Instructions to User
Dear Users, thank you very much for purchasing our product.
This Manual is written and compiled in accordance with the
council directive MDD93/42/EEC for medical devices and
harmonized standards. The Manual is written for the current Pulse Oximeter. In case of modifications and software upgrades, the
information contained in this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter's features and requirements, main structure, functions,
specifications, correct methods for transportation, installation, usage, operation, repair, maintenance and storage, etc. as well as
the safety procedures to protect both the user and equipment. Refer to the respective chapters for details.
Please read the Manual very carefully before using this equipment. These instructions describe the operating procedures to be
followed strictly, failure to follow these instructions can cause measuring abnormality, equipment damage and personal injury.
The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality, personal
injury and equipment damage due to user's negligence of the operation instructions. The manufacturer’s warranty service does not
cover such faults.
Owing to the forthcoming renovation, the specific products you received may not be totally in accordance with the description of
this User Manual. We would sincerely regret for that.
This product is medical device, and can be used repeatedly. Its using life is 3 years.
WARNING:
The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the microcirculation
barrier patients. It is recommended that the sensor should not be applied to the same finger for over 2 hours.
For the individual patients, there should be a more prudent inspecting in the placing process. The device can not be
clipped on the edema and tender tissue.
The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user and the maintenance
man, can not stare at the light.
Testee can not use enamel or other makeup.
Testee’s fingernail can not be too long.
Please peruse the relative content about the clinical restrictions and caution.
This device is not intended for treatment.
Caution: Federal law restricts this device to sale by or on the order of a physician.
1 Safety
1.1 Instructions for Safe Operations
Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient's
safety and monitoring performance about cables and transducers. It is recommended that the device should be inspected
once a week at least. When there is obvious damage, stop using the monitor.
Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted to maintain it by
themselves.
The oximeter cannot be used together with devices not specified in User's Manual.Only the accessory that appointed or
recommendatory by manufacture can be used with this device.
This product is calibrated before leaving factory.
1.2 Warnings
Explosive hazard—DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic
agents.
DO NOT use the oximeter while the testee measured by MRI and CT.
The person who is allergic to rubber can not use this device.
The disposal of scrap instrument and its accessories and packings(including battery, plastic bags, foams and paper boxes)
should follow the local laws and regulations.
Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list,
or else the device may have the possibility of working abnormally.
Please don't measure this device with function test paper for the device's related information.
1.3 Attentions
Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
If the oximeter gets wet, please stop operating it.
When it is carried from cold environment to warm or humid environment, please do not use it immediately.
DO NOT operate keys on front panel with sharp materials.
High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to User Manual in the relative
chapter for instructions of cleaning and disinfection.
Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface with medical alcohol by soft
material. Do not spray any liquid on the device directly.
When cleaning the device with water, the temperature should be lower than 60
℃
.
As to the fingers which are too thin or too cold, it would probably affect the normal measure of the patients' SpO
2
and pulse
rate, please clip the thick finger such as thumb and middle finger deeply enough into the probe.
Do not use the device on infant or neonatal patients.
The product is suitable for children above four years old and adults (Weight should be between 15kg to 110kg).
The device may not work for all patients. If you are unable to achieve stable readings, discontinue use.
The update period of data is less than 5 seconds, which is changeable according to different individual pulse rate.
The waveform is normalized.Please read the measured value when the waveform on screen is equably and steady-going,
Here this measured value is optimal value. And the waveform at the moment is the standard one.
If some abnormal conditions appear on the screen during test process, pull out the finger and reinsert to restore normal use.
The device has normal useful life for three years since the first electrified use.
The hanging rope attached the product is made from Non- allergy material, if particular group are sensitive to the hanging
rope, stop using it. In addition, pay attention to the use of the hanging rope , do not wear it around the neck avoiding cause
harm to the patient.
The instrument dose not have low-voltage alarm function, it only shows the low-voltage.please change the battery when
the battery energy is used out.
When the parameter is particularly, The instrument dose not have alarm function.Do not use the device in situations where
alarms are required.
Batteries must be removed if the device is going to be stored for more than one month, or else batteries may leak.
A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.
1.4 Indication for Use
The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin
(SpO
2
) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in
internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring.
2 Overview
The pulse oxygen saturation is the percentage of HbO
2
in the total Hb in the blood, so-called the O
2
concentration in the blood. It
is an important bio-parameter for the respiration. For the purpose of measuring the SpO
2
more easily and accurately, our company
developed the Pulse Oximeter. At the same time, the device can measure the pulse rate simultaneously.
The 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.
2.1 Classification
Class II b, (MDD93/42/EEC IX Rule 10)
2.2 Features
Operation of the product is simple and convenient.
The product is small in volume, light in weight (total weight is about 50g including batteries) and convenient in carrying.
Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for
20 hours.
The product will automatically be powered off when no signal is in the product within 5 seconds.
4 directions display mode without waveform.
Waveform display mode as line drawing or filling manner.
2.3 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through finger, and indicate the pulse
intensity by the bar-display. The product is suitable for use in family, hospital (Ordinary sickroom), Oxygen Bar, social medical
organizations and also the measure of saturation oxygen and pulse rate.
The product is not suitable for use in continuous supervision for patients.
The problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon
monoxide, the device is not recommended to be used under this circumstance.
2.4 Environment Requirements
Storage Environment
a) Temperature: -40
℃
~+60
℃
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) Temperature: 10
℃
~40
℃
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700hPa~1060hPa
3 Principle and Caution
3.1 Principle of Measurement
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 (Hb) and Oxyhemoglobin (HbO
2
) in glow &
near-infrared zones. Operation principle of the instrument is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in
accordance with Capacity Pulse Scanning & Recording Technology, so that two beams of different wavelength of lights 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 screen through treatment in electronic circuits and
microprocessor.
Figure 1 Operating principle
3.2 Caution
1.
The finger should be placed properly (see the attached illustration of this manual, Figure 5), or else it may cause inaccurate
measurement.
2.
The SpO
2
sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position there
between
．
3.
The SpO
2
sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving
intravenous injection.
4.
Make sure the optical path is free from any optical obstacles like rubberized fabric.
5.
Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct
sunlight and etc.
6.
Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.
7.
Testee can not use enamel or other makeup.
3.3 Clinical Restrictions
1.
As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject is required. For a subject
with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO
2
waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to interference.
2.
For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid indigo blue), or
carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem,
the SpO
2
determination by this monitor may be inaccurate.
3.
The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for serious error of
SpO
2
measure.
4.
As the SpO
2
value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some patients with serious
anemia may also report good SpO
2
measurement.
4 Technical Specifications
1)
Display Format:
OLED Display;
SpO
2
Measuring Range:
0% ~ 100%;
Pulse Rate Measuring Range:
30 bpm ~ 250 bpm;
Pulse Wave Display:
columniation display and the waveform display.
2)
Power Requirements:
2×1.5V AAA alkaline battery (or using the rechargeable battery instead), adaptable range:
2.6V~3.6V.
3)
Power Consumption:
Smaller than 30mA.
4)
Resolution:
1% for SpO
2
and 1 bpm for Pulse Rate.
5)
Measurement Accuracy:
±2% in stage of 70%-100% SpO
2
, and meaningless when stage being smaller than 70%. ±2 bpm
during the pulse rate range of 30-99 bpm and ±2% during the pulse rate range of 100~250 bpm .
6)
Measurement Performance in Weak Filling Condition:
SpO
2
and pulse rate can be shown correctly when pulse-filling
ratio is 0.4%. SpO
2
error is ±4%, pulse rate error is ± 2 bpm during the pulse rate range of 30~99 bpm and ±2% during the
pulse rate range of 100~250 bpm .
7)
Resistance to surrounding light:
The deviation between the value measured in the condition of man-made light or indoor
natural light and that of darkroom is less than ±1%.
8)
It is equipped with a function switch. The Oximeter can be powered off in case no finger is the Oximeter within 5 seconds.
9)
Optical
Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
5 Accessories
One hanging rope;
Two batteries(optional)
One User Manual.
6 Installation
6.1 View of the Front Panel
Figure 2 Front view Figure 3 Batteries installation Figure 4 Mounting the hanging rope
6.2 Battery
Step 1. Refer to Figure 3. and insert the two AAA size batteries properly in the right direction.
Step 2. Replace the cover.
Please take care when you insert the batteries for the improper insertion may damage the device.
6.3 Mounting the Hanging Rope
Step 1. Put the end of the rope through the hole.
Step 2. Put another end of the rope through the first one and then tighten it.
7 Operating Guide
1)
Insert the two batteries properly to the direction, and then replace the cover.
2)
Open the clip as shown in Figure 5.
Figure 5 Put finger in position
3)
Let the patient’s finger put into the rubber cushions of the clip (make sure the finger is in the right position), and then clip
the finger.
4)
Press the switch button once on front panel.
5)
Do not shake the finger and keep the patient at ease during the process. Meanwhile, human body is not recommended in
movement status.
6)
Get the information directly from screen display.
7)
The button
has three functions.When the device is power off, pressing the button can open it; When the device is
power on, pressing the button shortly can change direction of the screen; When the device is power on, pressing the button
long can change brightness of the screen.
Press the button shortly when the device is power on, the display mode will change, show as follow figure:
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