Indications For Use
Refer to the operator's manual for complete instructions for use.
Physiological pressure transducers are utilized during invasive pressure monitoring, catheterization procedures and fluid delivery.
Ensure that you are making secure connections when using this device to prevent the introduction of air into the system. All connections should be finger tightened. Over tightening can cause cracks and leaks to occur.
Check for fluid leakage before and during the procedure. Leaks can result in the loss of sterility, fluid or blood loss, and/or air embolism. If a product leaks before or during use, retighten the leaking connection or replace the product.
This product does not incorporate protection from accidental overpressurization. Over pressurizing may permanently impair the accuracy of the device.
Potential Adverse Effects
No potential adverse effects are described in the operator's manual. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Navilyst Medical representative.
Carefully read these instructions before using this product. If this product is being used in conjunction with other manufacturers' components, also read their instructions for use.
Use proper aseptic techniques while handling this product. The presence of air in the system may dampen the transmission of the patient's pressure to the transducer.
Be sure to eliminate all air bubbles.
The Compensator™ Line must be completely filled with saline to produce accurate pressure readings.
The female luer end of the Compensator™ Line (placed in the NAMIC® Compensator™ Plate) must be at heart level in order to produce accurate readings.
During fluid injection through the main lumen of the manifold, ensure proper orientation of the handles so that fluid does not enter the side ports.
Do not use transducer Zero/Compensator™ Port as an injection site for fluids.
Inspect prior to use to verify that no damage has occurred during shipping.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
Compensator™® are registered trademarks of Navilyst Medical or its affiliates.