ergoline ergoselect 100 - Page 10

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Additional equipment connected to medical electrical
equipment must comply with the respective IEC or ISO
standards (e.g. IEC 60950 for data processing equipment).
Furthermore all congurations shall comply with the re‑
quirements for medical electrical systems (see IEC 60601‑
1‑1 or clause 16 of the 3Ed. of IEC 60601‑1, respectively).
Anybody connecting additional equipment to medical
electrical equipment cong ures a medical system and is
therefore responsi ble that the system complies with the
requirements for medical electrical systems. Attention is
drawn to the fact that local laws take priority over the
above mentioned requirements. If in doubt, consult your
local representative or the technical service department.“
(Standard / directive references:
· IEC 60601‑1+Al +A2:1995: 6.8.2.c, 19.2.b, 19.2.c,
· IEC 60601‑1:2005: 7.9.2.5, 8.1, 16.2.d,
· MDD 93142lEEC: Annex I clause 13.6.c