Dräger BiliLux Instructions For Use Manual page 12

Safety-related information
2.3.6 Training
Training for users is available from the Dräger organization. See www.draeger.com.
Device misuse may result in harm to an infant.
► Only properly trained personnel should use the device as directed by a qualified
attending physician familiar with the currently known risks and benefits of infant
phototherapy equipment.
2.3.7 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.
► Assess the patient frequently to observe any change in condition.
► To make therapeutic decisions, also use medical expertise and visual
assessment of patient.
► If the surface that the patient is lying on is equipped with protective devices
designed to prevent the patient from falling off, ensure that they are inspected
regularly for safety.
2.3.8 Patient monitoring
Patient safety can be achieved by a wide variety of means ranging from electronic
surveillance of medical device performance and patient condition to direct
observation of clinical signs.
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.
The responsibility for selecting the best level of patient monitoring lies solely with
the user of the medical device.
12 Instructions for use BiliLux