Arthrex Synergy Insufflation FM134 Instructions D'utilisation page 13

WARNING!
Peripheral devices
Additional peripheral equipment connected to interfaces of the medical monitor
has to meet the requirements of the following specifications in the respective
current valid version: 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 signal 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!
Increased airway pressure/compression of the vena cava
When using the device on children, an increased risk of elevated airway pressure
and/or compression of the vena cava (low input syndrome) exists.
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!
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. 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:
absorption (idiosyncratic
2
concentrations in the blood or re-
2
absorption. The abdomen is sufficiently
2
. High pres-
2
General Information
EN
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