OPERATOR’S
MANUAL
V4.0C1
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
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.
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.
11
Significant levels of dysfunctional hemoglobins (such as carbonxy- hemoglobin or
methemoglobin) may affect the readings.
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 inaccurate readings.
15
High-frequency electrosurgical interference may cause inaccurate readings.
16
Venous pulsations may cause inaccurate readings.
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 SpO
2
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 and convenient in carrying.
3
Power consumption of the product is low and the two AAA batteries can be
operated continuously for 30 hours.
4
A 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
Fingertip PULSE OXIMETER is a portable non-invasive, spot-check, oxygen saturation
of arterial hemoglobin (SpO
2
) and pulse rate of adult and pediatric patient at home, and
hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). It is
not for continuously monitoring.
The PULSE OXIMETER requires no routine calibration or maintenance other than
replacement of batteries.
Operation Instructions
1
Install two AAA batteries into battery cassette before closing its cover.
2
Place clamp over finger nail as the following diagram.
3
Insert one finger into rubber hole of the Oximeter fully.
4
Press the switch for one time on front panel.
5
Finger and body should not tremble during measuring.
6
Read corresponding data on the display screen.
Note:
Please use medical alcohol to clean the rubber, inside the Oximeter, that touches
the finger. Also, clean the test finger with alcohol before and after each test. (The rubber
inside of the Oximeter is medical rubber, which has no toxins, and is not harmful to the
skin).
When your finger is inserted into the Oximeter, your nail
surface must be upward.
Operation Instructions
The Pulse bar graph displays corresponding with the patient
’s pulse beat. The height of
the bar graph shows the patient
’s pulse strength.
Product Accessories
1.
One strap
2.
Two batteries
3.
One user
’s manual
Battery Installation
1.
Put the two AAA batteries into battery compartment in correct polarities.
2.
Push the battery cover horizontally along the arrow shown as below:
Notes:
Battery polarities should be correctly installed.
Otherwise, damage may be caused to the
device.
Please put in or remove batteries in right
order, or may cause damage to the device
bracket.
Please remove the batteries if the Oximeter
will not be used for a long time.
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.
Calibrating the pulse oximeter
1.
The functional tester cannot be used to assess the accuracy of the oximeter.
2.
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.
3.
Index 2 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.
MD300C1
