Surgiquest AirSeal i.F.S. Gebrauchsanweisung Seite 15

WARNING!
Peripheral devices
Additional peripheral equipment connected to interfaces of the AirSeal® i.F.S.
must meet the requirements of the following specifications: IEC 60601-2-18 / EN
60601-2-18 for endoscopic devices and IEC 60601-1 / EN 60601-1 for electrical
medical devices. All configurations have to comply with IEC 60601-1 / EN 60601-
1 specifications. Whoever connects additional equipment to signal output or sig-
nal input is considered the system configurator and as such is responsible for
complying with requirements of the standard IEC 60601-1 / EN 60601-1.
WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher
risk of metabolic imbalance related to excessive CO
reaction).
WARNING!
CO absorption
2
CO is absorbed during insufflation (intravasation). This means the body absorbs
2
part of the CO gas used for insufflation. CO
2
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
sure or a high gas flow promotes CO
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!
The insufflation of CO2 should be done carefully and while monitoring the pa-
tient's response. The user, particularly the anesthetist, should be informed about
possible cardiovascular and respiratory problems of the patient and monitor
these intra-operatively.
WARNING!
Metabolic and cardiac reactions
Insufflating CO may result in metabolic acidosis. This can lead to cardiac irregu-
2
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. To reduce this risk, minimize high gas flows due to large leaks, and the
use of cold irrigation and infusion solutions. Always monitor the patient's body
temperature during the entire surgical procedure.
absorption (idiosyncratic
2
concentrations in the blood or re-
2
absorption. The abdomen is sufficiently
2
. High pres-
2
Device Purpose
EN
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