Acutus Medical Product Catalog 2016

Transcription

1 The AcQMap Patient Electrode Kit consists of localization patches, an analog ground (AG) patch and ECG electrodes. The AcQMap Patient Electrode Kit is compatible with the AcQMap High Resolution 3D Imaging & Mapping System and provides the following attributes: Acutus Medical Product Catalog 2016 Strong adhesion to skin Ease of identification for efficient connectivity Radiolucent Repels fluids Latex free, DEHP free, mercury free CONTENTS (PER KIT) (Pack of 5) AcQMap Patient Electrode Kit (6) Localization Reference Electrodes (1) Analog Ground Reference Electrode (15) Surface ECG Electrodes For more information Please contact your local Acutus Medical representative: Acutus Medical, Inc Faraday Ave Suite 100 Carlsbad, CA United States Tel: Acutus Medical NV Ikaroslaan Zaventem Belgium Tel Fax For further information regarding Acutus Medical and its products, please visit Acutus Medical, the Acutus Medical logo, AcQGuide and AcQMap are registered trademarks of Acutus Medical, Inc. This material is the property of Acutus Medical and its subsidiaries. Please do not copy, forward, or distribute this document. MC Rev. A

2 The AcQMap High Resolution Imaging and Mapping System is an advanced imaging, navigation and mapping system capable of displaying: The AcQMap 3D Imaging and Mapping Catheter is an advanced, non-contact, over-the-wire, intracardiac device used for standard and complex electrophysiology procedures. Key attributes include: CT-like cardiac chamber reconstructions using M-mode ultrasound acquisition Full chamber beat-to-beat electrical activation overlaid on the anatomic reconstruction Dynamic, real-time, threedimensional Dipole Density Maps Unipolar electrical activity as waveform traces Three-dimensional positioning of the AcQMap and conventional catheters 48 Engineered Electrodes 48 Ultrasound Transducers DIAMETER (F) Acquisition of up to 115,000 ultrasound data points per minute for CT-like anatomic reconstruction Collection of up to 150,000 biopotential samples per second for display of full chamber, real-time, high resolution cardiac electrical activity Ease of maneuverability using the AcQGuide steerable sheath USABLE LENGTH DEPLOYED BASKET DIAMETER (MM) GUIDEWIRE COMPATIBILITY (IN) AcQMap 3D Imaging and Mapping Catheter The AcQGuide Steerable Sheath is intended to facilitate the intracardiac placement of diagnostic and/or therapeutic devices. Key attributes include: AcQMap High Resolution Imaging and Mapping System The AcQMap System includes the following components: AcQMap Console AcQMap Workstation Cable Precise Shaft Deflectability Atraumatic tip Double-braided for kink resistance High visibility under fluoroscopy Ergonomic Handle AcQMap Workstation AcQMap Patient Interface Unit AcQMap Ablation Interface Unit Uninterruptable Power Manager, 220V Daily Calibration Test Fixture AcQMap Patient Interface Unit Cable AcQMap Ablation Interface Unit Cable AcQMap Auxiliary Catheter Cable AcQMap Surface ECG Cable I.D (F) O.D (F) DILATOR GUIDEWIRE COMPATIBILITY (IN) (1) AcQMap Catheter and (1) AcQGuide Sheath WORKING LENGTH OVERALL LENGTH AcQGuide Steerable Sheath

3 48 Engineered Electrodes 48 Ultrasound Transducers CT Quality Anatomic Reconstruction Accurate within 3 mm of CT/MRI using M-mode ultrasound acquisition 1 Global High Resolution Dipole Density Maps Four times higher resolution than voltage-based mapping 1 Optimal Maneuverability When used with the AcQGuide Steerable Sheath Ultrasound generates CT-quality cardiac chamber anatomy which is overlaid with high resolution, beat-to-beat dipole density maps that aid in visualizing the arrhythmic mechanisms to be targeted for ablation therapy. 1 Patrick Heck, MD, PhD, et al. NOVEL GLOBAL ULTRASOUND IMAGING AND CONTINUOUS DIPOLE DENSITY MAPPING: INITIAL FINDINGS IN AF PATIENTS, HRUK Meeting, October 2015

4 Indication for Use The AcQMap 3D Imaging and Mapping Catheter is intended to be used to collect imaging and electrical mapping data from the right and left atria. 100 cm ±5 cm 255 cm ±5 cm Product Details: DIAMETER (F) USABLE LENGTH DEPLOYED BASKET DIAMETER (MM) GUIDEWIRE COMPATIBILITY (IN) AcQMap 3D Imaging and Mapping Catheter AcQMap 3D Imaging and Mapping Catheter is intended for use with: AcQMap High Resolution Imaging and Mapping System AcQGuide Steerable Sheath For more information contact your Acutus Medical representative ACUTUS MEDICAL, INC Faraday Ave Suite 100 Carlsbad, CA United States Tel: ACUTUS MEDICAL NV Ikaroslaan Zaventem Belgium Tel Fax AcutusMedical.com Acutus Medical, the Acutus Medical logo, AcQGuide and AcQMap are registered trademarks of Acutus Medical, Inc. This material is the property of Acutus Medical and its subsidiaries. Please do not copy, forward, or distribute this document. Copyright 2016 Acutus Medical, Inc. All rights reserved. MC Rev. A

5 Optimal Maneuverability Braided shaft and unidirectional steering with deflection Highly Visible Under fluoroscopy 0 Atraumatic Tip Minimizes the possibility of trauma during use Two Sheath Side Holes Deflection Smooth Tip-to-Dilator Transition

6 Indication for Use The AcQGuide Steerable Sheath is intended to facilitate the intracardiac placement of diagnostic and/or therapeutic devices. 75 cm 4 cm reach cm 4.1 mm 16 F (5.3 mm) 12 F (4.3 mm) Product Details: I.D (F) O.D (F) DILATOR GUIDEWIRE COMPATIBILITY (IN) WORKING LENGTH OVERALL LENGTH AcQGuide Steerable Sheath For more information contact your Acutus Medical representative ACUTUS MEDICAL, INC Faraday Ave Suite 100 Carlsbad, CA United States Tel: ACUTUS MEDICAL NV Ikaroslaan Zaventem Belgium Tel Fax AcutusMedical.com Acutus Medical, the Acutus Medical logo, AcQGuide and AcQMap are registered trademarks of Acutus Medical, Inc. This material is the property of Acutus Medical and its subsidiaries. Please do not copy, forward, or distribute this document. Copyright 2016 Acutus Medical, Inc. All rights reserved. MC Rev. A

7 CT Quality Anatomic Reconstruction Accurate within 3 mm of CT/MRI using M-mode ultrasound acquisition 1 Highly Accurate Localization and Navigation Visualize AcQMap, Diagnostic and Therapeutic Catheters Dipole Density Mapping Four times higher resolution than voltage-based cardiac mapping 1 Easily Map and Re-Map Instantly reveals arrhythmic mechanisms to target pre- and post-ablation Ultrasound pings the chamber wall Final Surface Anatomy Dipole Density mapping overlaid on the Surface Anatomy 1 Patrick Heck, MD, PhD, et al. NOVEL GLOBAL ULTRASOUND IMAGING AND CONTINUOUS DIPOLE DENSITY MAPPING: INITIAL FINDINGS IN AF PATIENTS, HRUK Meeting, October 2015

8 Indication for Use The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheter, the AcQMap System is intended to be used in the right and left atria to visualize the selected chamber and display atrial electrical impulses. When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. AcQMap Console Physical characteristics Dimensions (cm) 68 L x 48 W x 73 D Weight, maximum 50 kg Functional and performance characteristics Ultrasound Output Frequency: 10 MHz +/- 10 khz Maximum Voltage: 50V p-p Maximum Power: 1 W peak Ultrasound Performance Single operating mode Thermal Index less than 1.0 Mechanical Index less than 1.0 AcQMap Workstation Physical characteristics Dimensions (cm) 173 (max) H x 64 W x 92D Weight 55 Kg AcQMap Patient Interface Unit Physical characteristics Dimensions (cm) 24 H x 16 W x 12 D Weight 2.6 kg AcQMap Ablation Interface Unit Physical characteristics Dimensions (cm) 24 H x 16 W x 12 D Weight 1.4 kg Localization Output ECG & EGM Input Frequency: Variable 10 khz to 100 khz Maximum current: < 5mA/cm2 Bandwidth: 0.1 Hz to 500 Hz Resolution: +/-10uV Timing Accuracy: +/-1.6 microsecond AcQMap High Resolution Imaging and Mapping System AcQMap System includes the following components: AcQMap Console AcQMap Workstation AcQMap Patient Interface Unit AcQMap Ablation Interface Unit Uninterruptable Power Manager, 220V Daily Calibration Test Fixture AcQMap Workstation Cable AcQMap Patient Interface Unit Cable AcQMap Ablation Interface Unit Cable AcQMap Auxiliary Catheter Cable AcQMap Surface ECG Cable The AcQMap System also requires use of the AcQMap Patient Electrode Kit for functionality (Order Number ). For more information contact your Acutus Medical representative ACUTUS MEDICAL, INC Faraday Ave Suite 100 Carlsbad, CA United States Tel: ACUTUS MEDICAL NV Ikaroslaan Zaventem Belgium Tel Fax AcutusMedical.com Acutus Medical, the Acutus Medical logo, AcQGuide and AcQMap are registered trademarks of Acutus Medical, Inc. This material is the property of Acutus Medical and its subsidiaries. Please do not copy, forward, or distribute this document. Copyright 2016 Acutus Medical, Inc. All rights reserved. MC Rev. A