Product Manual
4077-INS-LAB-RevB09 4
2 SAFETY INFORMATION
The safety statements presented in this chapter refer to the basic safety information that
the operator of the Fetal Monitor shall pay attention to and abide by. There are addition-
al safety statements in other chapters or sections, which may be the same as or similar
to the following, or specic to the operations. Please note the following special state-
ments, used throughout this manual, and their signicance:
WARNING: Indicates a potential hazard situation or unsafe practice that, if not
avoided, could result in death or serious personal injury.
Caution: Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
Note: Provides application recommendations or other useful information to ensure that
you get the most from your product.
The Grafco Fetal Monitor is designed to comply with the international safety require-
ments IEC 60601-1 for medical electrical equipment.
WARNING: Electrical shock hazard. Do not open the monitor. Any disassembly of
the device must be performed only by a qualied service technician.
WARNING: To reduce the risk of electric shock, perform leakage current measure-
ment and insulation testing on this device at least once per year.
WARNING: This Fetal Monitor is not protected against:
1. The effects of debrillator shocks
2. The effects of debrillator discharge
3. The effects of high frequency currents
4. The interference of electrosurgery equipment
5. The interference of mobile phone
The protective categories against electric shock of the patient connections are:
Ultrasound (FHR)
External TOCO
Remote Marker
Fetal Stimulator
This symbol indicates that the instrument is IEC 60601-1 Type
B equipment. Type B protection means that these patient con-
nections will comply with permitted leakage currents, dielectric
strengths and protective earthing limits of IEC 60601-1.
Caution: The Grafco External Fetal Monitor operates within specifications at ambi-
ent temperatures between 41°F and 104°F (5°C and 40°C). Ambient temperatures
that exceed these limits could affect the accuracy of the instrument and cause dam-
age to the modules and circuits. Allow at least 2 inches (5cm) clearance around the
instrument for proper air circulation.
Caution: Before use, check that the equipment, cables and transducers do not have
visible evidence of damage that may affect patient safety or monitoring capability.
Thereafter, inspect at least once per week. If damage is evident, replace compo-
nent before use.