Stryker PneumoSure, Instructions For Use Manual

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Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode
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7 Using and Controlling the PNEUMO SURE High Flow Insuf-
flator in Pediatric Operating Mode
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:
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).
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.
7.1 Device-Specific Dangers when Using the PNEUMO SURE High
Flow Insufflator in Pediatric Operating Mode
WARNING!
Only specially trained and qualified personnel may use this device on children or
for the endoscopic vessel harvesting procedure.
WARNING!
Gas flow limit
The gas flow may not exceed 14 l/min when performing a laparoscopy on new-
borns or patients weighing less than 25 kg (approx. 55 US pounds).
WARNING!
Recommended work settings
The flow values listed above for laparoscopic procedures performed on new-
borns, infants, and children are only suggested values. The selection of the suit-
able flow and pressure values is solely the responsibility of the attending
physician. However, adhering to the values listed above ensures an optimal per-
formance of the Pediatrich operating mode of the insufflator.
WARNING!
Pneumolabium/pneumoscrotum
Children are at risk of a pneumolabium or pneumoscrotum.
Age Group Weight Flow Range
Children younger than 1 year approx. 1-9 kg 0.1 -0.5 l/min
Children between 1 and 3 years approx. 10-15 kg 0.5 -1.0 l/min
Children between 3 and 4 years approx. 16-19 kg 1.0 -2.0 l/min
Children between 4 and 14 years > 20 kg > 2.0 l/min
All children < 25 kg < 14.0 l/min