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TECHNICAL SPECIFICATIONS
Nominal voltage: 100 -240V~
Nominal power: 46 VA
Transducer vibration frequency: 2.45 MHz ± 50 kHz
Conditions for using the device: 10' ON – 30' OFF
MMAD: 3.81± 0.18 μm
Drug tank maximum capacity: 8 ml
Appliance service life: 1,000 cycles/treatments
Service life of accessories: 1 year
Service life in storage conditions: 1 year
*Data on noise levels were measured on a new device. Values may vary with use.
The information on the unit's capabilities provided by the manufacturer in accordance with EN 13544-1 may not
apply to medicines provided in suspension form or those that are highly viscous.
EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- Collateral standard: electromagnetic compatibility.
- Requirements and tests.
EN 13544-1 Respiratory therapy equipment - Part 1: Nebulising systems and their components
This section contains information specific to product compliance with the EN
60601-1-2. AirProjet plus is a medical electrical device that requires special precautions regarding electromagnetic
compatibility and needs to be installed and commissioned according to the electromagnetic information
provided.
Mobile and portable RF communications equipment (mobile phones, transceivers, etc.) may affect the device.
AirProjet plus
02038204100000 is designed for use in an electromagnetic environment that meets the
specifications provided below. The person who purchased or who uses AirProjet plus
is responsible for ensuring that the device is used in an environment that complies with said specifications.
Manufacturer's Declaration and Guidelines – Electromagnetic Emissions
Phenomenon
Radiated and conducted radiofrequency EMISSIONS
Harmonic distortion
Voltage fluctuations/flicker
) The device is intended for use in a home environment or professional healthcare structure and may exclusively
a
be used in hospital rooms and in sections of hospitals or clinics set up for respiratory therapy. The strictest
acceptance limits required for Group 1 Class B (CISPR 11) have been considered and applied. The device is
suited for use in the environments mentioned above so long as it is connected to the public electric mains.
) The test may be applied to this environment so long as the ME EQUIPMENT and ME SYSTEM used are
b
connected to the PUBLIC ELECTRIC MAINS and the power supply is compliant with the standard applicable
policy regarding electromagnetic compatibility (EMC).
Frequency: 50/60 Hz
Fuse: T 2A - L250 V
Weight: approx. 0.75 Kg
Breathable fraction: 67.8 ± 2.9%
Noise level at 50 cm*: about 39 dB
Drug tank minimum capacity: 3 ml
Professional
healthcare
environments
)
a
)
a
IEC 61000-3-2
COMPLIANT WITH IEC 61000-3-3
17
02038204100000
HOME
ENVIRONMENT
a
)
CISPR 11
Group 1 Class B
) Class A
b
)
b
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