8.3 Emission and Immunity Declaration
According to IEC 60601-1-2:2014.
The performance of all functions of the ventilator is considered as essential performance
for the purpose of immunity testing.
8.3.1 Nippy 4 Essential Performance
The ventilator will deliver ventilation at the patient-connection port within its published
accuracy specifications and within the alarm limits set by the operator, or generate an alarm
condition for high pressure, low pressure, high EPAP, low tidal volume, low minute volume,
low breath rate, high and low FiO
2
, obstruction, low last power source, or power failure.
The ventilator will provide SpO
2
and pulse rate values within its published accuracy specifi-
cations and generate an alarm upon a low SpO
2
condition. The ventilator will provide indi-
cation when the SpO
2
value or pulse rate is potentially incorrect, and generate an alarm
condition to indicate when the SpO
2
value update period has exceeded 30 seconds.
The ventilator will provide FiO
2
values within its published accuracy specifications and gen-
erate an alarm condition upon high and low FiO
2
conditions.
Under the immunity test conditions, the following allowances are acceptable:
• Error of delivered volume and EPAP of individual breaths up to 35% and error of the
delivered volume and EPAP averaged over a one-minute interval up to 25%.
• Any temporary degradation of SpO
2
or FiO
2
performance following transient immunity
test exposure shall recover from any disruption within 30 seconds.
Additionally, the following shall not be allowed:
• permanent damage or unrecoverable loss of function,
• changes in programmable parameters or settings,
• reset to default settings,
• change of operating mode,
• initiation of unintended operation.
8.3.2 Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The ventilator is intended for use in the electromagnetic environment specified below. The
customer or the user of the ventilator should assure that it is used in such an environment.
Immunity Test Compliance Level Electromagnetic Environ-
ment - Guidance
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
±8 kV contact±15 kV air The relative humidity should
be at least 5 %.
Electrical fast transi-
ent/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
AC Power (Mains) quality
should be that of a typical
commercial, hospital and resi-
dential environment.
Surge IEC 61000-4-
5
±1 kV line to line AC Power (Mains) quality
should be that of a typical
commercial, hospital and resi-
dential environment.
124
Technical Specifications
User Manual
Doc. 006553 M-6
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