Contec CMS 50IW 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 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

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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.
Contents
1 Safety...................................................................................................1

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1.1 Instructions for safe operations......................................................1
1.2 Warning .........................................................................................1
1.3 Attention........................................................................................2
2 Overview..............................................................................................4
2.1 Features..........................................................................................4
2.2 Major applications and scope of application..................................4
2.3 Environment requirements.............................................................5
3 Principle ..............................................................................................6
4 Technical specifications.....................................................................7
4.1 Main performance..........................................................................7
4.2 Main parameters ............................................................................7
5 Installation...........................................................................................8
5.1 View of the front panel...................................................................8
5.2 Probe installation ...........................................................................9
5.3 Accessories....................................................................................9
6 Operating guide .................................................................................9
6.1 Application method........................................................................9
6.2 Attention for operation.................................................................17
6.3 Clinical restrictions......................................................................18
7 Maintain, transportation and storage ..........................................19
7.1 Cleaning and disinfecting.............................................................19
7.2 Maintain.......................................................................................19
7.3 Transportation and storage...........................................................19
8 Troubleshooting ................................................................................20
9 Key of symbols................................................................................22
10 Function specification....................................................................24
Appendix 1 .............................................................................................25

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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. 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.
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.

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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 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.

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֠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.

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2 Overview
The pulse oxygen saturation is the percentage of HbO
2
in the total Hb in the
blood, so-called the O
2
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 SpO
2
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' SpO
2
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 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 SpO
2
value,pulse rate value,Perfusion Index value and
pulse waveform with the high veracity and repetition.
2.1 Features
AUltra-thin wrist-design,concise and fashion.
BSmall in volume, light in weight and convenient in carrying.
CLow power consumption
DDisplay direction can be changed,easy to view.
EPerfusion Index measure.
F Wireless data communication
2.2 Major applications and scope of application

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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 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 :≤95%
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temperature:10~40
b) Relative Humidity :≤75%
c) Atmospheric pressure:700hPa~1060hPa