Cooper Surgical F9 Express, Руководство пользователя

Страница: 7 / 91

F9 Fetal & Maternal Monitor • User Manual
- 1 -
Chapter 1 Safety Guidance
NOTE: This User Manual is written to cover features of both the F9 and F9 Express
Monitors. Therefore, your model may or may not have some of the parameters and
functions described, depending on what you have ordered.
1.1 Intended Use
The CooperSurgical F9 Series Fetal & Maternal Monitor (hereinafter called F9 Monitor) is intended
for non-invasive monitoring of a fetus during antepartum examination, labor and delivery. It is
intended to be used only by trained and qualified personnel in antepartum examination rooms, labor
and delivery rooms.
The F9 Monitor provides non-stress testing for pregnant women from the 28th week of gestation. It
can externally monitor the Fetal Heart Rates (FHRs) using ultrasound and uterine activity via a
TOCO transducer. Alternatively, it can internally monitor one of the FHRs with Direct
Electrocardiography (DECG) and uterine activity with an Intrauterine Pressure Catheter (IUPC).
Contraindications: The F9 Monitor is not intended for use in intensive care units, operating
rooms or for home use.
1.2 Instructions for Safe Operation
•
The F9 Monitor is designed to comply with the international safety requirements IEC/EN
60601-1 for Medical Electrical Equipment. It is Class I equipment.
•
The F9 Monitor operates within specifications at ambient temperatures between 5 ºC (41 ºF) and
40 ºC (104 ºF). 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 (5 cm)
clearance around the instrument for proper air circulation.
•
You must check that the equipment, cables and transducers do not have visible evidence of
damage that may affect patient safety or monitoring capability before use. If damage is evident,
replace.
•
The F9 Monitor must be serviced only by authorized and qualified personnel. CooperSurgical
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.
•
Perform periodic safety testing to ensure proper patient safety. This should include leakage current
measurement and insulation testing. The recommended testing interval is once per year.