Acare Technology AE-CX User manual

Instruction Manual
Finger type
Pulse Oximeter
No. AE-CX
Children
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube
12. Intravascular dyes such as indocyanine green or
methylene blue.
13. SpO2measurements may be adversely affected in
the presence of high ambient light. Shield the
sensor area (with a surgical towel, or direct sunlight,
for example) if necessary.
14. Excessive patient movement
15. High-frequency electrosurgical interference and
defibrillators
16. Venous pulsations
17. Placement of a sensor on an extremity with a blood
pressure cuff, arterial catheter, or intravascular line.
18. The patient has hypotension, severe
vasoconstriction, severe anemia, or hypothermia
19. The patient is in cardiac arrest or is in shock
20. Fingernail polish of false finernails may cause
inaccurate SpO2readings.
Follow local ordinances and recycling instructions
regarding disposal or recycling of the device and
device components, including batteries.
4. Product Properties
1. Operation of the product is simple and convenient
2. The product is small in volume, light in weight
(total weight is about 50g including batteries)
and convenient in carrying.
3. Power consumption of the product is low and
the two originally-equipped two AAA batteries
can be operated continuously for 30 hours.
4. Low voltage warning will be indicated in visual
window when battery voltage is so low that
normal operation of the oximeter might be
influenced.
5. The product will automatically be powered off
when no signal is in the product for longer
than 8 seconds.
5. Product Operation Scope
The finger type pulse oximeter can be used to
measure human Haemoglobin Saturation and heart
rate through finger. The product is suitable for use in
family, hospital (including clinical use in internist/
surgery, Anaesthesia, paediatrics, intensive care and
etc.) Oxygen Club, social medical organizations,
physical care in sports (It can be used before or after
sports. Operation in sport procedure is not
recommended) and etc. The product is not suitable
to monitor patient continuously.
6. Operation Instructions
1. Install two AAA batteries into battery cassette
before covering its cover.
2. Nip the clamp as diagram.
3. Plug one of fingers into rubber hole of the
Oximeter (it is best to plug the finger thoroughly)
before releasing the clamp.
4. Press the switch once on front panel.
5. Your finger do not tremble during the Oximeter is
working. Your body is not recommended in
moving status.
6. Read correspondent datum from
display screen.
7. Six display modes
After turn on the oximeter, each time you
press the power switch, the oximeter
will switch to another display mode.
There are 6 display modes shown
as follows:
1. 2.
3. 4.
5. 6.
7. Brief Description of Front Panel
It is apparent the heart rate bargraph display
corresponds with pulse rate.
When you press the power switch for a long time
(more than one second), the brightness of the
oximeter will be changed by degrees, there are
10 levels on brightness; the default level is level
four.
Declaration: Please use the medical alcohol to
clean the rubber touching the finger inside of
Oximeter, and clean the test finger using
alcohol before an after each test. (The rubber
inside os the Oximeter belongs medical
rubber, which has no toxin, and no harmful to
the skin of human being).
When your finger is plugged into the Oximeter,
your nail surface must be upward.
PULSE OXIMETER
Low power indicator
SpO2waveform
Power Switch
PR Bar graph
SpO2Pulse Rate
3. Precautions for use
1. Do not use the pulse oximeter in an MRI
or CT environment.
2. Do not use the pulse oximeter in situations
where alarms are required. The device
has no alarms.
3. Explosion hazard: Do not use the pulse
oximeter in an explosive atmosphere.
4. The pulse oximeter is intended only as an
adjunct in patient assessment. It must be
used in conjunction with other methods of
assessing clinical signs and symptoms.
5. Check the pulse oximeter sensor application
site frequently to determine the positioning
of the sensor and circulation and skin
sensitivity of the patient.
6. Do not stretch the adhesive tape while
applying the pulse oximeter sensor. This
may cause inaccurate read the manual.
7. Before use, carefully read the manual.
8. The pulse oximeter has no SpO2alarms; it is
not for continuous monitoring, as indicated
by the symbol.
9. Prolonged use or the patient’s condition may
require changing the sensor site periodically.
Change sensor site and check skin integrity,
circulatory status, and correct alignment at
least every 4 hours.
10. Inaccurate measurements may be caused
by autoclaving, ethylene oxide sterilizing, or
immersing the sensors in liquid may cause
inaccurate readings.
11. Significant levels of dysfunctional
hemoglobins (such as carbonxy-hemoglobin
or methemoglobin)
1. Product Intended Use
2. Measurement principle
Intended Use:
Fingertip
Pulse Oximeter is a portable
non-invasive, spot-check, oxygen
saturation of arterial hemoglobin (SpO
2 )
and pulse rate of adult and pediatric patient
at home, and hospital (including clinical use
in internist/surgery,
Anesthesia, intensive care and etc). Not for
continuously monitoring.
The requires no routine calibration or
maintenance other than replacement of
batteries.
Principle of the Oximeter is as follows: An
experience formula of data process is established
taking use of Lambert Beer Law according to
Spectrum Absorption Characteristics of Reductive
hemoglobin (R Hb) and Oxyhemoglobin (O2Hb)
in glow and near-infrared zones. Operation
principle of the instrument is Photoelectric
Oxyhemoglobin inspection Technology is
adopted in accordance with Capacity Pulse
Scanning and Recording Technology, so that two
beams of different wavelength of lights (660nm
glow and 940nm near infrared light) can be
focused onto human nail tip through perspective
clamp finger-type sensor. Then measured signal
can be obtained by a photosensitive element,
information acquired through which will be shown
on two groups of LEDs through process in
electronic circuits and microprocessor.
8. Product Accessories
1. One hang lace
2. Two batteries
3. One User manual
4. One Silicone case
9. Battery Installations
1. Put the two AAA batteries into battery
cassette in correct polarities.
2. Push the battery cover horizontally along
the arrow shown as below:
Please put or remove batteries in right order,
or is likely to damage the device bracket.
Please remove the battery if the Oximeter will
not be used for long time.
Notes:Battery polarities must be correctly
installed. Otherwise, damage might be caused
to device.
Lanyard Hole
10. Hang Lace Installations
1. Thread thinner end of the hang lace
through the hanging hole.
2. Thread thicker end of the lace through the
threaded end before pulling it tightly.
11. Using the Lanyard
1. Thread thinner end of the lanyard through
the hanging hole.
2. Thread thicker end of the lanyard through
the threaded end before pulling it tightly.
Warnings!
1. Keep the oximeter away from young
children. Small items such as the battery
door, battery, and lanyard are choking
hazards.
2. Do not hang the lanyard from the device’s
electrical wire.
12. Maintenance and Storage
1. Replace the batteries timely when low
voltage lamp is lighted.
2. Clean surface of the finger type Oximeter
before it is used in diagnosis for patients

Cleaning the Oximeter
Please use the medical alcohol to clean the rubber
touching the finger inside of Oximeter with a soft cloth
dampened with 70% isopropyl alcohol, and clean the
test finger using alcohol before and after each test.
Do not pour or spray and liquids onto the Oximeter,
and do not allow any liquid to enter any openings in
the device. Allow the Oximeter to dry thoroughly before
reusing.
1. The functional tester cannot be used to
assedd te accuracy of the oximeter.
2. Index 2 that made by Bioteck company is
afunction tester. Set Tech to 1. R curve
to 2, then user can use this particular
calibratio curve to measure the oximeter.
3. The test methods used to establish the
SpO
2 accracy is clinical testing. The
oximeter used to measure the arterial
haemoglobin oxygen saturatin levels and
these levels are to be compared to the
levels determined from arterial blood
sampling with a CO-oximeter.
1. Display Type: OLED display
2. SpO2 :
Measurement range: 70%~99%
Accuracy: ±3% on the stage of 70%~99%
0%~69% no definition
3. Pulse Rate:
Measure range: 30~235 BPM
Accuracy: 30~99BPM, ±2 bpm ;
100~235bpm, ±2 %
Pulse lntensity: Bargraph lndication
4. Power Requirements: Two AAA 1.5V
Alkaline Batteries
Power consumption: less than 30mA
Low power indication:
Battery Life: Two AAA 1.5V, 800mAh
alkaline batteries could be continuously
operated as long as 30 hours.
5. Dimension:
Length: 50mm
Width: 28mm
Height: 28mm
Weight: 25g(without batteries)
6. Environment Requirements:
Operation Temperature: 5 ~ 40°C
Storage Temperature: -20 ~ 55°C
Ambient Humidity: ≤80% no condensation
in operation
≤93% no condensation
in storage
7. Declaration: EMC of this product comply
with IEC60601-1-1-2 standard.
8. Measurement Performance in Weak Filling
Condition: required the test equipment
(BIO-TEK INDEX Pulse Oximeter tester)
the pulse wave is available without failure
when the simulation pulse wave amplitude
is at 6%.
9. Interference Resistance Capacity aginst
Ambient Light: Device work normally when
mixed noise produced by BIO-TEK INDEX
Pulse Oximeter tester.
13. Calibrating the pulse oximeter
3. Remove the batteries inside the battery
cassette if the Oximeter will not be
operated for a long time.
4. It is best to preserve the product in a
place where ambient temperatures range
from -20°C to 55°C and ≤ 93% humidity.
16. Possible Problems and Resolutions
Problems Possible
reason Solution
1. Finger is not
plugged
correctly
2. Patient’s
Oxyhemoglobin
value is too
low to be
measured
1. Retry by plugging the
finger
2. Try some more
times, If you can
make sure about no
problem existing in
Please go to a
hospital timely
for exact diagnosis
1. Finger might not
be plugged deep
enough
2. Finger is trembling
or patient’s body
is in movement
status
1. Retry by plugging the
finger
2. Try not to move
The Oximeter
can not be
powered on
1. Power of
batteries might
be inadequate
or not be there
at all
2. Batteries might
be installed
incorrectly
3. The Oximeter
might be
damaged
1. Please replace
batteries
2. Please reinstall
the
batteries
3. Please contact
with local
customer service
centre
Indication
lamps are
suddenly off
1. The product
is automatically
powered off
when no signal
is detected
longer than 8
seconds
2. Power
quantity of the
batteries is
started being
inadequate
1. Normal
2. Replace the batteries
“Error3” or
“Error4”
displayed on
screen
1 .Low power
2. Receiving
tube being
shielded or
damaged
together with
broken connector.
3. Mechanical
misplace for
receive-emissi
on tube
4. Amp circuit
malfunction.
1. Change new
battery
2. Please
contact with
local customer
service center
3. Please
contact with
local customer
service center
4. Please
contact with
local customer
service center
5. It is recommended that the product should
be kept in a dry environment anytime.
A wet ambient might affect its lifetime
and even might damage the product.
6. Please follow the law of the local
government to deal with used battery.
SpO 2 or PR can
not be showed
normally
SpO
2 or PR is
showed unstably
“Error7”
“Error6’’
displayed on
screen
1. Low power
Err6 means the
screen is failure.
2. Emission
tube damaged.
3. Current
control circuit
malfunction.
1. Please
Please contact
local customer service
center.
change battery
2. Please contact with
local customer
service center
3. Please contact with
local customer
service center
14. Detailed descriptions of product
functions
the product.
Manufactured by:
Acare Technology Co., Ltd
6F.-3, No.24, Wuquan 2nd Rd., Xinzhuang Dist.,
New Taipei City 242 Taiwan
TEL: [phone]
FAX: [phone]
Email: [email protected]
http://www.acaretech.com
Notes: Please remove the battery when
product will not be in used for period of time.
MEDIPRO
Villapark Business Park, Av Quitapesares 8
Building 8, Villaviciosa de Odon (Madrid) 28670
Spain
2460
16. Symbol Definitions
Symbol Definition
The equipment type is BF
Refer to user manual before
application
Hemoglobin saturation
Heart rate (BPM)
Low power indication
SN Serial No. (Attached inside of
the unit )
% SpO2
No for continuous monitoring
SpO2
Made in Taiwan 20170809 Ver.5.0
15. Declaration
Guidance and Manufacture’s declaration –
electromagnetic emissions -
For all EQUIPMENT and SYSTEMS
Guidance and Manufacture’s declaration –
electromagnetic environment specified below. The
customer of the user of the Pulse Oximeter should
assure that it is used in such and environment.
Emission test Compliance Emission test Compliance
Electromagnetic
Environment – guidance
RF emissions
CISPR 11
Group 1 The pulse Oximeter uses
RF energy only for
very low and are not likely
to cause
interference in nearby
electronic equipment.
RF emission
CISPR 11
Class B
Harmonic
emissions
IEC 61000-3-2
Not
Applicable
Not
Applicable
The pulse Oximeter is
suitable for use in all
establishment, including
domestic establishments
and those directly
connected to the public
low-voltage power supply
network that supplies
buildings used for
domestic purposes.
Voltage
fluctuations/
flicker
emissions IEC
61000-3-2
Immunity
test
Compliance
Electromagnetic
Environment – guidance
Radiated
RF
IEC
61000-4-3
Portable and mobile RF
communications equipment
should be used no closer to
any part of the Pulse Oximeter
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
Guidance and Manufacture’s declaration –
electromagnetic immunity-
For all EQUIPMENT and SYSTEMS
IEC 60601
test
level
Compliance
Level
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the
compliance level in each frequency range. b
Interference may occur in the vicinity of
equipment marked with following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations, Electromagnetic propagation is
affected by absorption and reflection structures, objects and people.
A Field strengths from fixed transmitters, such as base station 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 electromagnetic site survey should be
considered. If the measured field strength in the location in which the Pulse Oximeter
should be observed to verify normal operation. If abnormal performance is observed,
additional measurements may be necessary, such as reorienting of the relocating the
Pulse Oximeter.
B Over the frequency range 150 kHz to 80 MHz, fields strengths should be less than 3 V/m
Recommended separation distances between portable and mobile RF communications
equipment and Pulse Oximeter
The Pulse Oximeter is intended for use in electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Pulse Oximeter can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Pulse
Oximeter as recommended below, according to the maximum output power of the
communications equipment.
Recommended separation distances between portable and
mobile RF communications equipment and
the EQUIPMENT or SYSTEMS -
For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.0 0.1167 0.2334
0.1 0.3689 0.7378
1 1.1667 2.3334
10 3.6893 7.3786
100 11.6667 23.3334