146
10.24.3 Electrical safety
The following are the precautions that shall be observed when combining these items (non-
medical equipment) with the system.
•
Items that do not complies the requirements of IEC 60601-1 cannot be placed within 1.5
m of the patient.
•
Do not connect non-medical electrical equipment directly to the wall outlet. Use AC
power supply with own transformer. Otherwise, current leakage will increase above the
levels accepted by IEC 60601-1 under normal conditions and single fault conditions.
This may cause dangerous electrical shock to the patient or the operator.
•
After connecting any equipment to these outlets, subject the system to a complete
leakage current test (in accordance with IEC 60601-1).
•
The electromedical system operator shall not touch non-medical electrical equipment
and the patient simultaneously. This may cause dangerous electrical shock to the
patient or the operator.
•
Do not connect a multiple socket or extension cable to the electromedical system.
10.25 Audible acoustic energy
Table 54
– Audible acoustic energy specification
Configuration
Sound Pressure Level
Sound Power Level
Volume ≥ 300 mL
47 dB ± 2 dB
55 dB ± 2 dB
300 mL ≥ Volume ≥ 50 mL
46 dB ± 2 dB
54 dB ± 2 dB
Volume ≤ 50 mL
45 dB ± 2 dB
53 dB ± 2 dB
10.26 Mask to non-invasive ventilation
Table 55
– Mask to NIV ventilation specification
Specification
Adult/ pediatric connection
22 mm
Neonatal connection
15 mm