Hologic thinprep 2000 Operator's Manual
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Hologic thinprep 2000 Operator's Manual

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See also: Instructions for Use Manual
L A B O R A T O R Y
S O L U T I O N S
Operator's Manual
MAN-02585-001 Rev. 005

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Sue Wager
January 16, 2025

Hi there, I'm looking for up to date versions of the package inserts for the ThinPrep T2000 Base Liners and Filter Cap please. The latest versions we have are; Base Liners: P/N 85632-001 Rev. A Filter Cap: P/N 04950-4501 Rev. A Many thanks

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  • Page 1 L A B O R A T O R Y S O L U T I O N S Operator’s Manual MAN-02585-001 Rev. 005...
  • Page 2 OLOGIC OLOGIC IMITED 250 C 2, L 10 N AMPUS RIVE APIER , MA 01752 USA RH10 9RA ARLBOROUGH RAWLEY USSEX 1-800-442-9892 NITED INGDOM 1-508-263-2900 : +44 (0) 1293 522 080 1-508-229-2795 : +44 (0) 1293 528 010 HOLOGIC MAN-02585-001...
  • Page 3 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 ThinPrep 2000 System. Preparation of microscope slides using the ThinPrep 2000 System 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-02624-001 Rev. 003 page 1 of 15...
  • Page 6 The ThinPrep sample vial is then capped, labeled, and sent to a laboratory equipped with a ThinPrep 2000 Processor. At the laboratory, the PreservCyt sample vial is placed into a ThinPrep 2000 Processor and a gentle dispersion step breaks up blood, mucus, non-diagnostic debris, and thoroughly mixes the cell sample.
  • Page 7 ThinPrep prepared slides by Hologic or by organizations or individuals designated by Hologic.  Supplies used in the ThinPrep 2000 System are those designed and supplied by Hologic specifically for the ThinPrep 2000 System. These include PreservCyt Solution vials, ThinPrep Pap Test Filters, and ThinPrep Microscope Slides. These supplies are required for proper performance of the system and cannot be substituted.
  • Page 8 PRECAUTIONS  Specific processing steps must be followed before and during use of the ThinPrep 2000 processor if planning to perform Chlamydia trachomatis and Neisseria gonorrhoeae testing, using the Roche Diagnostics COBAS AMPLICOR CT/NG test, on the residual specimen after a slide has been prepared using a ThinPrep 2000 processor.
  • Page 9 PreservCyt Solution. At the laboratory, the PreservCyt sample vial was placed into a ThinPrep 2000 Processor and a slide was then prepared from the patient’s sample. ThinPrep and conventional Pap smear slides were examined and diagnosed independently.
  • Page 10 demographics was obtained for 70% of the patients that participated in the study. The study population consisted of the following race groups: Caucasian (41.2%), Asian (2.3%), Hispanic (9.7%), African American (15.2%), Native American (1.0%) and other groups (0.6%). Table 1 describes the laboratories and the patient populations. Table 1: Site Characteristics Laboratory Characteristics Clinical Study Demographics...
  • Page 11 Table 3: Three Category Diagnostic Classification Table Conventional ASCUS/AGUS+ LSIL+ TOTAL ThinPrep 5224 5593 ASCUS/ 1154 AGUS+ LSIL+ TOTAL 5680 6747 Table 4: Two Category Diagnostic Classification Table, LSIL and More Severe Diagnoses Conventional NEG/ASCUS/ LSIL+ TOTAL AGUS+ ThinPrep NEG/ASCUS/ 5985 6110 AGUS+...
  • Page 12 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 13 Table 8: Independent Pathologist Results by Site, LSIL and More Severe Lesions Site Cases ThinPrep Conventional p-Value Method Favored Positive Positive Positive by Independent Pathologist 0.170 Neither 0.042 ThinPrep <0.001 ThinPrep <0.001 ThinPrep 0.876 Neither 0.170 Neither For LSIL and more severe lesions, the diagnostic comparison statistically favored the ThinPrep method at three sites and was statistically equivalent at three sites.
  • Page 14 Table 10 below shows the summary for all sites of the descriptive diagnosis for all Bethesda System categories. Table 10: Summary of Descriptive Diagnosis Descriptive Diagnosis ThinPrep Conventional Number of Patients: 6747 Benign Cellular Changes: 1592 23.6 1591 23.6 Infection: Trichomonas Vaginalis Candida spp.
  • Page 15 PreservCyt vial, without first making a conventional Pap smear. This specimen collection technique is the intended use for the ThinPrep 2000 System. Tables 15 and 16 present the split sample and direct to vial results.
  • Page 16 Table 14: Specimen Adequacy Results by Site Site Cases Thin Con- Thin Con- Thin Con- Prep vent. Prep vent. Prep vent. SBLB SBLB UNSAT UNSAT Cases Cases Cases Cases Cases Cases 1,386 1092 1178 1,668 1530 1477 1,093 1,046 1,049 All Sites 7,223 5656...
  • Page 17 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 18 (e.g. choice of excisional biopsy method versus conservative follow-up). Multiple peer-reviewed publications report on the improved ability of the ThinPrep 2000 System to detect glandular disease versus the conventional Pap smear. Although these studies do not consistently address sensitivity of different Pap...
  • Page 19 +44 1293 522 080 Hologic, PreservCyt, ThinPrep, and associated logos are registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.
  • Page 21 Section 1 (white tabs) describes the use of the ThinPrep 2000 system for gynecologic applications. In addition, it ® contains all information regarding the installation, operation, and maintenance of the ThinPrep 2000 processor. ® ThinPrep 2000 Processor Operator’s Manual i...
  • Page 22 This page intentionally left blank. ThinPrep 2000 Processor Operator’s Manual...
  • Page 23 INTRODUCTION SECTION A: Overview and Function ® of the ThinPrep 2000 System SECTION B: Principles of Operation SECTION C: ThinPrep 2000 System Technical Specifications 1.12 SECTION D: Internal Quality Control 1.16 SECTION E: ThinPrep 2000 Hazards 1.16 SECTION F: Disposal 1.19...
  • Page 24 SECTION I: Loading the Fixative Vial 5A.14 SECTION J: Closing the Door 5A.15 SECTION K: Selecting and Initiating a Sequence 5A.16 SECTION L: Unloading the ThinPrep 2000 Processor 5A.18 SECTION M: Interrupting the Slide Preparation Process 5A.20 SECTION N: Status, Maintenance, and Test Screens 5A.21...
  • Page 25 SECTION O: Interrupting the Slide Preparation Process 5B.21 SECTION P: Status, Maintenance, and Test Screens 5B.22 Chapter Six INSTRUMENT TROUBLESHOOTING SECTION A: Introduction SECTION B: How to use this Section SECTION C: Contents SECTION D: Error History 6.37 ThinPrep 2000 Processor Operator’s Manual v...
  • Page 26 7.17 SECTION M: Maintenance Schedule 7.18 Chapter Eight FIXATION, STAINING, AND COVERSLIPPING SECTION A: Introduction SECTION B: Fixation SECTION C: Staining SECTION D: Coverslipping SECTION E: References Chapter Nine THINPREP PAP TEST TRAINING PROGRAM INDEX ThinPrep 2000 Processor Operator’s Manual...
  • Page 28 Indication for Use Intended Use The ThinPrep 2000 system is intended as a replacement for the conventional method of Pap smear preparation for use in screening for the presence of atypical cells, cervical cancer, or its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial...
  • Page 29 ThinPrep 2000 processor. At the laboratory, the PreservCyt sample vial is placed into a ThinPrep 2000 processor and a gentle dispersion step breaks up blood, mucus, non-diagnostic debris, and thoroughly mixes the cell sample.
  • Page 30 As with conventional Pap smears, slides prepared with the ThinPrep 2000 system are examined in the context of the patient’s clinical history and information provided by other diagnostic procedures such as colposcopy, biopsy, and human papillomavirus (HPV) testing, to determine patient management.
  • Page 31 ThinPrep-prepared slides by Hologic or by organizations or individuals designated by Hologic. • Supplies used in the ThinPrep 2000 system are those designed and supplied by Hologic specifically for the ThinPrep 2000 system. These include PreservCyt Solution vials, ThinPrep Pap test filters, and ThinPrep microscope slides. These supplies are required for proper performance of the system and cannot be substituted.
  • Page 32 ** After 1 hour >5.7 log reduction *** Data is for 5 minutes MATERIALS REQUIRED Materials Provided The ThinPrep 2000 system consists of the following components: • ThinPrep processor instrument (Model: ThinPrep 2000) • PreservCyt Solution vial • Gyn ThinPrep Pap test filter (clear) •...
  • Page 33 • 2 spare filter seal O-rings • Waste bottle assembly — includes bottle, bottle cap, tubing set, fittings, waste filter • ThinPrep microscope slides Additional items supplied: • ThinPrep 2000 System Operator’s Manual • 10 fixative vials • Cervical collection device • Sealed cylinder Materials Required But Not Provided •...
  • Page 34 NTRODUCTION SECTION PRINCIPLES OF OPERATION The ThinPrep 2000 processor makes use of mechanical, pneumatic, and fluidic principles for cell dispersion, collection, and transfer. A rotary drive mechanism gently disperses samples. A pneumatic/fluidic system, controlled by a microprocessor, monitors cell collection.
  • Page 35 In preparation for sample processing, the operator loads four essential items into the ThinPrep 2000 processor: a PreservCyt Sample vial, a ThinPrep Pap test filter attached to the filter cap, a ThinPrep slide and a fixative vial containing a standard laboratory fixative.
  • Page 36 ThinPrep Pap test filter cylinder. After collection, the cells sit on a single plane over the pores, ready for transfer to the slide. Figure 1-2 illustrates cell collection. Figure 1-2 Cell Collection Negative pressure creates a vacuum ThinPrep Pap test filter Filter pores Flow of fluid ThinPrep 2000 Processor Operator’s Manual 1.9...
  • Page 37 All the motorized mechanisms return to their initial positions and the display returns to the Main Menu. If the system detects an error during the process, a message will be displayed and an audible alarm will sound. 1.10 ThinPrep 2000 Processor Operator’s Manual...
  • Page 38 Pap test filter in a cleared to waste Cells are transferred fixative bath. Filter bottle and sample controlled manner. to slide. returns to starting vial is lowered. point. ThinPrep 2000 Processor Operator’s Manual 1.11...
  • Page 39 NTRODUCTION SECTION THINPREP 2000 SYSTEM TECHNICAL SPECIFICATIONS Overview of Components Figure 1-4 ThinPrep 2000 System Components Waste bottle with cap ThinPrep 2000 and filter Fix vials Power cord Program Memory Card Operator’s manual Filter cap assemblies 1.12 ThinPrep 2000 Processor Operator’s Manual...
  • Page 40 NTRODUCTION ThinPrep 2000 Dimensions and Clearances Figure 1-5 Processor Dimensions 18”/46 cm 19.5”/50 cm 17”/43 cm 6”/15 cm 15”/38 cm Figure 1-6 Processor Clearances 22.5/59 cm 24/61 cm 18/46 cm ThinPrep 2000 Processor Operator’s Manual 1.13...
  • Page 41 Operating Humidity 20%–90% RH, non-condensing Pollution Degree: II, in accordance with IEC 60664. Category II, the ThinPrep 2000 is for indoor use only in an office or a clean laboratory environment. Altitude: 0 meters (sea level) to 2000 meters. Atmospheric Pressure: 1100 millibar to 500 millibar.
  • Page 42 Pin 6 ThinPrep 2000 Standards The ThinPrep 2000 System 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. Refer to the processor product label, located on the rear of the instrument, to see the safety certification markings.
  • Page 43 INTERNAL QUALITY CONTROL Power On Self Test (POST) When the ThinPrep 2000 processor is powered on (refer to page 2.9), the system goes through a self- diagnostic test. The electrical, mechanical and software/communications subsystems are tested to confirm that each performs properly. The operator is alerted to malfunctions by a message on the LCD display and audible beeps.
  • Page 44 NTRODUCTION Attention, refer to accompanying documents. Protective Conductor Terminal (internal use only, not accessible to operators). Waste Electrical and Electronic Equipment - contact Hologic for disposal of the instrument. ThinPrep 2000 Processor Operator’s Manual 1.17...
  • Page 45 Location of Labels Used on the Instrument Figure 1-7 Location of Labels Used on the Instrument Slide insertion label Serial number label Do not dispose symbol (Internal) (Internal) Model/rating label Flammable liquids Moving parts label label 1.18 ThinPrep 2000 Processor Operator’s Manual...
  • Page 46 • Used Filters. Dispose of as regular waste. • Base Liners (Absorbent Pads). Dispose of as regular waste. (If dripping wet, dispose of as hazardous waste.) • Used Filter Seal O-Rings and Filter Caps. Dispose of as regular waste. ThinPrep 2000 Processor Operator’s Manual 1.19...
  • Page 47 Your Responsibility As a Hologic customer, you are responsible for ensuring that devices marked with the symbol shown below are not placed into the municipal waste system unless authorized to do so by the authorities in your area. Please contact Hologic (see below) prior to disposing any electrical equipment provided by Hologic.
  • Page 48 Tel: (USA and Canada) 1-800-442-9892 Fax: 1-508-263-2967 Authorized European Representative Hologic UK Ltd. Unit 2, Link 10 Napier Way Crawley, West Sussex RH10 9RA United Kingdom Tel: +44 1293 522 080 Fax: +44 1293 528 010 ThinPrep 2000 Processor Operator’s Manual 1.21...
  • Page 49 NTRODUCTION This page intentionally left blank. 1.22 ThinPrep 2000 Processor Operator’s Manual...
  • Page 51 ACTION UPON DELIVERY Inspect the packing cartons for damage. Report any damage immediately to the shipper and/or Hologic Technical Support as soon as possible. (Refer to Service Information at the back of this manual.) If the instrument will not be unpacked right away, store the equipment in a suitable environment until installation: cool, dry, vibration-free area.
  • Page 52 SECTION INTERNAL PACKAGING REMOVAL The inside mechanism of the ThinPrep 2000 processor is secured for shipment in two areas. A formed foam insert secures the rotating plate in a vertical position, and a small foam block secures the slide handler. These internal securements must be removed before operating the instrument. Do not turn on the power of the processor until instructed to do so.
  • Page 53 Rotating Plate Packaging Removal: 1. Open the door of the ThinPrep 2000 processor by sliding it to the right. 2. Grasp the foam shipping insert and pull it straight forward, out of the instrument. The foam insert fits very tightly in the instrument. Use care when removing it to pull straight Note: outward and not dislodge any of the mechanisms.
  • Page 54 Figure 2-1 Removing the Rotating Plate Packaging Foam shipping insert Rotating plate Grasp and pull the foam insert straight forward, out of the instrument 3. The rotating plate can be turned clockwise into a horizontal position. ThinPrep 2000 Processor Operator’s Manual...
  • Page 55 The slide handler may be rotated to a horizontal position to remove the foam block. 3. Close the door by sliding it to the left. 4. Save the foam block for subsequent instrument packaging. ThinPrep 2000 Processor Operator’s Manual 2.5...
  • Page 56 When the proper connection has been established, the buttons on the con- nectors pop up/outward with a click sound. It may be necessary to push the button in before placing the waste tubing connector into the instrument connector. ThinPrep 2000 Processor Operator’s Manual...
  • Page 57 4. Insert the PMC into the unit as shown in Figure 2-4. Continue to insert the card until the small black button at the top of the receptacle snaps out. If the PMC does not enter the unit smoothly, do not force it into the ThinPrep 2000 processor socket. Figure 2-4...
  • Page 58 1. Ensure that the power switch, located on the rear of the ThinPrep 2000 Processor, is in the “O” (Off) position. For “Off,” the top half of the toggle power switch is in the “out” position (pro- trudes).
  • Page 59 2. With the door to the ThinPrep 2000 processor closed, turn the toggle power switch, located on the right rear of the instrument, to the “1” (ON) position. For “On,” the top half of the toggle power switch is in the “in”...
  • Page 60 5. The ThinPrep processor pressure sensor calibration occurs several times while the power is on: • at power up • 15 minutes after power up • 2 hours after power up • every 8 hours thereafter. 2.10 ThinPrep 2000 Processor Operator’s Manual...
  • Page 61 SECTION RUN A BLANK SAMPLE When operating the ThinPrep 2000 processor for the first time, it is important to run a sequence using a blank PreservCyt Solution vial (no cells) to ensure that the system is fully functional. Read Chapter 5A, “Operating Instructions”, of this manual before proceeding with the procedure below.
  • Page 62 2000 I NSTALLATION 14. The installation of the instrument is complete. The ThinPrep 2000 Processor is now ready for slide preparations. Read Chapter 7, “Maintenance”, of this manual before proceeding with addi- tional slide preparations. SECTION STORAGE AND HANDLING - POST INSTALLATION During operation the ThinPrep 2000 processor is sensitive to vibrations.
  • Page 64 RESERV OLUTION C h a p t e r T h r e e PreservCyt Solution SECTION INTRODUCTION The following sections describe the function and specifications of the cytologic preservative fluid, ® PreservCyt Solution. ThinPrep 2000 Processor Operator’s Manual 3.1...
  • Page 65 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 2000 system. • Vials(20 mL) of PreservCyt Solution are contained in each ThinPrep Pap test.
  • Page 66 15 minutes in the PreservCyt Solution. The log reduction of viable organisms is also pre- sented. As with all laboratory procedures, universal precautions should be followed. ThinPrep 2000 Processor Operator’s Manual 3.3...
  • Page 67 The use of lubricants (e.g., KY Jelly) should be avoided prior to specimen collection. 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. ThinPrep 2000 Processor Operator’s Manual...
  • Page 68 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 69 3. If multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. * 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 70 4. Absorbent material must be placed between the primary receptacle and the secondary packaging. The absorbent material (cotton balls, cellulose wadding, absorbent packets, paper towels) must be in sufficient quantity to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or the outer packaging.
  • Page 71 2. Always affix the Class 9, UN 1845 dry ice label as well as the UN 3373, Biological Substance, Category B label to these shipments 3. 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? ...
  • Page 72 Domestic Air Shipments: In addition to 1 and 2 above in Domestic Ground Shipments – Other than Limited Quantities, the following are recommendations for domestic air shipments: 3. Maximum allowable package sizes are: i. Sixty (60) liters (3000-vials) for passenger aircraft, and ii.
  • Page 73 International Air Shipments: The references used for the International Air recommendations are: In addition to a and b above in International Ground Shipments, the following are the recommendations for international air shipments: 1. Maximum allowable package sizes are: i. Sixty (60) liters (3000-vials) for passenger aircraft, and ii.
  • Page 74 Domestic Air Shipments: ™ ® When shipping ThinPrep CytoLyt Solution via air, follow the Domestic Air Shipments ™ ® recommendations for Shipping ThinPrep PreservCyt Solution Only that can be found in Section B of this document. International Ground and Air shipments: ™...
  • Page 76 1. Collection: Deposit the specimen directly into a PreservCyt Solution vial. 2. Allow to stand in PreservCyt Solution for 15 minutes ® 3. Run on ThinPrep 2000 processor using Sequence 4, Fix, Stain, and Evaluate ThinPrep 2000 Processor Operator’s Manual 4.1...
  • Page 77 The sample should be obtained before the application of acetic acid. 1. Papanicolaou Technique Approved Guidelines (NCCLS Document GP15-A3) 2. Lee et al. Comparison of Conventional Papanicolaou Smears and Fluid-Based, Thin-Layer System for Cervical Cancer Screening. Ob Gyn 1997; 90: 278-284. ThinPrep 2000 Processor Operator’s Manual...
  • Page 78 15 minutes before processing. If the sample is to be sent elsewhere for processing, continue with the next step. 5. Place the vial and requisition in a specimen bag for transport to the laboratory. ThinPrep 2000 Processor Operator’s Manual 4.3...
  • Page 79 PreservCyt Solution vial for at least 15 minutes before processing. If the sample is to be sent elsewhere for processing, continue with the next step. 7. Place the vial and requisition in a specimen bag for transport to the laboratory. ThinPrep 2000 Processor Operator’s Manual...
  • Page 80 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 2000 processor, lubricants can adhere to the fil- ter membrane and may cause poor cell transfer to the slide. If its use is unavoidable, the lubricant should be used in minimum amounts.
  • Page 81 The PreservCyt Sample vial fluid level should be within the frosted area of the sample vial. Figure 4-1 PreservCyt Sample Vial Fluid Level Frosted area • 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. ThinPrep 2000 Processor Operator’s Manual...
  • Page 82 YNECOLOGIC AMPLE REPARATION Run On ThinPrep 2000 Processor Using Sequence 4, Fix, Stain, and Evaluate The operator loads the instrument and selects sequence number 4 for the sample to be processed as described in Chapter 5A, “Operating Instructions”. At the completion of the process, the operator fixes and stains the slide according to the procedure in Chapter 8, “Fixa-...
  • Page 83 30 ml d. Invert the centrifuge tube by hand several times to mix. 5 Pellet the cells again by centrifugation — 1200 x g for 5 minutes. ThinPrep 2000 Processor Operator’s Manual...
  • Page 84 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 2000 processor according to the procedure for running gynecologic specimens. Evaluate the resultant slide according to The Bethesda System for Reporting Cervical/ Vaginal Cytologic Diagnosis.
  • Page 85 YNECOLOGIC AMPLE REPARATION This page intentionally left blank. 4.10 ThinPrep 2000 Processor Operator’s Manual...
  • Page 87 2000 processor if planning to perform Chlamydia trachomatis and Neisseria gonorrhoeae testing, using the Roche Diagnostics COBAS AMPLICOR™ CT/NG test, on the resid- ual specimen after a slide has been prepared using the ThinPrep 2000 processor. Fol- low the procedures found in Chapter 5B of the ThinPrep 2000 Operator's Manual.
  • Page 88 It is essential that the instructions in Chapter 5B be followed if the Roche Diagnostics COBAS AMPLICOR™ CT/NG test will be performed using the residual specimen after a slide has been prepared using the ThinPrep 2000 processor. 5A.2 ThinPrep 2000 Processor Operator’s Manual...
  • Page 89 9. Secure the vial cap. (The line on the cap and line on the vial should meet or slightly overlap.) 10. Dispose of the pipetting device in accordance with local, state, and federal regulations. 11. Refer to the remaining steps in this chapter to complete the ThinPrep Pap test. ThinPrep 2000 Processor Operator’s Manual 5A.3...
  • Page 90 The slide is specifically designed for use with the ThinPrep processor. Supplies used in the ThinPrep 2000 system are those designed and supplied by Hologic specifically for the ThinPrep 2000 processor. These include PreservCyt Solution vials for use with the ThinPrep...
  • Page 91 • Idle mode — Confirm that the instrument is powered on and in idle, or Main Menu, mode. If the Main Menu is not displayed, follow the instructions on the display until the idle mode appears. If the system’s power is off, refer to Chapter 2, “ThinPrep 2000 Installation”, for turn- ing system power on.
  • Page 92 OVERVIEW OF LOADING THE THINPREP 2000 PROCESSOR The next four sections describe in detail the methods for loading the ThinPrep 2000 processor. The following supplies must be loaded into the processor before initiating a sample run: • PreservCyt sample vial •...
  • Page 93 SECTION LOADING THE PRESERVCYT SAMPLE VIAL 1. Open the ThinPrep 2000 processor door by gripping the door tab and sliding it gently to the right until it is completely open. 2. Confirm that the sample holder, fixative vial holder, and slide handler are empty.
  • Page 94 3. Ensure there is no visible gap between the ThinPrep Pap test filter and the filter cap as shown in Figure 5A-5. The ThinPrep Pap test filter must seat against the filter cap lip. 5A.8 ThinPrep 2000 Processor Operator’s Manual...
  • Page 95 When properly loaded, the filter cap is level inside the instrument and the filter cylinder is above the PreservCyt sample vial and slightly to the left. If the positioning of the filter assembly does ThinPrep 2000 Processor Operator’s Manual 5A.9...
  • Page 96 PERATING NSTRUCTIONS not correspond to this description, remove it and try again. The filter assembly will easily rotate in the bobbins when properly seated. Figure 5A-7 Loading the Filter Assembly Bobbins 5A.10 ThinPrep 2000 Processor Operator’s Manual...
  • Page 97 Refer to Figure 5A-8. Figure 5A-8 Inserting the Slide onto the Clamps Clamps Slide L A B E L E N D ThinPrep 2000 Processor Operator’s Manual 5A.11...
  • Page 98 Slide properly placed L A B E L E N D L A B E L L A B E L E N D E N D Slide skewed to left Slide skewed to right 5A.12 ThinPrep 2000 Processor Operator’s Manual...
  • Page 99 Figure 5A-10 Inserting the Slide Fully Slide L A B E L E N D To remove a slide, press down on the front edge of the slide. Gently pull the slide toward you. Note: ThinPrep 2000 Processor Operator’s Manual 5A.13...
  • Page 100 2. Place the fixative vial into the fixative bath holder until the bottom of the vial rests on the base of the holder. Refer to Figure 5A-11. Ensure that the fixative vial is completely seated. Figure 5A-11 Loading the Fixative Vial F R O S T E D E N D 5A.14 ThinPrep 2000 Processor Operator’s Manual...
  • Page 101 Figure 5A-12 Door Opening and Closing Door open Door closed Caution: Do not open the door during processing. Depending on where a sequence is inter- rupted, cells may be lost or air-dried during recovery. ThinPrep 2000 Processor Operator’s Manual 5A.15...
  • Page 102 PERATING NSTRUCTIONS SECTION SELECTING AND INITIATING A SEQUENCE The ThinPrep 2000 processor has several program modes in its program card. There are two primary types of modes: 1. Sample processing sequences 2. Diagnostic The sample processing sequences are used to process different kinds of specimens.
  • Page 103 STOP key. If the ThinPrep 2000 processor detects an error condition during any sequence, the sequence will abort, the system will attempt to recover and a message will be displayed. Refer to Chapter 6, “Instrument Troubleshooting”, for more information.
  • Page 104 Dispose of the lint-free wipe with the ThinPrep Pap test filter. Method B: Remove the ThinPrep Pap test filter from the filter cap and wipe off your gloves with lint-free wipe to remove any liquid or change your gloves after each slide preparation cycle. 5A.18 ThinPrep 2000 Processor Operator’s Manual...
  • Page 105 7. Do not discard the sample vial until it has been determined that no additional slides are needed. Refer to Chapter 3, “PreservCyt Solution”, for information regarding solution disposal and sam- ple storage. ThinPrep 2000 Processor Operator’s Manual 5A.19...
  • Page 106 SECTION INTERRUPTING THE SLIDE PREPARATION PROCESS Ordinarily, the ThinPrep 2000 processor slide preparation process should not be interrupted. How- ever, if it is necessary to stop processing for any reason, use the following procedure to ensure the slide is not contaminated with another specimen.
  • Page 107 PERATING NSTRUCTIONS SECTION STATUS, MAINTENANCE, AND TEST SCREENS The ThinPrep 2000 processor has seven different Main Menu options which can be viewed by press- ing the up and down arrow keys: 1–4: Processing Sequences Status Maintenance Test Section K of this chapter describes how to initiate the sequences. The purpose of this section is to describe the functions of Status, Maintenance, and Test.
  • Page 108 (MINOR) is the minor error number which often provides additional information on the source of the error. The last column (CYCLE) is the total cycle count of the processor when the error occurred. To return to the Status Menu, press STOP. 5A.22 ThinPrep 2000 Processor Operator’s Manual...
  • Page 109 Pressing 7 from the Main Menu displays the following screen. Maintenance: 1 - LCD ADJUST 2 - WASTE SYSTEM 3 - SERVICE MODE To return to the Main Menu, press STOP. The processor must be completely empty of supplies before continuing with Maintenance. ThinPrep 2000 Processor Operator’s Manual 5A.23...
  • Page 110 • Sample vial holder rises — The sample vial holder rises to allow the operator to more easily clean under the holder. See “GENERAL CLEANING” on page 7.9 When the maintenance operation is complete, the operator must press ENTER with the door closed to return to the Main Menu. 5A.24 ThinPrep 2000 Processor Operator’s Manual...
  • Page 111 NSTRUCTIONS 3 – Service Mode: Pressing 3 initiates the Service Mode screen. This Service Mode is for Hologic use only. Technical Ser- vice may ask you to access this screen during troubleshooting. To return to the Main Menu, press STOP.
  • Page 112 Call Hologic Technical Support WASTE LINE CLOGGED Call Hologic Technical Support - TANK LINE CLOGGED Call Hologic Technical Support + TANK LINE CLOGGED Call Hologic Technical Support QTO LINE CLOGGED Call Hologic Technical Support 5A.26 ThinPrep 2000 Processor Operator’s Manual...
  • Page 113 SECTION L: Unloading the PreservCyt Sample Vial 5B.18 SECTION M: Unloading the ThinPrep Microscope Slide 5B.19 SECTION N: Unloading the Filter Assembly 5B.20 SECTION O: Interrupting the Slide Preparation Process 5B.21 SECTION P: Status, Maintenance, and Test Screens 5B.22 ThinPrep 2000 Processor Operator’s Manual 5B.1...
  • Page 114 The slide is specifically designed for use with the ThinPrep processor. Supplies used in the ThinPrep 2000 system are those designed and supplied by Hologic specifically for the ThinPrep 2000 processor. These include PreservCyt Solution vials for use with the ThinPrep Pap test, Gyn ThinPrep Pap test filters (clear), and ThinPrep microscope slides.
  • Page 115 The ThinPrep 2000 System Operator’s Manual contains detailed information about the ThinPrep 2000 system, such as the principles of operation, operating instructions, specifications, and maintenance information. The manual also contains information on the solutions and materials required to prepare slides with the ThinPrep 2000 processor.
  • Page 116 20 PreservCyt sample vials. Place the bleach bath and distilled water bath on the bench close to the ThinPrep 2000 processor. Place 2 filter caps in the bleach bath. Ensure the filter caps are completely covered by the bleach.
  • Page 117 OVERVIEW OF LOADING THE THINPREP 2000 PROCESSOR ® The following sections describe in detail the methods for loading the ThinPrep 2000 processor. Before initiating a run, the following supplies must be loaded into the processor in the order indicated. • Fixative vial •...
  • Page 118 Super Absorbent Wipe. The filter O-rings should be lightly greased. Refer to “FILTER CAP O- RING LUBRICATION” on page 7.5. 6. If the O-rings were greased, change to a clean pair of laboratory gloves. 5B.6 ThinPrep 2000 Processor Operator’s Manual...
  • Page 119 SECTION LOADING THE FIXATIVE VIAL Open the ThinPrep 2000 processor door by gripping the door tab and sliding it gently to the right until it is completely open. 1. Fill a fixative vial with standard laboratory fixative alcohol until the fluid level is between the “MIN”...
  • Page 120 4. Insert the filter assembly into the instrument. Hold the filter assembly by the ThinPrep Pap test filter cylinder and place the angled edges of the filter cap against the two front bobbins as shown in Figure 5B-6. 5B.8 ThinPrep 2000 Processor Operator’s Manual...
  • Page 121 PreservCyt sample vial holder and slightly to the left. If the positioning of the filter assembly does not correspond to this description, remove it and try again. The filter assembly will easily rotate in the bobbins when properly seated. Figure 5B-7 Loading the Filter Assembly Bobbins ThinPrep 2000 Processor Operator’s Manual 5B.9...
  • Page 122 4. The vial will remain loose in the sample holder until the process begins. The instrument will automatically grasp the vial during processing. Figure 5B-8 Loading the PreservCyt Sample Vial Sample holder 5B.10 ThinPrep 2000 Processor Operator’s Manual...
  • Page 123 Refer to Figure 5B-9. Figure 5B-9 Inserting the Slide onto the Clamps Clamps Slide L A B E L E N D ThinPrep 2000 Processor Operator’s Manual 5B.11...
  • Page 124 Slide properly placed L A B E L E N D L A B E L L A B E L E N D E N D Slide skewed to left Slide skewed to right 5B.12 ThinPrep 2000 Processor Operator’s Manual...
  • Page 125 Figure 5B-11 Inserting the Slide Fully Slide L A B E L E N D To remove a slide, press down on the front edge of the slide. Gently pull the slide toward you. Note: ThinPrep 2000 Processor Operator’s Manual 5B.13...
  • Page 126 Figure 5B-12 Door Opening and Closing Door open Door closed Caution: Do not open the door during processing. Depending on where a sequence is inter- rupted, cells may be lost or air-dried during recovery. 5B.14 ThinPrep 2000 Processor Operator’s Manual...
  • Page 127 ROCESSING AMPLES SECTION SELECTING AND INITIATING A SEQUENCE The ThinPrep 2000 Processor has several program modes in its program card. There are two primary types of modes: 1. Sample processing sequences 2. Diagnostic The sample processing sequences are used to process different kinds of specimens.
  • Page 128 COBAS AMPLICOR™ CT/NG PERATING NSTRUCTIONS FOR ROCESSING AMPLES Table 5B.1: ThinPrep 2000 Processor Sequences and Modes Description Number SUPERFICIAL SAMPLES Includes non-mucoid, superficial cell samples such as oral cavity samples, nipple secretions, skin lesions (Tzanck test) and buccal samples. FLUIDS, FNA AND FIRSTCYTE BREAST TEST SAMPLES Includes non-mucoid body cavity fluids and fine needle aspirates.
  • Page 129 STOP key. If the ThinPrep 2000 processor detects an error condition during any sequence, the sequence will abort, the system will attempt to recover and a message will be displayed. Refer to Chapter 6, “Instrument Troubleshooting”, for more information.
  • Page 130 3. Do not discard the sample vial until it has been determined that no additional slides are needed. Refer to Chapter 3, “PreservCyt Solution”, for information regarding solution disposal and sam- ple storage. 5B.18 ThinPrep 2000 Processor Operator’s Manual...
  • Page 131 2. Remove the prepared slide from the fixative vial and deposit the slide into a staining rack in a bath containing standard laboratory fixative. Refer to Chapter 8, “Fixation, Staining, and Covers- lipping”, for more information about the slide fixation and staining. 3. Return the fixative vial to its holder. ThinPrep 2000 Processor Operator’s Manual 5B.19...
  • Page 132 5. Discard gloves. For next sample processed, do not use the filter cap just returned to the bleach bath, Note: unless it has been soaking for a minimum of one (1) minute. 5B.20 ThinPrep 2000 Processor Operator’s Manual...
  • Page 133 SECTION INTERRUPTING THE SLIDE PREPARATION PROCESS Ordinarily, the ThinPrep 2000 processor slide preparation process should not be interrupted. How- ever, if it is necessary to stop processing for any reason, use the following procedure to ensure the slide is not contaminated with another specimen.
  • Page 134 PERATING NSTRUCTIONS FOR ROCESSING AMPLES SECTION STATUS, MAINTENANCE, AND TEST SCREENS The ThinPrep 2000 processor has seven different Main Menu options which can be viewed by press- ing the up and down arrow keys: 1–4: Processing Sequences Status Maintenance Test Section K of this chapter describes how to initiate the sequences.
  • Page 135 (MINOR) is the minor error number which often provides additional information on the source of the error. The last column (CYCLE) is the total cycle count of the processor when the error occurred. To return to the Status Menu, press STOP. ThinPrep 2000 Processor Operator’s Manual 5B.23...
  • Page 136 Pressing 7 from the Main Menu displays the following screen. Maintenance: 1 - LCD ADJUST 2 - WASTE SYSTEM 3 - SERVICE MODE To return to the Main Menu, press STOP. The processor must be completely empty of supplies before continuing with Maintenance. 5B.24 ThinPrep 2000 Processor Operator’s Manual...
  • Page 137 • Sample vial holder rises — The sample vial holder rises to allow the operator to more easily clean under the holder. See “GENERAL CLEANING” on page 7.9. When the maintenance operation is complete, the operator must press ENTER with the door closed to return to the Main Menu. ThinPrep 2000 Processor Operator’s Manual 5B.25...
  • Page 138 AMPLES 3 – Service Mode: Pressing 3 initiates the Service Mode screen. This Service Mode is for Hologic use only. Technical Ser- vice may ask you to access this screen during troubleshooting. To return to the Main Menu, press STOP.
  • Page 140 The procedures in this section are designed to help the operator to identify and correct the most common causes of error messages. If the problem cannot be corrected by the operator, these procedures can help Hologic Technical Support to quickly identify the problem. ThinPrep 2000 Processor Operator’s Manual 6.1...
  • Page 141 Follow the three-step procedure listed below for any displayed message. 1. Record the message displayed on the ThinPrep 2000 processor display panel before pressing the ENTER key. 2. Look up the message in the “CONTENTS” on page 6.3.
  • Page 142 Vial Too Full. 21 mL Max. Allowed 6.30 Waste System Failure 6.32 OPERATOR ERRORS PAGE Door Open While Processing Sample 6.34 Press ENTER With Door Closed to Retry Initialization. System Uninitialized. 6.35 Stop Key Pressed 6.36 Error History 6.37 ThinPrep 2000 Processor Operator’s Manual 6.3...
  • Page 143 The processor will pause until the door is closed. Possible Causes • Door opened during processing or error recovery. • Door not fully closed due to obstruction. • System hardware malfunction. Procedure See flowchart on next page. ThinPrep 2000 Processor Operator’s Manual...
  • Page 144 Close Door to Continue Processing Open door and check for obstructions in door track. Is the door open? Carefully remove any obstructions. Close door. Does message persist? Call Technical Service. No further action required. ThinPrep 2000 Processor Operator’s Manual 6.5...
  • Page 145 The processor can only detect the presence or absence of a fixative vial. It cannot determine if Note: the fixative vial contains fixative solution. Possible Causes • Fixative bath not installed. • Fixative bath improperly installed due to obstruction. • System hardware malfunction. Procedure See flowchart on next page. ThinPrep 2000 Processor Operator’s Manual...
  • Page 146 NSTRUMENT ROUBLESHOOTING Insert Fix Bath to Continue Processing Is the Remove fixative vial and fixative vial check for obstruction. installed? Insert fixative vial. Call Technical Service. Does message persist? No further action required. ThinPrep 2000 Processor Operator’s Manual 6.7...
  • Page 147 The processor will pause until the operator corrects the situation. Possible Causes • Slide not installed. • Slide improperly installed due to obstruction. • System hardware malfunction. Procedure See flowchart on next page. ThinPrep 2000 Processor Operator’s Manual...
  • Page 148 Insert Slide to Continue Processing Is the slide Remove slide and installed? check for obstruction. Check slide for damage. Insert slide. Replace if necessary. Does message persist? Call Technical Service. No further action required. ThinPrep 2000 Processor Operator’s Manual 6.9...
  • Page 149 Possible Causes • Filter not removed after last sequence. • Error recovery requires filter removal. • Filter cap was not removed by withdrawing it straight out of the bobbins. Procedure See flowchart on next page. 6.10 ThinPrep 2000 Processor Operator’s Manual...
  • Page 150 NSTRUMENT ROUBLESHOOTING Remove Filter Is the filter installed? Insert filter cap and Remove filter. then remove filter cap. Call Technical Service. Does the message persist? No further action required. ThinPrep 2000 Processor Operator’s Manual 6.11...
  • Page 151 The processor will pause until the operator corrects the situation. Possible Causes • Fixative vial never removed after completed sequence. • System powered on with fixative vial installed. Procedure See flowchart on next page. 6.12 ThinPrep 2000 Processor Operator’s Manual...
  • Page 152 NSTRUMENT ROUBLESHOOTING Remove Fix Bath Is the fixative vial installed? Remove fixative vial. Call Technical Service. Does message persist? No further action required. ThinPrep 2000 Processor Operator’s Manual 6.13...
  • Page 153 To remove a slide, push down on the front edge of the slide. While holding the slide by this edge, gently pull the slide out of the instrument. If the slide is installed and it has cells on it, the cells on the slide are likely to be air-dried. 6.14 ThinPrep 2000 Processor Operator’s Manual...
  • Page 154 Remove Slide Is the slide installed? Remove slide from holder. (See note on previous page) Does Place slide in slide have cells on fixative vial. Does message persist? Call Technical Service. No further action required. ThinPrep 2000 Processor Operator’s Manual 6.15...
  • Page 155 This message is designed to warn the operator that a fixative vial was in the fix vial holder when the instrument power was turned on. The processor will pause until the operator corrects the situation. Possible Causes • System powered on with fixative vial installed. Procedure See flowchart on next page. 6.16 ThinPrep 2000 Processor Operator’s Manual...
  • Page 156 NSTRUMENT ROUBLESHOOTING Remove Fix Bath to Continue Processing Is the fix vial installed? Remove fix vial from holder. Does message persist? Call Technical Service. No further action required. ThinPrep 2000 Processor Operator’s Manual 6.17...
  • Page 157 To remove a slide, push down on the front edge of the slide. While holding the slide by this edge, gently pull the slide out of the instrument. If the slide is installed and it has cells on it, the cells on the slide are likely to be air-dried. 6.18 ThinPrep 2000 Processor Operator’s Manual...
  • Page 158 Remove Slide to Continue Processing Is the slide installed? Remove slide from holder. (See note on previous page) Does Place slide in slide have cells on fixative vial. Does message persist? Call Technical Service. No further action required. ThinPrep 2000 Processor Operator’s Manual 6.19...
  • Page 159 ENTER key. The slide should be stained and screened. Reason for Message There is a possibility of low concentration of cells in the sample. Procedure See flowchart on next page. 6.20 ThinPrep 2000 Processor Operator’s Manual...
  • Page 160 If there is additional sample material available, make Is the ThinPrep another slide with more cells if possible. (Non-gyn) slide satisfactory? Otherwise, notify the clinician who collected the sample. No further action required. ThinPrep 2000 Processor Operator’s Manual 6.21...
  • Page 161 Reattach the fitting and attempt to run a blank on the processor. If the error persists, replace the waste tubing, or waste filter, as described in “WASTE TUBING REPLACEMENT” on page 7.10. 6.22 ThinPrep 2000 Processor Operator’s Manual...
  • Page 162 Check filter membrane for damage. Run the ThinPrep Processor with 20 ml of PreservCyt Solution (no cells) to confirm normal operation. Does message persist? Call Technical Service No further action required. ThinPrep 2000 Processor Operator’s Manual 6.23...
  • Page 163 This is done to ensure that a previously used filter will not con- taminate another sample. Possible Causes • Wet ThinPrep Pap test filter. • Obstructed ThinPrep Pap test filter membrane. • System hardware malfunction. Procedure See flowchart on next page. 6.24 ThinPrep 2000 Processor Operator’s Manual...
  • Page 164 Remove filter as instructed by display Save the filter Is the filter wet? Note lot #. Replace the filter Initiate the sequence again. Does message persist? Call Technical Ser vice No further action required. ThinPrep 2000 Processor Operator’s Manual 6.25...
  • Page 165 • Large hole in ThinPrep Pap test filter membrane. • Obstruction preventing cap seal from seating properly. • Damaged cap seal O-ring. • Pinched or obstructed pneumatic tubing. • System hardware malfunction. Procedure See flowchart on next page. 6.26 ThinPrep 2000 Processor Operator’s Manual...
  • Page 166 Pap Test Filter. present? Is ThinPrep Pap Test Replace ThinPrep Pap Test Filter. Filter damaged? Clean filter cap. Inspect filter seal and cap seal. Continue processing. Does message persist? Call Technical Service. No further action required. ThinPrep 2000 Processor Operator’s Manual 6.27...
  • Page 167 This will halt processing and no slide will be made. This message is followed by an audible alert until the operator presses the ENTER key. Reason for Message There is a possibility of high concentration of material in the sample vial. Procedure See flowchart on next page. 6.28 ThinPrep 2000 Processor Operator’s Manual...
  • Page 168 NSTRUMENT ROUBLESHOOTING Sample Too Dense. Dilute 20:1 ThinPrep 2000 Processor Operator’s Manual 6.29...
  • Page 169 • System hardware malfunction. Procedure See flowchart on next page. If it is necessary to reduce the sample vial volume to be between 17 mL and 21 mL, save any excess fluid in an appropriate container. 6.30 ThinPrep 2000 Processor Operator’s Manual...
  • Page 170 Is the volume of the sample vial greater than 21 ml? Reduce sample vial volume to be between 17 and 21 ml. Continue processing. Call Technical Service. Does message persist? No further action required. ThinPrep 2000 Processor Operator’s Manual 6.31...
  • Page 171 • Waste bottle cap is not secure • Waste fittings are disconnected from back of instrument • Waste tubing is disconnected or obstructed at any point • System hardware malfunction • Waste filter is wet 6.32 ThinPrep 2000 Processor Operator’s Manual...
  • Page 172 Correct any crimps or Is the waste tubing obstructions in the waste obstructed? tubing. Press the ENTER key to send the instrument into idle mode. Wait 60 seconds. Does messagepersist? Call Technical Service. No further action required. ThinPrep 2000 Processor Operator’s Manual 6.33...
  • Page 173 This message appears when the instrument detects that the door of the instrument was opened during a sequence. The instrument will automatically abort the sequence and perform error recovery. Possible Causes • Door opened during sequence • System hardware malfunction 6.34 ThinPrep 2000 Processor Operator’s Manual...
  • Page 174 This message appears when the instrument detects that the door of the instrument was open during start-up of the instrument. The operator must close the door and press ENTER to retry system initialization. Possible Causes • Door opened during instrument start-up • System hardware malfunction ThinPrep 2000 Processor Operator’s Manual 6.35...
  • Page 175 Reason for Message This message appears when the user presses the STOP key during a sequence. The instrument will automatically abort the sequence and perform error recovery. Possible Causes • STOP key pressed during a sequence 6.36 ThinPrep 2000 Processor Operator’s Manual...
  • Page 176 No Fluid Detected. Check Filter and Vial Evacuation Failure. Check Filter Waste System Failure Door Open While Processing Sample Sample Too Dense. Dilute 20:1 Stop Key Pressed Press ENTER with Door Closed to Retry Initialization. System Uninitialized ThinPrep 2000 Processor Operator’s Manual 6.37...
  • Page 177 NSTRUMENT ROUBLESHOOTING This page intentionally left blank. 6.38 ThinPrep 2000 Processor Operator’s Manual...
  • Page 179 SECTION J: Waste Filter Replacement 7.14 SECTION K: Emptying and Cleaning the Catch Tray 7.16 SECTION L: Moving the ThinPrep 2000 Processor 7.17 SECTION M: Maintenance Schedule 7.18 Any procedure not described in this section requires specially trained personnel. Contact Note: Hologic Technical Service for more information.
  • Page 180 2. Cap removal — Open the waste bottle cap by rotating the waste cap while holding the bottle in place to avoid tangling the waste tubing. See Figure 7-1. Do not remove the length of tubing connected to the inside of cap. Figure 7-1 Opening/Closing the Waste Bottle Bottle OPEN CLOSE ThinPrep 2000 Processor Operator’s Manual...
  • Page 181 8. Check that the quick disconnect fittings located at the rear of the ThinPrep processor are secure. See Chapter 2, “ThinPrep 2000 Installation”, for details. 9. Completion — Press the ENTER key when this operation is complete. The system will be avail- able for sample processing when the display returns to the Main Menu.
  • Page 182 Wipe the entire filter cap with a lint-free wipe dampened with deionized or distilled water to remove deposits. Dry the filter cap after cleaning. Handle the filter cap gently. Do not hit it against hard surfaces. Note: Figure 7-2 Filter Cap Cap seal O-ring Filter seal O-rings ThinPrep 2000 Processor Operator’s Manual...
  • Page 183 Perform the following procedure weekly on the cap seal O-ring and whenever any of the filter seal O-rings are dry. 1. Using the tube of high-vacuum silicone grease included with the ThinPrep 2000 processor, apply a small amount of grease to each of the three O-rings as shown in Figure 7-3.
  • Page 184 O-ring as described in Section D. Do not use the filter cap with only one filter seal O-ring installed. This may cause splashing Note: during the dispersion phase and produce an insufficient seal for proper operation. ThinPrep 2000 Processor Operator’s Manual...
  • Page 185 SECTION DOOR CLEANING The door of the ThinPrep 2000 processor may become dirty over time. To clean the door, it is best to use a commercially available glass cleaner. 1. It is necessary to open the door mechanism to clean the inside surface of the plastic. Slide the door open approximately three inches.
  • Page 186 Upon completion of the cleaning, press the ENTER key to return to the Main Menu. This procedure should be performed on a daily basis. ThinPrep 2000 Processor Operator’s Manual...
  • Page 187 In general, be sure to clean up spills when they occur. Use a lint-free wipe to absorb any spills and then wipe the area of the spill with a lint-free wipe dampened with deionized water. ThinPrep 2000 Processor Operator’s Manual 7.9...
  • Page 188 Do not attempt to unscrew them completely. Figure 7-6 3. Remove the access panel and set it aside. 4. Locate the pieces of flexible tubing shown in Figure 7-7. 7.10 ThinPrep 2000 Processor Operator’s Manual...
  • Page 189 5. Detach tubing from points A and B shown in Figure 7-8. Figure 7-8 6. Holding the tubing on each side of the valve, slide it out of the valve in the direction shown in Figure 7-9. Discard tubing. ThinPrep 2000 Processor Operator’s Manual 7.11...
  • Page 190 See Figure 7-10. Make sure tubing is fully inserted and not twisted. Figure 7-10 8. Connect the replacement tubing to points A and B shown in Figure 7-11. Make sure tubing fully covers each fitting. 7.12 ThinPrep 2000 Processor Operator’s Manual...
  • Page 191 Main Menu. 11. To test the new tubing installation, run a blank PreservCyt Solution sample vial (no cells) using the “Run Blank Sample” procedure outlined in Chapter 2, “ThinPrep 2000 Installation”, of this manual. Additional replacement tubing is available from Hologic.
  • Page 192 AINTENANCE SECTION WASTE FILTER REPLACEMENT If the waste bottle is allowed to overfill, the waste filter may become wet. The ThinPrep 2000 processor will detect a problem and report an error message. 1. Turn off the instrument. 2. Attempt to salvage the waste filter by draining the fluid from the waste filter. In the back of the instrument, detach the bottom connector (yellow) which has the waste filter in line.
  • Page 193 8. Reattach all the waste connectors to the rear of the instrument. Refer to Chapter 2, “ThinPrep 2000 Installation” for more information. 9. Turn on instrument power. 10. Run a blank (PreservCyt Solution vial with no cells) on the processor to test the operation of the instrument. ThinPrep 2000 Processor Operator’s Manual 7.15...
  • Page 194 EMPTYING AND CLEANING THE CATCH TRAY 1. If the ThinPrep 2000 processor is equipped with a catch tray, on a frequent basis observe how much liquid is collected in the catch tray. When the level is near the first indentation from the bot- tom, empty the tray.
  • Page 195 SECTION MOVING THE THINPREP 2000 PROCESSOR ® If it becomes necessary to change the location of your ThinPrep 2000 processor, be sure to follow one of the two procedures described below. Unit moved within building: 1. Turn off power. 2. Disconnect power cord from the electrical outlet and instrument.
  • Page 196 As needed Door Cleaning As needed General Cleaning Monthly Waste Tubing Replacement Six months (in pinch valve) Waste Filter Replacement As needed Cap Seal Cleaning Daily Empty and Clean Catch Tray (if present) As needed 7.18 ThinPrep 2000 Processor Operator’s Manual...
  • Page 197 DAILY WEEKLY MONTHLY WEEKLY EMPTY CLEAN FILTER PNEUMATIC CAP SEAL FILTER SEAL CLEAN CAP DOOR GENERAL DATE WASTE TEST O-RING LUBE O-RING LUBE SEAL CLEANING CLEANING BOTTLE This page is for photocopy purposes. Note: ThinPrep 2000 Processor Operator’s Manual 7.19...
  • Page 198 AINTENANCE This page intentionally left blank. 7.20 ThinPrep 2000 Processor Operator’s Manual...
  • Page 200 These guidelines are recommendations and should not be considered absolute requirements. ThinPrep 2000 Processor Operator’s Manual 8.1...
  • Page 201 95% ethyl alcohol. Use the following procedure to fix ThinPrep microscope slide preparations. 1. Remove each slide after it is deposited into the fixative vial in the ThinPrep 2000 processor. 2. Place the slide in a multi-slide holder and place the slide holder into a fixative bath containing 95% reagent alcohol or 95% ethyl alcohol.
  • Page 202 3. Standard staining times for ThinPrep slides may be different from conventional slides, and it may be necessary to increase or decrease these times. It is recommended that staining times be optimized following laboratory standard operating procedures. These differences may necessi- tate staining ThinPrep and conventional slides separately. ThinPrep 2000 Processor Operator’s Manual 8.3...
  • Page 203 0.1% • Ammonium Hydroxide 0.1% 5. Avoid the use of strong salt solutions like Scotts Tap Water Substitute. Hologic recommends the use of a dilute Lithium Carbonate solution or Ammonium Hydroxide solution as the bluing solu- tion. 6. During the hydration dehydration process, use graded concentrations e.g., 50%, 70% of alcohol.
  • Page 204 Mount in Permount Stains may be ordered from Richard-Allan Scientific, SC . Hematoxylin I (7221), Richard-Allan Cytology Stain (7511). Permount is a trademark of Fisher Scientific Corp. * Time may vary with stain lot or age. ThinPrep 2000 Processor Operator’s Manual 8.5...
  • Page 205 The use of Permount mounting media has been evaluated and is recommended for use with ThinPrep slides by Hologic. Since some mounting media cause “floating” of cells to occur on ThinPrep or conventional slides, each laboratory should evaluate their choice of mounting media to insure compatibility with ThinPrep slides.
  • Page 207 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 208 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 210 Close Door to Continue Processing COBAS AMPLICOR™ CT/NG Test Collection Broom-like device Endocervical brush/Spatula device Connect the waste bottle Dimensions 1.13 Dispersion 1.3, Disposal consumables 1.19 Door closing 5A.15, 5B.14 Environmental 1.14 Extended shutdown 2.12 ThinPrep 2000 Processor Operator’s Manual Index.1...
  • Page 211 Loading Fixative vial 5A.14, 5B.7 PreservCyt Sample vial 5A.4, 5A.7, 5B.10 ThinPrep Microscope Slide 5A.11, 5B.11 ThinPrep Pap Test Filter 5A.8, 5B.8 Location selection lubricant Maintenance screen 5A.23 Material requirements 1.5, 5B.2 Neisseria gonorrhoeae Index.2 ThinPrep 2000 Processor Operator’s Manual...
  • Page 212 Storage and handling 2.12 Symbols used on the instrument 1.16 Technical specifications 1.12 Test screen 5A.25 Troubleshooting Turning off the processor 2.12 Turning on the processor UNLOADING 5B.19 Unloading fixative vial 5A.18 PreservCyt Sample Vial 5B.18 ThinPrep 2000 Processor Operator’s Manual Index.3...
  • Page 213 NDEX slide 5A.18, 5B.19 ThinPrep Pap Test filter 5A.18, 5B.20 voltage 1.14, Warnings, Cautions, Notes 1.16 Weight 1.14 Index.4 ThinPrep 2000 Processor Operator’s Manual...
  • Page 215 Section 2 (blue tabs) contains information specific to the preparation of non-gynecologic samples. For all information related to the installation, operation, and maintenance of the ThinPrep 2000 processor, please ® refer to SECTION 1. ThinPrep 2000 Processor Operator’s Manual i...
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  • Page 217 SECTION E: Specimen Preparation Protocols 1.17 SECTION F: ThinPrep UroCyte Specimens 1.24 SECTION G: Sample Preparation Troubleshooting 1.27 Chapter 2 SOLUTIONS SECTION A: Introduction ® SECTION B: PreservCyt Solution ® SECTION C: CytoLyt Solution Solutions Storage Guide ThinPrep 2000 Processor Operator’s Manual iii...
  • Page 218 ONTENTS This page intentionally left blank. ThinPrep 2000 Processor Operator’s Manual...
  • Page 220 In order to perform sample preparation for ThinPrep UroCyte specimens, refer to “THINPREP® UROCYTE® SPECIMENS” on page 1.24. Sample preparation troubleshooting as described in Section G has not been evaluated for ThinPrep UroCyte samples. ThinPrep 2000 Processor Operator’s Manual 1.1...
  • Page 221 1.19 SECTION E-3: Body Fluids 1.21 SECTION E-4: Superficial Brushings And Scrapings 1.22 ® SECTION E-4: FirstCyte Breast Test Specimens 1.23 ® ® SECTION F: ThinPrep UroCyte Specimens 1.24 SECTION G: Sample Preparation Troubleshooting 1.27 ThinPrep 2000 Processor Operator’s Manual...
  • Page 222 • Standard laboratory fixative • Coverslips and mounting media • Anticoagulant for needle aspirates • Blender (optional) • Glacial acetic acid (troubleshooting only) • Saline (troubleshooting only) • DiThioThreitol (DTT, optional, mucoid samples only) ThinPrep 2000 Processor Operator’s Manual 1.3...
  • Page 223 SECTION DETAILS OF NON-GYNECOLOGIC SAMPLE PREPARATION STEPS The following are the common steps for preparing a non-gynecologic sample with the ThinPrep 2000 system. Each step is explained in detail in the following sections. 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 224 Samples to be processed on the ThinPrep processor will arrive in the lab either fresh or in 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 225 In cases where CytoLyt Solution is contraindicated, balanced electrolyte solutions, such as Plasma-Lyte and Polysol, may be used as collection media for samples to be processed on the ThinPrep 2000 processor. These solutions are primarily used as media for washings or lavages which contact the patient.
  • Page 226 Specimens must be centrifuged and washed in CytoLyt Solution and transferred to PreservCyt Solution prior to being processed on the ThinPrep 2000 processor. Refer to “CYTOLYT SOLUTION WASH” on page 1.16 for CytoLyt Solution wash instructions. See Chapter 2, “Solutions”, for more information on CytoLyt Solution.
  • Page 227 600 Gravities (g) column and into the rpm column. Read the rpm value from the straight edge as shown in Figure 1-2. Run your centrifuge at this speed to achieve a force of 600g on your samples. ThinPrep 2000 Processor Operator’s Manual...
  • Page 228 YNECOLOGIC AMPLE REPARATION Figure 1-2 Determining the Correct Centrifuge Speed To reduce the time required for the centrifugation step, operate your centrifuge at 1200g for 5 minutes. ThinPrep 2000 Processor Operator’s Manual 1.9...
  • Page 229 PreservCyt Solution vial and to improve the results of the CytoLyt Solution washing procedure. 1 Refer to Bales, CE, and Durfee, GR. Cytologic Techniques in Koss, L. ed. Diagnostic Cytology and its Histopathologic Basis. 3rd Edition. Philadelphia: JB Lippincott. Vol. II: pp. 1187–12600 for details. 1.10 ThinPrep 2000 Processor Operator’s Manual...
  • Page 230 • Concentrate by centrifugation. If the drops appear stringy or gelati- nous, then the mucus must be further • Pour off supernatant and vortex to resuspend cell liquefied. pellet. ThinPrep 2000 Processor Operator’s Manual 1.11...
  • Page 231 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 232 After sample transfer to the PreservCyt Solution vial, the sample should stand for at least 15 minutes before processing to allow the PreservCyt Solution to render the sample non-infectious. For more information on PreservCyt Solution, refer to Chapter 2, “Solutions”. ThinPrep 2000 Processor Operator’s Manual 1.13...
  • Page 233 FIX, STAIN, AND EVALUATE After the sample has been in contact with PreservCyt Solution for 15 minutes, it may be processed on the ThinPrep 2000 processor. The operator loads the instru- ment and selects the appropriate sequence number (sequence ‘n’) for the sample to be processed as described in “SELECTING AND INITIATING A SEQUENCE”...
  • Page 234 AMPLE REPARATION SECTION MECHANICAL AGITATION Mucoid specimens require vigorous agitation in CytoLyt Solution to break up the mucus. Hologic recommends two methods of mechanical agitation: Method A: Vortex the CytoLyt/sample mixture for at least 5 minutes on a “hands-free” vor- texor.
  • Page 235 30 mL of CytoLyt Solution to this sample, then the CytoLyt: sample ratio is only 2 to 1 and this is considered a sample collection step and still requires a CytoLyt Solution Wash. For more information on CytoLyt Solution, refer to Chapter 2, “Solutions”. 1.16 ThinPrep 2000 Processor Operator’s Manual...
  • Page 236 The following protocols outline the preferred methods for preparing the different types of speci- mens. The methods are described in general terms. For more detailed information about each step, refer to Section D in this Chapter. Section G provides troubleshooting for sample preparation. ThinPrep 2000 Processor Operator’s Manual 1.17...
  • Page 237 5. Add appropriate amount of specimen to PreservCyt Solution vial. Refer to page 1.12. 6. Allow to stand in PreservCyt Solution for 15 minutes. 7. Run on ThinPrep 2000 processor using Sequence 2, Fix, Stain, and Evaluate. 1.18 ThinPrep 2000 Processor Operator’s Manual...
  • Page 238 Confirm the cell pellet is in liquid form. If the cell pellet is not in liquid form, add 30 mL of CytoLyt Solution and repeat steps 2–4. 30 ml 6. Add appropriate amount of specimen to PreservCyt Solution vial. Refer to page 1.12. ThinPrep 2000 Processor Operator’s Manual 1.19...
  • Page 239 YNECOLOGIC AMPLE REPARATION 7. Allow to stand in PreservCyt Solution for 15 minutes. 8. Run on ThinPrep 2000 processor using Sequence 3, 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 240 If cell pellet is not free of blood, add 30 mL of CytoLyt Solution to cell pellet and repeat from step 2. 30 ml 6. Add appropriate amount of specimen to PreservCyt Solution vial. Refer to page 1.12. ThinPrep 2000 Processor Operator’s Manual 1.21...
  • Page 241 YNECOLOGIC AMPLE REPARATION 7. Allow to stand in PreservCyt Solution for 15 minutes. 8. Run on ThinPrep 2000 processor using Sequence 2, Fix, Stain, and Evaluate. SECTION SUPERFICIAL BRUSHINGS AND SCRAPINGS Superficial brushings and scrapings include oral cavity specimens, nipple secretions, skin lesions (Tzanck test), and eye brushings.
  • Page 242 5. Add appropriate amount of specimen to PreservCyt Solution Vial. Refer to page 1.12. Allow to stand in PreservCyt Solution for 15 minutes. 6. Run on ThinPrep 2000 processor using Sequence 2, Fix, Stain and Evaluate. ThinPrep 2000 Processor Operator’s Manual 1.23...
  • Page 243 ® SPECIMENS Your ThinPrep 2000 processor does not currently support UroCyte sample preparation. In order to perform urine cytology using this system, additional software must be obtained. Please refer to the Ordering Information in this manual or call Customer Service at 1-508-263-2900 for more information.
  • Page 244 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. ® A minimum of 33 mL of urine is required to perform the Vysis UroVysion assay. ThinPrep 2000 Processor Operator’s Manual 1.25...
  • Page 245 C (39 F–86 F). Preferred storage and ship- ping conditions are on ice packs (e.g., blue ice in styrofoam). Speci- men must be processed within 48 hours. Transport the specimen according to your internal procedures. 1.26 ThinPrep 2000 Processor Operator’s Manual...
  • Page 246 • A sparse cell spot lacking in a cellular component and containing blood, protein, and debris. This type of slide may be accompanied by a “Sample Is Dilute” message. Satisfactory slide appearance is a matter of judgment and experience. Hologic recommends Note: that you check the quality of the slide after staining.
  • Page 247 1 part glacial acetic acid. Add 30 mL of this solution to the sample centrifuge tube. If the sample contains protein: Add 30 mL of saline to the sample cen- trifuge tube. 1.28 ThinPrep 2000 Processor Operator’s Manual...
  • Page 248 8. Add appropriate amount of specimen to PreservCyt Solution vial. Refer to page 1.12. 9. Run on ThinPrep 2000 processor using Sequence 2, Fix, Stain, and Evaluate. 10. If the new slide is sparse, call Hologic Technical Service. ThinPrep 2000 Processor Operator’s Manual 1.29...
  • Page 249 3. Pour off supernatant and vortex to resuspend cell pellet. 4. CytoLyt Solution Wash MUCOID ONLY 30 ml 5. Evaluate cell pellet appearance. Refer to page 1.11. If pellet contains mucus, repeat from step 4. 30 ml 1.30 ThinPrep 2000 Processor Operator’s Manual...
  • Page 250 6. Add appropriate amount of specimen to PreservCyt Solution vial. Refer to page 1.12. 7. Run on ThinPrep 2000 processor using Sequence 2, Fix, Stain, and Evaluate. 8. If the new slide is sparse, call Hologic Technical Service. ThinPrep 2000 Processor Operator’s Manual 1.31...
  • Page 251 This artifact is a result of cells from the outer edge of the wet filter cylinder being transferred to the glass slide. This may be more evident on highly cellular samples because there will be more cells to be transferred in the liquid. 1.32 ThinPrep 2000 Processor Operator’s Manual...
  • Page 252 CytoLyt Solution. This should only be done after the sample has been in PreservCyt Solution. Do not use directly with fresh specimens; nuclear morphology may not be ade- quately preserved. ThinPrep 2000 Processor Operator’s Manual 1.33...
  • Page 253 YNECOLOGIC AMPLE REPARATION This page intentionally left blank. 1.34 ThinPrep 2000 Processor Operator’s Manual...
  • Page 255 C h a p t e r T w o Solutions SECTION INTRODUCTION The following sections describe the function and specifications of the two cytologic preservative flu- ® ® ids: PreservCyt Solution and CytoLyt Solution. ThinPrep 2000 Processor Operator’s Manual 2.1...
  • Page 256 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 2000 system. • Vials (20 mL) of PreservCyt Solution are contained in each ThinPrep Pap test.
  • Page 257 15 minutes in the PreservCyt Solution. The log reduction of viable organisms is also pre- sented. As with all laboratory procedures, universal precautions should be followed. ThinPrep 2000 Processor Operator’s Manual 2.3...
  • Page 258 The use of lubricants (e.g., KY Jelly) should be avoided prior to specimen collection. 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. ThinPrep 2000 Processor Operator’s Manual...
  • Page 259 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 2000 system. • Box of 4 bottles each containing 1 quart (946 mL) of CytoLyt Solution •...
  • Page 260 WARNING: CytoLyt Solution is not intended for complete inactivation of microbes. Dispose of CytoLyt Solution according to guidelines for disposing of biologically hazard- ous materials. Observe appropriate biological safety precautions for handling fresh speci- mens. ThinPrep 2000 Processor Operator’s Manual...
  • Page 261 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 262 3. If multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. * 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 263 4. Absorbent material must be placed between the primary receptacle and the secondary packaging. The absorbent material (cotton balls, cellulose wadding, absorbent packets, paper towels) must be in sufficient quantity to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or the outer packaging.
  • Page 264 2. Always affix the Class 9, UN 1845 dry ice label as well as the UN 3373, Biological Substance, Category B label to these shipments 3. 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? ...
  • Page 265 Domestic Air Shipments: In addition to 1 and 2 above in Domestic Ground Shipments – Other than Limited Quantities, the following are recommendations for domestic air shipments: 3. Maximum allowable package sizes are: i. Sixty (60) liters (3000-vials) for passenger aircraft, and ii.
  • Page 266 International Air Shipments: The references used for the International Air recommendations are: In addition to a and b above in International Ground Shipments, the following are the recommendations for international air shipments: 1. Maximum allowable package sizes are: i. Sixty (60) liters (3000-vials) for passenger aircraft, and ii.
  • Page 267 Domestic Air Shipments: ™ ® When shipping ThinPrep CytoLyt Solution via air, follow the Domestic Air Shipments ™ ® recommendations for Shipping ThinPrep PreservCyt Solution Only that can be found in Section B of this document. International Ground and Air shipments: ™...
  • Page 269 CytoLyt Solution composition handling/disposal packaging stability storage requirements CytoLyt Solution wash Dithiothreitol (DTT) filter membrane fine needle aspirates FirstCyte Ductal Lavage fixation fluid specimens glacial acetic acid mucoid specimens ThinPrep 2000 Processor Operator’s Manual Index.1...
  • Page 270 Stability storage requirements transportation red blood cells Required Materials saline solution Sample is Dilute Sequence 1 Sequence 2 Sequence 3 staining superficial specimen troubleshooting UroCyte specimens UroCyte Urine Collection Kit vial cap, align Index.2 ThinPrep 2000 Processor Operator’s Manual...
  • Page 272 Hologic, Inc., P.O. Box 3009, Boston, MA 02241-3009 Business Hours Hologic’s business hours are 8:30 a.m. to 5:30 p.m. EST Monday through Friday excluding holidays. Customer Service To order products, and place or amend standing orders, call Customer Service at 1-800-442-9892 or 1-508-263-2900 during business hours or fax your order to the attention of Customer Service at 1-508-229-2795.
  • Page 273 ERVICE NFORMATION This page intentionally left blank. Service.2 ThinPrep 2000 Processor Operator’s Manual...
  • Page 275 Hologic, Inc., P.O. Box 3009, Boston, MA 02241-3009 Business Hours Hologic’s business hours are 8:30 a.m. to 5:30 p.m. EST Monday through Friday excluding holidays. Ordering Information To order products, and place or amend standing orders, call Customer Service at 1-800-442-9892 or 1-508-263-2900 during business hours or fax your order to the attention of Customer Service at 1-508-229-2795.
  • Page 276 NFORMATION For returns on all other supplies, please call Customer Service at 1-800-442-9892 or 1-508-263-2900 to obtain a Return Goods Authorization number. Hologic will not accept any returned items without this number. For returns related to warranty issues, please contact Technical Support at 1-800-442-9892 or 1-508- 263-2900 and for questions regarding any other type of return, please contact Customer Service.
  • Page 277 ThinPrep Imaging System 70664-001 Microscope Slides Broom-Like Collection Contains: Devices Kit Broom-like Collection Devices (20 bags of 25 devices) 70101-001 Cytobrush/ Contains: Plastic Spatula Kit Cytobrush/Spatula Collection Devices (20 bags of 25 device pairs) 70124-001 ThinPrep 2000 Processor Operator’s Manual Ordering.3...
  • Page 278 50326-001 Fixative Vials 1 vial 70129-001 ® Multi-Mix Racked Vortexor Sealed Cylinder 02559-001 Base Liners Package of 4 70280-001 * Order number depends upon specific power requirements for each country. Contact Hologic Customer Service. Ordering.4 ThinPrep 2000 Processor Operator’s Manual...
  • Page 279 ThinPrep UroCyte PerservCyt Cups 50 cups per case 70991-001 ThinPrep UroCyte Urine Collection Kit 20 kits per case 70908-001 Arc-less slides (for IHC stains) Box, 1/2 gross 70126-002 Non-Gyn slides 100 slides per box 70372-001 ThinPrep 2000 Processor Operator’s Manual Ordering.5...
  • Page 280 RDERING NFORMATION Injection Solutions Available from Baxter Healthcare Corporation 1-800-933-0303 ® 500 mL 2B2543 Plasma-Lyte A Injection pH 7.4 ® 1000 mL 2B2544 Plasma-Lyte A Injection pH 7.4 Ordering.6 ThinPrep 2000 Processor Operator’s Manual...
  • Page 282 ATERIAL AFETY HEETS Material Safety Data Sheets ® CytoLyt Solution ® PreservCyt Solution The Material Safety Data Sheet (MSDS) for each solution may be requested from Hologic Technical Support, or found on-line at www.hologicmsds.com. ThinPrep 2000 System Operator’s Manual MSDS.1...
  • Page 283 ATERIAL AFETY HEETS This page intentionally left blank. MSDS.2 ThinPrep 2000 System Operator’s Manual...
  • Page 284 Hologic, Inc. • 250 Campus Drive • Marlborough, MA 01752 US • 1-800-442-9892 • 1-508-263-2900 • www.hologic.com Hologic UK Ltd. • Link 10 Napier Way • Crawley, West Sussex • RH10 9 RA • UK • +44 (0) 1293 522 080...

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