Chapter 1 Intended Use And Safety Guidance; Intended Use; Safety Guidance; Environment - EDAN iM8 Series User Manual

Patient Monitor User Manual Intended Use and Safety Guidance

Chapter 1 Intended Use and Safety Guidance

1.1 Intended Use

This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating
alarms for multiple physiological parameters including ECG, respiration (RESP), temperature
(TEMP), oxygen saturation of arterial blood (SpO ), non-invasive blood pressure (NIBP),
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invasive blood pressure (IBP) and carbon dioxide (CO ) of adults, pediatrics and neonates in
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hospital environments.
This monitor is suitable for use in hospital environments including wards, OR, PACU, ICU and
neonate intensive care room.

1.2 Safety Guidance

1.2.1 Environment

Follow the instructions below to ensure a 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℃ and 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 (5cms) clearance around the
instrument for proper air circulation.

1.2.2 Power Source Requirements

Refer to Appendix Ⅰ
.

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 in the main 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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