CoreLite Operator Manual Rev 002 Aug 2019

CoreLite CONTENTS 1.

Purpose & Scope

3

2.

Intended Use

3

3.

Warning Symbols

3

4.

Safety

4

5.

Product Overview

5

6.

Servicing

6

7.

Maintenance

6

8.

Unpacking

6

9.

Installation

7

10. CoreLite Front Panel

10

11. CoreLite Software

15

12. Troubleshooting

18

13. Labels and Enclosure

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14. Issues

22

15. Confidential Information

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16. Manufacturer Details

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Appendix

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CoreLite 1. PURPOSE & SCOPE This manual was created by Cirdan Imaging Ltd. It is intended as a guide on the setup and use of the CoreLite X-ray cabinet and software, both developed by Cirdan Imaging Ltd. Performance and safety may be impaired if used in a manner not specified by the manufacturer, as contained within this user guide.

2. INTENDED USE The CoreLite product is intended for use by trained personnel such as Radiographers and Radiologists for the verification of micro-calcifications in breast biopsy specimens at the point of care in the breast treatment room.

3. WARNING SYMBOLS The following symbols are used in this manual: Warns the reader of potential electrocution should the reader ignore the warning and deliberately use specialized tools to open a sealed electrical cabinet and handle its contents. Note: No tools are provided by Cirdan Imaging Ltd. Warns the reader of a 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. Cautions the reader to use care in lifting heavy equipment, to avoid personal injury and damage to the equipment.

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.

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.

Table 1: Warning Symbols

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CoreLite 4. SAFETY 4.1 Operator Safety Table 2: Operator Safety

*Requirement Reference

Description

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 be removed at any time. Radiation Local radiation protocols and monitoring should be observed at all times. No additional radiation protocols are required. Irritants/ Facility protocols and monitoring should be observed. No additional Bio Hazard cleaning agents are provided with the product. *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 & operating instructions contained with this operator manual.

4.2 Moving the System The product is designed to be used while stationary. DO NOT operate when in motion. Note: If the system has been moved then re-calibrate before using.

4.3 Protective earthing Protective earthing is provided via the mains cord. The CoreLite must be connected to an earthed mains outlet.

4.4 X-Ray Source Window The X-Ray source window should not be touched under any circumstances. If the beryllium window is damaged please follow local rules regarding contamination control. Follow instructions in Section 14.

4.5 Regulatory It is the responsibility of the facility or institution operating this system to ensure that all local, regional, and federal regulations affecting the use of the CoreLite product are followed. Cirdan products are inspected and tested before shipment and will be free of Mechanical/Electrical defects. In the event, that damage has incurred to product during transport, please refer to the Issues section on page 22 for further action. Generally, the CoreLite will be set up and configured on-site and left ready to use. Operators will be given training and instructed in the use of the system. Additional Installation/Quick setup instructions are contained within this manual.

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CoreLite 5. PRODUCT OVERVIEW 5.1 System Description System Components ▪ CoreLite X-Ray Cabinet ▪ Tools controlled by responsible body: Key & spare key. ▪ Medical grade computer with pre-installed software ▪ Computer stand, medical grade keyboard and mouse ▪ Optional barcode reader/stand

5.2 Specifications Input X-ray tube and Emission Control:

Detector Dimensions

Weight Cabling

Environmental

Supply voltage: 100-240 VAC, 50/60Hz, 3A, 265W Fuse rating: T 3.15AH 250Vac (2 off) Energy range: (kV range) 21kv - 25KV. Tube operating current: Max. 1mA, Power output: Max. 25W Anode material: W Focal spot size: 50um Window filter material: Beryllium System resolution: nominal 10 lp/mm +/-1 lp/mm Detector Size (field of view): 67 mm x 42 mm Interior Cabinet X-ray chamber dimensions – (H) 15cm x (D)16.5 x (W) 19.5cm Cabinet external dimensions – (H) 42cm x (L) 42 cm x (W) 32cm CoreLite X-ray Cabinet Weight: 30.2 kg CoreLite System Weight: 45 kg (cabinet and PC combined weight) Mains cable supplied: (3 core: Live, Neutral, Earth. length 2m; regional variations available) Ethernet cable supplied (Shielded CAT 6, length 2m Indoor use, Only for use in non-explosive atmospheres. Operating Temperature: - 15°C to 35°C Storage temperature: - 10°C to 70°C Maximum relative humidity 80 % for temperatures up to 31 °C Maximum usable altitude of 2000 Metres Leakage: - Integrated shielding surpasses regulatory requirements Table 3: Specifications

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CoreLite 6. SERVICING There are no customer or user serviceable parts in the CoreLite product. No tools or additional Personal Protection Equipment will be required with this product for operator usage.

7. MAINTENANCE ** *** 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. Anistel (or similar) surface disinfectant or Sani cloth detergent wipes are recommended to clean and wipe down the imaging area prior to calibration. Care is required when wiping around the imaging area – the circular aperture to x ray tube is located on the surface opposite the imaging area and should not have anything inserted into it, as this may damage or contaminate the X ray source window. X-Ray source window should not be touched under any circumstances. If the beryllium window is damaged please follow local rules regarding contamination control. Follow instructions in Section 14.

8. UNPACKING Your unit may be installed already, however if circumstances arise that requires you to unpack a new system please follow the instructions located in Appendix 1.

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CoreLite 9. INSTALLATION Your unit may be installed already, however if circumstances arise that requires you to install a new system please follow the instructions below.

9.1 Mount PC on stand PC Power & Network instructions. (i) Power socket/outlet requirements (ii) Network cabling requirements When using the PC and accessories provided, please ensure the system is connected as below.

(LAN 2) Connection to hospital IT

Figure 1: PC Power & Network Diagram.

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CoreLite 9.2 PC Connections

Ethernet port to CoreLite (LAN1)

Keyboard (USB1) Mouse (USB2) Barcode scanner (optional) (USB 3)

Ethernet port to network (LAN2)

Cable from PC power supply

Note 1: The mains cord to the PC power supply is detachable Use only with the mains cord supplied. Figure 2: PC Connections

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CoreLite 9.3 CoreLite Connections

Ethernet port from PC CoreLite power inlet and mains isolation switch

Note 2: The unit must be positioned such that the Power inlet, Ethernet cable and mains cord shall be easily accessible for connection / disconnection. Use only with the mains cord supplied. Note 3: The CoreLite mains cords is detachable. Rating of Cabinet MAINS supply cord 10 amps, 250Vac Use only with the mains cord supplied.

Figure 3: CoreLite Connections

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CoreLite 10. CORELITE FRONT PANEL

CoreLite display

X-Ray ON indicator Illuminated = X-rays ON

Power ON / standby button and indicator Flashing = Standby Constant = ON No Illumination = Power Disconnected

Key switch Fully clockwise = Disabled Fully anti-clockwise = Normal

Emergency stop button Out = Normal In = Disabled Figure 4: CoreLite Front Panel

10.1 CoreLite Display: The CoreLite display provides information on the status of the hardware. Information provided includes: ▪ ▪ ▪ ▪ ▪

Power on self-test status Ready status Interlock status X-ray on/off status Error status

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CoreLite 10.2 X ray on indicators ▪ ▪ ▪

The Radiation indicator will illuminate for the duration of the Xray exposure The CoreLite display will show the display the KV and mA during the exposure. The Sounder will activate for the duration of the X-ray exposure.

The CoreLite will monitor various parameters during and at the end of the exposure and will indicate if a problem is detected.

Fig 5.1: X-Rays On

10.3 Key switch It is a regulatory requirement that x-ray specimen cabinets have a means to disable the generation of x-rays when authorized personnel leave the vicinity of the equipment. The key switch on the CoreLite fulfills this requirement. The key & 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 unauthorized usage.

Fig 5.2: Key Switch

Ensure key switch fully turned 90 degrees anti-clockwise to unlock. Ensure key is not bent or broken off in Locked position. If damaged contact Support as soon as possible for assistance.

Fig 5.3: X-rays Off (Locked)

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CoreLite 10.4 Emergency stop It is a regulatory requirement that x-ray specimen cabinets have an emergency stop switch as part of the safety interlocks on the product. Simply push the emergency stop button to terminate x-rays. ▪

Ensure the Emergency stop button is not obstructed or damaged. Ensure Emergency stop has not been accidentally pressed in. Simply turn the Emergency stop switch clockwise to deactivate. Contact support ASAP for resolution if fault persists.

▪ ▪

Fig 5.4: Emergency Stop

10.5 Door Interlock The Door interlock ensures that it is impossible for x-ray generation with the door open. The CoreLite display will display the door status when the CoreLite is ON but not disabled by the Key Switch or Emergency stop switches i.e. if the CoreLite is in the READY state then when the door opens the CoreLite display and the CoreLite software should indicate that the door is open. If this is not the case, then: ▪ ▪

Ensure the door interlocks shown below are not obstructed or interfered with in any way.

Figure 5.5: Door Open

Ensure interlock door section is not bent or broken off. If damaged do not use and contact Support ASAP for a resolution if fault persists.

Figure 5.6.1: Door

Figure 5.6.2: Cabinet

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CoreLite 10.6 Turning the CoreLite ON and OFF Connect to mains and place in low-power stand-by: ▪ Ensure the CoreLite is connected to the mains supply via the supplied mains cord. ▪ The isolation switch at the rear of the unit as shown in Figure 3 should be switched to “1” which puts the unit into its low-power standby-mode as indicated by the blinking blue LED on front panel. If the LED fails to blink, please refer to Troubleshooting section 12. a) To Turn the unit ON: The CoreLite should be turned on before the PC. Turn the CoreLite on by pressing and holding in the Power ON button for three seconds then releasing, the blue LED should now remain on constantly and with activity on the CoreLite Display showing power-on self-test status before entering the Ready state: It is recommended that once the CoreLite is ON, that the unit should be left in this state if the unit is to be used at any time during the remainder of the working day. Figure 5.7: Powering Up

b) To Turn the unit OFF (low-power stand-by): At the end of the working day when all specimens have been imaged and no further work is intended, it is recommended that the CoreLite is put into its low-power standby state. This is achieved by pressing and holding in the power button for three seconds then releasing. The CoreLite display should go blank and the blue LED blink to indicate it is in its low power stand-by state (but still connected to mains).

10.7 Specimen container and placement Appropriate protection and care should be taken when handling biological specimens in adherence with the appropriate local regulations and guidelines. The sample should be placed in a suitable container prior to placing in the CoreLite X-ray cabinet. Containers should be uniformly RADIOLUCENT, (transparent to X-rays) to avoid image artefacts While the CoreLite unit was designed with a large door and specimen area to allow the end user to select and use a specimen container of their own choosing, the rectangular field-ofview is marked within a larger circle to make it easy to use cheap and readily available polystyrene petri dishes.

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CoreLite A printed template is provided to allow the biopsy specimens to be placed in a petri dish and stay within the imaging area when the dish is placed on the circular outline marked on the CoreLite.

Figure 5.8.1: Inside imaging area of CoreLite

Figure 5.8.2: Mock specimen placed on outline

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CoreLite 11. CORELITE SOFTWARE The CoreLite Application Software is pre-installed onto the Computer. In many installations of CoreLite the PC will be connected to the Radiology Information System (RIS) of the facility for the DICOM worklist and to the Picture Archiving and Communication System (PACS) for image storage. Typically, the task of connecting the PC to these will be completed by your local representative as part of the CoreLite installation. *A guide on how to use software can be found in the Quick Start Guide.

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11.1 Calibration. Periodic image calibration should be performed to ensure optimal image quality. During image calibration, reference images are acquired and stored in a folder on the PC. On acquisition of an image under normal operating conditions, the reference images are applied to the unprocessed image, to correct for any non-uniformities in the unprocessed image. All subsequently acquired images are corrected using the stored reference images, until the unit is recalibrated. ▪ ▪

The CoreLite software will prompt the user to calibrate the unit when required. Calibration takes approximately 20 seconds.

Step-by-step image calibration procedure 1. The software will prompt when a calibration is required. 2. Under normal operating procedures there should be no objects in the beam during calibration. 3. Care should be taken to ensure the cabinet is clear of objects and contamination. Prior to performing a calibration, the field of view should be cleaned gently with a suitable wipe as detailed in the Maintenance section of this document. 4. From the home screen (figure 6.1), click on “Calibration” to manually calibrate.

Figure 6.1 Main screen

CoreLite 5. When the calibration dialog opens (Figure 6.2) click on the Calibrate button. Pressing the Cancel button will return the user to the home screen, without commencing calibration.

Figure 6.2 Calibration dialog

6. The calibration sequence will commence automatically. The sounder will be audible while Xrays are generated.

Figure 6.3 A calibration in progress

7. When all reference images frames have been acquired, the screen in Figure 6.4 will be displayed. The previously stored reference images will be archived and replaced. Click on the OK button to exit the dialog.

Figure 6.4 Dialog indicates Calibration complete

System shut down protocol: ▪ ▪ ▪ ▪

Finish any open sessions. Remove samples from X ray chamber & store as per facility protocols. Exit the software. If the unit will not be used within 12 hours, press and hold the standby power button and turn off the PC.

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CoreLite 12. TROUBLE SHOOTING 12.1 Power-ON Self-Test: ▪ ▪ ▪ ▪ ▪

The Standby button will show a blue flashing LED light, when the CoreLite is connected to mains power but is in low-power standby mode. The CoreLite will carry out a power-ON self-test after the standby button is pressed for three seconds and released. If the tests are passed the tests will show “OK” as shown. Any self-test that is not passed will be highlighted with a FAIL in red font and the CoreLite will not proceed to READY. When the tests are passed, the CoreLite should proceed to the READY state

Figure 7.1: Powering up

Figure 7.2 READY state

*Please contact your local representative if any self-test fails

12.2 Interlocks Operation of the Door, Key Switch and Emergency Stop interlocks are described in sections 10.3, 10.4, and 10.5 respectively along with notes on proper use and troubleshooting notes. The capture button in the acquisition screen and the calibration dialog will also indicate the state of the interlocks.

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CoreLite 12.3 Camera Connection If the CoreLite application software cannot find the CoreLite cabinet, then an icon will be shown to indicate the following:

Figure 8.1: CoreLite Disconnection from Home Screen

Home screen dialogue in Figure 8 indicates that the CoreLite application software has not connected to the CoreLite cabinet via the green ethernet cable.

Figure 8.2: CoreLite Disconnection from Acquisition Screen

The ‘acquire’ icon in the acquisition stage changes to a ‘disconnected’ icon when connection is lost (See Figure 8.2).

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CoreLite Reasons for the loss of connection may be: ▪ ▪ ▪

Cabinet put into low-power standby or mains supply disconnected – check CoreLite is connected to mains power and is ON as described in section 10.6. The network cable has been disconnected form the PC or CoreLite RJ45 ethernet socket – check the network cable is properly inserted into the PC and CoreLite RJ45 sockets A faulty network cable – temporarily swap the cable for an alternative cable that has been tested as working.

12.4 Image Quality/Artifacts ▪

Specimen area – ensure the specimen area is clean prior to calibration as any contamination in this area may create unwanted artefacts in the specimen images displayed.

▪

Containers – as mentioned in section 10.7 on Specimen Container and Placement, the containers must not have any features that results in artifacts in the specimen image i.e. no molded features or contamination.

12.5 X-Ray output The CoreLite unit measures and displays the KV X-ray output in real time. The value displayed on the CoreLite unit should be equal to the value in the CoreLite application software on the PC. This provides the user an easy way to verify that the X-ray exposure matches the selection. In addition, the CoreLite unit monitors a whole range of parameters to monitor performance. If any of these fall outside the normal range a warning message will be displayed on the CoreLite unit and in the application software. Please contact Support if any warnings are present.

12.6 Cables • • •

Only cabling supplied or recommended for use should be used. Cables with insulation damage should be disposed of and replaced as required. Contact Support for information on replacement cables.

12.7 Enclosure casing, seals • • •

If enclosure damaged OR punctured OR exposing internal components, do not turn system on. Contact Support ASAP to report issue. Product should not be used until enclosure damage repaired or product replaced.

12.8 Worklist not loading • •

Ensure network cable in LAN 2 is connected correctly. Contact internal IT support to check the RIS is available. 20