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Operator´s Manual
1000-095-071-EN Rev. 1.1
OMNERA®
2020-09-14
Page 11
2 Safety
2.1 Compliance
External equipment intended for connection to signal input, signal output or other connectors
shall comply with the relevant product standard e.g. IEC 60950–1 for IT equipment and the
IEC 60601–series for medical electrical equipment.
In addition, all such combinations – systems – shall comply with the safety requirements sta-
ted in the collateral standard IEC 60601–1–1 or the general standard IEC 60601–1, edition
3.1, clause 16. Any equipment not complying with the leakage current requirements in IEC
60601–1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient
support.
Any person who connects external equipment to signal input, signal output or other connec-
tors has formed a system and is therefore responsible for the system to comply with the
requirements.
If in doubt, contact qualified medical technician or your local representative.
If external equipment is connected, an isolation device is needed to isolate the equipment lo-
cated outside the patient environment from the equipment located inside the patient environ-
ment. In particular such a separation device is required when a network connection is made.
The requirements on the separation device is defined in IEC 60601–1–1 and in IEC 60601–
1, edition 3.1, clause 16.
Содержание Omnera 500A
Страница 1: ...Technical Publication Operator s Manual 1000 095 071 EN Rev 1 1 ...
Страница 3: ...Revision history Chapter Pages Rev Date New Release 1 1 2020 09 ...
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Страница 62: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 54 2020 09 14 Safety Electromagnetic compatibility EMC ...
Страница 120: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 112 2020 09 14 Fig 4 16 Operating the System Perform examination ...
Страница 152: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 144 2020 09 14 Operating the System Portable detector table ...
Страница 158: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 150 2020 09 14 Error Handling Diagnostic ...
Страница 162: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 154 2020 09 14 Cleaning Wall stand Table OTC and X ray Tube ...
Страница 164: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 156 2020 09 14 Function and safety checks Monthly Checks ...
Страница 172: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 164 2020 09 14 Technical specification Wall stand ...
Страница 174: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 166 2020 09 14 Waste Disposal ...
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