Stryker PneumoSure, Instructions For Use Manual

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Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode
EN
6 Using and Controlling the PNEUMO SURE High Flow Insuf-
flator in High Flow Mode
Intended use The PNEUMO SURE High Flow Insufflator serves to create a cavity by insufflating
CO2 during diagnostics and/or therapeutical laparoscopy. High Flow operating
mode is designed explicitly for laparoscopies performed on normal weight and
slightly obese (BMI < 30 kg/m
2
) patients over the age of 14. While in High Flow
operating mode, the insufflator limits the pressure to max. 30 mm Hg and the
gas flow rate to max. 40 l/min. The device measures the pressure within the ab-
domen either continuously or at short intervals and constantly compares the
nominal with the actual abdominal pressure. The function of the device is to
maintain the nominal pressure. Any overpressure within the abdomen is lowered
to the preset nominal pressure by the automatic venting system.
Contraindications The device may not be used to fill an abdomen with CO2 if a laparoscopy is con-
traindicated. Please consult the manual of your laparoscope for absolute and rel-
ative contraindications. The device is not suitable for hysteroscopic insufflations,
i.e., it may not be used to distend the uterus.
The gas flow may not exceed 14 l/min when performing a laparoscopy on infants
or patients weighing less than 25 kilos.
6.1 Device-Specific Dangers when Using the PNEUMO SURE High
Flow Insufflator 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
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