Users Manual
Operating Modes of the PNEUMOCLEAR™ Insufflator
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CAUTION!
Low nominal flow setting
The nominal pressure cannot be reached in case of leaks if the nominal flow is set
too low.
WARNING!
Procedures with children
Only those who are specially trained and qualified for procedures with children or
endoscopic vessel harvesting procedures may use this device for these purposes.
WARNING!
Increased airway pressure
When laparoscopic procedures are performed on children, the increased intra-ab-
dominal pressure also increases the risk for higher airway pressures. Always strictly
monitor respiration and airway function when performing laparoscopic procedures
on children younger than 12 years of age.
WARNING!
Compression of the vena cava
When insufflating the abdomen of a child with medical CO
2
, an increased risk of
compressing the vena cava exists. This risk can be reduced by monitoring the
systolic and diastolic blood pressure during the entire surgery.
WARNING!
Haemodynamic stability
A laparoscopy performed on children younger than 12 years of age may result in
problems of the haemodynamic system due to the CO
2
content in the blood. It is re-
commended to increase the breathing rate of the patient and to work with low
flow values and pressure values not exceeding 12mmHg. The patient's circulatory
system should be monitored at all times.
WARNING!
Hypothermia
The insufflation gas flow usually drops significantly after the target pressure has
been reached and it is then only required to maintain the abdominal pressure.
However, leaks within the abdomen or the instrument can lead to a constant gas
flow of above 1 l/min. When operating on children younger than 12, a gas flow of
more than 1 l/min poses an increased risk of hypothermia for the patient. Corres-
ponding measures to prevent hypothermia include the use of blankets or pre-
warmed gas. The patient's body temperature has to be monitored at all times dur-
ing surgery.
WARNING!
Children with cardiovascular problems
Laparoscopy with CO
2
should not be performed on children with cardiovascular
problems.
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DRAFT