Search Results

Plethysmography Module: The device provides non-invasive measurement of pulse waveform and heart rate by photoclectric plethysmography. Electrogastrography (EGG) Module: A device that receives, records, and produces a visual display of the myoelectrical signal produced by the stomach as an aid to diagnosis of various gastric disorders.

The ACEM is an electronic accessory signal acquisition device. The ACEM includes five (5) signal conditioning circuits: respiration, plethysmograph, ECG and two channels of the EGG. Respiration and ECG have previous clearance under the InSight 510(k) K012232. The new plethysmograph accessory consists of a small, red LED placed against the finger and a photoelectric sensor to measure changes in the light intensity. The filter signal is amplified and digitized. The added EGG signal conditioning unit receives signals from the body through standard pad electrodes. The signals are filtered and digitized. Both the plethysmograph and EGG signals are forwarded to the Sandhill InSight System (K012232) for display.

The InSight Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal, biliary, and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis. The Accessory Model MII, when used in conjunction with a pH probe, can he used as an aid in differentiating acid vs. non-acid reflux events. In addition, the Accessory Model MIT is intended to measure motor function of the proximal gastrointestinal tract including swallow effectiveness and directional bolus transport by means of intraluminal impedance recording, The Accessory Model MII component of the InSight Gastrointestinal Motility System is not intended for use in biliary studies.

Not Found

Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients

Not Found

The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis. The SOM Module is intended for use only with the InSIGHT Model S980000 Gastrointestinal Motility system (K984444). The InSIGHT system consists of three basic subsystems: Signal conditioning and recording hardware, Analysis software, and Probes and transducers.

The InSIGHT Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal motility and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

The InSIGHT Model S980000 Gastrointestinal Motility system consists of three basic subsystems. These are: Signal conditioning and recording hardware, Analysis software, and Probes and transducers.

The software only provides visual guidance for data interpretation. It is not considered in and of itself to be diagnostic without skilled interpretation.

Continuous recordings provide information in the form of amplitude versus time, but it is difficult to understand because of the visual complexity of the record due to channel separation and duration of the recorded traces and sporadic nature of the activity. The software reports arranges the information in concise, reproducible, consistent reports that are more consistent than visual analysis. The Small Bowel software adds no new information, but takes existing information and rearranges it to make it more accessible to interpretation. Source information has dimensions of amplitude and time while the software presents the same information including numerous calculated results, such as duration, mean, maximum and median, motility index, frequency and cycle values for contractions and clusters (groups of contractions).