Stryker PneumoSure, Instructions For Use Manual

Page: 17 / 410

Device Purpose
11
EN
WARNING!
Pneumolabium/pneumoscrotum
Children are at risk of a pneumolabium or pneumoscrotum.
WARNING!
Increased airway pressure/compression of the vena cava
When using the pediatric application of the device on children, an increased risk
of high airway pressure and/or compression of the vena cava (low input syn-
drome) exists.
WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher
risk of metabolic imbalance related to excessive CO
2
absorption (idiosyncratic
reaction).
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 re-
spiratory 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 pres-
sure or a high gas flow promotes CO
2
absorption. The abdomen is sufficiently
distended using a pressure between 10 to 15 mmHg. Pressure values above
15 mmHg are required for only a few cases but do increase the risk of intravasa-
tion. Never exceed the max. intra-abdominal pressure of 30 mmHg.
WARNING!
Metabolic and cardiac reactions
Insufflating CO
2
may result in metabolic acidosis. This can lead to cardiac irregu-
larities expressed with the following symptoms:
• Reduced respiration with restricted diaphram function
• Hypercapnia
• Reduction of venous reflux
• Reduced cardiac output
• Metabolic acidosis
WARNING!
Hypothermia/monitoring body temperature
The gas flow can lead to a lowering of the patient's body temperature during in-
sufflation. Hypothermia during insufflation can cause heart and cardiovascular
problems. The risk for hypothermia can be significantly reduced with the use of
gas that is pre-warmed to body temperature. Always monitor the patient's body
temperature during the entire insufflation. Make especially sure that the follow-
ing, hypothermia promoting, surgical conditions are avoided as best as possible:
• High gas flow due to large leaks
• Long surgeries
• Use of cold (not preheated) irrigation and infusion solutions