Devilbiss Guidance And Manufacturer's Declaration - DeVilbiss Healthcare DV56 SleepCube BiLevel ST PAP Serie Mode D'emploi

Dynamic Short-Term Pressure Accuracy with and without DV5HH Humidifier (Per
ISO 17510-1:2007)
Waveform Volume [mL]
Sinusoidal
cycle with I:E =
1:1
Maximum Flow-Rate (per ISO 17510-1:2007)
Measured pressure at the patient
connection port (cmH O)
2
Average flow at the patient connection port
(l/min)
Long Term Static Pressure Accuracy ................................................................................................................. +/- 0.5 cmH
Additional Specifications
Equipment classification with respect to protection from electric shock ........................................................................ Class II
Degree of protection from electric shock ................................................................................................. Type BF Applied Part
Degree of protection against ingress of liquids ......................................................................................IPXI Drip-proof vertical
Mode of operation .................................................................................................................................................... Continuous
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.

DEVILBISS GUIDANCE AND MANUFACTURER'S DECLARATION

WARNING
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the Electromagnetic Compatibility [EMC] information provided in the accompanying
documents.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked
use is necessary, the equipment or system should be observed to verify normal operation in the configuration in
which it will be used.
NOTE– The EMC tables and other guidelines provide information to the customer or user that is essential in determining
the suitability of the Equipment or System for the Electromagnetic Environment of use, and in managing the
Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing
other Equipment and Systems or non-medical electrical equipment.
Guidance and Manufacturer's Declaration – Emissions All Equipment and
Systems
This device is intended for use in the electromagnetic environment specified below. The customer or user of this device
should assure that it is used in such an environment.
Emissions Test Compliance
RF Emissions
Group 1
CISPR 11
EN - 16
Breath Rate [min-1]
500 10, 15, 20
3.0 cmH
Electromagnetic Enforcement – Guidance
This 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.
Set Pressure
[cmH
3.0
9.0
14.0
20.0
25.0
Test Pressures
O 9.0 cmH O
2 2
3.0 8.4
85.0 150.3
Pressure Accuracy
O] [Pk-Pk cmH
2
14.0 cmH O 20.0 cmH
2
13.0 19.1
154.0 150.6
O]
2
0.5
0.5
1.0
1.0
1.0
O 25.0 cmH O
2 2
24.0
132.9
O
2
SE-DV56-1