12 Instructions for use Isolette 8000 plus SW 5.n
For your safety and that of your patients
2.2.5 Safety during cleaning and service
2.2.5.1 Risk of infection
Users and service personnel can become infected with pathogens.
► Disinfect and clean the device thoroughly before using it for the first time, and
then once a week and every time the patient changes.
2.2.5.2 Risk due to inappropriately reprocessed products
Reusable products must be reprocessed, otherwise there is an increased risk of
infection.
► Observe the hygiene regulations and reprocessing regulations of the healthcare
facility.
► Observe national hygiene regulations and reprocessing regulations.
► Use validated procedures for reprocessing.
► Reprocess reusable products after every use.
► Observe the manufacturer's instructions for cleaning agents, disinfectants, and
reprocessing devices.
2.2.6 Essential performance characteristics
The essential performance consists of:
– Skin temperature regulation
– The skin temperature setting (target value) is compared to the actual central
skin temperature which is regulated, or an alarm is generated.
– Air temperature regulation
– The incubator air temperature setting (target value) is compared to the actual
incubator air temperature which is regulated or an alarm is generated.
The medical device is equipped with basic safety features to reduce the possibility
of patient injury while the cause of an alarm is remedied.
2.2.7 Modifications to the product
Modifications to the product may lead to malfunctions and unforeseen risks. This
may result in injury to the patient or the user or in property damage.
► Do not modify this product.
► If this equipment is modified, appropriate inspection and testing must be
conducted to ensure continued safe use of the equipment.
2.2.8 Accidental disconnect
Catheters, breathing hoses, sample lines, lead wires, or cables could become
accidentally disconnected.
► To allow for the full range of mattress height adjustment, secure all lead wires,
infusion lines, and ventilator hoses to the mattress with sufficient excess length.
► Use caution when opening doors fitted with hose grommets.
Possible trip and fall hazards.
► Always properly secure the power cable.