Surgical imaging systems

O-arm™ surgical imaging system

<p>The O-arm™ surgical imaging system offers on-demand imaging, robotic positioning, and device mobility for spinal and cranial procedures.</p>

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Indications, Safety, and WarningsIntended useThe O-arm™ O2 imaging system is a mobile X-ray system designed for 2-D and 3-D imaging for adult and pediatric patients weighing 60 pounds or greater and having an abdominal thickness greater than 16 cm. It is intended to be used where a physician benefits from 2-D and 3-D information of anatomic structures and objects with high X-ray attenuation such as bony anatomy and metallic objects.The O-arm™ O2 imaging system is compatible with certain image-guided surgery systems.United States law restricts this device to sale, distribution, and use by or on the order of a physician.Residual risksThis discloses the potential complications associated with using the Medtronic O-arm™ O2 Imaging System and its accessories for cranial surgical procedures, spinal surgical procedures, or general imaging. Use of the system for cranial or spinal applications or general imaging present hazards that may include, but are not limited to: radiation exposure, emergent access to the patient, inaccurate navigation position, misinterpretation of navigation information, or additional surgery to complete a planned therapy. The potential complications for procedures completed with this imaging system identified by Medtronic include, but are not limited to: Radiation Exposure, Absence of Treatment, Inadequate/Inappropriate Treatment, Delay to Treatment/Therapy, Hospitalization or Prolonged Hospitalization, Additional Surgery, Surgical Intervention, Infection, Hypoxia, Movement Disorder, Loss of Range of Motion, Hearing Impairment, Visual Impairment, Fractures, Syncope, Neurogenic Shock, Pain, Tissue Damage, Therapeutic Response Decreased, Cerebrospinal Fluid Leak, Hemorrhage, Nerve Damage, Spinal Cord Injury, Brain Injury, Nervous System Injury, Death.Use of video graphics printerPrintouts from the optional video graphics printer are not intended to be used for diagnostic purposes. The printer’s primary use is for physician reference and documentation.Use of the DVD/CD RW driveInformation stored on DVDs is not intended to be used for diagnostic purposes. The primary use of such information is for physician reference and documentation.Equipment usersUsers of the O-arm™ imaging system should be trained, licensed, and/or certified in the proper use of medical X-ray equipment and its medical applications. Users should read this user manual and the labels on the image acquisition system (IAS) and the mobile view station (MVS).Safety overviewPotential hazards exist in the use of medical electronic devices and X-ray systems such as the O-arm™ imaging system. Personnel using the equipment should understand the safety issues, emergency procedures, and the operating instructions provided in the user manual.Caution: laser radiationDo not view directly with optical instruments. Class 1M laser product.WarningsThe laser alignment lights emit laser radiation and are a class 1M device. Do not view directly with optical instruments.

Features

Confidence in image clarity

With the ability to perform both 2-D and 3-D scans, the O-arm™ generates versatile images that assist in surgical planning, validate accurate placement during procedures, and facilitate post-operative positioning evaluation.

Gain confidence across the entire spinal procedural range with the O-arm™ system:

Obtain highly detailed images with a full 360-degree rotation around the patient.
Image a patient’s entire pelvis with a wide 40 cm field of view.
Accommodate challenging procedures involving heavier patients or individuals with unique anatomical characteristics using the powerful 32-kw generator within the O-arm™ system.

Get the image clarity you deserve without any compromises to your surgical workflow.

Product details

The O-arm™ system’s high quality, versatile imaging provides the information you need to guide your clinical decision making.

Along with StealthStation navigation, the O-arm™ system provides enhanced 3D visibility and surgical feedback. It also:

Enables advanced surgical approaches like MIS
Provides additional information in challenging procedures, like heavier patients or patients with unusual anatomy^1,2,3
Automatic registration keeps the process simple

The O-arm™ system also offers options for workflow efficiencies, such as:

In procedures where pre-op axial/coronal/sagittal slice data is necessary, it may be possible to use the O-arm™ system to provide the initial data set
Eliminating the need to send patients to be scanned in radiology

See the standard workflow in an OR compared to O-arm™ workflow.

Imaging protocols

The O-arm™ system provides flexibility for surgeons to achieve As Low As Reasonably Achievable (ALARA). Multiple image protocols allow the surgeon flexibility to choose the appropriate dose to the patient based upon individual clinical objectives.⁴

Surgical workflow

The O-arm™ system has been designed to complement the surgical workflow with:

Multiple surgical table options
Inter-room mobility for concurrent cases
On-demand imaging, no need to schedule in advance

O-arm system low dose protocol (50% less dose)

O-arm™ 4.3 software - now available in Canada

Medtronic surgical imaging has reached new levels.

Introducing 3 new functional enhancements: 3D Long Scan, Spine Smart Dose and Medtronic Implant Resolution.

3D Long Scan (3DLS) allows now 3D imaging up to 43.8cm, adding visibility to additional levels of the patients spinal anatomy.⁷

To support surgeons in making a confident clinical decision, the new Medtronic Implant Resolution (MIR) functionality aids. It helps with evaluation of the screw placement by enhancing the visualization of the bone anatomy around certain Medtronic screw systems.⁵

Standard dose

Spine Smart Dose

Spine Smart Dose (SSD) utilizes AI and approximately a quarter of the projections to enable ~70% less dose when compared to Standard Dose, or ~35% less dose when compared to Low Dose.⁵

O-arm™ is part of the AiBLE™ solution

O-arm™ Surgical Imaging System is a foundational component of AiBLE™, Medtronic's digital data-driven surgical ecosystem.

AiBLE™ is an integrated experience of innovative technology, software, services and people that aims to Connect, Predict and Advance.

This product is licenced with Health Canada as O-ARM O2 IMAGING SYSTEM on Health Canada licence number 97224.

1. Kovanda TJ, Ansari SF, Qaiser R, Fulkerson DH. Feasibility of CT-based intraoperative 3D stereotactic image-guided navigation in the upper cervical spine of children 10 years of age or younger: initial experience. J Neurosurg Pediatr. 2015;16(5):1-9.

2. Liu Y, Li X, Sun H, Yang H, Jiang W. Transpedicular wedge osteotomy for treatment of kyphosis after L1 fracture using intraoperative, full rotation, three-dimensional image (O-arm™)-based navigation: a case report. Int J Clin Exp Med. 2015;8(10):18889-18893.

3. Houten JK, Nasser R, Baxi N. Clinical assessment of percutaneous lumbar pedicle screw placement using the O-arm™ multidimensional surgical imaging system. Neurosurgery. 2012 Apr; 70(4):990-5

4. Dosimetry_Report_O2_BI-160-00227_Rev_2

5. Medtronic internal document: 10501 O-arm™ Journal Database - All Applications Q4FY21