AE176 User Manual EU

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Blood Pressure Monitor SET

T
STAR P
STO

Model : AE176 MEM

User Manual

Questions or Concerns? [email protected] (833)682-8655


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

2
Introduction and Note:

Intended Use Only a health-care professional is qualified to


interpret blood pressure measurements.
This manual is for AE176 models. It is a fully au- This device is not intended to replace regular
tomatic digital blood pressure measuring de- medical checkups.
vice for use by adults on the upper arm at home It is recommended that your physician review
or in your doctor’s/nurse’s office. It enables your procedure for using this device.
very fast and reliable measurement of systol- Blood pressure readings obtained by this
ic and diastolic blood pressure as well as pulse device should be verified before prescribing
through the oscillometric method. This device or making adjustments to any medications
offers clinically proven accuracy and has been used to control hypertension. Under no cir-
designed to be user friendly. cumstances should you alter the dosages of
any drugs prescribed by your doctor.
Before using, please read this instruction man- This monitor is intended for use by adults only.
ual carefully and then keep it in a safe place. Consult with a physician before using this in-
Please contact your doctor for further ques- strument on a child.
tions on the subject of blood pressure and its In cases of irregular heartbeat, measurements
measurement. made with this instrument should only be eval-
uated after consultation with your doctor.
Warning:Not suitable for neonatal and Familiarize yourself with the section titled "Im-
infants. portant Information on Blood Pressure and Its
Warning:Not suitable for people who Measurement". It contains important informa-
cannot express their ideas correctly. tion on the dynamics of blood pressure read-
This device cannot be used together with high ings and will help you to obtain the best re-
frequency surgical equipment. sults.

3
Host products, including accessories, shall Contraindication
be processed in accordance with local regu- Use of this instrument on patients under dialysis
lations after reaching the life cycle. therapy or on anticoagulant, antiplatelets, or ste-
roids could cause internal bleeding.
Note:
Warnings and Precautions
This device contains sensitive electronic com-
ponents. Avoid strong electrical or electromag- The device contains sensitive electronic com-
netic fields in the direct vicinity of the device ponents. Avoid strong electrical or electromag-
(e.g. mobile telephones, microwave ovens) netic fields in the direct vicinity of the device
during use. These can lead to erratic results. (e.g. mobile telephones, microwave ovens).
Do not attempt to service or repair this device These can lead to temporary impairment of the
yourself. Should a malfunction occur, refer to measuring accuracy.
local distributor or the manufacturer. Do not use cuffs, AC adapters or batteries
other than those included with this product or
Warning: replacement parts supplied by the manufac-
turer.
Too frequent measurements can cause This system may fail to yield specified measure-
injury to the PATIENT due to blood flow ment accuracy if operated or stored in tempera-
interference. ture or humidity conditions outside the limits
Do not place the cuff over wound part. stated in the specifications section of this man-
Pressurization of the CUFF can temporari- ual.
ly cause loss of function of simultaneously
used monitoring ME EQUIPMENT on the
same limb.

4
The separate ac adapter which is intended to Do not position the device to make it dif-
connect USB interface of Blood Pressure Mon- ficult to operate the disconnection device
itor has not been evaluated according to IEC while using adaptor.
60601-1. The safety of the product shall be re- Do not be prone to water leakage, high
appraised when it power supply by a separate temperature, moisture, direct sunlight or
ac adapter. more corrosive gas environment. Do not
Remove the battery if the ME EQUIPMENT is use this product in the above environment.
not likely to be used for some time.
The user must check that the equipment func- Cautions:
tions safely and see that it is in proper working To avoid any possibility of accidental strangu-
condition before being used. lation, keep this unit away from children and
No modification of this equipment is allowed. do not drape tubing around your neck.
The device is not suitable for use in the pres- To avoid damaging the device, keep this unit
ence of flammable anesthetic mixtures with away from children and pets.
air or with oxygen or nitrous oxide. The standard material used for the bladder
This equipment shall not be serviced or main- and tubing is latex-free.
tained while in use with the patient. Self-measurement means control, not diagno-
The patient is an intended operator, the func- sis or treatment. Unusual values must always
tions of monitoring blood pressure and pulse be discussed with your doctor. Under no cir-
rate can be safely used by patient. The rou- cumstances should you alter the dosages of
tine clean and changing batteries can be per- any drugs prescribed by your doctor.
formed by the patient. The pulse display is not suitable for checking
Use of power adapters the frequency of heart pacemakers!
Adapter: input 100-240v, 50/60hz output In cases of irregular heartbeat, measurements
DC 5V 1A. made with this instrument should only be
evaluated after consultation with your doctor.
5
Note:

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.

Important Information on Blood Pressure and Its


Measurement
How Does High or Low Blood Pressure Arise?
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.

6
Which Values are Normal?
Please refer to the diagram below (Picture-01)

Diastolic blood
pressure (mmHg)
Severe hypertension
110
Moderate hypertension
100
Mild hypertension
90
High normal value
85
Normal blood pressure
80
Optimal blood
pressure Systolic blood
(target value) pressure (mmHg)

120 130 140 160 180


Picture-01

7
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 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

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.

8
If you have blood pressure values that are too What Can be Done if Regular High
low, (i.e., systolic values under 105 mmHg and/or
or Low Values are Obtained?
diastolic values under 60 mmHg), consult your
physician. Even with normal blood pressure val- Consult your doctor.
ues, a regular self-check with your blood pres- Increased blood pressure values (various
sure monitor is recommended. You can detect forms of hypertension) are associated with
possible changes in your values early and re- considerable health risks over time. Arterial
act appropriately. If you are undergoing medical blood vessels in your body are endangered
treatment to control your blood pressure, keep due to constriction caused by deposits in the
a record of values along with time of day and vessel walls (Arteriosclerosis). A deficient
date. Show these values to your physician. Nev- supply of blood to important organs (heart,
er use the results of your measurements to in- brain, muscles) can result from arterioscle-
dependently alter the drug doses prescribed by rosis. Furthermore, the heart will become
your physician. structurally damaged with increased blood
pressure values.
Further Information There are many different causes of high
blood pressure. We differentiate between
If your values are mostly normal under resting the common primary (essential) hyperten-
conditions but exceptionally high under condi- sion, and secondary hypertension. The latter
tions of physical or psychological stress, it is group can be ascribed to specific organ mal-
possible that you are suffering from so-called functions. Please consult your doctor for in-
“labile hypertension.” Consult your doctor. formation about the possible origins of your
Correctly measured diastolic blood pressure own increased blood pressure values.
values above 120mmHg require immediate There are measures which you can take to re-
medical treatment. duce and even prevent high blood pressure.

9
Components of Your Blood
Pressure Monitor
C
A. Backlit Display
B. Air Hose B
C. Artery Mark
F
D E
D. Air Plug
A
E. Cuff
F. Micro USB Power Cable
G. Memory Button SET

H. Start / Stop Button STA


STO RT
P
J
I. Set Button ME
M 5
C
DV

J. AC Adapter Port M
K. Battery Compartment
I
L. Cuff Connector Port
H
M. Speaker
G
K L
Picture-02

10
The Symbols on the LCD Display

1. Systolic Blood Pressure


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

11
Features of Model AE176
Double users: Date/time Irregular heartbeat
Talking function
2 x 120 sets memory display checking

Average value
Low battery display WHO function Auto power-off
function

External power Cuff self-checking Volume Large Backlit


adapter support function adjustment Display

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 2. Install 4 “AAA” size batteries so the + (posi-
tive) and - (negative) polarities match the po-
the First Time larities of the battery compartment, replace
the battery cover. Make sure that the battery
Battery Installation cover is securely in position.
Use only 1.5V “AAA” alkaline batteries with this
device.

1. Press the hook on the bottom of the battery


cover and lift the cover off in the direction of
the arrow.

12
Battery Replacement 4. Dispose of the device, components and op-
tional accessories according to applicable lo-
Low Battery Indicator cal regulations. Unlawful disposal may cause
environmental pollution.
5. Battery is dangerous stuff, do not mix it with
other rubbish.

Micro USB Power Cable


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-
1. When the Low Battery Indicator appears on tor.
the display, turn the monitor off and remove all DC
SET
the batteries. Replace with 4 new batteries at 5V

STA
the same time. Long-life alkaline batteries are STO RT
P
recommended.
SET C
DV
5
STAR
STO T

2. To prevent the damage of monitor from leaked MEM ME


M
P

DCV
5

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. 1. Make sure the power cable is not damaged.
Contact a physician immediately. 2. Plug the cable into the power socket on the
3. Attached battery is only for testing the func- right side of the blood pressure monitor.
tion of the monitor. Long-life alkaline batter- 3. Plug the USB into a 5V powered USB port.
ies are recommended.

13
Note: 1. Press the MEM button to select User A or
No battery power is consumed while the mi- User B.
2. Then press SET button to confirm.
If electrical power is interrupted (such as by
Setting the Year:
power socket), the monitor must be reset by When the year display is flashing, press the MEM
removing the power cable from the power button, the year will increase by 1 year each, hold
socket on the monitor and reinserting it. the MEM button and it will increase continuously
1 by 1, and then rollover to initial year, once the
System Settings year set is OK, press SET button to confirm.
Press the SET button and hold it for more than
Setting Month/Date:
3 SECONDS. The User symbol will then flash.
Set User, Date and Time, and Talking Volume Initial Month/Date is 1/01, when the Month display
follow the steps below. is flashing, press the MEM button, the month will
increase by 1, press SET button to confirm, and
Setting the User: follow the same way to set the date. Press SET
button to confirm.

14
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.
Year Month Time

Setting Volume: Delete All Saved Results:


When display with SP is flashing, press MEM but- Select a user. Press MEM button to display results.
ton to switch volume 1, volume 2, volume 3 or OFF. Press and hold again until all measurements turn
Press SET button to confirm. 0.

15
Note:
You can’t delete individual results. All results
Measurement Procedure
will be deleted at once. Note: You should always be seated and calm be-
Taking out the batteries will not delete saved fore and during measurement.
results. However, it will reset some of your set-
tings, such as date, time, and speaker volume. Before Measurement:
Cuff Tube Connection Avoid eating and smoking as well as all forms
of exertion directly before measurement. These
Insert the cuff tube into the opening on the left factors influence the measurement result. Find
side of the monitor indicated by the drawing of a time to relax by sitting in an armchair in a quiet
cuff. atmosphere for about ten minutes before taking
a measurement.
SET
T
STAR P
Remove any garment that fits closely to your
STO
upper arm.
MEM

SET
Always measure on the same arm (normally
START P
STO left).
Always compare measurements taken at the
MEM

same time of day, since blood pressure changes


during the course of the day, as much as 20-40
mmHg.

16
Common Sources of Error: Cuff works under the pressure range 0-300 mmHg.
The wide range rigid cuff is: 8.7” – 15.7” (22 - 40
Note: Comparable blood pressure measurements cm).
always require the same conditions.
Note: Only use approved cuffs!
Conditions should always be quiet.
All efforts by the user to support the arm can A loose cuff or a sideways protruding air pocket
increase blood pressure. Make sure you are in causes false measurement values.
a comfortable, relaxed position and do not flex With repeated measurements,
16 blood accumu-
any of the muscles in the measurement arm lates in the arm, which can lead to false results.
during the measurement. Use a cushion for Consecutive blood pressure measurements
support if necessary. should be repeated after a 1 minute pause or
If the arm artery lies considerably lower or high- after your arm has been held up in order to
er than the heart, an erroneously high or low allow the accumulated blood to flow away. If
blood pressure will be measured. Each 25-30 you decide to take your Averaging Mode mea-
cm difference in height between your heart surement again, be sure to wait at least one
and the cuff results in a measurement error of minute beforehand.
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.

17
Fitting the Cuff
Please refer to Picture-04
1. The cuff is pre-formed for easier use. Remove
tight or bulky clothing from your upper arm.
2. Wrap the cuff around your upper left arm. The SET
T
STAR P

rubber tube should be on the inside of your


STO

MEM

arm extending downward to your hand. Make SET

START P
STO

certain the cuff lies approximately 1/2” to 3/4”


MEM

(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.
3. To secure the cuff, wrap it around your arm and
press the hook and loop closure together.
4. 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.
5. Lay your arm on a table (palm upward) so the
cuff is at the same height as your heart. Make Picture-04
sure the tube is not kinked.
6. Remain seated quietly for at least two minutes
before you begin the measurement.
18
Measure Procedure 5. When the measurement has been concluded,
the measured systolic and diastolic blood
Please refer to Picture-05
pressure values, as well as the pulse will be
Sit comfortably in a chair with your feet flat on displayed.
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:

1. Select your User ID (A or B).


2. 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.
3. After automatically reaching an individual
pressure, the pump stops and the pressure
slowly falls. The cuff pressure is displayed
during the measurement.
4. When the device has detected your pulse, the
heart symbol in the display begins to blink. Picture-05

19
Memory 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). 1. Press the MEM button. Select a user (A or B).
2. The first display reading with AVG symbol
Mute/Unmute is the average of the last 3 results.
3. Press MEM again to view each result, begin-
ning with the most recent measurement taken.
4. Press MEM again to view the next result.
1. When the monitor is OFF, press the SET but- 5. Alternatively, press and hold MEM to scroll to
ton. The time and user symbol will display. any result.
2. Press SET button to turn on the mute.
3. Press the SET button again to turn off the Discontinuing a Measurement
mute.
If it is necessary to interrupt a blood pressure
Switch User 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.
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.

20
Display Readings Irregular Heartbeat Indicator
The measurement results are displayed until you
switch the device off. If no button is pressed for
60 seconds, the device switches off automati- This will display if an irregular heartbeat is de-
cally. tected during measurement. The result may differ
from your normal basal blood pressure.
Cuff Placement Indicators
This indicator is only a caution. In most cases,
Cuff is placed correctly there is no cause for concern—simply repeat the
measurement. Stay relaxed, remain still, and
Cuff is placed incorrectly
avoid talking during measurement.
If If you see the irregular heartbeat indicator regu-
in, and check to see if the cuff is too lose or too larly (such as several times a week with measure-
tight. Adjust accordingly until is displayed. ments taken daily), contact your physician.

Movement Error Indicator Note: Patient Position


Comfortably seated
Legs uncrossed
This will display if the monitor has detected Feet flat on the floor
movement. Remove the cuff and wait 2-3 min- Back and arm supported
utes. Replae the cuff and measure again. Do not Middle of the cuff at the level of the right atri-
move during measurement. um of the heart

21
Recommended Use Methods
Recommend that the patient relax as much as Upper arm is not
possible and not talk during the measurement covered or pressed
by gusset
procedure.
Recommend that take a 5 min break between
Cuff and the
measurements. Please sit vertically heart are at
Any reading can be affected by the measurement and relax your body the same level
site, the position of the patient, exercise, or the
patient’s physiologic condition.
Performance of the automated sphygmoma-
nometer can be affected by extremes of tem-
perature, humidity and altitude.
To stop the inflation or measurement, push the
Relax the hand and
START/STOP button. The monitor will stop in- Height difference
palm is upwards
flating, start deflating, and will turn off. between the table
and the chair:
After the monitor has detected your blood pres- 20-30cm
sure and pulse rate, the cuff automatically de-
flates. Your blood pressure and pulse rate are
displayed.
The monitor will automatically turn off after one Picture-06
minute.

22
Display Error Readings
Symbol Cause Solution
Replace both batteries with new ones. Check the bat-
No display Weak battery or
tery installation for proper placement of the battery
appears improper placement
polarities.

Check if the pump is working or not. If it is working,


Sensor abnormal then the problem is sensor abnormal. Please send it to
the local distributor.
Check if the air releasing is too slow or not. If it is too
Monitor could not
slow, please check if there is any dust in the tube plug
detect pulse wave or
of the cuff and the cuff port in the device. If yes, please
cannot calculate the
clean and start the measurement again. If no, please
blood pressure data
send the device back to the local distributor.
Measurement result is
Occasionally - measure for one more time/Always -
abnormal (SYS≦45
send it to local distributor.
mmHg, DIA≦24 mmHg)

Too loose cuff or air


Tie the cuff correctly and make sure the air plug is
leakage (Cannot inflate to
properly inserted in the unit.
30 mmHg within 15 s)

The air tube is crimped Correct it and make the measurement again.

The sensor is sensing


great fluctuation in the Please keep quiet and don’t move.
pressure

23
Symbol Cause Solution
The pressure that the
sensor sensing is over Please send back to the local distributor.
the limit
The demarcation is incor-
rect or the device has not Please send back to the local distributor.
been demarcated

Trouble Shooting

Problem Check This Solution


Check the battery power Replace new batteries
No power
Check the polarity position Installation batteries correctly

Whether the plug is inserted Insert plug into the air socket tightly
No inflation
Whether move the arm when inflate Change a new cuff

Error and stop Whether the plug is broken or leak Keep the body peaceful
working
Check if chatting when measured Keep quite when measure

Whether the cuff wrap too loose Wrap the cuff tightly
Cuff leak
Whether the cuff broken Change a new cuff

Please contact the distributor if you can’t solve the problem. Do not disassemble the unit by yourself.

24
Symbol Descriptions
The following symbols may appear in this manual, on the Digital Blood Pressure Monitor, or on it's
accessories. Some of the symbols represent standards and compliances associated with the Digital
Blood Pressure Monitor and its use.

Authorized Representative in the Disposal: Do not dispose this product as


European Community unsorted municipal waste. Collection of
such waste separately for special treat
ment is necessary.
CE Mark: conforms to essential
requirements of the Medical
Follow instructions for use
Device Directive 93/42/EEC.

Date of manufacture. Put up

Manufacturer Fragile

Specifies serial number

Type BF applied part Avoid the sun

Direct current

No Sterilize requirement
Not category AP / APG equipment
Mode of operation: continuous
25
Replacing Batteries Do not allow batteries to run out of charge in-
side the monitor. This will damage the moni-
When it is time to replace the batteries, will tor. Always replace batteries once ap-
flash on the display. You cannot take any further pears on the display.
measurements and must replace the batteries. If you do not intend to use the device for a
week or more, always remove or recharge bat-
To Replace the Batteries: teries!
1. Turn the monitor upside down and remove Using the AC Adapter
the battery compartment cover.
2. Remove the batteries and insert new bat- You may also operate this monitor using the AC
teries. adapter (output 5V DC/1A with Micro USB plug).
3. Replace the battery compartment cover.
Note: AC Adapter is not included in this prod-
Note: uct. It is sold separately.

Use 4 new 1.5V AAA long-life, alkaline batter- Use only the approved AC adapter to avoid dam-
ies. If using reusable batteries, only use aging the unit.
“NiMH” reusable batteries.
Ensure that the AC adapter and cable are not
Taking out the batteries will reset the date and
damaged.
time but will not delete saved results. To reset
Plug the adapter cable into the AC adapter
the date and time, see Setting the Date and
port on the right side of the blood pressure
Time (page 14).
monitor.
Do not use batteries beyond their expiration
Plug the adapter into your electrical outlet.
date. If the monitor is not going to be used for
When the AC adapter is connected, no battery
a prolonged period the batteries should be re-
current is consumed.
moved.
26
Note: No power is taken from the batteries Handle the tube carefully. Do not pull on it. Do
while the AC adapter is connected to the moni- not allow the tubing to kink and keep it away
tor. If electrical power is interrupted, (e.g., by ac- from sharp edges.
cidental removal of the AC adapter from the out- Do not drop the monitor or treat it roughly in
let) the monitor must be reset by removing the any way. Avoid strong vibrations.
plug from the socket and reinserting the AC Never open the monitor! This invalidates the
adapter connection. manufacturer’s warranty.
Batteries and electronic instruments must be
Care and Maintenance disposed of in accordance with the locally ap-
plicable regulations, not with domestic waste.
Wash hands after each time measurement.
If one device is used by different patients, Accuracy Test
wash hands before and after each use. Sensitive measuring devices must be checked
Do not expose the device to either extreme for accuracy from time to time. We recommend a
temperatures, humidity, dust or direct sun- periodical inspection of your unit by an autho-
light. rized dealer every 1 year. Please turn to local dis-
The cuff contains a sensitive air-tight bubble. tributor or the manufacturer.
Handle this cuff carefully and avoid all types
of stress through twisting or buckling.
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. The cuff with bladder
must not be washed in a dishwasher, clothes
washer, or submerged in water.

27
Warranty Certifications
Your blood pressure monitor is guaranteed for 1 Device Standard
year against manufacturers’ defects for the orig-
This device is manufactured to meet the
inal purchaser only, from date of purchase. The
European blood pressure monitors:
warranty does not apply to damage caused by
IEC 80601-2-30 • IEC60601-1-11 • IEC60601-1
improper handling, accidents, professional use,
not following the operating instructions or alter-
ations made to the instrument by third parties. Electromagnetic compatibility:
Device fulfills the stipulations of the Interna-
Warranty only applies to the instrument. All ac- tional standard
cessories including the cuff are guaranteed for IEC60601-1-2
one year, USB charging cable is not included.
There are no user serviceable parts inside. Bat- Package Contents
teries or damage from old batteries is not covered
by the warranty. 1 × Blood Pressure Monitor
Note: According to international standards, your 1 × Cuff
monitor should be checked for accuracy every 4 x AAA Batteries
year. 1 x Micro USB Cable
1 x Storage Bag
1 × User Manual
1 × Quick Start Guide

28
Technical Specifications
Model AE176 Pulse 40 to 199 per minute
Weight 252.1 g (Batteries are not included) Cuff Pressure
<300 mmHg
Display Range
64*95 mm【2.52"x3.74"】
Display
LCD Digital Display Automatically stores the last 120
Memory measurements for 2 users
11.8 x 11x 5.7 cm /
Monitor Size (total 240)
4.65 x 4.33 x 2.24 inch
Cuff Measuring
8.7" – 15.7" (22 - 40 cm) 1 mmHg
Circumference Resolution

Temperature: 5°C - 40°C / Pressure within ± 3 mmHg


Operating Accuracy pulse ± 5 % of the reading
41°F – 104°F
Conditions
Relative Humidity: 15% - 93% a) 4*AAA batteries, 1.5 V
Power b) AC adapter INPUT:100-240 VAC
Storage and Temperature: -25°C to 70°C / Source
Shipping -13°F to 158°F 50/60 HZ OUTPUT:5V DC 1A
Conditions Relative Humidity: ≤ 93%
Automatically
Atmospheric 60 seconds
Power off
Pressure 70 kPa~106 kPa
Range Users Adult
Measuring
Oscillometric Expected
Method
Service Life of
the Device and 5 years
Pressure
Resistive Accessories
Sensor
Measuring SYS:60-230mmHg
Range Technical alterations reserved
DIA:40-130mmHg

29
EMC Declaration
1. This product needs special precautions regarding EMC and needs to be installed and put into service according
to the EMC information provided, and this unit can be affected by portable and mobile RF communications
equipment.
2. Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in in-
correct operation of the unit.
3. Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation.
4. Caution: This machine should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary. This machine should be observed to verify normal operation in the configuration in
which it will be used.

Guidance and manufacture’s declaration – electromagnetic emission


The device is intended for use in the electromagnetic environment specified below. The customer of the
user of the device should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance


The device use RF energy only for its internal function. There-
RF emissions CISPR 11 Group 1 fore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B
Harmonic emissions The device is suitable for use in all establishments, including
Not applicable domestic establishments other than domestic and those di-
IEC 61000-3-2
rectly connected to the public low-voltage power supply net-
Voltage fluctuations/ work that supplies buildings used for domestic purposes.
flicker emissions Not applicable
IEC 61000-3-3

30
Guidance and manufacture’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the us-
er of device should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Floors should be wood, concrete or ceramic


Electrostatic ±8 kV contact ±8 kV contact
tile. If floor are covered with synthetic ma-
discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV,
terial, the relative humidity should be at
IEC 61000-4-2 ±15 kV air ±15 kV air
least 30%.
±2 kV for power
Electrical fast
supply lines
transient/burst
±1 kV for input/output Mains power quality should be that of a typ-
IEC 61000-4-4 Not applicable
lines ical commercial or hospital environment.
Surge ± 1 kV line(s) to line(s)
IEC 61000-4-5 ± 2 kV line(s) to earth

Mains power quality should be that of a typ-


Voltage dips, short 0 % UT; 0.5 cycle
ical commercial or hospital environment. If
interruptions and at 0°,45°,90°, 135°,
the user of the device requires continued
voltage variations 180°, 225°, 270°, 315°
Not applicable operation during power mains interruptions,
on power supply 0 % UT ; 1 cycle
it is recommended that the device be pow-
input lines 70 % UT; 25/30 cycle
ered from an uninterruptible power supply
IEC 61000-4-11 0% UT; 250/300 cycle
or a battery.

31
Guidance and manufacture’s declaration – electromagnetic immunity

Power frequency Power frequency magnetic fields should


(50Hz/60Hz) 30 A/m 30 A/m be at levels characteristic of a typical lo-
magnetic field 50/60 Hz 50/60 Hz cation in a typical commercial or hospital
IEC 61000-4-8 environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacture’s declaration – electromagnetic immunity


The device is intended for use in the electromagnetic environment specified below. The customer or the
user of device should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Portable and mobile RF communications


3 Vrms equipment should be used no closer to any
150 kHz to 80 MHz part of the device, including cables, than
3 V RMS outside the the recommended separation distance cal-
Conducted RF culated from the equation applicable to the
ISM band, 6 V RMS Not applicable
IEC 61000-4-6 frequency of the transmitter.
in the ISM and
amateur bands
Recommended separation distance
80% AM at 1 kHz
d=0.35 √p
d=1.2 √p

32
Guidance and manufacture’s declaration – electromagnetic immunity

80 MHz to 800 MHz:d=1.2 √p


800 MHz to 2.7 GHz:d=2.3 √p
Where, P is the maximum output power
rating of the transmitter in watts (W) ac-
cording to the transmitter manufacturer and
10 V/m 10 V/m d is the recommended separation distance.
Radiated RF
80 MHz to 2.7 GHz 80 MHz to 2.7 GHz Field strengths from fixed RF transmitters,
IEC 61000-4-3
80% AM at 1 kHz 80% AM at 1 kHz as determined by an electromagnetic site
survey, should be less than the compliance

level in each frequency range. Inter-


ference may occur in the vicinity of equip-
ment marked with the following symbol:

At 80 MHz and 800 MHz, the higher frequency range applies.


These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

A. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an elec-
tromagnetic site survey should be considered. If the measured field strength in the location in which the
device is used exceeds the applicable RF compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the device.
B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

33
Recommended separation distances between
portable and mobile RF communications equipment and the device

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the device
as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter(m)


Rated maximum
output power of 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
transmitter
(W)

0.01 0.12 0.12 0.23


0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by a bsorption
and reflection from structures, objects and people.

34
Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user
of the device, should assure that it is used in such an environment.

Test Maximum Immunity


Band a) Distance
frequency Service a) Modulation a) power Test Level
(MHz) (m)
(MHz) (w) (V/m)

Pulse Modulation b)
385 380-390 TETRA 400 1.8 0.3 27
18 Hz
FM c)
450 430-470 GMRS 460, ±5 kHz deviation 2 0.3 28
FRS 460 1 kHz sine
710
LTE Band 13, Pulse Modulation b)
745 704 – 787 0.2 0.3 9
17 217 Hz
780

810 GSM 800/900,


TETRA 800,
Pulse Modulation b)
870 800 – 960 IDEN 820, 2 0.3 28
18 Hz
CDMA 850,
930 LTE Band 5

35
Guidance and manufacturer’s declaration - electromagnetic immunity

1720 GSM 1800;


CDMA 1900;
GSM 1900; Pulse Modulation b)
1845 1700 – 1990 2 0.3 28
DECT; 217 Hz
LTE Band 1, 3
1970 4, 25;UMTS

Bluetooth,
WLAN
Pulse Modulation b)
2450 2400 – 2570 802.11 b/g/n, 2 0.3 28
217 Hz
RFID 2450,
LTE Band 7
5240
WLAN 802.11 Pulse Modulation b)
5500 5100 – 5800 0.2 0.3 9
a/n 217 Hz
5785

Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC
61000-4-3.

a ) For some services, only the uplink frequencies are included.


b ) The carrier shall be modulated using a 50% duty cycle square wave signal.
c ) As an alternative to FM modulation. 50% pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case.

36
Guidance and manufacturer’s declaration - electromagnetic immunity

The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT,
and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance.
Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following
equation:

Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST
LEVEL in V/m.

38
Customer Support
If you have any questions or concerns about your product, please contact our helpful Customer
Support Team.*

Email: [email protected]
Toll-Free: (833)682-8655
www.AlcedoHealth.com

Support Hours
Monday-Friday 10:00 am – 4:00 pm EST

Distributed by:

Nature Major Inc.


500 7th Ave
New York, NY 10018

*Please have your order invoice and order ID ready before contacting Customer Support.

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