Cirdan CoreLite™ Specimen Radiography System

Intended Use:

The CoreLite product is intended for use by medical professionals to provide rapid verification, through x-ray examination in or near the biopsy procedure room, that the correct tissue has been excised during percutaneous biopsy.

Warning Symbols:

Symbol 1 – Electric: Warns the reader of potential electrocution should the reader ignore the warning and deliberately use specialised tools to open a sealed electrical cabinet and handle contents. Note: No tools are provided by Cirdan Imaging Ltd.

Symbol 2 – Notice: Warns the reader of hazardous condition. This symbol is generally accompanied by a more specific symbol and appropriate instructions as to the nature of the hazard, the expected outcome of the hazard and information on avoiding the hazard.

Symbol 3 – Lifting: Cautions the reader to use care in lifting heavy equipment, to avoid personal injury and damage to the equipment.

Symbol 4 – Radiation: Warns the reader that ionized radiation is emitted into the labelled area when the x-ray beam is energized. The Product has safety interlocks to prevent the labelled area from being accessed while the x-ray beam is energized.

Symbol 5 – Protective Materials: Warns the reader to use appropriate protection (such as surgical gloves or an approved specimen container) to avoid exposure to potentially infections materials such as patient tissue samples or cleaning materials.

Operator Safety Warnings(s):

• Manual Handling: Facility manual handling protocols should be observed.
• High Voltage: Due to the presence of High Voltage components the rear panel should not be removed at any time.
• Mains Voltage: Due to the presence of Mains Voltage, the rear panel should not 
• Radiation: Radiation local radiation protocols and monitoring should be observed at all times. No additional radiation protocols are required.
• Irritants/biohazards: Facility protocols and monitoring should be observed. No additional cleaning agents are provided with the product.
• Protective earthing warning: Protective earthing is provided via the mains cord. The CoreLite must be connected to an earthed mains outlet. Warns the reader of potential electrocution should the reader ignore the warning and deliberately use specialised tools to open a sealed electrical cabinet and handle its contents.
• Maintenance Warning: X-Ray source window should not be touched under any circumstances. If the beryllium window is damaged please follow local rules regarding contamination control. Report the issue as per section 14 of the user manual.
• Protection: Appropriate protection and care should be taken when handling biological specimens in adherence with the appropriate local regulations and guidelines.
• Imaging Area: The imaging area of the CoreLite unit must be kept clean and free from contamination to avoid the creation of artefacts in the images acquired.
• Movement warning: Cautions the reader to use care in lifting heavy equipment, to avoid personal injury and damage to the equipment. If the system has been moved then re-calibrate before using.
• Troubleshoot: *Please contact your local representative if any self-test fails.

Handling:

•  *X-ray systems should only be operated by staff trained and deemed competent in radiation safety and who have made themselves familiar with the setup and operating instructions contained with this operator manual.
• The key and spare key are designated as a controlled tool, which is to be controlled by the responsible body. Turn the key 90 degrees clockwise and remove the key when unit is not in operation to prevent unauthorised usage.

BD and the BD logo are trademarks are trademarks of Becton Dickinson and Company or its affiliates. CoreLite is the trademark of Cirdan. All other trademarks are the property of their respective owners. © 2023 BD. All rights reserved.

BD-74916