Using Bariatric Operating Mode; Contraindications For Laparoscopy Applications; Using Vessel Harvest Operating Mode; General Device-Inherent Dangers - Stryker PNEUMO SURE Instrucciones De Uso

Device Purpose
EN
Contraindications
Contraindications
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If the nominal flow is set too low, the nominal pressure cannot be reached. Check
for possible leaks. Due to the special operating method used during the Pediatric
application, the speed of equalizing the leak is slower than when using the High
Flow application (lower effective flow in the Pediatric application).
3.1.3

Using Bariatric Operating Mode

Bariatric operating mode is used for laparoscopies performed on severely over-
2
weight (BMI > 30 kg/m ) adults. While in Bariatric mode, the insufflator limits the
pressure to max. 30 mm Hg and the gas flow to max. 45 l/min. This operating
mode delivers rapid insufflation of large volumes.
3.1.4

Contraindications for Laparoscopy Applications

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.
3.2

Using Vessel Harvest Operating Mode

WARNING!
Before using the insufflator to harvest vessels, please check whether the used in-
strument is intended for surgical procedures using CO2.
Vessel Harvest operating mode is designed for the controlled insufflation of
medical-grade CO2 when harvesting vessels (veins and arteries) during a mini-
mally invasive procedure within the scope of heart bypass surgery. While in Ves-
sel Harvest operating mode, the insufflator limits the pressure to max.
20 mm Hg and the gas flow rate to max. 10 l/min. Surgery to harvest vessels re-
quires the use of a special instrument.
The device may not be used for the endoscopic harvesting of vessels if this surgi-
cal application is contraindicated. Please consult the manual of the instrument
for absolute and relative contraindications.
3.3

General Device-Inherent Dangers

WARNING!
Positioning the patient
Always position the patient lower than the device to prevent body fluids from
leaking into the insufflation tube. Actual pressure may increase and fluid may
penetrate the insufflation tube if the patient is repositioned during surgery. If
this occurs, immediately disconnect the insufflation tube. When the patient is
repositioned onto his or her side, internal tissue may block the insufflation chan-
nel. Always insufflate through the elevated side of the patient.
WARNING!
Removing the insufflation tube
Always disconnect the insufflation tube after ending surgery and before switch-
ing off the device to prevent backflow of bodily fluids. Fluid may penetrate the
insufflation tube whenever you change the gas bottle and/or when you stop the
gas flow during the operation. If this happens, you must immediately disconnect
the insufflation tube from the trocar or from the device.