16 Instructions for use Isolette 8000 plus SW 5.n
For your safety and that of your patients
► Make sure that there is a safe connection to the basic device.
Installing accessories incorrectly can lead to compromised hygienic safety.
► Ensure the cover is installed on the mattress before use and before reusing after
cleaning.
2.5 Electrical safety
The potential for electrical shock exists when electrical equipment is used. To avoid
the risk of personal injury and property damage, the following preventive measures
must be taken:
► The maximum total earth leakage current of the system, including all items
plugged into the auxiliary mains outlets and any items plugged into external
sockets, must not exceed 500 µA.
► Establish policies and procedures to educate your staff on the risks associated
with electrical equipment.
► Due to the risk of electrical shock, only properly trained personnel with
appropriate service documentation should service the device.
► To avoid the risk of electrical shock, this equipment must only be connected to a
supply mains with protective grounding.
► To prevent damage to the device or accidental power disconnections, do not
connect a power cable from the incubator controller directly to an AC wall
connection.
► Always provide power to the incubator by using the power cable coming directly
from the trolley.
► Do not connect the Isolette 8000 plus to a surge suppressor.
► Do not reset circuit breakers or replace fuses without assessing and correcting
what caused the circuit breaker or fuse to activate.
► Power cables must be accessible if it becomes necessary to quickly disconnect
from the main power.
► Additional equipment connected to the patient must be electrically safe.
2.5.1 EMC precautions
The use of accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the resulting
system.
► All medical accessory equipment in the patient vicinity must comply with the
safety requirements of IEC 60601-1 and must have the relevant safety
certifications.
► The equipment shall not be used near other devices unless normal operation is
verified in the configuration in which it is to be used.
► Use of accessories other than what is listed and approved for use in this product
as original or replacement items may result in increased electromagnetic
emissions or decreased electromagnetic immunity.
► Devices connecting to the serial port must be compliant with IEC60601-1-2, the
EMC requirement for Medical Devices.
► The incubator display may go blank during an episode of static discharge to the
sensor module.
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