Instructions for use Isolette 8000 plus SW 5.n 17
For your safety and that of your patients
► Medical electrical equipment needs special precautions regarding EMC and
must be installed and put into service according to the EMC information
provided in this manual.
► In addition, portable and mobile RF communications equipment can affect
medical electrical equipment.
2.5.2 Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special precautionary measures
concerning electromagnetic compatibility. Observe the EMC information during
installation and initial operation. For further information, see the following section:
"EMC Declaration" (page 172).
Portable and mobile high-frequency communication equipment can affect medical
electrical equipment.
To avoid the risk due to electromagnetic interference, malfunctions that endanger
the patient may occur if no protective measures against electrostatic discharge are
employed in the following situations:
► When touching the pins of connectors that carry the ESD warning symbol.
► When establishing connections with these connectors.
To prevent malfunctions, observe the following measures and train the relevant
personnel:
► Observe the ESD protective measures. Such measures may include wearing
anti-static clothing and shoes, touching a potential equalization pin before and
while making the connection, or using electrically insulating and anti-static
gloves.
► Observe the requirements for the electromagnetic environment. Observe the
following section: "Electromagnetic immunity" (page 172).
Electromagnetic fields may interfere with the device function and consequently
endanger the patient. Electromagnetic fields are generated by, e.g.:
– Cellular phones
– High-frequency electrosurgical equipment
– Defibrillators
– Shortwave therapy equipment
► Maintain the separation distances. Observe the following section:
"Recommended separation distances to portable and mobile radio frequency
communication devices" (page 172).
► Do not use device in MRI environment.
2.5.3 Anti-static castors
Castor wheels do not control all the ESD characteristics of the device on which they
are mounted. They do, however, prevent the build-up of charge on the wheels from
friction during motion.
► ESD is a product of the environment and only the user/owner can control the
ESD in that environment. Control is accomplished by maintaining a conductive
floor, equipping employees with ESD clothing and control devices, etc.
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