Product Manual

4077-INS-LAB-RevB09 5
ULTRASOUND SAFETY GUIDE
Fetal Use
The Grafco Fetal Monitor is designed for continuous fetal heart rate monitoring during
pregnancy and labor. Clinical interpretation of fetal heart rate trends can diagnose fetal
and/or maternal problems and complications.
Instructions for Use in Minimizing Patient Exposure
The acoustic output of the Grafco Fetal 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.
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:
To reduce the risk of burns and/or serious personal injury
WARNING: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
WARNING: Use this product only for its intended use as described in this manual.
WARNING: This device is to be used only in accordance with the prescription of a
physician and this user manual.
WARNING: EXPLOSION HAZARD—Do not use the Grafco Fetal Monitor in a am-
mable atmosphere where concentrations of ammable anesthetics or other mate-
rials may occur.
WARNING: SHOCK HAZARD—The power receptacle must be a three-wire ground-
ed outlet. A hospital-grade outlet is required. Never adapt the three-prong plug
from the monitor to t 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: Disconnect power cord before changing fuse. Replace with the same
rating and type only.
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 touch-
ing a power cord.
WARNING: Do not apply this monitor and other ultrasonic equipment simultane-
ously on the same patient, in case of the possible hazard caused by leakage cur-
rent superposition.