ASTS Enterprises A310 User manual

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Model: A310
Pulse Oximeter
USER MANUAL
\
PLEASE NOTE:
THIS MEDICAL INSTRUMENT MUST BE USED ACCORDING
TO INSTRUCTIONS TO ENSURE ACCURATE READINGS.
File No.: A310-OPE V 1.3 202004

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Section 1 Safety
1.1 Instructions for the Safe Operation and Use of the A310 Pulse Oximeter
Do not attempt to service the Pulse Oximeter . Only qualified service personnel should attempt
any needed internal servicing.
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 2 hours.
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.
The following reason will cause interference to the testing accuracy of the A310 Pulse Oximeter .
High-frequency electrosurgical equipment.
Placement of a sensor on an extremity with a blood pressure cuff arterial catheter, or intravascular
line
The patient has hypotension severe vasoconstriction severe anemia or hypothermia.
The patient is in cardiac arrest or is in shock.
Fingernail polish or false fingernails may cause inaccurate SpO2 readings.
The device should be kept at least 10 minutes from non-working temperature to normal
temperature.
The device is non-sterile and not intended to be sterilized.
1.2 Warnings
WARNING: EXPLOSION HAZARD — Do not use the Pulse Oximeter in a
flammable atmosphere where concentrations of flammable anesthetics or other
materials may occur.
WARNING: Do not throw batteries in fire as this may cause them to explode.
WARNING: Do not attempt to recharge normal dry-cell batteries, they may leak.
And may cause a fire or even explode.
WARNING: Do not use the Pulse Oximeter in an MRI or CT environment.
WARNING: Do not modify this equipment without authorization of the
manufacturer.
WARNING: If this equipment is modified, appropriate inspection and testing
must be conducted to ensure continued safe use of equipment.
WARNING: Although the ME equipment conforms to the intent of the standard EN
60601-1-2 in relation to electromagnetic compatibility, electrical equipment may
produce interference. If interference is suspected, move equipment away from
sensitive device or contact us.
The portable and mobile RF communication equipment can affect this instrument‘s
normal operation.

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1.3 Definitions and Symbols
Symbol
Description
Symbol
Description
Type BF Equipment
Batch code*
Information of manufacture, including
name and address
Date of manufacture*
Temperature limitation
Serial NO*
When the end-user wishes to discard
this product, it must be sent to separate
collection facilities for recovery and
recycling
Information of EU
authorized representative
Follow user manual
Caution ：
The information you should
know to protect the
equipment from possible
damage
IP22
Anti-dust & Anti-water class
Note ：
The important information
you should know
Warning ：
The information you should know to protect patients and medical staff from possible
injury
If a Pulse Oximeter Monitor is not provided with a low SpO2 ALARM CONDITION, a
statement to the effect “NoSpO2 Alarms” or Symbol IEC 60417‐5319
(DB‐2002‐10) (see IEC 60601‐1‐8:2006 +AMD1:2012,TableC.1, Symbol 3).
*Batch code, Date of manufacturer and Serial No are printed on the label on the battery cover.
CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or
flammable materials, and extremes of temperature and humidity.
CAUTION: Do not operate the unit if it is damp or wet because of condensation or
spills. Avoid using the equipment immediately after moving it from a cold
environment to a warm, humid location.
CAUTION: Never use sharp or pointed objects to operate the front-panel switches.
CAUTION: The batteries must be taken out from the battery compartment if the
device will not be used for a long time.
CAUTION: The device shall only be used if the battery cover is closed.
CAUTION: The batteries must be proper disposed according to local regulation after
their use.
CAUTION: The device should keep away from the children, pets and pests to avoid
swallowing.

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Section 2 Introduction
2.1 General
This chapter provides a general description of the A310 Pulse Oximeter including:
Brief device description
Product features
2.2 Indication for use/ intended use
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use
in adult patients in clinical institution and home environments.
2.3 Brief Device Description
The Pulse Oximeter , based on all digital technology, is intended for noninvasive spot-check
measurement of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP
algorithm* can minimize the influence of motion artifact and improve measurement accuracy of low
perfusion*.
The Pulse Oximeter can be used to measure human SpO2 and heart rate through finger. The
product is suitable for family, hospital (including clinical use in internist/surgery, Anesthesia,
pediatrics and etc.) Oxygen Bar,social medical organizations, physical care in sports and etc.
2.4 Product Features
Lightweight for carrying and Easy-To-Use.
Manually adjust the direction of interface.
Color OLED display, simultaneous display for testing value and plethysmography.
Low Perfusion: 0.2%. (Advanced DSP algorithm can improve measurement accuracy, under
the condition of low perfusion.)
Visual & Sound reminder function. Real-time spot-checks.
Low Battery voltage indicator.
Automatically switch off.
Standard two AAA 1.5V Alkaline Battery support more than 20 hours continuous work.
CAUTION: The device cannot be used to measure the child below 3 years as the test result is
not guarantee to accurate.
CAUTION: 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.
CAUTION: The patient is an intended operator and can perform the maintenance the
equipment.

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*DSP algorithm: Digital signal processor algorithm.
*Low Perfusion: In physiology, perfusion is the process of a body delivering blood to a capillary bed in its
biological tissue. Under the condition of low perfusion, the measurement of non-invasive saturation of
pulse-blood oxygen is low-accurate.
*Plethysmograph: is an instrument for measuring changes in volume within an organ or whole body (usually
resulting from fluctuations in the amount of blood or air it contains).
PI （Perfusion Index ）is the ratio of the pulsatile blood flow to the non-pulsatile static blood flow in a patient's
peripheral tissue, such as finger tip, toe, or ear lobe. Perfusion index is an indication of the pulse strength at the
sensor site.
2.5 Expected Service Life
–The expected service life of the ME equipment;
–The expected service life of parts or accessories shipped with the ME equipment;
–Where the shelf life is less than the expected service life, the shelf life of parts or
Accessories shipped with the ME equipment.
CAUTION: A function tester cannot be used to assess the accuracy of a Pulse Oximeter
monitor or sensor.
Clinical testing is used to establish the SpO2 accuracy. The measured arterial SpO2 value
(SpO2) of the sensor is compared to arterial hemoglobin oxygen(SaO2) value, determined
from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in
comparison to the CO-oximeter samples measured over the SpO2 range of 70-100%.
Accuracy data is calculated using the root-mean-square (Arms value) for all subjects. Only
about two-thirds of PULSE OXIMETER EQUIPMENT measurements can be expected to
fall within ±Arms of the value measured by a CO-oximeter.
Pulse simulator shall be used to assess pulse rate Accuracy. The measured pulse rate is
compared to the preset pulse rate value in simulator. Accuracy data is calculated using the
root-mean-square(Arms value) for all subjects.

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Section 3 Installation, Setup,and Operation
3.1 Description of the Front Panel (as figure 3.1.1)
Figure 3.1.1 Parts of front & back panel
Table 3.1.1 Part Definition and Description
Item
Name
Description
1
Power button
Turn on the machine
2
OLED Panel
Display the SPO2/PR data &
Plethysmogram
3
Battery Compartment
3.2 Display
After switching on, the OLED display of the A310 Pulse Oximeter is as follows:
Figure 3.2.1 OLED display
3.3 Parameter setting
When the device is under measuring interface, press the direction button for 1 second in order to
enter into menu page (figure 3.3.1 and figure 3.3.2). There are two submenus for choice:
3.3.1 Remind Setup
Press the direction button for 1 second and enter into the Reminder Setup. User can adjust the
setting through moving the “*” symbol to the back of the Sound Reminder, Beep, Restore or
Brightness.
Sound Reminder

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Press the direction button for 1 second, move the “*” symbol to the back of Sound Reminder, long
press the direction button to turn it on/off.
(Note: If the measured value exceeds the maximum or minimum value of SPO2 or PR, there will
give off sound when sound reminder is turned on.)
Beep
Press the direction button for 1 second, move the “*” symbol to the back of Beep, long press the
direction button to turn it on/off.
(Note: When Beep is turned on, the sound emitted during the test indicates the pulse rate sound)
Restore
When the “*” symbol show behind “Restore”, long press the direction button can be changed to
“OK”, which causes the device to restore factory data setting.
Demo
Press the direction button for 1 second, move the “*” symbol to the back of Demo, long press the
direction button to turn it on/off.
Brightness
When the “*” symbol show on “Brightness”, long press the direction button to change the
Brightness value from 1 to 5.
3.3.2 Limit Value Setting
When the * symbol show on the Reminder Setup, long press the direction button until enter into
the Reminder Limit setup menu (figure 3.3.2). User can press the direction button to select the items.
And press the direction button for 1 second to change the data you need.
On the Reminder Limit setup menu page (figure 3.3.2), when the * symbol show behind the
“+/-”. Press direction button for 1 second to change the “+” to “-” or change the “-” to “+”.
When “+” shows on the right side, press the direction button for 1 second, move the “*” after the
Spo2 Hi or PR Hi setting, can increase the value to a higher value (until it reaches to the highest.)
When “-” shows on the right side, press the direction button for 1 second, move the “*” after
the Spo2 Lo or PR Lo value setting, can reduce the value to a lower value (until it reaches to the
lowest).
Figure3.3.1 Figure3.3.2
Note:
1.The sound reminder have 1 second delay after the incorrect result being detected.

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2.The customer can preset the limit value to the 98 or 99 to check whether it is normal for sound
reminder setting.
3.If no sound reminder that includes the capability to detect an SpO2 or pulse rate
PHYSIOLOGICAL SOUND REMINDER CONDITION is provided, a statement to that effect
4.The range of the peak wavelengths and maximum optical output power of the light emitted by
the PULSE OXIMETER PROBE and a statement to the effect that information about
wavelength range can be especially useful to clinicians.
3.4 Operation
3.4.1 Install battery
Installing two AAA batteries into battery cassette in correct polarities and cover it.
3.4.2 Turn the Pulse Oximeter on
Put one of fingers into rubber hole of the Pulse Oximeter (it is best to put the finger thoroughly)
with nail surface upward, then releasing the clamp.
Press power button to turn the Pulse Oximeter on. The oximeter will be automatically powered
off when no finger in the device for longer than 16 seconds.
3.4.3 Read correspondent data from display screen.
3.4.4 Display Description of OLED
The display interface of OLED can rotate four directions with six different display modes after
pressing the power button for less than 0.5s. It is shown as below:
WARNING: Do not attempt to recharge
normal alkaline batteries, they may leak
and may cause a fire or even explode.

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Note:
1. When battery power is at lowest level, the battery capacity indicates symbol of in OLED,
remind users of replacement of battery.
2. The plethymogram can been regarded as correct if the wave is fluctuated regularly.
Section 4 Cleaning and Disinfection
4.1 Cleaning
Switch off the power and take out the batteries before cleaning.
Keep the exterior surface of the device clean and free of dust and dirt. Cleaning exterior surface
(OLED display screen included) of the unit with a dry and soft cloth. Use 75% density of medical
alcohol to clean the surface and use dry fabric with little alcohol to avoid alcohol permeates into the
device.
4.2 Disinfection
Disinfect the machine after using by the patient if multiple patient uses the machine in the
hospital.
Use 75% density of medical alcohol to clean the surface that contacting with the patient.
CAUTION:Don’t use strong solvent. For example, acetone.
CAUTION:Never use an abrasive such as steel wool or metal polish.
CAUTION:Do not allow any liquid into the product, and do not immerse any parts of the
device into any liquids.
CAUTION:Avoid pouring liquids on the device while cleaning.
CAUTION:Don’t remain any cleaning solution on the surface of the device.

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Section 5 Troubleshooting and Maintenance
5.1 Maintenance
Replace the batteries timely when battery indication is low. Clean surface of the Pulse Oximeter
before it is used in diagnosis for patients.
Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long
time.
It is better to preserve the product in a place where ambient temperature is –25°C to 55°C(-13℉
-131℉) and humidity is 15%-85%.
Regular inspection to make sure that no obvious damage existed to affect the safety and
performance of device.
No flammable substance, overtops or lower temperature and humidity existed in operation
conditions.
5.2 Troubleshooting
Table 5.2.1 troubleshooting
Problems
Possible Reason
Resolutions
Oxyhemoglobin or heart
rate can not be shown
normally
1. Finger is not plugged correctly.
2. Patient’s perfusion 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
Oxyhemoglobin of heart
rate is shown unstably
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, Let the patient keep
calm.
Oxyhemoglobin or heart
rate is abnormal, and
cause sound remind
1. Finger is not plugged correctly.
2. Patient’s SPO2&PR is abnormal.
1. Retry by plugging the finger
2. Go to the hospital for further
examination.
The Oximeter ca 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 center
The screen is suddenly off
1.The product is automatically
powered off when no signal is
detected longer than 16 seconds
2. Power quantity of the batteries is
exhausted.
1.Normal
2.Replace the batteries

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Section 6 Specification
Name
Pulse Oximeter
Model
A310
Anti-electric Shock Type
Internally powered equipment
Anti-electric Shock Equipment Degree
Type BF
EMC Type
Type B Class I
Enclosure Degree of ingress protection
IP22
Internal Power:
2xAAA 1.5v alkaline battery
Power Consumption
Below 45mA
Screen
0.96’OLED
SpO2 Display
35-100%
Pulse rate Display
30-250 BPM
PI Display
0-20%
Resolution
SpO2: 1%
Pulse rate: 1BPM
PI:0.1%
Measure Accuracy
SpO2
±3% (70%-100%)
Unspecified (<70%)
PR: ±2BPM
PI 0.1%: (0-1%)
1%: (1-20%)
Operating Environment
Temperature: 5°C to 40°C (41℉to 104℉)
Humidity:15% to 85% non-condensing
Air Pressure: 86Kpa-106Kpa
Storage & Transport Environment
Temperature:-25℃to 55℃(-13℉-131℉)
Humidity:15% to 85% non-condensing
Dimensions
62mm×34mm×31mm
Weight
50±2g（including 2 x AAA battery）
Accessories
AAA battery------------------------2 pcs
Hang String-------------------------1 pc
User manual -----------------------1 pc
Section 7 Manufacturer’s Declaration of the EMC
Guidance and manufacturer´s declaration – electromagnetic emission –

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for all EQUIPMENT AND SYSTEMS
1
Guidance and manufacturer´s declaration – electromagnetic emission
2
The A310 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of A310 Pulse Oximeter should assure that it is used in such an environment.
3
Emissions test
Compliance
Electromagnetic environment - guidance
4
RF emissions
CISPR 11
Group 1
The A310 Pulse Oximeter uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
5
RF emissions
CISPR 11
Class B
The A310 Pulse Oximeter is suitable for use in
all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supplynetwor
k that supplies buildings used for domesticpurposes.
6
Harmonic emissions
IEC 61000-3-2
N/A
7
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
N/A
Guidance and manufacturer's declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic immunity
TheA310 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of the A310 Pulse Oximeter should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrostatic
transient / burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/output
lines
N/A
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common mode
N/A
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips,
short
0 % UT; 0,5 cycle g)
At 0°, 45°, 90°, 135°, 180°,
N/A
Mains power quality should be that of a
typical commercial or hospital

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interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
225°, 270° and 315°
0 % UT; 1 cycle and
70 % UT; 25/30 cycles
at 0°
0 % UT; 250/300 cycle
environment. If the user of the
A310 Pulse Oximeter requires continued
operation during power mains
interruptions, it is recommended that the
A310 Pulse Oximeter be powered from
an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be
at levels characteristic 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 manufacturer´s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
Guidance and manufacturer´s declaration – electromagnetic immunity
The A310 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of the A310 Pulse Oximeter should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6Vrms in ISM banda
between
150 kHz to 80 MHz
80 MHz to 2.7 GHz
N/A
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of theA310 Pulse Oximeter , including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
P
V
d]
5.3
[
1

P
E
d]
5.3
[
1

80 MHz to 800 MHz
P
E
d]
7
[
1

800 MHz to 2.5 GHz
where pis the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and dis the
recommended separation distance in metres
(m).b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in
each frequency range. b

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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 situations. Electromagnetic is affected by absorption and
reflection from structures, objects and people.
aField 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 can not 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
A310 Pulse Oximeter is used exceeds the applicable RF compliance level above, the A310 Pulse Oximeter
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the A310 Pulse Oximeter .
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM -
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the A310 Pulse Oximeter
The A310 Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of theA310 Pulse Oximeter can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and theA310 Pulse Oximeter as recommended below, according
to the maximum output power of the communications equipment
Separation distance according to frequency of transmitter
m
Rated maximum
output of
transmitter
W
150 kHz to 80 MHz
P
V
d]
5.3
[
1

80 MHz to 800 MHz
P
E
d]
5.3
[
1

800 MHz to 2.7 GHz
P
E
d]
7
[
1

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 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.

15 /15
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
absorption and reflection from structures, objects and people.
Section 8 Disposal
Observe the applicable regulations when disposing of the infrared thermometer and batteries.
This infrared thermometer must not be disposed of together with domestic waste.
All users are obliged to hand in all electrical or electronic devices, regardless of whether or not
they contain toxic substances, at a municipal or commercial collection point so that they can
be disposed of in an environmentally acceptable manner.
Please remove the batteries before disposing of the infrared thermometer. Do not dispose
of old batteries with your household waste, but at a battery collection station at a recycling site
or in a shop.
Section 9 Certificate of guarantee
Aeon guarantees the Pulse Oximeter against any manufacturing defect for two years from the
date of purchase if it is returned to the dealer from whom it was purchased.
During this period the unit will be repaired or replaced free of charge if the fault is due to
defective design or assembly.
This guarantee does not cover any damage or defect caused by improper handling resulting from
use that is not in compliance with these instructions or from unauthorized attempts to repair it. Your
local dealer cannot declare this manufacturer’s guarantee invalid but may expand it by additional
guarantees at his discretion and at his own expense.
Listed with the Australian therapeutic good administration.
ARTG identifier : 3183357.
For information and warranty in Australia
Please contact:
ASTS Enterprises (AUST) Pty Ltd
2/11 Evans St, Burwood, VIC, 3125
Ph: [phone]
Fax: [phone]