MI-42-0001 Rev. 19 5
GENERAL INFORMATION: AIRO Mobile CT System
Contraindications AIRO is contraindicated as the principal means of guidance during invasive procedures when real-
time imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify
navigation accuracy using an adequate verification method when used with Navigation Systems
during surgical procedures.
Intended Use AIRO is intended for use in several environments such as mobile or fixed General Radiology,
Intensive Care Unit (ICU), Emergency Department (ED), Surgical/Operating Room (OR), Clinic or
Office. AIRO will provide CT images that assist in a range of clinical applications which includes
neuro (cranial and spinal), ENT, head and neck, orthopedic and general surgery.
Medical Purpose AIRO can provide an aid to diagnosis when used by a qualified physician and is intended for
computed tomography applications that can be imaged in the 107cm aperture.
AIRO is not designed to be relied on as the principal means of guidance during
invasive procedures when real time imaging is needed. (e.g., CT Fluoro). Risk of
patient injury.
The physician must verify navigation accuracy using known anatomical landmarks or
an equivalent verification method.
Intended Users and
Operators
AIRO is intended to be operated by medical personnel trained in its operation by authorized trainers.
CT functions may be further limited by local regulations.
AIRO is only intended to be shipped or serviced by qualified service personnel and manufacturing
technicians.
Only
trained medical personnel may operate system components and accessory
instrumentation.
See section 1.7 Training and Documentation
Patient Group AIRO is to be used at the request of the supervising physician on pediatric and adult patients
weighing less than 182 kg (400 lbs).
This instrument is designed to image patients with a mass of less than 182 kg (400
lbs). For patients heavier than 182 kg, device X-ray exposure limitations result in poor
image quality and unused dose.
Refer to the instruction manual for the operating table you will be using to determine the respective
effective load limits.
Do not exceed the indicated load limit of the operating tabletop. Failure to adhere to
proper loading limits can lead to patient injury due to tabletop structural integrity
failure.
For more information about using AIRO on Pediatric patients, see section 1.4.2 Pediatric Use
Summary.
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