SUNRAY SRF618B6 - Chapter 1 Safety Guidance; Indications, Contraindications, and Patient Populations; Critical Warnings and Safety Notes

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Chapter 1 Safety guidance
NOTE:
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 Indications for Use
The SRF618B6 Fetal Monitor is intended for non-invasive monitoring of the Fetal Heart Rate (FHRs),
Uterine Activity (UA), and Fetal Movement (FM). It also provides the fetal heart beat sound with
internal speaker.
It is intended for antepartum use by trained healthcare personnel. It is not intended for home use.
1.2 Contraindication
The Sunray Fetal Monitor is NOT intended for:
 use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI).
1.3 Patient Populations
Pregnant women
1.4 Warning
 This monitor cannot be used for monitoring neonate.
 To avoid the risk of electric shock, this equipment must only be connected with the supply mains
with protective earth. For this purpose, this instrument is equipped with a three-wire power cord.
When this cord is plugged into a suitable three-wire socket, the casing of this instrument is
connected to the earth wire. The operator shall check whether this instrument is properly earthed
before using this instrument every time. Whenever there is a possibility that the protective earth is
damaged, the use of this instrument shall be stopped, and measures shall be taken to avoid this
instrument being operated by someone accidentally. If GND is not available, this socket shall not
be used, but rechargeable battery can be used to supply power for monitor.
 No unauthorized modification of this monitor is allowed.
 The monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all
transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI,
otherwise harm to the patient or the user can result.
 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,