Device-Inherent Dangers - Vessel Harvesting - Stryker PNEUMO SURE Instrucciones De Uso

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Device Purpose
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12
WARNING!
Dehydration
Insufflation can lead to dehydration of the tissue. This can result in organ tissue
damage and cardiovascular reactions of the patient. Long surgeries and large
leaks increase the risk of dehydration (especially at the insertion points of the
trocars or when changing instruments).
WARNING!
Embolism
Improper placement of the insufflation instrument could cause insufflation of
gas into a vessel, resulting in air or CO
CO
embolism, perform initial insufflation at a low flow rate and ensure that the
2
insufflation instrument is correctly positioned. Check the position of the insuf-
flation instrument immediately if the actual pressure rapidly reaches the nomi-
nal pressure value. CO
embolisms can also be caused by a high intra-abdominal
2
pressure. Avoid high-pressure settings and close damaged blood vessels at once.
WARNING!
Additional insufflation sources
The use of additional insufflation sources increases the intra-abdominal pres-
sure. Continuously monitor intra-abdominal pressure over the course of the en-
tire insufflation if additional sources are used.
WARNING!
Automatic venting system
Make sure the automatic venting system is activated (see chapter 10 Configura-
tion Menu (Overview), page 58) when using Pediatric application and an addi-
tional insufflation source. It is not possible to use an additional insufflation
source when the automatic venting system is deactivated.
WARNING!
Only specially trained and qualified personnel may use this device on children or
for the endoscopic vessel harvesting procedure.
3.3.2

Device-Inherent Dangers - Vessel Harvesting

WARNING!
Before using the insufflator to endoscopic harvest vessels, please check whether
the used instrument is intended for CO2 insufflation.
WARNING!
Pneumoperitoneum
When a vessel is harvested from the leg of a patient with a perforated groin, it is
possible for CO2 to reach the abdomen and cause a pneumoperitoneum. Make
sure the abdomen does not fill with CO2 during surgery.
WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher
risk of metabolic imbalance related to excessive CO
embolisms. To reduce the risk of air or
2
absorption (idiosyncratic
2

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