CADENCE II Fetal Monitor User Manual
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Chapter 1 Safety Guidance
NOTES:
1) In order to ensure the operator and patient’s safety, read through this chapter before
using this monitor.
2) This user manual is written to cover the maximum configuration. Therefore, your
model may not have some of the parameters and functions described, depending on
what you have ordered.
1.1 Intended Use
The CADENCE II fetal monitor is intended for monitoring physiological parameters of pregnant
women 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. It is
not intended for use in intensive care units, operating rooms or for home use.
1.2 Instruction for Safe Operation
A The CADENCE II Fetal Monitor (hereinafter called “CADENCE II”) is designed to comply
with the international safety requirements IEC/EN 60601-1 for medical electrical equipment.
It is class I equipment.
A CADENCE II operates within specifications at ambient temperatures between 5 ºC (41 ºF)
and 40 ºC (104 ºF) after it is powered on for one minute. Ambient temperatures that exceed
these limits could affect the accuracy of the instrument and cause damage to the modules and
circuits. Allow at least two inches (5 cm) clearance around the instrument for proper air
circulation.
A 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 each use. If damage is
evident, replacement is recommended before use.
A The monitor must be serviced only by authorized and qualified personnel. The manufacturer
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.
A 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.
A The protective categories against electric shock of the patient connections are:
1) Ultrasound (FHR1, FHR2) 2) External TOCO
3) Fetal Movement (FM) 4) Fetal Stimulator (FS)
This symbol indicates that this is an IEC/EN 60601-1 Type B applied part.
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