SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM
SICAT JMT
⁺
Jaw Motion Analysis System
Page 29 of 37
ENVIRONMENT OF THE PATIENT / TEST PERSON
In practice, an experience value with a clearance of 1.5 m from the patient has proven effective for the
determination of the patient environment.
CAUTION
When operating the system, the user [2] must make sure that they never touch
the PC [3] and the patient [1] at the same time. The same applies to all other
non-medical electrical components that are only to be used outside the patient
environment.
Furthermore, the user must also make sure that they never touch the contacts of
the measurement system plug connectors and the patient at the same time.
Failure to comply can lead to the occurrence of dangerous leakage currents.
The following components of the SICAT JMT
+
system may only be used within the patient environment:
■ SICAT JMT
+
including sensor technology
CAUTION
The computer and other non-medical electrical accessories have to be set up
outside of the patient environment (1.5 m clearance).
ELECTROMAGNETIC COMPATIBILITY FOR GUIDELINES /
MANUFACTURER DECLARATION
The SICAT JMT
+
system satisfies the requirements of the EN 60601-1-2 standard. (Medical electrical
devices - part 1-2: General concerning for safety including the key performance attributes -
supplementary norm: Electromagnetic compatibility - requirements and tests).
Testing authority:
Schwille Elektronik in Munich
Produktions- und Vertriebs GmbH
6.2.2
6.3
