AURORA

ELECTROMAGNETIC TRACKING SYSTEM

FROM A WORLD LEADER IN NAVIGATION TECHNOLOGY

The Aurora® electromagnetic (EM) spatial measurement system from NDI is based on over 30 years of advanced 3D measurement technology, providing unsurpassed customization and integration with the world’s most sophisticated OEM surgical navigation systems and surgical instruments.

THE AURORA ELECTROMAGNETIC TRACKING SYSTEM OVER 3000 INSTALLATIONS WORLDWIDE The Aurora EM Tracking System provides real-time, sub-millimetric, sub-degree position and orientation tracking of miniaturized sensors in five or six degrees of freedom (5DOF / 6DOF). Sensors may be located inside or outside of the body; no line of sight is required to maintain accurate tracking. These sensors are designed for integration into surgical tools and instruments such as needles, catheters, probes and scopes, for use in a broad range of image-guided medical applications: interventional radiology, oncology, neurosurgery, and many more. The ability to place the sensor at the tip of an instrument allows for the localization of flexible instruments within the body, allowing for a host of unprecedented medical applications. The Aurora EM Tracking System supports the simultaneous tracking of up to sixteen (16) 5DOF or eight (8) 6DOF electromagnetic tools. The system additionally supports varying tracking volumes through the use of different Field Generators, providing optimal anatomical visualization. The result is highly accurate and reliable measurement required by the most precise surgical navigation and image-guidance applications in medicine.

SYSTEM FEATURES ӹӹ

Sub-millimetric and sub-degree tracking with no line-of-sight

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Two Field Generator (FG) designs available

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Custom FG designs that withstand up to 100 autoclave cycles

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Customized FG and electronics form factors to best match clinical

restrictions ӹӹ

Full offering of sensors and ready-to-use tools ••

Cost-effective sensors, allowing for disposable applications

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Robust sensor designs for daily re-use applications

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Sensors as small as 0.3 mm in diameter for integration into highgauge needles

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Electronics available in enclosed and bare PCB formats

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Track up to 16 sensors (customizable up to 32 sensors)

workflow ӹӹ

Tracking unaffected by the presence of most medical-grade metals

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Compliant with medical equipment safety standards

APPLICATIONS

INTERVENTIONAL RADIOLOGY AND IMAGING ӹӹ

Enables new ultrasound imaging capabilities through localization of the ultrasound transducer: •• Overlay live ultrasound images on pre-operatively acquired CT or MRI images through image fusion •• Mark or tag anatomical features during an examination and re-navigate to landmarks for subsequent review and reporting •• Visualize needles both in-plane and out-of-plane for needlebased drug delivery (anesthesia), biopsy, drainage and vascular access

ENT SURGERY ӹӹ

steps and to avoid critical cranial anatomy close to the sinus

CARDIOLOGY ӹӹ ӹӹ

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Tracking needle tips within fluoro, CT, ultrasound or MRI images: •• RF, microwave and other forms of ablation •• Core tissue biopsy •• Fluid aspirations •• Brachytherapy Tracking of ablation catheters

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Targeting and tracking in radiation therapy

ANESTHESIA ӹӹ

Visualization of needles in ultrasound image for nerve block,

GUIDEWIRE AND CATHETER TRACKING ӹӹ

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PULMONOLOGY ӹӹ

Tracking the tip of a bronchoscope or pulmonary catheter for accessing lesions in the lungs

Peripheral chronic total occlusions

ORTHOPAEDIC TRAUMA ӹӹ

Fluoroscope-free targeting of distal locking holes in intramedullary nails

LAPAROSCOPIC/THORACIC SURGERY ӹӹ

ENDOSCOPY Tracking tip position and orientation of rigid and flexible endoscopes Tracking of tip position and visualization of colonoscope shape

Endovascular procedures: •• Abdominal aortic aneurysm •• Renal denervation •• Stent and shunt placement ••

vascular access and pain management

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Tracking electrophysiology catheters to create high-resolution spatial maps of the electrical activity of the heart Tracking of cardiac ablation catheters to precisely locate and address cardiac arrhythmia

ONCOLOGY ӹӹ

Tracking surgical instruments to confirm and facilitate procedural

Tracking of absolute and relative poses of laparoscopic ultrasound and video: •• Kidney •• Liver •• Gall bladder ••

Lymph nodes

SIMULATION AND SURGEON PERFORMANCE ӹӹ

Tracking simulation instruments in virtual environments

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Quantification and evaluation of surgeon movements

NDI AURORA EM TRACKING SYSTEM

SYSTEM COMPONENTS AND PRINCIPLES OF OPERATION FIELD GENERATOR Emits a low-intensity, varying electromagnetic field and establishes the position of the tracking volume. NDI now offers multiple FG types that feature plug-and-play functionality with the System Control Unit.

PLANAR FIELD GENERATOR For mounting on a positioning arm which offers flexible setup options around the patient.

TABLETOP FIELD GENERATOR Only 3.4 cm thick, this FG is designed to be placed between the patient and the table. The FG incorporates a thin barrier that minimizes any tracking distortions caused by conductive or ferromagnetic materials located below it.

SYSTEM CONTROL UNIT (SCU) Controls the FG, collects information from the SIUs, calculates the position and orientation of each sensor, and interfaces with the host computer. Available in both enclosed and PCB formats.

SENSOR INTERFACE UNIT (SIU) Amplifies and digitizes the electrical signals from the sensors and provide an increased distance between the SCU and sensors, while minimizing the potential for data noise. Up to 2 SIUs can be connected. Available in both enclosed and PCB formats. Supports eight 5DOF or four 6DOF sensors.

METAL IMMUNITY All electromagnetic tracking systems use a magnetic field to determine the location of sensors in space. Outside influences on that magnetic field, for example eddy currents in nearby conductive materials, may lead to position errors of the sensors. While the effects of these external influences cannot be completely counteracted, the Aurora system software and hardware is specifically designed and integrated in a way that greatly minimizes them. Aurora is unaffected by most medical-grade stainless steel (300 series) and titanium. A Tabletop FG is available which minimizes any distortions produced by patient tables or other materials below it. For more information on metal immunity, please contact your local NDI office or visit our website.

SENSORS AND TOOLS NDI offers a wide selection of both individual sensors and ready-to-use tools for use with the Aurora System. NDI manufactures the smallest, most cost-effective electromagnetic tracking sensors on the market today. These sensors are designed for integration into third-party instruments and offer the following features: ••

Cost-effective sensors, allowing for disposable applications

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Robust sensor designs for daily re-use applications

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Sensors as small as 0.3 mm in diameter for integration into high-gauge needles

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Sensors and tools that can survive sterilization

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Select ready-to-use tool designs able to withstand multiple autoclave cycles

Photo courtesy of Filip Banovac, MD, Georgetown University Hospital

Please refer to the Aurora Sensors and Tools brochure for detailed descriptions of our sensor and tool offerings, or visit our website - www.ndigital.com/medical/aurora.

SENSORS Small currents are induced in the sensors by the varying electromagnetic field produced by the Field Generator. The characteristics of these electrical signals are dependent on the distance and angle between a sensor and the Field Generator.

ACCESSORIES AND SOFTWARE Please visit our website www.ndigital.com/medical/aurora for a detailed description of the following offerings: ••

Planar FG mounting arm

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NDI ToolBox software

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NDI 6D Architect software

NDI AURORA EM TRACKING SYSTEM

TECHNICAL SPECIFICATIONS PLANAR FG CUBE VOLUME

TABLETOP FG

DOME VOLUME

DOME VOLUME

RMS

95% CI

RMS

95% CI

RMS

95% CI

0.70 mm

1.40 mm

1.10 mm

2.00 mm

0.20 °

0.35 °

0.20 °

0.40 °

0.50 °

0.70 °

0.48 mm

0.88 mm

0.70 mm

1.40 mm

0.80 mm

1.20 mm

0.30 °

0.48 °

0.30 °

0.55 °

0.70 °

0.80 °

Accuracy - 5DOF Sensors*+ Position Orientation

1.20 mm

1.80 mm

+

Accuracy - 6DOF Sensors* Position Orientation

CHARACTERIZED MEASUREMENT VOLUMES

660

(All dimensions in mm)

500

500

50 R480

+Y +Z

+X +X

500

+Y

660

Cube Volume

Dome Volume

Dome Volume

Cube Volume

500

R480

+Y +X

500

+Y

+X

660

e

Dome Volume

Cube Volume

Number of Sensors

16 5DOF or 8 6DOF (customizable up to 32 5DOF or 16 6DOF)

Measurement Rate

40 Hz Each measurement is independent, established using data not shared with earlier measurements (as is done when reporting update rate specifications).

Interface

USB Isolated RS-422 External synchronization port via 9 pin D-type connector RS-232 available on request

Power

100-240 VAC, 50/60 Hz

Planar Field Generator

200 mm x 200 mm x 70 mm, 3.2 kg

Tabletop Field Generator

762 mm x 507 mm x 34 mm, 13.3 kg

System Control Unit

Enclosed 230 mm x 170 mm x 53 mm, 1.2 kg PCB 206 mm x 135 mm x 23 mm, 0.3 kg

Sensor Interface Unit

Enclosed 114 mm x 170 mm x 53 mm, 0.6 kg PCB 135 mm x 89 mm x 23 mm, 0.1 kg

Approvals and Classifications†

EN/IEC 60601-1, UL60601-1, CAN/CSA C22.2 No. 601.1 and IEC 60601-1-2:2007 with CISPR 11 and FCC Class B RF emissions. Refer to the user guide for a complete listing of approvals and classifications.

* All data collected with the Aurora V2 System in an environment free of electromagnetic disturbances. Aurora V3 systems have same performance. + Accuracy depends on tool design and the presence of metal. Note: Results based on more than 1000 random positions and orientations distributed throughout the characterized volume. † Applies only to enclosed System Control Unit and System Interface Unit.

AURORA BY DESIGN OEM CUSTOMIZATION NDI recognizes that OEMs wishing to incorporate electromagnetic tracking in their applications are generally interested in customizing the Aurora components. This allows for the creation of new form-factors and seamless integration into existing workflow.

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Customized FGs become part of the solution rather than hardware to work around. ••

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Customized electronic components allow for various form-factor solutions ••

SIU can be expanded up to 8 ports, or as small as 2 ports

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SCU and SIU can be combined into a single enclosure

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Simultaneous tracking of up to 32 sensors

Customized sensors and tools ••

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NDI provides FG simulation and design services

Talk to us about your specific requirements

Customized services ••

Tool design

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Sub-tool assembly

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Tool characterization

The Aurora EM Tracking System as presented in this brochure may be considered a starting point for understanding the principle components and system operation. NDI has designed the system and developed resources to be able to quickly respond to requests for customization. We work closely with our OEM partners to provide an optimized hardware solution. Talk to us about your specific requirements.

NDI AURORA EM TRACKING SYSTEM

THE COMPANY NDI is a global leading innovator and manufacturer of advanced 3D measurement technology systems, with over 45,000 installations worldwide. For over 30 years, the company’s optical measurement and electromagnetic tracking solutions have been trusted by the world’s foremost organizations and institutes in medicine, industry and academia. From imageguided surgery to aeronautics; from quality assurance to biomechanics research, NDI solutions are used whenever best-in-class measurement accuracy and reliablity are required.

NDI INTERNATIONAL HEADQUARTERS

ASCENSION TECHNOLOGY CORPORATION (an NDI company)

NDI EUROPE GmbH

NDI ASIA PACIFIC

CANADA Tel: + 1 (877) 634-6340 Email: [email protected] Website: www.ndigital.com

USA Tel: + 1 (802) 985-1114 Email: [email protected] Website: www.ascension-tech.com

GERMANY Tel: + 49 (77 32) 8234-0 Email: [email protected] Website: www.ndieurope.com

HONG KONG Tel: + (852) 2802 2205 Email: [email protected] Website: www.ndigital.com

www.ndigital.com

www.ascension-tech.com

Copyright 2013 Northern Digital Inc. All rights reserved. Due to continuous product improvement, specifications subject to change without notice. NDI, Aurora and Measurement You Can Trust are registered trademarks of Northern Digital Inc. The Aurora is a general metrology instrument. Use in a particular application must be determined by the user. Manufacture, use and/or sale under one or more of the following patents: 6,385,482; 6,553,326; 6,625,465; 6,288,785; 6,836,745; 7,783,441; 7,469,187 B2; 7,353,125 B2; 7,957,925. Other patents pending. Printed in Canada - November 2013 NDI P/N 8300163 (Rev007)