Cooper Medical Supplies CMS-50H User manual

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Instruction Manual
CMS-50H

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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:
Discomfort or pain may appear if using the device ceaselessly, especially for the
microcirculation barrier patients. It is recommended that the pulse oximeter should not be
used on the same finger for more than 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 look at the light source.
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.

III
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......................................................................................................................................... 3
4.1 Main performance ............................................................................................................................................ 3
4.2 Main Parameters............................................................................................................................................... 4
5 Installation.............................................................................................................................................................. 4
5.1 View of the front panel..................................................................................................................................... 4
5.2 Lanyard installation.......................................................................................................................................... 5
5.3 Probe installation.............................................................................................................................................. 5
5.4 Accessories....................................................................................................................................................... 5
6 Operating Guide.................................................................................................................................................... 5
6.1 Application method .......................................................................................................................................... 5
6.2 Attention for operation ................................................................................................................................... 10
6.3 Clinical restrictions......................................................................................................................................... 10
7 Maintain、transportation and storage..............................................................................................................11
7.1 Cleaning and Disinfecting ...............................................................................................................................11
7.2 Maintain ..........................................................................................................................................................11
7.3 Transportation and storage...............................................................................................................................11
8 Troubleshooting.....................................................................................................................................................11
9 Key of Symbols................................................................................................................................................... 12
10 Function Specification ...................................................................................................................................... 13
Appendix 1................................................................................................................................................................. 14

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1Safety
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. It is recommended that the
device should be inspected weekly 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 is 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 the environment with tinder such as
anesthetic .
DO NOT use the oximeter while the patient is being scanned by MRI or CT.
DO NOT strand the lanyard in order to avoid device drop and damage.The lanyard is made of
non-sensitive material.Please do not use lanyard if the user is allergic to lanyard.Do not enwind neck
with lanyard in order to avoid accident.
The person who is allergic to rubber can not use this device.
The disposal of scrap instrument and its accessories and packing (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 which are appointed or recommended by the manufacturer for
avoiding device damage.
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, tinder, high temperature
and moisture.
If the oximeter gets wet, please stop operation.
When it is carried from cold environment to warm or humid environment, please do not use it
immediately.
DO NOT operate button on front panel with sharp things.
High temperature or high pressure steam disinfection for the oximeter is not permitted. Refer to
User Manual in the relative chapter (7.1) for 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℃.
The fingers which are too thin or too cold may affect the measure accuracy , please clip the
thicker finger such as thumb and middle finger deeply enough into the probe.
The oximeter probe which is optional can be used to children.
The update period of data is less than 5 seconds, which is changeable according to different

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individual pulse rate.
Please read the measure value when the waveform on screen is equably and steady-going. This
measure 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 the finger out and
reinsert to restore normal use.
The device has normal life for three years since the first electrified use.
The device has alarm function, this function can either be paused, or closed (default setting) for
good.Please check the chapter 6.1 as reference.
The device has the function of beyond limit alarm.When the measure data is beyond the highest
or lowest limit, the device would start alarm automatically on the premise of the alarming function is
on.
The device may be not fit for all patients. If you are unable to receive approving measure,
discontinue use.
Do not contort or drag the wire of the device.
2Overview
The pulse oxygen saturation is the percentage of HbO2in 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 SpO2in 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' SpO2is of great help for the doctor to discover the potential danger, and is of
great importance in the clinical medical field.
The Pulse Oximeter is small in volume,low in power consumption,convenient in operation and
portable. With high-definition display screen,the device is concise and fashion.It is only necessary for
patient to put one finger into probe for diagnosis, and the display screen will directly show the
SpO2 value,pulse rate value,Perfusion Index value and pulse waveform with the high veracity and
repetition.
2.1 Features
AUltra-thin design,concise and fashion.
BSmall in volume, light in weight and convenient in carrying.
CLow power consumption
DDisplay direction can be changed automatically,easy to view.
EPerfusion Index measure.
2.2 Major applications and scope of application
The Pulse Oximeter can be used in measuring the pulse oxygen saturation, pulse rate and perfusion
index through finger.The product is fit for 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.
The problem of overrating would emerge when the patient is suffering from toxicosis

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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
3Principle
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 work elements
4Technical specifications
4.1 Main performance
SpO2value display
Pulse rate value display, bar graph display
Pulse waveform display
Perfusion Index value display
Charge function: Lithium battery is the power supply and can be charged up time and again.
Low-power indication: low-power indication symbol appears before working abnormally which
is due to low-power.
Automatic power-off when there is no finger in device under measure interface in 5 seconds.
With direction sensor,the display direction can be changed by automatic or manual mode
Screen brightness can be adjusted
Pulse sound indication

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With alarm function
With SpO2value and pulse rate value record function
The record data can be uploaded to the computer
It can be connected with oximeter probe
4.2 Main Parameters
AMeasurement of SpO2
Measuring range: 0%～100％
Accuracy: 70~100%:±2%;Below 70%:unspecified.
B Measurement of pulse rate
Measuring range:30bpm～250bpm
Accuracy: 30bpm～100bpm:±2bpm;101bpm～250bpm：±2%
C Perfusion Index
Range: 0%～20％
D Resolution
SpO2: 1%, Pulse rate: 1bpm
E Measurement Performance in Weak Filling Condition:
SpO2and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2error is ±4%;
pulse rate error is ±2 bpm or ±2% (select larger).
F 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%.
G Power supply requirement: 3.6 V DC ~4.2V DC.
H Optical Sensor
Red light (wavelength is 660nm，6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
I Adjustable alarm range:
SpO2：0%~100%
Pulse Rate: 0bpm~254bpm
5Installation
5.1 View of the front panel
Pulse sound indication
Alarm indication Power indication
Auto direction switch sign Pulse rate value
Perfusion Index
SpO2value
SpO2alarm low-limit Button
Pulse bar graph Pulse waveform
Figure 2. Front View

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5.2 Lanyard installation
A. Put the thinner side of the lanyard through the hole.
B.Put the wider side of the lanyard through the thinner side which has been put through the hole,
then tighten it.
5.3 Probe installation
A. Open the USB cover,inserting the probe into the USB port of the pulse oximeter.
B. Insert the finger into the probe (the side with finger sign and the nail should be in the same
side ).The connected probe could work normally when the luminescent tube in the device doesn't
emit red light.
In order to ensure device life and measure accuracy,external probe is limited to the matching
model ,and can't be replaced by other model.Or else the device will be damaged or usage is affected.
5.4 Accessories
A. A lanyard
B. A User Manual
C. A power adapter(optional)
D. A data line
E. A disk (PC software)
F. Aoximeter probe (optional)
6Operating Guide
6.1 Application method
6.1.1 Measurement
a. Insert the finger into the probe of the device.
b. Long press button to turn the device on.
c. Do not shake the finger and keep the patient in a stable state during the process.
d. The data can be read directly from the display screen in the measuring interface.
6.1.2 Lay finger
The right method of laying finger is as figure 3.
Figure 3

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Fingernails and the luminescent tube should be in the same side.
Automatic power-off when there is no finger in device in 5 seconds.
6.1.3 Pause alarm
a. Alarm includes the alarm of measure data's going beyond the limits, the alarm of low-power,
and the alarm of finger out.
b. In the measuring interface, if the alarm function is on, during the period of alarming, alarm can
be suspended by short pressing the button, but the function will be renewed in about 60 seconds.
c. If you want to turn off the alarm, you should enter the menu for operation.Please refer to
chapter "Alarm setting" for detail.
6.1.4 Change display direction
The device could change display direction by automatic or manual mode. When the direction sensor
is on, the device could change display direction according to the handing direction;When the
direction sensor is off, short press button to change the display direction.Please refer to chapter
"Direction sensor setting" for detail.
6.1.5 Menu operations
In the measuring interface, long press button to enter the main menu interface as figure 4.( When the
display direction is lengthways, you can not enter the main menu interface.Please change to
landscape orientation.).The user can adjust the settings through the main menu, such as backlight,
alarm, direction sensor, data transmission (with the data line). The specific operation methods are as
follows:
Figure 4 Main Menu Interface
ABrightness adjustment
In the main menu interface,short press button to move the choice bar to the "Brightness" item,then
long press the button to adjust the brightness of screen (4 levels adjustable).
BAlarm setting
In the main menu interface,short press button to move the choice bar to "Alarm‖ item, then long
press button to enter the alarm setting menu as figure 5:

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Figure 5. Alarm Setting Menu
aThe high/low limit of alarm setting
In alarm setting menu,short press button to move the choice bar to "Dir" item,long press button to
choose Up or Down (This will be the direction the value of the high-low limits of SpO2and pulse
rate will be adjusted).Short press button to adjust alarm item:SpO2high limit (SpO2ALM HI), SpO2
low limit (SpO2ALM LO), Pulse rate high limit (PR ALM HI), Pulse rate low limit (PR ALM
LO).Long press button to change the value.Long press button once,and the value raise or descend
once.The low limit can't be above high limit,and the high limit can't be below the low limit.
If the alarm function is on, the device will provide medium-priority alarm signal when the
data of SpO2or pulse rate is beyond the limit. Intermittent alarm will occur and the values
show in yellow.
Medium priority indicating that prompt operator response is required.
bThe alarm indication setting
In alarm setting menu,short press button to move the choice bar to the "Alarm" item, then long press
button to turn on or turn off the alarm sound.Choose ―on ―to turn on the alarm, and choose ―off‖ to
turn off the alarm.
cPulse sound indication setting
In alarm setting menu,short press button to move the choice bar to the "Pulse Sound" item, then long
press button to turn on or turn off the pulse sound.Choose ―on ―to turn on pulse sound, and choose
―off‖ to turn off pulse sound.
d Exit operation
In alarm setting menu,short press button to move the choice bar to "Exit‖item, then long press
button to exit alarm setting menu and return to the main menu.
C Direction sensor setting
In the main menu interface, short press button to move the choice bar to "DIR Sensor‖item, then
long press button to enter the direction sensor setting menu as figure 6.