Utah Medical IUP-650 - Intran Plus Transducer-Tipped IUPC (small tip) with Zero Switch on Reusable Cable and Amniolumen, 10/BX
Utah Medical IUP-650 Intran Plus Transducer-Tipped IUPC (small tip) with Zero Switch on Reusable Cable
Intran Plus is the original transducer-tipped intrauterine pressure catheter (IUPC) preferred by thousands of clinicians for its unrivaled accuracy, safety and reliability.
The sensitive, single-use pressure transducer of Intran Plus is located at the tip of the catheter that is placed inside the uterus. Placement of the transducer inside the uterus ensures that clinical decisions are based on the most accurate contraction frequency, duration, resting tone and peak pressure data.
The transducer of Intran Plus is encapsulated in a soft, blunt boot which prevents partial obstruction by maternal or fetal tissue from affecting the pressure tracing. Coupled with the proprietary SensaFlex tubing material of Intran Plus, the blunt tip allows clinicians to sense and avoid tissue obstructions prior to causing injury. Since its release in 1991, over 5 million Intran Plus IUPC's have been used without a single reported serious injury.
Unique Design of Utah Medical IUP-650 Intran Plus Transducer-Tipped IUPC (small tip) with Zero Switch on Reusable Cable
- INSERTION TACTILITY & SAFETY: Intran Plus is designed with SensaFlex, a tactile tubing material that is stiff enough to allow insertion while maintaining the pliability necessary to avoid injuries. Combined with the soft, blunt tip of Intran Plus, SensaFlex tubing allows the clinician to sense tissue obstructions prior to causing injury.
- TIP SIZE AND SHAPE: Intran Plus is available in small and regular catheter tip sizes. The small tip (.19" H x .25" W x .90" L) may be slightly easier to introduce through tightly stretched cervical tissues. The regular tip (.25" H x .30" W x 1" L) is also inserted easily but is the optimal size, shape and softness to facilitate safe placement and avoidance of patient tissue injury.
- DUAL LUMEN DESIGN & AMNIOINFUSION: The dual lumen design of Intran Plus allows simultaneous monitoring of uterine contractions and baseline readings while amnioinfusing.
- AMNIOTIC FLUID VISUALIZATION: All Intran Plus configurations are designed with a clear covering over the lumen used for amnioinfusion (Amniolumen). Clinicians may use the clear Amniolumen to assess amniotic fluid return upon IUPC placement or for visualization of fluid during the course of labor. The Amnio View Port option provides a convenient means of amniotic fluid visualization and includes a meconium color scale to facilitate observation of changes in meconium color over time.
- RE-ZERO CAPABILITIES: The Intran Plus IUPC system typically requires a single monitor zeroing procedure. However, a convenient method for re-zeroing the system is provided through the availability of a re-zero switch on the catheter or button on the re-usable cable.
- LATEX-FREE: Intran Plus contains no latex or latex by-products.
Utah Medical IUP-650 Intran Plus Transducer-Tipped IUPC (small tip) with Zero Switch on Reusable Cable Instructions for Use
These instructions are intended for the Disposable Intrauterine Pressure Monitoring System, INTRAN Plus, developed, manufactured and marketed by Utah Medical Products, Inc.
This product is sterile, single patient use device that does not require fluid filling. It is designed with a pressure transducer tip for continuous, accurate measurement of intrauterine pressures. Although the catheter is designed to be inserted with or without the use of an introducer, a simple and safe introducer for the insertion of INTRAN Plus is enclosed. Additionally, an Amnio Port has been incorporated into the design of INTRAN Plus to allow open communication into the amniotic sac while simultaneously monitoring continuous, accurate uterine pressure. The INTRAN Plus cable connector interfaces with a reusable cable that is specifically designed for the type of monitor being used.
INTRAN Plus does not require levelling the transducer at a particular anatomical landmark when zeroing the system since the pressure is measured at the catheter tip. INTRAN Plus provides a convenient method of zeroing the monitor while in situ. Models IUP-4xx or IUP-5xx have the zero slide switch located on the catheter cable connector. Models IUP-6xx or IUP-7xx have the zero button located on the reusable cable which connects the catheter to the monitor.
Device Characteristics of Utah Medical IUP-650 Intran Plus Transducer-Tipped IUPC (small tip) with Zero Switch on Reusable Cable
|What MRI safety information does the labeling contain?||Labeling does not contain MRI Safety Information|
|Device required to be labeled as containing natural rubber latex or dry|
natural rubber (21 CFR 801.437):
|Device labeled as "Not made with natural rubber latex":||Yes|
|Prescription Use (Rx):||Yes|
|Over the Counter (OTC):||No|
|Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):||No|