Aeon Technology A3 Pulse Oximeter User Manual

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Date Submitted	2018-08-06 00:00:00
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Creation Date	2018-08-06 09:37:45
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Document Title	User manual
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Document Author:	xfinal

A310B Fingertip Pulse Oximeter
Operator’s Manual
File No.: A310B-OPE
V 1.0
20180712
A310B Pulse Oximeter
Section 1
Safety
Instructions for the Safe Operation and Use of the
A310B Pulse Oximeter
Do not attempt to service the A310B 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 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.
A310B Pulse Oximeter
1.2
Warnings
WARNING: EXPLOSION HAZARD — Do not use the A310B
in a flammable atmosphere where concentrations of flammable
anesthetics or other materials may occur.
WARNING: Do not throw batteries in fire as this may causes
them to explode.
WARNING: Do not attempt to recharge normal dry-cell
batteries, they may leak. And may cause a fire or even
explode.
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
authorization of the manufacturer.
equipment
without
WARNING: If this equipment is modified, appropriate
inspection and testing must be conducted to ensure continued
safe use of equipment.
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
3 using the equipment
of condensation or spills. Avoid
immediately after moving it from a cold environment to a
A310B Pulse Oximeter
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.
A310B Pulse Oximeter
1.3
Definitions and Symbols
Symbol
Description
Type BF Equipment
Batch code*
Date of manufacture*
SN
Serial NO*
Information of manufacture, including
name and address
Temperature limitation
Bluetooth Indication
When the end-user wishes to discard this
product, it must be sent to separate
collection facilities for recovery and
recycling
A310B Pulse Oximeter
Follow instruction for use
IP22
Anti-dust& Anti-water class
Warning：
The information you should know to
protect patients and medical staff from
possible injury
Caution：
The information you should know to
protect the equipment from possible
damage
Note：
The important information you should
know
*Batch code, Date of manufacturer and Serial No are printed on
the label on the battery cover.
Section 2
Introduction
2.1 General
This chapter provides a general description of the A310B Pulse
Oximeter including:
Brief device description
Product features
2.2 Brief Device Description
A310B Pulse Oximeter
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 Oximeter can be used to measure human Hemoglobin
Saturation and heart rate through finger. The product is suitable
for family, hospital (including clinical use in internist/surgery,
Anesthesia, pediatrics, intensive care and etc.) Oxygen Bar, social
medical organizations, physical care in sports and etc.
2.3 Product Features
 Lightweight for carrying and Easy-To-Use.
 Manually adjust the direction of interface .
 Color OLED display, simultaneous display for testing
value and plethysmogram.
 Low Perfusion : 0.2%. (Advanced DSP algorithm can
improve measurement accuracy, under the condition of low
perfusion.)
 Visual & Sound alarm function. Real-time spot-checks.
 Wireless Bluetooth for data transmission.
 Low Battery voltage indicator.
 Automatically switch off.
 Standard two AAA 1.5V Alkaline Bаttеrу support more
than 20 hours continuous work.
A310B Pulse Oximeter

CAUTION: The device cannot be used to measure the child
below 1 years as the test result is not guarantee to accurate.
CAUTION: The fingertip 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: 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 hemoglobin saturation 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.
*DSP algorithm: Digital signal processor algorithm.
A310B Pulse Oximeter
*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).
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
A310B Pulse Oximeter
Item
Name
Description
Power button
OLED Panel
Turn on the machine
Display the SPO2/PR
data &
Plethysmogram,etc.
Battery Compartment
3.2.Display
After switch on, the OLED display of A310B is as follows:
Figure 3.2.1 OLED display
10
A310B Pulse Oximeter
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:
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 , Bluetooth,
Restore or Brightness.
Sound Reminder
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.
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.
Bluetooth
Press the direction button for 1 second, move the ―*‖ symbol
to the back of Bluetooth, long press the direction button to turn it
on/off.
11
A310B Pulse Oximeter
Restore
When the ―*‖ symbol shown behind ―Restore‖, long press the
direction button can be changed to ―OK‖, which causes the
device to restore factory data setting.
Brightness
When the ―*‖ symbol shown on ―Brightness‖, long press the
direction button to change the Brightness value from 1 to 5.
Limit Value Setting
When the * symbol shown 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 shown 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 (untill it reaches to
the lowest).
12
A310B Pulse Oximeter
Figure3.3.1
Figure3.3.2
Note:
1.The alarm have 1 second delay after the incorrect result being detected.
2. The customer can preset the alarm value to the 98 or 99 to check whether
it is normal for alarm setting.
3.4 Operation
3.4.1 Install battery
Installing two AAA batteries into battery cassette in correct
polarities and cover it.
WARNING: Do not attempt to recharge normal alkaline
batteries, they may leak and may cause a fire or even
explode.
13
A310B Pulse Oximeter
3.4.2 Turn the Pulse Oximeter on
Put one of fingers into rubber hole of the 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:
14
A310B Pulse Oximeter
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 pletismogragh can been regarded as correct if the wave is fluctuated regularly.
3.4.5 Date Transmission
1. The current measurement will transmit to the App automatically. after data
transmission successfully, the measurement
flashing for 8s, then the device will power off automatically. If there is no Bluetooth
connection over 1 min, the device will power off automatically and the data will not be
15
A310B Pulse Oximeter
stored.
If there is no reading, the device will power off automatically.
Notes:
With the Bluetooth 4.0 to transmit the data to App.
The transmission distance is 10 m at most.
Section 4
Cleaning and Disinfection
4.1 Cleaning
Cleaning the machine once every day. Switch off the power and
take out the batteries before cleaning, 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
Disinfecting the machine after using by the patient if multiple
patient use the machine in the hospital.
Use 75% density of medical alcohol to clean the surface that
contacting with the patient.
16
A310B Pulse Oximeter
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.
Section 5
Troubleshooting and Maintenance
5.1 Maintenance
Replace the batteries timely when battery indication is low.
Clean surface of thе 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 -10-50℃ and humidity is 15%-80%.
Regular inspection to make sure that no obvious damage
existed to affect the safety and performance of device.
No flammable substance, overtop or lower temperature and
17
A310B Pulse Oximeter
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 exact diagnosis
Oxyhemoglobin or 1. Finger might not be
heart rate is shown plugged deep enough
unstably
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 alarm
1. 1. Retry by plugging
the finger
2. go to the hospital for
further examination.
1. Finger is not
plugged correctly.
2. Patient’s
SPO2&PR is
abnormal.
18
A310B Pulse Oximeter
The oximeter can 1. Power of batteries
not be powered on might be inadequate
or not be there at all
2.Batteries might be
installed incorrectly
3.The Oximeter might
be damaged
1.The product is
he screen are
automatically
suddenly off
powered off when no
signal is detected
longer than 8 seconds
2.Power quantity of
the batteries is
exhausted.
1. Please replace batteries
2.Please reinstall the
batteries
3.Please contact with
local customer service
center
1.Normal
2.Replace the batteries
Section 6
Specification
Fingertip Pulse Oximeter Specifications:
Physical Characteristics
Machine:
Dimensions -60 mm (L) x 36mm (W) x28mm (D)
Weight -approx: 50 g（including 2 x AAA battery）
Color box:
19
A310B Pulse Oximeter
Dimensions-80mm(L)x60mm(w)x55mm(D)
Gross Weight: 70g
Outer carton:
Dimensions-440mm (L) X340mm (W) X290mm (H)
Gross Weight: 8.7 kg
Classification ：
Anti-electric Shock Type：Internally powered equipment
Anti-electric Shock Degree：Type BF equipment
EMC：Type B
Mode of operation: Continuous Operation
Enclosure Degree of ingress protection: IP22
IP22 means shell of this product can withstand the water dropping
to the surface when the shell deviate 15 degree from horizontal
surface.
Power
Internal:
2xAAA 1.5v alkaline battery
Power Consumption
Smaller than 30mA(Normal)
20
A310B Pulse Oximeter
Environmental:
Operating Temperature:
5°C to 40°C
Storage Temperature:
–10°C to 50°C
Relative Humidity:
15% to 80%
non-condensing
Air Pressure
86Kpa-106Kpa
Alarm default value:
Parameter
Value
Hemoglobin saturation:
Upper limit: 100/ bottom limit:94
Pulse rate:
Upper limit: 130 /bottom limit:50
Electronics Parameters:
Parameter
Value
Hemoglobin saturation
display
35-100%
Pulse rate Display
30-250 BPM
Resolution
Hemoglobin
Saturation
1%
Pulse rate
1 BPM
21
A310B Pulse Oximeter
Measure
Accuracy:
PI
Hemoglobin
Saturation
±3% (70%-100%)
Unspecified (<70%)
Pulse rate
±1 BPM
Display
0-20%
Resolution
0.1%
Measure
Accuracy
0-1%: 0.1%
1-20%: 1%
Probe LED Specification;
Wave Length
Radiant Power
RED
660±2 nm
1.8 mW
Infra RED
905±2 nm
2.0 mW
22
A310B Pulse Oximeter
FCC Statement
This equipment has been tested and found to comply
with the limits for a Class B digital device, pursuant to
Part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful
interference in a residential installation. This
equipment generates uses and can radiate radio
frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful
interference to radio communications. However,
there is no guarantee that interference will not occur
in a particular installation. If this equipment does
cause harmful interference to radio or television
reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to
correct the interference by one or more of the
following measures:
-- Reorient or relocate the receiving antenna.
23
A310B Pulse Oximeter
-- Increase the separation between the equipment
and receiver.
-- Connect the equipment into an outlet on a circuit
different from that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV
technician for help.
§ 15.19 Labeling requirement.
This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions
(1) This device may not cause harmful interference,
(2)this device must accept any interference received,
including interference that may
cause undesired operation.
§ 15.21 Information to user.
Any Changes or modifications not expressly
approved by the party responsible for compliance
could void the user's authority to operate the
equipment.
Specific Absorption Rate (SAR) information:
This product meets the government's requirements
for exposure to radio waves. The guidelines are
based on standards that were developed by
independent scientific organizations through
periodic and thorough evaluation of scientific studies.
24
A310B Pulse Oximeter
The standards include a substantial safety margin
designed to assure the safety of all persons
regardless of age or health.
Body-worn Operation
This device was tested for typical body-worn
operations. To comply with RF exposure
requirements, a minimum separation distance of
5mm for body worn must be maintained between the
user’s body, including the antenna. Third-party
belt-clips, holsters, and similar accessories used by
this device should not contain any metallic
components. Body-worn accessories that do not
meet these requirements may not comply with RF
exposure requirements and should be avoided. Use
only the supplied or an approved antenna
25

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