Chapter 1 Intended Use And Safety Guidance; Intended Use/Indications For Use; Safety Guidance - EDAN elite V5 User Manual

Patient Monitor User Manual

Chapter 1 Intended Use and Safety Guidance

1.1 Intended Use/Indications for Use

The monitors are intended to be used for monitoring, storing, and reviewing of, and to generate
alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are
intended for use by trained healthcare professionals in hospital environments.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP),
oxygen saturation of arterial blood (SpO
invasive blood pressure (IBP), carbon dioxide (CO
bispectral index (BIS), respiration mechanics (RM) and, impedance cardiography (ICG). Also,
the V-Link module is intended for connecting external devices, such as Neuromuscular
transmission (NMT), Hemodynamic monitoring, Ventilators and Anesthesia devices, to the
monitor, and it allows the data from external devices to be displayed on the monitor.
BIS is intended for use on adult and pediatric patients.
ICG monitoring is intended for use on adults only.
NMT is intended for use on adult and pediatric patients.
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The monitors are additionally intended for use during patient transport inside hospitals.
The monitors are not intended for MRI environments.

1.2 Safety Guidance

Federal (U.S.) law restricts this device to sale by or on the order of a physician.
1 To ensure that the monitor works properly, please read the user manual and follow
the steps before using the monitor.
2 Before using the device, the equipment, patient cable and electrodes etc. should be
checked. Replacement shall be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
3 Medical technical equipment such as these monitor/monitoring system must only be
used by persons who have received adequate training in the use of such equipment
and who are capable of applying it properly.
4 SHOCK HAZARD-To avoid the RISK of electric shock, this equipment must only be
connected to a SUPPLY MAINS with protective earth.
5 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
), pulse rate (PR), non-invasive blood pressure (NIBP),
2
), cardiac output (C.O.), anesthetic gas (AG),
2
WARNING
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Intended Use and Safety Guidance