User's Manual
Fingertip
Pulse Oximeter
USER MANUAL
Ve
r
1.0C108
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. 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 low power consumption, convenient operation and portability. Place one fingertip i nto the
photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. 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 (HbO
2
) in red 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 red a
nd 905nm near
infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. A measured s ignal 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． 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． Pulse Oximeters require suf ficient blood fl ow to obtain proper readings. Poor blood circulation can result in inaccurate
readings. If your hands are cold or you have poor circulation, warm your hands by rubbing them together or use another
method before attempting to obtain a reading. A tourniquet, blood pressure cuff or other blood flow hindrances may also
result in inaccurate readings.
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． In order to ensure correct sensor alignment and skin integrity, the maximum application time at a single site for our device
should be less than half an hour.
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 for medical electrical equipment and/or
systems. 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 medical electrical equipment.
13． This equipment is not intended for use during patient transport outside the healthcare facility
14． This equipment should not be used adjacent to or stacked with other equipment.
15． It may be unsafe to：
—use accessories、detachable parts and materials not described in the instructions for use.
—interconnect this equipment with other equipment not described in the instructions for use.
—disassemble, repair or modify the equipment.
16． These materials that contact with the patient’s skin contain medical si licone and ABS plastic enclosure are all pass the
ISO10993-5 Tests for invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
17． When the signal is not stable, the reading may inaccurate. Please do not reference.
Rx only: “Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.”
Contraindication
It is not for continuous monitoring.
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 patient 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 patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
9. The patient is in cardiac arrest or is in shock.
10. Fingernail polish or false fingernails.
11. Weak pulse quality (low perfusion).
12. Low hemoglobin.
Product Features
1 Simple to operate and convenient to carry.
2 Small volume, light weight.
3 High brightness LEDs display SpO
2
, PR, Pulse bar .
4 2 display directi on.
5 2pcs AAA-size alkaline batteries; battery-low indicator.
6 Wireless Bluetooth for data transmission.
7 When low signal is detected or no operation, the pulse oximeter will power off automatically.
8 Compatible with iChoicelife App.
Intended Use
Fingertip pulse oximeter is a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO
2
) and
pulse rate of adult and pediatric patients in hospitals, hospital-type facilities.
Operation Instructions
1 Install two AAA batteries according to the Battery Installation instructions.
2 Place one of your fingers into the rubber opening of the pulse oximeter.
3 Press the switch button one time on front panel to turn the pulse oximeter on.
4 Keep your hands still for the reading. Do not shake your finger during the test. It is recommended that you do not move your
body while taking a reading.
5 Read the data from the display screen
After turning on the Oximeter, each time you press the power switch, the Oximeter will switch to another display mode.
Front Panel
The height of the bar graph indicates of the pulse and signal strength. The bar should be greater than 30% for a proper reading.
Data Transmission
1. The current measurement will transmit to the App automatically. After data transmission successfully, the measurement
flashing for 8s, then the device will power off automatically power off. If there is no Bluetooth connection over 1min, the
device will power off automatically and the data will not be stored.
2. If there is no reading, the device will power off automatically.
Notes:
1. With the Bluetooth 4.0 to transmit the data to App.
2. The transmission distance is 10m at most.
Battery Installation
1. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) sign
s
in the compartment. If the polarities are not matched, damage may be caused to th
e
oximeter.
2. Slide the battery door cover horizontally along the arrow shown as the picture.
Notes:
Please remove the batteries if the pulse oximeter will not be used for long periods of time.
Please replace the battery when the power indicator starting flickering.
Using the Lanyard
1. Thread thinner end of the lanyard through the hanging hole.
2. Thread thicker end of the lanyard through the threaded end before pulling i
t
tightly.
Warnings!
Keep the oximeter away from young children. Small items such as the batter
y
door, battery, and lanyard are choking hazards.
Do not hang the lanyard from the device’s electrical wire.
Please notice that the lanyard which is tied to the oximeter may caus
e
strangulation due to excessive length.
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 in diagnosis for patients.
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.
Cleaning the fingertip pulse oximeter
Please use medical alcohol to clean the silicone touching the finger inside of oximeter with a soft cloth dampened with 70%
isopropyl alcohol. Also clean the being tested finger using alcohol before and after each test.
Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device. Allow the oximeter to
dry thoroughly before reuse.
The fingertip pulse oximeter requires no routine calibration or maintenance other than replacement of batteries.
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.
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. Clinical testing is used to establish
the SpO
2
accuracy. The measured arterial hemoglobin saturation value (SpO
2
) of the sensors is compared to arterial hemoglobin
oxygen (SaO
2
) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to
the CO-oximeter samples measured over the SpO
2
range of 70%~100%. Accuracy data is calculated using the root-mean-squared
(Arms value) for all subjects, per ISO 9919:2005, Medical Electrical Equipment–Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use.
A functional tester is used to measure how accurately Fingertip Pulse Oximeter is reproducing the specified calibration curve and
the PR accuracy.
The model of functional tester is Index2 FLUKE simulator and the version is 2.1.3.
Specifications
1. Display Type
LED display
2. SpO
2
Display range: 35%~99%
Measurement range: 70%~99%
Accuracy: 70%~99%: ±2%; 0%~69% no definition
Resolution: 1%
A
RMS
Value Analysis
Item 70--100 90--100 80--<90 70--<80
#pts 231 82 89 60
Bias 1.10 0.49 1.35 1.62
A
RMS
1.68 1.09 1.77 2.14
Bland-Altman plot analysis of sampled data points on all subjects as below
MD
300C
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