User Manual

8
General Information
en
DANGER!
The product may be used only by doctors or health care professional in accor-
dance with the intended use. Personnel must have training that qualifies them
to operate laparoscopy pumps. In addition, personnel must read the user manual
and operating instructions and become familiar with handling the device before
first use. Personnel must have mastered handling and operation of the product
before first use during a surgery. This user manual does not include descriptions
or instructions for surgical procedures/techniques. It is also not intended to in-
troduce to or train physicians in the use of surgical techniques.
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The vacuum tube sets for this device contain diethylhexylphthalate (DEHP),
which is classified as toxic to reproduction according to the EU Directive 1272/
2008/EEC on Classification, Labeling and Packaging of Dangerous Substances.
DEHP may impair fertility and may cause harm to the unborn child. Therefore,
this product must not be used for unauthorized applications. When applied
within the intended use, the potential risk to pregnant or breastfeeding women
as well as to children resulting from the DEHP contained in this product is not
critical.
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Not explosion-proof
The device is not explosion-proof. Do not operate the device in the vicinity of ex-
plosive anesthetic gases and not in the vicinity of oxygen-enriched environ-
ments.
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Falls and crashes
Place the device on a stable and level surface. Cables must be laid safely. Tubes
between the device and the patient must not create any obstruction.
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Set up the device in such a way as to allow for easy monitoring of the display val-
ues, device functions, and access to the control elements.
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Position the device in such a way that it is easy to operate and switch off.
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Risk of electrical shock
To avoid the risk of electrical shock, only use this device when connected to a
properly grounded power supply network.
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Use only parts and/or devices from ME systems (see chapter 14 "Glossary") in pa-
tient environments in compliance with the standard IEC 60601-1 in the respec-
tive currently valid version