Suresense A330 User manual

User Manual
PULSE OXIMETER
Product: Pulse Oximeter
Product Code: A330
Please note: This medical device must be used according to instructions to ensure accurate readings
Version: V2.0 (10/6/2020)

Suresense Pulse Oximeter User Manual V2.0 (10/6/2020)
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Section 1 Safety
1.1 Instructions for the Safe Operation and Use
• Do not attempt to service the Suresense 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 for example) if necessary.
• The following reasons may cause interference to the testing accuracy of the Suresense Pulse
Oximeter.
o High-frequency electrosurgical equipment.
o Placement of a sensor on an extremity with a blood pressure cuff arterial catheter,
or intravascular line.
o The patient has hypotension severe vasoconstriction severe anemia or hypothermia.
o The patient is in cardiac arrest or is in shock.
• Fingernail polish or false fingernails may cause inaccurate SpO2 readings.
• The device should not be used for at least 10 minutes when moving from non-working
temperatures to normal temperatures.
• The device is non-sterile and not intended to be sterilised.
1.2 Warnings
Warning
: Although this device 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. Portable and mobile RF communication
equipment can affect this instrument’s normal operation.
Warning:
EXPLOSIVE HAZARD – Do not use the Suresense Pulse Oximeter in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
Warning:
Do not dispose of 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 Suresense Pulse Oximeter in an MRI or CT environment.
Warning:
Do not modify this equipment without authorisation from the manufacturer.
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 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 object 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 properly disposed according to the local regulation after their use.
Caution:
The device should keep away from the children, pets and pests to avoid swallowing.
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 authorised
representative

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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 the Suresense Pulse Oximeter 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.
Section 2 Introduction
2.1 General
This chapter provides a general description of the Suresense Pulse Oximeter.
• Brief device description
• Product features
2.2 Indication for use/ intended use
The Suresense 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 Suresense Pulse Oximeter, based on digital technology, is intended for noninvasive spot-check
measurement of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP algorithm* can
minimise the influence of motion artifact and improve measurement accuracy of low perfusion*.
The Suresense 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 organisations, 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: 0.3%. (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 is not accurate for children 3 years or younger.
Caution:
The Suresense 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 should not perform maintenance on the 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. Measured arterial SpO2 value (SpO2) from the sensor
is compared to arterial hemoglobin oxygen (SaO2) value, determined directly from blood samples taken with
a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO-oximeter samples measured
ranges between 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 measure by a CO-oximeter.

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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.
*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 fingertip, toe, or ear lobe. Perfusion index is an indication of the pulse
strength at the sensor site.
Section 3 Installation, Setup and Operation
3.1 Description of the front panel (as figure 3.1.1)
Figure 3.1.1 Parts of the 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 and
plethysmogram
3
Battery compartment
3.2 Display
After switching on, the OLED display of the Suresense Pulse Oximeter is as follows:
Figure 3.2.1 OLED display

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3.3 Parameter setting
When the device is under measuring interface, press the power 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 power 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
Press the power button for 1 second, move the “*” symbol to the back of Sound Reminder.
Hold down the power 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 power button for 1 second, move the “*” symbol to the back of Beep, hold down 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 displays behind “Restore”, hold down the power button to select. This will
restore the device to the factory settings.
Demo
Press the power button for 1 second, move the “*” symbol to the back of Demo, hold down the
power button to turn it on/off.
Brightness
When the “*” symbol displays on “Brightness”, hold down the power button to change the Brightness
value from 1 to 5.
3.3.2 Limit Value Setting
When the * symbol displays on the Reminder Setup, hold down the power button until it opens the Reminder
Limit setup menu (figure 3.3.2). User can press the power button to select the items. And hold down the
power button for 1 second to change the data you need.
On the Reminder Limit setup menu page (figure 3.3.2) when the * symbol displays the “+/-”.
Press the power button for 1 second to change the “+” to “-” or change the “-” to “+”.
When “+” displays on the right side, press the power 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).
Figure 3.3.1 Figure 3.3.2
When “-” displays on the right side, press the power 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).
Note:
1. The sound reminder has 1 second delay after the incorrect result being detected.
2. The patient can preset the limit value to 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
Suresense Pulse Oximeter and a statement to the effect that information about wavelength range can be
especially useful to clinicians.

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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.
3.4.2 Turn On
Press the clamp and place a finger into rubber hole of the pulse oximeter with the fingernail upwards. Release
the clamp to secure.
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 Reading the Display
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:
Note:
1. When the symbol is displayed on screen, the battery level is at it’s lowest and should be replaced.
2. The plethysmogram can been regarded as correct if the wave is fluctuated regularly.

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Section 4 Cleaning and Disinfecting
4.1 Cleaning
Switch off the power and take out the batteries before cleaning.
Clean the exterior surface including the OLED display screen using a dry and soft cloth with a small amount
of isopropyl alcohol (75% or more). Avoid getting the device too wet so alcohol doesn’t get inside.
4.2 Disinfection
Disinfect the device after each patient by wiping all surfaces that was in contact with the patient. Wipe with a
dry and soft cloth with a small amount of isopropyl alcohol (75% or more). Avoid getting the device too wet
so alcohol doesn’t seep inside.
Caution:
Don’t use any strong solvents to clean, such as acetone.
Caution:
Never use an abrasive, such as steel wool.
Caution:
Don’t allow any liquids 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 leave any cleaning solution on the surface of the device.
Section 5 Troubleshooting and Maintenance
5.1 Maintenance
Clean surface of the Pulse Oximeter before using it with a new patient.
Replace the batteries timely when battery indication is low.
Remove the batteries if not in use for extended periods.
Store the device within temperatures of –25°C to 55°C (-13°F - 131°F) and a humidity level of 15% to 85%.
Regularly inspect the device to make sure that there’s no damage to effect it’s safety and performance.
5.2 Troubleshooting
Table 5.2.1 troubleshooting
Problems
• Possible Reason
• Resolutions
Oxyhemoglobin
or heart rate isn’t
displaying
normally.
• Finger is not inserted correctly
• Patient’s perfusion is too low to
be measured
• If the results are the same after
retrying, seek medical attention
Oxyhemoglobin
of heart rate is
shown unstably.
• Finger might not be inserted
deep enough
• Finger is trembling, or patient's
body is in movement status
• Retry by inserting the finger
• Calm the patient and
try not to move
Oxyhemoglobin
or heart rate is
abnormal, and
cause sound
reminder.
• Finger is not inserted correctly
• Patient’s SPO2&PR is abnormal
• Retry by inserting the finger
• Go to the hospital for further
examination.
The device won’t
turn on.
• Power of batteries might be
inadequate or not be there at all
• Batteries might be installed
incorrectly.
• The device might be damaged
• Please replace batteries
• Please reinstall the batteries
• Please contact the manufacturer
The screen won’t
turn on.
• The product is automatically
powered off when no signal is
detected longer than 16 seconds
• Power quantity of the batteries is
exhausted
• Replace the batteries

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Section 6 Specification
Name:
Suresense Pulse Oximeter
Model:
A330
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°F to 104°F)
Humidity: 15% to 85% non-condensing
Air Pressure: 86Kpa-106Kpa
Storage & Transport Environment:
Temperature: –25°C to 55°C (-13°F -131°F)
Humidity: 15% to 85% non-condensing
Dimensions:
62mm ×33mm ×32mm
Weight:
55±2g（including 2 x AAA battery)
Accessories:
AAA battery x2 pcs
Hang String x1 pc
User manual x1 pc

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Section 7 Manufacturer’s Declaration of the EMC
Guidance and manufacturer’s declaration – electromagnetic emission –
for all EQUIPMENT AND SYSTEMS
1
Guidance and manufacturer´s declaration – electromagnetic emission
2
The Suresense Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of the Suresense 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 Suresense 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 Suresense 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 used for domestic purposes.
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
The Suresense Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of the Suresense 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
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
0 % UT; 0,5 cycle g) At 0°,
45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle and 70 %
UT; 25/30 cycles
at 0°
0 % UT; 250/300 cycle
N/A
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
Suresense Pulse Oximeter requires
continued operation during power
mains interruptions, it is recommended
that the Suresense 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.

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Guidance and manufacturer’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
Guidance and manufacturer´s declaration – electromagnetic immunity
The Suresense Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of the Suresense 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 the Suresense Pulse Oximeter ,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
80 MHz to 800 MHz
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
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 Suresense Pulse Oximeter is used exceeds the applicable RF compliance level above, the Suresense
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 Suresense Pulse Oximeter.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

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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 Suresense Pulse Oximeter
The Suresense Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Suresense Pulse Oximeter can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Suresense Pulse Oximeter as recommended below,
according to the maximum output power of the communications equipment
Separation distance according to frequency of transmitter
Rated maximum
output of
transmitter W
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.7 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 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.
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 Suresense Pulse Oximeter and batteries.
This device 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. 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
Bird Healthcare guarantees the Suresense 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 unauthorised attempts to repair it. Your local dealer cannot
declare this manufacturer’s guarantee invalid but may expand it by additional guarantees at their discretion
and at their own expense.
Shenzhen Aeon Technology Co., Ltd.
RM6H02, Block 27-29 Tianxia IC Industrial Park,
Majialong No.133 of Yiyuan road, Nantou Street
Nanshan District, Shenzhen, China.
Shanghai International Holding
Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Distributed by
Bird Healthcare Pty Ltd.
18 Corporate Blvd,
Bayswater VIC Australia 3153
P: 1300 365 561 ([phone])
F: 1300 949 815 ([phone])
E: [email protected]