ResMed Astral 100 Series User Manual

Technical specifications
English 71
Guidance and Manufacturer’s Declaration Electromagnetic Emissions
& Immunity
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to EMC information provided in this document.
This declaration currently applies for the following ResMed devices:
• Astral
™
Series of Ventilators.
Guidance and manufacturer’s declaration—electromagnetic emissions
These devices are intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that the device is used in such an environment.
Emissions test
Compliance
Electromagnetic environment—guidance
RF emissions CISPR 11
Group 1
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
RF emissions CISPR 11
with or without USB adapter
with or without Oximeter adapter
Class B
The device is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage
network that supplies buildings used for domestic
purposes.
Harmonic Emissions
IEC 61000-3-2
with or without specified accessories
Class A
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
with or without specified accessories
Complies
WARNING
• The device should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
• The use of accessories other than those specified for the device is not recommended. They
may result in increased emissions or decreased immunity of the device.
• Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards (eg, IEC 60950 for data processing equipment). Furthermore all
configurations shall comply with the requirements for medical electrical systems (see
IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting
additional equipment to medical electrical equipment configures a medical system and is
therefore responsible that the system complies with the requirements for medical electrical
systems. Attention is drawn to the fact that local laws take priority over the above mentioned
requirements. If in doubt, consult your local representative or the technical service department.

ResMed Astral 100 Series Specifications

General

Device Type	Portable Ventilator
Max Pressure	60 cm H2O
Operating Temperature	5°C to 40°C (41°F to 104°F)
Operating Humidity	10% to 95% relative humidity, non-condensing
Display	Color LCD touchscreen
Modes of Ventilation	CPAP
Data Storage	SD card
Alarms	Adjustable visual and audible alarms
Tidal Volume	50 to 2500 mL
Inspiratory Time	0.3 – 5 seconds
FiO2 Monitoring	Yes
Power Supply	AC 100 – 240V, 50/60 Hz
Oxygen Compatibility	Yes
Pressure Range	4 – 60 cm H2O
PEEP	4 to 25 cm H2O