ResMed Lumis Serie Guia Del Usuario página 21

Declaration of Conformity (DoC to the Radio Equipment Directive)
ResMed declares that the Lumis device (models 285xx) is in compliance with the essential requirements and other
relevant provisions of Directive 2014/53/EU (RED). A copy of the Declaration of Conformity (DoC) can be found on
Resmed.com/productsupport
This device can be used in all European countries without any restrictions.
All ResMed devices are classified as medical devices under the Medical Device Directive. Any labelling of the product
and printed material, showing
Directive amendment (2007/47/EC).
Operating pressure range
S, ST, T, PAC, iVAPS:
CPAP
Supplemental oxygen
Maximum flow:
Pneumatic flow path
Design life
Device, power supply unit:
Cleanable humidifier:
Air tubing:
General
The patient is an intended operator.
Humidifier performance
Mask Pressure
cm H O (hPa)
2
3
4
10
20
25
1
AH - Absolute Humidity in mg/L
2
BTPS - Body Temperature Pressure Saturated
20
0123, relates to the Council Directive 93/42/EEC including the Medical Device
Nominal RH output %
Setting 4
85
85
85
85
85
2 to 25 cm H
4 to 20 cm H
15 L/min (S, ST, T, PAC, CPAP), 4 L/min (iVAPS)
1. Flow sensor
2. Blower
3. Pressure sensor
4. Mask
5. Air tubing
6. Humidifier
7. Device
8. Inlet filter
5 years
2.5 years
6 months
Setting 8
100
100
100
90
90
O (2 to 25 hPa)
2
O (4 to 20 hPa)
2
Nominal system output AH
Setting 4
6
6
6
6
6
1 , BTPS 2
Setting 8
>10
>10
>10
>10
>10