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.
MAT-2208661 v2.0
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.
MAT-2208672 v1.0
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.
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™ 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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