USER MANUAL 16-2040N / 16-2041N / 16-2042N
Rev. 07/2016
1. SAFETY INSTRUCTIONS
Please read this manual carefully before using the device, pay particular attention to the sections detailing the
safety and environmental conditions related to the device.
1.1 INTENDED USE
This device is designed to create and maintain a pneumoperitoneum (distension of the abdomen with CO2
gas) as part of a diagnostic and/or laparoscopic operative procedure.
Please refer to your laparoscope user manual for information on specific use.
This manual is only designed to assist the user with proper installation, set up and operation of the insufflaor.
FEDERAL LAW:
Federal Law in the United States restricts the use of this device solely to, or under the supervision of, a
surgeon.
1.2 CONTRAINDICATION
The device should only be used for an endoscopic procedure when insufflation of the abdomen is necessary
to faciliate navigation of the endoscope. Please refer to your laparoscope user manual for absolute and
relative contraindications.
This device is contraindicated for hysteroscopic insufflation; under no circumstances must it be used in cases
of intrauterine distension.
Note: the distension pressure of an insufflator for laparoscopy must not exceed 24 mmHg
1.3 WARNING
• Metabolic acidosis and resulting cardiac irregularity
Avoid prolonged intra-abdominal pressures above 20 mm of mercury. This would cause one of the following
risks:
• Reduction of respiration with compromised diaphragmatic movement
• Reduction of venous return
• Reduction of cardiac output
• Acidosis
Excessive absorption of CO2 is due to either a too high flow rate or excessive pressure, or both. The
abdomen can be sufficiently distended by a pressure between 10 and 15 mm of mercury. It is rarely
necessary to select an abdominal pressure higher than 15 mm of mercury. At these levels, the extent of
intravascular penetration should be low. Pressures higher than 20 mm of mercury are hardly ever necessary;
they will increase the quantity and the speed of intravascular penetration. Adequate respiration helps to
prevent problems associated with CO2.
• Idiosyncratic reactions
For patients suffering from microdrepanocytic diseases or pulmonary insufficiency, the use of these devices
can present an increased risk of metabolic imbalance related to the excessive absorption of CO2.
• Hypothermia
High-flow insufflation allows for a potential risk of hypothermia; therefore we recommend using a heating
system to keep the patient’s temperature stable.
• Gas flow
Surgical procedures must be carried out with insufflators able to reach flows between 4 to 10 l/min.
Insufflators providing lower flow must only be used for diagnostics procedures.
PAGE 4
OF 21
