Fingertip
Pulse Oximeter
USER MANUAL
Ver1.0C11
General Description
Oxygen Saturation is a percentage of Oxyhemoglobin (HbO
2
) 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. Therefore, it is very important to know the oxygen saturation.
The fingertip pulse oximeter features low power consumption, convenient operation and portability. Place one fingertip into the
photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display.
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.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube
Precautions For Use
1
Before use, carefully read the manual.
2
Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
3
The fingertip pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO
2
measurement. Verify
that nothing is hindering the pulse measurement before relying on the SpO
2
measurement.
4
Do not use the fingertip pulse oximeter in an MRI or CT environment.
5
Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms. It is not for
continuous monitoring.
6
Do not use the fingertip pulse oximeter in an explosive atmosphere.
7
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.
8
Check the pulse oximeter sensor application site every 4 hours to determine the positioning of the sensor and circulation
and skin sensitivity of the patient.
9
Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not
intended for sterilization.
10
Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components,
including batteries.
11
This equipment complies with IEC 60601-1-2:2007 for electromagnetic compatibility . However, because of the proliferation
of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is
possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of
this device.
12
Portable and mobile RF communications equipment can affect the equipment.
Inaccurate measurements may be caused by
1
Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin);
2
Intravascular dyes such as indocyanine green or methylene blue;
3
High ambient light. Shield the sensor area if necessary;
4
Excessive user movement;
5
High-frequency electrosurgical interference and defibrillators;
6
Venous pulsations;
7
Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line;
8
The user has hypotension, severe vasoconstriction, severe anemia, or hypothermia;
9
The user is in cardiac arrest or is in shock;
10
Fingernail polish or false fingernails;
11
Weak pulse quality (low perfusion);
12
Low hemoglobin;
Product Properties
1
Operation of the product is simple and convenient.
2
The product is small in volume, light in weight and convenient to carry.
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 when battery voltage is low and normal operation of the oximeter might be
influenced.
5
The product will automatically power off when there is no signal for longer than 8 seconds.
Intended Use
Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin
(SpO
2
) and pulse rate.
Operation Instructions
1
Install two AAA batteries according to the Battery Installation instructions listed above in the right column.
2
Open the clamp as illustrated in the picture below.
3
Fully insert one fingertip into the silicone hole of the oximeter before releasing the clamp.
4
Press the switch button once on front panel.
5
Keep your finger still during measurement.
6
Read corresponding data from display screen.
Front Panel
The pulse bar graph displays corresponds with the user
’s pulse beat. The height of the bar graph shows the user’s pulse strength.
Product Accessories
1.
One lanyard
2.
Two AAA batteries
3.
One user
’s manual
Battery Installation
1.
Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-)
signs in the compartment. If the polarities are not matched, damage may be caused to
the oximeter.
2.
Slide the battery door cover horizontally along the arrow shown as the picture.
Notes:
Install the batteries with the correct polarity. Incorrect placement may cause damage to
the bracket.
Please remove the batteries if the pulse oximeter will not be used for long periods of time.
Using the Lanyard
1.
Thread thinner end of the lanyard through the loop.
2.
Thread thicker end of the lanyard through the threaded end before pulling it tightly.
Warnings!
Keep the oximeter away from young children. Small items such as the battery door,
battery, and lanyard are choking hazards.
Do not hang the lanyard from the
device’s electrical wire.
Maintenance and Storage
1.
Replace the batteries in a timely manner when low voltage lamp is lighted.
2.
Clean surface of the fingertip oximeter before it is used.
3.
Remove the batteries if the oximeter is not operated for a long time.
4.
It is best to store the product in -20
℃～+
55
℃
and
≤
93% humidity
.
5.
Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage.
6.
Dispose of battery properly; follow any applicable local battery disposal laws.
The use life of the device is five years when it is used for 15 measurements every day and 10 minutes per one
measurement. Stop using and contact local service center if one of the following cases occurs:
An error in the
Possible Problems and solutions
is displayed on screen.
The oximeter cannot be powered on in any case and not the reasons of battery.
There is a crack on the oximeter or damage on the display resulting readings cannot be identified; the spring is invalid; or the
key is unresponsive or unavailable.
Specifications
1. Display Type
LED display
2. SpO
2
Display range: 0-99%
Measurement range: 70-99%
Accuracy: 70%-99%: ±3%; 0%~69% no definition
Resolution: 1%
3. Pulse Rate
Display range: 0~254BPM
Measure range: 30-235 BPM
Accuracy: 30~99bpm, ±2bpm; 100~235bpm, ±2%
Resolution: 1BPM
4. Probe LED Specifications
Wavelength
Radiant Power
RED
660
±
2nm
1.8mW
IR
940
±
10nm
2.0mW
5. Power Requirements
Two AAA alkaline Batteries
Power consumption: Less than 25mA
Low power indication:
Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be continuously operated as long as 30 hours.
It is equipped with a function switch, through which the oximeter can be powered off in case no finger is the oximeter longer than 8
seconds.
6. Outline Dimension
Length: 56mm
Width: 32mm
Height: 30mm
Weight: 50g (including two AAA batteries)
7. Environment Requirements
Operation Temperature: 5
～
40
℃
Storage Temperature: -20
～+
55
℃
Ambient Humidity: 15%~80% in operation;
≤
93% in storage
8. Equipment Response Time
As shown in the following figure.
Response time of slower average is 12.4s.
9. Classification
According to the type of protection against electric shock: INTERNALLY POWERED EQUIPMENT;
According to the degree of protection against electric shock: TYPE BF APPLIED PART;
According to the method(s) of sterilization or disinfection recommended by the manufacturer: Equipment with method(s) of
sterilization or disinfection recommended by the manufacturer;
According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH
OXYGEN OR NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE.
According to the degree of protection against ingress of water: IPX1
According to the mode of operation: CONTINUOUS OPERATION
