OPERATOR’S
MANUAL
V1.0C3
Fingertip Pulse Oximeter
General Description
Haemoglobin Saturation is percentage of Oxyhemoglobin (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 fingertip pulse oximeter features in small volume, low power consumption, convenient operation and being portable. It is only
necessary for patient to put one of his fingers into a fingertip 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.
Measurement principle
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 (O2 Hb) 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.
Diagram of Operation Principle
1. Red and Infrared-ray Receipt Tube
2. Red and Infrared-ray Emission Tube
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 readings or skin
blisters.
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
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 or false fingernails may cause inaccurate SpO2 readings.
Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components,
including batteries.
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.
Product Operation Scope
The fingertip 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.
Operation Instructions
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:
1
2
3
4
5
6
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 and after each test. (The rubber inside of 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.
8
PR tone modulation function
9
LCD display
10
Adjustable brightness
11
Alarm:
Alarm range:
SpO2:<90
Pulse rate:
：
<60 or >100
Alarm mode: audio alarm and visual alarm
Visual alarm: The measuring value will be flashing when it is through over the alarm limitation.
Audio alarm: The audible alarms can be heard if there is no silence. The buzzer will beep shortly for two times when the
value excesses the alarm limitation.
Alarm silence:
When the audio alarm occurs, press the button and then the Oximeter will enter into the “alarm silence mode” for 30
seconds, and then there is only the visual alarm. This silence operating has only effect on the alarm sound not on the pulse
rate sound.
In the silence mode, press the button, and then the display mode will be changed.
It will exit the silence mode automatically when a new alarm occurs or the value is in the normal range again.
Brief Description of Front Panel
Low power indicator
SPO
2
waveform
Bar graph SpO
2
Pulse rate
It is apparent the pulse rate bar graph display corresponds with pulse rate.
Product Accessories
1. One hangs lace
2. Two batteries
3. One user manual
Battery Installation
1.
Put the two AAA batteries into battery cassette in correct polarities.
2.
Push the battery cover horizontally along the arrow shown as below:
Notes: Battery polarities must be correctly installed. Otherwise, damage might be caused to device.
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.
Hang Lace Installation
1.
Thread thinner end of the hang lace through the hanging hole.
2.
Thread thicker and of the lace through the threaded end before pulling it tightly.
Maintenance and Storage
1.
Replace the batteries timely when low voltage lamp is lighted.
2.
Clean surface of the fingertip 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
–10-40
℃
(14-104
℉
) and humidity is 10%-80%.
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.
Calibrating the pulse oximeter
1.
The functional tester cannot be used to assess the 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
calibration curve to measure the oximeter.
3.
The test methods used to establish the SpO
2
accuracy is clinical testing. The oximeter used to measure the arterial
haemoglobin oxygen saturation levels and these levels are to be compared to the levels determined from arterial blood
sampling with a CO-oximeter.
Declaration:
EMC of this product comply with IEC60601-1-1-2 standard
The materials which user can come into contact is no toxicity and no action on tissues, comply with ISO10993-1,-5,-10.
Detailed descriptions of product functions:
Function
Descriptions
Function
Descriptions
Display Type
LCD display
Declaration
EMC of this product comply with
IEC60601-1-2 standard.
SpO2
Measurement range:
：
70-99%
Accuracy
：
±2% on the stage of 80%-99%;
±3% on the stage of 70%-80%;
Measurement
Performance
in
Low
Perfusion
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 0.6%.
Pulse Rate
Measure range
：
30-235bpm
Accuracy
：
30-99bpm
±2bpm
；
100-235bpm ±2%
Pulse Intensity: Bargraph Indicator
Interference
Resistance
Capacity against
Ambient Light
Device work normally when mixed
noise
produced
by
BIO-TEK
INDEX Pulse Oximeter tester
Power
Requirements
Two AAA 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.
Environment
Requirements
Operation Temperature: 5-40
℃
Storage Temperature: -10-40
℃
Ambient Temperature:
15%-80% in operation
10%-80% in storage
Dimension
Length: 60mm Width: 34mm Height: 30mm Weight: 50g (including two AAA batteries)
PR tone modulation function
Adjustable brightness
Pulse signal strength indicator
Guidance and manufacture’s declaration – electromagnetic emissions-for all EQUIPMENT and SYSTEMS
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
– guidance
RF emissions
CISPR 11
Group 1
The
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.
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 used for domestic purposes.
Possible Problems and resolutions
Problems
Possible reason
Solution
SpO2 or PR
can not be
shown
normally
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
SpO2 or PR 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
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-emission 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
“Error7”
displayed on
screen
1. Low power
2. Emission tube damaged.
3. Current control circuit malfunction.
1 Please change battery
2 Please contact with local customer service center
3 Please contact with local customer service center
Symbol Definitions
Symbol
Definition
Symbol Definition
The equipment type is BF
Heart rate (BPM)
Refer to user manual before
application
Low power indication
SpO
2
﹪
Hemoglobin saturation
SN
Serial No