USER MANUAL 16-2040N / 16-2041N / 16-2042N
Rev. 07/2016
• Gas coagulation system
Some medical devices delivering gas to the interior of the peritoneal cavity during surgical laparoscopies (gas
lasers, for example) may lead to abdominal overpressurization. If venous sinuses are formed, triggering an
embolism, the use of a secondary gas source that is far less soluble in the blood than CO2 can cause a rapid
rise in intra-abdominal pressure. We recommend avoiding the use of these coagulation systems during
laparoscopic procedures, as we, the manufacturer could not be held responsible for any incident associated
with their use.
• Bacterial filter
The use of a hydrophobic bacterial filter is essential for preventing cross-contamination with the patient
• Please follow the conditions of use and storage.
• Keep the device in a dry and clear environment.
• This device must only be opened by a technician approved by us, the manufacturer.
• In order to prevent any danger of electrocution, fire, short circuits or dangerous emissions, do not
insert metal objects into the device.
• Do not expose the device to water spray or splashes, and do not install it in a very humid area.
• Use only the ancillary equipment delivered with the device or suggested by the manufacturer as an
option.
• Do not connect this device to any other device.
• This insufflator must not be used in the presence of flammable anesthetics.
• This device has not been designed for use in an ionizing environment.
2. SATUTORY RECOMMENDATIONS
2.1 COMPLIANCE
This device was designed and manufactured by Ackermann in a certified quality system.
It complies with the requirements of European directive 93/42/EEC on medical devices.
Consequently it complies in particular with the specific standards relating to electrical safety (IEC) and
electromagnetic compatibility (EMC).
2.2 ELECTROMAGNETIC COMPATIBILITY
Although this product complies with the electromagnetic compatibility standards (Appendix XII) it is possible
that, in very particular circumstances, it could interfere with other devices, or that other devices or an adverse
electromagnetic environment could interfere with it.
To prevent probability of these situations, we recommend to:
• check the quality of the electrical network (and in particular the earthing of all the devices and trolleys)
• keep the device away from electromagnetic sources (for example mobile phones, compressors, motors,
transformers, HF generators, etc.)
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