Pic Solution Mister 8 Instrucciones De Uso página 16

Device service life when in use:
Noise level at 50cm:
The information provided by the manufacturer on the device's performance capabilities 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 safety.
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 one: Nebulising systems and their components
This section contains information specific to product compliance with the EN 60601-1-2 standard. The Mister 8 is a
medical electrical device that requires special precautions regarding electromagnetic compatibility and needs to
be installed and commissioned in accordance with the electromagnetic information provided.
Mobile and portable RF communications equipment (mobile phones, transceivers, etc.) may affect the device.
The Mister 8 02038211000000 was designed to be used in an electromagnetic environment in accordance with the
specifications provided below. The person who buys or uses the Mister 8
device is used in an environment that complies with these specifications.
Guidelines and Manufacturer's Declaration – Electromagnetic Emissions
Phenomenon
Conducted and radiated radiofrequency EMISSIONS
Harmonic distortion
Voltage fluctuations/flicker
) The device is destined for household use or use in professional healthcare facilities and may only be used in the
a
patient's room and in locations designated for respiratory therapy in a hospital or clinic. The most restrictive acceptance
limits established for Goup 1 Class B (CISPR 11) have been applied. The device is suited for use in the aforementioned
environments so long as it is connected to the public mains.
) The test may be applied to this environment provided that the ME EQUIPMENT and the ME SYSTEM used are connected
b
to the PUBLIC MAINS and that the power supply is compliant with the prescriptions set by the reference policy governing
electromagnetic compatibility (EMC).
Guidelines and Manufacturer's Declaration - Electromagnetic Immunity - Enclosure Door
Phenomenon
ELECTROSTATIC
DISCHARGES
Radiated, radio-frequency,
electromagnetic fields
1000 cycles/treatments
< 56,5dB(A)
EMC Regulation or test
method
IEC 61000-4-2
IEC 61000-4-3
02038211000000 must ensure that the
Professional healthcare
facilities )
a
)
a
IEC 61000-3-2
COMPLIANT WITH IEC 61000-3-3
Immunity test levels
Professional healthcare
facilities
± 8 kV contact
± 2 kV, ±4 kV, ±8 kV, ±15 kV air
)
a
16
HOUSEHOLD
ENVIRONMENT )
a
CISPR 11
Group 1 Class B
b ) Class A
)
b
Household environment
10 V/m b ) 80 MHz - 2.7 GHz
80% AM at 1 kHz