Dräger Isolette 8000 plus User Manual

Instructions for use Isolette 8000 plus SW 5.n 13
For your safety and that of your patients
2.2.9 Training
Training for users is available from the Dräger organization, see www.draeger.com.
Incubator misuse may result in harm to an infant.
► Only properly trained personnel should use the incubator as directed by an
appropriately qualified attending physician aware of currently known risks and
benefits.
2.2.10 Use of temperature probes
Using incorrect temperature probes can negatively impact device performance.
► For proper operation of the incubator, use only skin temperature probes from
Dräger, identified on the list of accessories.
2.2.11 Patient safety
The design of the medical device, the accompanying documentation, and the
labeling on the medical device are based on the assumption that the purchase and
the use of the medical device are restricted to persons familiar with the most
important inherent characteristics of the medical device.
Instructions and precautionary statements are therefore limited to the specifics of
the Dräger medical device.
The instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the medical device
– Potentially negative effects on patients with different underlying diseases
Medical device modification or misuse can be dangerous.
Risk of patient injury.
► Do not make therapeutic decisions based solely on individual measured values
and monitoring parameters.
► To make therapeutic decisions, also use visual assessment of patient and
medical expertise.
Accidental opening could occur.
► Do not raise the hood at any time while the infant is in the incubator.
► Gain access to the infant through the access panels and hand ports.
► Secure all hand port latches and access panel locking knobs.
► For infant safety, do not leave the infant unattended when the access panels or
hand ports are open.
► Do not use the device if access panels are removed or broken.
2.2.12 Patient monitoring
The user of the medical device is responsible for choosing a suitable patient
monitoring system that provides appropriate information on medical device
performance and patient condition.

Dräger Isolette 8000 plus Specifications

General

Brand	Dräger
Model	Isolette 8000 plus
Category	Medical Equipment
Language	English