ControlRad Brief Summary

ControlRad Select Model Z

Indications for Use

Select Model Z: The ControlRad® Select Model Z with the Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients’ and clinicians’ radiation exposure (Dose Area Product) outside of the ControlRad® Select Model Z’s region of interest (ROI) as compared to Artis zee non-collimated image area.1 The ControlRad® Select Model Z semi-transparent filter should not be used in lieu of the Artis zee’s collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

  • Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.
  • 1Relative to open Field of View (FOV), the ControlRad® Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.
Contraindications:  The ControlRad Select Model Z shall not be used outside of the ControlRad® Select Model Z Indications for Use. The ControlRad® Select Model Z is only compatible with the 20x20 detector and associated collimator. Use of this system on other collimator sizes is prohibited.
 
Warnings: Do not attempt removing any cover or component of the system as this bears the risk of electrical hazard and damage to the system. Such actions should only be performed by ControlRad qualified service engineers.
  • Before using the ControlRad® Select Model Z, verify that the system is approved for use by a ControlRad qualified service engineer. Such approval is provided with installation and planned maintenance documents.
  • The assembly is not waterproof. Water, soap, or other liquids, if allowed to drip into the equipment, can cause electrical short circuits leading to electric shock and fire. Should liquids accidentally spill into the system, DO NOT apply power or turn on the system until the liquids have dried or evaporated completely.
  • Electrical circuits inside the equipment use voltages which are capable of causing serious injury or death from electric shock. To avoid this hazard, never remove any of the cabinet covers.
  • The use of the wrong type of fire extinguisher presents electrical shock and burn hazards. To avoid these hazards, a fire extinguisher which meets applicable regulations and standards must be available in the room where the equipment is being used. Remember that the Mobile C-arm's batteries are a source of electrical current, even when the interconnect cable is disconnected.
  • The ControlRad Filter can contribute to Dose Area Product (DAP) reduction. When considering patient skin burn risk, the users should only use AK as reported by Artis zee.
  • Use of approved power supplies is essential for operator safety. Usage of a non-approved power supply is forbidden and may cause injury.
  • Ignoring error and warning messages may result in equipment damage and personal injury.
  • Use of other gloves is at the user’s discretion and risk.
  • When cleaning, there is a risk of electrical hazard or damage to the system.
  • The system is not waterproof. Be careful not to spill or splash liquids where they can enter electronic assemblies.
  • Do not use any solvents or other materials which may damage or discolor paint finishes or plastic components.
  • It is the user’s responsibility to ensure the annual performance of Planned Maintenance of ControlRad Select.
  • Operating ControlRad® Select Model Z beyond the annual Planned Maintenance might result in inadequate system performance or failure.
  • The ControlRad Filters can contribute to Dose Area Product (DAP) reduction. The ControlRad Filters do not reduce Air Kerma (AK) at the center of the image, as reported by Artis Zee. When considering patient skin burn risk, the users should only use AK as reported by Artis zee.

Notes and Precautions: The ControlRad Filter is designed to always include the center of the field of view (FOV) in the ROI. Therefore, when selecting an ROI by the user, the actual ROI might be expanded to include the center of the FOV.

  • The ControlRad Filter contributes to DAP reduction only in image parts that are not obscured by the Artis zee collimator. For example, if the Artis zee collimated image is enclosed within the selected ROI, ControlRad Select Model Z will not contribute to DAP reduction.
  • Verify that the charger cable is positioned along a safe path and that it will not disturb the operation.
  • If sterile Tablet cover is not available, the ControlRad Tablet must be positioned in a non-sterile zone of the operating room and operated from there. NON-STERILE option must be selected.
  • The ControlRad Select semi-transparent filter should not be used in lieu of the Artis zee’s collimator, as it blocks the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.
  • The image quality outside the ROI is reduced due to the decreased radiation in this area and provides peripheral image context to the ROI Image.
  • The Physician Settings are saved for the first named physician and will automatically be used whenever this physician name is selected for the first physician.
  • The system can be configured by a service engineer to display on the live monitor cumulated DAP per pedal press and/or DAP Reduction per the user’s preferences.
  • In acquisition, at the first frames of the reference images, right after the pedal press, the user might see the ControlRad Filters in motion while being removed from the FOV. This is not a problem and DSA will be generated properly.
  • When using Roadmap with ControlRad Filters, the background image might appear darker or brighter than in standard Fluoro mode. The background becomes more similar to the ROI in higher kVp than in low kVp.
  • Maintenance shall be performed according to the instructions detailed in the ControlRad Select Model Z Service Manual.
  • Circuits inside the equipment use voltages which can cause serious injury or death from electrical shock. Do not remove the covers or open door cabinets of the Artis zee, or perform any type of service task, except as specifically instructed here.
  • The attenuation values of ControlRad Filters refer to reduction of Air Kerma only in image parts that are filtered by the ControlRad Filters. These values do not provide indication to DAP reduction levels which depend also on the Artis zee collimator settings.

Caution: Federal law restricts this device to sale by or on the order of a physician. Rx Only. Prior to use, please see complete User Manual for more information on indications, contraindications, warnings, precautions, and operator’s instructions.

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