ResMed Astral Series User Manual page 80

Oxygen measurement 5
Electromagnetic compatibility
Potential impact of electromagnetic
disturbances
Aircraft use
Automotive use
Air pressure: 1100 hPa to 700 hPa
Altitude: 3000 m
Note: The performance may be limited below 800 hPa or at altitudes above
2000m.
IP22 (Protected against finger sized objects. Protected against dripping
water when tilted up to 15 degrees from specified orientation.) when
placed horizontally on flat surface, or vertically with handle up.
IP21 (Protected against finger sized objects and against vertically dripping
water.) when placed on a table stand, when used with the ResMed
Homecare Stand, or when attached to the RCM or RCMH.
Internally mounted oxygen sensor.
1,000,000 % hours at 25°C
Astral complies with all applicable electromagnetic compatibility
requirements (EMC) according to IEC 60601-1-2:2014, for home and
professional healthcare environments; and emergency medical service
environment. It is recommended that mobile communication devices are
kept at least 1 m away from the device
The loss or degradation of the following clinical functions due to
electromagnetic disturbances could result in compromised patient safety:
Accuracy of ventilation control
•
Accuracy of monitoring of airway pressure, expired volume and FiO2
•
Therapy alarms.
•
Detection of this degradation could be observed by the following device
behaviour:
Erratic ventilation delivery
•
Rapid fluctuations in monitored parameters
•
False activation of therapy or technical alarms (eg, System Fault or Battery
•
comms lost alarms)
Medical-Portable Electronic Devices (M-PED) that meet the Federal
Aviation Administration (FAA) requirements of RTCA/DO-160 can be used
during all phases of air travel without further testing or approval by the
airline operator.
ResMed confirms that the Astral meets the Federal Aviation Administration
(FAA) requirements (RTCA/DO-160, section 21, category M) for all phases
of air travel.
IATA classification for internal battery: UN 3481 – Lithium-Ion batteries
contained in equipment.
Product complies with ISO 16750-2 Road Vehicles - Environmental
Conditions and Testing for Electrical and Electronic Equipment - Part 2:
Electrical Loads", Tests 4.2, 4.3.1.2, 4.3.2, 4.4, 4.6.1 and 4.6.2. The
functional status classification shall be Class A.
Product complies with ISO7637-2 "Road Vehicles - Electrical Disturbance by
Conduction and Coupling - Part 2 Electrical Transient Conduction Along
Supply Lines Only", Section 4.4 Transient Immunity Test. The functional
status classification shall be Class A to test level III and Class C to test
level IV.
Technical specifications
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