Users Manual

General Information
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WARNING!
Dehydration
Insufflation can lead to dehydration of the tissue, especially if the surgery time is
prolonged. This can lead to damage of peritoneal cell structures within the tissue.
Insufflation, especially with unconditioned gas, is associated with post-operative
pain. Long surgeries and large leaks increase the risk of dehydration especially at
the insertion points of the trocars.
The use of humidified and prewarmed gas can reduce risks associated with tissue
dehydration.
WARNING!
Embolism/insufflation of internal organs
Improper placement of the insufflation instrument could cause gas penetrating a
vessel or an internal organ, resulting in air or CO
2
embolisms. To reduce the risk,
use a low flow rate for the first insufflation and ensure that the insufflation instru-
ment is correctly positioned. Check the position of the insufflation instrument im-
mediately if the actual pressure rapidly reaches the nominal pressure value. CO
2
embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pres-
sure settings and close damaged blood vessels at once.
WARNING!
Procedures with children
Only those who are specially trained and qualified for procedures with children or
endoscopic vessel harvesting procedures may use this device for these purposes.
WARNING!
Instrument used for CO
2
insufflation
Before using the insufflator to endoscopically harvest vessels, please check
whether the instrument used is intended for CO
2
insufflation.
WARNING!
Pneumoperitoneum
When a vessel is harvested from the leg of a patient with a perforated groin, it is
possible for CO
2
to reach the abdomen and cause a pneumoperitoneum. Make sure
the abdomen does not fill with CO
2
during surgery.
3.3.5 Warnings TAMIS Operation Mode
WARNING!
CO
2
absorption
CO
2
is absorbed during insufflation (intravasation). This means the body absorbs
part of the CO
2
gas used for insufflation. CO
2
concentrations in the blood or respir-
atory system that are too high can lead to death of the patient in extreme cases. To
lower this risk, always carefully and closely monitor the patient's vital signs during
the entire insufflation process and make sure patient is breathing well. Sufficient
respiration can help avoid or limit problems with CO
2
. High pressure or a high gas
flow promotes CO
2
absorption. Pressure values above 15 mmHg are required for
only a few cases but do increase the risk of intravasation. It is recommended not to
exceed insufflation pressures of 15mmHg during transanal minimally invasive sur-
gery.
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DRAFT