American Diabetes Association.The Diabetes-Heart Disease Link Surveying Altitudes Knowledge and Risk (2002)
SYSTEM TROUBLESHOOTING
If you follow the recommended action but the problem persists, or error messages other
than the ones b elow appear, please call your local customer service. Do not at tempt to
repair by yourself and never try to disassemble the monitor under any circumstances.
Error Messages
Troubleshooting
1. If no display appears after pressing Power button
2. If the heart rate is higher/lower than user’s average
3. If the result is higher/lower than user’s average measurement
4. If the cu inates again while measuring
SYMBOL INFORMATION
SPECIFICATIONS
System Performance
Blood pressure measurement performance
This device has been tested to meet the electrical and safety requirements of :
IEC/EN 60601-1,
IEC/EN 60601-1-2
Reference to Standards :
• EN 1060-1 /-3, NIBP-requirements
• IEC60601-1 General requirement for safety
• IEC60601-1-2 Requirements for EMC
• EN1060-4, NIBP clinical investigation
• AAMI / ANSI / IEC 80601-2-30, ANSI/AAMI/ISO 81060-2, NIBP requirements
Category
Optimal
Normal*3
High normal
Grade 1 hyper tension
Grade 2 hyper tension
Grade 3 hyper tension
Isolated systolic hypertension
Systolic (mmHg)
< 120
120–129
130–139
140 – 159
160–179
≥ 180
≥ 140
and
and/or
and/or
and/or
and/or
and/or
and
Diastolic (mmHg)
< 80
80–8 4
85–89
90 – 99
100–109
≥ 110
< 90
MESSAGE CAUSE WHAT TO DO
Ination or pressure
error
Blood pressure
measurement error
Ret cu tightly and correctly.
If error still remains, contact local
customer service for help.
Ret cu tightly and correctly.
Relax and repeat the measurement.
If error still remains, contact local
customer service for help.
Relax and repeat the measurement.
Improper movement
detecte d during
measurement (Artifact).
No pulse detected
Problems with the
monitor
Ret cu tightly and correctly.
Relax and repeat the measurement.
If error still re ma ins, co nt ac t lo ca l
customer ser vice for help.
Review the ins tru ctions a nd re peat
the test.
If the moni to r stil l do es not wo rk ,
pleas e co nt ac t the local custo mer
service for help.
POSSIBLE CAUSE
Batteries exhausted.
Batteries inco rrectly installe d or absent.
WHAT TO DO
Replace the b atteries.
Che ck that the bat teries a re corre ctly
installed.
POSSIBLE CAUSE
Movement during measurement.
Measurement taken just af ter exercise.
WHAT TO DO
Repeat measurement.
Rest at least 30 minutes beforehand.
POSSIBLE CAUSE
May not be in correct position while
measuring.
Blood pressure naturally varies from
time to time.
WHAT TO DO
Adjust to the correct position to
measure.
Keep in mind for next measurement.
POSSIBLE CAUSE
Cu is not fastened.
If user ’s bloo d pressure is higher than the pressure the dev ice has inated, t he
devi ce will autom atic ally increase the pressure and start to inate a gain. Stay
relaxed and wait for the measurement.
WHAT TO DO
Fasten the cu again.
Blood Pressure Owner’s Manual
Symbol Referent Symbol Referent
Consult ins tructions for u se Aut hori zed r epres enta tive in
the Europe an Community
Manufac turer Class II
Humidity li mitation
Water-proo f grade
CE mark
Serial numbe r
Caution , consult
accompanyin g documents
Type BF Equipmen t
Dispose o f in accordance with
the requireme nts of your
country.
Power source
Size of monitor w/o cuff
Weight
Cuff Size
Memory
Power saving
System operating condition
Meter storage condition
Pressure range
Heart rate range
Systolic Measurement Range
Diastolic Measurement Range
Pulse Rate Measurement Range
Maximum inflation pressure
Accuracy of Pressure
Accuracy of Pulse rate
Measurement unit
Four 1.5V AAA alkaline batteries,5V 0.6A mains adaptor
138 (L) x 94 (W) x 33 (H) mm,
260g ± 5g with batteries
M (medium) : 22-38cm / 8.7”~14.9”
Maximum 90 memory records
Automatic power off if system idle 1.5 min.
10oC to 40oC (50oF to 104oF),
15-95% relative maximum humidity
-20oC to 55oC (-4oF to 131oF),
15-95% relative maximum humidity
20 - 280 mmHg
40 - 200 beat per minute
50 mmHg -250 mmHg
30 mmHg -180 mmHg
40 - 200 beats / minute
280 mmHg
±3 mmHg or ±2% of the reading
±4% of the reading
mmHg
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