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

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Device Use and Control with Bariatric Operating Mode

The Bariatric operating mode is used for laparoscopies performed on severely
overweight adults (BMI > 30 kg/m
its the pressure to max. 30 mmHg and the gas flow rate to the max. value listed
on the equipment data label located on the back of the device. This operating
mode enables the rapid insufflation of large volumes.
7.1 Device-Specific Risks Associated With Use of the Device in Bar-
iatric Operating Mode
WARNING!
Altered Respiratory Physiology
Always monitor the patient's respiratory functions during the entire surgery. The
larger body mass supported by the thoracic cage and the larger amount of fat in
the abdominal cavity may reduce the elasticity of the thoracic wall. In addition,
the increased intra-abdominal pressure secondary to insufflation may alter the
normal physiological lung parameters thus resulting in a reduction of the func-
tional lung volume. Shallow, rapid breathing is symptomatic of this condition.
Even modest physical stress causes a tremendous increased demand for oxygen,
which stands in contrast to the ineffective respiratory musculature that requires
more oxygen because it must overcome the reduced elasticity of the thoracic
cage. The functional capacity of the lungs is small and even moderate stress can
lead to respiratory failure.
WARNING!
Subcutaneous Emphysema
When puncturing the thicker abdominal wall of morbidly obese patients with
the Veress cannula or the trocar, carefully monitor the correct position of the in-
strument in the abdomen.
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!
CO supersaturation
2
To avoid generating CO supersaturation, an increased level of respiratory activ-
2
ity is required. An overweight patient's oxygen demand and carbon dioxide pro-
duction are greater and increase faster under physical stress than do those of
2
). While in Bariatric mode, the insufflator lim-
absorption (idiosyncratic
2
concentrations in the blood or re-
2
absorption. The abdomen is sufficiently
2
Device Use and Control with Bariatric Operating Mode
. High pres-
2
EN
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