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Instrument
Classifications
Electromagnetic
Compatibility
07-19-01-518 – January 2009
A
C
LYX
OMPONENT
Switzerland
United Kingdom
This section provides information about the type of
classifications that have been assigned to the A
Collection System.
• Medical Device: FDA Class II
• Medical Device Directive 93/42/EEC; Class IIb
• Type of Protection Against Electric Shock: Class I
• Degree of Protection Against Electric Shock: Type BF
Applied Parts
• Degree of Protection Against Ingress of Water: Ordinary
• Mode of Operation: Continuous Operation With
Intermittent Loading
This equipment is not suitable for use in the presence of a
flammable anesthetic with air, oxygen, or mixture of nitrous
oxide.
The following information needs to be provided according to
IEC 60601-1-2:2001:
The A
Component Collection System, as well as all medical
LYX
electrical equipment, needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed
and put into service according to the following information.
• Because the intensity of electromagnetic energy is greatest
near the source of a transmitting antenna, portable and
mobile RF communications equipment can affect medical
electrical equipment.
The A
Component Collection System has been designed to
LYX
withstand the effects of electromagnetic interference (EMI) and
meets the most current EMC standards that apply to the
instrument. However, extremely high levels of electromagnetic
energy (above the levels of IEC 60601-1-2) may still produce
interference.
C
S
O
OLLECTION
YSTEM
C
7 – S
HAPTER
YSTEM
Component
LYX
'
M
PERATOR
S
ANUAL
S
PECIFICATIONS
7-7
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