Page 1 ThinPrep 5000 Processor with AutoLoader ® Operator’s Manual...
Page 2 ™ with AutoLoader Operator’s Manual Hologic, Inc. Hologic BV Australian Sponsor: UK Responsible 250 Campus Drive Da Vincilaan 5 Hologic (Australia and Person: Marlborough, MA 1930 Zaventem New Zealand) Pty Ltd Hologic, Ltd. 01752 USA Belgium Suite 302, Level 3...
Page 3 Hologic or by organizations or individuals designated by Hologic. © Hologic, Inc., 2022. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any...
Page 4 Date Description AW-22290-002 Rev. 001 Clarify instructions. Add instructions regarding reporting serious 11-2020 incidents. Remove urine collection kit information. AW-22290-002 Rev. 002 Replace CE mark. Remove reference to hologic.com/package- 4-2021 inserts. Add UKCA mark. AW-22290-002 Rev. 003 1-2022 Administrative change...
Page 5 This page intentionally left blank.
Page 7 ThinPrep™ 5000 System Instructions for Use ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 1/36...
Page 8 At the laboratory, the PreservCyt sample vial is bar-coded along with the test request form to establish a sample chain of custody and is placed into a ThinPrep 5000 Processor. A glass slide bearing the same sample identification number as on the sample vial is loaded into the Processor.
Page 9 (HPV) testing, to determine patient management. The PreservCyt™ Solution component of the ThinPrep 5000 System is an alternative collection and transport medium for gynecologic specimens tested with the Digene Hybrid Capture System HPV DNA and Hologic APTIMA COMBO 2™ CT/NG Assays. Refer to the respective manufacturer’s package inserts for instructions for using PreservCyt Solution for collection,...
Page 10 Roche Diagnostics COBAS AMPLICOR CT/NG package insert for instructions for use of that system. If any serious incident occurs related to this device, or any components used with this device, report it to Hologic Technical Support and the competent authority local to the user and/or patient. LIMITATIONS •...
Page 11 Other solutions cannot be substituted for PreservCyt Solution. PreservCyt Solution should be stored and disposed of in accordance with all applicable regulations. • Alternative collection media, filters and slides have not been validated by Hologic and may lead to erroneous results. PRECAUTIONS •...
Page 12 Log Reduction After Organism Initial Concentration 15 Minutes HIV-1 3.2 x 10 TCID ≥7.0*** † Hepatitis B virus 2.2 x 10 TCID ≥4.25 SARS-CoV-2 virus 1.8 x 10 TCID ≥3.75 After 1 hour 4.7 log reduction After 1 hour 5.7 log reduction Data is for 5 minutes †...
Page 13 PERFORMANCE CHARACTERISTICS: REPORT OF CLINICAL STUDIES The ThinPrep 5000 System is technologically similar to the ThinPrep 2000 System. A critical review of the ThinPrep 5000 System demonstrated that the clinical evaluation of the ThinPrep 2000 System applies to the ThinPrep 5000 System and is described below.
Page 14 Table 1 describes the laboratories and the patient populations. Table 1: Site Characteristics Laboratory Characteristics Clinical Study Demographics Site Type of Laboratory Cases Patient Post- Previous Convent. Patient Volume - Age Range Meno-pausal Abnormal Pap Prevalence Population Smears per Smear LSIL+ Year Screening...
Page 15 Table 2: Diagnostic Classification Table, All Categories Conventional ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL ThinPrep 5224 5593 ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL 5680 6747 Abbreviations for Diagnoses: NEG = Normal or negative, ASCUS = Atypical Squamous Cells of Undetermined Significance, AGUS = Atypical Glandular Cells of Undetermined Significance, LSIL = Low- grade Squamous Intraepithelial Lesion, HSIL = High-grade Squamous Intraepithelial Lesion, SQ CA = Squamous Cell Carcinoma, GL CA = Glandular Cell Adenocarcinoma...
Page 16 Table 4: Two Category Diagnostic Classification Table, LSIL and More Severe Diagnoses Conventional NEG/ASCUS/ LSIL+ TOTAL AGUS+ NEG/ASCUS/ 5985 6110 ThinPrep AGUS+ LSIL+ TOTAL 6209 6747 Table 5: Two Category Diagnostic Classification Table, ASCUS/AGUS and More Severe Diagnoses ASCUS/AGUS+ TOTAL 5224 5593 ThinPrep...
Page 17 The diagnostic data analysis from the sites is summarized in Table 6 and 7. When the p-value is significant (p < 0.05), the method favored is indicated in the tables. Table 6: Results by Site, LSIL and More Severe Lesions Site Cases ThinPrep...
Page 18 One pathologist served as an independent reviewer for the six clinical sites, receiving both slides from cases where the two methods were either abnormal or discrepant. Since a true reference cannot be determined in such studies and therefore true sensitivity cannot be calculated, the use of an expert cytologic review provides an alternative to histologic confirmation by biopsy or human papillomavirus (HPV) testing as a means for determining the reference diagnosis.
Page 19 Table 9: Independent Pathologist Results by Site, ASCUS/AGUS and More Severe Lesions Site Cases Positive ThinPrep™ Conventional p-Value Method Favored Positive Positive Independent Pathologist 0.900 Neither 0.005 ThinPrep <0.001 ThinPrep 0.237 Neither 0.330 Neither 1.000 Neither For ASCUS/AGUS and more severe lesions, the diagnostic comparison statistically favored the ThinPrep method at two sites and was statistically equivalent at four sites.
Page 20 Table 10 below shows the summary for all sites of the descriptive diagnosis for all Bethesda System categories. Table 10: Summary of Descriptive Diagnosis ThinPrep Conventional Descriptive Diagnosis Number of Patients: 6747 Benign Cellular Changes: 1592 23.6 1591 23.6 Infection: Trichomonas Vaginalis Candida spp.
Page 21 Table 11 shows the rates of detection for infection, reactive changes, and the total benign cellular changes for both the ThinPrep™ and conventional methods at all sites. Table 11: Benign Cellular Changes Results ThinPrep Conventional Infection 1392 20.6 1348 20.0 Benign Cellular Reactive...
Page 22 Table 12: Summary of Specimen Adequacy Results Specimen Adequacy ThinPrep Conventional Number of Patients: 7223 Satisfactory 5656 78.3 5101 70.6 Satisfactory for Evaluation 1431 19.8 2008 27.8 but Limited by: Air-Drying Artifact Thick Smear Endocervical Component 1140 15.8 Absent Scant Squamous Epithelial Component Obscuring Blood Obscuring Inflammation...
Page 23 Table 14: Specimen Adequacy Results by Site Site Cases ThinPrep Convent. ThinPrep Convent. ThinPrep Convent. SAT Cases SBLB SBLB UNSAT UNSAT Cases Cases Cases Cases Cases 1,386 1092 1178 1,668 1530 1477 1,093 1,046 1,049 All Sites 7,223 5656 5101 1431 2008 The Satisfactory But Limited By (SBLB) category can be broken down into many subcategories,...
Page 24 SBLB-No Endocervical Component rate. Direct-to-Vial HSIL+ Study Following initial FDA approval of the ThinPrep System, Hologic conducted a multi-site direct-to- vial clinical study to evaluate the ThinPrep 2000 System versus conventional Pap smear for the detection of High Grade Squamous Intraepithelial and more severe lesions (HSIL+). Two types of patient groups were enrolled in the trial from ten (10) leading academic hospitals in major metropolitan areas throughout the United States.
Page 25 ThinPrep 5000 Processor Compared to ThinPrep 2000 System A study was conducted to estimate the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for specimens processed on the ThinPrep 5000 processor as compared with processing using the ThinPrep 2000 System.
Page 26 6 weeks of specimen collection. All study specimens were processed both on a ThinPrep 5000 processor and a ThinPrep 2000 system. The order in which the slides were processed was alternated in blocks of 20. All slides were stained, coverslipped, and read manually following standard laboratory procedures;...
Page 27 Reference Diagnosis by Adjudication Review After all slides in the study were reviewed, all ThinPrep 2000 and ThinPrep 5000 slides were subject to an adjudication review. Adjudication was done at a facility that was not one of the study sites conducting the study. Slides for adjudication were evenly divided between three (3) adjudication panels each consisting of one (1) cytotechnologist and three (3) independent pathologists.
Page 28 NILM specimens. Thirty-four (34) specimens had UNSAT either with ThinPrep 2000 or with ThinPrep 5000 or with both. Clinical sensitivity and specificity (e.g., with reference to a histological diagnosis) cannot be measured in this study which relied on cytological examination alone.
Page 29 Table 21: Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results for the Specimens with Reference Diagnosis of LSIL+ In the study, there were 387 specimens with Reference Diagnosis of LSIL+ (combined LSIL, ASC-H, HSIL, and Cancer) and 839 specimens with Reference Diagnosis of (combined NILM, ASC-US, and AGUS).
Page 30 Table 22: Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results for the Specimens with Reference Diagnosis of ASC-H+ In the study, there were 185 specimens with Reference Diagnosis of ASC-H+ (combined ASC-H, HSIL, and Cancer) and 1,041 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, and LSIL).
Page 31 (90.1% to 93.3%) (90.6% to 93.8%) (-2.1% to 1.2%) In the study, there were 2.06% (26/1260) ThinPrep 2000 slides with UNSAT results by Adjudication and 1.83% (23/1260) ThinPrep 5000 slides with UNSAT results by Adjudication. ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev.
Page 32 The following tables indicate the extent to which the laboratory cytotechnologists / pathologists at a given site agreed amongst themselves on the diagnosis, comparing the ThinPrep 5000 processor to the ThinPrep 2000 system. Tables are provided for ASC-US+ and ASC-H+.
Page 33 The rate of agreement between the ThinPrep 5000 result and the ThinPrep 2000 result from the previous table is presented below. PPA is the positive percent agreement, percent of specimens of ASC-H+ diagnosis with ThinPrep 5000 slides by a majority of laboratory CT/Pathologists among all specimens of ASC-H+ diagnosis with ThinPrep 2000 slides by a majority of laboratory CT/Pathologists.
Page 34 (706/741) (93.5% to 96.6%) The rate of agreement between the ThinPrep 5000 result and the ThinPrep 2000 result from the previous table is presented below. PPA is the positive percent agreement, percent of specimens of ASC-US+ diagnosis with ThinPrep 5000 slides by a majority of laboratory CT/Pathologists ThinPrep™...
Page 35 Within-Instrument Precision The study was designed to examine the ability of the ThinPrep 5000 system to prepare reproducible slides from the same patient specimen using the same instrument. A total of 80 specimens were enrolled in the study. Each specimen was split into three portions and processed on three separate runs of one instrument.
Page 36 Between-Instrument Precision The study was designed to examine the ability of the ThinPrep 5000 system to prepare reproducible slides from the same patient specimen using multiple instruments. A total of 120 specimens were enrolled in the study. Each specimen was split into three portions and processed on three instruments.
Page 37 Deming regression analysis was performed and the slope was 0.98 with 95% CI: 0.94 to 1.01 and the intercept was 300 with 95% CI: -300 to 897. The data demonstrate similar cell count values on the ThinPrep 2000 and ThinPrep 5000 slides. Cellular Carry-Over Study Cellular carry-over between slides was evaluated in a laboratory study, with comparison of the ThinPrep 5000 and ThinPrep 2000.
Page 38 Since the ThinPrep 5000 System is technologically similar to the ThinPrep 2000 System, we conclude that the ThinPrep 5000 is also significantly more effective than the conventional Pap smear for the detection of Low-grade Squamous Intraepithelial (LSIL) and more severe lesions in a variety of patient populations.
Page 39 Absorbent pad for filter plug • Absorbent pad for evaporative cover ThinPrep 5000 Processor with AutoLoader • ThinPrep 5000 Processor with AutoLoader • ThinPrep 5000 Processor with AutoLoader Operator’s Manual • Power cord • System Accessory Kit • Optional items (printer, LIS networking) MATERIALS REQUIRED BUT NOT PROVIDED •...
Page 40 STORAGE • Store PreservCyt Solution between 15°C (59°F) and 30°C (86°F). Do not use beyond the expiration date printed on the container. • Store PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing between 15°C (59°F) and 30°C (86°F) for up to 6 weeks. •...
Page 41 TECHNICAL SERVICE AND PRODUCT INFORMATION For technical service and assistance related to use of the ThinPrep 5000 System, contact Hologic: Telephone: 1-800-442-9892 Fax: 1-508-229-2795 For international or toll-free blocked calls, please contact 1-508-263-2900. Email: info@hologic.com Hologic, Inc., 250 Campus Drive, Marlborough, MA 01752 1-800-442-9892, www.hologic.com...
Page 42 Revision History Revision Date Description AW-22289-001 Rev. 001 11-2020 Add Precision Study and Cell Count Study Information. Add data in microbial/viral organism table. AW-22289-001 Rev. 002 4-2021 Replace the CE mark. Correct Figure 1-2. Add UKCA mark. AW-22289-001 Rev. 003 11-2021 Administrative change.
Page 44: Table Of Contents
SECTION B: Action Upon Delivery ..........2.1 SECTION C: Preparation Prior to Installation ......2.1 SECTION D: Storage and Handling Post Installation ....2.4 SECTION E: Turn on the ThinPrep 5000 Processor with AutoLoader ............2.5 SECTION F: Set User Preferences..........2.6 SECTION G: Turn Off the ThinPrep 5000 Processor with AutoLoader ............2.7...
Page 45 ONTENTS Chapter Four GYNECOLOGIC SAMPLE PREPARATION SECTION A: Gynecologic Specimen Preparation.......4.1 SECTION B: Collection Preparation..........4.2 SECTION C: Specimen Collection ..........4.3 SECTION D: Special Precautions ..........4.5 SECTION E: Sample Processing Troubleshooting......4.6 Chapter Five NON-GYNECOLOGIC SAMPLE PREPARATION SECTION A: Introduction ..............5.1 SECTION B: Required Materials...........5.2 SECTION C: Specimen Collection ..........5.3 SECTION D: General Steps for Sample Preparation ....5.5 SECTION E: Specimen Preparation Guidelines .......5.13...
Page 46 SECTION A: Introduction ..............7.1 SECTION B: Material Requirements ..........7.1 SECTION C: Labeling the Sample Vials........7.3 SECTION D: Load the ThinPrep 5000 AutoLoader ....7.5 SECTION E: Initiate a Batch ............7.15 SECTION F: Processing Slides ............7.17 SECTION G: Pause a Batch in Process........7.18 SECTION H: Batch Complete ............7.18...
Page 47 ONTENTS Chapter Nine TROUBLESHOOTING SECTION A: General...............9.1 SECTION B: Sample Processing Errors........9.1 SECTION C: Batch Processing Errors.........9.13 SECTION D: System Errors............9.18 Chapter Ten STAINING AND COVERSLIPPING SECTION A: General..............10.1 SECTION B: Fixation ..............10.1 SECTION C: Recommended Staining Guidelines ....10.2 SECTION D: Coverslipping ............10.4 Chapter Eleven ™...
Page 49 AutoLoader Mode The ThinPrep 5000 processor with AutoLoader can process a batch of up to 160 specimens. Four trays of sample vials are loaded into the AutoLoader portion of the instrument. Each tray holds up to 40 vials.
Page 50 (all gynecologic or all non-gynecologic or all UroCyte). Figure 1-1 A ThinPrep 5000 Processor with AutoLoader Note: The instructions for using the ThinPrep 5000 processor with AutoLoader are the same regard- less of the instrument color. Intended Use ThinPrep 5000 processor The ThinPrep™...
Page 51 At the laboratory, matching barcoded labels are applied to the sample vial, and accompanying test request form. The sample vial is then placed in a sample vial tray and loaded into the ThinPrep 5000 processor with AutoLoader. (Refer to Figure 1-2.) During the slide preparation process, a gentle dispersion step breaks up blood, mucus and non-diagnostic debris and thoroughly mixes the cell sample.
Page 52 Refer to the instructions provided with the collection device for warnings, contraindications, and limitations associated with specimen collection. • Preparation of microscope slides using the ThinPrep 5000 system should be performed only by personnel who have been trained by Hologic or by organizations or individuals designated by Hologic.
Page 53 • Alternative collection media, filters, and slides have not been validated by Hologic and may lead to erroneous results. Hologic does not provide a warranty for results using any of these alternatives. • Strong oxidizers, such as bleach, are incompatible with PreservCyt Solution and therefore should not be used to clean the waste bottle.
Page 54 NTRODUCTION interference, in which case the user will be required to correct the interference at his/her own expense. • PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing must be stored between 15°C (59°F) and 30°C (86°F) and tested within 6 weeks of collection. PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche •...
Page 55 Vial trays, slide cassettes and filter trays are loaded into the instrument. The carousel is placed into the ThinPrep 5000 processor compartment. Fixative baths containing a staining rack and fixative alcohol are placed into the output compartment.
Page 56: Thinprep ™ 5000 Processor With Autoloader
ThinPrep filters Fixative baths with Input carousel staining racks Figure 1-3 ThinPrep 5000 Processor with AutoLoader Components Overview of Processing For routine batch processing, the system proceeds in this fashion once the batch is started: AutoLoader Mode Small Batch Mode...
Page 57 (These items may vary according to your order.) • ThinPrep 5000 processor with AutoLoader • ThinPrep 5000 Processor with AutoLoader Operator’s Manual • Power cord • System accessory kit, including: Waste bottle with tubing harness and transport cover...
Page 58 NTRODUCTION Absorbent pads for the evaporation cover (4) Staining racks (package of 10) USB flash drive UPS (uninterruptible power supply) Sample vial trays (8) Filter waste box and liner bag Robotic arm area waste bin and liner Slide waste box Slide cassettes (6) HEPA filters (5) Carbon filter...
Page 59 Laser fume extractor filters Main door (input door) Slide transport arm Touch screen Baths door Filter/vial transport arm Filter plug Vial gripper Fixative bath evaporative cover ThinPrep 5000 processor Figure 1-4 Overview of Components 1.11 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 60 145 cm 54 inches 28 inches 137 cm 71 cm Clearances 75 inches 190 cm 63 inches 48 inches 160 cm 122 cm Figure 1-5 ThinPrep 5000 Processor with AutoLoader Dimensions and Clearances 1.12 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 61 NTRODUCTION Environmental Operating temperature 16–32°C 60–90°F Operating humidity 20%–80% RH, non-condensing Non-operating temperature -28°C–50°C -20°F–122°F Non-operating humidity 15%–95% RH, non-condensing Sound levels Below 85 dBA maximum at normal operator’s position Heat load Maximum 529 watts = 1805 BTU/hr or 1904 Joule/hr Power Electrical Voltage &...
Page 62 NTRODUCTION approved for safety by an appropriate agency should be connected to the ThinPrep 5000 pro- cessor with AutoLoader. Safety, EMI and EMC Standards The ThinPrep 5000 processor with AutoLoader has been tested and certified by a U.S. nationally recognized testing Laboratory (NRTL) to comply with current Safety, Electro-Magnetic Interference (EMI) and Electro-Magnetic Compatibility (EMC) standards.
Page 63: Section C: Internal Quality Control
SECTION THINPREP 5000 HAZARDS The ThinPrep 5000 processor with AutoLoader is intended to be operated in the manner specified in this manual. Be sure to review and understand the information listed below in order to avoid harm to operators and/or damage to the instrument.
Page 64 Do not re-use Fuse Waste Electrical and Electronic Equipment. Do not dispose in municipal waste. Contact Hologic for disposal of the instrument. In Vitro diagnostic medical device Laser device (internal to the laser and not accessible to the operator)
Page 65 NTRODUCTION Date of manufacture Catalogue number Serial number Protective Conductor Terminal Power Switch On Power Switch Off Direction of flow Made in USA Information is applicable only in the USA and Canada Product meets the requirements for CE marking in accordance with EU-IVD Regulation 2017/ 1.17 ThinPrep™...
Page 66 NTRODUCTION Caution: Federal (USA) law restricts this device to sale by or on the order of a physician, or any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device and are trained and experienced in the use of the product.
Page 67 Figure 1-8 Right Side of Processor and Waste Bottle Warnings Used in this Manual: WARNING Service Installation Only This system is to be installed by trained Hologic personnel only. WARNING Moving Parts The processor contains moving parts. Keep hands, hair, loose clothing, jewelry, etc., clear. Do not operate with the doors open.
Page 68 NTRODUCTION ™ Danger. CytoLyt Solution contains methanol. Harmful if swallowed. Harmful if inhaled. Causes damage to organs. Cannot be made non-poisonous. Keep away from heat, sparks, open flames and hot surfaces. Follow the manufacturer’s recommendations for reagent handling and cleanup of spills. Refer to manufacturer’s SDS for more information.
Page 69 (PrPsc) derived from a person with a TSE, such as Creutzfeldt-Jakob disease, on the ThinPrep 5000 processor with AutoLoader. A TSE-contaminated processor cannot be effectively decontaminated and therefore must be properly disposed of in order to avoid potential harm to users of the processor or service personnel.
Page 70: Section Edisposal
Do not dispose in municipal waste. Please contact Hologic Technical Support. Hologic will provide for the collection and proper reclamation of electrical devices we provide to our customers. Hologic strives to reuse Hologic devices, subassemblies, and components whenever possible. When reuse is not appropriate, Hologic will ensure the waste material is properly disposed of.
Page 71 1-508-229-2795 Web: www.hologic.com Safety Data Sheet CytoLyt Solution; PreservCyt Solution: The Safety Data Sheet (SDS) for these solutions may be requested from Hologic Technical Support, or found online at www.hologicsds.com. For other reagents, refer to the manufacturer’s SDS. 1.23 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 72 NTRODUCTION This page intentionally left blank. 1.24 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 74: Chapter Two
Location Locate the ThinPrep 5000 processor with AutoLoader near (within 3 meters) a 3-wire grounded power outlet that is free of voltage fluctuations and power surges. The processor will be connected to a UPS (uninterruptible power supply), which will be plugged into the electrical outlet.
Page 75 5000 processor with AutoLoader should be close enough to comfortably make all connections. During operation the ThinPrep 5000 processor with AutoLoader is sensitive to vibrations. It should be located on a flat, sturdy surface that can support the 660 lbs/300 kg that it weighs. It should be placed away from any vibrating equipment.
Page 76 Figure 2-2 Local Network Interconnection Schematic (Example) The NAS device is provided by Hologic as a means to store files from the ThinPrep 5000 processor with AutoLoader. This NAS device will be added to the Hologic network side of the router.
Page 77: Section D: Storage And Handling Post Installation
Maintenance chapter of this manual. If the ThinPrep 5000 processor with AutoLoader is to be moved or shipped to a new location, please contact Hologic Technical Support. (Refer to Service Information, Chapter 12.)
Page 78: Section E: Turn On The Thinprep 5000 Processor
The doors will unlock. Note: The ThinPrep 5000 processor with AutoLoader is intended to be left on. For shutdown or extended shutdown, see page 2.7. ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 79: Section F: Set User Preferences
NSTALLATION Startup screen Main screen Figure 2-5 Startup Screens SECTION SET USER PREFERENCES The following preferences may be set via the touch screen interface. These settings may be reset at any time and any settings will persist even if the instrument is powered off and powered on again. •...
Page 80: With Autoloader
NSTALLATION SECTION TURN OFF THE THINPREP ™ 5000 PROCESSOR WITH AUTOLOADER Normal Shutdown CAUTION: Never turn off power to the instrument without first quitting the application via the user interface. If the instrument is to be turned off, it must be in an idle state. If a batch is in progress, either let it finish, or stop the batch.
Page 81 NSTALLATION Extended Shutdown If the instrument is to be shut down for an extended amount of time, or be taken out of service, empty the waste bottle (Maintenance chapter), remove any items that may be on board and close all doors.
Page 83: Chapter Three
Packaging Please refer to the Ordering Information in this manual for part numbers and detailed information regarding the ordering of solutions and supplies for the ThinPrep 5000 system. • Vials (20 mL) of PreservCyt Solution are contained in each ThinPrep Pap test.
Page 84 ™ & C ™ S RESERV OLUTIONS • Store PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche Diagnostics COBAS AMPLICOR CT/NG test between 4°C (39°F) and 25°C (77°F) for up to 6 weeks. Note: Refer to “OPTIONAL INSTRUCTIONS FOR ANCILLARY TESTING” on page 7.37 for instructions for aliquot removal for ancillary testing prior to running the ThinPrep Pap test.
Page 85 ™ & C ™ S RESERV OLUTIONS Handling/Disposal Handle all chemical-containing materials carefully in accordance with safe laboratory practices. When required by reagent composition, additional precautions are marked on the reagent containers or in the instructions for use. ™ Dispose of PreservCyt Solution according to the guidelines for disposing of hazardous waste.
Page 86 ™ & C ™ S RESERV OLUTIONS Log Reduction After Organism Initial Concentration 15 Minutes Note: All log reduction values with a ≥ designation yielded undetectable microbial presence after exposure to PreservCyt Solution. The listed values represent the minimum allowable claim given the initial concentration and the detection limit of the quantitative method.
Page 87 ™ & C ™ S RESERV OLUTIONS SECTION CYTOLYT ™ SOLUTION CytoLyt Solution is a methanol-based, buffered, preservative solution designed to lyse red blood cells, prevent protein precipitation, dissolve mucus, and preserve morphology of general cytology samples. It is intended as a transportation medium and is used in specimen preparation prior to processing.
Page 88 ™ & C ™ S RESERV OLUTIONS Handling/Disposal Handle all chemical-containing materials carefully in accordance with safe laboratory practices. Safety Data Sheet The SDS for CytoLyt Solution is included in the packaging of the product. It may also be accessed at www.hologicsds.com.
Page 89 Solution classifications: PreservCyt – Class IC; CytoLyt – Class II; CellFyx – Class IB This information is Hologic’s summary of the various regulations. To view the codes in their entirety, please refer to NFPA 30 and NFPA 45. A Liquid Warehouse shall have a sprinkler system that complies with the appropriate system indicated in NFPA 30.
Page 90 ThinPrep® Solutions Storage Guide Allowable quantities in a warehouse can be increased with a sprinkler system rated higher than standard systems. (10) A Liquid Warehouse is a separate, detached building or attached building used for warehousing-type operations for liquids. (11) Quantities are permitted to be increased 100% where stored in approved flammable liquids storage cabinets.
Page 91 Exempt specimens: Specimens that with the minimal likelihood that pathogens are present (fixed tissue, etc.) * These instructions are Hologic’s interpretation of the various regulations as of the effective date. However, Hologic will not be responsible for any non-conformance to the actual regulations.
Page 92 Shipping Requirements Category B or Exempt – Ambient Temperature: 1. Packaging must consist of three components a. a primary receptacle, leak proof b. secondary packaging, leak proof c. a rigid outer packaging NOTES: • FedEx will not accept clinical samples or diagnostic specimens packaged in FedEx envelopes, FedEx tubes, FedEx Paks, or FedEx Boxes, Styrofoam boxes, plastic bags, or paper envelopes.
Page 93 10. If using FedEx, the FedEx USA Airbill, Section 6, Special Handling must be completed with dangerous goods/dry ice information: Does this shipment contain dangerous goods?  YES- Shipper’s Declaration not required 11. The outer container of all diagnostic/clinical specimen packages must display the following: a.
Page 94 Notes: ThinPrep ® PreservCyt ™ Solution is classified as a Class 3 Flammable liquid, assigned to Packing Group III (PG III). 49 CFR 173.150 (Limited Quantities) allows ThinPrep ® PreservCyt ™ Solution in vials to be shipped in Limited Quantities when shipped via ground transportation in a sturdy box. The total volume in a package cannot exceed 5 liters or weigh more than 30 kg (66 lbs).
Page 95 4. Single packages containing more than sixty (60) liters (3000-vials) of total product must be clearly marked “FOR CARGO AIRCRAFT ONLY”. 5. The vials must be shipped in United Nations (UN) certified 4G packaging for any quantity in ® ™ an aircraft.
Page 96 1. Do not include “Ltd Qty” in the wording on the package or on the Shipping papers as indicated in c and d above. 2. Affix both a Class 3 “Flammable Liquid” label and a secondary Class 6.1 “Toxic” label to the package adjacent to the markings.
Page 97 ™ ThinPrep ® CytoLyt Solution has a flash point of 109° F. For domestic ground transportation only, a flammable liquid with a flashpoint at or above 100° F that does not meet the definition of any other ™ ® hazard class may be reclassed as a combustible liquid. As such, ThinPrep CytoLyt Solution, shipped via ground, is exempt from the requirements of the DOT Hazardous Materials Regulations.
Page 99 YNECOLOGIC AMPLE REPARATION C h a p t e r F o u r Gynecologic Sample Preparation SECTION GYNECOLOGIC SAMPLE PREPARATION Includes cell samples from the ectocervix and the endocervix. ™ 1. Collection: Deposit the specimen directly into a PreservCyt Solution vial.
Page 100 YNECOLOGIC AMPLE REPARATION SECTION COLLECTION PREPARATION ™ ThinPrep Collection Techniques The detection of cervical cancer and its precursors as well as other gynecologic abnormalities is the primary purpose of obtaining a cervical cell sample. The following guidelines are referenced from CLSI Document GP15-A3 and are recommended in the collection process for obtaining a ThinPrep Pap test (TPPT) specimen.
Page 101 YNECOLOGIC AMPLE REPARATION SECTION SPECIMEN COLLECTION Collect Gynecologic Sample Using the Broom-Like Device Physician/clinician instructions for collecting gynecologic samples. 1. Obtain an adequate sampling from the cervix using a broom- like device. Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix.
Page 102 YNECOLOGIC AMPLE REPARATION Collect Gynecologic Sample, Using the Endocervical Brush/Spatula Device Physician/clinician instructions for collecting gynecologic samples. 1. Obtain an adequate sampling from the ectocervix using a plastic spatula. ™ 2. Rinse the spatula as quickly as possible into the PreservCyt Solution vial by swirling the spatula vigorously in the vial 10 times.
Page 103: Section A: Preservcyt Solution
The Clinical and Laboratory Standard Institute Guidelines and ACOG recommend that you not take a Pap during menses. For samples to be processed on the ThinPrep 5000 processor, lubricants can adhere to the filter membrane and may cause poor cell transfer to the slide. If its use is unavoidable, the lubricant should be used in minimum amounts.
Page 104: Section Esample Processing Troubleshooting
YNECOLOGIC AMPLE REPARATION Dispose of PreservCyt Solution according to your guidelines for disposing of hazardous waste. PreservCyt Solution contains methanol. SECTION SAMPLE PROCESSING TROUBLESHOOTING ™ REPROCESSING A THINPREP PAP TEST SAMPLE VIAL FOLLOWING AN UNSATISFACTORY RESULT ™ Laboratory personnel may reprocess ThinPrep Pap test specimens where slides have been interpreted as inadequate (“Unsatisfactory for Evaluation”) for diagnosis following cytotechnologist screening.
Page 105 YNECOLOGIC AMPLE REPARATION 4 a. Carefully pour off the supernatant from the centrifuge tube to avoid loss of cells. Dispose of according to local regulations. b. Vortex the centrifuge tube briefly. ™ c. Pour 30 mL of the CytoLyt Solution and 10% glacial acetic acid mixture into the centrifuge tube and cap securely.
Page 106 YNECOLOGIC AMPLE REPARATION This page intentionally left blank. ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 108: Chapter Five
YNECOLOGIC AMPLE REPARATION C h a p t e r F i v e Non-Gynecologic Sample Preparation SECTION INTRODUCTION This chapter provides instructions for preparing non-gynecologic (non-gyn) samples and making ™ slides with the ThinPrep 5000 system. For the best results, carefully follow the instructions in this chapter. Because there is biological variability among samples and variability in collection methods, standard processing may not always yield a satisfactory and uniformly distributed preparation on the first slide.
Page 109 WARNING: Do not process a cerebrospinal fluid (CSF) specimen or other sample type that is suspected of possessing prion infectivity (PrPsc) derived from a person with a TSE, such as Creutzfeldt-Jakob disease, on the ThinPrep 5000 processor with AutoLoader. A TSE-contaminated processor cannot be effectively decontaminated and therefore must be properly disposed of in order to avoid potential harm to users of the processor or service personnel.
Page 110 CytoLyt Solution. There are preferred collection methods for different sample types. This section will describe the Hologic recommended procedure as well as alternate collection methods. WARNING: For washes and lavages, do not expose the patient to CytoLyt Solution.
Page 111 ThinPrep 5000 processor with AutoLoader. These solutions are primarily used as media for washings or lavages which contact the patient. Non-Recommended Collection Media Hologic does not recommend the use of the following collection solutions with the ThinPrep system. Use of these solutions will produce sub-optimal results: •...
Page 112: Section D: General Steps For Sample Preparation
YNECOLOGIC AMPLE REPARATION Refer to page 5.12 for CytoLyt Solution wash instructions. Note: See Chapter 3, PreservCyt™ & CytoLyt™ Solutions, for more information on CytoLyt Solution. WARNING: CytoLyt Solution is a poison (contains methanol) and it must never come in direct contact with the patient.
Page 113 YNECOLOGIC AMPLE REPARATION Figure 5-1 Measuring the Centrifuge Find the radius of your centrifuge in the first column of Figure 5-2. Draw a line from the radius value through the 600 Gravities (g) column and into the rpm column. Read the rpm value from the straight edge as shown in Figure 5-2.
Page 114 YNECOLOGIC AMPLE REPARATION Figure 5-2 Determining the Correct Centrifuge Speed To reduce the time required for the centrifugation step, operate your centrifuge at 1200g for 5 minutes. POUR OFF SUPERNATANT AND VORTEX TO RESUSPEND CELL PELLET Pour off the supernatant completely to effectively concentrate the sample. To do this, invert the centrifuge tube 180 degrees in one smooth movement, pour off all the supernatant, and then return the tube to its original position as shown in Figure 5-3.
Page 115 YNECOLOGIC AMPLE REPARATION CAUTION: Failure to completely pour off the supernatant may produce a sparse sample and an unsatisfactory slide due to dilution of the cell pellet. START Figure 5-3 Pouring Off Supernatant After pouring off the supernatant, place the centrifuge tube onto a vortexor and agitate the cell pellet for 3 seconds.
Page 116 YNECOLOGIC AMPLE REPARATION EVALUATE CELL PELLET APPEARANCE Appearance of Cell Pellet Procedure Cell pellet is white, pale pink, tan, or ™ Add specimen to PreservCyt Solution vial not visible. See page 5.10 in this chapter Cell pellet is distinctly red or brown ™...
Page 117 Factors to Consider The type of pipette that you use may affect the concentration of the sample that is added to the PreservCyt Solution vial, and therefore may affect the volume of sample. Hologic recommends using standard, 1 mL, graduated, plastic pipettes.
Page 118 For more information on PreservCyt Solution, refer to Chapter 3, PreservCyt™ & CytoLyt™ Solutions. RUN ON THINPREP 5000 PROCESSOR USING SEQUENCE NON-GYN. FIX, STAIN, AND EVALUATE. After the sample has been in contact with PreservCyt Solution for 15 minutes, it ™...
Page 119 YNECOLOGIC AMPLE REPARATION CYTOLYT SOLUTION WASH MUCOID ONLY ™ Addition of CytoLyt Solution to cell pellets is required to wash the sample. A CytoLyt Solution Wash performs the following functions while preserving cellular morphology: • Lyse red blood cells • Dissolve mucus •...
Page 120: Section Especimen Preparation Guidelines
YNECOLOGIC AMPLE REPARATION SECTION SPECIMEN PREPARATION GUIDELINES The following guidelines outline the preferred methods for preparing the different types of specimens. The methods are described in general terms. For more detailed information about each step, refer to the description of the methods in Section D of this chapter. See Section F for troubleshooting sample preparation.
Page 121 YNECOLOGIC AMPLE REPARATION FINE NEEDLE ASPIRATES (FNA) ™ 1. Collection: Collect sample directly into 30 mL of CytoLyt Solution. If specimen must be collected in an intravenous solution, use a balanced electrolyte solution. Note : If possible, flush the needle and syringe with a sterile anticoagulant solution prior to aspirating the sample.
Page 122 YNECOLOGIC AMPLE REPARATION MUCOID SPECIMENS Mucoid Specimens may include respiratory and gastrointestinal specimens. 1. Collection: ™ Collect sample directly into 30 mL of CytoLyt Solution. OR Add 30 mL of CytoLyt Solution to the fresh specimen as soon as possible. Note: Large specimens (greater than 20 mL) should be concentrated before addition of CytoLyt Solution to the sample.
Page 123 YNECOLOGIC AMPLE REPARATION 7. Allow to stand in PreservCyt Solution for 15 minutes (page 5.11) ™ 8. Run on ThinPrep 5000 processor with AutoLoader using Sequence Non-Gyn. Fix, stain, and evaluate. Procedure for the Use of DiThioThreitol (DTT) with Mucoid Non-Gyn Samples DTT has been shown to be a reagent that is effective in reducing the amount of mucus in respiratory samples.
Page 124 YNECOLOGIC AMPLE REPARATION BODY FLUIDS Body Fluids may include serous effusions, urinary and cerebrospinal fluids. 1. Collection: Collect body fluids fresh. Note ™ : Fluids collected in CytoLyt Solution also require a CytoLyt Solution wash prior to instrument processing. Note : For extremely bloody fluids (i.e., pericardial), start with only 10 mL of fresh fluid.
Page 125 YNECOLOGIC AMPLE REPARATION 7. Allow to stand in PreservCyt Solution for 15 minutes (page 5.11) ™ 8. Run on ThinPrep 5000 processor with AutoLoader using Sequence Non-Gyn. Fix, stain, and evaluate. ® URINE SPECIMENS FOR THE VYSIS UROVYSION ASSAY For use with Vysis UroVysion. If performing urine cytology, follow the Body Fluids protocol. 1.
Page 126 YNECOLOGIC AMPLE REPARATION ™ 4. CytoLyt Solution wash (page 5.12) Add 30 mL of CytoLyt Solution to one 50-mL centrifuge tube and vortex. Transfer the contents of this tube into the second 50-mL centrifuge tube and vortex. The specimen is now combined into one 50-mL tube. The empty tube can be discarded.
Page 127 YNECOLOGIC AMPLE REPARATION Urine Specimen Collection 1. On the specimen collection cup, record patient information in the space provided. 2. Collect urine in a routine manner. If urine volume exceeds 60 mL, pour off excess. The total volume of urine must not exceed 60 mL. ®...
Page 128: Section F: Sample Preparation Troubleshooting
This type of slide may be accompanied by a “Sample Is Dilute” message. Note: Satisfactory slide appearance is a matter of judgment and experience. Hologic recommends that you check the quality of the slide after staining. If you determine that the slide is unsatisfactory, use the procedures in this section to make additional slides.
Page 129 Non-Gyn. NO  YES  If a halo is present on the new slide, call Hologic Technical Service (page 12.1) C. Is the slide sparse and 1. Pour the contents of the PreservCyt sample does it contain blood, vial into a centrifuge tube.
Page 130 YNECOLOGIC AMPLE REPARATION Problem Procedure 3. Pour off supernatant and vortex to resuspend cell pellet. (page 5.7) 4. If the sample contains blood or non- cellular debris: Mix a solution of 9 parts CytoLyt Solution to 1 part Glacial acetic acid. Add 30 mL of this solution to the sample centrifuge tube.
Page 131 (page 5.10). ™ 9. Run on ThinPrep 5000 processor with AutoLoader using Sequence Non-Gyn. Fix, stain, and evaluate. 10. If the new slide is sparse, call Hologic Technical Service (page 12.1). 5.24 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 132 Sequence Non-Gyn. NO  YES  If a halo is present on the new slide, call Hologic Technical Service (page 12.1). C. Is the slide sparse and 1. Pour the contents of the PreservCyt sample does it contain mucus? vial into a centrifuge tube.
Page 133 7. Run on ThinPrep 5000 processor with AutoLoader using Sequence Non-Gyn. Fix, stain, and evaluate. 8. If the new slide is sparse, call Hologic Technical Support (page 12.1). Techniques Used in Troubleshooting Diluting the Sample 20 to 1 To dilute a sample suspended in PreservCyt Solution, add 1 mL of the sample that is suspended in PreservCyt Solution to a new PreservCyt Solution vial (20 mL).
Page 135: Chapter Six
NTERFACE C h a p t e r S i x User Interface This chapter provides detailed information on the User Interface screens and how to use them to ™ operate, troubleshoot and maintain the ThinPrep 5000 processor with AutoLoader. The content found in this chapter: MAIN SCREEN, INSTRUMENT IDLE.
Page 136 NTERFACE • Tray Processing ......6.33 • LIS ........6.35 •...
Page 137: Section A: Main Screen, Instrument Idle
NTERFACE SECTION MAIN SCREEN, INSTRUMENT IDLE ™ When the ThinPrep 5000 processor with AutoLoader is powered on and ready for use, the main screen will be displayed. Status bar - indicates readiness for processing or prompts for user action Slides status Baths status Filters status Vials status...
Page 138 NTERFACE More Info button is on the status bar. Pressing that will display a message window which lists all items to be seen to. If the Start batch button is pressed, the same message window will appear. A batch will not start with unresolved issues. Figure 6-3 System Status Not Ready Note: Some screen displays also say, “Tap for more information.”...
Page 139: Status Indicators
NTERFACE Status Indicators The status indicators aid in identifying whether the system is ready or not to process a batch. A table of the status indicators is shown below. Table 6.1: Main Screen Status Indicators Status Icon Meaning Ready for processing Completed The batch has been paused Not ready or error.
Page 140: Slides
NTERFACE Slides Touch the Slides button or anywhere on the pane to open the Slides Details display. Cassette 1 is selected as Gyn type slide and it is partially full Cassette 2 is selected as Non-Gyn type slide and it is full Cassette 3 is selected as UroCyte type slide and it is empty Grayed out: Cassettes 2 and 3 have been selected as Gyn type, but the...
Page 141 NTERFACE When a slide cassette is placed into the instrument, the system assumes it is “full” until it checks for the presence of slides in the cassette, which it does when first attempting to retrieve slides from the cassette. The status is “partial” if the cassette is not filled to the top or after the system has used slides out of a cassette.
Page 142: Vials
NTERFACE Vials Touch the Vials button or anywhere on the pane to open the Vial Details display. Tray 1 is selected as Gyn sample type and it is ready for processing Tray 2 is selected as Non-Gyn sample type and it is ready for processing Tray 3 is selected as UroCyte sample type and it is unable to process...
Page 143 NTERFACE Process Sequences Press the button for the vial tray number (1, 2, 3 or 4) and then select the process sequence for the sample vials that will be run in that tray. Only one type of sample may be run in each vial tray. For running a tray of gynecologic specimens.
Page 144: Baths
NTERFACE Baths Touch the Baths button or anywhere on the pane to open the Bath Details display How many baths are in the instrument, ready to process How many baths are in the instrument that have completed slides and must be unloaded How many baths are in the instrument that need operator action to correct an error Figure 6-9 Baths Pane on Main Screen...
Page 145 NTERFACE When baths are being moved, the baths door locks while the carousel rotates. The door unlocks when movement has stopped. The user can access the bath at the door. Figure 6-11 A Bath Moving to the Door Fixative Bath Status The baths compartment has room for eight fixative baths of 20 slides each.
Page 146 NTERFACE Bath position with Fixative bath Empty bath Bath position fixative bath with error position at the empty present condition door Completed fixative Completed fixative Fixative bath In bath positioned at bath with slides in use for the the door current batch Figure 6-12 Fixative Bath Status - Gyn Slides as Example Baths Movement Commands...
Page 147 NTERFACE Note: Be sure to remove the bath’s evaporative cover before placing it into the processor. Remove Used Baths - to remove completed fixative baths that are on board the instrument, press the Remove Used Baths button. The door locks and a completed bath is moved to the door. The door unlocks.
Page 148: Filters
NTERFACE Filters Touch the Filters button or anywhere on the pane to open the Filters Details display. Tray 1 is selected as Gyn filter type and it is full Tray 2 is selected as Non-Gyn filter type and it is partially full Tray 3 is selected as UroCyte filter type and the tray is not present...
Page 149 NTERFACE Touch the button for each filter tray to display the selection of filter types. Select the exact type by touching the name on the screen. The button label for that tray will change to reflect the selection. The types of ThinPrep filters are: •...
Page 150: Section B: Main Screen, During Processing
NTERFACE Start Button To begin a batch, press the Start button. Figure 6-15 Start Button MAIN SCREEN, DURING PROCESSING SECTION Processing When the Start button is pressed, the doors can be heard to lock. The main screen changes to display a preparing to process message, a graphical inventory of consumable items, the Admin Options button and a Pause button, as shown below.
Page 151 NTERFACE The system checks for slides in the cassettes. If cassettes have been newly loaded, this can take one to two minutes while it determines how full the cassettes are. If it is a continued batch, the system already has a running slide count. The progress bar indicates how many samples of the vial tray have been processed.
Page 152: Processing Complete
NTERFACE Two trays have completed processing. Tray 3 had The tray has completed processing. an unresolved issue and was skipped. Tray 4 is The check mark indicates OK status. Figure 6-18 During Processing with Trays Completed Processing Complete When a batch has completed processing, the processor returns to an idle state, with a processing complete message on the screen.
Page 153: Pause A Batch
NTERFACE Press the OK button. The Processing Complete screen is displayed (Figure 6-20). Figure 6-20 Processing Complete Screen Each batch report can be viewed by pressing the View Report button. At that time the report can be printed or saved to USB device. Refer to Batch Reports, page 6.68. After viewing each report, this screen will be displayed.
Page 154 NTERFACE Note: It may take several minutes for the Pause process to complete, depending on which operation of sample processing the system was at when the Pause button was pressed. Wait for the user interface to display the Paused screen (Figure 6-22) before attempting to open any doors. Interrupting Processing screen Batch Paused screen Administrative Options button -...
Page 155: Section C: Switch Modes
NTERFACE Press the Stop Processing button to end further processing for that batch. The Processing Complete screen will display. Refer to the next section. Cancel button will return to the paused screen. End Immediately button will end the batch Figure 6-23 Stop Processing After Batch Pause SECTION SWITCH MODES When the instrument is in an idle state, it can be switched to small batch mode, for running 20 or...
Page 156: Section D: Administrative Options
NTERFACE SECTION ADMINISTRATIVE OPTIONS About button System Settings button Empty Liquid Waste button Reports and Logs Clean Screen button button Clean System Design Labels button Configure Change Air Barcodes button Filter Done button (return to Service button Shutdown button main screen) Figure 6-25 Administrative Options Screen The Administrative Options screen allows user interface with the processor outside of processing samples.
Page 157: About Button
• Shut down the instrument • A Service button is available for Hologic service personnel usage, and it is password- protected About Button Press the About button to display the serial number for the instrument as well as the software version information.
Page 158 NTERFACE Instrument Name Date button button Lab Name button Time button Vial & Slide ID Sound button Pre-match button Alert Tones Language button button Done - return to More settings, main screen shown below Tray Install Printer processing stop button or continue on empty slots LIS button...
Page 159: Set Date
NTERFACE Set Date Date button shows current setting Figure 6-27 Set Date Button To change the date (day, month or year) touch the up/down button for that field until the desired value is displayed. Press the Save Changes button to return to the System Settings screen. Press Cancel to cancel changes and revert to the previous setting.
Page 160: Set Time
NTERFACE Set Time Time button shows current setting Figure 6-29 Set Time Button To change the time (hour, minute, meridian), touch the up/down button for that field until the desired value is displayed. For the meridian, press the AM or PM button, as appropriate. Press the Save Changes button to save and return to the Systems Setting screen.
Page 161: Lab Name
NTERFACE Lab Name Lab Name button shows current setting Figure 6-31 Set Lab Name Button To enter or edit a name for the facility at which the instrument is located, press the Lab Name button. Press the letter buttons to enter a name, up to 20 characters long. (Long names that use wide letters may appear cut off on the display, but 20 characters are accepted in the field and will print on the reports.) Refer to Figure 6-32.
Page 162: Instrument Name
Figure 6-33 Instrument Name Button To enter or edit a name for the ThinPrep 5000 processor with AutoLoader, press the Instrument Name button. Press the letter buttons to enter a name, up to 20 characters long. (Long names that use wide letters may appear cut off on the display, but 20 characters are accepted in the field and will print on the reports.)
Page 163: Set Sound
NTERFACE Press the abc/123 button to display a screen to enter numbers and characters. Use the Alt key to enter characters on the top row. Switch between keyboard and keypad as often as desired before saving changes. Press the Save Changes button to save and return to the System Settings screen. Figure 6-34 Edit Instrument Name Screen Set Sound Sound volume button shows...
Page 164: Alert Tones
NTERFACE Sound volume Decrease Increase Done - Save setting adjustment Preview - Press this button to hear the sound at the and return to System Settings current volume. The button becomes a Stop button, screen which is pressed to cease the volume test. Figure 6-36 Sound Screen Press the -1 button repeatedly to decrease the volume.
Page 165 NTERFACE Having differentiated tones makes it easier to know if the instrument has completed a batch or needs attention. In a setting that might have multiple machines, the different tones can help identify them. Alert tones for an error condition. Alert tones for batch completion.
Page 166: Language
NTERFACE Language Language button shows the current setting Figure 6-40 Language Button Press the Language button to select the language that is displayed on the user interface and on the reports. Cancel button to abort changes and return to List of System Settings languages screen...
Page 167: Install Printer
NTERFACE This system setting is only used for small batch mode, when running 20 or fewer samples directly from the carousel. If Vial & Slide ID Pre-match is selected the system will check the match between each vial/slide ID set in the carousel before beginning to process the batch. If any of the vial/slide IDs do not match, a dialog box appears, listing the carousel positions of the discrepant vial/slide IDs.
Page 168: Tray Processing
Multiple instruments may be connected to a single printer. Tray Processing During processing, the ThinPrep 5000 processor with AutoLoader moves vials from the vial tray to the carousel. The instrument can be configured to stop loading vials at an empty slot in the vial tray, or to continue past empty slots in the vial tray.
Page 169: Lis
NTERFACE To change the setting, touch the desired option and press Save Changes. Figure 6-46 Vial Tray Search Mode LIS (Laboratory Information System) LIS button shows the current setting Figure 6-47 LIS Button If your system is equipped with the optional LIS interface, •...
Page 170 NTERFACE Batch reports will not be copied to the LIS server. Batch reports will be copied to the NAS for access via the LIS server. (Note, they will also reside in the system database for 8 weeks before being Vials will not be processed if the label design calls purged.) for LIS data that is not available.
Page 171: Design Labels
NTERFACE Design Labels Figure 6-49 Design Labels Button The information that is laser etched onto the microscope slide can be configured with the Design Labels feature. It is a five-step process: 1. Select Slide ID format: OCR Imager, OCR Non-Imager, 1-D barcode or 2-D barcode 2.
Page 172 NTERFACE Set the Configure Barcodes settings and other System Settings, such as instrument name, lab name, and the date, before designing the slide labels. The Design Labels feature can use information from these System Settings. The slide ID is derived from the sample vial ID. There are length and character restrictions on the resulting slide ID, based on the selected format and the primary vial ID used.
Page 173 ID in a DataMatrix barcode is likely between 30 and 44 characters. The maximum length for the slide ID in a QR code barcode is likely the 64-character limit of the ThinPrep 5000 processor. Each should be tested. See “Test slide ID settings” on page 6.58.
Page 174 NTERFACE OCR: Non-Imager The slide is etched on one or two rows, depending how many digits are present in the ID. • Only digits are read from the vial barcode. Non- digit characters are removed. • The data length must be between 5 and 14 digits. Figure 6-54 Step 1 - Slide ID Format - OCR: Non-Imager Table 6.2: Slide Restrictions Based on Barcode Symbology Used 1-D Code 128...
Page 175 NTERFACE LIS fields are available only when LIS is enabled. When using an LIS or Vial ID/Slide ID field, the Next button prompts you to select the type of data If your facility uses different IDs for Vial IDs and The Vial Field buttons are available only when the Slide IDs, the Vial/Slide ID can be a text instrument is configured for a vial label that has...
Page 176 NTERFACE The data field under the slide ID can be a barcode or text. The upper text and the lower text are each text fields. Select the size for the text. Figure 6-56 Select the size of text on the slide label Figure 6-57 Step 3 - Add Upper Text 6.42 ThinPrep™...
Page 177 When label type is selected from the Admin Options screen, the current design will be etched onto the microscope slides. Note: This is only for the ThinPrep 5000 processor with AutoLoader. If samples are to be processed directly from the carousel in small batch mode, the slides need to be labeled or etched prior to processing.
Page 178: Configure Barcodes
NTERFACE Configure Barcodes The ThinPrep 5000 processor compares the vial ID with a slide ID. The Configure Barcodes option establishes the ways that the processor will compare the ID information. The Configure Barcodes settings are a series of questions about how sample vials are labeled when the vials are prepared for processing and a series of questions about how a slides are labeled in your laboratory.
Page 179 Settings button that lets the instrument scan example labels from a vial and/or slide to check that the ThinPrep 5000 processor is configured to read the ID labels used in your lab. The screen displays are designed to guide the operator through the sequence of steps to configure all of the barcode information.
Page 180 Configure Vial ID The ThinPrep 5000 processor can be set up to read vial IDs as 1-D barcodes or 2-D barcodes. Select 1- D barcode or 2-D barcode, and then select the type(s) of barcodes used for vial IDs at your facility.
Page 181 NTERFACE The ThinPrep 5000 processor can be set up to use the entire vial ID as the slide ID, or it can be set up to recognize a portion of the vial ID for use in the slide ID. To skip the next...
Page 182 For example, if a vial ID always starts with data that is not the accession ID, the ThinPrep 5000 processor with AutoLoader can be configured to consider the vial ID as two segments: “Field 1” and the accession ID.
Page 183 NTERFACE The screen display shows the number of sections and the position of the accession ID within the vial Press Back to return to Press Cancel to cancel Press Next to go to the Vial the previous screen. the vial ID configuration. ID summary screen.
Page 184 NTERFACE Review the summary of the vial ID configuration. To save the configuration, press Save Changes. To change a setting, use the Back button. To check that the vial ID configuration matches vial IDs in your laboratory, press the Test Settings button. Use the Test Settings button to check the vial...
Page 185 When the vial ID is properly configured, return to the summary screen and save the changes. Configure Slide ID Note: Particular components, available through Hologic Technical Support, are required to etch the EAN-13/JAN and Codabar 1-D barcode types and the QR Code 2-D barcode type. 6.51...
Page 186 ID that is used to configure the slide ID. It is referred to as “vial ID” in the Configure Slide ID settings. The ThinPrep 5000 processor with AutoLoader can be configured to laser-etch the slide ID onto each slide, or it can be configured to process slides to which labels are applied prior to loading the slides into the slide carousel, for Small Batch mode.
Page 187 Figure 6-68 What will the laser-etched Slide ID look like? Segment of ID The ThinPrep 5000 processor with Autoloader can be configured to etch slide IDs that are always the same segment of the vial IDs. Accession ID section...
Page 188 D. Press Done to close the keypad. 4. Press Save Changes to save the details. Replace characters The ThinPrep 5000 processor with Autoloader can be configured to etch slide IDs that are the vial IDs with certain characters replaced. Accession ID section...
Page 189 NTERFACE Insert characters The ThinPrep 5000 processor with Autoloader can be configured to etch slide IDs that are the vial IDs with certain characters added at the beginning of the slide ID. Accession ID section Slide ID of the vial label...
Page 190 NTERFACE The screen display shows a summary of the Slide ID custom settings. Figure 6-69 Configure laser-etched slide ID - summary screen Review the summary of the slide ID configuration. To save the configuration, press Save Changes. To change a setting, use the Back button. The OCR and 1-D barcode types often require shorter slide IDs than 2-D barcode types.
Page 191 NTERFACE To test the slide ID configuration, use a labeled vial. Place the labeled vial into slot 1 of the input carousel. Close the doors and press Continue to scan. The instrument moves the vial in slot 1 of the carousel and scans the vial ID. The test not only checks that the vial ID scanned matches the vial ID configured, but the screen display also shows a preview of the information that will be etched onto slides, including the accession ID and any additional slide configuration information.
Page 192 NTERFACE The screen display shows the vial ID that was scanned and it shows the custom slide ID, which is the accession ID portion from the vial customized by using a chosen segment, and/or with characters replaced, inserted or appended. Successful Slide ID configuration.
Page 193 NTERFACE Configure slide ID for pre-labeled slides For Small Batch mode when the slides are already labeled prior to loading the ThinPrep 5000 processor, configure the type of barcode(s) used on the slide labels so that the ThinPrep 5000 processor recognizes the vial ID and slide ID from other information that may be printed on the labels.
Page 194 NTERFACE For 1-D barcodes, touch an ID type to select it. To skip the next steps, use the Review button to go directly to the The All 1-D last screen in the barcodes button sequence, the slide selects all of the ID summary available 1-D screen.
Page 195 The slide ID and the vial ID can be identical, or they can differ. The slide ID and the vial ID must share a unique portion of their IDs. Specify whether they are identical or where the slide ID and vial ID differ so that the ThinPrep 5000 processor recognizes a match between the vial ID and slide ID 6.61...
Page 196 NTERFACE and distinguishes the vial ID and slide ID from other information that may be printed on the vial label and/or slide label. If all of the vial’s accession ID (vial ID) is used in If all of the slide ID matches the vial’s accession the slide ID, select Entire ID.
Page 197 NTERFACE The Configure Slide ID screen shows a summary of the pre-labeled Slide ID setting. To test that the settings for the pre-labeled slide ID configuration are correct for your facility, press the Test Settings button. Use the Test Settings button to check the vial ID and slide ID configuration by...
Page 198: Change Air Filter
NTERFACE The screen display shows the vial ID that was scanned, the slide ID that was scanned and the section of the vial ID and slide ID that match. If the vial ID and/or slide ID do not match their Successful slide ID configuration for pre-printed configuration settings, or if the specified segment slides.
Page 199: Clean System
NTERFACE Clean System This is described in Chapter 8, Maintenance. Reports And Logs Figure 6-78 Reports and Logs Button The Reports and Logs interface presents system information in five forms: • System Events - a log of all system errors excluding UPS power status events or sample preparation errors that do not interfere with the operation of the instrument.
Page 200: System Events
NTERFACE Usage Details - the Instrument name - number of slides if one has been successfully set up created Usage Summary - Carousel Report - tally of vials status of sample processed errors resulting in vial or slides left in the carousel at the System Events end of a batch...
Page 201 NTERFACE Event Codes button displays Instrument Name an event code list List of System Events: • Event ID • Date/Time • Usage Count (total of all samples run to Save to USB date) Done to return to Print report (if Reports and Logs optional printer is screen...
Page 202 NTERFACE Batch Reports Figure 6-83 Batch Reports Button The system creates an individual batch report for each tray processed from the AutoLoader. A display will show a list of the reports generated for the last eight weeks, with the most recent at the top of the list.
Page 203 The names of the lab and the processor (if this is set up in the Settings tab, page 6.27) • The serial number of the ThinPrep 5000 processor with AutoLoader • The type of process sequence selected for the batch to run •...
Page 204: 5000 Batch Report
® Batch report header with 10/21/2010 10:15 AM Start Time: identifying information and 10/21/2010 11:45 AM End Time: batch status Lab: Hologic Instrument: T5000 D002K09DP List of sample errors (no slide Serial number: Sequence: was made) Status: 2 Sample Errors Tray-Pos.
Page 205 NTERFACE The same keypad/keyboard screen that is used for entering lab name/instrument name is displayed. Type in all or some of the ID that is being searched for. Keypad and keyboard display Type in numbers or letters Delete to remove entries abc/123 to switch between keypad and keyboard Cancel to return to Batches screen Continue to search for the ID...
Page 206 NTERFACE Refresh button to clear search results and return Search result to Batches screen found match Touch a batch report to view Find Vial By ID Done button to button to search return to Reports again and Logs screen Save the found batch reports to Figure 6-89 Find Vial ID Search Results Screen If a match or matches are found in the batch reports for value searched for, the batch report is...
Page 207: Save A Report To Usb Key
NTERFACE Vial ID that was searched for appears in green Figure 6-90 Vial ID Search Results Note: Batch reports are stored in the system database for eight weeks and purged as new ones are generated. If your configuration includes the optional LIS interface, reports are also stored indefinitely on the NAS until your system administrator purges them.
Page 208 NTERFACE Figure 6-91 The Report Has Been Saved Message The system creates a folder titled T5000Reports on the USB device. Each report is written to there. Reports are automatically named by the convention of “Report type - Processor Name - Date and Time.
Page 209: Usage Details
Print report (if a printer is USB key installed) Figure 6-94 Usage Details Screen The usage details report keeps a tally of the number of slides created to date on the ThinPrep 5000 processor with AutoLoader. The usage history report header identifies: •...
Page 210: Carousel Report
NTERFACE Note: A sample vial that is picked up, uncapped and placed into the dispersion well increments the Total samples run counter. A slide deposited into the fixative bath increments the Successful samples run counter. Carousel Report Figure 6-95 Carousel Report Button At the conclusion of processing, there may be vials, filters and slides left in the carousel.
Page 211 NTERFACE ThinPrep 5000 Carousel Report ® 10/21/2010 10:15 AM Start Time: Report header contains date/time 10/21/2010 11:45 AM End Time: Hologic Lab: stamp and instrument identification T5000 Instrument: Serial number: D002K09DP Autoloader Serial Number: D004M10DA Carousel Report Summary Carousel Report Summary indicates the Pos.
Page 212: Vial Event Report
NTERFACE Vial Event Report A Vial Event Report is generated every time vials are processed. The vial events report identifies the position of a vial when an error occurs during processing. A vial event report only lists a vial tray if that vial tray has a processing error.
Page 213 Gather Diagnostics Figure 6-99 Gather Diagnostics Button Gather Diagnostics is a function intended for instrument troubleshooting by Hologic Technical Support. It gathers and zips the error history log and other instrument operating information. The zip file contents are password protected.
Page 214 Figure 6-100 Select the Option for Gathering Diagnostic Data Figure 6-101 Gather Diagnostics Screen The instrument operating information will be gathered into a folder on the USB device titled T5000Logs. There will be three zipped files in the folder. These can be e-mailed to Hologic Technical Support. 6.80...
Page 215 NTERFACE Clean Screen This is described in Chapter 8, Maintenance. Empty Liquid Waste This is described in Chapter 8, Maintenance. 6.81 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 216 NTERFACE This page intentionally left blank. 6.82 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 218: Chapter Seven
PERATING NSTRUCTIONS C h a p t e r S e v e n Operating Instructions SECTION INTRODUCTION Normal instrument operation consists of loading supplies, starting the batch and unloading the prepared slides and processed sample vials when the batch is complete. A batch report is generated at the completion of each batch.
Page 219 The ThinPrep 5000 Processor with AutoLoader Operator’s Manual contains detailed information about the operation, troubleshooting and maintenance of the processor. It also contains information on the solutions and materials required to prepare slides with the ThinPrep 5000 processor with AutoLoader.
Page 220: Section C: Labeling The Sample Vials
SECTION LABELING THE SAMPLE VIALS The ThinPrep 5000 processor with AutoLoader reads the sample vial ID labels and etches the ID onto the frosted area of the microscope slides. A slide scanner then reads the slide label and verifies they match.
Page 221 5 mm (0.20 in.) from the bottom of the vial, close to but not covering the frosted area of the vial. For the ThinPrep 5000 processor to properly read the 2-D barcode, do not put any other 2-D barcode label on the vial.
Page 222 LOAD THE THINPREP ™ 5000 AUTOLOADER CAUTION: Prior to loading and operating the ThinPrep 5000 instrument, please note that if ancillary testing is to be performed, read and understand the instructions in “OPTIONAL INSTRUCTIONS FOR ANCILLARY TESTING” on page 7.37.
Page 223 PERATING NSTRUCTIONS CAUTION: For best slide preparation results, use the correct slide and filter type for the sample type that is processed. Table 7.1: Sample/Filter/Slide Configurations ThinPrep ThinPrep + Imaging UroCyte PreservCyt Sam- Gynecologic Non-gynecologic Gynecologic Urine for use with Vysis UroVysion molecular test- Filter Clear...
Page 224 PERATING NSTRUCTIONS Figure 7-4 Microscope Slides and Cassette Table 7.2: Load the Cassette with Slides 1. Unlatch the clasp that holds the slide cassette closed. 2. Open the cassette and clean it. 3. Open a box of microscope slides. Orient the slides so that the frosted area will be facing upward in the cassette.
Page 225 PERATING NSTRUCTIONS Table 7.2: Load the Cassette with Slides 4. Place the cassette onto the box of slides. 5. Holding the cassette and box of slides, invert them so the slides transfer into the cassette from the box. 6. Remove the slide box. 7.
Page 226 PERATING NSTRUCTIONS Figure 7-5 Load Slide Cassettes The operator must identify the type of slides in each cassette. See “Slides” on page 6.6. ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 227 PERATING NSTRUCTIONS Load Vial Trays into the Instrument Figure 7-6 Vial Tray The AutoLoader has four bays that hold ThinPrep sample vial trays. Each tray holds up to 40 samples. Each tray is considered a batch and a report will be generated at the completion of a tray. Each tray can only have one sample type in order to ensure that the correct filter type and slide type is used in processing the sample.
Page 228 PERATING NSTRUCTIONS Load Filter Trays into the Instrument The AutoLoader has a filter compartment with three shelves that each hold a filter tray. There are clear filters for use with gynecologic samples, blue filters for use with non-gynecologic samples and yellow filters for use with UroCyte (urine) samples.
Page 229 PERATING NSTRUCTIONS Start Start Finish (or at first empty position) Finish (or, if configured, at first empty position) Figure 7-8 Robotic Arm Tray Search Pattern 7.12 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 230 PERATING NSTRUCTIONS Load Alcohol Fixative Baths into the Instrument The processor has a baths’ compartment that holds up to eight fixative baths. Each bath holds up to 20 microscope slides. Two baths are required for every sample vial tray processed. Slides from tray positions 1 - 20 will be deposited into one bath and slides from tray positions 21–40 will be deposited into another bath.
Page 231 PERATING NSTRUCTIONS Slide the fixa- tive bath into the processor Figure 7-10 Load Fixative Bath into the Processor See “Baths” on page 6.10 for details on loading baths and bath status indicators. Load the Carousel into the Processor Load an empty carousel into the processor. Open the front door and slide the tray into the center of the processing area.
Page 232: Section Einitiate A Batch
PERATING NSTRUCTIONS SECTION INITIATE A BATCH When the consumable items have been placed in the instrument and any status bar warnings have been resolved, close all doors and press the Start button (Figure 7-12). Figure 7-12 Start Batch Button The doors will be heard to lock. The processor checks for the presence of vials, filters and slides. The batch preparing to process screen displays.
Page 233 PERATING NSTRUCTIONS Progress bar and tray position indicate how much of the vial tray has been processed. Admin Options are available, but some items are disabled during processing Pause the batch is available. Figure 7-14 Processing Samples Screen 7.16 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 234: Section F: Processing Slides
PERATING NSTRUCTIONS SECTION PROCESSING SLIDES The sequence of events that occurs when a batch is initiated goes in this order: AutoLoader Mode Small Batch Mode Checks that the carousel is empty (Operator manually loads vials, filters and slides into the car- ousel and loads the carousel into the processor) Pick up the first vial, place it in the carousel and read the vial Pick a filter and put it in the carousel...
Page 235: Section G: Pause A Batch In Process
PERATING NSTRUCTIONS SECTION PAUSE A BATCH IN PROCESS To interrupt a batch in progress, press the Pause button. The system will finish processing the sample that is in progress. The mechanisms will move out of the way and the bath door will unlock. Refer to “Pause a Batch”...
Page 236 PERATING NSTRUCTIONS Figure 7-16 Processing Complete Message Window Press the OK button to acknowledge. The Processing Complete screen is displayed. Processing Complete, no errors. One tray was Processing Complete, due to operator cancella- tion of the batch. skipped due to an unresolved conflict. Figure 7-17 Examples of Processing Complete Screens The batch reports are available for viewing, printing or saving to USB device.
Page 237: Section I: Unload The Thinprep 5000 Processor With Autoloader
PERATING NSTRUCTIONS SECTION UNLOAD THE THINPREP™ 5000 PROCESSOR WITH AUTOLOADER Vial Trays Open the bays that contain processed vial trays and remove the trays. Slide Cassettes and Filter Trays These may be left in the instrument at the end of a batch. If they remain untouched, the instrument continues to keep track of inventory level when the next batch begins and will alert the operator when replenishment is required.
Page 238 PERATING NSTRUCTIONS SMALL BATCH MODE System status indicators Baths button to Process go to the baths Sequences screen (Gyn selected) Admin Options button to access user Start Process preferences button and settings Switch to AutoLoader Mode button Figure 7-18 Small Batch Mode Main Screen Status Indicators The system status indicators are located at the top of the main screen display.
Page 239 PERATING NSTRUCTIONS SMALL BATCH MODE Table 7.3: Status Indicators CAROUSEL DOORS BATHS WASTE POWER Status OK, ready to Status OK, ready to Status OK, ready to process Status OK, ready to Status OK, ready to process process process process Carousel not One or more doors A fixative bath is not Liquid waste must be...
Page 240 PERATING NSTRUCTIONS SMALL BATCH MODE • 1-D Code 93 • 2-D DataMatrix • 2-D QR Code Refer to “Table 6.2: Slide Restrictions Based on Barcode Symbology Used” on page 6.40 for detailed description of constraints placed on the ID depending on the slide format used. Figure 7-20 Examples of How Barcodes Fit onto a ThinPrep Slide The barcode must have a minimum height of 0.22 inch (5.88 mm) and a maximum width no wider than 0.75 inch (19.05 mm).
Page 241 PERATING NSTRUCTIONS SMALL BATCH MODE Figure 7-22 Example of a Laser Printed OCR Label on a ThinPrep Slide ™ Required Slide Label Format for Use with the ThinPrep Imaging System For ThinPrep Pap test slides that will subsequently be imaged by the ThinPrep Imaging System Imaging System, slide labels must be in an OCR, 14 character, 7 digits over 7 digits format, with the last 3 digits being a CRC number.
Page 242 PERATING NSTRUCTIONS SMALL BATCH MODE Table 7.4: Sample/Filter/Slide Configurations ThinPrep ThinPrep + Imaging UroCyte PreservCyt sam- Gynecologic Non-gynecologic Gynecologic Urine for use with Vysis UroVysion molecular test- Filter Clear Blue Clear Yellow Slide Cell spot arc Cell spot arc Cell spot arc with fidu- Cell spot circle or arc-less cial marks...
Page 243 PERATING NSTRUCTIONS SMALL BATCH MODE Note: The filters, slides and vials can be loaded in any order that is convenient for loading (filters then slides then vials), as long as the patient ID labels match up. Load the carousel into the processing area. (Refer to page 7.14.) Fill and load fixative baths into the bath compartment.
Page 244 PERATING NSTRUCTIONS SMALL BATCH MODE Select the Sample Processing Sequence Select the desired pro- cessing sequence for the batch Figure 7-25 Sample Processing Sequence Gyn for running a batch of gynecologic samples Non-Gyn for running a batch of non-gynecologic samples ®...
Page 245 PERATING NSTRUCTIONS SMALL BATCH MODE Disable Slide ID Match Select sample Disable slide ID type in order to match - in order run the correct to run a sample process with the vial/slide sequence ID match turned off. OK button to accept selec- tion and return to main screen...
Page 246 PERATING NSTRUCTIONS SMALL BATCH MODE Figure 7-27 Disable Slide ID Match Selected Note: When the sample has been processed, the system reverts to Slide ID Match ON. To process another sample without the vial/slide ID match, repeat the steps above. Note: Only one vial may be loaded into the carousel.
Page 247 PERATING NSTRUCTIONS SMALL BATCH MODE SMALL BATCH MODE Multiple Slides per Vial Select Multiple slides per vial in order to process Only Non-Gyn up to 10 slides sample type may out of one vial be processed with this feature OK button to return to the main screen Figure 7-28 Multiple Slides per Vial...
Page 248 PERATING NSTRUCTIONS SMALL BATCH MODE Figure 7-29 Multiple Slides Per Vial Selected Initiate a Batch When the input carousel has been loaded with labeled sample vials, the appropriate filters and slides, and a fixative bath is ready in the bath compartment, select the sample processing sequence and press the Start button (Figure 7-30).
Page 249 PERATING NSTRUCTIONS SMALL BATCH MODE Selected Status of the batch process sequence Progress bar of the batch Admin Options Pause button button Figure 7-31 Starting the Batch Screen During processing, a progress bar indicates how much of the batch has been completed. It increments during the processing of each vial, as well as to indicate overall batch progress.
Page 250 PERATING NSTRUCTIONS SMALL BATCH MODE Pause a Batch A batch may be paused by pressing the Pause button. When the Pause button is pressed the system will complete processing the current vial and then pause. The batch status line will report “Interrupting” as the processor puts items away and parks the mechanisms.
Page 251 PERATING NSTRUCTIONS SMALL BATCH MODE Press the Stop Processing button to end further processing for that batch. A confirmation screen will appear (Figure 7-34.) Cancel button to End Immediately return to process- button to end the ing paused batch now screen Figure 7-34 Stop Processing Screen Press the Cancel button to return to the processing paused screen.
Page 252 PERATING NSTRUCTIONS Processing Complete message Batch Report button - displays the report Done button - returns to the main screen, idle Figure 7-35 Batch Complete Screen To view the batch report, press the Batch Report button. The report will display and there is the opportunity to print the report or save it to USB key via that screen.
Page 253 PERATING NSTRUCTIONS The batch reports are the same as described for AutoLoader on page 6.68, except the carousel positions are listed instead of vial tray positions. 7.36 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 254: Section Koptional Instructions For Ancillary Testing
Pap testing. It is contraindicated to perform Chlamydia trachomatis and Neisseria gonorrhoeae testing, using the Roche Diagnostics COBAS AMPLICOR CT/NG Test, if the sample has already been processed using the ThinPrep 5000 processor. 7.37 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 255 PERATING NSTRUCTIONS Removing an Aliquot (of up to 4 mL) from the PreservCyt Sample Vial prior to Performing the ThinPrep Pap Test Note: Only one aliquot may be removed from the PreservCyt sample vial prior to performing the ThinPrep Pap test, regardless of the volume of the aliquot (maximum aliquot volume = 4 mL). Note: Good laboratory practices should be followed to avoid introducing contaminants into either ™...
Page 257: Chapter Eight
AINTENANCE C h a p t e r E i g h t Maintenance Table 8.1: Routine Maintenance Daily or Change fixative every 100 slides or daily, more whichever comes first Before filling a slide cassette, wipe down the inside with a dry, non-abrasive cloth Weekly Clean around the slide cassettes, the carousel and dispersion area...
Page 258: Section A: Daily
AINTENANCE SECTION DAILY Change Fixative Reagent The fixative alcohol in any bath should be changed out every 100 slides, or daily, whichever comes first. Consider how your laboratory uses baths in the count to 100. For example, one bath used with 20 slides for 5 batches needs the fixative alcohol changed before the next batch is run (or daily).
Page 259 AINTENANCE Clean System Use the Clean System button in several weekly maintenance activities. The Clean System button moves the mechanical arms in the processing area to positions that make them easier to reach for routine maintenance. 1. Touch the Clean System button and the display screen guides the operator through the process. 2.
Page 260 AINTENANCE And, the mechanisms in the filter waste area move toward the processing area to make them easy to reach for cleaning. The mechanisms in the filter waste area move towards the processing area The robot arm moves the Auto- Loader slide grip- per towards the processing area.
Page 261 AINTENANCE Clean Around Carousel And Dispersion Areas On a weekly basis, remove the carousel and clean around the bottom of the processing area, using deionized water and lint-free towels. Do not dislodge the carousel sensors, but do keep the area around them clean and make sure nothing blocks them.
Page 262 AINTENANCE Filter plug body Filter puncture point (filter shown on for reference) Figure 8-5 Clean Filter Plug and Filter Puncture Area Clean Slide Holder Pneumatic Cups, AutoLoader Slide Gripper and Sensor A lint-free cloth soaked with de-ionized water may be used to wipe down the surfaces of the slide holder cups.Wipe any glass dust out of the AutoLoader slide gripper area.
Page 263 AINTENANCE Wipe off sensor lens and suction cups Slide cassette compartment Slide processing area AutoLoader slide gripper on the robot arm Figure 8-6 Clean Slide Holder Pneumatic Suction Cups Empty the Filter and Slide Waste Bins The right-most cabinet of the AutoLoader is the waste area compartment. Open this door to access the filter waste bin and the slide waste bin.
Page 264 AINTENANCE Filter waste chute Slide waste bin is located behind the liquid waste bottle Filter waste bin Figure 8-7 Waste Cabinet Door Open On a weekly basis pull out the filter waste bin and empty it of used filters. Depending on the processing volume of your laboratory, the filter waste bin may require more or less frequent emptying.
Page 265 AINTENANCE Figure 8-8 Slide Waste Bin ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 266: Section C: Empty The Waste Bottle
AINTENANCE SECTION EMPTY THE WASTE BOTTLE Waste resulting from sample processing is routed to and stored in the waste bottle. The instrument senses when the waste bottle is full and displays a message to empty the waste (see Figure 8-10). Or the waste may be emptied during routine maintenance of the instrument. The waste bottle is located inside the waste cabinet - the door on the right of the AutoLoader cart.
Page 267 AINTENANCE Figure 8-10 Empty Liquid Waste Button and Message The system can be heard to vent, which depressurizes the waste bottle. It takes about 10 seconds. Figure 8-11 Venting the Waste Bottle A message prompts for the operator to dispose of the waste according to the instructions in this manual.
Page 268 Figure 8-12 Empty and Maintain the Waste Bottle CAUTION: At no time should bleach be present in the waste bottle while it is connected to the ThinPrep 5000 processor. 6. To remove the waste cap, rotate the waste cap with one hand while holding the waste bottle in place with the other hand.
Page 269 AINTENANCE WARNING: Hazardous Waste Toxic Mixture Flammable Liquid and Vapor 7. Place the transport cover onto the waste bottle for transporting to the waste disposal area. 8. Dispose of the liquid waste from the waste bottle according to your laboratory guidelines. 9.
Page 270 1. The waste bottle is located inside the waste cabinet door of the AutoLoader cart. If for some reason, the waste bottle is relocated outside of the cabinet, the waste bottle should be placed at the same height or below the ThinPrep 5000 processor. Do not place the waste bottle above the instrument.
Page 271 AINTENANCE Blue - waste tubing No color - sensor tubing Yellow - vacuum tubing Waste filter Figure 8-16 Waste Bottle Tubing Connections 4. Connect the color-coded waste tubing connectors to the corresponding connectors located in the rear of the instrument. When the proper connection has been established, the buttons on the connectors pop up/outward with a click sound.
Page 272: Section E: Clean Input Carousel And Dust Cover
AINTENANCE Figure 8-17 Touch Screen Disabled for Cleaning The system disables the touch screen for 20 seconds so that the screen may be cleaned without inadvertently activating buttons or having to power off the instrument. SECTION SECTION SECTION CLEAN INPUT CAROUSEL AND DUST COVER Input Carousel As needed, clean the input carousel by wiping it down with soap and water.
Page 273: Section F: Change Absorbent Pads
AINTENANCE SECTION CHANGE ABSORBENT PADS There are two absorbent pads in the processing compartment of the instrument that absorb drips that may result from processing. One is located at the base of the filter plug and the other is on the top of the evaporative cover over the fixative bath carousel.
Page 274: Section G: Change Fume Extractor Filters
AINTENANCE SECTION CHANGE FUME EXTRACTOR FILTERS The fume extractor for the laser etcher has a HEPA filter and a carbon filter to capture particulate matter and gas and odor. The fume extraction cabin is located inside the waste cabinet door. (See Figure 8-20.) The instrument will prompt the user if the HEPA filter needs to be changed.
Page 275 AINTENANCE The fume extractor is located at the bottom of the waste cabinet of the AutoLoader. Figure 8-20 Location of Fume Extractor Open the fume extractor door by rotating the retaining latch on the left side of the door. Swing the door open.
Page 276 AINTENANCE Carbon filter HEPA filter Figure 8-22 Remove the HEPA and Carbon Filters The floor of the filter cabin is labeled to show the order of the new filter replacement and to indicate the direction of air flow. When replacing the filters, be sure to match the arrows that indicate direction of air flow.
Page 277: Section H: Remove And Clean Drip Trays
There are two user-accessible fuses located on the rear of the processor, just above the power cord module (Figure 8-25). If the instrument fails to operate, the fuses can be replaced as outlined below. Hologic Field Service can replace the fuses as needed. 8.21...
Page 278 AutoLoader power cord module (Figure 8-25). If the AutoLoader fails to operate, the fuses can be replaced as outlined below. Hologic Field Service can replace the fuses as needed. 1. Shut down the processor. Make sure the power switch is in the “off” position.
Page 279 AINTENANCE fuse holder cover Figure 8-26 Remove the fuse holder 3. Using a small, flat-head screwdriver, pry the cover near the power cord receptacle open. Pry out the fuse holder. 4. Pull the two fuses out of the receptacles on the holder. They may be discarded as regular waste.
Page 280 6. Push the fuse holder back into the AutoLoader. Push the cover back into position. 7. Reattach the power cord to the AutoLoader. 8. Turn the processor power switch on. If the instrument fails to operate, contact Hologic Technical Support. 8.24 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 281 ThinPrep ™ 5000 Processor with AutoLoader Maintenance Maintenance Schedule for the Month/Year: Instrument # Daily or more Weekly As Needed Change Empty Clean Empty Clean Replace Clean Clean Change Remove Filter & Carousel, Waste Carousel Fume Reagent Slide Touch Absorbent and Clean Slide Waste Dispersion...
Page 282 AINTENANCE This page intentionally left blank. 8.26 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 284: Chapter Nine
ROUBLESHOOTING C h a p t e r N i n e Troubleshooting SECTION GENERAL There are three categories of error/status that the system can generate: • Sample Processing Errors • User Correctable Batch Errors • System Errors SECTION SAMPLE PROCESSING ERRORS At the conclusion of batch processing sample errors are reported on the batch report.
Page 285: Section B: Sample Processing Errors
ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action This error message indicates This is usually caused by a low Gyn slides - 5000 - Sample Is the entire sample was utilized concentration of cells in the If the slide is satisfactory for Dilute in preparing the slide.
Page 286 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action The barcode on the vial could The barcode label is missing, Examine the barcode label to 5003 - Failed to not be read or is an invalid for- damaged, or printed at poor see if it is missing, damaged, Read Vial ID...
Page 287 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action The vial could not be tightened Damaged vial cap. Check the vial and cap. Make 5005- Failed to prior to the dispersion step. sure the cap does not have Tighten Cap Mechanical failure prevented broken cap ridges.
Page 288 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action Barcode on the slide is not a Barcode data on the slide is too Check and correct the Slide ID 5008 - Invalid Slide valid format. long or too short. barcode configuration on the instrument.
Page 289 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action The vial does not contain Filter not present. Make sure a filter is present 5010 - Insufficient enough fluid to process prop- and loaded correctly, with the Fluid or Filter Not erly.
Page 290 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action The vial and slide IDs were Slides placed in wrong carou- Examine the vial and slide IDs 5012 - Vial/Slide ID both successfully read, but did sel slot. to confirm they do not match.
Page 291 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action Failure to read both vial and Labels not present, damaged, Examine the vial barcode label 5014 - IDs on Vial slide IDs. The sample was not or printed at poor quality. to see if it is missing, dam- and Slide Could Not processed and no slide was...
Page 292 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action Multiple slides were labeled In Small Batch Mode, multiple Check the sample IDs and con- 5015 - Duplicate with the same ID number in the slides were labeled with the firm that they are duplicates.
Page 293 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action Multiple slides were labeled In Small Batch Mode, multiple Check the sample IDs and con- 5015 - Duplicate with the same ID number in the slides were labeled with the firm that they are duplicates.
Page 294 ROUBLESHOOTING Table 9.1 Sample Processing Errors Error Description Possible Cause Corrective Action The vial could not be inserted Possible obstruction in the dis- Misshaped vial cap on the vial. 5018 - Failed to properly into the dispersion persion well. Place Vial in well.
Page 295 (AutoLoader mode only) Invalid character in barcode Refer to characters supported 5204 - Invalid string. by the ThinPrep 5000 proces- Character in sor on page 6.40. Only when Barcode String LIS error policy is enabled. (AutoLoader mode only) Invalid barcode string length.
Page 296 ROUBLESHOOTING SECTION BATCH PROCESSING ERRORS Batch processing errors are errors that the system is capable of recovering from with user intervention. The errors occur during the processing of a batch. When the system encounters a batch error condition, the batch halts (terminates, or pauses, depending on the cause) and signals the error via a message on the user interface and by sounding the audible alarm, if it is enabled.
Page 297: Section C: Batch Processing Errors
ROUBLESHOOTING Table 9.2 Batch Processing Errors Error Description Possible Cause Corrective Action No vials were detected while No vials are in the carousel. At least one vial must be in the 4005 - No Vials starting a batch. There must be Sensor malfunction.
Page 298 ROUBLESHOOTING Table 9.2 Batch Processing Errors Error Description Possible Cause Corrective Action Failed to uncap the vial during Vial cap is screwed on too Check the vial and cap. Make 4008 - Vial Not the batch. tight. sure the plastic over wrap has Successfully been removed from the vial.
Page 299 ROUBLESHOOTING Table 9.2 Batch Processing Errors Error Description Possible Cause Corrective Action The carousel is not empty A vial, filter, slide or any combi- Clear the carousel of any 4013 - Carousel during the start of AutoLoader nation is present in the carou- media and start again.
Page 300 ROUBLESHOOTING Table 9.2 Batch Processing Errors Error Description Possible Cause Corrective Action Three consecutive occur- Barcode data on the slide is too Check and correct the Slide ID 4051 - Invalid Slide rences of an invalid slide ID long or too short. barcode configuration on the ID (3 in a row, instrument.
Page 301: Section D: System Errors
SECTION SYSTEM ERRORS System errors are errors that the ThinPrep 5000 processor with AutoLoader is not capable of recovering from without user intervention. The current batch terminates and the system attempts to create a batch report. A system error is an error that will most likely require field service assistance. A user may choose or be instructed to restart the system.
Page 302 ROUBLESHOOTING • Attempt to recap the vial and attempt to deposit a slide in a fixative bath • Move mechanisms out of the way, release the input carousel lock, unlock the doors and return to an idle state. • Display the error message and sound the audible alarm, if enabled (see Figure 9-1.) The system attempts to recover (a minute or less).
Page 303 ROUBLESHOOTING Figure 9-2 Restricted Mode Admin Options Screen To recover from an error requiring shutdown, press the Shutdown button. Wait for the computer to turn off (wait until the touch screen interface goes blank). Then turn off the power switch on the right side of the instrument. After a few seconds of the power being fully off, turn the processor on again and let it boot up.
Page 304 ROUBLESHOOTING Release Vial Cap will open the fin- gers of the vial gripper to drop the vial cap Release Slide will release the slide gripper fingers to let go of the slide and release the suction vacuum of the slide holder cups at the cell transfer area.
Page 305 ROUBLESHOOTING Release Vial Cap The vial gripper fingers remain closed in an error condition, so that a vial will not drop. Move the vial transport arm toward the middle of the instrument and then press the Release Vial Cap button to open the gripper and retrieve the vial. See Figure 9-5. Figure 9-5 Release Vial, Check Dispersion Well Note: Often just the vial cap is in the mechanism.
Page 306 ROUBLESHOOTING Media down the Elevator Shaft Figure 9-7 Media in the Elevator Shaft Message If the robotic arm was holding a vial, filter or slide during error recovery, the item may have been released down into the elevator shaft. It can be retrieved from the waste tray at the bottom of the shaft.
Page 307 ROUBLESHOOTING System Error Code A system error has a two-part error code associated with it. The first four digits represent the error category and the following characters represent the status of the particular electromechanical device at the time the fault occurred. See Figure 9-9. Error category Mechanism Operation...
Page 309: Chapter Ten
SECTION FIXATION The ThinPrep 5000 processor with AutoLoader deposits completed slides into a staining rack immersed in a fixative bath that contains 95% reagent alcohol or 95% ethyl alcohol. Use the following procedure to fix ThinPrep microscope slide preparations.
Page 310: Section C: Recommended Staining Guidelines
• The use of mild bluing solutions and dilute acid baths will optimize nuclear staining and minimize possible cell shedding. Hologic recommends the use of a dilute Lithium Carbonate solution, or Ammonium Hydroxide solution as the bluing solution. •...
Page 311 TAINING AND OVERSLIPPING Table 10.1: Hologic Staining Protocol Solution Time* 70% Reagent Alcohol 1 minute with agitation 50% Reagent Alcohol 1 minute with agitation Distilled H O (dH 1 minute with agitation Richard-Allan Hematoxylin I 30 seconds with agitation Distilled H...
Page 312 Each laboratory should evaluate their choice of coverslip and mounting media to ensure compatibility with ThinPrep slides. Hologic also recommends that 24 mm x 40 mm or 24 mm x 50 mm glass coverslips be used. Plastic coverslip material used with automated coverslipping instrumentation is also acceptable.
Page 314: Chapter Eleven
SECTION OBJECTIVE The ThinPrep Pap Test Training Program was developed by Hologic to assist laboratories in the conversion process from the conventional Pap smear to the ThinPrep Pap test. Hologic offers information, support and training for the conversion process, including communicating the change to the clinician, cytopreparatory training, ThinPrep Pap test morphology training and guidelines to assist with training the entire cytology staff in the laboratory.
Page 315: Section C: Bibliography
Participants of the training program receiving less than 90% on the Final Assessment would require remedial training in their individual laboratories. This training involves the screening/diagnosing of an additional ThinPrep Pap test slide module provided by Hologic and requires a score of 90% or better to complete Hologic’s ThinPrep Pap Test Training Program.
Page 317: Chapter Twelve
Product orders, which include standing orders, are placed through Customer Service by phone during business hours. Contact your local Hologic representative. Warranty A copy of Hologic’s limited warranty and other terms and conditions of sale may be obtained by contacting Customer Service . Technical Support For technical support, contact your local Hologic Technical Solutions office or your local distributor.
Page 318 ERVICE NFORMATION Protocol for Returned Goods For returns on warranty-covered ThinPrep 5000 processor with AutoLoader accessory and consumable items, contact Technical Support. Service contracts can also be ordered through Technical Support. 12.2 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 320 Product orders, which include standing orders, are placed through Customer Service by phone during business hours. Contact your local Hologic representative. Warranty A copy of Hologic’s limited warranty and other terms and conditions of sale may be obtained by contacting Customer Service at the numbers listed above. Protocol for Returned Goods ™...
Page 321 Liner bags for filter Poly plastic bags, 14” x 14” x 26”, 1 carton of 500 bags 50816-001 waste bin * Order number depends upon specific power requirements for each country. Contact Hologic Technical Support. 13.2 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 322 RDERING NFORMATION Table 13.2: Supplies for the ThinPrep Pap Test (Gynecologic) Application Item Description Order Number ThinPrep Pap Test Kit Materials for 500 ThinPrep Pap Tests Contains: Vials of PreservCyt Solution for use with the ThinPrep Pap Test ThinPrep Pap Test Filters (Clear) ThinPrep Microscope Slides (approximately 500 slides) Collection Devices...
Page 323 RDERING NFORMATION Table 13.2: Supplies for the ThinPrep Pap Test (Gynecologic) Application Item Description Order Number ThinPrep Pap Test Contains: Laboratory Kit ThinPrep Pap Test Filters (Clear) ThinPrep Microscope Slides (approximately 500 slides) 70137-001 ThinPrep Pap Test Contains: Laboratory Kit (for use ThinPrep Pap Test Filters (Clear) with the ThinPrep Imaging System)
Page 324 RDERING NFORMATION Table 13.3: Supplies and Solutions for Non-Gynecologic Applications Item Description Order Number PreservCyt Solution 20 mL in a 2 oz. vial ASY-14753 100 vials/box 946 mL in a 32 oz. bottle 70406-002 4 bottles/box CytoLyt Solution 946 mL in a 32 oz. bottle 70408-002 4 bottles/box 30 mL in a 50 mL centrifuge tube...
Page 325 RDERING NFORMATION This page intentionally left blank. 13.6 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 327 NDEX Index absorbent pad evaporation cover 8.17 13.2 filter plug 8.17 13.2 Administrative Options 6.22 alert tones 6.30 aliquot removal 7.37 ancillary testing 7.37 barcode label format slide 7.22 vial 7.3 batch complete 6.18 7.18 7.34 batch processing errors 9.13 bath details 6.10 baths pane on main screen 6.10 bloody specimens (non-gyn) 5.22...
Page 328 NDEX COBAS AMPLICOR™ CT/NG Test 7.37 Collection Broom-like device 4.3 broom-like device 13.4 Endocervical brush/Spatula device 4.4 13.4 collection media 5.4 Configure barcodes accession ID 6.47 configure slide ID 6.51 laser-etched slides 6.52 replace 6.54 segment 6.53 test settings, vial ID 6.50 Configure slide ID 6.51 Configure vial ID 6.46 coverslipping 10.4...
Page 329 NDEX empty liquid waste tank 6.81 7.22 8.10 9.15 Environmental 1.13 fixation 10.1 fixative bath status 6.11 fixative bath, ordering 13.2 fluid specimens collection 5.3 preparation 5.17 FNA specimens collection 5.3 preparation 5.14 fuse 1.13 1.21 8.21 replacing 8.21 fuse, ordering 13.2 gather diagnostics 6.79 glacial acetic acid 4.6 5.23...
Page 330 NDEX instrument name 6.28 Intended use (ThinPrep 5000 Processor) 1.2 interrupt a batch 6.19 lab name 6.27 language selection 6.32 leak test 8.13 Load carousel 7.14 filters, slides, vials 7.25 load baths 6.12 slide cassette with slides 7.7 lubricant 4.2 main screen during processing 6.16...
Page 331 NDEX OCR label format 7.23 operator’s manual, ordering 13.2 pad, robotic arm waste bin 13.2 pause a batch 6.19 7.33 power 1.13 power off 2.7 power on 2.5 power on self-test 1.15 power switch 2.5 PreservCyt Solution 3.1 13.5 antimicrobial properties 3.3 composition 3.1 packaging 3.1 stability 3.2...
Page 332 NDEX safety data sheet CytoLyt Solution 1.23 PreservCyt Solution 1.23 sample is dilute 9.2 sample processing errors 9.1 sample too dense 9.2 save a report to USB key 6.73 segment of ID 6.53 shutdown extended 2.8 normal 2.7 silence alarm 6.31 slide details 6.7 slide ID duplicate 9.9...
Page 333 NDEX status bar 6.3 status indicators 6.5 7.21 switch modes 6.21 symbols used on the instrument 1.16 system error 9.18 code 9.24 system settings 6.23 Technical Solutions 12.1 Technical Support 12.1 ThinPrep Pap Test 1.3 ThinPrep Pap Test filters 7.2 13.3 ThinPrep Pap Test kit 13.3 time 6.26...
Page 334 NDEX vial and slide ID pre-match 6.32 vial details 6.9 vial labels 7.4 vials pane on main screen 6.8 voltage 1.13 Warnings, Cautions, Notes 1.15 waste bottle 8.10 8.14 waste bottle, ordering 13.2 weight 1.12 Index.8 ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual...
Page 336 The system does not recognize the type of vial, ﬁlter or slide on its own. Hologic, Inc. • 250 Campus Drive • Marlborough, MA 01752 USA 1-800-442-9892 • 1-508-263-2900 • www.hologic.com Hologic BVBA • Da Vincilaan 5 • 1930 Zaventem • Belgium...
Page 337 – placing labels on the torque features of the vial ©2020 Hologic, Inc. All rights reserved. This guide is designed to be used in conjunction with, but not to replace, the ThinPrep® 5000 Processor Operator’s Manual. As with all laboratory procedures, universal precautions should be followed.
Page 338 Load Slide Cassettes into the Instrument Load Vial Trays into the Instrument ©2021 Hologic, Inc. All rights reserved. This guide is designed to be used in conjunction with, but not to replace, the ThinPrep® 5000 Processor with AutoLoader Operator’s Manual. As with all laboratory procedures, universal precautions should be followed.
Page 339 U-shaped collar, all the way to the rear wall. - stops against the rear wall, - sits flat and - cannot be lifted up. ThinPrep 5000 Processor with AutoLoader Setup Guide English MAN-03930-001 Rev. 004...
Page 340 Consider emptying the filter waste bin each time the liquid waste bottle is emptied. Clean around carousel and dispersion areas Lint-free towel and deionized water Carousel area Dispersion area ThinPrep 5000 Processor with AutoLoader Maintenance Quick Reference Guide English MAN-03929-001 Rev. 005...
Page 341 • Replacing the carbon filter • Cleaning the carousel and the dust cover ©2021 Hologic, Inc. All rights reserved. Refer to the ThinPrep® 5000 Processor Operator’s Manual for full operating instructions, including any warnings, contraindications and safety information. Contact your local Hologic representa- tive or, in Canada, call Technical Support at 1-800-442-9892.
Page 342 Change the HEPA Filter ThinPrep® 5000 Processor with AutoLoader 1. Unlatch and open the door. 2. Replace the filter. Pay attention to which filter is the HEPA filter and which is the carbon filter. Match the arrows for the direction of air flow. 4. Conduct the air flow test. 3. Close and latch the fume extractor door. ©2021 Hologic, Inc. All rights reserved. Refer to the ThinPrep® 5000 Processor Operator’s Manual for full operating instructions, including any warnings, contraindications and safety information. Contact your local Hologic representative or, in Canada, call Technical Support at 1-800-442-9892. ThinPrep 5000 Processor with AutoLoader Change the HEPA Filter English MAN-03931-001 Rev. 004...
Page 343 ﬁ lter, if present, from the ﬁ lter stripper. In most cases, following the “Clear Media” steps will resolve the error. If an error is persistent, contact your local Hologic representative with the complete error code. Report the complete error code because, for some errors, the ﬁ rst four digits represent the error category, and the remaining characters represent additional information about the mechanisms involved and their actions at the time of the error.
Page 344 Press the button... on the touch screen and the slide will drop. Each button on the Clear Media screen must be pressed before the message box will close. ThinPrep 5000 Processor Error Recovery Guide English MAN-04004-001 Rev. 003...
Page 346 Hologic, Inc. Hologic BV 250 Campus Drive Da Vincilaan 5 Marlborough, MA 01752 USA 1930 Zaventem +1-508-263-2900 Belgium www.hologic.com MAN-07494-002 Rev. 003...

Hologic ThinPrep 5000 Operator's Manual

Table of Contents

C H a P T E R S I X User Interface

Quick Links

Chapters

Troubleshooting

Need help?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Hologic ThinPrep 5000

Summary of Contents for Hologic ThinPrep 5000

Table of Contents