Use the ViewMate™ Multi Ultrasound System with ViewFlex™ Xtra ICE Catheter to visualize cardiac structures, blood flow and devices within the heart.
The ViewMate Multi Ultrasound System delivers superb image quality across the entire field and intuitive touch-screen capabilities, all on a robust platform built for 4D ICE capabilities.
The ViewFlex™ Xtra ICE Catheter provides seamless maneuverability, allowing physicians to focus more on the procedure and less on catheter manipulation to enhance workflow efficiency.
Such as pericardial effucsion, tamponade, thrombus formation, pulmonary vein stenosis, with microbubbles detected as a result of overheating.3
*When paired with a ViewFlex™ Xtra ICE Catheter
**With a software upgrade when available
Rx Only. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.
United States: Required Safety Information
MAT-2302212 v2.0
Indications: ViewMate™ Multi Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, Intra-operative (abdominal, thoracic, and vascular), Pediatric, Small Organ (Thyroid, Breast, Testes), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Intra-cardiac, and Peripheral vessel exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, TDI, Color M.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Contraindications: The diagnostic ultrasound system is not intended for ophthalmic use.
Warnings: Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case. Reference manual for full list of warnings.
Precautions: This system must be used only by qualified medical professionals. Reference manual for full list of precautions.
MAT-2302213 v2.0
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
The ViewFlex™ Xtra ICE Catheter is contraindicated if there is an occurrence of conditions which create unacceptable risk during catheterization. The ViewFlex™ Xtra ICE Catheter is contraindicated if the patient has a mechanical tricuspid valve (a prosthetic tissue valve is permissible). The ViewFlex™ Xtra ICE Catheter is contraindicated if the patient has any condition that, in the opinion of the investigator, contraindicates the placement and use of the cardiac catheter or internal ultrasound. The ViewFlex™ Xtra ICE Catheter is contraindicated if the patient has ongoing sepsis or known hypercoagulable state where the catheter could serve as a focal point for septic or bland thrombus formation.
The ViewFlex™ Xtra ICE Catheter is to be used only with the ViewFlex™ Catheter Interface Module, the ViewMate™, the ViewMate™ Multi, and the Philips‡ CX50 ultrasound consoles. Any other use or inappropriate electrical connection may pose a serious risk to patient safety. The ViewFlex™ Xtra ICE Catheter includes a 9F shaft. The physician should consider anatomical size restrictions if considering use of the ViewFlex™ Xtra ICE Catheter on pediatric patients. The ViewFlex™ Xtra ICE Catheter is to be used for ultrasound imaging only.
Do not bend, kink, stretch, or forcefully wipe the catheter. These actions may damage the catheter. Have antiarrhythmic drugs, an external defibrillator, and respiratory assist equipment available in case of complications during the use of this device.
Although temporary intracardiac catheter sonography procedures have been proven to be safe, the physician should also be aware that complications can occur with the use of any cardiac catheter. Risks that may be associated with the use of the ViewFlex™ Xtra ICE Catheter are those that may be encountered with the introduction and placement of any temporary cardiac catheter or pacing lead. Additional risk may also be incurred as a result of the delivery of electrical energy during internal defibrillation. Specific risks include, but are not limited to: bleeding, hematoma or thrombus at the catheter introduction or excessive bending, infection/sepsis, and intercostal or phrenic nerve stimulation. Reference device Instructions for Use f warnings, precautions, and potential complications.
MAT-2302214 v1.0
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