6
Instructions For Use
EN
1. Safety Guide
Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a
physician.
NOTE: In order to ensure the operator and patient’s safety, read through this
chapter before using this system.
NOTE: 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/Indications for Use
The FTS-3 wireless telemetry system is a wireless system that is compatible with
fetal & maternal monitors. It is intended for invasive or noninvasive monitoring
of fetal/maternal physiological parameters, including fetal heart rate (FHR),
fetal movement (FM), uterine activity , direct ECG (DECG) and maternal ECG
(MECG) for pregnant women >28 weeks gestation. It is intended for monitoring
in a bath or shower and only by trained and qualified personnel in antepartum
examination rooms, labour and delivery rooms.
1.2
Instruction for Safe Operation
NOTE: In this manual, System refers to FTS-3
• The system is designed to comply with the international safety requirements IEC/
EN 60601-1 for medical electrical equipment. It is class I equipment.
•
The system operates within specifications at ambient temperatures b5
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, replacement is recommended before use.
•
The system must be serviced only by authorised and qualified personnel. The
manufacturer does not accept responsibility for safety compliance, reliability and
performance if modifications or repairs are carried out by unauthorised personnel.
Identical replacement parts must be used.
• The typical operator's position is in front of the system. Please position the device in
a location where the operator can easily access the operating controls.
