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Chapter 1 Safety Guide
NOTE:
For Operator and Patient safety, please read through this instruction manual before using the
Wallach Fetal2EMR Fetal Monitor.
1.1 Intended Use
The Wallach Fetal2EMR (Model F3) Fetal Monitor (hereinafter called Fetal2EMR) is intended
for non-invasive monitoring of a single or twin fetuses 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 Fetal2EMR provides fetal monitoring. It can externally monitor the Fetal Heart Rates (FHRs)
using ultrasound and uterine activity via a TOCO transducer.
Contraindications: The Fetal2EMR Monitor is not intended for use in intensive care units,
operating rooms or for home use.
1.2 Instruction for Safe Operation
The Fetal2EMR Monitor is designed to comply with the international safety requirements
IEC/EN 60601-1 for medical electrical equipment. It is class I equipment.
The Fetal2EMR Monitor operates within specifications at ambient temperatures between
+5ºC (+41ºF) and +40ºC (+104ºF). Ambient temperatures that exceed these limits could
affect the accuracy of the instrument and cause damage to the modules and circuits. Allow at
least 5 cm (2 inches) 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, replacement is recommended.
The Fetal2EMR Monitor must be serviced only by authorized and qualified personnel.
Wallach Surgical Devices 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.
The protective categories against electric shock of the patient connections are:
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Chapter 1: Safety Guide
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