OPERATOR’S MANUAL
VER1.0C615
Fingertip Pulse Oximeter
General Description
Oxygen Saturation is a percentage of Oxyhemoglobin (HbO2) capacity, compounded
with oxygen, by all combinative hemoglobin (Hb) capacity in blood. In other words, it
is consistency of Oxyhemoglobin in blood. It is a very important parameter for the
Respiratory Circulation System. Many respiratory diseases can result in oxygen
saturation being lowered in human blood. Additionally, the following factors can
reduce oxygen saturation: Automatic regulation of organ dysfunction caused by
Anesthesia, Intensive Postoperative Trauma, injuries caused by some medical
examinations. That situation might result in light-headedness, asthenia, and vomiting.
Therefore, it is very important to know the oxygen saturation of a patient so that
doctors can find problems in a timely manner.
The fingertip pulse Oximeter features small size, low power consumption, convenient
operation and portability. It is only necessary for a patient to put one of his fingers into
the fingertip photoelectric sensor for diagnosis, and a display screen will show oxygen
saturation. It has been proven in clinical experiments that it also features high
precision and repeatability.
Measurement Principle
Principle of the Oximeter is as follows: A mathematical formula is established making
use of Lambert Beer Law according to Spectrum Absorption Characteristics of
Reductive hemoglobin(RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared
zones. Operation principle of the instrument: 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 a human nail tip through a clamping
finger-type sensor. A measured signal obtained by a photosensitive element, will be
shown on the Oximeter’s display through process in electronic circuits and
microprocessor shown on the Oximeter’s display through electronic circuits and a
microprocessor.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube
Product Operation Scope
Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of
arterial hemoglobin (SpO
2
) and pulse rate of adult and pediatric patients at home, and
hospital (including clinical use in internal medicine/surgery, anesthesia, intensive care
and etc). The device is not intended for continuously monitoring.
The PULE OXIMETER requires no routine calibration or maintenance other than
replacement of batteries.
Technical Specifications
1. Display:
LED
2. SpO
2
:
Measurement range
：
70
～
99%
Accuracy
：
70%
～
99%, ±3%; <70% no definition
3. Pulse Rate:
Measure range
：
30~235 bpm
Accuracy
：
30~100bpm ±2bpm; 101~235bpm, ±2%
Pulse Intensity: Bar graph Indicator
4. 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.
5. Dimension:
Length: 58mm
Width: 32mm
Height: 37mm
Weight: 33g (without batteries)
6. Environment Requirements:
Operation Temperature: 5
～
40
℃
Storage Temperature: -20
～
55
℃
Ambient Humidity:
≤
80%, no condensation in operation;
≤
93%, no condensation in storage
7.Measurement Performance in Low Perfusion Condition:
The pulse wave is
available without failure when the simulation pulse wave amplitude is at 0.6% using
the test equipment (BIO-TEK INDEX Pulse Oximeter Tester).
8.Interference Resistance Capacity against Ambient Light:
Device works
normally when mixed noise produced by BIO-TEK INDEX Pulse Oximeter Tester.
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 SpO
2
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 SpO
2
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 may cause accurate readings.
15
Venous pulsations may cause accurate readings.
16
Placement of a sensor on an extremity with a blood pressure cuff, arterial
catheter, or intravascular line may cause accurate readings.
17
The patient has hypotension, severe vasoconstriction, severe anemia, or
hypothermia.
18
The patient is in cardiac arrest or in shock.
19
Fingernail polish or false fingernails may cause inaccurate SpO
2
readings.
Follow local ordinances and recycling instructions regarding disposal or
recycling of the device and device components, including batteries.
Product Properties
1. Easy to use.
2. Small in volume, light in weight.
3. Lower power consumption.
4. Low voltage warning will be indicated in visual window when battery voltage is low.
5. The product will automatically be powered off when no signal is in the product for
longer than 8 seconds.
Operation Instructions
1. Install two AAA batteries into battery cassette, and then close its cover.
2. Open the clamp as shown in the picture below.
3. Insert one finger into the flexible fingertip of the Oximeter fully.
4. Press the power switch once on the front panel.
5. The patient’s finger should remain still while the Oximeter is working.
6. Read corresponding data from display screen.
When you insert a finger into the Oximeter, your nail surface must be upward.
NOTE:
Please use the medical alcohol to clean the rubber touching the finger inside of
Oximeter, and clean the test sensor using alcohol before and after operation. (The
rubber inside of the Oximeter is medical rubber, which has no toxin and no harm to the
skin of human being).
Product Accessories
1. One strap
2. Two batteries
3. One user’s manual
Strap Installation
1. Thread thinner end of the strap through the loop.
2. Thread thicker end of the strap through the threaded end before pulling it tightly.
Brief Description of Front Panel
