Device combinations
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The RS232 interface of Cryo 7 can be used only in connection with medical
devices according to IEC 60601-1 Ed 3.1. Please also follow the instructions for
use of the other medical device.
Anyone (referred to as “organisation” below) who combines the devices must
observe the requirements of standard IEC 60601-1, Ed. 3.1 listed below:
The organisation which combines the device and thus operates a medical
system is itself responsible for the correct combination of the devices.
The Cryo 7 device may be combined only with a medical device which meets
IEC 60601-1 Ed 3.1.
In the case of a combination, observe the instructions for use of the combined
device.
If Cryo 7 is connected to an IT network (for example, to an aesthetic medical
laser), previously unidentified risks to patients, operators, or third parties may
arise.
The organisation should identify, analyse, evaluate, and monitor these risks.
Subsequent changes to the IT network could introduce new risks and
necessitate an additional analysis.
Changes to the IT network include:
•
changes to the IT network configuration;
•
the connection of additional elements to the IT network;
•
the disconnection of objects from the IT network;
•
updating of devices which are connected to the IT network;
•
upgrading of devices which are connected to the IT network.