4b079b25-f351-4269-b443-1e836d7238b3UpdatePublished32022-08-052018-03-20In Commercial Distribution08033737712290PrimaryGS138033737712284PackageGS10803373771229015In Commercial DistributionCartoon Box28033737712287PackageGS1080337377122901In Commercial DistributionCartoon BoxTHD SensyProbeTHD SensyProbe710010338430324THD SPA1THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform a THD anorectal manometry examination. THD SensyProbe allows measuring of the actual mean sphincter tone pressure in the various functional activations (resting, squeeze and strain tone). In addition, thanks to a balloon fitted at the end of the probe and connection via a dedicated line, THD SensyProbe allows analysing the rectal ampulla volume and hence assessing rectal sensitivity and anorectal inhibitory reflex (this measurement can be made after inflating the balloon with the dedicated THD SensyProbe Accessory). THD SensyProbe does not need to be calibrated, as this is automatically done each time a procedure with THD Anopress is started. The probe is equipped with an ergonomic grip and has a fully atraumatic tip ensuring maximum comfort for the medical staff and the patient during the examination, and it has been dimensioned so as to reproduce the conditions during a normal digital exploration. A Probe Card to record the examination is included in the package. falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+390522634311Regulatory@thdlab.comK18013500017745Gastrointestinal motility manometric catheter, non-electronicA non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. It functions via infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in/connected to a dedicated analysis system. This is a single-use device.falseActiveKLAMonitor, Esophageal Motility, And TubeLengthOuter DiameterWeightStorage Environment Humidityfalsefalse