Chapter 1 Intended Use And Safety Guidance; Intended Use; Safety Guidance; Environment - EDAN M3 User Manual

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance

Chapter 1 Intended Use and Safety Guidance

1.1 Intended Use

The Vital Signs Monitor (hereinafter called monitor) is intended to be used for non-invasive
continuous monitoring of SpO (oxygen saturation of the blood), NIBP (non-invasive blood
2
pressure) and TEMP (temperature).
The monitor is intended to be used only under regular supervision of clinical personnel. It is
applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and
intra-hospital moves.
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.

1.2 Safety Guidance

1.2.1 Environment

Follow the instructions below to ensure completely safe electrical installation. The environment
where the monitor will be used should be reasonably free from vibration, dust, corrosive or
explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation,
allow sufficient room at the front for operation and sufficient room at the rear for servicing with
the cabinet access door open.
℃
The monitor operates within specifications at ambient temperatures between +5℃~+40 .
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 (5cm) clearance around the
instrument for proper air circulation.

1.2.2 Power Source Requirements

Ⅰ
Refer to Appendix .

1.2.3 Grounding the Monitor

To protect the patient and hospital personnel, the cabinet of the monitor must be grounded.
Accordingly, the monitor is equipped with a detachable 3-wire cable which grounds the
instrument to the power line ground (protective earth) when plugged into an appropriate 3-wire
receptacle. If a 3-wire receptacle is not available, consult the hospital electrician.
Connect the grounding wire to the equipotential grounding terminal on the mains system. If it is
not evident from the instrument specifications whether a particular instrument combination is
hazardous or not, for example due to summation of leakage currents, the user should consult the
manufacturers concerned or an expert in the field, to ensure that the necessary safety of all
instruments concerned will not be impaired by the proposed combination.
- 1 -