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