Contec CMS-50E User manual

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CONTEC MEDICAL SYSTEMS CO., LTD
CMS-50E
Pulse Oximeter

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This Manual is written and complied in accordance with the council directive MDD 93/42/EEC
for medical devices and corresponding standards. The Manual written is in accordance the
Fingertip Pulse Oximeter. In case of modifications and software upgrades, you will be advised in
due time with a Modification Notice.
The Manual includes the Fingertip 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.
This manual is used for the experienced personnel who is familiar with the measure and the use of
the instrument. This manual is compiled by our company, and the copyright is possessed by our
company.
Instructions to User
Dear Users, thank you very much for purchasing Fingertip Pulse Oximeter. Please read the
following two pages very carefully before using this equipment.
Please read these instructions carefully before using this equipment. These instructions describing
the operating procedures should be followed strictly. Failure to follow these instructions can cause
measuring abnormality, equipment damage and personal injury. The manufacturer is NOT
responsible for the safety, reliability and performance issues and any monitoring abnormality,
personal injury and equipment damage due to user’s negligence of the operation instructions. The
manufacturer’s warranty service does not cover such faults.
This product is medical device, and can be used repeatedly. Its using life is 3 years.
WARNING:
0For 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.
0The 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.
0Testee can not use enamel or other makeup.
0Testee’s fingernail can not be too long.
0Please refer to the correlative literature about the clinical restrictions and caution.

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0This device is not intended for treatment.
Table of Contents
1. SAFETY.............................................................................................................................................1
1.1. INSTRUCTIONS FOR SAFE OPERATIONS................................................................................... 1
1.2. WARNINGS............................................................................................................................. 1
1.3.ATTENTIONS........................................................................................................................... 1
2. OVERVIEW......................................................................................................................................1
2.1. FEATURES .............................................................................................................................. 2
2.2. ANTICIPATIVE APPLICATION ................................................................................................... 2
2.3. ENVIRONMENT REQUIREMENTS............................................................................................. 2
3. PRINCIPLE AND CAUTION...........................................................................................................2
3.1. PRINCIPLE OF MEASUREMENT................................................................................................ 2
3.2. THE ATTENTION OF OPERATION ............................................................................................. 3
3.3. CLINICAL RESTRICTIONS........................................................................................................ 4
4. TECHNICAL SPECIFICATIONS ...................................................................................................4
5. ACCESSORIES ................................................................................................................................5
6. INSTALLATION ..............................................................................................................................5
6.1. VIEW OF THE FRONT PANEL.................................................................................................... 5
6.2. MOUNTING OF THE LANYARD CORD................................................................................. 5
7. OPERATING GUIDE......................................................................................................................6
8. CLEANINGAND DISINFECTING.................................................................................................9
9. REPAIRINGAND MAINTENANCE.............................................................................................10
10. TROUBLESHOOTING.................................................................................................................10
11. KEY OF SYMBOLS.......................................................................................................................11
12. FUNCTION SPECIFICATION....................................................................................................11

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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 once a week at least. Please stop using the monitor when there is obvious
damage.
◇ 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. Please use
the devices recommend by Manufacturer.
1.2 Warnings
0Explosive hazard—DO NOT use the oximeter in environment with inflammable gas such as
some ignitable anesthetic agents.
0DO NOT use the oximeter while the testee is under measurement of MRI and CT.
0Be cautious of the lanyard cord, please do not break the lanyard cord during usage to avoid
device damage. Please don’t use lanyard cord if allergic to lanyard cord.
0Please don’t use this product if allergic to rubber cushion.
0Please dispose the device, accessory and packing (including plastic bag, foam and carton)
according to local law.
1.3 Attentions
Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high
temperature and moisture.
If the oximeter gets wet, please stop using.
When it is carried from cold environment to warm and humid environment, please 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’s Manual for instructions of cleaning and disinfection.
Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface
with disinfect solution by soft material. Do not spray any liquid on the device directly.
When cleaning the device with water, the temperature should be less than 60℃.
2. Overview
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. For the purpose of

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measuring the SpO2more easily and accurately, our company developed the Fingertip Pulse
Oximeter. The device can measure the pulse rate simultaneously.
The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry.
You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the
screen immediately. In the clinical practice, the tolerance is smaller than ±2% in the range from 70%
to 100%.
2.1. Features
A. The device can accurately measure SpO2 and pulse rate.
B. The device will power off automatically if no signal is detected within 5 seconds.
C. Lithium batteries is required for operating, and the continuous working time is 12 hours.
D. When Low-Voltage Warning is shown on screen, the device maybe not operate normally.
E. Light and portable, total weight with batteries is about 50g.
F. Classification: Class II a, （MDD93/42/EEC IX Rule 10）
G. With the function of USB transmission and wireless transmit.
H. It can store patient’s data and with alarm function.
2.2. Anticipative application
The Fingertip Pulse Oximeter can detect SpO2 and pulse rate through patient’s finger, and indicate
the pulse intensity by the bar-display. This device is applicable for use in home, hospitals (surgery,
anesthesiology department, department of pediatrics, ordinary sickroom), oxygen bar, the
community medical treatment, physical care in sports (you can use the device before or after the
sport, but it is not recommended to use it during the sport) and so on.
This device is not appropriate for the ceaseless monitoring of the patients.
2.3. Environment requirements
Transport and storage
a）Temperature: -20°C~55°C
b）Humidity: ≤95%
c）Pressure: 500hPa~1060hPa
Operating
a）Temperature: 10°C ~40°C
b）Humidity: 35%~75%
c）Pressure: 700hPa~1060hPa
3. Principle and Caution
3.1. Principle of measurement
The measurement of pulse oximeter is that it uses a multi-functional oxyhemoglobinometer to