Leica BIOSYSTEMS HistoCore LIGHTNING S Instructions For Use Manual

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HistoCore LIGHTNING S

Laser Slide Printer

Instructions for Use

English

Order No.: 14 0610 80101 - Revision K

Always keep this manual with the instrument.

Read carefully before working with the instrument.

Version 2.0, Revision K - 12.2024

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Page 1 HistoCore LIGHTNING S Laser Slide Printer Instructions for Use English Order No.: 14 0610 80101 - Revision K Always keep this manual with the instrument. Read carefully before working with the instrument. Version 2.0, Revision K - 12.2024...
Page 3 – including any electronic systems and media – requires express prior permission in writing by Leica Biosystems Nussloch GmbH. For the instrument serial number and year of manufacture, please refer to the nameplate on the back of the instrument.
Page 4: Table Of Contents
Table of contents Important information ....................6 Naming conventions ........................6 Symbols and their meanings ....................... 6 Instrument type ........................10 Intended purpose ........................10 1.5 Qualification of personnel ......................10 Statement for user data security and privacy ................10 Safety ........................12 Safety notes ..........................12 Warnings ..........................12 2.2.1 Markings on the instrument itself ....................13 2.2.2 Transport and installation......................13 2.2.3 Operating the instrument ......................14...
Page 5 Changing the dust bag/carbon filter/HEPA filter (standard filter) ..........56 6.3 Changing the dust bag/batch filter-HEPA carbon (batch filter) .............56 General maintenance ........................57 Replacing fuses ........................57 Troubleshooting ......................58 Error codes ..........................58 Power failure ..........................60 Possible faults ..........................60 Ordering information ....................61 A1. Decontamination Confirmation ..................62 A2. Warranty and Service ....................63 HistoCore LIGHTNING S...
Page 6: Important Information
Important information Naming conventions Note • The full name of the device is HistoCore LIGHTNING S Laser Slide Printer. The device is called the printer to ensure that the Instructions for Use are well legible. Symbols and their meanings Danger: Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injuries.
Page 7 Indicates the need for the user to consult the Instructions for Use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the device itself. Alternating current PE terminal Stand-by HistoCore LIGHTNING S...
Page 8 Important information (Power): In the position of power on (Power): In the position of power off Caution, sharp element Laser label Indicates the product is class 1 laser product. Label Re-install the laser cover after cleaning or maintenance. Certification label Indicates this laser product complies with CFR 1040.10 and 1040.11. Keep dry: The package must be kept in a dry environment.
Page 9 With a pitch of 60° or more, the blue quartz sand flows into the arrow-shaped indicator window and sticks there permanently. Improper handling of the shipment is immediately detectable and can be proven definitively. Recycle symbol: Indicates the item can be recycled where correct facilities exist. HistoCore LIGHTNING S...
Page 10: Instrument Type
The scanner is a plug-in accessory that connects to the HistoCore LIGHTNING S via a USB interface. It reads 2D codes or barcodes embedded in tissue cassettes or slides, providing print data that initiates a print job on the HistoCore LIGHTNING S.
Page 11 • Use of usernames and user IDs: User account information including username and password for authentication and authorization will be collected, retained till removal by the Administrator. And the database used to store account information will be encrypted. HistoCore LIGHTNING S...
Page 12: Safety
Only qualified service personnel authorized by Leica Biosystems may repair the instrument and access its internal components. • If the instrument is to be returned to Leica Biosystems for repair, it must be cleaned and decontaminated in the appropriate manner (→ p. 62 – A1. Decontamination Confirmation). • Before connecting the instrument to the line voltage, ensure that the electrical power requirements of your laboratory match the values on the nameplate of the instrument.
Page 13: Markings On The Instrument Itself
A wide range of factors beyond Leica's control can have negative effects on the results. The test conditions stated below can therefore only serve as an outline for individual laboratory test specifications. The laboratory shall bear full responsibility for the legibility of the imprint after processing with reagents. HistoCore LIGHTNING S...
Page 14: Operating The Instrument
Safety 2.2.3 Operating the instrument Warning • Use only the provided power cord. It must not be replaced with a different power cord. If the power plug does not fit in your socket, contact our service. • The instrument is de-energized after disconnection of the power supply through the power cord. In emergencies, disconnect the power plug.
Page 15: Instrument Components And Specifications
Instrument components and specifications Instrument components and specifications Overview 3.1.1 Instrument components Fig. 1 Fig. 2 Fig. 3 Fig. 5 Fig. 4 HistoCore LIGHTNING S...
Page 16: Optional Accessories
Instrument components and specifications Touch screen 11 Connection port to the Slide stacker, type db-9 Channel A & B 12 Heat sink Magazine A & B 13 Side maintenance window Slide chute 14 Front maintenance window USB port for Scanner 15 Scanner Ethernet port 16 Batch filter (Optional) Slide stacker (Optional) 17 Exhaust fan (Batch)
Page 17: Side View
Instrument components and specifications Scanner Fig. 10 Fig. 11 3.1.3 Side view Fig. 12 Fig. 13 Dust bag Laser cover HEPA filter Side maintenance window Carbon filter HistoCore LIGHTNING S...
Page 18: Rear View
Instrument components and specifications 3.1.4 Rear view Fig. 15 Fig. 14 Power inlet socket Power supply of batch filter Main switch Extraction pipe Version 2.0, Revision K...
Page 19: Main Features Of The Instrument
Instrument components and specifications Main features of the instrument The HistoCore LIGHTNING S is a UV laser technology-based microscope slide printer delivering fast and efficient printing. The HistoCore LIGHTNING S promotes switching between batch slides printing and on- demand slide printing to fulfill different needs from laboratory workflow through the features designed as following: • UV laser module consistently provides stable printing life expectancy for 7 years or 1 million printing times based on the printing contents and time.
Page 20 Instrument components and specifications Dimensions and weight specification - Laser Slide Printer Overall height of the device after installing the 515 mm batch filter Overall depth of the device after installing the pipe 305 mm assembling of batch filter Overall footprint of the device after installing the 380 mm (W) x 367 mm (D) slide stacker Overall size serial packaging 565 x 420 x 800 (Width x Depth x Height, mm) Empty weight (without accessories, kg)
Page 21 Printing speed • Up to 4s/pcs. (15 pcs./min) Print resolution (theoretical) 2500 DPI Printing quality (2D code) Above or equal to Grade B (ISO 29158) Chemical resistance Resistant to HE & IHC staining reagents Printing medium UV laser HistoCore LIGHTNING S...
Page 22: Print Specifications
• Slides to be used in the printer must be stored appropriately in closed containers and protected from dust and moisture. Only standard specimen slides with imprintable edges can be imprinted in the HistoCore LIGHTNING S. Printing directly onto the glass is not possible.
Page 23: Printing Barcode/2D Code
3.4.1 Printing barcode/2D code Barcode/2D code type • QR code • EAN 8 • Code 128A • Data Matrix • EAN 13 • Code 128B • Code 39 • UPC-A • Code 128C • Code 93 • UPC-E HistoCore LIGHTNING S...
Page 24: Setting Up The Instrument
*Local power cord needs to be ordered separately. **Note for Japan only: Instead of the international bundle, a printout in Japanese is available. See cover page for order number. If the supplied local power cord is defective or lost, please contact your local Leica Biosystems representative. Note In the scenario of on-demand printing, except the standard delivery, it is recommended to order the validated scanner;...
Page 25: Unpacking The Instrument
For setting up the instrument, refer to the Instructions for Use supplied with the instrument. 1. Remove the packing strips (→ Fig. 16-1), corner protectors (→ Fig. 16-2), and wrapping film (→ Fig. 16-3). Fig. 16 2. Remove the tape (→ Fig. 16-4). 3. Remove the flat foam padding (→ Fig. 17-1). 4. Remove the foam (→ Fig. 17-2) to retrieve the accessory box (→ Fig. 17-3). HistoCore LIGHTNING S...
Page 26 Setting up the instrument Fig. 17 5. Open the accessory box and take out the HEPA filter (→ Fig. 18-1), carbon filter (→ Fig. 18-2), laser cover (→ Fig. 18-3), slide chute (→ Fig. 18-4), magazine A (→ Fig. 18-5), anti-collision feet, dust bag and time-lag fuse (→ Fig. 18-6). 6. Remove foam (→ Fig. 18-7) and take out magazine B (→ Fig. 18-8). Fig. 18 7. Remove the upper foam padding (→ Fig. 19-1) and take out the packing list, power cord and Instructions for Use (→ Fig. 19-2).
Page 27 10. Remove the blue tape (→ Fig. 20-1) and protective foam (→ Fig. 20-2). Fig. 20 11. Remove the foam pads (→ Fig. 21-1) from the slots of magazine A and magazine B. 12. Open the maintenance access panel and remove the foam pads (→ Fig. 21-2). HistoCore LIGHTNING S...
Page 28: Setting Up The Instrument
Setting up the instrument Fig. 21 Setting up the instrument Install the following components and make the appropriate adjustments to make the instrument ready for use: • Remove anchor foam from the instrument. • Install the dust bag (→ Fig. 13-1). Slide the hardboard side into the slot. •...
Page 29 Make sure that the instrument is switched off using the main switch (→ Fig. 14-2) located on the back of the instrument before installing the stacker. Then insert the stacker into the instrument and ensure that it is firmly attached. The slide stacker has a minimum capacity of 200 slides. HistoCore LIGHTNING S...
Page 30 Setting up the instrument Connection of barcode scanner (Optional) Connect the barcode scanner by inserting one end of the USB cable into the scanner and the other end into the designated USB port on the instrument. Ensure that the USB port on the instrument is designated for scanner use.
Page 31: Switching On/Off The Instrument
(→ Fig. 15-4) connected to the printer. Alarm messages In HistoCore LIGHTNING S, states can occur that require the attention of, or a decision on the part of, the user. In the simplest case, these are confirmations for continuing the printing job. In addition, however, during continuous monitoring of the hardware, errors can be identified that must be eliminated as soon as possible for a printing job to be finished successfully. Correspondingly, all messages are classified into three levels according to their severity.
Page 32: Installing Printer Driver
Setting up the instrument • Error messages (→ p. 58 – 7. Troubleshooting) The system provides audible notifications for warnings and errors. The sound volume levels for buzzer can be set (→ p. 53 – 5.6 Instrument settings). Installing printer driver If you need to install the printer driver, please download the software installation instructions from our website.
Page 33: Operation
5.1.3 Main Menu After system start-up, the homepage and navigation bar will be displayed. You can start printing after system warmup (→ Fig. 24-1). The software features a function bar at the top of the screen. Tap a button on the function bar to access specific screens or menus offering options for related functionalities. Fig. 24 HistoCore LIGHTNING S...
Page 34: Access Level
Print options Channels and channel locks Daily statistic Active user 5.1.4 Access level The HistoCore LIGHTNING S has two access tiers: Operator and Administrator. Select Admin > Users view all the users. Fig. 26 • Operators are allowed to perform all routine tasks, such as printing slides, setting templates and adjusting the instrument settings.
Page 35: Using The Software
The instrument accommodates the connection of 2.4G wireless keyboard and mouse for on-screen inputs. Use any of the USB ports (→ Fig. 1-9) located on the right side of the instrument to connect to a computer keyboard. The system is designed to support input in different languages. HistoCore LIGHTNING S...
Page 36: Adding/Editing/Deleting A User Account
Operation 5.1.6 Adding/Editing/Deleting a user account Note • The password shall have 6-20 characters mixed with numbers and English letters. Adding a user account 1. Tap Admin > Users. 2. Tap (→ Fig. 29-1). 3. Enter the user name once and the password twice. 4. Tap OK. Fig. 29 Editing a user account 1.
Page 37: Log-Out
Users can adjust the automatic log-out interval to any duration ranging from 5 to 480 minutes (→ p. 53 – 5.6 Instrument settings). To log out manually, follow below steps. 1. Tap the username icon (→ Fig. 26-1). 2. Select Log out and decide on the subsequent action to take. HistoCore LIGHTNING S...
Page 38: Loading Slides
Operation Loading slides The system features two slots for slide insertion. Before operation, ensure that both slide magazines are filled with slides. Load slides in accordance with the directional indicator present on the magazine. Each magazine can hold up to 75 slides. Pay attention to the maximum volume indicator on the magazine. Slides must not be loaded beyond this mark to prevent them from toppling over. The magazines will be inserted to their corresponding channels.
Page 39: Printing Slides
9. Tap Continue (→ Fig. 25-14) to continue printing. 10. Unload the printed slides after printing is completed or unload the print slides at a timely manner when the slide chute reaches to the maximum volume of 20 slides. The first slide printed will be positioned at the top of the stack in the slide collection area. HistoCore LIGHTNING S...
Page 40: Batch Printing
Operation 5.3.2 Batch printing Note • The slide stacker and the enhanced hazardous fume/particle filtration system for batch printing shall be ordered. • Before installing the stacker, make sure the instrument is turned off through the power switch located at the rear side. Insert the stacker securely into the instrument. To print batches of slides, follow the steps below. 1.
Page 41: Editing Print Jobs
Delete to cancel a print job; use to prioritize a print job; use Resume to continue a print job (→ Fig. 37-1). Tap the More (→ Fig. 37-2) to view the details of the selected job. HistoCore LIGHTNING S...
Page 42: Printing Slides Via Lis
Operation Fig. 38 The green icon (→ Fig. 38-1) indicates that the priting job is completed. Fig. 39 Tap the Print History button, then the print history is displayed (→ Fig. 39). Tap the More button (→ Fig. 39-1) to view the details of the selected job. 5.3.4 Printing slides via LIS The system supports remote slide printing via LIS control.
Page 43: Merge Printing
Merge. You can also tap and hold Print options for three seconds, until a window pops up, select Merge and press OK. 7. Scan the two blocks of one patient and press Print. 8. Remove the printed slides after the print job is done. HistoCore LIGHTNING S...
Page 44: Templates Administration
Operation Templates administration Template administration allows for the customization of how data fields and barcodes appear on the printed material. To tailor the template layout to your specific needs, you can adjust various elements, such as the length of printing area, printing direction, item positions, fonts, font sizes and barcodes. It is important to leave a sufficient margin around the edges of the template and around barcodes. The system has 4 pre-configured printing templates for laboratory use, including 1 horizontal template (1 HE with 2D code) (→ Fig. 41-2) and 3 vertical templates (1 HE with 2D code (→ Fig. 41-1), 1 IHC with 2D code (→ Fig. 41-4)), and 1 IHC with barcode (→ Fig. 41-3)). The pre-configured templates are identified by the Leica icon (→ Fig. 41-5).
Page 45 B. Set the length of print range. Make sure that the settings matches the actual painting size of the slides. The default length of painting is 20 mm. You may set the length between 16 mm to 25 mm with an increment of 1 mm. C. Set the text orientation. 5. Tap OK. The keyboard for entering the template name is displayed. 6. Enter the template name, and tap OK. The Edit Template screen is displayed (→ Fig. 44). HistoCore LIGHTNING S...
Page 46 Operation Fig. 44 7. Define the items on the template. In addition to Timestamp, QR code and barcode, the system allows up to 6 editable entries or a total of 10 entries on a template. You may create new items by selecting customized item. Take setting the Pathology number for example. A. Tap the plus symbol (→ Fig. 44-1) at the beginning of the line.
Page 47 Home page or tap Admin > Template. 2. Tap one of the three tabs (→ Fig. 47-1): H&E templates, IHC templates or Others. 3. Select the template to be edited, and tap Edit (→ Fig. 47-2). The Edit Template screen (→ Fig. 48) is displayed. HistoCore LIGHTNING S...
Page 48 Operation Fig. 48 4. Tap the up and down buttons (→ Fig. 48-1) to view all items on the template. 5. To edit an item, tap the edit button (→ Fig. 48-2) at the end of the line, and the setting screen is displayed. Make changes as required and tap OK. 6.
Page 49: Print Settings
The slide type is available in H&E, IHC, or Customized. Tap the button of A (H&E) or B (IHC) (→ Fig. 49-1) to select the type. The confirmed selection will be shown on the channel buttons (→ Fig. 25-15) on the Home page. Admin can assign templates to Channel A and Channel B by clicking Assign Templates (→ Fig. 49-7) choose the templates you want to use (→ Fig. 50). Fig. 50 HistoCore LIGHTNING S...
Page 50: Print Settings
Operation 5.5.2 Print settings On-demand printing Tap On-demand Printing (→ Fig. 49-2), and the On-Demand Printing Settings interface (→ Fig. 51) displayed. Fig. 51 You can set the items as follows. • Set On/Off automatic printing after scanning the barcode or 2D code (→ Fig. 51-1). If it is On, printing will automatically start after successful scanning.
Page 51: Lis Configuration
Set enable/disable to clear entry automatically after the printing process starts (→ Fig. 49-4). 5.5.3 LIS configuration The system supports remote slide printing via LIS. Settings > Print > Connection (→ Fig. 49-5) to configure the connection to LIS. Fig. 53 • Activate the connection to LIS (→ Fig. 53-1). HistoCore LIGHTNING S...
Page 52 Operation • Set LIS shared folder path (→ Fig. 53-2). It is recommended to create a shared folder as a root folder, for example, //192.168.0.xx/LIS_Shared_Folder, then set the folder of "//192.168.0.xx/LIS_Shared_ Folder" as the shared folder. Setting any subfolders under the root folder as the shared folder may result in failure to access.
Page 53: Printing Request From Another Devices
Operation 5.5.4 Printing request from another devices The system supports printing request from other devices. Contact Leica Biosystems service for more information. Instrument settings Settings > Device, the device settings interface is displayed. Fig. 55 Sound volume for buzzer System time Network for the printer...
Page 54: Cleaning And Maintenance
Cleaning and maintenance Cleaning and maintenance Cleaning the instrument • Prior to cleaning the instrument, always switch off the power supply and unplug the power cord. • When handling cleaning detergents, follow the instructions of the manufacturer and make sure all laboratory regulations in force in your country are complied with.
Page 55 1. Open the lid of side maintenance window (→ Fig. 4-13). 2. Remove the laser cover (→ Fig. 13-4) of the laser module. 3. Use the lint-free cloth or lens wipes to clean the F-theta lens. Make sure to remove any dust from the lens. HistoCore LIGHTNING S...
Page 56: Changing The Dust Bag/Carbon Filter/Hepa Filter (Standard Filter)
Cleaning and maintenance 4. Re-install the laser cover (→ Fig. 13-4) of the laser module. 5. Close the lid of side maintenance window (→ Fig. 4-13). Outer surfaces • Clean the outer surfaces (including those of the automated slide unload station) with a mild detergent and subsequently dry the surface with a slightly moistened cloth.
Page 57: General Maintenance
• At the end of the warranty period, enter a service contract. For more information, please contact your local Leica technical service center. Replacing fuses Use only the supplied replacement fuses. Both fuses must have the same rating (check the imprint). Replace the fuses in pairs. HistoCore LIGHTNING S...
Page 58: Troubleshooting
Troubleshooting Troubleshooting Error codes When an instrument error occurs, an error code will appear on the screen. The table below lists the error codes that may be displayed. Follow the instructions in the column of User action. For further instructions, please refer to (→...
Page 59 Batch unloading error Stop printing and slides 1. Shut down the instrument. transportation. 2. Dis-assemble batch station to remove stuck slides. 3. Assemble batch station. 4. Power on. 5. If the error code still exists, call service. HistoCore LIGHTNING S...
Page 60: Power Failure
Troubleshooting Error code Description Instrument behavior User action 7.6.11 Batch collecting error Stop printing and slides 1. Shut down the instrument. transportation. 2. Remove stuck slides on batch collecting channel. 3. Power on. 4. If the error code still exists, call service.
Page 61: Ordering Information
14 0610 61745 Magazine B 14 0610 61746 Dust bag 14 0610 61918 Carbon filter 14 0610 61517 HEPA filter 14 0610 61518 Dust bag - Batch 14 0610 62288 Batch filter-HEPA Carbon 14 0610 62291 Slide chute 14 0610 61758 HistoCore LIGHTNING S...
Page 62: A1 Decontamination Confirmation
Decontamination Confirmation A1. Decontamination Confirmation Any product that is to be returned to Leica Biosystems or serviced on site must be properly cleaned and decontaminated. Please find the dedicated template for confirming decontamination by using the search function on our website at www.LeicaBiosystems.com. This template must be used to enter all required data. If a product is returned, a copy of the completed and signed decontamination certificate must either be enclosed or handed over to a service technician.
Page 63: A2. Warranty And Service
Warranty and Service A2. Warranty and Service Warranty Leica Biosystems Nussloch GmBH guarantees that the contractual product delivered has been subjected to a comprehensive quality control procedure based on the Leica in-house testing standards, and that the product is faultless and complies with all warranted technical specifications and/or agreed-upon characteristics. The scope of the warranty is based on the contents of the contract concluded. The warranty terms of your Leica sales organization or the organization from which you have purchased the contractual product shall apply exclusively.
Page 64 Notes Version 2.0, Revision K...
Page 66 Leica Biosystems Nussloch GmbH Heidelberger Strasse 17 - 19 69226 Nussloch Germany Tel.: +49 - (0) 6224 - 143 0 Fax: +49 - (0) 6224 - 143 268 Web: www.LeicaBiosystems.com...