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Hologic ThinPrep 3000 Operator's Manual

Hologic ThinPrep 3000 Operator's Manual

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  • Page 2 ® ThinPrep 3000 Processor Operator’s Manual OLOGIC 250 C AMPUS RIVE , MA 01752 USA ARLBOROUGH : 1-800-442-9892 1-508-263-2900 : 1-508-229-2795 HOLOGIC For Use With Version 1.x.y Software MAN-02586-001...
  • Page 3 ThinPrep 3000 processor. Preparation of microscope slides using the ThinPrep 3000 processor should be performed only by personnel who have been trained by Hologic or by organizations or individuals designated by Hologic.
  • Page 5 Instructions for Use MAN-03939-001 Rev. 004 page 1 of 13...
  • Page 6 INTENDED USE ® The ThinPrep 3000 Processor (TP-3000) is a device that produces cytologic preparations on glass microscope slides from gynecologic (cervical) samples, and is intended for use in cervical cytologic examinations of material collected for the ThinPrep Pap Test. TP-3000 prepared microscope slides are examined by trained cytotechnologists and pathologists for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions),...
  • Page 7  Preparation of slides on the TP-3000 should be performed only by personnel who have been trained by Hologic or by organizations or individuals designated by Hologic.  ®...
  • Page 8 Chlamydia trachomatis and Neisseria gonorrhoeae testing using the Roche ® Diagnostics COBAS AMPLICOR and Gen-Probe APTIMA COMBO 2 CT/NG assays should not be performed on a sample that has already been processed using the ThinPrep 3000 processor. WARNINGS  For In Vitro Diagnostic Use. ...
  • Page 9  PreservCyt Solution was challenged with a variety of microbial and viral organisms. The following table presents the starting concentrations of viable organisms, and the number of viable organisms found after 15 minutes in the PreservCyt solution. The log reduction of viable organisms is also presented. As with all laboratory procedures, universal precautions should be followed.
  • Page 10 LABORATORY AND PATIENT CHARACTERISTICS The cytology laboratories participating in the study were comprised of one referral center (designated as S1), one screening/referral center (designated as S2) and one screening center (designated as S3). The screening center in the study served patient populations (screening populations) with rates of abnormality (Low-grade Squamous Intraepithelial Lesion [LSIL] and more severe lesions) similar to the United States average of less than 5%.
  • Page 11 Table 2: Unadjudicated 7 x 7 Classification Table, All Categories TP-3000 NEG ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL 2570 2709 2000 ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL 2710 3224 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,...
  • Page 12 Table 5: Adjudicated Results by Site, LSIL and More Severe Lesions (Includes adjudicated cases only) Site Cases TP-3000 TP-2000 Method LSIL+ LSIL+ Value Favored 0.791 Neither 1.000 Neither 1.000 Neither For LSIL and more severe lesions, the adjudicated diagnostic comparison was statistically equivalent at all sites.
  • Page 13 Table 8 below shows the summary of the Bethesda System categories of the unadjudicated descriptive diagnosis data for all sites. Table 8: Unadjudicated Summary of Descriptive Diagnosis Descriptive Diagnosis TP-2000 TP-3000 Number of Patients: 3224 Benign Cellular Changes: 28.0 23.6 Infection: Trichomonas Vaginalis Candida spp.
  • Page 14 Table 9 shows the summary of the Bethesda System categories of the adjudicated descriptive diagnosis data for all sites. Table 9: Adjudicated Summary of Descriptive Diagnosis (Includes adjudicated cases only) Descriptive Diagnosis TP-2000 TP-3000 Number of Patients: 376 Benign Cellular Changes: 43.4 46.3 Infection:...
  • Page 15 Tables 10 and 11 show the summary of the Bethesda System categories of the unadjudicated and adjudicated specimen adequacy data for all sites. Table 10: Unadjudicated Summary of Specimen Adequacy Results Specimen Adequacy TP-2000 TP-3000 Number of Patients: 3489 Satisfactory 2985 85.6 2951...
  • Page 16 REQUIRED MATERIALS The TP-3000 consists of the following components:  The ThinPrep ® 3000 Processor (Model TP-3000)  ThinPrep 3000 Processor Operator’s Manual  Power Cord  Program Memory Card  Staining Rack Adapters  Accessory Kit MATERIALS REQUIRED BUT NOT PROVIDED ...
  • Page 17 3. Jones HW. Impact of The Bethesda System, Cancer 77 pp. 1914-1918, 1995. 4. American Cancer Society. Cancer Facts and Figures, 1995. Hologic, Inc. 250 Campus Drive Marlborough, MA 01752, USA  2017 Hologic, Inc. All rights reserved. 1-800-442-9892 www.hologic.com AW-07101-001 Rev. 006 MAN-03939-001 Rev. 004 page 13 of 13...

  • Page 19: Table Of Contents

    SECTION B: Overview of Instrument Systems SECTION C: Material Requirements SECTION D: ThinPrep 3000 Processor Technical Specifications SECTION E: Internal Quality Control 1.12 SECTION F: ThinPrep 3000 Processor Hazards 1.12 SECTION G: Disposal 1.17 Chapter Two THINPREP 3000 INSTALLATION SECTION A: General...
  • Page 20 ABLE OF ONTENTS Chapter Three PRESERVCYT AND CELLFYX SOLUTIONS SECTION A: Introduction ® SECTION B: PreservCyt Solution SECTION C: CellFyx™ Solution Chapter Four GYNECOLOGIC SAMPLE COLLECTION AND PREPARATION SECTION A: Introduction SECTION B: Specimen Collection SECTION C: Special Precautions SECTION D: Specimen Processing SECTION E: Sample Processing Troubleshooting Chapter Five INSTRUMENT OPERATION...
  • Page 21 ABLE OF ONTENTS Chapter Six INSTRUMENT MAINTENANCE SECTION A: Recommended Maintenance Schedule SECTION B: Fixative System Preventative Maintenance SECTION C: Emptying the Slide Waste Bin SECTION D: Lubricating the Sample Processing Arm O-Rings 6.10 SECTION E: Pneumatic System Testing 6.13 SECTION F: Cleaning the Slide Path 6.17 SECTION G: Replacing the Fixative Shield...
  • Page 22 MATERIAL SAFETY DATA SHEETS SERVICE.1 PreservCyt Solution CellFyx Solution Versa-Clean™ Solution APPENDIX ThinPrep 3000 Processor: Laboratory Flow Barcode Label Specifications for the ThinPrep 3000 Processor Sample Vial Label Application Guide ThinPrep 3000 Processor Quick Reference Guide ® ThinPrep 3000 Processor Operator’s Manual...

  • Page 24: Section A: Overview And Function Of The

    ® OVERVIEW AND FUNCTION OF THE THINPREP 3000 PROCESSOR The ThinPrep 3000 processor (refer to Figure 1-1) automates key steps in the batch processing of ® fluid-based gynecologic specimens for use with the ThinPrep Pap test. The samples are collected, processed, transferred and fixed onto microscope slides in preparation for staining, cover slipping and screening.
  • Page 25 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 3000 processor. (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 26 NTRODUCTION Figure 1-2 The ThinPrep Sample Preparation Process Dispersion Cell Collection Cell Transfer The sample vial is A gentle vacuum is The ThinPrep Pap test rotated, dispersing created in the filter is inverted and debris and mucus ThinPrep Pap test the collected cells are while thoroughly filter, which collects...

  • Page 27: Section B: Overview Of Instrument Systems

    Sample vials Results printer Slide printer Slide output Sample vial Filter waste bin Slide system Slide Display & keypad gripper translator cartridges Slide cell transfer arm Fixative reader dispenser THINPREP 3000 PROCESSOR (FRONT OF INSTRUMENT) ® ThinPrep 3000 Processor Operator’s Manual...
  • Page 28 NTRODUCTION Vial Handling System Figure 1-4 Vial Handling System 1. The sample vial is picked from the tray. 2. The barcode is scanned and read. 3. The sample vial is delivered to the sample processing station and the sample is dispersed by spinning the vial.
  • Page 29 NTRODUCTION Filter Handling System Figure 1-5 Filter Handling System Filter elevator (detail) New filter Used filter position position Disposal chute 1. A ThinPrep Pap test filter is picked from the tray. 2. The filter is delivered to the filter elevator. 3.
  • Page 30 NTRODUCTION Slide Handling System Figure 1-6 Slide Handling System 1. Slide cartridge(s) loaded with slides are placed in the instrument. 2. The slide translator picks a slide from the cartridge and carries it to the slide printer. 3. The barcode number scanned from the sample vial is printed onto the slide, along with the time, date and facility name (optional).

  • Page 31: Section C: Material Requirements

    NTRODUCTION SECTION MATERIAL REQUIREMENTS Components of the ThinPrep 3000 Processor 1. Slide printer ribbon 7. Waste bottle assembly 2. Staining racks 8. Filter waste box 3. CellFyx Solution 9. ThinPrep Pap test filter trays 4. Sample vials (with barcode) 10. Results printer paper 5.

  • Page 32: Section D: Thinprep 3000 Processor

    NTRODUCTION SECTION THINPREP 3000 PROCESSOR TECHNICAL SPECIFICATIONS ThinPrep 3000 Processor Dimensions All measurements in this manual are rounded to the nearest whole number. Note: Figure 1-8 Dimensions 57 in. (145 cm) 29 in. (74 cm) 49 in. (124 cm) Approximate weight: 700 lb/318 kg.
  • Page 33 NTRODUCTION ThinPrep 3000 Processor Clearances A minimum installation clearance of 1 foot (30.5 cm) at the rear, top, and sides of the instrument is required for ventilation. (Shown with service cover open.) Figure 1-9 Clearances Shown with service door open 9 in.
  • Page 34 Non-Operating Humidity Range: 15–95% RH, non-condensing Pollution Degree: II, in accordance with IEC 664. The ThinPrep 3000 processor is for indoor use only in an office or a clean laboratory environment. Power Voltage: 100–240~ (Volts Alternating Current, no selection required) Mains supply voltage not to exceed ±...

  • Page 35: Section E: Internal Quality Control

    INTERNAL QUALITY CONTROL Power On Self Test (POST) At the time the ThinPrep 3000 processor is powered on (refer to page 2.4) the system goes through a self-diagnostic test. Electrical, mechanical and software systems are tested to confirm each performs properly.
  • Page 36 NTRODUCTION Warning Symbol Used on the Instrument The ThinPrep 3000 processor has the exclamation mark within a triangle symbol placed on it specifically to warn the operator to refer to the operator’s manual. (Refer to the illustration below.) Be sure to review and understand the warnings listed below in order to avoid damage to the instrument and any harm to operators.
  • Page 37 NTRODUCTION WARNING Flammable Liquid and Vapor Flammable liquid and vapor. Keep away from heat, sparks, open flames and hot surfaces. WARNING Strong oxidizers, such as bleach, are incompatible with PreservCyt Solution and therefore should not be used to clean the waste bottle. WARNING Toxic Mixture Refer to Safety Data Sheets (SDS) at www.hologicsds.com for safe handling instructions.
  • Page 38 NTRODUCTION WARNING Waste Removal Use caution when emptying the waste bottle. Refer to “Emptying the Waste Bottle” on page 6.28 for instructions on removing and emptying the waste bottle. WARNING Do not process a cerebral spinal 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 a ThinPrep processor.
  • Page 39 NTRODUCTION A label illustrating how to remove and replace the slide printer ribbon is located inside the top hatch. Attention - labels are located at different parts of the instrument. Refer to the explanation and list of warnings on the previous pages. ®...

  • Page 40: Section G: Disposal

    • Pinch valve tubing. Dispose of as regular waste. • Broken glass. Dispose of in a Sharps container. • Super Lube. Dispose of as regular waste. Disposal of the Instrument Do not dispose in municipal waste. Contact Hologic for information regarding proper disposal. OLOGIC 250 C AMPUS RIVE...
  • Page 41 NTRODUCTION This page intentionally left blank ® 1.18 ThinPrep 3000 Processor Operator’s Manual...

  • Page 43: Chapter Two

    3000 Processor must be installed by Hologic service personnel. When installation is complete, the service personnel trains the operator(s), using the operator’s manual as the training guide. In the event the instrument must be moved after installation, please contact Hologic Technical Support.
  • Page 44 You will receive the following items when the ThinPrep 3000 processor is delivered for installation. (These items may vary according to your order.) • ThinPrep 3000 processor • ThinPrep 3000 Processor Operator’s Manual • Power cord • Program Memory Card •...

  • Page 45: Section C: Preparation Prior To Installation

    SECTION STORAGE AND HANDLING - POST INSTALLATION Be sure to clean and maintain the ThinPrep 3000 processor as instructed in this manual. Refer to “Instrument Maintenance” on page 6.1. If the instrument is to be moved after installation, please contact Hologic Technical Support.

  • Page 46: Section E: Connect Power

    *Serial port: For use by Hologic personnel only. SECTION HOW TO TURN THE PROCESSOR ON/OFF Turn the Processor On To turn the ThinPrep 3000 processor on, press the rocker switch, located by the power cord, as shown below. ® ThinPrep...
  • Page 47 To turn the instrument off, press the rocker switch to the opposite position. To completely remove power from the instrument, unplug the power cord from the wall outlet. The ThinPrep 3000 processor is intended to remain on. Note: Extended Shutdown (Taking the Instrument Out of Service) If the instrument is to be shut down for an extended time, turn it off as instructed above.

  • Page 48: Section G: System Startup

    User interface Upon startup, the instrument conducts an initial self test for several minutes. During this time, Self Test in Progress and a progress bar are displayed on the message screen: CYTYC ThinPrep 3000 TP3 xx.xxxxxx Corporation Self Test in Progress...

  • Page 49: Section H: Setting The Time And Date

    3000 I NSTALLATION SECTION SETTING THE TIME AND DATE Setting the Time In this procedure, first select the desired time format, then set the time. 1. In the main menu screen, select Menu. 2. Select Setup. 3. Select More (option at the upper right of the display). Set Time More Set Date...
  • Page 50 3000 I NSTALLATION 6. Press Back to return to the Set Time display screen. Select Set Time. Hour Set 1:05 PM Minute Set Back 7. To set the hour, press the Hour Set prompt key until the correct hour appears. 8.
  • Page 51 3000 I NSTALLATION Select Date Format MM/DD/YY Main Menu DD.MM.YY Back 6. Press Back to return to the Set Date display screen. Select Set Date. Year Set Month Set 04/28/00 Date Set Back 7. To set the year, press the Year Set prompt key until the correct year appears. 8.

  • Page 52: Section I: Setting The Slide Printer Output

    3000 I NSTALLATION SECTION SETTING THE SLIDE PRINTER OUTPUT The sample barcode number automatically prints on each slide. To record the date, time, and your facility’s name on the ThinPrep microscope slide, you must enter this information using this setup utility.

  • Page 53: Section J: Setting The Audible Key Press

    3000 I NSTALLATION SECTION SETTING THE AUDIBLE KEY PRESS This is an option that sounds a ‘beep’ every time a key on the user interface panel is pressed. 1. In the main menu screen, select Menu. 2. In the next display, select Setup. 3.
  • Page 54 3000 I NSTALLATION This page intentionally left blank ® 2.12 ThinPrep 3000 Processor Operator’s Manual...
  • Page 56 SECTION A: Introduction ® SECTION B: PreservCyt Solution ™ SECTION C: CellFyx Solution SECTION INTRODUCTION The following sections describe the function and specifications of Hologic cytologic preservative fluid, PreservCyt Solution and fixative fluid, CellFyx Solution. ® ThinPrep 3000 Processor Operator’s Manual 3.1...
  • Page 57 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 3000 processor. Vials (20 mL) of PreservCyt Solution are contained in each ThinPrep Pap Test Kit.
  • Page 58 ® ™ S RESERV OLUTIONS Storage Requirements • Store PreservCyt Solution between 15°C (59°F) and 30°C (86°F). Do not use beyond the expi- ration 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 59 ® ™ 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. PreservCyt Solution contains methanol.
  • Page 60 CellFyx Solution is a methanol-based, fixative solution designed to preserve morphologic features of cells for up to 5 days at room temperature. CellFyx Solution is optimized for the ThinPrep 3000 pro- cessor slide preparation process and cannot be substituted with any other reagents.
  • Page 61 ® ™ S RESERV OLUTIONS This page intentionally left blank ® ThinPrep 3000 Processor Operator’s Manual...
  • Page 62 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 63 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 64 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 65 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 66 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 67 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 68 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 69 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 70 ™ ® 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 72 YNECOLOGIC AMPLE OLLECTION AND REPARATION C h a p t e r F o u r Gynecologic Sample Collection and Preparation CONTENTS SECTION A: Introduction SECTION B: Specimen Collection SECTION C: Special Precautions SECTION D: Specimen Processing SECTION E: Sample Processing Troubleshooting SECTION INTRODUCTION ®...

  • Page 73: Section B: Specimen Collection

    YNECOLOGIC AMPLE OLLECTION AND 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 ecto- cervix.
  • Page 74 YNECOLOGIC AMPLE OLLECTION AND 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 spat- ula. 2. Rinse the spatula as quickly as possible into the PreservCyt Solution vial by swirling the spatula vigorously in the vial 10 times.

  • Page 75: Section C: Special Precautions

    YNECOLOGIC AMPLE OLLECTION AND REPARATION SECTION SPECIAL PRECAUTIONS ® PreservCyt Solution After sample transfer to the PreservCyt Solution vial, the sample should stand for at least 15 minutes before processing. For more information on PreservCyt Solution, refer to Chapter 3, “PreservCyt® and CellFyx™ Solutions”.
  • Page 76 • 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. Run on ThinPrep 3000 Processor Process samples on the ThinPrep 3000 processor. Refer to “Instrument Operation” on page 5.1. ® ThinPrep...

  • Page 77: Section E: Sample Processing Troubleshooting

    YNECOLOGIC AMPLE OLLECTION AND REPARATION SECTION SAMPLE PROCESSING TROUBLESHOOTING REPROCESSING A THINPREP PAP TEST SAMPLE VIAL FOLLOWING AN UNSATISFACTORY RESULT This section specifically addresses reprocessing ThinPrep Pap test samples following an Note: “unsatisfactory for evaluation” result. The ‘reprocessing’ of samples described in this section should not be confused with the reprocessing related to specimen sample errors outlined in Chapter 7 of this manual.
  • Page 78 Invert the centrifuge tube several times to mix and transfer the sample back into the retained specimen vial. 8 Process the specimen using a ThinPrep 3000 processor according to the pro- cedure for running gynecologic specimens. Evaluate the resultant slide according to The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnosis.
  • Page 79 YNECOLOGIC AMPLE OLLECTION AND REPARATION This page intentionally left blank ® ThinPrep 3000 Processor Operator’s Manual...
  • Page 81 NSTRUMENT PERATION C h a p t e r F i v e Instrument Operation CONTENTS SECTION A: Chapter Overview SECTION B: Optional Instructions for Ancillary Testing SECTION C: Instrument Doors SECTION D: Items Required to Begin Batch Processing SECTION E: Begin Batch Processing 5.14 SECTION F: Completing a Batch 5.18...

  • Page 82: Section B: Optional 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 3000 processor. ® ThinPrep...
  • Page 83 NSTRUMENT PERATION Removing an Aliquot (of up to 4 mL) from the PreservCyt Sample Vial prior to Performing the ThinPrep Pap Test Only one aliquot may be removed from the PreservCyt sample vial prior to performing the Note: ThinPrep Pap test, regardless of the volume of the aliquot (maximum aliquot volume = 4 mL).

  • Page 84: Section C: Instrument Doors

    NSTRUMENT PERATION SECTION INSTRUMENT DOORS Top door Slide printer cover Center door Front door Left & right cart doors Center cart door • Top door provides access to the slide cartridges, slide printer cover, staining racks, fixative ™ dispense area and the CellFyx Solution reservoir.

  • Page 85: Section D: Items Required To Begin Batch Processing

    NSTRUMENT PERATION SECTION ITEMS REQUIRED TO BEGIN BATCH PROCESSING To begin batch processing, it is necessary to have the following items ready for use: ® 1. Trays of Gyn ThinPrep Pap test filters 2. ThinPrep microscope slides and slide cartridges 3.
  • Page 86 NSTRUMENT PERATION Gyn ThinPrep Pap Test Filters ® Gyn ThinPrep Pap test filters are disposable, clear plastic cylinders used in the collection and trans- fer of cells from gynecologic specimens onto ThinPrep microscope slides. The filters come in trays of 100. Two trays can be loaded into the instrument. (A minimum of one is required.) Loading the Gyn ThinPrep Pap test filters CAUTION: Only replace filter trays if they are empty.
  • Page 87 The slides must be oriented correctly to work with the automated functions of the Note: ThinPrep 3000 processor. The microscope slide package and the slide cartridge are keyed to ensure accurate loading of slides. A visual check of the slides after being loaded into the cartridge is recommended.
  • Page 88 NSTRUMENT PERATION 4. Place an open slide cartridge over the slide package so that its metal grooves fall into the cutout slots. 5. Holding them together, gently flip the slide cartridge and slide package over. 6. After the slides are transferred into the slide cartridge, remove and discard the wrapper and plas- tic package.
  • Page 89 NSTRUMENT PERATION 7. Tilt the cartridge up slightly and make sure the slides are aligned squarely, evenly and are sitting flat on the bottom of the cartridge. Confirm correct orientation of the slides. Gently close the slide cartridge door over the slides. The latch will click when the cartridge is completely closed. Loading the slide cartridges into the processor CAUTION: Only reload slide cartridges when prompted by the instrument.
  • Page 90 NSTRUMENT PERATION Incorrect Cradle Lever Correct 3. Place an empty staining rack into each of the four cradles. ® 5.10 ThinPrep 3000 Processor Operator’s Manual...
  • Page 91 NSTRUMENT PERATION Removing the staining racks 1. Positioning the thumb and index finger of one hand, grasp the rack as shown below. CAUTION: Avoid touching the slides with your fingers when removing the staining racks. 2. With the other hand, pull the lever down. CAUTION: Slides are not securely held in the staining rack.
  • Page 92 Place sample vials into the numbered holes of the sample vial tray (the tray does not have to be full to run a batch; the vials can be in any order). The ThinPrep 3000 processor can process up to 80 samples, (two full sample vial trays) per batch.
  • Page 93 NSTRUMENT PERATION Loading the sample vial trays 1. Open the tray latches as shown below. WARNING: Sharp Edges & Hot Surfaces. Moving Parts Tray latch closed Tray latch open 2. Remove any previously processed sample vial trays, if present. 3. Load the sample vial trays into the empty slots so that the ThinPrep Pap test logo on the tray is facing outward.

  • Page 94: Section E: Begin Batch Processing

    NSTRUMENT PERATION SECTION BEGIN BATCH PROCESSING 1. Confirm that the main menu, shown below, is displayed. If this menu is not displayed, follow the prompts to return to the main menu. System Ready Start Batch Load Samples and Supplies Menus Select "Start Batch"...
  • Page 95 NSTRUMENT PERATION If the instrument does not detect materials necessary to process a batch, the “Items Must Be Addressed” message screen appears. Items Must Be Addressed Items Must Be Addressed: Filters Slides Staining Racks Continue Sample Tray Add Fixative Fluid Empty Waste Bottle and Waste Bins Cancel Insert Clean Fixative Shield...
  • Page 96 NSTRUMENT PERATION Sample trays The processor does not detect at least one tray of sample vials. • A minimum of one sample tray must be loaded before batch processing can begin. CAUTION: Never add fixative unless prompted by the instrument. Only add one bottle to the fix- ative reservoir.
  • Page 97 NSTRUMENT PERATION Please Address Items Please Address Items: Filters Slides Staining Racks Load Sample Trays Continue This message notifies you that these items are low in supply. Although the processor can start batch processing, the full batch of sample vials may not be completed. The following items may appear on this screen: Filters Slides...

  • Page 98: Section F: Completing A Batch

    NSTRUMENT PERATION Processing begins when the following screen is displayed: Batch Status Pause Samples In Process Processed SECTION COMPLETING A BATCH 1. At the completion of batch processing, “Batch Complete, Unload Staining Racks & Remove Vial Trays” is displayed on the message screen. If a sample error occurred, a bottom line reads “Address Samples with Processing Errors”.
  • Page 99 NSTRUMENT PERATION 6. Fold and insert the appropriate batch report into its corresponding sample vial tray for identifica- tion. Place the report so that the time and date can be seen. This will aid in locating a sample if nec- Note: essary.
  • Page 100 NSTRUMENT PERATION SECTION READING THE BATCH REPORT A sample batch report is shown. The samples needing operator attention are marked with an asterisk. TP 3000 Batch Result Date Instrument/batch Time batch was started identification 04/28/00 07:35 Software TP3 XX.XXXXXXXX revision Instrument serial Serial No.: 00001A00A0 number...

  • Page 101: Section G: Reading The Batch Report

    24-hour format, even if you have configured your display to show a.m. and p.m.), the version of software running on the ThinPrep 3000 processor and the instrument serial number. Refer to Chapter 7, “Troubleshooting”, for detailed sample status, error description and resolution.

  • Page 102: Section H: Pausing A Batch In Process

    NSTRUMENT PERATION SECTION PAUSING A BATCH IN PROCESS Processing of a batch may be halted and resumed using the “Pause” function. (For example, an oper- ator may wish to remove completed staining racks for staining while the instrument finishes processing the batch.) 1.

  • Page 103: Section I: Canceling A Batch In Process

    NSTRUMENT PERATION SECTION CANCELING A BATCH IN PROCESS A batch that has begun processing may be canceled by using the “Pause” function. (For example, an operator may wish to start a small batch over again if a large number of samples is delivered to the lab, or to process rush samples.) 1.
  • Page 104 NSTRUMENT PERATION Batch Canceled Due To Cancellation By User Continue 4. Carefully unload the staining racks from the processor. 5. Tear off the printed batch report by pulling it toward you, against the edge of the paper opening. 6. Separate “A” (top) batch report from “B” (bottom) batch report. 7.
  • Page 106 NSTRUMENT AINTENANCE C h a p t e r S i x Instrument Maintenance CONTENTS SECTION A: Recommended Maintenance Schedule SECTION B: Fixative System Preventative Maintenance SECTION C: Emptying the Slide Waste Bin SECTION D: Lubricating the Sample Processing Arm O-Rings 6.10 SECTION E: Pneumatic System Testing 6.13...

  • Page 107: Section A: Recommended Maintenance Schedule

    NSTRUMENT AINTENANCE SECTION RECOMMENDED MAINTENANCE SCHEDULE ® Regular maintenance of the ThinPrep 3000 processor will greatly reduce the risk of sample handling or mechanism errors. A brief outline of recommended maintenance is listed below. The same proce- dures in chart form are on the next two pages, which may be removed and copied as needed. Daily Maintenance •...
  • Page 108 NSTRUMENT AINTENANCE ® ThinPrep 3000 Processor Operator’s Manual 6.3...
  • Page 109 NSTRUMENT AINTENANCE ® ThinPrep 3000 Processor Operator’s Manual...

  • Page 110: Section B: Fixative System Preventative Maintenance

    NSTRUMENT AINTENANCE SECTION FIXATIVE SYSTEM PREVENTATIVE MAINTENANCE CellFyx Solution fixes the prepared slides inside the instrument. The fixative properties of being very tacky as well as quick-drying can cause the slender air brush dispenser to clog easily. Long idle peri- ods (when fixative is not being sprayed) may cause a clog to form.
  • Page 111 NSTRUMENT AINTENANCE 4. Observing the tip of the nozzle, press the Spray key. • If a fine, evenly distributed fan of fixative is sprayed, the solution is running freely through the system. • If there is no spray visible or the spray is uneven, repeat steps 3 and 4 several times. Desired spray Spray pattern pattern...
  • Page 112 Stop pressing Prime and hold the lever up for 30 to 60 seconds. CAUTION: The spray nozzle that delivers fixative solution to the slides is very delicate. DO NOT attempt to disassemble it. If recommended maintenance does not dissolve a clog, contact Hologic Technical Support.
  • Page 113 NSTRUMENT AINTENANCE 4. Remove the container from the nozzle. Prime and spray as outlined previously, until the proper spray pattern is achieved. 5. Repeat steps 3 and 4 as needed. A longer soak time of 5–10 minutes and holding the spray lever up will help.

  • Page 114: Section C: Emptying The Slide Waste Bin

    WARNING: Sharp Edges Glass 1. Open the front door on the ThinPrep 3000 processor. 2. Open the center door. 3. Remove the slide waste bin. 4. Dispose of the glass waste according to your laboratory’s guidelines.
  • Page 115 NSTRUMENT AINTENANCE SECTION LUBRICATING THE SAMPLE PROCESSING ARM O-RINGS Once a day, or at the start of each shift, lubricate the sample processing arm (filter seal) O-rings. This maintenance lubricates the O-rings for ease of filter loading and disposal. Filter load failure errors and filter handling errors may occur if the sample processing arm O-rings are dry.
  • Page 116 NSTRUMENT AINTENANCE 4. Wet the end of a swab with lubricant (Super Lube) and spread a light layer all around the inside surface of the pneumatic test vial. 5. Load the pneumatic test vial into tray position A1, which is the first slot of the upper sample vial tray.
  • Page 117 NSTRUMENT AINTENANCE Preparing Mechanisms for O-Rings Lube SPA Stem O-Rings Lubrication in Progress “SPA O-Rings Lubrication In Progress” appears on the message screen throughout the duration of the procedure. 9. The message screen displays completion of the lubrication. SPA Stem O-Rings Lubrication Complete Continue Press Continue.

  • Page 118: Section E: Pneumatic System Testing

    NSTRUMENT AINTENANCE SECTION PNEUMATIC SYSTEM TESTING The pneumatic system must be tested to verify proper operation. The message “Please Run Pneumatic Test” will display when this is required. It is important to run the test when prompted. The test will take approximately 9 minutes to com- plete.
  • Page 119 NSTRUMENT AINTENANCE 4. Wet the end of a swab with lubricant and spread a light layer all around the inside surface of the pneumatic test vial. 5. Load the pneumatic test vial into tray position A1, which is the first slot of the upper sample vial tray.
  • Page 120 NSTRUMENT AINTENANCE The following sequence of screens will be displayed. Preparing Mechanisms for Pneumatic Test Calibrating PMS for Pneumatic Test “Pneumatic Test In Progress” appears on the message screen throughout the duration of the sys- tem testing. Pneumatic Test in Progress 9.
  • Page 121 13. Repeat the pneumatic system test one more time. CAUTION: Do not process samples on the instrument after failing pneumatic system testing. Contact Hologic Technical Support. 14. If the pneumatic test fails again, contact Hologic Technical Support before resuming instrument operation. ®...

  • Page 122: Section F: Cleaning The Slide Path

    NSTRUMENT AINTENANCE SECTION SECTION CLEANING THE SLIDE PATH CAUTION: Proper instrument operation depends on routinely cleaning the slide path, as prompted. Frequent cleaning of the mechanisms which handle the slides will greatly reduce the risk of sample errors or slide handling problems. The message “Please Clean Slide Path” will display when this is required.
  • Page 123 NSTRUMENT AINTENANCE Inside of Slide Cartridge Well Remove the slide cartridges and pull the black bezel off by pulling it upward. With a damp, lint-free cloth, wipe the surfaces to remove dust and any slide debris. Slide Printer Area Open the lid covering the slide printer. If a slide is there, remove it. Using a water dampened swab, clean the black urethane pads on the arms of the slide pick mechanism.
  • Page 124 The slide cell transfer arm is located centrally in the instru- ment (refer to Slide Handling System illustration on page 1.7). Use the ThinPrep 3000 Maintenance Kit to clean the slide cell transfer arm and slide ejector path. Directions are below. The first time you use the kit, the cleaning solu- tion must be mixed.
  • Page 125 NSTRUMENT AINTENANCE 2. Put an ordinary paper towel under the slide cell transfer arm to catch the cleaning solution that drips off of the mechanism. 3. From the Maintenance menu, select System Access. Lube O-Rings System Access Fixative System Main Menu Paper Advance Back Open...
  • Page 126 NSTRUMENT AINTENANCE 6. Wipe the solution off the arm using lint-free wipes. Wipe from the top to the bottom, moving Loose Link gently around the slide clamps. Hole 7. Using foam tipped swabs, wipe out the grooves in the slide holder part of the arm, around the joints and underside of the slide clamps, the loose Slide Presence link holes and the slide presence switch.
  • Page 127 NSTRUMENT AINTENANCE Slide ejector tip Slide ejector path Rollers Staining rack Fixative spray cradles area Fixative spray area Using a swab or lint-free cloth moistened with water, clean around the fixative spray area as shown above. The staining rack cradles should be cleaned of spray and any glass dust. Replace the fixative shield when finished.

  • Page 128: Section G: Replacing The Fixative Shield

    NSTRUMENT AINTENANCE SECTION REPLACING THE FIXATIVE SHIELD The fixative shield collects excess CellFyx Solution from the fixative spray noz- zle during its distribution onto the slide. Each time the fixative is replenished with a bottle of CellFyx Solution, dispose of the old fixative shield and replace it with a new one. Remove the Fixative Shield WARNING: Toxic Mixture Highly Flammable Liquid and Vapor...

  • Page 129: Section H: General Cleaning

    CAUTION: Do not use strong solvents such as acetone or xylene, as they may damage the paint or plastic surfaces. We suggest you wipe down the exterior of the ThinPrep 3000 processor monthly or as needed with a lint-free wipe dampened with water. Clean the inside front door and under the top door and slide printer cover.
  • Page 130 NSTRUMENT AINTENANCE Preparing Mechanism, Please Wait Open Slide Clamps Close Open Evac Valve Close Access Available Continue Press Continue When Finished 4. When the screen above displays, the doors will unlock. The instrument may be accessed. When finished, close the doors and press Continue. The following screen will display.

  • Page 131: Section I: Pinch Valve Tubing Replacement

    The doors will lock while the processor moves trays and mechanisms out of the way for access to the instrument. The doors will unlock and the following screen is displayed: CAUTION: Only use Hologic-supplied tubing for replacement. Open Slide Clamps...
  • Page 132 NSTRUMENT AINTENANCE 4. Hold the tubing on each side of the pinch valve and slide it in an upward motion, as shown below. Removal Replacement 5. Discard the old tubing. 6. Slide the new tubing back down into the pinch valve opening. Make sure it is completely seated in the valve, with no kinks.

  • Page 133: Section J: Waste System Maintenance

    NSTRUMENT AINTENANCE SECTION WASTE SYSTEM MAINTENANCE Waste resulting from sample processing is routed to and stored in the waste bottle. Waste tubing Waste cap Waste bottle M A X Emptying the Waste Bottle The message screen will notify you when to empty the waste bottle. The batch will not begin until the waste bottle has been emptied.
  • Page 134 NSTRUMENT AINTENANCE 3. Place the transport cover onto the waste bottle for transport- Transport cover ing. 4. Remove the waste bottle from the instrument. 5. Dispose of the liquid waste from the waste bottle according to your laboratory guidelines. Dispose of all solvents as hazard- ous waste.
  • Page 135 NSTRUMENT AINTENANCE • If debris is present, clean the seal with water using a lint-free wipe. • Apply a thin layer of lubricant to the O-ring. O-ring seal 7. Return the waste bottle back to its original location and retighten the waste cap onto the bottle. •...

  • Page 136: Section K: Emptying The Filter Waste Box

    Waste box liner 1. Open the center door on the ThinPrep 3000 processor cabinet. 2. Carefully pull the filter waste box out of the cabinet. Look for loose filters that might have missed the waste box and remove them as well.
  • Page 137 REPLENISHING CELLFYX SOLUTION CellFyx Solution is a methanol-based fixative that is designed to preserve the morphologic features of the cell nucleus and cytoplasm. It is formulated for use with the ThinPrep 3000 processor. WARNING: Toxic Mixture Highly Flammable Liquid and Vapor Do not use any other fixative solution with the instrument.
  • Page 138 NSTRUMENT AINTENANCE If the solution drips or spills, take care to wipe it off the surface of the instrument at that time. Note: Do not let CellFyx Solution remain on the machine. Insert Clean Fixative Shield Remove the fixative shield and dispose of it. Replace it with a new fixative shield. Refer to “REPLACING THE FIXATIVE SHIELD”...

  • Page 139: Section M: Replacing The Slide Printer Ribbon

    NSTRUMENT AINTENANCE SECTION REPLACING THE SLIDE PRINTER RIBBON The slide printer ribbon is used to print the sample ID number and labora- tory information directly onto the slides prior to sample processing. The message screen will notify you when to replace the slide printer ribbon cartridge.
  • Page 140 NSTRUMENT AINTENANCE 6. Insert the cartridge with the tab in the center facing outward, as shown. Guide Lock • When inserting the cartridge, the printing ribbon should be routed slightly below the print head and above the ribbon separator, as shown below. Ribbon Ribbon feed knob...

  • Page 141: Section N: Replacing The User-Accessible Fuses

    NSTRUMENT AINTENANCE SECTION REPLACING THE USER-ACCESSIBLE FUSES There are two user-accessible fuses located in the instrument. If the instrument fails to operate, replace these fuses as outlined below: 1. Turn off the instrument. 2. Remove the power cord from the wall outlet. 3.
  • Page 142 NSTRUMENT AINTENANCE Fuse holder 7. Remove the existing fuses and discard them. Refer to the Ordering Information in this manual for ordering fuses. 8. Insert two new 250V T6.3AL 5x20 mm fuses into the fuse holder as shown. 9. Insert the fuse holder back into the power entry module. The module can only be installed in one orientation.

  • Page 143: Section O: Replacing The Results Printer Paper

    NSTRUMENT AINTENANCE 11. Plug the power cord into the socket on the instrument. 12. Reattach the power cord to the wall outlet. 13. Turn on the instrument. 14. If the instrument still fails to operate, contact Technical Support. SECTION REPLACING THE RESULTS PRINTER PAPER The results printer paper roll needs to be replaced when a red or black line appears along the edge of the batch report.
  • Page 144 NSTRUMENT AINTENANCE 1. Open the lid above the user interface panel. 2. If there is still paper left on the roll, press the left side of the green release lever down. Pull the end of the paper out from under the platen. Return the lever to the set position. 3.
  • Page 145 NSTRUMENT AINTENANCE 5. Slide the new thermal paper roll onto the metal roll holder. The paper has a thermal sensitive side, on which the results are printed. If the batch report is Note: not printing properly, check to see if the paper is loaded correctly. The orientation of the roll should be as shown, with the feeding edge being pulled from the bottom of the roll.
  • Page 146 NSTRUMENT AINTENANCE RELEASE 9. Select Menu from the main menu. 10. Select Maintenance. 11. Press and hold Paper Advance to advance the paper three to four inches. Lead it through the opening of the cover. Lube O-Rings System Access Fixative System Main Menu Paper Advance Back...
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  • Page 149 ROUBLESHOOTING C h a p t e r S e v e n Troubleshooting CONTENTS SECTION A: Chapter Overview SECTION B: Sample Errors SECTION C: System Fault Errors 7.30 SECTION D: Batch Canceled Due To’ Reporting 7.53 SECTION CHAPTER OVERVIEW Instrument troubleshooting falls into two categories: Sample Errors and System Fault Errors.
  • Page 150 ROUBLESHOOTING Reprocessing Required (continued) Too Much Vial Fluid 7.24 Vial Cap Too Tight 7.26 Waste System Failure 7.28 System Fault Errors 7.30 Reprocessing Required Vial Handling Operation 7.32 Filter Handling Operation 7.38 Slide Handling Operation 7.44 ‘Batch Canceled Due To’ Reporting 7.53 SECTION SAMPLE ERRORS...
  • Page 151 ROUBLESHOOTING Figure 7-1 Batch Report Example with Special Sample Status and Reprocessing Required Date TP 3000 Batch Result Instrument/batch Time batch was started identification Software 04/28/00 07:35 TP3 XX.XXXXXXXX revision Instrument serial Serial No.: 00001A00A0 number Sample tray Tray A Reprocessing Required Lists reason Reason...

  • Page 152: Sample Is Dilute

    ROUBLESHOOTING Sample Is Dilute Special Sample Status This error message indicates the entire sample was utilized in preparing the slide. This is usually caused by a low concentration of cells in the sample. This message usually indicates a problem with the sample that was collected, rather than an issue with the instrument and its mechanisms.
  • Page 153 Does the error message persist No further action required. with subsequent samples? Perform the pneumatic system test Did the pneu- Contact Hologic matic system Technical Support. test pass? No further action required. ® ThinPrep 3000 Processor Operator’s Manual 7.5...

  • Page 154: Reprocessing Required

    2. Examine the vial cap and remove plastic outer packaging, if it is present. Examine the cap for defect or damage. 3. Reprocess the sample vial. 4. If the error persists with subsequent batches, contact Hologic Technical Support. Preventative Action When loading sample vial trays, ensure that all vials are unwrapped of their outer packaging and do not exhibit any obvious damage.
  • Page 155 ROUBLESHOOTING Cap Tighten Failure Reprocessing Required Before reprocessing, remove any extra outer packaging on the vial. Reprocess the sample. Does the Contact Hologic message Technical Support. persist? No further action required. ® ThinPrep 3000 Processor Operator’s Manual 7.7...
  • Page 156 000000010531 000000018376 permanent marker or pen. Place the new barcode label else- 000000018377 where on the vial. 000000018378 000000018379 000000018380 3. If this error persists with subsequent batches, contact Hologic Tech- 000000018381 000000018382 nical Support. 000000018383 000000010527 B15* 000000010532 000000010533...

  • Page 157: Duplicate Barcode

    Locate the sample vial indicated on the batch report. Mark the vial with its tray posi- tion. Check its barcode against barcodes on already processed vials in that batch. Is the Contact Hologic barcode a Technical Support. duplicate? TP 3000 Batch Result Mark the tray position on each vial.

  • Page 158: Filter Load Failure

    Refer to “LUBRICATING THE SAMPLE PROCESSING ARM O- RINGS” on page 6.10. 4. Reprocess the sample. 5. If the message persists with subsequent processing, contact Hologic Technical Support. Preventative Action Perform the Lube O-Rings maintenance daily or at the start of each shift. Perform the pneumatic test when prompted.
  • Page 159 Filter Load Failure error. Are dropped filters found in the filter Discard dropped filters. area? Perform Lube O-Rings maintenance. Reprocess the sample. Does the Contact Hologic message Technical Support. persist? No further action required. ® ThinPrep 3000 Processor Operator’s Manual 7.11...

  • Page 160: Fixative Clog

    ROUBLESHOOTING Fixative Clog Reprocessing Required A fixative clog developed, causing the batch to terminate. The sample must be reprocessed; no slide was made. Possible Cause • The instrument has been idle for an hour or more, enabling the fixative solution to form a clog in the spray nozzle.
  • Page 161 Chap- ter 6, Section B. Reprocess the sample. Does the message Perform a pneumatic persist? system test. Did the No further action required. Contact Hologic test Technical Support. pass? Reprocess the sample. Does the message Contact Hologic persist? Technical Support.

  • Page 162: Insufficient Vial Fluid

    ROUBLESHOOTING Insufficient Vial Fluid Reprocessing Required The vial does not contain enough sample fluid to properly process the sample. The sample was not processed and a slide was not made. Possible Cause • Previous testing with the sample vial may have reduced the volume of sample fluid in the vial below the minimum required.
  • Page 163 Add PreservCyt Solution, if needed. Reprocess the sample. Does the No further action required. message persist? Perform the pneumatic system test. Did the pneu- Contact Hologic matic system Technical Support. test pass? Reprocess the sample. Does the Contact Hologic message Technical Support.

  • Page 164: No Barcode

    4. Confirm that a bar code label for use with the ThinPrep 3000 processor is applied to the sample vial. Apply a correct type of bar code label and update the patient information with a matching label.
  • Page 165 Check the orientation and condition of the label. Replace if necessary. Remove/obliterate old barcode label. (Update the patient information.) Reprocess the sample. Does the Contact Hologic message Technical Support. persist? No further action required. ® ThinPrep 3000 Processor Operator’s Manual 7.17...

  • Page 166: Out Of Consumables

    ROUBLESHOOTING Out of Consumables Reprocessing Required Required consumable item(s) are not in place to process sample vials, consequently the sample vial cannot be processed. If the instrument detects that there are not enough consumable items to complete processing a sam- ple, the “Items Must Be Addressed”...
  • Page 167 ROUBLESHOOTING Out of Consumables Reprocessing Required The batch halts processing and the message screen shown below appears. Only items needing attention will be listed. The display may show some or all of Note: the items listed below. Items Must Be Addressed: Filters Slides Staining Racks...

  • Page 168: Pneumatic Failure

    1. Perform a pneumatic system test. Refer to “PNEUMATIC SYSTEM TESTING” on page 6.13. 2. If the test passes, reprocess the sample. 3. If the pneumatic test fails, or if the message persists with subsequent processing, contact Hologic Technical Support.
  • Page 169 ROUBLESHOOTING Pneumatic Failure Reprocessing Required Perform a pneumatic system test. Did the test Contact Hologic pass? Technical Support. Reprocess the sample. Does the Contact Hologic message Technical Support. persist? No further action required. ® ThinPrep 3000 Processor Operator’s Manual 7.21...

  • Page 170: Slide Misprint

    THE SLIDE PATH” on page 6.17, cleaning the slide path. 5. Reprocess the sample vial. 6. If the error persists with subsequent batches, contact Hologic Technical Support. Preventative Action Inspect the quality of the printed text on the slides from time to time. Change the printer ribbon car- tridge when the text becomes too light.
  • Page 171 Is the thumbscrew on Tighten the thumb- the slide printer screw. Refer to chassis secure? Chapter 6, Section F. Reprocess the sample. Does the Contact Hologic message Technical Support. persist? No further action required. ® ThinPrep 3000 Processor Operator’s Manual 7.23...
  • Page 172 2. Perform the pneumatic system test. Refer to “PNEUMATIC SYSTEM TESTING” on page 6.13. If the test passes, reprocess the sample. 3. If the pneumatic test fails, or if the message persists with subsequent processing, contact Hologic Technical Support. Preventative Action If PreservCyt Solution is added to a sample vial, ensure that the fluid does not exceed the maximum level, which is indicated by the frosted area of the vial.
  • Page 173 Is the volume Perform the pneumatic system test. above the frosted area of the vial? Did the pneumatic Contact Hologic Remove excess fluid and store in an system test Technical Support. appropriate container. pass? Reprocess the sample. Does the...
  • Page 174 2. Before reprocessing, loosen the cap. Tighten again and align the mark on the cap with the line on the vial. 3. Reprocess the sample vial. 4. If the error persists with subsequent batches, contact Hologic Technical Support. Preventative Action Avoid overtightening the cap onto the sample vial.
  • Page 175 Vial Cap Too Tight Reprocessing Required Before reprocessing, loosen the cap. Tighten again to align the mark on the cap with the line on the vial. Reprocess the sample. Does the Contact Hologic message Technical Support. persist? No further action required. ® ThinPrep...
  • Page 176 (Refer to “PINCH VALVE TUBING REPLACEMENT” on page 6.26.) Replace tubing if it is damaged. 3. Contact Hologic Technical Support if the error persists. Preventative Action Empty the waste bottle when prompted to do so by the instrument. Refer to “WASTE SYSTEM MAINTENANCE”...
  • Page 177 Refer to Chapter 6, Chapter 6, Section J. or discon- Section E. nected? Reconnect or replace Did the Contact Hologic the pinch tubing as test pass? Technical Support. described in Chapter 6, Section I. Reprocess the sample.
  • Page 178 ROUBLESHOOTING SECTION SYSTEM FAULT ERRORS Reprocessing Required System fault errors indicate a mechanical malfunction has occurred within the instrument while han- dling a consumable item, during sample processing, or during system self test. The sample is not processed if the fault occurs during batch processing. The instrument also stops processing the remainder of the batch.
  • Page 179 Press Continue. The doors Press Continue. The doors unlock. Remove sample trays unlock. Remove sample and any prepared slides. Unpro- trays and any prepared cessed samples go into a new slides. batch. Contact Hologic Technical Support. ® ThinPrep 3000 Processor Operator’s Manual 7.31...
  • Page 180 ROUBLESHOOTING Vial Handling Operation 1. The sample vial is picked from the tray. 2. The barcode is scanned and read. 3. The sample vial is delivered to the sample processing station and the sample is dispersed by spinning the vial. 4.
  • Page 181 Alarm Off 15 XX XX XX [x xx xx xx xx] Continue Error/sample status codes (record for Hologic Technical Support) Possible Cause • Labels applied improperly to the sample vial • A foreign object is in the sample vial. • Barcode scanning problem or error •...
  • Page 182 ROUBLESHOOTING Vial operation Refer to “Barcoded Sample Vials” on page 5.12 for sample vial label application guidelines. 4. Check the condition of the sample vial(s) which caused the system fault. (The sample(s) will be flagged with an asterisk on the batch report, and described as a system fault error.) •...
  • Page 183 Repeat steps 1 through 7, above, to try to clear any obvious mechanical jams or interference. If the system does not recover, the following screen is displayed: Please Check Mechanism Continue Any mechanical faults should be addressed by Hologic Technical Support. If errors recur, or do not appear as described here, contact Hologic Technical Support. ® ThinPrep...
  • Page 184 ROUBLESHOOTING Vial Handling System Fault Recovery WARNING: Sharp Edges Hot Surfaces A System Fault occurs. The instrument halts, with a display of “Vial Handling Error”. The batch report prints. Press Continue. The instrument moves mechanisms to allow internal access. The doors unlock. Remove the sample trays and inspect the vial bay area.
  • Page 185 See Slide Error "Slide Handling Handling Section. Error" display? Allow the instrument to attempt to recover. "Check Mechanism" message displays. Press Continue. Remove the sample trays and any prepared slides. Contact Hologic Technical Support. ® ThinPrep 3000 Processor Operator’s Manual 7.37...
  • Page 186 ROUBLESHOOTING Filter Handling Operations Filter elevator (detail) New filter Used filter position position Disposal chute 1. A ThinPrep Pap test filter is picked from the tray. 2. The filter is delivered to the filter elevator. 3. The sample processing arm retrieves the filter. 4.
  • Page 187 Alarm Off 15 XX XX XX [x xx xx xx xx] Continue Error/sample status codes (record for Hologic Technical Support) Possible Cause • Error finding, transporting or disposing of filter • Filter dropped • A non-gynecological filter was detected. (Error code 16 13 42 30) •...
  • Page 188 ROUBLESHOOTING Filter operation Look at the sample processing arm, to see if a filter is stuck or was not pushed all the way on. Remove it. Look to see if a filter is stuck in the new filter position of the filter elevator. Remove it. (See illustra- tion to the right on page 7.38.) If the error code is specifically 16 13 42 30, a non-gynecological filter was detected in the system.
  • Page 189 Continue 8. Press Continue. The main menu will display. Remove sample trays and staining racks. Any mechanical faults should be addressed by Hologic Technical Support. If errors recur, or do not appear as described here, contact Hologic Technical Support. ®...
  • Page 190 ROUBLESHOOTING Filter Handling System Fault Recovery WARNING: Sharp Edges Hot Surfaces A System Fault occurs. The instrument halts, with a display of "Filter Handling Error". The batch report prints. Press Continue. The instrument moves mechanisms to allow internal access. The doors unlock. Remove the filter trays and inspect the filter bay area.
  • Page 191 See Slide Error Handling Error" Handling Section. display? Allow the instrument to attempt to recover. "Check Mechanism" message displays. Press Continue. Remove the sample trays and any prepared slides. Contact Hologic Technical Support. ® ThinPrep 3000 Processor Operator’s Manual 7.43...
  • Page 192 ROUBLESHOOTING Slide Handling Operations 1. Slide cartridge(s) loaded with slides, are placed in the instrument. 2. The slide translator picks a slide from the cartridge and carries it to the slide printer. 3. The barcode number scanned from the sample vial is printed onto the slide, along with the time, date and facility name (optional).
  • Page 193 Alarm Off 15 XX XX XX [x xx xx xx xx] Continue Error/sample status code (record for Hologic Technical Support) Possible Cause: • Slide(s) jammed when picked from slide cartridge. • Slide misprint or caught in printer area • Slide fails to be released from slide transport arm.
  • Page 194 ROUBLESHOOTING WARNING: Glass Sharp Edges 3. Look in the slide handling area (Area C) for stuck or broken slides. Slide operation a. Check the staining racks to see if a slide was not ejected properly. (As example, the slide bumped the rack and was not ejected, or the staining rack was not aligned correctly.) If this is the case, manually remove the slide.
  • Page 195 ROUBLESHOOTING Slide presence switch Slide clamps Slide cell transfer The slide cell transfer arm, viewed from the arm, detail. vial bay with the sample trays removed. If the numeric error code is specifically 16 17 67 xx or 16 17 68 xx, the slide cell transfer arm must be thoroughly cleaned, especially the slide presence switch and the slide clamps.
  • Page 196 NANCE” on page 6.5 for detailed steps on reversing clogs. If the nozzle will not spray freely in a few attempts, contact Hologic Technical Support. 4. Close the door(s) and press Close to shut the slide clamps. Press Continue. The instrument will attempt recovery.
  • Page 197 Continue 6. Press Continue. The main menu will display. Remove sample trays and staining racks. Any mechanical failures should be addressed by Hologic Technical Support. If errors recur, or do not appear as described here, contact Hologic Technical Support. ®...
  • Page 198 ROUBLESHOOTING Slide Handling System Fault Recovery WARNING: Glass Sharp Edges A System Fault occurs. The instrument halts, with a display of “Slide Handling Error”. The batch report prints. Press Continue. The instrument moves mechanisms to allow internal access. The doors unlock. Open the top door and inspect the slide handling path.
  • Page 199 ROUBLESHOOTING Slide Handling System Fault Recovery (continued) Slide Handling System Fault (continued) Lift the slide cartridges out and see if slides are jammed at the exit slot. Carefully open the cartridge and remove the jammed slides. Refer slides jammed in to Chapter 5, Section D for correct the cartridge? placement of slides into the car-...
  • Page 200 Slide Handling System Fault Recovery (continued) Slide Handling Fault (continued) Allow the instrument to attempt to recover. “Check Mechanism” message displays. Press Continue. Remove the sample trays and any prepared slides. Contact Hologic Technical Support. ® 7.52 ThinPrep 3000 Processor Operator’s Manual...
  • Page 201 ROUBLESHOOTING SECTION ‘BATCH CANCELED DUE TO’ REPORTING For batches that concluded because of an interruption during processing, the batch report will indi- cate a reason for the halt. Batches may be canceled by the operator, by sample error or a system fault. TP 3000 Batch Result 03/28/01 07:35 am...
  • Page 202 ROUBLESHOOTING Batch Canceled Due To: Barcode scan failure No Bar- The instrument was unable to successfully scan two consecutive sample vial barcodes. See “ code Reprocessing Required” on page 7.16. Cancellation by user • An operator intentionally canceled a batch by pressing Pause and then pressing Cancel Batch. •...
  • Page 203 ROUBLESHOOTING Vial fluid level error Three or more consecutive vial fluid level errors will cancel the batch. Insufficient Vial Fluid • Sample vials did not have enough fluid volume. See “ Reprocess- ing Required” on page 7.14. Too Much Vial Fluid •...
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  • Page 206 Hologic has established a recommended set of guidelines for staining and coverslipping slides ® prepared on the ThinPrep 3000 processor. ThinPrep microscope slides are prepared and fixed inside the ThinPrep 3000 processor. They are ready for staining when they are delivered to the staining racks. ® ThinPrep...
  • Page 207 • The use of mild bluing solutions and dilute acid baths will optimize nuclear staining and min- imize possible cell shedding. Hologic recommends the use of a dilute Lithium Carbonate solu- tion, or Ammonium Hydroxide solution as the bluing solution.
  • Page 208 1 minute with agitation Xylene 1 minute with agitation Xylene 3 minutes with agitation * Place slides directly from the ThinPrep 3000 processor into distilled water to remove the CellFyx™ Solution. Hologic does not use commercially prepared clarifier or bluing reagent. Note: ®...
  • Page 209 ThinPrep-processor-prepared slides. Surgipath Clearium is also acceptable mounting media for use with ThinPrep-processor-prepared slides. Hologic also recommends that 24 mm x 30 mm or 24 mm x 40 mm glass coverslips be used. Plastic coverslip material used with automated coverslipping instrumentation is also acceptable.
  • Page 210 TAINING AND OVERSLIPPING SECTION COMMON ARTIFACTS Halo Artifact In some cases of dense specimens, only the outer edge of cellular material may transfer to the ThinPrep slide forming a thin ‘halo’ or ring of cellular material on the slide. Evaluate the slide for adequacy and diagnostic category according to established laboratory guidelines.
  • Page 211 TAINING AND OVERSLIPPING This page intentionally left blank ® ThinPrep 3000 Processor Operator’s Manual...
  • Page 213 ThinPrep Pap Test Training Program 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 214 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 216 NTERFACE CREENS C h a p t e r T e n User Interface Screens CONTENTS SECTION A: Overview of the User Interface Screens 10.1 SECTION B: Menu Trees 10.1 SECTION OVERVIEW OF THE USER INTERFACE SCREENS ® Operation of the ThinPrep 3000 processor is via menu options selected by pressing the prompt keys.
  • Page 217 NTERFACE CREENS Main/ Menu/ Setup (Refer to Chapter 2, Sections H, I, J for operation.) ® 10.2 ThinPrep 3000 Processor Operator’s Manual...
  • Page 218 NTERFACE CREENS (Continued from previous page) (Only English is available at this time) ® ThinPrep 3000 Processor Operator’s Manual 10.3...
  • Page 219 NTERFACE CREENS Main/ Menu/ Maintenance (Refer to Chapter 6, Sections B, D, F, H, I, O for operation.) (No display, the results printer advances paper as long as the key is pressed.) * Opens and closes the slide clamps on the Slide Cell Transfer Arm.
  • Page 220 NTERFACE CREENS Main/ Menu/ Status (Useful for Technical Support, Instrument Maintenance, and Troubleshooting) (Prints Error History Report) (View Error History on Screen) ® ThinPrep 3000 Processor Operator’s Manual 10.5...
  • Page 221 Chapter 6, Section E for operation.) These tests are for These tests are for Field Service usage Field Service usage Example only. Contact Hologic Technical Support if the Pneumatic Test is not successful. ® 10.6 ThinPrep 3000 Processor Operator’s Manual...
  • Page 222 NTERFACE CREENS Start Batch/ Address Items (Refer to Chapter 5, Section D for operation.) Item(s) in Low Supply. Item(s) Not Detected. (Doors Unlock) (Unlocks the Doors, Items may be loaded.) ® ThinPrep 3000 Processor Operator’s Manual 10.7...
  • Page 223 Start Batch/ NTERFACE CREENS Pause Cancel (Refer to Chapter 5, Section G, H for operation.) ® 10.8 ThinPrep 3000 Processor Operator’s Manual...
  • Page 224 NTERFACE CREENS System Fault (Refer to Chapter 7, Section C for Operation.) Error Code Supply Status * 1 of 3 screens will display: Vial Handling Error in Area A Filter Handling Error in Area B Slide Handling Error in Area C (Continued on next page) ®...
  • Page 225 NTERFACE CREENS System Fault (Continued from previous page) Mechanical Error Resolved Mechanical Error Encountered ® 10.10 ThinPrep 3000 Processor Operator’s Manual...
  • Page 227 CellFyx Solution 1.2, 3.5, 5.16, Ordering.3 CellFyx Solution, replenish 6.32 cleaning the slide path 6.17 clearances, ThinPrep 3000 Processor 1.10 clearing clogs via the user interface Close Doors and Press Continue 5.17 common artifacts completing a batch 5.18 coverslipping recommendations Customer Service Service.1...
  • Page 228 NDEX extended shut down Filter handling 7.38 filter handling error 7.39 Filter handling system Filter Load Failure 7.10 filter waste box 6.31, Ordering.2 filter waste box liner Ordering.3 Filter, ThinPrep Pap test filters 5.15 fixative cap 5.16 Fixative Clog 7.12 fixative reservoir 6.32 fixative shield...
  • Page 229 NDEX maintenance kit Ordering.3 Maintenance schedule Materials required 1.8, 4.4, microscope slides 1.2, 5.7, 5.15, 6.17 No Barcode 7.16 Operator’s Manual Ordering.2 Ordering Information Ordering.1 Out of Consumables 7.18 pausing a batch in process 5.22 pinch valve tubing Ordering.2 pinch valve tubing replacement 6.26 Please Address Items 5.17...
  • Page 230 NDEX Sample collection Broom-like device Endocervical brush/Spatula device Sample collection and preparation sample errors Sample Is Dilute sample trays 5.16 sample vial tray Ordering.2 sample vials 5.12 Service Information Service.1, Service.2 setting the date setting the time shipping container checklist silicone lubricant Ordering.3 slide cartridges...
  • Page 231 NDEX Technical specifications Technical Support Service.1 temperature 1.11 ThinPrep Pap Test ThinPrep Pap Test Filters Too Much Vial Fluid 7.24 Troubleshooting turn the processor off turn the processor on User Interface Screens 10.1 Versa-Clean Solution 6.19, Ordering.3 Vial Cap Too Tight 7.26 Vial Handling 7.32...
  • Page 232 NDEX This page intentionally left blank ® Index.6 ThinPrep 3000 Processor Operator’s Manual...
  • Page 234 1-800-442-9892 Option 5. Orders can also be faxed to the attention of Customer Service at 1-800-409-7591. 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.
  • Page 235 Service contracts can also be ordered through Technical Support. Protocol for Returned Goods For returns on warranty-covered ThinPrep 3000 processor accessory and consumable items, contact Technical Support. For returns on warranty-covered ThinPrep Pap test consumable items, contact Customer Service to obtain a Return Goods Authorization (RGA) Number.
  • Page 237 Orders can also be faxed to the attention of Customer Service at 1-800-409-7591. 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 238 Replacement waste bottle and harness 70213-001 Assembly assembly Waste Bottle Transport Additional waste bottle transport cover 50247-001 Cover ThinPrep 3000 Processor Additional operator’s manual (for use in U.S.) MAN-02586-001 Operator’s Manual Aerosol Spray Bottle Spray bottle for Versa-Clean Solution 1 bottle 51432-001 ®...
  • Page 239 RDERING NFORMATION Consumable Items for the ThinPrep 3000 Processor Item Description Quantity Part Number CellFyx Solution CellFyx Solution bottles, boxed (115 mL each) 6 bottles, 70207-001 and 6 fixative shield replacements 6 fixative shields Filter Waste Box Liner Plastic bag insert for filter waste box...
  • Page 240 The barcode standard used is Code 128, subset C, with .013 “x” dimension. (Narrow bar width.) 1. Black bars on blue-white face stock with rubber based adhesive on back. Refer to the Barcode Label Specifications for the ThinPrep 3000 Processor sheet in the Appendix for a copy of this information suitable for photocopy/facsimile use.
  • Page 241 RDERING NFORMATION Consumable Items for the ThinPrep Pap Test Item Description Quantity Part Number ThinPrep Pap Test Kit Materials for both the laboratory and the 500 Tests physician’s office Vials of PreservCyt Solution for use with the ThinPrep Pap test ThinPrep Pap test filters ThinPrep microscope slides Collection devices:...
  • Page 242 RDERING NFORMATION This page intentionally left blank ® Ordering.6 ThinPrep 3000 Processor Operator’s Manual...
  • Page 244 Solution ® ™ Fisher brand Versa-Clean The Safety Data Sheets (SDS) for each solution may be requested from Hologic Technical Support at 1-800-442-9892 Option 6 (USA and Canada), or found on-line at www.hologicsds.com. ® ThinPrep 3000 Processor Operator’s Manual SDS.1...
  • Page 245 AFETY HEETS This page intentionally left blank ® SDS.2 ThinPrep 3000 Processor Operator’s Manual...
  • Page 247 3000 P ROCESSOR ABORATORY ThinPrep 3000 Processor: Laboratory Flow ® ThinPrep 3000 Processor Operator’s Manual Lab Flow.1...
  • Page 248 3000 P ROCESSOR ABORATORY This page intentionally left blank ® Lab Flow.2 ThinPrep 3000 Processor Operator’s Manual...
  • Page 249 3000 P ARCODE ABEL PECIFICATIONS FOR THE ROCESSOR Barcode Label Specifications for the ThinPrep 3000 Processor ® ThinPrep 3000 Processor Operator’s Manual Barcode.1...
  • Page 250 Many laboratories currently utilize barcode labels for specimen tracking. The barcode standard selected for use with the ThinPrep 3000 processor is one that is commonly used in many labo- ratories. The following information provides specifications for the barcode labels used with the ThinPrep 3000 processor.
  • Page 251 AMPLE ABEL PPLICATION UIDE Sample Vial Label Application Guide ® ThinPrep 3000 Processor Operator’s Manual Sample Vial.1...
  • Page 252 AMPLE ABEL PPLICATION UIDE This page intentionally left blank ® Sample Vial.2 ThinPrep 3000 Processor Operator’s Manual...
  • Page 253 Replace printer cartridge when prompted. Always be sure the Waste Bottle ribbon is seated in the ribbon guide properly. © 2017, Hologic, Inc. Refer to the ThinPrep 3000 Processor Operator's Manual for complete operating instructions. Part No. AW-03369-001 Rev. 002...
  • Page 254 • A filter stuck on the processing bay for any dislodged filters or obvi- arm or in the filter elevator ous obstruction. Let the instrument • Mechanical fault attempt to recover. If it does not, con- tact Hologic Technical Support.

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