Device Purpose; Laparoscopy Applications; Using High Flow Operating Mode; Using Pediatric Operating Mode - Stryker PNEUMO SURE Instrucciones De Uso

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Device Purpose

The PNEUMO SURE High Flow Insufflator serves to create a cavity by insufflating
CO2 during diagnostics and/or therapeutical laparoscopy. High Flow operating
mode, Pediatric operating mode, and Bariatric operating mode of the device are
used in conjunction with a laparoscope to fill and distend a peritoneal cavity with
gas. Pediatric operating mode is designed specifically for use on newborns, in-
fants, and children. Vessel Harvest operating mode is used to create a cavity
along the saphenous vein and/or the radial artery during an endoscopic vessel
harvesting procedure.
Two alternative configurations are provided:
1. PNEUMO SURE High Flow Insufflator contains the applications
High Flow operating mode -> Insufflation for adults and the
Pediatric operating mode -> Insufflation for infants and children.
2. PNEUMO SURE XL High Flow Insufflator contains the applications
High Flow operating mode -> Insufflation for adults and the
Pediatric operating mode -> Insufflation for infants and children,
Bariatric operating mode -> Insufflation for morbidly obese patients,
Vessel Harvest operating mode -> Insufflation for Vessel Harvesting proce-
dure.
The PNEUMO SURE XL configuration is available directly or via software upgrade.
High Flow operating mode, Pediatric operating mode, and Bariatric operating
mode of the device are used in conjunction with a laparoscope to fill and distend
a peritoneal cavity with gas. Bariatric operating mode is used for laparoscopic
surgery on morbidly obese patients.
Vessel Harvesting operating mode is used to create a cavity along the saphenous
vein and/or the radial artery during an endoscopic vessel harvesting procedure.
3.1

Laparoscopy Applications

3.1.1

Using High Flow Operating Mode

High Flow operating mode is designed explicitly for laparoscopies performed on
normal weight and slightly obese (BMI < 30 kg/m
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 abdomen and compares the nominal with the actual abdominal pres-
sure. The function of the device is to maintain the nominal pressure. Any over-
pressure within the abdomen is lowered to the preset nominal pressure by the
automatic venting system.
3.1.2

Using Pediatric Operating Mode

Pediatric operating mode is designed specifically for use on newborns, infants,
and children. While in Pediatric operating mode, the insufflator limits the pres-
sure to max. 20 mm Hg and the gas flow rate to max. 20 l/min. When used on
children, the device should be set depending on the selected nominal flow and
the age and weight of the treated child as outlined in the table below:
Age Group Weight
Children younger than 1 approx. 1-9 kg
year
Children between 1 and approx. 10-15 kg
3 years
Children between 3 and approx. 16-19 kg
4 years
Children between 4 and > 20 kg
14 years
2
) patients over the age of 14.
Flow Range
0.1 -0.5 l/min
0.5 -1.0 l/min
1.0 -2.0 l/min
> 2.0 l/min
Intended use
Device Purpose
EN
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