Contec CMS-50E Bedienungsanleitung

CONTEC MEDICAL SYSTEMS CO., LTD

CMS-50E

Pulse Oximeter

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.

III

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

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

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

transmit some narrow spectrum light bands through blood samples, and to measure attenuation of

spectrum with different wavelengths according to the characteristic that RHb, O2Hb, Met Hb and

COHb absorb the light of different wavelength, thereby determining O2Hb saturation of different

fractions. O2Hb saturation is called “fractional” O2Hb saturation.

Fractional O2Hb saturation = [O2Hb / (RHb + O2Hb + Met Hb + COHb) x 100

Oppositely, pulse oxygen oximeter measures functional O2Hb saturation:

Functional O2Hb saturation = [O2Hb / (RHb + O2Hb)] x 100

Present SpO2oximeter transmits light of two wavelengths only, red light (wavelength 660 nm) and

infrared (wavelength 940nm), to differentiate HbO2from HbR. One side of the sensor contains two

LEDs, and the other side contains a photoelectric detector. SpO2oximeter measures HbO2saturation

in the blood by the light plethysmograph when the pulse beats. The result is quite precise when

HbO2saturation is over 70 % ~ 100%.

Figure1. Operating Principle

3.2. The attention of Operation

A. The equipment should be fully tested to see if it can be used normally before using.

B. The finger should be placed properly (see the attached illustration of this manual), or else it

may cause inaccurate measurement.

C. The SpO2sensor and photoelectric receiving tube should be arranged in a way with the testee’ s

arteriole in a position in between．

D. The SpO2sensor should not be used at a location or limb tied with arterial canal or blood

pressure cuff or receiving intravenous injection.

E. Make sure the optical path is free from any optical obstacles like rubberized fabric, otherwise it

may result in venous pulsation and inaccurate measure of SpO2.

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 testee or extreme electrosurgical interference may also affect the

accuracy.

H. Please clean and disinfect the device after operating according to the user manual.

3.3. Clinical restrictions

A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of the

testee is required. For a testee with weak pulse due to shock, low ambient/body temperature,

major bleeding, or use of vascular contracting drug, the SpO2waveform (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 thiosalicylic hemoglobin, and some with icterus problem, the SpO2determination 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 SpO2measure.

D. The SpO2value serves only as a reference value for judgement of anemic anoxia and toxic

anoxia, some patients with serious anemia may also report good SpO2measurement.

4. Technical specifications

A. Display mode：65K Color OLED display

SpO2measuring range: 35%~100%

Pulse rate measuring range: 30bpm～240bpm

Pulse waveform display: bar graph display

Battery indication: OLED Signal

B. Power supply requirement:

Lithium battery × 1

Adaptable range: 3.5V~4.2V

C. Operating current: ≤80mA

D. Resolution: SpO2：1%

Pulse Rate ：1bpm

E. Accuracy: SpO2：70% to 100%±2 digits, below 70% unspecified

Pulse rate：±2 bpm or ±2% (select larger)

F. Measurement at low perfusion:

The values of SpO2and pulse rate can be displayed properly when pulse saturation is at 0.4%.

Accuracy of SpO2：±4%

Accuracy of Pulse rate：±2bpm or ±2% (select larger)

G. Resistance to surrounding light:

The difference between the value measured in the condition of man-made light and indoor natural

light and that of darkroom is less than ±1%.

H. Automatic shutdown function:

The device will power off automatically within 5 seconds when there is no finger in the device.

I. The view direction (four direction) can be changed by pressing the power button when it works.

J. One lithium battery continuous working time is 12 hours.

K. It can store patient’s data for 24 hours.

L. This product has the real-time transmission function, it can upload the measured value to pc with

wire or wireless.

5. Accessories

1. A lanyard cord

2. A User Manual

3. A Charger (used for recharge the lithium battery)

4. An USB cable (used for recharge the battery in the computer and transfer the data to the pc)

5. A CD (drive for USB and software for the pc)

6. Installation

6.1. View of the front panel

Figure2. front view

6.2. Mounting of the lanyard cord

Step1. Put the end of the cord through the hole.

Step2. Put another end of the cord through the first one and then tighten it.

7. Operating Guide

7.1 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.

a) Press the Power Button on the front panel.

b) Using first finger, middle finger or ring finger when doing test. Low finger temperature, fat

finger, thin finger may cause inaccurate measurement.

c) Do not shake the finger and keep the patient at ease during the process.

7.2 Get the information directly from screen display.

Put the finger in the oximeter like Figure 3.

Figure3 FingerPlaced

7.3 This product has the function of USB communications.

Firstly setup the USB driver in the computer (See details in CD), store the oximeter users’

software in the computer, open the user’s interface, then connect the oximeter and the computer

with the USB cable to fulfill the communication.

NOTE: This function is only used to data-transfer to the computer, but no downloading.

7.4 When working, the display direction can be changed by pressing the button shortly. There are

four modes of direction.

Press the button long time to enter the following menu interface- Figure 4 ( When the display

direction on the screen is plumb with the finger input direction, you cannot enter the menu

interface, press the button shortly again, let the display direction on screen level with the finger

input direction, continue next step): The user can setup the following parameters in

menu—lightness of backlight, alarm and high-low limit, data transmission( with USB cable),

data store, data upload to computer( with USB cable). See details as following:

Figure4 MenuInterface

1) Backlight Adjust

Press the button shortly, move to item below, select the “Brightness”, press the button

long to adjust the backlight lightness (This product has four mode to adjust the

ligntness)

2) Alarm and adjust the up-low limit

Press the button shortly, move to the item “Alarm”, press the button long to enter the

alarm setting interface as Finger 5:

Figure 5 Alarm setting interface

A. Adjust the up and low limit of alarm

Press the button shortly, move to “Dir”, then press the button long to choose Up or Down value

of the high-low limit of Spo2 and pulse rate.

To raise the Spo2 and pulse rate limit, put the Dir in Up, then press the button to choose the

parameter to be adjusted: SpO2 high limit (SPO2 ALM HI), SpO2 low limit (SPO2 ALM LO),

Pulse rate high limit (PR ALM HI), Pulse rate low limit (PR ALM LO), press the button long

time to adjust the limit to a higher value.

Andere Handbücher für CMS-50E

Inhaltsverzeichnis

Andere Contec Medizinische Geräte Handbücher

Contec

Contec CMS50DL Bedienungsanleitung

Contec

Contec CMS60D Bedienungsanleitung

Contec

Contec ESA0008 Bedienungsanleitung

Contec

Contec CMS50DA Bedienungsanleitung

Contec

Contec 300G Bedienungsanleitung

Contec

Contec CMS50EW Bedienungsanleitung

Contec

Contec CMS50M Bedienungsanleitung

Contec

Contec CMS-50f Bedienungsanleitung

Contec

Contec CMS60C Bedienungsanleitung

Contec

Contec CMS-50f Bedienungsanleitung

Contec

Contec CMS800G Bedienungsanleitung

Contec

Contec CMS-50E Bedienungsanleitung

Contec

Contec CMS60C Bedienungsanleitung

Contec

Contec CMS8000 Bedienungsanleitung

Contec

Contec CMS-50f Bedienungsanleitung

Contec

Contec CMS50DL Bedienungsanleitung

Contec

Contec CMS 50IW Bedienungsanleitung

Contec

Contec CMS50DL Bedienungsanleitung

Contec

Contec ABPM 50 Referenzhandbuch

Contec

Contec CMS50DL1 Bedienungsanleitung

Contec

Contec CMS50D Bedienungsanleitung

Contec

Contec CMS-50D Plus Bedienungsanleitung

Contec

Contec CMS-50f Bedienungsanleitung

Contec

Contec KT88-3200 Bedienungsanleitung

Beliebte Medizinische Geräte Handbücher anderer Marken

TekTone

TekTone Tek-CARE160 Bedienungsanleitung

NeuroMetrix

NeuroMetrix Quell 2.0 Bedienungsanleitung

AMT

AMT XLR8 Bedienungsanleitung

Medipost-Nutristoma

Medipost-Nutristoma MD300K2 Bedienungsanleitung

EDAN

EDAN SONOTRAX Pro Bedienungsanleitung

Restorative Therapies

Restorative Therapies RT300 Bedienungsanleitung

Gendex

Gendex Expert DC Bedienungsanleitung

Dexcowin

Dexcowin ADX4000W Bedienungsanleitung

Libelium

Libelium MySignals Bedienungsanleitung

Acelity

Acelity V.A.C.ULTA 4 Bedienungsanleitung

Caputron

Caputron ActivaDose II tDCS Bedienungsanleitung

FujiFilm

FujiFilm Sonart Betriebsanleitung

Plinth 2000

Plinth 2000 93CDT Bedienungsanleitung

GE SENOGRAPHE 800T Bedienungsanleitung

GE Definium 5000 Bedienungsanleitung

Kanmed

Kanmed GE-1380 Bedienungsanleitung

Huntleigh

Huntleigh FD1 Bedienungsanleitung

Stryker

Stryker SPR Plus Bedienungsanleitung