Search Results

Indications for Use: • The Clarisonus Plus Esophageal Stethoscope with temperature sensor with attached earpiece is intended for use when the esophageal temperature is continuously monitored along with the auscultation of the heart and lung sounds. • The Esophageal Stethoscope with temperature sensor is intended for use when the esophageal temperature is continuously monitored along with the auscultation of the heart and lung sounds. • The Esophageal/Rectal Temperature Probe is indicated for continuous monitoring of esophageal, rectal, and nasopharyngeal temperatures. The products are intended for use in surgical and critical care patients.

Esophageal Stethoscope has been used in clinical application for continuous measurement of temperature and auscultation of heart and lung sounds. Esophageal Stethoscope is used in anesthetized patients and is placed inside of esophagus. The stethoscope consists of a sound transmitting part and a temperature monitoring part. Sound transmitting part consists of a PVC tube whose distal end has openings at the end and the side of the tube. The distal end is covered with a flexible membrane in form of a cuff. The proximal end of the tube has a Luer lock connector for the connection to the anesthesiologist monoscope with earpiece. Heart and lung sounds are transmitted across the esophageal wall and across the cuff membrane through distal openings into the PVC tube. The sound waves travel through the tube into the anesthesiologist monoscope and into the anesthesiologist's ear. The temperature monitoring part consists of thermistor sub-assembly whose temperature sensing tip is placed inside of the PVC tube to the tube's distal end. On its proximal end, it terminates with an electrical connector for the connection to the patient monitoring system. When in application, the sound transmitting part of the stethoscope is connected to a custom made connecting line with an earpiece or disposable monoscope. In many' situations the anesthesiologist forgets the earpiece or monoscope so that the auscultations of the heart and lung sounds are not performed. The proposed device incorporates the esophageal stethoscope and a monoscope in a single unit which would provide the anesthesiologist with an ease of application. The earpiece at the end of the connecting line is made of a memory ear plug. Prior to the insertion, the foam is squeezed and placed inside of the ear canal for auscultation of heart and lung sounds. The Esophageal stethoscope with temperature sensor and Esophageal/Rectal temperature probe are non-sterile version of predicate device K111050.

Esophageal / Rectal temperature probe (4009-ER and 40012-ER): The Starboard Medical Esophageal / Rectal temperature probe is indicated for continuous patient temperature monitoring, when these placement sites are clinically recommended. The probe is designed for insertion into the esophagus, nasopharynx, or rectum. Esophageal Stethoscope with temperature sensor (4009-ES, 40012-ES, 40018-ES, and 40024-ES): The Starboard Medical Esophageal Stethoscope with temperature sensor is indicated for continuous monitoring of patient temperature along with auscultation of the heart and lung sounds. The probe is designed for insertion into the esophagus.

The Starboard Medical temperature probes are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The probes are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature probes or equivalent. This 510(k) includes the following probes: 4009-ER (Esophageal / Rectal temperature probe - 9FR) 40012-ER (Esophageal / Rectal temperature probe - 12FR) 4009-ES (Esophageal Stethoscope with temperature sensor - 9FR) 40012-ES (Esophageal Stethoscope with temperature sensor - 12FR) 40018-ES (Esophageal Stethoscope with temperature sensor - 18FR) 40024-ES (Esophageal Stethoscope with temperature sensor - 24FR) The probes are single use, and they are sterile.

Skin Temperature Sensor (400-STS) The Starboard Medical Skin temperature sensor is indicated for continuous patient temperature monitoring when the skin placement site is clinically recommended. The sensor is designed for placement on the surface of the skin. Tympanic Temperature Sensor (400-TY, 400-TYP) The Starboard Medical Tympanic Temperature sensor is indicated for continuous monitoring of patient temperature when the ear canal placement site is clinically recommended. The probe is designed for insertion into the ear canal in the proximity of the Tympanic membrane. Interconnect Instrument Cables (C400MP-M, C400MP-MJ, C400P-M, and C400M-MJ) The instrument cables are indicated for interconnecting the disposable temperature sensor or probe with the monitoring instrument.

The Starboard Medical temperature sensors are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The sensors are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature sensors or equivalent. The Interconnect Instrument cables are used to interconnect the disposable temperature probe / sensor with the patient monitor. This 510(k) includes the following probes: 400-SK (Skin Temperature Sensor) 400-TY (Tympanic Temperature Sensor - Adult) 400-TYP (Tympanic Temperature Sensor - Pediatric) C400MP-M (Interconnect Instrument Cable) C400MP-MJ (Interconnect Instrument Cable) C400P-M (Interconnect Instrument Cable) C400P-MJ (Interconnect Instrument Cable) The probes / sensors are single use, and they are sterile.