Electromagnetic Compatibility (Emc) - Derungs Dmed VISIANO 20-2 C T1 Montage- Und Gebrauchsanweisungen

ENG
Classification:
VISIANO 20-2 C T1
VISIANO 20-2 P TX
Degree of protection according to IEC 60529
Classification according to directive 93/42/EWG – annex IX (medical device class)
U.S. FDA Device Class
Electrical safety test and EMC according to:
Blue light hazard according to EN/IEC 62471
Service life of the light source:
Service life LED

13. ELECTROMAGNETIC COMPATIBILITY (EMC)

Electrical medical devices are subject to special precautionary measures regarding electromagnetic compatibility. This device can be affected by
other electrical devices.
This device was tested with accessories from the accessory list for electromagnetic compatibility. Other accessories can be used only if the electro-
magnetic compatibility is not interfered with. Use of noncompliant accessories can cause amplified electromagnetic emissions or decreased
electromagnetic interference resistance in the device.
WARNING
Hazard due to inadequate safety distance
If high-frequency mobile communication devices are used to close to this device, malfunctions can occur that may endanger the patient.
A safety distance of at least 0.3 m (1 foot) must be maintained.
Electromagnetic environment
The device is only to be used in environments indicated in the "Intended use" section of the operating manual.
The medical device is intended only for operation in the electromagnetic environment indicated below.
Emissions
HF emissions
EN 55011 (CISPR 11)
Radiated: 30 MHz to 1 GHz
Conducted: 150 kHz to 30 MHz
Harmonic emissions
(IEC 61000-3-2)
Emissions from
Voltage fluctuations/flickering
(IEC 61000-3-3)
24
Correspond to
Class B, Group 1
Class A
Requirement is met.
Protection class I (C-version)
Protection class II (P-version)
IP 20
Class I
Class I
AAMI ES60601-1 :
2005/A2 :2010/(R)2012
CAN/CSA-C22.2 No 60601-1:14
IEC 60601-1:2005 + A1 :2012
IEC 60601-1-2:2014
IEC 60601-2-41:200- + A1 :2013
RG 2 (moderate risk)
50'000h (L70/B50)
Electromagnetic environment
The medical device is intended for use in all facilities,
including residential buildings and facilities that are
directly (without a transformer) connected to the same
low voltage network as the residential building.