Essential Performance Charac- Teristics; Notification Requirement Of Serious Incidents; Only Use Genuine Parts - Air Techniques SensorX Installation And Operating Instructions Manual

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Important information
EN-
Immediately replace any damaged cables or
plugs.
US
Comply with the EMC rules concerning
medical devices
The unit is intended for use in professional
healthcare facilities (in accordance with IEC
60601-1-2). If the unit is operated in any other
environment, potential effects on the electro-
magnetic compatibility must be taken into
account.
Do not use the device near HF surgical devices
and MRI equipment.
Keep a minimum distance of 30 cm between
the device and other electronical devices.
Note that cable lengths and cable extensions
have effects on electromagnetic compatibility.
No maintenance measures are required to
maintain the basic EMC safety.
NOTICE
Negative effects on the EMC due to
non-authorized accessories
Use only Air Techniques accessories or
accessories approved by Air
Techniques.
Using any other accessories may result
in increased electromagnetic interfer-
ence emissions or the unit having
reduced electromagnetic immunity,
leading to an erroneous operation
mode.
NOTICE
Erroneous operation mode due to use
immediately adjacent to other devices
or with other stacked devices
Do not stack the unit together with
other devices.
If this is unavoidable, the unit and other
devices should be monitored in order
to ensure that they are working cor-
rectly.
6
NOTICE
Reduced performance features due to
insufficient distance between unit and
mobile HF communication devices
Keep at least 30 cm distance between
the unit (including parts and cables of
the unit) and mobile HF communica-
tion devices (wireless units) (including
their accessories such as antenna
cables and external antennas).
2.5
Essential performance char-
acteristics
The unit does not have any essential perform-
ance characteristics as set out in IEC 60601-1
section 4.3.
The unit meets the requirements according to
IEC 60601-1-2:2014.
2.6
Notification requirement of
serious incidents
The operator/patient has to report any serious
incident related the product to the manufacturer
and the competent authority of the Member
State, in which the operator and/or patient is
established/resident.
2.7

Only use genuine parts

Only use accessories and optional items speci-
fied or approved by Air Techniques.
Only use original working parts and spare
parts.
Air Techniques accepts no liability for
damage resulting from the use of non-
approved accessories, optional items or
any parts other than original spare and
wear parts.
The use of non-approved accessories,
optional items or non-genuine wear
parts / replacement parts (e. g. mains
cable) can adversely affect the electrical
safety and EMC.
2121100020L29 2101V007

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