3
General Information
3.1
Device Description
The device Flow 50 is an insufflator and serves to create a cavity through the in-
sufflation of CO
with a preset flow rate and pressure. The gas will be transported
2
to the patient via a tube connected with a trocar. The insufflator limits the pres-
sure to maximum 30 mmHg (mm mercury column) and the flow rate to maxi-
mum 50 l/min.
The device measures the actual pressure in the cavity and compares it with the
set nominal pressure. The function of this device is to maintain the nominal pres-
sure. Any overpressure within the cavity is lowered to the preset nominal pres-
sure by the automatic venting system.
The user and patient comfort can be increased by additional accessories:
1. Tube set with integrated gas heating to heat the insufflation gas.
2. Tube set with evacuation function to remove surgical smoke from the cavity.
These functions are available when using the appropriate tubing sets; see chap-
ter 5.2 Insufflation Tube Sets.
The insufflator is a pneumatic device that works through the port on the back,
with central gas as well as bottled gas. It is operated via buttons and indicators
or displays on the front of the device.
3.2
Intended Use and Contraindications
3.2.1
Intended Use
The device Flow 50 is a CO
insufflator intended for use during diagnostic and/or
2
therapeutic endoscopic procedures to distend a cavity by filling it with CO
The indications Standard, Bariatric and Pediatric of the device are indicated to fill
and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pe-
diatric indication is indicated for pediatric laparoscopic procedures. Vessel Har-
vesting is indicated for use during endoscopic vessel harvesting procedures to
create a cavity along the saphenous vein or radial artery. The Fieldflooding is in-
dicated for use in open and endoscopically assisted cardiac surgery to displace
ambient air from the surgical site.
3.2.2
Contraindications
The device should not be used to fill a cavity with CO
indicated. Please consult the manual of your endoscope for absolute and relative
contraindications. The device is not suitable for hysteroscopic insufflation proce-
dures, i.e., it may not be used to distend the uterus.
gas.
2
if an endoscopy is contra-
2
General Information
Essential performance
EN
5