Patient Monitor User Manual Intended Use and Safety Guidance
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Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
iM8 Series: The Patient Monitor (hereinafter called monitor) is intended to be used for
continuous monitoring of ECG, RESP, SpO
2
, NIBP (Non-invasive Blood Pressure), dual-TEMP,
dual-IBP and CO
2
.
M8 Series: The Patient Monitor (hereinafter called monitor) is intended to be used for continuous
monitoring of ECG, RESP, SpO
2
, NIBP (Non-invasive Blood Pressure), dual-TEMP, dual-IBP
and CO
2
.
The monitor is intended to be used only under regular supervision of clinical personnel. It is
applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient
transport inside a healthcare facility.
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 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 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 (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
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