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Section 1-3 - Safety Considerations
Figure 1-1 Sketch of the patient’s environment
WARNING
WARNING
Danger of Electrical Shock!
Danger of Electrical Shock!
A connection between the patient and a personal computer can result in risks for the patient from
electric current. Consider, therefore, these safety references:
– Use only CE marked electrical equipment!
– Install a galvanic isolator to insulate the connection between the personal computer and all
connected medical equipment (e.g. fibre optic cable or certified video isolator)!
– Set up the personal computer outside the patient's vicinity (1.5 m/4.9 ft.)!
Use only CE marked galvanic isolators or medical devices appropriate under
EN/IEC 60601-1 and EN/IEC 60601-1-1!
WARNING
WARNING
Danger of Electromagnetic Incompatibility!
Devices that are not CE marked can create an electromagnetic field which could impair the
operation of other devices.
To prevent this, check if the device is CE marked or FCC-marked.
Use only CE marked devices and medical devices appropriate under
EN/IEC 60601-1-2.
