Use Instructions

General Information
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3General Information
3.1 Device Description
The device LAP-Pump is a pump with an irrigation and suction function for lapa-
roscopy.
The device itself is non-invasive and designed for use in multi-unit racks (non-
sterile area). It pumps medically sterile irrigation fluids through a sterile tube.
These fluids are used to irrigate corresponding body cavities The device can be
used with electrolyte-free media (e.g., glycine 1.5 % and sorbitol 3.0 %) and with
isotonic, electrolyte containing media (e.g., saline 0.9 % and Lactated Ringer's).
The device is equipped with a vacuum suction function used to suction off secret-
ed fluids. The secretion liquid is sucked through a tube into the container. The de-
vice functions only with the tube sets described in the accessory list (see chapter
12 "Accessory List").
Essential performanceThe essential performance of the device in laparoscopy mode is to provide a
flushing flow. Another essential performance of the device is to provide suction
pressure to suction the fluid from the patient.
3.2 Intended Use and Contraindications
3.2.1 Intended Use
The device LAP-Pump is a suction and irrigation pump for minimally invasive sur-
gical procedures. It pumps fluid into and aspirates fluid from the abdomen.
3.2.2 Contraindications
Do not use this device LAP-Pump for procedures where a specific pressure has to
be preset and reached such as a hysteroscopy or an arthroscopy.
3.3 General Warnings and Precautions
3.3.1 General Warnings
WARNING!
The product may be used only by doctors or health care professional in accor-
dance with the intended use. Personnel must have training that qualifies them
to operate laparoscopy pumps. In addition, personnel must read the user manual
and operating instructions and become familiar with handling the device before
first use. Personnel must have mastered handling and operation of the product
before first use during a surgery. This user manual does not include descriptions
or instructions for surgical procedures/techniques. It is also not intended to in-
troduce to or train physicians in the use of surgical techniques.
WARNING!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient
and determine if the use of this device is indicated. The physician must deter-
mine the specific technique and procedure that will accomplish the desired clin-
ical effect.
WARNING!
Check all factory settings
Factory settings are not mandatory settings for the physician. The physician is re-
sponsible for all settings affecting the surgical procedure.