User Manual

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Electromagnetic Compatibility
en
11 Electromagnetic Compatibility
Precautionary measures Medical devices are subject to special safety and protective measures concerning
electromagnetic compatibility (hereafter abbreviated as EMC).
This device is to be used only for the purposes described in the manual and has
to be installed, set up, and operated in compliance with the EMC notes and in-
structions.
WARNING!
Accessories
To ensure compliance with the requirements of IEC 60601-1-2 in the current ver-
sion, the device FLUID CONTROL Lap 2216 must be used only with the accessories
listed in chapter 10 "Accessory List".
To ensure the basic safety and essential functionality in relation to electromag-
netic interference over the life of the device, the device must be restarted after
24 hours so that a self-test can be performed. In addition, the specified mainte-
nance intervals (see chapter 7 "Care and Maintenance") must be observed.
11.1 Impact of Mobile and Portable HF Communication Devices
The emission of high frequency energy by mobile communication devices may
impact the function of the electrical medical device. Operating such devices (e.g.,
cell phones, GSM phones) in the proximity of the electrical medical device is pro-
hibited.
11.2 Electrical Connections
ESD (Electrostatic Discharge) precautionary
measures
The following are ESD precautionary measures:
• Apply potential equalization (PE), if available on your equipment, to all devices
to be connected.
• Use only the listed equipment and accessories.
Hospital employees should be informed about and trained in ESD precautionary
measures.
11.3 Guidelines and Manufacturer’s Statement – Electromagnetic
Emissions
The FLUID CONTROL Lap 2216 is intended for use in an environment as described
below. The user/operator of the FLUID CONTROL Lap 2216 should make sure the
device is operated within such an environment.
Emitted interference
measurements
Compliance Electromagnetic environment guide-
lines
HF emission according
to CISPR 11
Group 1 The FLUID CONTROL Lap 2216 uses
HF energy solely for its internal func-
tions. Therefore, the camera's HF
emission is very low and it is unlikely
that devices in close proximity will
experience interference.
HF emission according
to CISPR 11
Class B The FLUID CONTROL Lap 2216 is suit-
able for use in all facilities including
those in residential areas and those
directly connected to a public utility
network supplying buildings used for
residential purposes as well.
Emission of harmonic
oscillations according
to IEC 61000-3-2
Class A
Emission of voltage
fluctuations / flickers
according to
IEC 61000-3-3
In compliance