AE176 User Manual EU
AE176 User Manual EU
AE176 User Manual EU
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User Manual
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Introduction and Note:
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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.
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)
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There are six grids in the display of device. Please refer to the Table-01. Different grids represent
different interval scales of WHO.
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
J. AC Adapter Port M
K. Battery Compartment
I
L. Cuff Connector Port
H
M. Speaker
G
K L
Picture-02
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The Symbols on the LCD Display
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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
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.
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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.
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the same time. Long-life alkaline batteries are STO RT
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recommended.
SET C
DV
5
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DCV
5
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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
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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
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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
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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.
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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
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MEM
START P
STO
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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.
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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.
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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.
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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.
The air tube is crimped Correct it and make the measurement again.
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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
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.
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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.
Manufacturer Fragile
Direct current
No Sterilize requirement
Not category AP / APG equipment
Mode of operation: continuous
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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.
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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.
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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
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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
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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.
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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
31
Guidance and manufacture’s declaration – electromagnetic immunity
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
32
Guidance and manufacture’s declaration – electromagnetic immunity
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.
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.
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
35
Guidance and manufacturer’s declaration - electromagnetic immunity
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.
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:
*Please have your order invoice and order ID ready before contacting Customer Support.