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

Superior image quality

With the ability to perform both 2-D and 3-D scans, the O-arm™ generates exceptional and 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 superior volume and power of 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 generator within the O-arm™ system.

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

O-arm™ surgical imaging system

Features

Superior image quality

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United States

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