Use Instructions

General Information
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EN
3General Information
3.1 Device Description
The GYN-Pump is a system providing a suction and irrigation function for two dif-
ferent indications:
• Laparoscopy
•Hysteroscopy
The device is non-invasive and designed for use in non-sterile areas. It pumps
medically sterile irrigation fluids through a sterile tube. These fluids are used to
distend and irrigate corresponding body cavities to provide space and improve
visibility for the attending physician. The device can be used with electrolyte-free
media (e.g., glycine 1.5% and sorbitol 3.0%) and with isotonic, electrolyte con-
taining media (e.g., saline 0.9% and Lactated Ringer's). The device is equipped
with a vacuum suction function used to suction off secreted fluids. The device
functions only with the tube sets described in the accessory list (see chapter 19).
The pump is equipped with a balancing system that monitors the volume differ-
ential between the irrigation fluid flowing in and out of the uterus during hys-
teroscopic procedures.
The device can be operated at max. flow rates of up to 2.0 l/min when used dur-
ing laparoscopic procedures. During hysteroscopic procedures, a maximum flow
rate of 800 ml/min can be selected. Pressure settings of up to 150 mmHg can be
selected during hysteroscopic procedures.
The device operates with a completely non-contact pressure measurement of the
irrigation medium. The contact-free pressure measurement is taken by integrat-
ing the pressure chamber into the tube system. The pressure membrane trans-
fers the tube pressure to the electronics of the device via a pressure sensor. The
pressure control circuit continuously compares the actual pressure with the
nominal pressure to maintain the nominal pressure. If the nominal flow rate is
set too low, the nominal pressure cannot be reached. Pay attention to possible
leaks.
3.2 Intended Use and Contraindications
3.2.1 Intended Use
The GYN-Pump is designed for body cavity distension, fluid irrigation and fluid
suctioning. The GYN-Pump monitors the volume differential between the irriga-
tion fluid flowing into and out of the patient during hysteroscopic procedures.
The GYN-Pump is designed for the following indications:
• Laparoscopy: Irrigation of body cavities and fluid aspiration during diagnostic
and operative procedures.
• Hysteroscopy: Uterine distention, fluid aspiration and monitoring of fluid def-
icit during diagnostic and operative procedures.
3.2.2 Contraindications
• Use of the GYN-Pump is contraindicated for the distention of body cavities
when endoscopic surgery is contraindicated as well.
• Use of the GYN-Pump is contraindicated if, in the opinion of the responsible
physician, its use endangers the health of the patient.
3.3 General Warnings and Precautions
3.3.1 General Warnings
CAUTION!
The device may not be used in conjunction with a defibrillator since it is not
equipped with corresponding safety elements. The manufacturer accepts no lia-
bility in this case for ensuing damage.