Oximetro Contec CMS60C User Manual
Oximetro Contec CMS60C User Manual
Oximetro Contec CMS60C User Manual
CMS60C
Pulse Oximeter
I
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.
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
Testee’’s fingernail can not be too long.
� Please refer to the correlative literature about the clinical restrictions and caution.
II
Contents
1Safety ............................................................................................................................................................................
1Safety............................................................................................................................................................................ 1
1.2Warning................................................................................................................................................................. 1
1.3Attention............................................................................................................................................................... 1
2.Overvi ew .....................................................................................................................................................................
ew..................................................................................................................................................................... 2
2.1Features................................................................................................................................................................. 2
3.Principle ......................................................................................................................................................................
3.Principle...................................................................................................................................................................... 3
4.1Main performance.............................................................................................................................................. 3
4.2Main Parameters................................................................................................................................................. 4
5Installation ..................................................................................................................................................................
5Installation.................................................................................................................................................................. 5
5.3Rear View............................................................................................................................................................ 5
5.4Accessories........................................................................................................................................................... 6
6.1Application method............................................................................................................................................ 6
6.2Attention for operation................................................................................................................................... 11
6.3Clinical restrictions.......................................................................................................................................... 11
7.2Maintain.............................................................................................................................................................. 12
Appendix1 ...................................................................................................................................................................
Appendix1................................................................................................................................................................... 16
Appendix2 ...................................................................................................................................................................
Appendix2................................................................................................................................................................... 18
III
1 Safety
� 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. 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.
� 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 choose the battery chargers which should be ensured compliance with the requirements
of IEC 601-1, or else it may damage the device.
� The device can only be matched with the compatible probe.
� Please don't measure this device with functional tester for the device's related information.
1.33 Attention
1.
␇ 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.
1
␇ The pulse oximeter can be used to adult or infant. Whether the device is used to adult or
infant,it depends on the probe selected.
␇ 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.
␇ This device has the function of alarming, users can check on this function according to chapter
6.1 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 for good,
please check the chapter 6.1 as a reference.
␇ The device may not work for all patients. If you are unable to achieve stable readings,
discontinue use.
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. 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
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,
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.
2
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.
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
3. 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.
4. Technical specifications
3
H . With alarm function
I . With SpO2 value and pulse rate value of storage, the stored data can be uploaded to computers
J. It can be connected with an external oximeter probe
K . Real-time data can be transmitted to computers.
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
C. Resolution
SpO2 : 1%, Pulse rate: 1bpm.
G. Optical Sensor
Red light (wavelength is 660nm,6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
H. Adjustable alarm range:
SpO2 : 0%~100%
Pulse Rate: 0bpm~254bpm
4
5 Installation
5.3 RearView
Finger 4. RearView
(Refer to Figure 4 and insert the lithium battery properly in the right direction. )
5
5.44 Accessories
5.
6 Operating Guide
A.
a) Open the lid of battery box and put the battery in side, then close.
b) Put the suitable probe into the jack on the right side of the oximeter. (The probe is limited to be
produced by our company; never replace it with the similar ones by other manufacturers).
c) Put the finger into the probe.
d) Press the "power on/off button" long about a few seconds,the power is on,and the device will
start to self-inspect.The device displays the measuring interface after self-inspecting.
e) Do not shake the finger and keep the patient in a stable state during the process.
f) The data can be read directly from the screen on the measuring interface.
Figure 5
(Actual probe may be different with the probe as figure 5,please accept the actual probe with the
device )
6
B. Change display direction:
On the measuring interface, press the"screen change button"can change the display direction.
C. Pause alarm:
a) Alarm including the alarm of measure data's going beyond the limits, the alarm of low-voltage,
the alarm of probe or finger's out of position.
b) When alarm is on,press the"alarm pause button"can pause the alarm,it can renew alarm in about
60s,and if pressing the"alarm pause button" Again with in 60s,it can renew alarm .
c) If you want to turn off the alarm for good, you should enter the menu for operation.
D. Menu operations:
On the measuring interface,press the"menu button"can enter the menu of figure 6.Users can adjust
the setting through the main menu, such as alarm,pulse sound indication,backlight,data storage,data
transmission (with the use of data line),the specific method is as follows:
a) Alarm setting
On the main menu interface,press the"up button"or"down button",move the menu choice bar to
"Alarm" ,then press the"menu button"to enter the alarm setting menu of figure 7:
Press the"up button"or"down button"to choose the parameter to be adjusted, then press the"menu
button"again to enter the similar dialog box shown as figure 8,then press the"up button"or"down
button"to change data. Each press of the"up button"or"down button", the data will raise or descend
for one time accordingly, until it gets to the required number , then press the "menu button"for
another time to end the setting.
on,, the device will provide midium-priority alarm signal when the
If the alarm function is on
data of SpO2 or pulse rate is beyond the limit. Intermittent alarm will occur and the
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measurement shows in yellow.
Medium priority indicating that prompt operator response is required.
When operating at the beginning, the operator inserts his finger, and setup the Spo2 ALM
HI lower than the current measured value, then the machine will start alarm. The pulse rate
alarm test is the same with the above.
Figure 8.
Press the"up button"or"down button",move the menu choice bar to "Alarm",then choose the alarm
state (on/off) by pressing the "menu button", choose “on”to start the alarm function, and choose
“off” to close it for good.
On the main menu interface,press the"up button"or"down button",move the menu choice bar
to"Pulse Sound", then choose the pulse sound indication state (on/off) by pressing the "menu
button",press “on” to start the function, and press “off” to close it.
c) Backlight adjustment
On the main menu interface,press the"up button"or"down button",move the menu choice bar to
"Brightness",then press the"menu button"to change the number in order to adjust the brightness of
screen.
This device has the function of 24 hours data storage , it has the capability of accurately storing
pulse rate and SpO2 data, then transmit the data to computer with the data line for replay and
analysis.
a. On the main menu interface,press the"up button"or"down button",move the menu choice bar
to"Record",then press the"menu button"again to enter the dialog box of figure 9:if it is in recording
state,the"Stop"is displayed on menu;if it is not in recording state,the"Start"is displayed on menu.
Figure 9.
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b. When the"Start"is displayed on the menu,if the memory still have the former data in storage ,the
" Do you really want to recover the memory" dialog box will be displayed when pressing the
"menu"button ,then press the"up button"or"down button"to choose setting,then press the"menu
button"to confirm setting,the dialog box will be displayed as figure 10:It needs to set the starting
time for data storage by users, users can change the setting value by pressing the"up button"or"down
button",and confirm the setting value by pressing the"menu button",the black cursor will move to
next place after setting.When the black cursor move to"Yes"(store) or "No"(don't store),press the"up
button"or"down button"to choose setting,then press the"menu button"to confirm setting.
c. When the"Stop"is displayed on menu,the"Do you really want to stop recording "dialog box
will be displayed when pressing the "menu button".then press the"up button"or"down button"to
choose setting,then press the"menu button"to confirm setting.
Figure 10.
d. If the data storage function is being turned on, when return to the measuring interface, a red
"REC"sign and a flashing red dot would appear on screen, which means the device is in a state of
storing.
e. In the state of storing, whatever interface the device is on (measuring interface, menu interface),
the sign "Recording" would appear on the screen in 30 seconds, and then the screen will be
automatically shut down. If pressing any button(power on/off excluded) at this moment, the sign
"Recording" would appear on the screen, and then the screen will be automatically shut down
again;if pressing the "power on/off button", the device would return to the former interface.
f. If turning on the data storage function, the former data storage will be automatically removed.
g. In the state of data storing, after the screen is automatically shut down, the pulse sound
indication would be off for saving power.
h. 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, if press any button(power on/off excluded) again, it will enter the
measuring interface.
Firstly, please install the affiliated software into the computer, and then 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 11; the icon of SpO2 Review is a program for receiving stored data which is shown
as figure 12.
9
Figure 12. SpO2 Review program
a. Please connect the device to computer with the affiliated data line , then double click"SpO2
Review"icon to start the program.
b. On the main menu interface,press the"up button"or"down button" in order to move the menu
choice bar to"Upload",then press the"menu button"to transmit the stored data to computer for replay
and analysis.
c. In the state of storing, it is not applicable for the users to upload the stored date to computer.
d. When the stored data is being uploaded ,the screen displays as figure 13.
Figure 13.
e. When the upload of stored data is finished, the device will automatically return to the main
menu, and the menu choice bar will move to "Exit"automatically as well.
On the main menu interface,press the"up button"or"down button" in order to move the menu choice
bar to"Exit",then press the"menu button"to exit the main menu.
a) Please connect the device with computer by the data line which is equipped with the device,then
double click "SpO2"icon to open"SpO2"program.
b) The data can be displayed on computer screen in a few seconds.
c) 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.
F. Charge
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Power supply by battery only, and battery status is full
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 3 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.
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).
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
11
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.
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 recharge the battery when the screen shows .
C. Recharge the battery soon after the over-discharge. The device should be recharged every six
months when it is no regular used. It can extend the battery life following this guidance.
D. Please take out the batteries if the oximeter is not in use for a long time.
E. 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.
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%
8 Troubleshooting
12
The display is off The battery is drained away or almost
Please recharge the battery
suddenly drained away .
9 Key of Symbols
Signal Description
Menu button
Type BF
13
SN Serial number
WEEE (2002/96/EC)
10 Function Specification
Pulse Intensity
14
Continuous bar-graph display, the higher display
Range
indicate the stronger pulse.
Battery Requirement
Power Adapter
PowerAdapter
Oximeter Probe
Wavelength:660nm 880nm
15
Appendix 1
16
manufacture’’s declaration-electromagnetic immunity
Guidance and manufacture
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
manufacture’’s declaration-electromagnetic immunity
Guidance and manufacture
The Pulse Oximeter(CMS60C) is intended for use in the electromagnetic environment specified below. The
customer or the user of the Pulse Oximeter(CMS60C) should assure that it is used in such an environment
IEC60601 Compliance
Immunity test Electromagnetic environment -guidance
guidance
test level level
Portable and mobile RF communication equipment should be
used no closer to any part of the Pulse Oximeter(CMS60C),
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
recommended separation distance
Conducted RF 3Vrms 3Vrms
IEC 61000-4-6 150kHZ to
80MHZ
⎡ 3.5 ⎤
d =⎢ ⎥ P 80MHz to 800MHz
⎣ E1 ⎦
⎡7⎤
Radiated RF 3V/m 3V/m d =⎢ ⎥ P 800MHz to 2.5GHz
IEC 61000-4-3 80MHz to ⎣ E1 ⎦
2.5GHz Where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, a should be less than the compliance
level in each frequency range. b
Interference may occur in the vicinity of equipment marked with
the following symbol:
17
Recomme nde d se par atio n dis tanc e s be twe e n portab le and mobile RF
communica tions equipme nt and the EQU I P ME NT or SYSTE M for
EQUI P M EN T or SYSTE M that not LI FE -SUP P OR TI NG
Appendix 2
18