Instructions to User

Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter.
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for
medical devices and harmonized standards. 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 User Manual carefully before using this product. The User Manual which describes
the operating procedures should be followed strictly.Failure to follow the User Manual may cause
measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible
for the safety, reliability and performance issues and any monitoring abnormality, human injury and
equipment damage due to users' 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, which can be used repeatedly.
WARNING:
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 special 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 should not stare at the light.
Testee can not use enamel or other makeup.
Testee’s fingernail can not be too long.
Please refer to the correlative literature about the clinical restrictions and caution.
This device is not intended for treatment.
The User Manual is published by our company. All rights reserved.
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CONTENTS
1 Safety ........................................................................................................................................................ 1
1.1 Instructions for safe operations .......................................................................................................... 1
1.2 Warning .............................................................................................................................................. 1
1.3 Attention ............................................................................................................................................. 1
2 Overview .................................................................................................................................................. 2
2.1 Features .............................................................................................................................................. 2
2.2 Major applications and scope of application ...................................................................................... 2
2.3 Environment requirements ................................................................................................................. 3
3 Principle ................................................................................................................................................... 3
4 Technical specifications ........................................................................................................................... 4
4.1 Main performance .............................................................................................................................. 4
4.2 Main Parameters ................................................................................................................................. 4
5 Installation ............................................................................................................................................... 5
5.1 View of the front panel ....................................................................................................................... 5
5.2 Battery installation ............................................................................................................................. 6
5.3 Accessories ......................................................................................................................................... 6
6 Operating Guide ...................................................................................................................................... 6
6.1 Application method ............................................................................................................................ 6
6.2 Attention for operation ..................................................................................................................... 10
6.3 Clinical restrictions .......................................................................................................................... 11
、
7 Maintain transportation and storage ................................................................................................ 11
7.1 Cleaning and Disinfecting ................................................................................................................ 11
7.2 Maintain ........................................................................................................................................... 11
7.3 Transportation and storage ............................................................................................................... 12
8 Troubleshooting ..................................................................................................................................... 12
9 Key of Symbols ...................................................................................................................................... 13
10 Function Specification ......................................................................................................................... 14
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1.1
Safety
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 device.
Necessary maintenance must be performed by qualified service engineers ONLY. There are no
user serviceable parts and 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
Warning
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.
Be careful with the use of the lanyard cord. Improper use of the lanyard cord will cause device
damage not covered under the manufacturer’s warranty. Swinging the device by the lanyard cord
will void the warranty. Please do not use lanyard cord if allergic to lanyard cord.
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 choose the accessories and probe which are approved or manufactured by the
manufacturer, or else it may damage the device.
Please don't measure this device with functional tester for the device's related information.
1.3 Attention
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 (7.1)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' SpO2 and pulse rate, please clip the thick finger such as thumb and middle finger
deeply enought into the probe.
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The update period of data is less than 5 seconds, which is changeable according to different
individual pulse rate.
Please read the measured value when the waveform on screen is equably and steady-going,
This measured value is optimal value. And the waveform at the monment 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 to the device 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 on the purpose of avoiding harm to the patient.
This device has the function of alarming, users can check on this function according to chapter
6.2 as a reference.
The device has the function of limits alarming, when the measured data is beyond the highest
or lowest limit, the device would start alarming automatically on the premise of the alarming
function is on.
The device has the function of alarming, this function can either be paused, or closed (default
setting) for good.This function could be turned on through menu operation if you need.Please check
the chapter 6.2 as a reference.
The device may not work for all patients. If you are unable to achieve stable readings,
discontinue use.
A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.
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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. A number of diseases
relating to respiratory system may cause the decrease of SpO2 in the blood, furthermore, some other
causes such as the malfunction of human body's self-adjustment, damages during surgery, and the
injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in
human body, and the corresponding symptoms would appear as a consequence, such as vertigo,
impotence, vomit etc. Serious symptoms might bring danger to human's life. Therefore, prompt
information of patients' SpO2 is of great help for the doctor to discover the potential danger, and is of
great importance in the clinical medical field.
The Pulse Oximeter features in small volume, low power consumption, convenient operation and
being portable.It is only necessary for patients to put one of his fingers into a probe for diagnosis, and
a display screen will directly show the measured value of pulse oxygen saturation with the high
veracity and repetition.
2.1 Features
A. Operation of the product is simple and convenient.
B. The product is small in volume, light in weight and convenient in carrying.
C. Low power consumption
2.2
Major applications and scope of application
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through
finger. The product is suitable for being used in family, hospital, oxygen bar, community healthcare,
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physical care in sports (It can be used before or after doing sports, and it is not recommended to use
the device during the process of having sport) and etc.
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.
2.3 Environment requirements
Storage Environment
a) Temperature :-40℃～+60℃
b) Relative humidity :5%～95%
c) Atmospheric pressure :500hPa～1060hPa
Operating Environment
a) Temperature:10℃～40℃
b) Relative Humidity :30%～75%
c) Atmospheric pressure:700hPa～1060hPa
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Principle
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-infrared zones. Operation principle of
the device 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.
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4.1
Technical specifications
Main performance
A. SpO2 value display
B. Pulse rate value display, bar graph display
C. Pulse waveform display
D. Low-voltage indication: low-voltage indicator appears before working abnormally which is due
to low-voltage
E. Automatically power off function: when the device is under the state of measuring interface . it
will automatically power off within 5 seconds if the finger falls out of probe.
F. The display mode can be changed
G. A pulse rate sound indication
H. With alarm function
I. With SpO2 value and pulse rate value of storage, the stored data can be uploaded to computers
J. Data can be transmitted to computers
4.2
Main Parameters
A. Measurement of SpO2
Measuring range: 0%～100％
Accuracy:
When the SpO2 measuring range is 70%～100％,the permission of absolute error is ±2％；
below 70% unspecified
B. Measurement of pulse rate
Measuring range:30bpm～250bpm
Accuracy: ±2 bpm or ±2% (select larger)
C. Resolution
SpO2 : 1%, Pulse rate: 1bpm.
D. Measurement Performance in Weak Filling Condition
SpO2 and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2 error is ±4%,
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pulse rate error is ±2 bpm or ±2% (select larger).
E. 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%.
F. Power supply requirement: : 2.6 V DC ~ 3.6V DC.
G. Optical Sensor
Red light (wavelength is 660nm，6.65mW)
Infrared (wavelength is 880nm,
H. Adjustable alarm range:
SpO2
：
6.75mW)
0%~100%
Pulse Rate: 0bpm~250bpm
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5.1
Installation
View of the front panel
Figure 2. front view
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5.2 Battery installation
A. Refer to Figure 3. and insert the two AAA size batteries properly in the right direction.
B. Replace the cover.
Please take care when you insert the batteries for the improper insertion may damage
the device.
Figure 3.
5.3 Accessories
A.
B.
C.
D.
E.
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a hanging rope
two dry batteries(AAA)
a user manual
a data line
a disk (PC software)
Operating Guide
6.1 Application method
A.
a) Insert the two batteries properly to the direction, and then replace the cover.
b) Open the clip as shown in Figure 4.
c) 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.
d) Do not shake the finger and keep the patient in a stable state during the process.
e) The data can be read directly from the screen on the measuring interface.
Fingernails and the luminescent tube should be on the same side.
If the alarm function is on,the device will provide midium-priority alarm signal when
finger is out
。Intermittent
alarm will occur and the user interface
presents "FINGER
OUT".
Medium priority indicating that prompt operator response is required.
Figure 4.
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Put finger in position
B. Change display direction
On the measuring interface, short press the button to change the display.
C. Pause alarm:
a) Alarm including the alarm of measure data's going beyond the limits, the alarm of low-voltage,
the alarm of finger's out of position.
b) On the measuring interface, if the alarm function is on, during the period of alarming, you can
pause it by pressing the button shortly, but the function will be renewed in about 30 seconds.
c) If you want to turn off the alarm for good, you should enter the menu for operation.
D.
Data transmission setting
Firstly, please install the affiliated software into the computer, and two icons would appear on the
desktop after installation. The icon of "SpO2 "is a program for receiving real-time data which is
shown as figure 5; the icon of "SpO2 Review" is a program for receiving stored data which is shown
as figure 6.
a. Please connect the device to computer with the affiliated data line , then double click the "SpO2
"icon to start the program.
b. When you unplug the data line from computer, there is a dialog box "Save data at view"
appearing on the desktop, in which you can input some patient's basic information.
Figure 5. SpO2 program
Figure 6. SpO2 Review program
If the users choose to turn on the synchronizing display function on computer, it would
probably take several seconds for the data to appear on the computer screen.
E.
Menu operations
On the measuring interface, , the display direction can be changed by pressing the power button with
a short push (click). There are six modes of data display that can be viewed.
Press the power button with a prolonged push (1 second) to enter the Settings Menu Interface (see
Figure7).
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The user can setup the following parameters in the Settings Menu –Turn on alarm,turn on pulse
sound, alarm high-low limits, data storage (recording).
Please note in the Settings Menu:
CLICK = short press of power button
and PRESS = prolonged push of power button (1sec)
Figure 7. Main Menu Interface
a) Alarm setting
On the main menu interface, click the power button to select “Alarm”, Press the power button (1sec)
to enter the alarm setting interface as shown in Figure 8:
Figure 8.
a. Adjusting the high and low limits of alarms
On the alarm setting interface,Click the power button to select “Dir”, then Press the button (1sec) to
enter the alarm direction setting interface as shown in Figure 9:
Figure 9.
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On the alarm direction setting interface,Click the power button to select “SpO2
Alm”or “PR
Alm”,then Press the button (1sec) to enter the SpO2 or PR direction setting interface as shown in
Figure 10:
Figure 10.
Click the power button to select “Dir”, then Press the button to choose Up or Down (this will be the
direction the value of the high-low limits of SpO2 and pulse rate will be adjusted)
To raise the SpO2 and pulse rate limit, choose “Dir” as ‘Up’, then Click the power button to select
high limit (High) or low limit (Low), Press the power button and hold to adjust the selected limit to
the desired higher value and release the power button once the higher limit has been reached.
To lower the SpO2 and pulse rate limit, choose “Dir” as ‘Down’, then Click the power button to
select high limit (High) or low limit (Low). Press the power button and hold to adjust the selected
limit to the desired lower value and release the power button once the lower limit has been reached.
If the alarm function is on,the device will provide midium-priority alarm signal when the
data of SpO2 or pulse rate is beyond the limit. Intermittent alarm will occur and the measuring
value will be flashing.
b.
Medium priority indicating that prompt operator response is required.
Pulse sound indication setting
On the alarm setting interface as shown in Figure 8:,Click the power button to select “Psound”, then
Press the power button to choose to have the Pulse Sound (heart beat) alarm “on” or “off”.
c. The alarm state setting
On the alarm setting interface as shown in Figure 8,Click the power button to select “Alarm”, then
Press the power button to choose alarm on or off, press “ on” to turn on the alarms and “ off” to turn
off the alarms.
d. Exit the Alarm settings , the alarm direction setting , the SpO2 or PR direction setting
Click the power button to select “Exit”, then Press the power button to exit the Menu and return
the previous Menu .
b）
to
Data storage setting
This instrument has the ability to store 24 hours worth of data. It can store the measured pulse rate
and SpO2 value accurately, transfer the data to the computer, display the data and print reports (with
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the included SpO2 Software - Green Heart)
a. On the main menu interface as shown in Figure 7, Click the button to select “Record”, then
press the button to choose whether store the data or not, choose “on” to permit storing, choose “off ”
to forbid storing.
b. If the data storage function is being turned on, when return to the measuring interface, a flashing
yellow dot would appear on screen, which means the device is in a state of storing.
c. In the state of storing, the device is on measuring interface, the sign "Recording" would appear
on the screen in 30 seconds, and then the screen will be automatically shut down, only a flashing
yellow dot appear on screen.If short press the button at this moment, the sign "Recording" would
appear on the screen, and then the screen will be automatically shut down again; if long press the
button, the device would return to the measuring interface.
d. If turning on the data storage function, the former data storage will be automatically removed.
e. When the storage space is full, it displays “Memory is full” on the screen, and then shut down in
a few seconds. But it will still display “Memory is full” by the next time you turn on the device on
the purpose of warning the user, and a few seconds later enter the measuring interface.
c）Uploading the data to the PC after recording
a. Please connect the device with computer by the data line which is equipped with the device,
then double click "SpO2 Review" icon which is shown as figure 5 to open"SpO2 Review" program,
click the ‘New Session’ Icon in the software, enter the patient data and then click ‘ok’. The
Software will then display “device connected, waiting for data”.
b. on the main menu interface,the users to upload the stored date to computer when the symbol
"Record" shows "off ".
d） Exit the main menu
On the main menu interface, Click the button to select "Exit", then press the button to exit the main
menu.
F. Power off
If the measuring finger out of the device on the measuring interface,The device will power off
automatically when it gets no signal within 5 seconds.The device can't being power off when it is in
a state of storing.
6.2
Attention for operation
A. Please check the device before using, and confirm that it can work normally.
B. The finger should be in a proper position (see the attached illustration of figure 4 for reference), or
else it may result in inaccurate measure.
C. The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject’ s
arteriole in a position there between.
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D. The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure
cuff or receiving intravenous injection.
E. Do not fix the SpO2 sensor with adhesive or else it may result in venous pulsation and inaccurate
measure of SpO2 and pulse rate.
F. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby
light, infrared heater, direct sunlight and etc.
G. Strenuous action of the subject or extreme electrosurgical interference may also affect the
accuracy.
H. Testee can not use enamel or other makeup.
I. Please clean and disinfect the device after operating according to the User Manual(7.1).
6.3 Clinical restrictions
A. 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 SpO2 waveform (PLETH) will decrease. In this
case, the measurement will be more sensitive to interference.
B. 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 SpO2 determination by this monitor
may be inaccurate.
C. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor
blamed for serious error of SpO2 measure.
D. 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.
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Maintain、transportation and storage
7.1 Cleaning and Disinfecting
Using medical alcohol to disinfect the device, nature dry or clean it with clean soft cloth.
7.2
Maintain
A. Please clean and disinfect the device before using according to the User Manual(7.1).
B. Please change the battery when the screen shows
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.
C. Take out the battery if leave the equipment unused for long time.
D. The device needs to be calibrated once a year (or according to the calibrating program of
hospital). It also can be performed at the state-appointed agent or just contact us for calibration.
7.3 Transportation and storage
A. The packed device can be transported by ordinary conveyance or according to transport contract.
The device can not be transported mixed with toxic, harmful, corrosive material .
B.
The packed device should be stored in room with no corrosive gases and good ventilation.
Temperature: -40°C~60°C; Humidity: ≤95%
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Troubleshooting
Trouble
Possible Reason
Solution
The SpO2 and Pulse
Rate can not be
displayed normally
1. The finger is not properly
positioned.
2. The patient’s SpO2 is too low to be
detected.
1. Place the finger properly and try
again.
2. Try again; Go to a hospital for a
diagnosis if you are sure the device
works all right.
The SpO2 and Pulse
Rate are not
displayed stably
1. The finger is not placed inside
deep enough.
2. The finger is shaking or the patient
is moving.
1. Place the finger properly and try
again.
2. Let the patient keep calm
The device can not
be turned on
1. The battery is drained away or
almost drained away.
2. The battery is installed incorrectly.
3. The device’s malfunction.
1.Please change batteries.
2.Please Install the battery again.
3. Please contact the local service
center.
The display is off
suddenly
1. This device is set to be
automatically power off within 5
seconds when it cannot detect any
signal
2. The battery is drained away or
almost drained away.
1. Normal
2.Please change batteries.
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9
Key of Symbols
Signal
Description
Warning – See User Manual
%SpO2
The pulse oxygen saturation(%)
PRbpm
Pulse rate (bpm)
Low-voltage
Open the alarm sound indication
Open the pulse sound indication
menu button/power button/function button
Type BF
SN
Serial number
1. the finger clip falls off ( no finger inserted)]
2. Probe error
3. Signal inadequacy indicator
battery positive electrode
battery cathode
USB
IPX1
Ingress of liquids rank
WEEE (2002/96/EC)
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Function Specification
Information
Display Mode
The Pulse Oxygen Saturation（SpO2）
2-digit digital OLED display
Pulse Rate（PR）
3-digit digital OLED display
Pulse Intensity (bar-graph)
bar-graph
OLED display
SpO2 Parameter Specification
Measuring range
0%～100%, (the resolution is 1%).
Accuracy
70%～100%：±2% ,Below 70% unspecified.
Average value
Calculate the Average value in every 4 measure value.
The deviation between average value and true value does not
exceed 1%.
Pulse Parameter Specification
Measuring range
30bpm～250bpm, (the resolution is 1bpm)
Accuracy
±2bpm or±2% (select larger)
Moving calculate the Average pulse rate every 4 cardio-beat,s
cycle.
The deviation between average value and true value does not
exceed 1%
Average pulse rate
Safety Type
Interior Battery，ＢＦType
Pulse Intensity
Range
Continuous bar-graph display, the higher display indicate the
stronger pulse.
Battery Requirement
1.5V (AAA size) alkaline batteries × 2
Battery working life
Two1.5V (AAA size)600mAh alkaline batteries can work continually for 24 hours
Dimensions and Weight
Dimensions
58.5(L) × 31(W) × 32 (H) mm
Weight
About 52g (with the batteries)
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