Chapter 1 Indication For Use And Safety Guidance; Indication For Use; Safety Guidance - EDAN iM80 User Manual

Patient Monitor User Manual

Chapter 1 Indication for Use and Safety Guidance

1.1 Indication for Use

iM80:
The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration
(RESP), Functional arterial oxygen saturation (SpO
(2/4 channels IBP NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO
Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as
loose or defective electrodes), physiologic parameters that have exceeded the limits set by the
operator, or both.
iM50:
The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP),
Functional arterial oxygen saturation (SpO
NIBP), Temperature (dual-TEMP), Expired CO
monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes),
physiologic parameters that have exceeded the limits set by the operator, or both.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

1.2 Safety Guidance

1 Before using the device, the equipment, patient cable and electrodes etc. should be
checked. Replacement should be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
2 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.
3 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
4 SHOCK HAZARD-The power receptacle must be a three-wire grounded outlet. A
hospital grade outlet is required. Never adapt the three-prong plug from the monitor to
fit a two-slot outlet.
5 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
electrodes, transducers. It is very important that these conductive parts do not come
into contact with other grounded, conductive parts when connected to the isolated
patient input of the device. Such contact would bridge the patient's isolation and
cancel the protection provided by the isolated input. In particular, there must be no
contact of the neutral electrode and ground.
Indication for Use and Safety Guidance
), Invasive or noninvasive blood pressure
2
), Invasive or noninvasive blood pressure (dual-IBP,
2
and Quick Temperature (Quick TEMP. The
2
WARNING
- 1 -
and
2