Device Use And Control With High Flow Operating Mode; Device-Specific Risks Associated With Use Of The Device In High Flow Operating Mode - Arthrex Synergy Insufflation FM134 Instructions D'utilisation

Device Use and Control with High Flow Operating Mode

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6 Device Use and Control with High Flow Operating Mode
The Synergy Insufflation FM134 is a CO
diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal
cavity by filling it with gas The High Flow operating mode is designed explicitly
for laparoscopies performed on normal weight and slightly overweight patients
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(BMI < 30 kg/m ). While in High Flow mode, the insufflator limits the pressure to
max. 30 mmHg and the gas flow rate to max. 40 l/min. The device measures the
pressure within the abdomen either continuously or at short intervals and com-
pares the nominal with the actual abdominal pressure. The function of this de-
vice is to maintain the nominal pressure. Any overpressure within the abdomen
is lowered to the preset nominal pressure by the automatic venting system.
6.1 Device-Specific Risks Associated With Use of the Device in High
Flow Operating Mode
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
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CO is absorbed during insufflation (intravasation). This means the body absorbs
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part of the CO gas used for insufflation. CO
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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-
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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
insufflator intended to be used during
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absorption (idiosyncratic
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concentrations in the blood or re-
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absorption. The abdomen is sufficiently
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. High pres-
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