Alcedo AE174 User manual

Pulse Oximeter AE174 (OLED)
Date of Issue: 2019.11, Version: V1.0
Precauons
Do not aempt to maintain the Oximeter unless you are professional engineers. Only professionals with
maintenance qualicaon are allowed to perform interior maintenance necessary.
Periodically change the contact posion between the Oximeter probe and the nger for a measurement
that lasts a long me. Adjust the posion of the probe before the measurement lasts two hours, and check
the integrity of skin, the blood circulaon condion of the ger as well as the posion of the nger.
This product is not applicable to the examinaon of newborn babies.
Seek for medical care in me if the measured value goes beyond the normal range while you are sure that
the instrument does not malfuncon.
Do not directly expose your eyes to light-emig components of the Oximeter, as that could cause harm
to your eyes.
For details about clinical limitaons and contraindicaons, please carefully consult relevant medical
literatures.
The following factors may cause disturbance to or aect the accuracy of examinaon:
This product is used in an environment involving high-frequency devices, such as high-frequency electric
knives and CT apparatuses.
The probe of the Oximeter is placed on the same body part or limb as with blood pressure cuarterial
duct or intravenous injecon.
The user suers from hypotension, severe vascular atrophy, severe anemia, or low oxygen.
The user is in sudden cardiac arrest or shock state.
The ger with nail polish or a fake ngernail may cause wrong readings of pulse oxygen saturaon.
Warnings
Warning: Do not use the Oximeter in an environment with any ammable gases, ammable anesthec, or other
ammable substances.
Warning: Keep unit and lanyard away from children as the included lanyard may present an entanglement or choking
hazard to small children. Adult supervision required; never leave children unaended with unit or lanyard
Warning: Do not throw the baeries into re, as that could cause an explosion.
Warning: Do not aempt to charge the included baeries, as that could cause leakage, re disaster, or even
explosion. Dispose the used baeries in accordance to the local laws and regulaons.
Warning: Do not use the Oximeter in an MRI or CT environment.
Warning: Do not operate the Oximeter if it is wet. Avoid moving the oximeter from a cold to a hot and humid
environment.
Warning: Install the baeries properly before powering on the Oximeter for normal use. Please remove the baeries
if you are not planning to use the Oximeter for a long me.
Warning: Close the baery cover when the instrument is in use.
Warning: The paent is an intended operator.
Warning: Do not modify the device and use the device for other purposes.
Warning: The Funconal tester cannot be used to evaluate the accuracy of pulse oximetry probes or pulse
oximetry monitors.
Product Accessories
1.One lanyard;
2.Carrying case;
2.Two AAA baeries;
3.One user manual;
4.One quick start guide
Symbol Convenons
Symbol
Descripon
Type BF applied part
Cauon: Please see this manual.
%SpO2
Symbol of oxygen saturaon.
bpmPR
Symbol of pulse rate.
No SpO2alarms.
Consult the instrucons for use.
IP22 The degree of protecon against harmful ingress of water and parculate maer.
When end users abandon this product, they must send the product to the collecon
place for recycling.
Overview
Oxygen saturaon is the percentage of oxyhemoglobin (HbO2) that is combined with oxygen against all combinable
hemoglobin (Hb). It is an important physiological parameter involved in respiraon and circulaon. The oxygen
saturaon of arterial blood in a normal human body is 98%. Oxygen saturaon is an important indicator of the
oxygen condion in the human body. In general, the normal values of oxygen saturaon shall not be lower than 94%.
If the measured value of oxygen saturaon is lower than 94%, an insucient supply of oxygen is considered.
The pulse rate is the number of pulse beats per minute. Normally, the pulse rate is consistent with the heart rate. In
general, the pulse rate of every people is 60 to 90 beats per minute.
The Perfusion Index (PI) usually reects the limb perfusion status of an examined paent, and shows the detecon
precision of the instrument as well; that is, examinaon can s be performed even in the low or weak perfusion
condion. The PI of a normal human body is 3% or greater.
Working Principles, Expected Usage, and Applicable Scope
Based on full digital technology, the Finger Pulse Oximeter non-invasively measures the actual content (oxygen
saturaon) of oxyhemoglobin (HbO2) in arterial blood using the opcal transmiance method.
The Finger Pulse Oximeter measures the blood oxygen saturaon and pulse rate of a human body via ger artery. It
is applicable to a wide range of elds, such as families, oxygen bars, and sports & health. Use this instrument for
measurement before or aer sports. You are not advised to use this instrument during sports acvies.
Appearance of the structure
Screen Display
The following gure shows the informaon display on the OLED screen of the Oximeter in normal detecon state:
Power-On buon/Funconal buon Operaons
Press and release the buon to turn on, hold the buon for about one second. The Oximeter shows a parameter
seng interface. Press or hold the buon to perform corresponding operaons. Hold it to set an item, or press it to
switch an opon. Press means no more than 0.5 seconds, while Hold means more than 0.5 seconds.
Alert Sound Seng
Hold the funconal buon while the Oximeter is in powered-on state. Parameter seng interface 1 is displayed, as
shown in the following gure. Move "*" to the corresponding opon, and hold the funconal buon to set Alm to on
and set Beep to o. When Alm is set to on and the measured values of the blood oxygen saturaon and pulse rate
go beyond the upper limit or lower limit, the Oximeter gives oan alert sound. When Alm is set to off and the
measured values go beyond the limit, the Oximeter will not give any alert sound. When Beep is set to on, a ck will
be heard along with pulse beats during pulse rate measurement. When Beepis set to o, no sound will be output
along with pulse beats during pulse rate measurement. While the "*" symbol stays on the Restore opon, hold the
funconal buon to restore factory sengs.
Brightness Seng
On parameter interface 1, press the funconal buon to select the Brightness opon and then hold the funconal
buon to set the brightness to a value ranging from 1 to 5. The greater the value, the greater the brightness of the
screen.
Alert Range Seng
On parameter interface 2, press the funconal buon to switch between opons. On this interface, you can set the
upper limit and lower limit of SpO2 Alm and PR Alm. While the "*" symbol stays on the +/- opon, hold the
funconal buon to set the opon to +or -. In +mode, select the corresponding opon and hold the funconal
button to increment the upper or lower limit; in -mode, hold the funconal buon to decrement the upper or lower
limit. Move "*" to the Exit opon, and hold the funconal buon to return to the monitoring interface.
Interface 1 Interface 2
Operaon Guide
Sck one nger completely into the measuring parts of the Oximeter, keep the gernail surface upward, and release
the clip. Then press the power buon to power on the Oximeter.
If you do not yet completely insert your nger into the cavity, the
measurement result may be inaccurate.
Do not vibrate your nger during measurement. Preferably, ensure
that your body does not move. Aer the readings become stable, read
the measured values of oxygen saturaon and the pulse rate on the
screen.
NOTE: The Oximeter will automacally shut down 10 seconds later
aer your nger leaves away.
Replace the baeries when the baery capacity is insucient and the symbol ckers on the screen.
Open the baery coverwith your gers, you can replace the baeries according to the correct baery polarity.
Cleaning
Power othe instrument and remove the baeries before cleaning. Ensure that the appearance of the instrument is
neat, dust-free, and dirt-free. Clean the outer surface of the instrument (including the OLED screen) using 75%
medical alcohol and a piece of dry socloth.
Cauon: Avoid liquid owing into the instrument during cleaning.
Caution: Do not immerse any part of the instrument into any liquid.
Disinfecon
Before measurement with the instrument, wipe the rubber ger pad using a piece of dry socloth dipped with 75%
medical alcohol. Clean the nger to be measured using the medical alcohol for disinfecon purposes before and aer
use.
Do not disinfect the instrument by means of high-temperature /high-pressure or gas disinfecon.
Maintenance
Remove the baeries from the baery slot and properly store them if you do not plan to use the Oximeter for
a long period of me.
Avoid using the Oximeter in an environment with inammable gases or using it in an environment where the
temperature or humidity is excessively high or low.
Check the accuracy of the oxygen saturation and pulse rate readings by using an appropriate calibraon
apparatus.
Technical Specicaons
1. Dimensions: 58.2 mm (Width) ×32.2 mm (Depth) ×32.0 mm (Height)
Weight: 51.5 g (without baeries)
2. Peak wavelength range of the light emied from the probe: red light 660 nm ±3; infrared light 905 nm ±5.
3. Maximum opcal output power of the probe: 1.2 mW for infrared light (905 nm).
4. Manufacturing date: see the label
5. Normal working condion
Working Temperature
5 C to 40 C (41 F to 104 F)
Relave Humidity
15% to 80%, non-condensing
Atmospheric Pressure
70 kPa to 106 kPa
Rated Voltage
DC 3.0 V
6. Default values and condions of alert
Parameter
Value
Oxygen saturaon
Upper limit: 100
Lower limit: 94
Pulse rate Upper limit: 130
Lower limit: 50
Alert condion
When the alert switch is on and the actual measured
value goes beyond the preset alert parameter range, the
Oximeter gives an alert sound.
7. Technical parameters
V2.12
Alm setup *
Alm on
Beep off
Demo off
Restore ok
Brightness 4
Exit
V2.12
Sounds Setup *
SpO2 Alm Hi 100
SpO2 Alm Lo 94
PR Alm Hi 130
PR Alm Lo 50
+/- +
Exit

Safety Type
An-electric-shock type: internal power supply device
An-electric-shock degree: Type BF applied part
Running mode: conous working
Waterproof grade: IP22
Storage and Transportaon
Temperature : –10 C - 50 C(14 -122 )
Relave humidity : 10%-93% (no condensaon)
Atmospheric pressure : 50kPa–106 kPa.
Aer-sale Service
Aer-sale service unit: Nature Major Inc.
Address: 315 W 36th Street, New York, NY 10018
[e-mail]
Website: www.alcedohealth.com
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES
Guidance and manufacturer’s declaraon — electromagnec immunity
The device is intended for use in the electromagnec environment specied below. The customer or the
user of the device should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnec
environment-guidance
Electrostac
discharge (ESD)
lEC61000-4-2
±6kV
contact
±8kV air
±6kV contact
±8kV air
Floors should be wood , concrete or ceramic le. If
oors are covered with
synthec material, the relave humidity should be at
least 30%
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for
power
supply
lines
± 1 kV
Input/
output line
not applicable
not applicable
(For INTERNALLY POWERED ME EQUIPMENT)
Surge
IEC 61000-4-5
± 1 kV
Dierena
l mode
voltage
± 2 kV
not applicable
not applicable
(For INTERNALLY POWERED ME EQUIPMENT)
Common
mode
voltage
Voltage dips,
short
interrupons
and voltage
variaons on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
not applicable
not applicable
(For INTERNALLY POWERED ME EQUIPMENT
Power
frequency
(50Hz/60Hz)
magnec eld
IEC 61000-4-8
3A/m 3A/m Power frequency magnec elds should be at levels
characterisc of a typical location in a typical
commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaraon – electromagnec immunity
The device is intended for use in the electromagnec environment specied 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 Electromagnec environment - guidance
Radiated
RF
IEC
61000-4-3
3 V/m
80
MHz
to 2.5
GHz
3 V/m
Portable and mobile RF communicaons equipment should be
used no closer to any part of the Blood Pressure Monitor,
including cables, than the recommended separaon distance
calculated from the equaon applicable to the frequency of the
transmier.
Recommended separaon distance
Pd 2.1
Pd 2.1
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rang of the transmier
in was (W) according to the transmier manufacturer and d is
the recommended separaon distance in metres (m).
Field strengths from xed RF transmiers, as determined by an
electromagnec site survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with
the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situaons. Electromagnec propagaon is aected by
absorpon and reecon from structures, objects and people.
a Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theorecally with accuracy. To assess the electromagnec environment due to xed RF transmiers, an
electromagnec site survey should be considered. If the measured eld strength in the locaon in which the
Blood Pressure Monitor is used exceeds the applicable RF compliance level above, the Blood Pressure
Monitor should be observed to verify normal operaon. If abnormal performance is observed, addional
measures may be necessary, such as reorienng or relocag the Blood Pressure Monitor.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [Vi] V/m.
Recommended separaon distances between portable and mobile RF communicaons equipment and the
device.
The device is intended for use in an electromagnec environment in which radiated RF disturbances are
controlled. The customer or the user of the device can help prevent electromagnec interference by
maintaining a minimum distance between portable and mobile RF communicaons equipment
(transmiers) and the device as recommended below, according to the maximum output power of the
communicaons equipment.
Maximum
output power of
transmier
(W)
Separaon distance according to frequency of transmier
(m)
80 MHz to 800
MHz
Pd 2.1
800 MHz to 2.5
GHz
Pd 2.1
800 MHz to 2.5
GHz
0.01
/
0.12
0.23
0.1
/
0.38
0.73
1
/
1.2
2.3
10
/
3.8
7.3
100
/
12
23
For transmiers rated at a maximum output power not listed above, There commended separaon distance
d in meters(m) can be esmated using the equaon applicable to the frequency of the transmier, where P
is the maximum output power rang of the transmier in was(W) accordable to the transmier
manufacturer.
NOTEI At 80 MHz and 800 MHz. the separaon distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situaons. Electromagnec propagaon is aected by
absorpon and refecon from structures, objects and people.
Distributed by:
NATURE MAJOR INC.
500 7th Ave
New York, NY 10018
E-mail: [e-mail]
Web: www.alcedohealth.com
Parameter
Value
Display range Oxygen saturaon 35% to 100%
Pulse rate
25 bpm to 250 bpm
Resoluon
Oxygen saturaon
1%
Pulse rate
1 bpm
Measurement
precision
Oxygen saturaon
±2% (70% to 100%)
No requirement ( 69%)
Pulse rate
±2 bpm
Alert range
Oxygen saturaon
Upper limit: 50% to 100%
Lower limit: 50% to 100%
Pulse rate
Upper limit: 25 bpm to 250 bpm
Lower limit: 25 bpm to 250 bpm
Alert error
Oxygen saturaon
±1% of the preset value
Pulse rate
The greater of ±10% of the preset value and ±5 bpm
PI
Weak PI
Min. 0.3%
Guidance and manufacturer’s declaraon - electromagnec emissions
The device is intended for use in the electromagnec environment specied below. The customer or the
user assure that it is used in such an environment.
Emissions test
Compliance
Electromagnec environment - guidance
RF emissions
CISPR11
Group 1 The devuce device use RF energy only for its internal funcon.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR11
Class B
The device is suitable for use in all establishments other than
domesc and those directly connected to the public low-voltage
power supply network that supplies buildings used for domesc
purposes
Harmonic
emissions
lEC61000-3-2
Not applicable
Voltage
ctuaons/
Ficker
emissionslEC6100
0-3-3
Not applicable