Creo Medical 7-EMR-050 Instructions D'utilisation page 35

Specifications
Essential Performance
The generator automatically performs a series of self-checks at start-up and persistent self-
monitoring of internal circuits during normal operation to maintain accuracy of RF and
microwave power outputs. Detection of abnormal conditions result in a distinct system fault
response on the user interface, requiring a system re-start using the on/standby button.
Following successful completion of system self-checks and transition into the treatment ready
mode, it is deemed that the PG1 generator outputs are within specification.
NOTE: Under certain electromagnetic disturbance conditions, the generator operation may be
halted to avoid system degradation. This requires the operator to re-start the system. A
system re-start could take up to 1 minute to complete.
Additional requirement:
For the microwave output freedom from the display of incorrect numerical values associated
with the therapy to be performed.
For RF output there is no additional essential performance.
Electrical Interference Safety Warnings
Warnings
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Electrosurgical System (model ref 7-EMR-050) including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment might not offer
adequate protection to radio-frequency communication services. The user might
need to take mitigation measures, such as relocating or re-orienting the equipment.
Page 35 of 248