Introduction
1.3 User groups
Intended environment
The SCD 19102 is intended to be used in professional healthcare facilities such as clinics
and hospitals. The monitor can be used in operating rooms (OR) or near patients, but is not
limited to them. The monitor is not intended for direct patient contact!
The SCD 19102 is not suited for the following environments:
• Home-based healthcare facilities.
• Near short-wave therapy devices.
• Near an MRI-System.
• Built into vehicles, including ambulances.
Note
Serious incident
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or
patient is established.
1.3 User groups
User
In the following, healthcare personnel such as surgeons or medical technicians are referred
to as the "user".
Service / service personnel
"Service" or "Service personnel" identifies authorized personnel with knowledge of electrical
and signal connection, local standards for image quality requirements, and safety of medical
products, for example a hospital technician or manufacturer of medical devices.
Cleaning staff
"Cleaning staff" refers to personnel responsible for cleaning medical devices.
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SCD 19102
Instructions for Use, 06/2022