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 har
monized standards. The Manual is written for the current Pulse Oximeter
the information contained in this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter’
ications, correct methods for transportation, installation, usage, operation, repair
the safety procedures to pr
Please read the Manual very carefully befor
be followed strictly
injury
personal injury and equipment damage due to user’
service does not cover such faults.
Owing to the forthcoming renovation, the specic products you r
tion of this User Manual. W
This product is medical device, and can be used repeatedly
WARNING:
patients. It is recommended that the sensor should not be applied to the same nger for over 2 hours.
clipped on the edema and tender tissue.
can not stare at the light.
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 af
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 qualied service engineers ONL
by themselves.
• The oximeter cannot be used together with devices not specied 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 envir
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
boxes) should follow the local laws and regulations.
• Please check the packing before use to make sur
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’
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.
chapter for instructions of cleaning and disinfection.
material. Do not spray any liquid on the device directly
When cleaning the device with water, the temperatur
As to the ngers which are too thin or too cold, it would probably af2 and
pulse rate, please clip the thick nger such as thumb and middle nger 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 (W
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.
Here this measured value is optimal value. And the waveform at the moment is the standar
If some abnormal conditions appear on the screen during test process, pull out the nger and reinsert to r
use.
The device has normal useful life for three years since the rst electried use.
rope, stop using it. In addition, pay attention to the use of the hanging rope , do not wear it ar
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.
alarms are requir
Batteries must be removed if the device is going to be stored for more than one month, or else batteries may leak.
A exible 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 hemo-
globin (SpO2 ) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in
internist/surgery
2 Overview
The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the
blood. It is an important bio-parameter for the respiration. For the purpose of measuring the SpO2 more easily and accu-
rately
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 ngers into a ngertip photoelectric sensor for diagnosis, and a display screen will
directly show measured value of Hemoglobin Saturation.
2.1 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 enter standby mode when no signal is in the product within 5 seconds.
• Display direction can be changed automatically
2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through nger
pulse intensity by the bar
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 suf
oxide, the device is not recommended to be used under this circumstance.
2.3 Environment Requirements
Storage Environment
a)T
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) T
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 (HbO2 ) in glow &
near
ed in accordance with Capacity Pulse Scanning & Recording T
can be focused onto human nail tip through perspective clamp nger
by a photosensitive element, information acquired through which will be shown on scr
circuits and micropr
Figure 1 Operating principle
3.2 Caution
1. The nger should be placed properly (see the attached illustration of this manual, Figure 5), or else it may cause inaccurate
measurement.
2. 2 sensor and photoelectric receiving tube should be arranged in a way with the subject’
there between.
3. The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or r
intravenous injection.
4.
5. Excessive ambient light may affect the measuring result. It includes uor
direct sunlight and etc.
6.
7.
3.3 Clinical Restrictions
1.
ject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug,
the SpO2 waveform (PLETH) will decrease. In this case, the measurement will be mor
2.
or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus
problem, the SpO2 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 SpO2 measure.
4. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some patients with
serious anemia may also report good SpO2 measurement.
4 T
1) Display Format: LCD Display;
SpO2 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) Smaller than 30mA.
4) Resolution: 1% for SpO2 and 1 bpm for Pulse Rate.
5) ±2% in stage of 70%-100% SpO2 , 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) SpO2 and pulse rate can be shown corr
ratio is 0.4%. SpO2 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 measur
natural light and that of darkroom is less than ±1%.
8) It is equipped with a function switch: The product will enter standby mode when no signal is in the product within 5
seconds.
9)
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 905nm, 6.75mW)
5 Accessories
• One hanging rope
• T
• 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 dir
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, as shown in Figur
Step 2. Put another end of the rope through the rst one and then tighten it.
7 Operating Guide
1) Insert the two batteries pr
2) Open the clip as shown in Figur
Figure 5 Put nger in position
3) Let the patient’
the nger
4) Pr
5) Do not shake the nger and keep the patient at ease during the process. Meanwhile, human body is not r
movement status.
6) Get the information dir
7)
operation status, pressing the button long can change brightness of the screen.
8) The device could change display dir
Fingernails and the luminescent tube should be on the same side.
Glow and Infrared-ray
Emission T
Glow and Infrared-ray
Receipt T
User manual
OXY
PROFESSIONAL MEDICAL PRODUCTS
Pulse rate
bar graph
Waveform
Pulse
rate
The display SpO2
