EDAN F6 User manual - 1.4 Ultrasound Safety Guide
F Series Fetal & Maternal Monitor User Manual Safety Guide
- 3 -
does 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.
The protective degree against electric shock of the patient connections is:
Ultrasound (FHR1, FHR2)
External TOCO
Fetal Movement Mark (FM)
Intrauterine Pressure (IUP)
Type BF
Non-invasive Blood Pressure (NIBP)
Arterial Oxygen Saturation (SpO
2
)
Type BF, defibrillation-proof
Direct Electrocardiography (DECG)
Type CF
Electrocardiography (ECG)
Temperature (TEMP)
Type CF, defibrillation-proof
The monitor described in this user manual is not protected against:
a) The effects of high frequency currents
b) The interference of electrosurgery equipment
1.4 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 traces 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.
The exercising of clinical judgment in the monitoring of low risk patients will avoid unnecessary
insonation.