User Manual

General Information
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3General Information
3.1 Device Description
The device FLUID CONTROL Lap 2216 is a pump with an irrigation and suction
function for laparoscopy.
The device itself is non-invasive and designed for use in multi-unit racks (non-
sterile area). It pumps medical sterile irrigation fluid through a sterile tube. This
flushes the corresponding fluids into the body cavity. The device can be used with
electrolyte-free media (such as glycine 1.5% or sorbitol 3.0%) and with isotonic
electrolyte-containing media (such as saline 0.9% or Ringer's Lactate solution).
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
10 "Accessory List").
Essential PerformanceThe essential performance of the device in the laparoscopy indication consists of
providing an irrigation pressure to produce an irrigation flow. Another key per-
formance characteristic of the device is to provide suction pressure to suction the
fluid from the patient.
3.2 Used as Intended and Contraindications
3.2.1 Intended Use
The device FLUID CONTROL Lap 2216 is a suction and irrigation pump for Mini-
mally Invasive Surgeries (MIS). It flushes fluid into and suctions fluid from the ab-
domen.
3.2.2 Contraindication
Do not use the device FLUID CONTROL Lap 2216 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
DANGER!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.
DANGER!
Do not use this system if a defect is suspected or detected during the function
check. This also applies to obvious defects, especially defects and damage to the
power plug and power cord.
DANGER!
Device Errors
Do not use this device if a defect is suspected or detected during the function
check. It is prohibited to use the device in the case of obvious defects.
DANGER!
An authorized service technician must check the device if the specified parame-
ters and tolerances are exceeded.