ERBE 20132-250 Verwendungshinweis Seite 37

OBJ_DOKU-193776-005.fm Seite 37 Donnerstag, 21. März 2019 1:16 13
5.7 Risks in the case of endoscopic use
Risk of capacitive coupling: HF current can be transferred from
the activated instrument to the trocar, even if the two are not
touching (known as "capacitive coupling"). Risk of burns to the
patient and/or operating theater staff. Do not use hybrid trocars
(e.g. a combination of metal and plastic). Only use trocars de-
signed for use with electrosurgical devices.
Unwanted stimulation of nerves and muscles due to low-fre-
quency currents. Dangerous summation of patient leakage cur-
rents from several power sources: It is not possible to entirely
avoid low-frequency currents in electrosurgery, but they can be
limited by applying technical measures to equipment and acces-
sories. Limit types show how wide-ranging these measures are,
e.g. type B, BF or CF as per EN 60601. Type CF offers the highest
level of protection against low-frequency currents. However,
please note the following: If you use an electrosurgical device
and an endoscope that is supplied with energy at the same time,
the low-frequency currents from both power sources accumu-
late to form one single patient leakage current. If the electrosur-
gical device belongs to type CF and the endoscope to type BF, the
less favorable limit values for type BF apply to the overall patient
leakage current. You should therefore only use power sources
with the same type classification, ideally those of type CF.
5.8 Risk of burns to the patient
Flash-overs, activation in the trocar or without visual control of
the distal end of the instrument can cause unwanted thermal in-
juries to the patient. Therefore, check that the distal end of the
instrument protrudes at least 10 mm out of the trocar before
each activation.
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