Contec CMS800G Bedienungsanleitung

CONTEC MEDICAL SYSTEMS CO., LTD

CMS800G

FETAL MONITOR

TABLE OF CONTENTS

1 Safety Guidance ………………………………………………………………………………….2

1.1 Introduction For The Safe Operation ……………………………………………………2

1.2 ltrasound Safety Guide ……………………………………………………………………2

1.3 Safety Precautions ………………………………………………………………………...3

2 Introduction………………………………………………………………………………………5

2.1 Intended se and Application………………………………………………………………5

2.2 Features………………………………………………………………………………………5

3 Monitor and Setup………………………………………………………………………………..6

3.1 The Monitor…………………………………………………………………………………..6

3.2 Setup………………………………………………………………………………………….11

4 Installation………………………………………………………………………………………..16

4.1 Open the Package and Check………………………………………………………………16

4.2 Connect the Power Cable…………………………………………………………………...16

4.3 Connect with Network………………………………………………………………………17

4.4 Feeding Paper and Removing Paper Jam…………………………………………………17

4.5 Power On the Monitor………………………………………………………………………17

4.6 Connect Transducers………………………………………………………………………..17

5 Monitoring………………………………………………………………………………………..17

5.1 Operation Procedure ……………………………………………………………………….17

5.2 Print Operation……………………………………………………………………………...20

5.3 Operation After Monitoring ………………………………………………………………..21

6 Maintenance, Care and Cleaning……………………………………………………………….21

6.1 Preventive Maintenance…………………………………………………………………….21

6.2 Care and Cleaning of Monitor……………………………………………………………...22

6.3 Care and Cleaning of Transducer…………………………………………………………..22

6.4 Care of Recorder and Paper………………………………………………………………...23

6.5 Cleaning of Belt………………………………………………………………………………23

6.6 Sterilization…………………………………………………………………………………...24

6.7 Disinfection…………………………………………………………………………………...24

7 Warranties…………………………………………………………………………………...........24

Attachment 1 Product Specification……………………………………………………………….25

A 1.1 Monitor……………………………………………………………………………………..25

A 1.2 Transducers………………………………………………………………………………...26

Attachment 2 Troubleshooting……………………………………………………………………..27

Attachment 3 Monitoring Figure…………………………………………………………………..28

Attention

This document contains proprietary in ormation protected by copyright law. No part o this

document may be photocopied, reproduced or translated to another language without prior written

consent o CONTEC.

CONTEC assumes no responsibility or any errors that may appear in this document, or or

incidental or consequential damage in connection with the urnishing, per ormance or use o this

material. The in ormation contained in this document is subject to change without notice.

Responsibility of the Manufacturer

CONTEC only considers itsel responsible or any e ects on sa ety, reliability and per ormance o

the equipment i :

Assembly operations, extensions, re-adjustments, modi ications or repairs are carried out by

persons authorized by CONTEC, and the electrical installation o the relevant room complies with

national standards, and the instrument is used in accordance with the instructions or use.

Note: This device is not intended or home use.

WARNING : This device is not intended or treatment.

I there is doubt as to etal well-being a ter using the unit, urther investigations should be

undertaken immediately using alternative techniques.

The accuracy o FHR is controlled by the equipment and can not be adjusted by user.

I the FHR result is distrust ul, please use other method such as stethoscope to veri y

or contact the local distributor or manu acture to get help.

Using This Label Guide

This guide is designed to give key concepts on sa ety precautions.

WARNING

A WARNING label advises against certain actions or situations that could result in personal injury

or death.

CAUTION

A CAUTION label advises against actions or situations that could damage equipment, produce

inaccurate data, or invalidate a procedure.

Note: A NOT provides use ul in ormation regarding a unction or procedure.

1 Safety Guidance

1.1 Introduction For the Safe Operation

The CMS800G Ultrasonic Fetal Doppler Monitor (Monitor) is Class I equipment and

designed to comply with IEC 60601-1.

Switching within 1 minute, at ambient temperatures between 5℃ and 40℃ . Ambient

temperatures that exceed these limits could a ect the accuracy o the instrument and cause

damage to the modules and circuits. Allow at least 2 inches (5cm) clearance around the

instrument or proper air circulation.

The user must check the equipment, cables and transducers do not have visible evidence o

damage that may a ect patient sa ety or monitoring capability be ore use. The recommended

inspection interval is once per week or less. I damage is evidence, replacement is

recommended be ore use.

The user must be serviced only by authorized and quali ied personnel, The manu acturer can

not accept responsibility or sa ety compliance, reliability and per ormance i modi ications

or repairs are carried out by unauthorized personnel. Identical replacement parts must be

used.

Per orm period sa ety testing to insure proper patient sa ety. This should include leakage

current measurement and insulation testing. The recommended testing interval is once per

year.

The protection categories against electric shock o the patient connections are:

①FHR1 ②FHR2 ③TOCO MARK④

This symbol indicates that the instrument is IEC 60601-1 Type B equipment. Type B protection

means that these patient connections will comply with permitted leakage currents, dielectric

strengths and protective earthing limits o IEC 60601-1.

The monitor described in this user manual is not protected against:

A) The e ect o de ibrillator shocks

B) The e ects o de ibrillator discharge

C) The inter erence o high requency currents

D) The inter erence o electrosurgery equipment

E) The inter erence o mobile phone

1.2 Ultrasound Safety Guide

Fetal Use

The Monitor is designed or continuous etal heart rate monitoring during pregnancy and

labor . Clinical interpretation o etal heart rate patterns can diagnose etal and/or maternal

problems and complications.

Instructions for Use in Minimizing Patient xposure

The acoustic output o the Monitor is internally controlled and can not be varied by the

operator in the course o the examination. The duration o exposure is, however, ully under

the control o the operator. Mastery o the examination techniques described in the User

Manual will acilitate obtaining the maximum amount o diagnostic in ormation with the

minimum amount o exposure.

1.3 Safety Precautions

WARNING and CAUTION messages must be observed. To avoid the possibility o injury,

observe the ollowing precautions during the operation o the instrument.

WARNING : XPLOSION HAZARD-Do not use the in a lammable atmosphere where

concentrations o lammable anesthetics or other materials may occur.

WARNING : SHOCK HAZARD-the power receptacle must be a three-wire grounded

outlet. A hospital grade outlet is required. Never adapt the three-prong

plug rom the monitor to it a two-slot outlet. I the outlet has only two

slots, make sure that it is replaced with a three-slot grounded outlet be ore

attempting to operate the monitor.

WARNING : SHOCK HAZARD-Do not attempt to connect or disconnect a power cord

with wet hands. Make certain that your hands are clean and dry be ore

touching a power cord.

WARNING : The monitor should be installed by an authorized and quali ied service

engineer.

WARNING : SHOCK HAZARD-Do not remove the top panel covers during operation or

while power is connected.

WARNING : Only connect the device to Contec supplied or recommended accessories, to

avoid the injury o the doctors and patient.

WARNING : Do not switch on device power until all cables have been properly connected

and veri ied.

WARNING : Don’t touch signal input or output connector and the patient simultaneously.

WARNING : Accessory equipment connected to the analog and digital inter aces must be

certi ied according to the respective IEC standards (e.g. IEC 950 or data

processing equipment and IEC 60601-1 or medical equipment). Furthermore

all con igurations shall comply with the valid version o the system standard

IEC 60601-1-1. Everybody who connects additional equipment to the signal

input connector or signal output connector con igures a medical system, and is

there ore responsible that the system complies with the requirements o the

valid version o the system standard IEC 60601-1-1. I in doubt, consult our

technical service department or your local distributor.

CAUTION : The device is designed or continuous and is “ordinary” (i.e. not drip or

splash-proo ).

CAUTION : Keep the environment clean. Avoid vibration. Keep it ar rom corrosive

medicine, dust area, high-temperature and humid environment.

CAUTION : Do not operate the unit i it is damp or wet because o condensation or spills.

Avoid using the equipment immediately a ter moving it rom a cold

environment to a warm, humid location.

CAUTION : Do not immerse transducers in liquid. When using solutions, use sterile wipes

to avoid pouring luids directly on the transducers.

CAUTION ④Do not use high temperature heating or gas to disin ect the monitor and its

accessories.

CAUTION ④Turn o the power supply be ore clean the machine.

CAUTION : The temperature should not exceed 60℃ when clean the belt.

CAUTION : lectromagnetic Interference-Ensure that the environment in which the

etal monitor is installed is not subject to any sources o strong

electromagnetic inter erence, such as radio transmitters, mobile telephones,

etc.

CAUTION : The monitor must serviced by proper training and knowledge, practical

personnel. The recommended testing interval is once twice year or under the

leakage current measurement and insulation testing.

CAUTION : The device and reusable accessories could be sent back to the manu acturer

or recycling or proper disposal a ter their use ul lives.

2 Introduction

The Fetal Monitor can provide di erent con igurations according to di erent user requirements:

FHR1 (Ultrasonic Channel ), FHR2 (Ultrasonic Channel ),TOCO, FMOV (Fetal MovementⅠ Ⅱ

Marker). Monitoring results can be recorded by built-in recorder or continuous or intermittent

records.

The monitor can be used individually or connected with PC through RJ45 Inter ace or the

purpose o central monitoring.

2.1 Intended Use and Application

Fetal Monitor can acquire etal heart rate, maternal uterine contraction when pregnancies over 28

weeks to provide re erence data or clinical use.

Dual Heart Rate Monitoring allows simultaneous monitoring o two heart rates or twins. This is

achieved by using the acilities o two ultrasound transducers and an external contractions

(TOCO) transducer with a recorder.

The monitor can display FHR, TOCO, MARK (remote) sinuously, by analyzing their mutual

relations, to judge etal physiology, pathology and maternity status, and so on, or medical

pro essionals re erence.

It is only suitable or the equipment in hospitals, clinics, doctors o ices and patients at home by

trained medical personnel.

2.2 Features

Light dexterous appearance, tops horizontally and walls can be hoisted

8.4screen color LCD display, rotatable screen to 60°

Display o the patient data and curve clearly

Print paper etal heart rate 120-160bpm normal range label

Manual records etal movement

Sound and color alarm or high and low etal heart rate

Continuous 24-hour real-time monitoring unction

Continuous 12-hour patient curve and data storage and playback

With picture reeze unction

Optional English inter ace

Single, Twins Monitoring optional

9 chip pulse width beam probe

Extra-long li e, high-resolution built-in thermal printer matrix, the output wave orm, text, and

other in ormation

Built-in communication port, can be connected with central monitoring system.

3 Monitor and Setup

3.1 The Monitor

Figure 3.1 Appearance (Twins con iguration, only or re erence)

3.1.1 Transducer Introduction

Ultrasound TransducerⅠ④TOCO Transducer④Remote Marker④Ultrasound TransducerⅡ

④1④Ultrasound TransducerⅠ

The multi-crystal, broad beam ultrasound transducer is used or monitoring etal heart

rate(FHR1).The ultrasound transducer operates at a requency o 1.0MHz. Put the ultrasound

transducer on maternal abdomen to transmit lower energy ultrasound wave to etal heart, then

receive the echo signal rom it.

④2④TOCO Transducer

This transducer is a toco tonometer whose central section is depressed by the orward

displacement o the abdominal muscles during a contraction. It is used or assessment o

requency and duration o uterine contractions. It gives a subjective indication o contractions

pressure.

④3④Remote Marker

The remote marker is a hand-held switch operated by patient. The mother is normally instructed

to push down the switch when eeling etal movement.

Ultrasound TransducerⅠ④TOCO Transducer④Remote Marker are three in one transducers, their

sockets are marked FHR1/TOCO/MARK on the monitor panel.

④4④Ultrasound TransducerⅡ is the transducer or FHR 2(Twins Con iguration), it’s socket is

marked FHR2 on the monitor panel.

3.1.2 Left Side Sockets

Figure 3.2 Le t Side Sockets

3.1.3 Interfaces and Symbols

FHR1/TOCO/MARK socket: Socket or FHR1/TOCO transducer and remote Marker

FHR2 socket: Socket or FHR2 Transducer

: Socket or Grounding Cable

NET.: Socket or network

: Warning Symbol

Push: LCD Screen rotation lock

3.1.4 Main Interface

Figure 3.3 Twins Monitoring inter ace

The main monitoring inter ace(Twins Monitoring) is divided into 5 parts according to display

content, they are status bar ④data section④

parameter section④

indicate bar and wave display section.

It displays in status bar that sound channel and volume④

connection status o ultrasound Transducer

I④ultrasound Transducer II(twins monitoring) and TOCO transducer, Freeze status ④print

status④alarm on /o ; It displays FHR 1 rom Ultrasound Transducer I ④FHR 2 rom Ultrasound

Transducer II (Twins monitoring) and TOCO④

Fetal Movement data; parameter section displays the

important parameter o current settings; time④

bed number④

time o pregnancy and age o pregnant

woman are displayed in indicate bar; waves rom ultrasound transducer I channel ④ultrasound

transducer II channel(Twins Monitoring) and TOCO transducer are displayed in wave display

section. Detail instruction as ollowed.

（1（Status Bar

④A④Sound channel and volume

Icon ④Ⅰ:3 Ⅰ:0

④Sound Icon

④Sound o Icon

I④The No. o FHR sound channel, it is I under single etal monitoring mode which is

de ault; I④II selectable under twins monitoring mode, it can be changed through

the main menu.

3④Volume level, ranging rom 0-7, 0 stands or sound o . It can be changed through the

buttons on the panel or set in the main menu.

④B④Connection status o ultrasound transducer

Icon Ⅰ④: : Ⅱ

I④Channel No. o ultrasound transducer, there is only I under single monitoring mode,

there are I and II under twins monitoring mode

④Normal connection o ultrasound transducer

④Error connection o ultrasound transducer

④C④Connection Status o TOCO transducer

④Normal connection o TOCO transducer

④Error connection o TOCO transducer

④D④Freeze status

④Shows current screen is rozen; icon will disappear when un rozen.

④E④Recorder status

④Printing

④out o paper

④Failed to print

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