Contec CMS-50D Plus User manual

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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

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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.........................................................3
2 OVERVIEW ..............................................................6
2.1 CLASSIFICATION:................................................6
2.2 FEATURES...........................................................7
2.3 MAJOR APPLICATIONS AND SCOPE OF
APPLICATION..............................................................7
2.4 ENVIRONMENT REQUIREMENTS .........................7
3 PRINCIPLE...............................................................9
4 TECHNICAL SPECIFICATIONS..........................10
4.1 MAIN PERFORMANCE .......................................10
4.2 MAIN PARAMETERS..........................................10
5 INSTALLATION.....................................................12
5.1 VIEW OF THE FRONT PANEL..............................12
5.2 BATTERY INSTALLATION...................................12
5.3 ACCESSORIES ...................................................13
6 OPERATING GUIDE..............................................14
6.1 APPLICATION METHOD.....................................14
6.2 ATTENTION FOR OPERATION.............................22
6.3 CLINICAL RESTRICTIONS..................................23
7 MAINTAIN, TRANSPORTATION AND STORAGE25

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7.1 CLEANING AND DISINFECTING .........................25
7.2 MAINTAIN.........................................................25
7.3 TRANSPORTATION AND STORAGE .....................25
8 TROUBLESHOOTING ..........................................26
9 KEY OF SYMBOLS................................................28
10 FUNCTION SPECIFICATION ............................31

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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 device. In addition ,the overall
check of monitor, including the safety check such as the
leakage current ,should be performed only by qualified
personnel once every 12 months.
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.

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Ensure that the environment in which the device is
operated is not subject to any sources of strong
electromagnetic interference, such as radio transmitters,
mobile telephones, etc. Keep them far away High level
electromagnetic radiation emitted from such devices
may greatly affect the monitor performance.
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.

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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.
When uploading, do keep the patient form touching the
USB port. The computer used when uploading must be
in accordance with EN60950. In addition, when the
data line connected to a computer, the medical
electrical systems should be in accordance with
IEC60601-1-1.
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.

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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' SpO2and pulse rate, please clip the thick
finger such as thumb and middle finger deeply enough
into the probe.
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.

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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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2 Overview
The pulse oxygen saturation is the percentage of HbO2in the
total Hb in the blood, so-called the O2concentration 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 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 Classification:
Class II b(MDD93/42/EEC IX Rule 10)

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Class II (U.S.FDA)
2.2 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
2.3 MajorApplications and Scope ofApplication
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.
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: 500 hPa ~ 1060 hPa
Operating Environment

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a) Temperature: 10 ℃~ 40 ℃
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700 hPa ~ 1060 hPa

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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.

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4 Technical Specifications
4.1 Main Performance
A. SpO2value 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. Display direction can be changed automatically,easy
to view.
F. The product will enter standby mode when no signal
is in the product within 5 seconds.
G. Apulse rate sound indication
H. With alarm function
I. With SpO2value 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 SpO2measuring range is 70% ~
100％,the permission of absolute error is ±2％;
below 70% unspecified

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B. Measurement of pulse rate
Measuring range: 30 bpm ~ 250 bpm
Accuracy: ±2 bpm or ±2% (select larger)
C. Resolution
SpO2: 1%, Pulse rate: 1 bpm.
D. 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).
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 660 nm, 6.65 mW)
Infrared (wavelength is 880 nm, 6.75 mW)
H. Adjustable alarm range:
SpO2: 0% ~ 100%
Pulse Rate: 0 bpm ~ 254 bpm

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5 Installation
5.1 View of the Front Panel
Figure 2. Front view
5.2 Battery Installation
A. Refer to Figure 3. and insert the two AAAsize
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.
When you don’t use the device for more than 2
hours,please take out the dry batteries.

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Figure 3.
5.3 Accessories
A. a hanging rope
B. a user manual
C. a data line
D. a disk (PC software)

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6 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
medium-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.

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Figure 4. Put finger in position
B. Change display direction
The device could change display direction according to
the handing 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 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 Assistant "is a

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program for receiving real-time data and stored data
which is shown as Figure 5.
a). Please connect the device to computer with the
affiliated data line , then double click the "SpO2
Assistant"icon and click " "
and then click the "Connect"to start the program.
b). When you close the "SpO2 Assistant", there is a dialog
box "Save To File " appearing on the desktop, in
which you can input some patient's basic information.
Figure 5. SpO2program
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 according to the handing direction.
Press the button with a prolonged push (1 second) to
enter the Settings Menu Interface (see Figure 6).
The user can setup the following parameters in the
Settings Menu –Turn on alarm, turn on pulse sound, alarm