Contec CMS800G User manual
CMS800G
FETAL MONITOR
CONTEC MEDICAL SYSTEMS CO., LTD
TABLE OF CONTENTS
1 Safety Guidance ………………………………………………………………………………….2
1.1 Introduction For The Safe Operation ……………………………………………………2
1.2 Ultrasound Safety Guide ……………………………………………………………………2
1.3 Safety Precautions ………………………………………………………………………...3
2 Introduction………………………………………………………………………………………5
2.1 Intended Use 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
Copyright
Copyright: Contec Medical System CO., LTD.2007
Attention
This document contains proprietary information protected by copyright law. No part of this
document may be photocopied, reproduced or translated to another language without prior written
consent of CONTEC.
CONTEC assumes no responsibility for any errors that may appear in this document, or for
incidental or consequential damage in connection with the furnishing, performance or use of this
material. The information contained in this document is subject to change without notice.
Responsibility of the Manufacturer
CONTEC only considers itself responsible for any effects on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by CONTEC, and the electrical installation of the relevant room complies with
national standards, and the instrument is used in accordance with the instructions for use.
Note: This device is not intended for home use.
WARNING : This device is not intended for treatment.
If there is doubt as to fetal well-being after using the unit, further investigations should be
undertaken immediately using alternative techniques.
The accuracy of FHR is controlled by the equipment and can not be adjusted by user.
If the FHR result is distrustful, please use other method such as stethoscope to verify
or contact the local distributor or manufacture to get help.
Using This Label Guide
This guide is designed to give key concepts on safety 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 NOTE provides useful information regarding a function 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 affect the accuracy of the instrument and cause
damage to the modules and circuits. Allow at least 2 inches (5cm) clearance around the
instrument for proper air circulation.
The user must check the equipment, cables and transducers do not have visible evidence of
damage that may affect patient safety or monitoring capability before use. The recommended
inspection interval is once per week or less. If damage is evidence, replacement is
recommended before use.
The user must be serviced only by authorized and qualified personnel, The manufacturer can
not accept responsibility for safety compliance, reliability and performance if modifications
or repairs are carried out by unauthorized personnel. Identical replacement parts must be
used.
Perform period safety testing to insure proper patient safety. This should include leakage
current measurement and insulation testing. The recommended testing interval is once per
year.
The protection categories against electric shock of 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 of IEC 60601-1.
The monitor described in this user manual is not protected against:
A) The effect of defibrillator shocks
B) The effects of defibrillator discharge
C) The interference of high frequency currents
D) The interference of electrosurgery equipment
E) The interference of mobile phone
1.2 Ultrasound Safety Guide
Fetal Use
The Monitor is designed for continuous fetal heart rate monitoring during pregnancy and
labor . Clinical interpretation of fetal heart rate patterns can diagnose fetal and/or maternal
problems and complications.
Instructions for Use in Minimizing Patient Exposure
The acoustic output of the Monitor is internally controlled and can not be varied by the
operator in the course of the examination. The duration of exposure is, however, fully under
the control of the operator. Mastery of the examination techniques described in the User
Manual will facilitate obtaining the maximum amount of diagnostic information with the
minimum amount of exposure.
1.3 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING : EXPLOSION HAZARD-Do not use the in a flammable atmosphere where
concentrations of flammable 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 from the monitor to fit a two-slot outlet. If the outlet has only two
slots, make sure that it is replaced with a three-slot grounded outlet before
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 before
touching a power cord.
WARNING : The monitor should be installed by an authorized and qualified 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 of the doctors and patient.
WARNING : Do not switch on device power until all cables have been properly connected
and verified.
WARNING : Don’t touch signal input or output connector and the patient simultaneously.
WARNING : Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC standards (e.g. IEC 950 for data
processing equipment and IEC 60601-1 for medical equipment). Furthermore
all configurations shall comply with the valid version of the system standard
IEC 60601-1-1. Everybody who connects additional equipment to the signal
input connector or signal output connector configures a medical system, and is
therefore responsible that the system complies with the requirements of the
valid version of the system standard IEC 60601-1-1. If in doubt, consult our
technical service department or your local distributor.
CAUTION : The device is designed for continuous and is “ordinary” (i.e. not drip or
splash-proof).
CAUTION : Keep the environment clean. Avoid vibration. Keep it far from corrosive
medicine, dust area, high-temperature and humid environment.
CAUTION : Do not operate the unit if it is damp or wet because of condensation or spills.
Avoid using the equipment immediately after moving it from a cold
environment to a warm, humid location.
CAUTION : Do not immerse transducers in liquid. When using solutions, use sterile wipes
to avoid pouring fluids directly on the transducers.
CAUTION
CAUTION
CAUTION : The temperature should not exceed 6
CAUTION : Electromagnetic Interference-Ensure that the environment in which the
CAUTION : The monitor must serviced by proper training and knowledge, practical
Do not use high temperature heating or gas to disinfect the monitor and its
④
accessories.
Turn off the power supply before clean the machine.
④
when clean the belt.
0℃
fetal monitor is installed is not subject to any sources of strong
electromagnetic interference, such as radio transmitters, mobile telephones,
etc.
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 manufacturer
for recycling or proper disposal after their useful lives.
2 Introduction
The Fetal Monitor can provide different configurations according to different user requirements:
FHR1 (Ultrasonic Channel ), FHR2 (Ultrasonic Channel ),TOCO, FMOV (Fetal MovementⅠ Ⅱ
Marker). Monitoring results can be recorded by built-in recorder for continuous or intermittent
records.
The monitor can be used individually or connected with PC through RJ45 Interface for the
purpose of central monitoring.
2.1 Intended Use and Application
Fetal Monitor can acquire fetal heart rate, maternal uterine contraction when pregnancies over 28
weeks to provide reference data for clinical use.
Dual Heart Rate Monitoring allows simultaneous monitoring of two heart rates for twins. This is
achieved by using the facilities of 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 fetal physiology, pathology and maternity status, and so on, for medical
professionals reference.
It is only suitable for the equipment in hospitals, clinics, doctors offices 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 of the patient data and curve clearly
Print paper fetal heart rate 120-160bpm normal range label
Manual records fetal movement
Sound and color alarm for high and low fetal heart rate
Continuous 24-hour real-time monitoring function
Continuous 12-hour patient curve and data storage and playback
With picture freeze function
Optional English interface
Single, Twins Monitoring optional
9 chip pulse width beam probe
Extra-long life, high-resolution built-in thermal printer matrix, the output waveform, text, and
other information
Built-in communication port, can be connected with central monitoring system.
3 Monitor and Setup
3.1 The Monitor
Figure 3.1 Appearance (Twins configuration, only for reference)
3.1.1 Transducer Introduction
Ultrasound TransducerⅠ④TOCO Transducer④Remote Marker④Ultrasound TransducerⅡ
Ultrasound TransducerⅠ
④1④
The multi-crystal, broad beam ultrasound transducer is used for monitoring fetal heart
rate(FHR1).The ultrasound transducer operates at a frequency of 1.0MHz. Put the ultrasound
transducer on maternal abdomen to transmit lower energy ultrasound wave to fetal heart, then
receive the echo signal from it.
TOCO Transducer
④2④
This transducer is a toco tonometer whose central section is depressed by the forward
displacement of the abdominal muscles during a contraction. It is used for assessment of
frequency and duration of uterine contractions. It gives a subjective indication of contractions
pressure.
Remote Marker
④3④
The remote marker is a hand-held switch operated by patient. The mother is normally instructed
to push down the switch when feeling fetal movement.
Ultrasound TransducerⅠ④TOCO Transducer④Remote Marker are three in one transducers, their
sockets are marked FHR1/TOCO/MARK on the monitor panel.
Ultrasound TransducerⅡ is the transducer for FHR 2(Twins Configuration), it’s socket is
④4④
marked FHR2 on the monitor panel.
3.1.2 Left Side Sockets
Figure 3.2 Left Side Sockets
3.1.3 Interfaces and Symbols
FHR1/TOCO/MARK socket: Socket for FHR1/TOCO transducer and remote Marker
FHR2 socket: Socket for FHR2 Transducer
: Socket for Grounding Cable
NET.: Socket for network
: Warning Symbol
Push: LCD Screen rotation lock
3.1.4 Main Interface
Figure 3.3 Twins Monitoring interface
The main monitoring interface(Twins Monitoring) is divided into 5 parts according to display
content, they are status bar ④data section④parameter section④indicate bar and wave display section.
It displays in status bar that sound channel and volume④connection status of ultrasound Transducer
I④ultrasound Transducer II(twins monitoring) and TOCO transducer, Freeze status④print
status④alarm on /off; It displays FHR 1 from Ultrasound Transducer I④FHR 2 from Ultrasound
Transducer II (Twins monitoring) and TOCO④Fetal Movement data; parameter section displays the
important parameter of current settings; time④bed number④time of pregnancy and age of pregnant
woman are displayed in indicate bar; waves from ultrasound transducer I channel④ultrasound
transducer II channel(Twins Monitoring) and TOCO transducer are displayed in wave display
section. Detail instruction as followed.
Status Bar
（1（
Sound channel and volume
④A④
Icon
④Sound Icon
④Sound off Icon
I④The No. of FHR sound channel, it is I under single fetal monitoring mode which is
default; I④II selectable under twins monitoring mode, it can be changed through
the main menu.
3④Volume level, ranging from 0-7, 0 stands for sound off. It can be changed through the
buttons on the panel or set in the main menu.
Connection status of ultrasound transducer
④B④
IconⅠ④: : Ⅱ
I④Channel No. of ultrasound transducer, there is only I under single monitoring mode,
there are I and II under twins monitoring mode
④Normal connection of ultrasound transducer
④Error connection of ultrasound transducer
④ Ⅰ
:3 Ⅰ:0
Connection Status of TOCO transducer
④C④
④Normal connection of TOCO transducer
④Error connection of TOCO transducer
Freeze status
④D④
④Shows current screen is frozen; icon will disappear when unfrozen.
Recorder status
④E④
④Printing
④out of paper
④Failed to print
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