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:
①
FHR1
②
FHR2
③
TOCO MARK
④
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.
