PROCEDURES WORLDWIDE1
Use the ViewMate™ Ultrasound Console with ViewFlex™ Xtra ICE Catheter to visualize cardiac structures, blood flow and devices within the heart.
The ViewMate™ Ultrasound Console features comprehensive imaging capabilities, which can eliminate the need for additional imaging equipment to be transported to the lab.1
The ViewFlex™ Xtra Intracardiac Echocardiography (ICE) Catheter provides seamless maneuverability, allowing physicians to focus more on the procedure and less on catheter manipulation to enhance workflow efficiency.
**Not available with ICE.
MAT-2302212 v1.0
This device is intended for use by a qualified physician for ultrasound evaluation of ophthalmic; fetal/obstetric, gynecological; abdominal (renal, GYN/pelvic); intra-operative (abdominal, thoracic, and vascular), intra-operative neurological; pediatric; small organ (thyroid, breast, testes, etc), adult and neonatal cephalic; trans-rectal, trans-vaginal, trans-cranial, trans-esophageal (non-cardiac and cardiac); musculoskeletal (conventional and superficial); 3-D/4-D; cardiac — adult/pediatric/fetal; echo, intra-cardiac; pelvic; peripheral vascular; harmonic tissue and contrast imaging and tissue elasticity.
Use only transducers that are specifically approved and licensed for the ultrasound system. If the proper identification of a connected transducer is not displayed on screen, do not proceed with its use. The transducer must be removed from patient contact before application of a high-voltage defibrillation.
The system is not intended for use in conjunction with high frequency (HF) surgical equipment (tissue ablation devices). Do not use transducers connected to the ultrasound system on patients while HF surgical devices are in use.
Long-term exposure to ultrasound should be minimized. Although there have been no confirmed adverse effects produced by diagnostic levels of ultrasound, unnecessary patient exposure to ultrasound energy should be avoided, especially in the Doppler mode. The system is not indicated for differentiation between malignant and benign breast lesions.
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:
MAT-2302213 v1.0
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™ 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 site, cardiac irritability, catheter kinking or excessive bending, infection/sepsis, and intercostal or phrenic nerve stimulation.
MAT-2302214 v1.0
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Precautions
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
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