The SensiTherm™ Multi Esophageal Monitoring System provides critical information necessary to adapt therapy where needed, enabling the physician to monitor temperatures in the esophagus between 0° C and 75° C.
ViewMate™ Ultrasound Console with ViewFlex™ Xtra ICE Catheter provides clear visualization of intracardiac anatomy and accurate interpretation of blood flow direction and velocity.
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at manuals.sjm.com or eifu.abbottvascular.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
The SensiTherm Multi Esophageal Monitoring System is composed of SensiTherm Multi Monitor and SensiTherm Multi Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The SensiTherm Multi Probe must be used in conjunction with the SensiTherm Multi Monitor. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation related esophageal injury has not been established. The performance of the SensiTherm Multi system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
The insertion of the SensiTherm Multi Probe in the esophagus is not recommended if the esophagus is deformed or irritated. There are no specific contraindications or side effects related to the use of SensiTherm Multi Monitor. However, the insertion of the probe by an unskilled operator can cause discomfort and slight abrasions to the patient. To avoid that risk, it is essential that SensiTherm Multi Monitor is used only by medical personnel.
Thermal stabilization: The technology used by SensiTherm Multi Monitor for the metering process requires that the handle of the probe and that of the patient cable are approximately at the same temperature. Hence, it is recommended to wait at least 15 minutes between the instant in which the components are brought in the working environment and the start of a measurement session, especially if the probe or the patient cable have long stationed in environments with temperature and/or humidity significantly different from those of use. It is recommended not to place the two handles in such a way that during the measurements only one of the two objects remains for a prolonged time in proximity to or in contact with a heat or cold source. Failure to observe these precautions can lead to an accuracy of the instrument lower than the one stated in the technical specifications. MR Unsafe: Due to the presence of metallic parts in the components of SensiTherm® Multi Monitor, the device and its accessories must never be kept inside or in close proximity to a patient who is about to undergo magnetic resonance imaging. For the full list of warnings and precautions, please refer to the applicable Instructions for Use.
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:
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.