14 Instructions for use Isolette 8000 plus SW 5.n
For your safety and that of your patients
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 responsibility for selecting the best level of patient monitoring lies solely with
the user of the medical device.
2.2.13 Safe connection with other electrical equipment
Unapproved electrical connections can lead to patient injury or device failure.
► Electrical connections to equipment not listed in these instructions for use or
these assembly instructions must only be made when approved by each
respective manufacturer.
2.3 Target groups
2.3.1 Duties of the operating organization
The tasks described in this document specify the requirements that have to be met
by each respective target group.
The operating organization of this product must ensure the following:
– The target group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience).
– The target group has been trained to perform the task.
– The target group has read and understood the chapters required to perform the
task.
2.3.2 Description of target groups
The target groups may only perform the following tasks if they meet the
corresponding requirements.
2.3.2.1 User
2.3.2.2 Reprocessing personnel
Task Requirement
Use of the product in accordance with
the intended use
Specialist medical knowledge in neona-
tology
Use of the product in accordance with
the intended use
Specialist medical knowledge in the use
of the product
Task Requirement
Reprocessing Specialist knowledge in the reprocessing
of medical devices
To Next Page
Loading...
