Acare OxiSmarter I User manual

1. General Description
2. Measurement principle
Diagram of Operation Principle
3. Precautions for use
1. Red and Infrared-ray Emission
2. Red and Infrared-ray Receipt
≤
4. Product Properties
5. Product Operation Scope
6. Operation Instructions
1.
2.
3.
4.
5.
6.
When your finger is plugged into the
Oximeter, your nail surface must be
upward.
Haemoglobin Saturation is percentage of Oxyhe-
moglobin (HbO2) capacity, compounded with
oxygen, by all combinativable haemoglobin (Hb)
obin (HbO2) capacity in blood. In other words, it is
consistence of Oxyhemoglobin in blood. It is a very
important ecological parameter for Respiratory
circulation System. Many respiratory diseases can
result in haemoglobin Saturation being lowered in
human blood. Moreover, the following factors can
also lead to problems in oxygen supply, so that
human haemoglobin saturation might be reduced:
Automatic Organic Regulation Malfunction caused
by Anesthesia, Intensive Postoperative Trauma,
hurts resulted in by some medical examination and
etc. In the situation, illnesses, such as light head,
asthenia, vomitory and etc, might happen to
patients and even endanger the patient’s life.
Therefore, it is very important to know Hemoglobin
saturation of patient timely in clinical medical
aspects. So that doctors can find problems in time.
The Finger type Pulse Oximeter features in small
volume, low power consumption, convenient opera-
tion and being portable. It is only necessary for
patient to put one of his fingers into a finger type
photoelectric sensor for diagnosis, and a display
screen will directly show measured value of
hemoglobin Saturation. It has been proved in
clinical experiments that it features in rather high
precise and repeatability.
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.
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 SpO2 alarms; 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)
12. Intravascular dyes such as indocyanine green or
methylene blue.
13. SpO2 measurements 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 vasocon-
striction, severe anemia, or hypothermia
19. The patient is in cardiac arrest or is in shock
20. Fingernail polish of false finernails may cause
inaccurate SpO2 readings.
Follow local ordinances and recycling instructions
regarding disposal or recycling of the device and
device components, including batteries.
1 Operation of the product is simple and conve-
nient
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
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.
The finger type 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, pediatrics,
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.
1 Installing 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 button 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:
When you press the power switch for a long
time (more than on 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).
7. Brief Description ofFront Panel
It is apparent the heart rate bargraph display
corresponds with pulse rate.
Instruction Manual
OxiSmarter I
Finger type
Pulse Oximeter
No. AE-XX
Low power indicator
OxiSmarter I
SpO 2% PR bp m
98 77
SPO2 waveform
OxiSmarter I
SpO
2%
PR
bpm
98
77
PR Bargraph
SPO2
PR
Power
Switch

2460
Made in Taiwan
20170807 Version: 6.0
Notes:Battery polarities must be correctly
installed. Otherwise, damage might be caused
to device.
4. Power Requirements: Two AAA 1.5V
Alkaline Batteries
Power consumption: less than 40mA
Low power indication:
Battery Life: Two AAA 1.5V, 600mAh
alkaline batteries could be continuously
operated as long as 30 hours.
5. Dimension:
Length: 61mm
Width: 32mm
Height: 37mm
Weight: 50g(including two AAA 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.
8. Product Accessories
1 One hang lace
2 Two batteries
3 One User manual
4 One drawsting bag
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
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. Maintenance and Storage
12. Calibrating the pulse oximeter
14. Detailed descriptions of product
13. Declaration
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
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
15. 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 the
product.
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
17. Symbol Definitions
16. Guidance and manufacture’s declaration
- electronmagnetic emissions -
for all Equipmnet and Systems
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.
1. The functional tester cannot be used to
assedd te accuracy of the oximeter.
2. Index 2 that made by Bioteck company is a
function 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
SpO2accracy 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.
EMC of this product comply with IEC60601-1-
1-2 standsard.
The materials which user can come into
contact is no toxicity and no action on tissues,
comply with ISO10993-1 -5, -10.
1. Display Type: OLED display
2. SpO2:
Measurement range: 70%~100%
Accuracy: ±2% on the stage of 70%~100%
0%~69% no definition
3. Pulse Rate:
Measure range: 30~235 BPM
Accuracy: 30~99BPM, ±2 BPM ;
100~235BPM, ±2 %
SpO2or PR can
not be showed
normally
SpO2or 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
functions
Guidance and manufacture’s declaration -
electromagnetic emission
The Pulse Oximeter is intended for use in the
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 Electromagnetic
environment-guldance
RF emissions
CISPR 11
Group 1 The Pulse Oximeter
uses RF energy only
for its internal function.
Therefor, its RF
emissionslare very low
and are not likely to
cause any interference
in nearby electronic
equipment.
RF emission
CISPR 11
Class B The Pulse Oximeter is
suitable for use in all
establishments,
including domestic
establishments and
those directly
connected to the public
low-voltage power
supply network that
supplies buildings use
for domestic purposes.
Manufactured by:
Acare Technology Co., Ltd
6F.-3, No.24, Wuquan 2nd Rd.,Xinzhuang Dist.,
New Taipei City 242 Taiwan
TEL: [phone]
FAX: [phone]
http://www.acaretech.com
MEDIPRO
Villapark Business Park, Av Quitapesares 8
Building 8, Villaviciosa de Odon (Madrid) 28670
Spain
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 )
Notes: Please remove the battery when
product will not be in used for period of time.
No SpO2alarm
SpO2%
PRbpm
i
from -20°C to 55°C and ≤ 93% humidity.