Alcedo B21 User manual

Blood Pressure Monitor
User Manual
Model : B21
Questions or Concerns? [email protected] [phone]

Table of Contents
Introduction and Intended Use
Important Information on Blood Pressure and its Measurement
Components of Your Blood Pressure Monitor
Using Your Monitor for the First Time
Measurement Procedure
Care and Maintenance
Warranty
Certifications
Technical Specifications
EMC Declaration
3
6
10
12
16
27
28
28
29
30
2

This manual is for B21 models. It is a fully au-
tomatic digital blood pressure measuring de-
vice for use by adults on the upper arm at home
or in your doctor’s/nurse’s office. It enables
very fast and reliable measurement of systol-
ic and diastolic blood pressure as well as pulse
through the oscillometric method. This device
offers clinically proven accuracy and has been
designed to be user friendly.
Before using, please read this instruction man-
ual carefully and then keep it in a safe place.
Please contact your doctor for further ques-
tions on the subject of blood pressure and its
measurement.
Only a health-care 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 cir-
cumstances 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 in-
strument on a child.
In cases of irregular heartbeat, measurements
made with this instrument should only be eval-
uated after consultation with your doctor.
Familiarize yourself with the section titled "Im-
portant Information on Blood Pressure and Its
Measurement". It contains important informa-
tion on the dynamics of blood pressure read-
ings and will help you to obtain the best re-
sults.
Warning：Not suitable for neonatal and
infants.
Warning：Not suitable forpeople who
cannot express their ideascorrectly.
This device cannot be used together with high
frequency surgical equipment.
Introduction and
Intended Use
Note:
3

Too frequent measurements can cause
injury to the PATIENT due to blood flow
interference.
Do not place the cuff over wound part.
Pressurization of the CUFF can temporari-
ly cause loss of function of simultaneously
used monitoring ME EQUIPMENT on the
same limb.
4
The device contains sensitive electronic com-
ponents. Avoid strong electrical or electromag-
netic fields in the direct vicinity of the device
(e.g. mobile telephones, microwave ovens).
These can lead to temporary impairment of the
measuring accuracy.
Do notuse cuffs, AC adapters or batteries
other than those included with this product or
replacement parts supplied by the manufac-
turer.
This system may fail to yield specified measure-
ment accuracy if operated or stored in tempera-
ture or humidity conditions outside the limits
stated in the specifications section of this man-
ual.
This device contains sensitive electronic com-
ponents. Avoid strong electrical or electromag-
netic fields in the direct vicinity of the device
(e.g. mobile telephones, microwave ovens)
during use. These can lead to erratic results.
Do not attempt to service or repair this device
yourself. Should a malfunction occur, refer to
local distributor or the manufacturer.
Note:
Use of this instrument on patients under dialysis
therapy or on anticoagulant, antiplatelets, or ste-
roids could cause internal bleeding.
Contraindication
Warnings and Precautions
Warning：
Host products, including accessories, shall
be processed in accordance with local regu-
lations after reaching the life cycle.

5
The separate ac adapter which is intended to
connect USB interface of Blood Pressure Mon-
itor has not been evaluated according to IEC
60601-1. The safety of the product shall be re-
appraised when it power supply by a separate
ac adapter.
Remove the battery if the ME EQUIPMENT is
not likely to be used for some time.
The usermust checkthat the equipment func-
tions safely and see that it is in proper working
condition before being used.
No modification of this equipment is allowed.
The device is not suitable for use in the pres-
ence of flammable anesthetic mixtures with
air or with oxygen or nitrous oxide.
This equipment shall not be serviced or main-
tained while in use with the patient.
The patient is an intended operator, the func-
tions of monitoring blood pressure and pulse
rate can be safely used by patient. The rou-
tine clean and changing batteries can be per-
formed by the patient.
Use of power adapters
Do not position the device to make it dif-
ficult to operate the disconnection device
while using adaptor.
Do not be prone to water leakage, high
temperature, moisture, direct sunlight or
more corrosive gas environment. Do not
use this product in the above environment.
To avoid any possibility of accidental strangu-
lation, keep this unit away from children and
do notdrape tubing around your neck.
To avoid damaging the device, keep this unit
away from children and pets.
The standard material used for the bladder
and tubing is latex-free.
Self-measurement means control, not diagno-
sis or treatment. Unusual values must always
be discussed with your doctor. Under no cir-
cumstances should you alter the dosages of
any drugs prescribed by your doctor.
The pulse display is not suitable for checking
the frequency of heart pacemakers!
In cases of irregular heartbeat, measurements
made with this instrument should only be
evaluated after consultation with your doctor.
Cautions:
Adapter: input 100-240v, 50/60hz output
DC 5V 1A.

To obtain the greatest accuracy from your blood pressure instrument, it is recommended that the in-
strument be used within the specified temperature and the relative humidity, please see the Techni-
cal Specifications.
The cuff is treated as the applied part. The user should contact the manufacturer for assistance, if
needed, in setting up, using or maintaining the device.
Your level of blood pressure is determined in the circulatory center of the brain and adjusts to a va-
riety of situations through feedback from the nervous system. To adjust blood pressure, the strength
and speed of the heart (Pulse), as well as the width of circulatory blood vessels is altered. Blood ves-
sel width is controlled by fine muscles in the blood vessel walls.
Your level of arterial blood pressure changes periodically during heart activity: During the “blood ejec-
tion” (Systole) the value is highest (systolic blood pressure value). At the end of the heart’s “rest peri-
od” (Diastole) pressure is lowest (diastolic blood pressure value).
Blood pressure values must lie within certain normal ranges in order to prevent particular diseases.
How Does High or Low Blood Pressure Arise?
Important Information on Blood Pressure and Its
Measurement
Note:
6

7
Please refer to the diagram below (Picture-01)
Which Values are Normal?
Optimal blood
pressure
(target value)
Normal blood pressure
High normal value
Mild hypertension
Moderate hypertension
Severe hypertension
120
80
85
90
100
110
130 140 160 180
Diastolic blood
pressure (mmHg)
Systolic blood
pressure (mmHg)
Picture-01

8
There are six grids in the display of device. Please refer to the Table-01. Different grids represent
different interval scales of WHO.
Blood pressure is very high if your diastolic pressure is above 90 mmHg and/or your systolic blood
pressure is over 160 mmHg, while at rest. In this case, please consult your physician immediately.
Long-term values at this level endanger your health due to continual damage to the blood vessels
in your body. If your systolic blood pressure values are between 140 mmHg and 159 mmHg and/or
the diastolic blood pressure values between 90 mmHg and 99 mmHg, consult your physician. Regu-
lar self-checks are necessary.
Blood Pressure Value WHO Grids in Device WHO Classification
DIA <80 & SYS <120 1 Optimal blood pressure
DIA <85 & SYS <130 2 Normal blood pressure
DIA <90 & SYS <140 3 High normal value
DIA <100 & SYS < 160 4 Mild hypertension
DIA <110 & SYS <180 5 Moderate hypertension
DIA >=110 or SYS >=180 6 Severe hypertension
Table-01

9
If you have blood pressure values that are too
low, (i.e., systolic values under 105 mmHg and/or
diastolic values under 60 mmHg), consult your
physician. Even with normal blood pressure val-
ues, a regular self-check with your blood pres-
sure monitor is recommended. You can detect
possible changes in your values early and re-
act 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 physician. Nev-
er use the results of your measurements to in-
dependently alter the drug doses prescribed by
your physician.
If your values are mostly normal under resting
conditions but exceptionally high under condi-
tions of physical or psychological stress, it is
possible that you are suffering from so-called
“labile hypertension.” Consult your doctor.
Correctly measured diastolic blood pressure
values above 120mmHg require immediate
medical treatment.
Further Information
What Can be Done if Regular High
or Low Values are Obtained?
Consult your doctor.
Increased blood pressure values (various
forms of hypertension) are associated with
considerable health risks over time. Arterial
blood vessels in your body are endangered
due to constriction caused by deposits in the
vessel walls (Arteriosclerosis). A deficient
supply of blood to important organs (heart,
brain, muscles) can result from arterioscle-
rosis. Furthermore, the heart will become
structurally damaged with increased blood
pressure values.
There are many different causes of high
blood pressure. We differentiate between
the common primary (essential) hyperten-
sion, and secondary hypertension. The latter
group can be ascribed to specific organ mal-
functions. Please consult your doctor for in-
formation about the possible origins of your
own increased blood pressure values.
There are measures which you can take to re-
duce and even prevent high blood pressure.

10
Components of Your Blood
Pressure Monitor
DC
5
V
SET
MEM
START
STOP
LCD Display
Air Hose
Artery Mark
Air Plug
Cuff
Micro USB Power Cable
Memory Button
Start / Stop Button
Set Button
AC Adapter Port
Battery Compartment
Cuff Connector Port
Speaker
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
A
B
DE
I
G
H
K L
M
J
C
F
Picture-02

11
Systolic Blood Pressure
Diastolic Blood Pressure
Heartbeat Symbol (Flashes
During Measurement)
Irregular Heartbeat Symbol
Memory Symbol
Date/Time Display
USER A
USER B
Movement Error Symbol
Mute Symbol
Average Value Symbol
Low Battery Symbol
Cuff Self-Checking Function
Pulse Unit Symbol
WHO Function Symbol
The Symbols on the LCD Display
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Picture-03
1
2
3
4
5
613
14
15
78 9 10 11 12

12
Features of Model B21
Use only 1.5V “AAA” alkaline batteries with this
device.
Note: Arm circumference should be measured with a measuring tape in the middle of the relaxed upper
arm. Do not force cuff connection into the opening. Make sure the cuff connection is not pushed into the
AC adapter port.
Using Your Monitor for
the First Time
Double users:
2 x 120 sets memory
Average value
function
Cuff self-checking
function
Low battery display
Talking function Irregular heartbeat
checking
Date/time
display
Volume
adjustment
WHO function Auto power-off
Large LCD
Display
External power
adapter support
Battery Installation
Press the hook on the bottom of the battery
cover and lift the cover off in the direction of
the arrow.
Install 4 “AAA” size batteries so the + (posi-
tive) and - (negative) polarities match the po-
larities of the battery compartment, replace
the battery cover. Make sure that the battery
cover is securely in position.
1.
2.

13
Battery Replacement
Low Battery Indicator
When the Low Battery Indicator appears on
the display, turn the monitor off and remove all
the batteries. Replace with 4 new batteries at
the same time. Long-life alkaline batteries are
recommended.
To prevent the damage of monitor from leaked
battery fluid, please take out of battery if the
monitor unused in a long time (generally more
than 3 months). If battery fluid get in your eyes,
immediately rinse with plenty of clean water.
Contact a physician immediately.
Attached battery is only for testing the func-
tion of the monitor. Long-life alkaline batter-
ies are recommended.
1.
2.
3.
Dispose of the device, components and op-
tional accessories according to applicable lo-
cal regulations. Unlawful disposal may cause
environmental pollution.
Battery is dangerous stuff, do not mix it with
other rubbish.
4.
5.
Micro USB Power Cable
Make sure the power cable is not damaged.
Plug the cable into the power socket on the
right side of the blood pressure monitor.
Plug the USB into a 5V powered USB port.
You may also use the monitor with the 5V micro
USB power cable. Only use an approved micro
USB power cable to avoid damaging the moni-
tor.
1.
2.
3.
DC
5 V
DC
5V
SET
MEM
START
STOP
DC
5
V
DC
5 V
START
STOP
SET
MEM

14
No battery power is consumed while the mi-
If electrical power is interrupted (such as by
power socket), the monitor must be reset by
removing the power cable from the power
socket on the monitor and reinserting it.
Press the SETbutton and hold it for morethan
3 SECONDS. The User symbol will then flash.
Set User, Date and Time, and Talking Volume
follow the steps below.
Note:
Press the MEM button to select User A or
User B.
Then press SET button to confirm.
1.
2.
System Settings
Setting the User:
Setting the Year:
When the year display is flashing, press the MEM
button, the year will increase by 1 year each, hold
the MEM button and it will increase continuously
1 by 1, and then rollover to initial year, once the
year set is OK, press SET button to confirm.
Setting Month/Date:
Initial Month/Date is 1/01, when the Month display
is flashing, press the MEM button, the month will
increase by 1, press SET button to confirm, and
follow the same way to set the date. Press SET
button to confirm.

15
Setting Time:
When the hour display is flashing, press the MEM button, the hour will increase by 1, press SET button
to confirm, and follow the same way to set the minute. Press SET button to confirm.
Setting Volume:
When display with SP is flashing, press MEM but-
ton to switch volume 1, volume 2, volume 3 or OFF.
Press SET button to confirm.
Delete All Saved Results:
Select a user. Press MEM button to display results.
Press and hold again until all measurements turn
0.
Month TimeYear

16
You can’t delete individual results. All results
will be deleted at once.
Taking out the batteries will not delete saved
results. However, it will reset some of your set-
tings, such as date, time, and speaker volume.
Note:
Insert the cuff tube into the opening on the left
side of the monitor indicated by the drawing of a
cuff.
Cuff Tube Connection
Measurement Procedure
Note: You should always be seated and calm be-
fore and during 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 ten minutes before taking
a measurement.
Remove any garment that fits closely to your
upper arm.
Always measure on the same arm (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.
Before Measurement:
START
STOP
SET
MEM

Note: Comparable blood pressure measurements
always require the same conditions.
Common Sources of Error:
17
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 high-
er than the heart, an erroneously high or low
blood pressure will be measured. Each 25-30
cm difference in height between your heart
and the cuff results in a measurement error of
10 mmHg.
Cuffs that are too narrow or too short result in
false measurement values. Selecting the correct
cuff is extremely important. Cuff size is depen-
dent upon the circumference of the arm (mea-
sured in the center). The permissible range is
printed on the cuff.
16
A loose cuff or a sideways protruding air pocket
causes false measurement values.
With repeated measurements, blood accumu-
lates 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 mea-
surement again, be sure to wait at least one
minute beforehand.
Cuff works under the pressure range 0-300 mmHg.
The wide range rigid cuff is: 8.7” – 15.7” (22 - 40
cm).
Note: Only use approved cuffs!

18
1.
2.
3.
4.
5.
6.
The cuff is pre-formed for easier use. Remove
tight or bulky clothing from your upper arm.
Wrap the cuff around your upper left arm. The
rubber tube should be on the inside of your
arm extending downward to your hand. Make
certain the cuff lies approximately 1/2” to 3/4”
(2 to 3 cm) above the elbow.
Important! The on the edge of the cuff
(Artery Mark) must lie over the artery which
runs down the inner side of the arm.
To secure the cuff, wrap it around your arm and
press the hook and loop closure together.
There should be little free space between your
arm and the cuff. You should be able to fit 2
fingers between your arm and the cuff. Cuffs
that don’t fit properly result in false measure-
ment values. Measure your arm circumference
if you are not sure of proper fit.
Lay your arm on a table (palm upward) so the
cuff is at the same height as your heart. Make
sure the tube is not kinked.
Remain seated quietly for at least two minutes
before you begin the measurement.
Picture-04
Please refer to Picture-04
Fitting the Cuff

19
Picture-05
Select your User ID (A or B).
Press the START/STOP button. The pump be-
gins to inflate the cuff. In the display, the in-
creasing cuff pressure is continually dis-
played.
After automatically reaching an individual
pressure, the pump stops and the pressure
slowly falls. The cuff pressure is displayed
during the measurement.
When the device has detected your pulse, the
heart symbol in the display begins to blink.
1.
2.
3.
4.
When the measurement has been concluded,
the measured systolic and diastolic blood
pressure values, as well as the pulse will be
displayed.
5.
Sit comfortably in a chair with your feet flat on
the floor. Stretch your arm forward on the desk
and keep relaxing, make sure the palm of hand
is upturned. Make sure arm is in correct position,
to avoid body movement. Sit still and do not talk
or move during the measurement. After the cuff
has been appropriately positioned on the arm
and connected to the blood pressure monitor, the
measurement can begin:
Please refer to Picture-05
Measure Procedure

20
When the monitor is OFF, press the SET but-
ton. The time and user symbol will display.
Press SET button to turn on the mute.
Press the SET button again to turn off the
mute.
1.
2.
3.
Press SET button and hold it for more than 3
seconds until the User Symbol flash.
Press MEM button to select user A or B.
Then press START/STOP button to turn off
the device.
Mute/Unmute
Switch User
Memory
Press the MEM button. Select a user (A or B).
The first display reading with AVG symbol
is the average of the last 3 results.
Press MEM again to view each result, begin-
ning with the most recent measurement taken.
Press MEM again to view the next result.
Alternatively, press and hold MEM to scroll to
any result.
If it is necessary to interrupt a blood pressure
measurement for any reason (e.g the patient feels
unwell), the START/STOP button can be pressed
at any time. The device then immediately lowers
the cuff pressure automatically.
Discontinuing a Measurement
1.
2.
3.
4.
5.
Viewing the Stored Values
At the end of a measurement, this monitor auto-
matically stores each result with date and time.
Each unit stores 120 sets measurements for 2 us-
ers, totally 240 sets (User A and B).