Chapter 1 Intended Use And Safety Guidance; Intended Use/Indications For Use; Safety Guidance; Environment - EDAN M3A User Manual

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance

Chapter 1 Intended Use and Safety Guidance

1.1 Intended Use/Indications for Use

This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating
alarms for SpO (oxygen saturation of arterial blood), NIBP (non-invasive blood pressure) and
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TEMP (quick temperature or infrared ear temperature) of adults, pediatrics and neonates in
hospital environments.
This monitor is used to monitor vital signals for patients and is suitable for use in hospital
environments including out-patient department, wards and NICU.
Monitored paramenters include: NIBP, SpO , pulse rate, Quick TEMP/Infrared TEMP.
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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 0 C and +40 C.
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.

1.2.2 Power Source Requirements

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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 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.
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