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MAN-03939-001 Rev. 004 page 6 of 13

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%.

3

The referral center in the

study served a high risk referral patient population (referral populations) characterized by
high rates (>10%) of cervical abnormality. The screening/referral center’s abnormality rate
was a combination of the two previously mentioned rates. Table

1 describes the

laboratories and the patient populations.

Table 1: Site Characteristics

Laboratory Characteristics

Clinical Study Demographics

Site Type of Patient

Population

Laboratory

Volume -

Smears per

Year

Cases Patient

Age Range

Post

Menopausal

%

Previous

Abnormal

Pap Smear

%

Con-current

Infection

%

S1 Referral

44,709 1188 18-85

11.8

51.8

35.2

S2

Screening/Refer

ral

62,195 1141

18-77

6.0

21.8

15.1

S3 Screening

90,639

1198 18-82

12.5

22.7

10.2

Cases with patient’s age less than 18 years or patients with a hysterectomy were
excluded from this analysis.

CLINICAL STUDY RESULTS

The diagnostic classes of the Bethesda System are used to present the comparison between
the TP-3000 and TP-2000 findings from all of the clinical trial sites.

Three independent pathologists served as an adjudication panel for the three clinical sites.
The panel reviewed all discordant cases (a one-grade or higher cytologic difference) for
descriptive diagnosis and specimen adequacy. Since a true reference cannot be determined
in such studies and therefore true sensitivity cannot be calculated, the use of an independent
adjudicated review provides an alternative to histologic confirmation by biopsy or human
papillomavirus (HPV) testing as a means for determining the reference diagnosis.
Consensus was determined when a minimum of 2 out of 3 independent pathologists
rendered an equivalent diagnosis. If a majority vote could not be obtained, a consensus was
achieved during a review by all three pathologists at a multi-headed scope.

Table 2 shows the unadjudicated descriptive diagnosis results from all sites for the TP-
3000 and TP-2000. Of the 3,527 total patients enrolled in the study, 3,224 were included
in the descriptive diagnosis analysis after all data integrity sorting was applied.

Few cases of cervical cancer were represented in the clinical study, as is typical in the
United States patient population.

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Summary of Contents for ThinPrep 3000

Page 1: ......

Page 2: ...INC 250 CAMPUS DRIVE MARLBOROUGH MA 01752 USA TEL 1 800 442 9892 1 508 263 2900 FAX 1 508 229 2795 WEB WWW HOLOGIC COM For Use With Version 1 x y Software ThinPrep 3000 Processor Operator s Manual MAN 02586 001 ...

Page 3: ...ion to ensure accuracy Hologic assumes no liability for any errors or omissions nor for any damages resulting from the application or use of this information This product may be covered by one or more U S patents identified at http hologic com patentinformation Hologic CellFyx PreservCyt and ThinPrep are trademarks or registered trademarks of Hologic Inc and or its subsidiaries in the United State...

Page 4: ...The ThinPrep Processor The ThinPrep Processor ...

Page 5: ...MAN 03939 001 Rev 004 page 1 of 13 Instructions for Use ...

Page 6: ...rents in the fluid that are strong enough to separate debris and disperse mucus but gentle enough to have no adverse effect on cell appearance The cells are then captured on a Gynecological ThinPrep Pap Test Filter that is specifically designed to collect cells The TP 3000 constantly monitors the rate of flow through the ThinPrep Pap Test Filter during the collection process in order to prevent th...

Page 7: ...for instructions for using PreservCyt Solution for collection transport storage and preparation of specimens and to the Roche Diagnostics COBAS AMPLICOR CT NG package insert for instructions for use of that system LIMITATIONS Gynecologic samples collected for the TP 3000 should be collected using a broom type or endocervical brush plastic spatula combination collection devices Refer to the instruc...

Page 8: ...ederal regulations PRECAUTIONS A TP 3000 generates uses and can radiate radio frequency energy and if not installed and used in accordance with the Operator s Manual may cause interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his her own expense Preser...

Page 9: ...r TP 2000 The objective of this clinical study was to demonstrate that gynecologic specimens prepared using both instruments were equivalent when used for the detection of atypical cells and cervical cancer or its precursor lesions in a variety of patient populations In addition an assessment of specimen adequacy was performed The initial clinical study protocol was a single masked direct to vial ...

Page 10: ...ient s age less than 18 years or patients with a hysterectomy were excluded from this analysis CLINICAL STUDY RESULTS The diagnostic classes of the Bethesda System are used to present the comparison between the TP 3000 and TP 2000 findings from all of the clinical trial sites Three independent pathologists served as an adjudication panel for the three clinical sites The panel reviewed all discorda...

Page 11: ...TP 3000 NEG ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL TP NEG 258 25 0 5 1 0 0 289 2000 ASCUS 29 11 0 11 0 0 0 51 AGUS 0 0 0 0 0 0 0 0 LSIL 6 9 0 10 2 0 0 27 HSIL 1 2 0 3 3 0 0 9 SQ CA 0 0 0 0 0 0 0 0 GL CA 0 0 0 0 0 0 0 0 TOTAL 294 47 0 29 6 0 0 376 Abbreviations for Diagnoses NEG Normal or negative ASCUS Atypical Squamous Cells of Undetermined Significance AGUS Atypical Glandular Cells of Undetermin...

Page 12: ...nostic Classification Table HSIL and More Severe Lesions Includes adjudicated cases only TP 3000 NEG ASCUS AGUS LSIL HSIL TOTAL TP NEG ASCUS AGUS LSIL 364 3 367 2000 HSIL 6 3 9 TOTAL 370 6 376 The diagnostic data analysis from each site is summarized in Table 7 for adjudicated cytologic results of HSIL When the p value is significant p 0 05 the method favored is indicated in the tables Table 7 Adj...

Page 13: ...10 7 0 0 0 1 0 2 9 7 0 5 0 0 0 0 2 8 848 67 193 347 1 2 2 292 16 0 0 72 23 6 2 1 6 0 10 8 0 0 0 1 0 1 9 1 0 5 0 0 0 0 2 2 Epithelial Cell Abnormalities Squamous Cell ASCUS combined Favor reactive Favor neoplastic Undetermined LSIL HSIL Carcinoma Glandular Cell Benign Endometrial cells in Postmenopausal Women AGUS combined Favor reactive Favor neoplastic Undetermined 526 239 82 81 76 189 81 2 11 6 ...

Page 14: ...l Cell Abnormalities Squamous Cell ASCUS combined Favor reactive Favor neoplastic Undetermined LSIL HSIL Carcinoma Glandular Cell Benign Endometrial cells in Postmenopausal Women AGUS combined Favor reactive Favor neoplastic Undetermined 88 87 9 33 45 27 9 0 1 0 0 0 0 23 4 23 2 2 4 8 8 12 0 7 2 2 4 0 0 0 3 0 0 0 0 0 0 0 0 82 78 7 31 40 29 6 0 0 0 0 0 0 21 8 20 7 1 9 8 2 10 6 7 7 1 6 0 0 0 0 0 0 0 ...

Page 15: ...than one subcategory Table 11 Adjudicated Summary of Specimen Adequacy Results Includes adjudicated cases only Specimen Adequacy TP 2000 TP 3000 Number of Patients 57 N N Satisfactory 12 21 1 9 15 8 Satisfactory for Evaluation but Limited by Air Drying Artifact Thick Smear Endocervical Component Absent Scant Squamous Epithelial Component Obscuring Blood Obscuring Inflammation No Clinical History C...

Page 16: ...icroscope slides used in the detection of atypical cells cervical cancer or its precursor lesions as well as all other cytologic categories as defined by The Bethesda System TECHNICAL SERVICE AND PRODUCT INFORMATION For technical service and assistance related to use of the ThinPrep 3000 Processor contact Hologic Telephone 1 800 442 9892 Fax 1 508 229 2795 For international or toll free blocked ca...

Page 17: ...lFyx Solution between 15 C and 30 C Do not use beyond the expiration date printed on the container CellFyx Solution preserves cells on slides up to 5 days at 15 C to 30 C prior to staining BIBLIOGRAPHY 1 Kurman RJ Solomon D The Bethesda System for Reporting Cervical Vaginal Cytologic Diseases Springer Verlag New York 1994 2 United States Pharmacopeia U S P Preservative Antimicrobial Effectiveness ...

Page 18: ...Table of Contents Table of Contents ...

Page 19: ...ernal 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 2 1 SECTION B Action Upon Delivery 2 1 SECTION C Preparation Prior to Installation 2 3 SECTION D Storage and Handling Post Installation 2 3 SECTION E Connect Power 2 4 SECTION F How to Turn the Processor On Off 2 4 SECTION G System Startup 2 6 S...

Page 20: ... SECTION C Special Precautions 4 4 SECTION D Specimen Processing 4 4 SECTION E Sample Processing Troubleshooting 4 6 Chapter Five INSTRUMENT OPERATION SECTION A Chapter Overview 5 1 SECTION B Optional Instructions for Ancillary Testing 5 2 SECTION C Instrument Doors 5 4 SECTION E Items Required to Begin Batch Processing 5 5 SECTION E Begin Batch Processing 5 14 SECTION F Completing a Batch 5 18 SE...

Page 21: ...ubing Replacement 6 26 SECTION J Waste System Maintenance 6 28 SECTION K Emptying the Filter Waste Box 6 31 SECTION L Replenishing CellFyx Solution 6 32 SECTION M Replacing the Slide Printer Ribbon 6 34 SECTION N Replacing the User Accessible Fuses 6 36 SECTION O Replacing the Results Printer Paper 6 38 Chapter Seven TROUBLESHOOTING SECTION A Chapter Overview 7 1 SECTION B Sample Errors 7 2 SECTIO...

Page 22: ...ns 10 1 SECTION B Menu Trees 10 1 INDEX INDEX 1 SERVICE INFORMATION SERVICE 1 ORDERING INFORMATION ORDERING 1 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 ...

Page 23: ...1 Introduction 1 Introduction ...

Page 24: ... Disposal 1 17 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 Key system components include ...

Page 25: ...of solution containing the sample and forwarded to a laboratory equipped to process the ThinPrep Pap test 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...

Page 26: ...g debris and mucus while thoroughly mixing the cell sample Cell Collection A gentle vacuum is created in the ThinPrep Pap test filter which collects cells on the exterior surface of the membrane Cell Transfer The ThinPrep Pap test filter is inverted and the collected cells are gently and evenly transferred onto the ThinPrep microscope slide in a defined area ...

Page 27: ... gripper Filters Filter tray handler Results printer Display keypad Slide cartridges Slide translator Slide printer Slide ejector Slide output system OCR reader Fixative dispenser Slide cell transfer arm Filter waste bin Sample vials Sample vial gripper Vial tray handler Barcode reader Sample processing station THINPREP 3000 PROCESSOR FRONT OF INSTRUMENT Electronic and pneumatic systems Filter rob...

Page 28: ...ed 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 The vial is uncapped 5 The filter is introduced for cell collection 6 The vial is recapped 7 The sample vial is returned to the sample tray 005532 1 005532 2 3 4 5 6 005532 7 ...

Page 29: ...sample processing arm retrieves the filter 4 The filter is brought to the sample processing station and placed in the vial for sample collection 5 The sample processing arm rotates and precisely meets with the slide cell transfer arm bearing a slide Cell transfer occurs 6 The used filter is returned to the filter elevator for disposal 1 4 5 6 2 3 Disposal chute Filter elevator detail New filter po...

Page 30: ...code number scanned from the sample vial is printed onto the slide along with the time date and facility name optional 4 The slide translator hands the slide off to the slide cell transfer arm 5 The slide cell transfer arm pivots to convey the slide to meet the ThinPrep Pap test filter for cell transfer 6 The slide cell transfer arm delivers the slide to the fixative dispenser where fixative is ap...

Page 31: ...bly 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 Sample vial trays 11 ThinPrep microscope slides 6 Slide waste bin 12 Slide cartridges Figure 1 7 Material Requirements SECTION C 1 2 5 6 7 9 10 12 00001168 4 MA X MA X 3 CellFyx SOLUTION ª 8 11 ThinPre p Micr oscope Slides ...

Page 32: ...NPREP 3000 PROCESSOR TECHNICAL SPECIFICATIONS ThinPrep 3000 Processor Dimensions Note All measurements in this manual are rounded to the nearest whole number Figure 1 8 Dimensions SECTION D CYTYC 49 in 124 cm 29 in 74 cm 57 in 145 cm Approximate weight 700 lb 318 kg ...

Page 33: ...or 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 67 in 170 cm 29 in 74 cm 17 in 43 cm 49 in 124 cm 9 in 23 cm CYTYC Shown with service door open ...

Page 34: ... environment Power Voltage 100 240 Volts Alternating Current no selection required Mains supply voltage not to exceed 10 of the nominal voltage Frequency 47 63Hz Current 4A maximum 500W maximum Heat Generated Approximately 1100BTU HR WARNING Instrument Fusing Fusing External 2 X T6 3AL 250V 5 x 20mm 6 3A time delay low break capacity Internal 1 X 15A 250V 3AB 15A fast blow high break capacity fuse...

Page 35: ...errors contact Hologic Technical Support THINPREP 3000 PROCESSOR HAZARDS The ThinPrep 3000 processor is intended to be operated in the manner specified in this manual Be sure to review and understand the information listed below in order to avoid harm to operators and or damage to the instrument If this equipment is used in a manner not specified by the manufacturer then the protection provided by...

Page 36: ... WARNING Service Installation Only This instrument is to be installed and or moved by trained Hologic personnel only CAUTION There is a miniature barcode laser scanner embedded inside this product for identifying samples There is no intended access to this laser source for operators Use of controls adjustments or procedures other than those specified in this manual may result in hazardous radiatio...

Page 37: ...oors open WARNING Power Connection To ensure safe operation the instrument must be connected to a three wire grounded receptacle WARNING Sharp Edges Hot Surfaces The instrument contains sharp edges and hot surfaces Use extreme caution when handling items near these areas Allow hot surfaces to cool before handling WARNING Glass Sharp Edges The instrument uses glass microscope slides which have shar...

Page 38: ...processor cannot be effectively decontaminated and therefore must be properly disposed of in order to avoid potential harm to users of the processor or service personnel Location of Instrument Labels The model rating label for the instrument is located on the left side of the machine The serial number label is located inside the flip down center door A label illustrating how to insert a batch prin...

Page 39: ...tor s Manual 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: ...lines Dispose of all solvents as hazardous waste CellFyx Solution Follow local state provincial and federal or country guidelines Dispose of all solvents as hazardous waste Versa Clean Solution Follow local state provincial and federal or country guidelines Dispose of all solvents as hazardous waste Pinch valve tubing Dispose of as regular waste Broken glass Dispose of in a Sharps container Super ...

Page 41: ...1 INTRODUCTION 1 18 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 42: ...2 ThinPrep 3000 Installation 2 ThinPrep 3000 Installation ...

Page 43: ...e ThinPrep 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 CAUTION Vibrating machinery such as centrifuges should not be installed near the instrument ACTION UP...

Page 44: ...emory Card 1 Staining rack adapters 4 Installation Kit including 1 Filter waste box 1 Fixative shield mount 1 Pinch valve tubing 4 pieces Pneumatic test vial in protective case 1 Sample vial trays 4 per package 2 packages Slide cartridges 2 Staining racks 4 per package 2 packages Slide waste bin 2 Transport cover for the waste bottle 1 Aerosol spray bottle 1 bottle Consumable Items Filter waste bo...

Page 45: ...e ThinPrep 3000 processor near a three wire grounded power outlet that is free of voltage fluctuations and power surges Vibrating equipment such as vortexors or centrifuges should not be installed near the instrument Refer to Figure 1 9 Clearances for space needed for installation STORAGE AND HANDLING POST INSTALLATION Be sure to clean and maintain the ThinPrep 3000 processor as instructed in this...

Page 46: ...o the wall outlet To ensure safe operation of the instrument use a three wire grounded outlet Figure 2 1 Connect Power to the Instrument WARNING Grounded Outlet Serial port For use by Hologic personnel only 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 SECTION E CYTYC SECTION F Serial p...

Page 47: ... intended to remain on 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 Remove and safely store any patient slides and sample vials that may be on board the instrument Empty the waste bottle the slide waste bin and the filter waste box refer to Instrument Maintenance for each of these items Close all of...

Page 48: ...elf test the main menu screen is displayed Select Start Batch to begin processing samples Select Menu to access the Utility menu Status Maintenance Setup and Test menus Select Print Results to print the batch report from the previous batch of samples processed SECTION G Message screen User interface Prompt keys ThinPrep 3000 TP3 xx xxxxxx CYTYC Corporation Self Test in Progress System Ready Start ...

Page 49: ... More option at the upper right of the display 4 Press Select Time Format 5 Select a time format AM PM or 24 HR Note Time format is for the user interface display only All reporting slide printing and batch reports will automatically have 24 hour formats on them SECTION H Set Time More Set Date Main Menu Slide Printer Output Back Select Date Format More Select Time Format Main Menu Audible Key Pre...

Page 50: ...s 9 Select Set to save Note Selecting Back at any time prior to selecting Set will delete all new entries and return to the previous screen Setting the Date 1 In the main menu screen select Menu 2 Select Setup 3 Select More option at the upper right of the display 4 Press Select Date Format 5 Select a date format MM DD YY or DD MM YY Hour Set 1 05 PM Minute Set Set Back Set Time More Set Date Main...

Page 51: ...t year appears 8 To set the month press the Month Set prompt key until the correct month appears 9 To set the day press the Date Set prompt key until the correct day appears 10 Select Set to save Note Selecting Back at any time prior to selecting Set will delete all new entries and return to the previous screen Select Date Format MM DD YY Main Menu DD MM YY Back Year Set Month Set 04 28 00 Date Se...

Page 52: ...ox appears next to Date Time Stamp 5 Press prompt key 4 or 5 until Enable appears Selecting Disable deactivates the date time fea ture 6 To activate the facility s name press prompt key 1 until the highlighted box appears next to Facility Name 7 Press prompt key 4 or 5 until Enable appears 8 To input your facility s name press prompt key 1 until the highlighted box appears next to Enter Name 9 Use...

Page 53: ...lay select Setup 3 In the Setup menu select More Select Audible Key Press 4 The key will toggle between the Enable and Disable choices for this function To produce an audible beep with each key press highlight Enable and then press Set To turn off the audible beep if it has already been set on highlight Disable and press Set SECTION J Select Date Format More Select Time Format Main Menu Audible Ke...

Page 54: ...2 THINPREP 3000 INSTALLATION 2 12 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 55: ...3 PreservCyt and CellFyx Solutions 3 PreservCyt and CellFyx Solutions ...

Page 56: ...rvCyt and CellFyx Solutions CONTENTS SECTION A Introduction 3 1 SECTION B PreservCyt Solution 3 2 SECTION C CellFyx Solution 3 5 INTRODUCTION The following sections describe the function and specifications of Hologic cytologic preservative fluid PreservCyt Solution and fixative fluid CellFyx Solution SECTION A ...

Page 57: ...on 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 Composition PreservCyt Solution contains buffered methanol It contains no reactive ingredients It contains no active ingredients WARNING Toxic Flammable WARNING Danger PreservCyt S...

Page 58: ...ark on the cap with the mark on the vial as shown in the figure below Figure 3 1 PreservCyt Solution Vial The shipping category for PreservCyt Solution is flammable liquids n o s methanol USA only flammable liquids toxic n o s methanol outside the USA The shipping category for PreservCyt Solution containing cells is diagnostic sample Please refer to the Shipping Requirements and Recommendations gu...

Page 59: ...sms found after 15 minutes in the PreservCyt Solution The log reduction for viable organisms is also pre sented As with all laboratory procedures universal precautions should be followed After 1 hour 4 7 log reduction After 1 hour 5 7 log reduction Data is for 5 minutes Interfering Substances The use of lubricants e g KY Jelly should be minimized prior to specimen collection Lubricants can adhere ...

Page 60: ...Fyx Solution is up to two years from date of manufacture at 15 C to 30 C Slides fixed with CellFyx are preserved for 5 days at room temperature Stability Do not use CellFyx Solution after the expiration date on the container label Expired bottles should be discarded using appropriate laboratory procedures Handling Disposal Handle all chemical containing materials carefully in accordance with safe ...

Page 61: ...3 PRESERVCYT AND CELLFYX SOLUTIONS 3 6 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 62: ... 45 2015 1 4 200 75 284 14 200 2 7 5 375 150 570 28 500 I II IIIA 45 2015 1 4 200 75 284 14 200 2 7 5 375 150 570 28 500 Maximum Quantities of PreservCyt Solution Class IC That Can Be Stored per Fire Area 9 Outside a Safety Flammable Cabinet Location NFPA Code Gallons Liters Vials 8 General Warehouse 10 12 13 30 2015 120 460 23 000 Liquid Warehouse 3 11 30 2015 Unlimited Unlimited Unlimited Office...

Page 63: ...ngs equipped throughout with an automatic sprinkler system installed in accordance tiwh NFPA13 Standard for the Installation of Sprinkler Systems This table lists the NFPA ratings for all the ThinPrep products ThinPrep Product Health Hazard Flammability Hazard Instability Hazard Specific Hazard ThinPrep PreservCyt Solution 2 3 0 N A ThinPrep CytoLyt Solution 2 2 0 N A ThinPrep CellFyx Solution 2 3...

Page 64: ...ne or more of the other hazards risks must be shipped according to the shipping requirements for that hazard risk s 4 ThinPrep PreservCyt Solution is a Flammable liquid when shipped domestic or international Therefore follow the instructions in Section C below Shipping ThinPrep PreservCyt Solution Only such as from a laboratory to a physician B Shipping Biological Specimens in Solutions other than...

Page 65: ...g of material This quantity excludes ice dry ice or liquid nitrogen when used to keep specimens cold 6 An itemized list of contents must be enclosed between the secondary packaging and the outer packaging 7 The packaging must successfully pass a 4 ft drop test Section 6 6 1 IATA regulations 8 The UN3373 mark must be displayed on the external surface of the outer packaging one surface of the outer ...

Page 66: ...ion after the ice or dry ice has dissipated If ice is used the outside packaging or overpack must be leak proof If dry ice is used the packaging must be designed and constructed to permit the release of CO2 gas to prevent a buildup of pressure that could rupture the packaging 2 Always affix the Class 9 UN 1845 dry ice label as well as the UN 3373 Biological Substance Category B label to these ship...

Page 67: ... Affix a Class 3 Flammable Liquid hazard label to the outer package in close proximity of the wording described in C above See the example of the label on the last page of these recommendations 3 Mark the package as Flammable liquids n o s Methanol Solution 3 UN1993 Net Qty Domestic Air Shipments In addition to 1 and 2 above in Domestic Ground Shipments Other than Limited Quantities the following ...

Page 68: ...ntities When shipping internationally ThinPrep PreservCyt Solution is classified with a primary hazard of Class 3 Flammable Liquid and with a secondary hazard of Class 6 1 Toxic It is assigned to PG III The reference used for the international ground recommendations is the ADR European Agreement Concerning the International Carriage of Dangerous Good by Road United Nations A Limited Quantity is de...

Page 69: ... vials for cargo aircraft 2 Packages containing more than sixty 60 liters of product must be clearly marked FOR CARGO AIRCRAFT ONLY 3 The vials must be shipped in United Nations UN certified 4G packaging for any quantity in an aircraft e g ThinPrep PreservCyt Solution 250 vial box or equivalent Pack vials in a manner adding protective packing material as necessary as to limit movement of individua...

Page 70: ... Shipping ThinPrep PreservCyt Solution Only guidelines that can be found in Section C of this document E Shipping ThinPrep CytoLyt Solution With Patient Sample such as from a physician to a laboratory Domestic Shipments ThinPrep CytoLyt Solution containing a patient sample is classified as a Biological Substance Category B Follow the recommendations in Section B of this document International Ship...

Page 71: ...4 Sample Collection and Preparation 4 Sample Collection and Preparation ...

Page 72: ...ON A Introduction 4 1 SECTION B Specimen Collection 4 2 SECTION C Special Precautions 4 4 SECTION D Specimen Processing 4 4 SECTION E Sample Processing Troubleshooting 4 6 INTRODUCTION The ThinPrep 3000 processor prepares microscope slides from ThinPrep Pap test gynecologic sam ples The collected specimen includes cell samples from the ectocervix and the endocervix SECTION A ...

Page 73: ...vial 10 times forcing the bristles apart As a final step swirl the broom vigorously to further release material Discard the collection device 3 Tighten the cap so that the torque line on the cap meets or passes the torque line on the vial 4 Record the patient s name and ID number on the vial Record the patient information and medical history on the cytology request form Note If the sample is to be...

Page 74: ... quickly as possible in the PreservCyt Solution by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall Swirl vigorously to further release material Dis card the brush 5 Tighten the cap so that the torque line on the cap meets or passes the torque line on the vial 6 Record the patient s name and ID number on the vial Record the patient information and medical...

Page 75: ...er to the slide 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 the instructions for use Dispose of PreservCyt Solution according to the guidelines for disposing of hazardous waste PreservCyt Solution contains methanol SPECIMEN PROCES...

Page 76: ...rea of the sample vial Figure 4 1 PreservCyt Sample Vial Fluid Level Specimen Stability 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 ID 00001168 Frosted area ...

Page 77: ...in order to properly reprocess these specimens Note Reprocessing a ThinPrep Pap test specimen may only be performed once Note Good laboratory practices should be followed to avoid introducing contaminants into the PreservCyt Solution sample vial Reprocessing Protocol 1 Prepare a wash solution of sufficient volume to add 30 mL to every Thin Prep Pap test specimen being reprocessed The wash solution...

Page 78: ...of cells Dispose of according to local regulations b Vortex the centrifuge tube briefly 7 a Using the volume markings on the centrifuge tube pour the necessary quantity of unused i e containing no patient specimens PreservCyt Solution to the cells and fill to a final volume of 20 mL Secure the cap tightly b Invert the centrifuge tube several times to mix and transfer the sample back into the retai...

Page 79: ...4 GYNECOLOGIC SAMPLE COLLECTION AND PREPARATION 4 8 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 80: ...5 Instrument Operation 5 Instrument Operation ...

Page 81: ...ION H Pausing a Batch in Process 5 22 SECTION I Canceling a Batch in Process 5 23 CHAPTER OVERVIEW Routine instrument operation consists of loading supplies starting the batch process and unloading the prepared slides and processed sample vials when the batch is complete A batch report or results printout is automatically generated at the completion of each batch Any samples that may require furth...

Page 82: ...ccur if they are very rare If negative results from the specimen do not fit with the clinical impression a new specimen may be necessary Aliquot Removal from low cellularity specimens may leave insufficient material in the PreservCyt sample vial for preparation of a satisfactory ThinPrep Pap test slide Aliquot Removal may leave insufficient material In the PreservCyt sample vial for perfor mance o...

Page 83: ...al to ensure homogeneity of the sample 2 Carefully remove the vial cap 3 Using a pipetting device withdraw an aliquot of up to 4 mL from the vial Take care to avoid contaminating gloves with solution If gloves should become contaminated replace with a clean pair before proceeding to the next specimen 4 Dispense the aliquot into a suitably sized and labeled polypropylene tube and close tightly to p...

Page 84: ...rinter ribbon and the slide printer assembly Center door flips down to access the slide waste bin and for replacement of the pinch valve tubing The instrument serial number is located here Front door provides access to the filter trays and area the center door and the sample vial trays and area This door locks with the top door during batch processing or when the proces sor is moving mechanisms Le...

Page 85: ...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 Staining racks 4 Barcoded ThinPrep Pap test sample vials 5 Sample vial trays SECTION D 3 5 1 2 00001168 4 ThinPre p Micr oscope Slides ...

Page 86: ...y loaded trays should remain in place 1 Open the tray latches as shown below 2 Remove any empty filter trays if present 3 Remove and discard the clear plastic cover from the new tray s of filters 4 Insert the new tray s of filters Slide the tray all the way to the back of the shelf until it hits the stops at the rear 5 Secure the trays by closing their respective latches Note Do not handle the fil...

Page 87: ...ng a cartridge with microscope slides wipe the inside of the cartridge with a lint free cloth to remove glass dust Clean the bottom surface where the slides sit to ensure proper slide pick ing Refer to CLEANING THE SLIDE PATH on page 6 17 Loading the ThinPrep microscope slides into the slide cartridge Note The slides must be oriented correctly to work with the automated functions of the ThinPrep 3...

Page 88: ...n 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: ...pted by the instrument Do not manually load a partially filled cartridge With the slide cartridge clasp up and facing as shown slide it into slot A or B Staining Racks Staining racks are plastic frames that hold the processed ThinPrep microscope slides The slides remain in the staining racks until batch processing ends The processor can hold up to four staining racks Each rack has a capacity of 20...

Page 90: ...5 INSTRUMENT OPERATION 5 10 ThinPrep 3000 Processor Operator s Manual 3 Place an empty staining rack into each of the four cradles Incorrect Correct Cradle Lever ...

Page 91: ...w 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 Use caution when removing the racks 3 Gently slide the rack toward the lever 4 Tilt the staining rack as shown above 5 Carefully lift out the staining rack Avoid dislodging any processed slides ...

Page 92: ...bels or on the torque features Sticking labels on incorrectly can cause a failure to read the barcode or a failure of the instrument removing the vial from the tray The uncovered strip of the sample vial allows you to see the frosted band which indicates the maxi mum minimum acceptable fluid fill range for a sample Make sure the fluid level is within this range Refer to Chapter 7 Troubleshooting i...

Page 93: ... in one way Be sure to slide each tray fully into the instrument until it hits the stops at the rear 4 Secure the trays by closing their respective latches Refer to READING THE BATCH REPORT on page 5 20 for batch report information Note The top tray is designated tray A and the bottom tray is tray B Raised letters on the instru ment cover near the latches help identify each tray A results report f...

Page 94: ...Pap test filters Slide cartridge s containing ThinPrep microscope slides Empty staining racks 3 Close both the front and top door of the instrument Processing will not begin if they are not com pletely shut 4 Press Start Batch to begin batch processing 5 The instrument performs a check of supplies needed to process a batch 6 Processing begins when the following screen is displayed 1 Prompt Text th...

Page 95: ...east one tray of Gyn ThinPrep Pap test filters A minimum of one tray of filters must be loaded before batch processing can begin Empty fil ter trays must be removed Slides The processor does not detect at least one slide cartridge containing slides A minimum of one slide cartridge containing slides must be inserted before batch processing can begin If slide cartridges are present check that both c...

Page 96: ...ly screwed onto the top of the fixative reservoir before processing can begin Empty waste bottle and waste bins The level of waste fluid within the waste bottle is above the maximum level Make sure the slide waste bin is present and loaded correctly The waste bottle must be emptied before processing can begin Empty the filter waste box and slide waste bin at this time The slide waste bin must be p...

Page 97: ...pplies are loaded the Checking Consumables Please Wait screen is displayed Select Continue to bypass loading item s at this time beginning batch processing Note If the user does not respond to this message within five minutes the batch will start by itself Close Doors and Press Continue This message notifies you that an instrument door is open Confirm that both the front door and top door are clos...

Page 98: ...ing processed slides from the instrument as described in Removing the staining racks on page 5 11 3 Tear off the printed batch report by pulling it toward you against the edge of the paper opening 4 Separate tray A top batch report from tray B bottom batch report Match them with the correct sample tray The tray slots are marked A and B on the instrument near the tray latches Refer to READING THE B...

Page 99: ...essed from the tray s Address the issue if possible Refer to Chapter 7 Include these sample vials in another batch for reprocessing Routine Maintenance Required Every 800 slides 10 full batches the instrument will prompt for Operator Maintenance CAUTION It is important to perform these maintenance tasks at this time to ensure proper instrument operation Press Continue Refer to PNEUMATIC SYSTEM TES...

Page 100: ...5 000000010531 A 6 000000018376 A 7 000000018377 A 8 000000018378 A 9 000000018379 A10 000000018380 A11 000000018381 A12 A13 000000018383 A14 000000010525 A15 000000010532 A16 000000010533 A17 000000010534 000000010535 000000010536 A20 000000010537 A21 000000010538 A22 000000010539 A23 000000010540 A24 000000010541 A25 000000018384 518 Total Samples Processed No Barcode Date Instrument batch ident...

Page 101: ...s error description and resolution Error reporting This area reports any samples that may be problematic or did not result in a slide being prepared Samples that require reprocessing are listed by their tray position with a reason why the instru ment did not prepare a slide for that sample Sample identification The next area lists the samples encountered by the instrument during processing They ar...

Page 102: ...s as the processor interrupts batch processing Batch Paused is displayed once the batch is paused The doors of the instrument may be opened at this time Note The system may take up to 3 minutes before Batch Paused is displayed This allows the samples in process to finish before the system is made available for access CAUTION Do not remove or replace the sample vial tray s or the batch will be canc...

Page 103: ...d after the processor has interrupted batch processing Note The system may take up to 3 minutes before Batch Paused is displayed This allows the samples in process to finish before the system is made available for access 2 To cancel the batch select Cancel Batch The instrument checks the status of consumables and prints the batch report 3 The following message is displayed when the batch is cancel...

Page 104: ...per opening 6 Separate A top batch report from B bottom batch report 7 Review the batch report for sample vials not processed 8 Fold and insert the appropriate batch report into its sample vial tray for identification 9 Remove sample vial tray s 10 Remove the sample vials not processed from the tray s Include these sample vials in another batch for reprocessing Batch Canceled Due To Cancellation B...

Page 105: ...6 Maintenance 6 Maintenance ...

Page 106: ...essing 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 6 23 SECTION H General Cleaning 6 24 SECTION I Pinch Valve Tubing Replacement 6 26 SECTION J Waste System Maintenance 6 28 SECTION K Emptying the Filter Waste Box 6 31 SECTION L Replenishing CellFyx Solution 6 32 SECTION M Replacing the Slide Printer Ribbon...

Page 107: ... slide waste bin Check filter waste box Lubricate the sample processing arm O rings Monthly Maintenance General cleaning Twice Yearly Maintenance Pinch valve tubing replacement Instrument Prompted Maintenance Refer to the Ordering Information in this manual for ordering supplies Pneumatic system testing Cleaning the slide path Replacing the fixative shield Empty waste bottle filter waste box and s...

Page 108: ...ive spray Empty slide waste bin Check ﬁlter waste box Lubricate the sample processing arm o rings Instrument prompted Maintenance Initial and Date Pneumatic system test Clean slide path Empty waste bottle slide waste bin ﬁlter waste box CellFyx Solution replenishment Insert clean ﬁxative shield Slide printer ribbon This page is for photocopy purposes page 6 5 page 6 9 page 6 31 page 6 10 page 6 13...

Page 109: ...nPrep 3000 Processor Recommended Maintenance Schedule Year Instrument Initial and Date Monthly Maintenance J F M A M J J A S O N D General Cleaning Twice yearly Maintenance Initial and Date Pinch valve tubing replacement This page is for photocopy purposes page 6 24 page 6 26 ...

Page 110: ...llowing screen 1 Lift the fixative dispenser lever three or four times as shown below 2 Observing the tip of the nozzle select Spray The fixative spray from the nozzle should appear in a fine evenly distributed fan of mist as shown in the following illustration Note Laying a tissue across the top of the fixative shield will capture the spray and indicate the spray pattern 3 If that does not clear ...

Page 111: ...e three or four times and select Clear This performs a series of spray prime functions The fixative spray from the nozzle should appear in a fine evenly distributed fan of mist as illustrated above 2 If the fixative solution does not spray or does not appear evenly distributed repeat step 1 two or three more times Note The fixative pressure tanks need a few seconds to recharge before the fixative ...

Page 112: ...ly return to the main menu to continue instrument operation If this fails to resolve the problem continue with the following procedure Dissolving Clogs with warm water If an airbrush cannot be unclogged via the user interface the following steps may be performed 1 Fill a microcentrifuge tube or any other small container with warm water 2 Place the tube under the airbrush and lift the tube so the n...

Page 113: ...d 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 6 When the fixative sprays freely return to the main menu to continue instrument operation If the clog persists contact Technical Support ...

Page 114: ...rompts you to empty the slide waste bin at the conclusion of each batch and when the waste bottle needs to be emptied 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 5 Return the slide waste bin to its original location SECTION C Center door ...

Page 115: ...g errors may occur if the sample processing arm O rings are dry Refer to the Ordering Information in this manual for ordering silicone lubricant The pneumatic test vial is used for this maintenance lubricant is required The procedure takes about two minutes 1 From the main menu select Menu 2 Select Maintenance 3 Select Lube O Rings The following screen will be displayed SECTION D Setup Maintenance...

Page 116: ...tray position A1 which is the first slot of the upper sample vial tray 6 Rotate the test vial clockwise until the locator pins catch against the molded stops of the tray 7 Load the tray into the instrument close the tray latch and close all doors 8 Press Continue The doors will lock The following sequence of screens will be displayed F R E E O F LUBRICANT K E E P T H I S S U R F A C E F R E E O F ...

Page 117: ... Continue The doors will unlock CAUTION The pneumatic test vial should always be stored in its protective box when not in use Handle the vial with care 10 Unload the sample tray Remove the pneumatic test vial With a lint free cloth wipe off any lubri cant in and on the test vial Return the test vial to its storage box Preparing Mechanisms for O Rings Lube SPA Stem O Rings Lubrication in Progress S...

Page 118: ...en prompted The test will take approximately 9 minutes to com plete Lubricant is required for this maintenance procedure 1 From the main menu select Menu 2 Select Test Refer to the Ordering Information in this manual for ordering silicone lubricant 3 Select Pneumatic Test The following screen will be displayed SECTION E Setup Maintenance Status Test Back Pneumatic Test More Display Test Main Menu ...

Page 119: ...e vial tray 6 Rotate the test vial clockwise until the locator pins catch against the molded stops of the tray 7 Load the tray into the instrument close the tray latch and close all doors 8 Press Continue The results printer will print the start of a report for this procedure The time date and serial number of the instrument will be printed with the message Pneumatic Test Started F R E E O F LUBRI...

Page 120: ... The message screen displays the test results The pneumatic system test report completes printing as shown below Preparing Mechanisms for Pneumatic Test Calibrating PMS for Pneumatic Test Pneumatic Test in Progress Pneumatic Test Complete Pneumatic Test Result Continue Pneumatic Test Successful Serial No 00001A00A0 Pneumatic Test Started 04 28 00 10 25 Pneumatic Test Complete 04 28 00 10 34 Pneuma...

Page 121: ...ailed will be listed under Pneu matic Test Results There are 21 system tests the message may be different from that shown below The printed test report will show the same message 12 Press Continue to return to the main menu 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 I...

Page 122: ...e Clean Slide Path will display when this is required It is important to perform this maintenance when prompted Note Only de ionized or distilled water should be used to moisten swabs or lint free cloth for cleaning the instrument Microscope Slide Areas Interior of Slide Cartridge Each time a cartridge is loaded with microscope slides wipe the inside of the cartridge with a lint free cloth to remo...

Page 123: ... pads on the arms of the slide pick mechanism Also clean any glass dust from the metal surface surrounding the urethane pads Clean under the print head around the slide retainer and around the thumbscrew The thumbscrew at the front releases the assembly from the chassis on one side Swing the module up to clean underneath With a dry cloth or swab brush any glass dust off of the slide translator car...

Page 124: ...e 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 Prepare the Versa Clean Solution 1 Fill the plastic aerosol spray bottle with 100 mL of plain water and add 3 33 mL of Versa Clean Solution 2 Close and shake the bottle to mix Pump the overcap piston assembl...

Page 125: ...verheating the solenoids do not leave the slide clamps open for more than 15 minutes 5 Spray the cleaner on the silver surface of the arm spraying from top to bottom Let it sit for 30 seconds to dissolve the fixative residue The slide clamps are fragile Only use foam tipped swabs to clean and dry them DO NOT USE FORCE Thoroughly swab the slide presence switch plunger and opening Lube O Rings Syste...

Page 126: ... Close the slide clamps Do a final wipe down of the arm using the alcohol pad Also use that to wipe the slide ejector path rollers and the tip of the slide ejector 9 Open the clamps once more Wipe them with the alcohol pad then thoroughly dry around and under them with foam tipped swabs Close the clamps 10 The alcohol will evaporate completely within one minute of cleaning the surface 11 Remove an...

Page 127: ...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 Slide ejector tip Slide ejector path Rollers Fixative spray area Staining rack cradles ...

Page 128: ...e Fixative Shield WARNING Toxic Mixture Highly Flammable Liquid and Vapor 1 The fixative shield assembly is removed by sliding it straight out from below the spray nozzle The plastic base of the assembly has a notch at either side useful for gripping with your fingers to pull the block out Each CellFyx Solution package contains six 115 mL bottles of CellFyx and six fixative shields 2 Observe how t...

Page 129: ... 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 System Access To gain the most room for cleaning maintaining or accessing the interior of the instrument a S...

Page 130: ...llowing screen will display The instrument returns all trays and mechanisms to their ready position When complete the main menu screen appears Preparing Mechanism Please Wait Open Slide Clamps Close Open Evac Valve Close Access Available Continue Press Continue When Finished Homing Mechanisms Please Wait System Ready Start Batch Load Samples and Supplies Menu Select Start Batch Print Results 08 25...

Page 131: ...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 Press Open Evac Valve to open the pinch valve 2 Open the front door and then open the center door The pinch valve tubing is located to the right of the Slide Waste Bin 3 Detach tubin...

Page 132: ...th no kinks 7 Connect the replacement tubing to points A and B 8 Press the Close Evac Valve key on the display to close the pinch valve 9 Close the center door and close the front door to the instrument 10 Select Continue on the displayed menu 11 The instrument doors will lock and the mechanisms will be returned to idle mode state The Sys tem Ready screen will display and the doors will unlock 12 ...

Page 133: ...processor cabinet 2 To remove the waste cap rotate the waste cap with one hand while holding the waste bottle in place with the other hand Not much pressure is needed to unscrew the cap do not exert too much force on the door hinge as you remove the waste cap If the waste tubing becomes dislodged from the waste cap during this process reconnect the tubing before continuing WARNING Hazardous Waste ...

Page 134: ... of viable organisms and the number of via ble organisms found after 15 minutes in the PreservCyt Solution The log reduction for viable organisms is also presented As with all laboratory procedures universal precautions should be followed After 1 hour 4 7 log reduction After 1 hour 5 7 log reduction Data is for 5 minutes Refer to the Ordering Information in this manual for ordering silicone lubric...

Page 135: ... lubricant to the O ring 7 Return the waste bottle back to its original location and retighten the waste cap onto the bottle Verify that the waste cap is firmly tightened and confirm that the waste tubing is not pinched or twisted Once the waste bottle is connected to the instrument the process is complete 8 Select Continue to return to the main menu O ring seal ...

Page 136: ...binet 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 Refer to the Ordering Information in this manual for ordering liners 3 Remove the waste box liner 4 Tie the waste box liner to prevent filters from falling out of the bag 5 Dispose of the used filters and liner according to your laboratory s guidelines ...

Page 137: ... Pressing Cancel will cancel the current message but a batch will not start until the reservoir has been replenished Filling the Fixative Reservoir 1 Open the top door on the instrument and locate the fixative reservoir 2 Unscrew and remove the cap on top of the fixative reservoir 3 Pour one bottle of CellFyx Solution 115 mL into the fixative reservoir Replace and tighten the cap on top of the fix...

Page 138: ...n is pressed and the fixative reservoir is low a mes sage Add Fixative Fluid appears on the display 2 From the Fixative maintenance menu select Level 3 The pressure in the fixative reservoir resets allowing the instrument to detect the fixative level The level function only takes a minute to complete A Please Wait message appears while the instrument performs Level 4 When the level function has fi...

Page 139: ...rint error is recorded on the batch report If you notice an increase in slides discarded but no Slide Misprint messages on the batch report the printer ribbon may be wearing out and causing a mix of normal and too lightly printed slides Try replacing the slide printer rib bon 1 Open the top door on the instrument 2 Open the slide printer cover and locate the ribbon cartridge Note the routing of th...

Page 140: ...e cartridge the printing ribbon should be routed slightly below the print head and above the ribbon separator as shown below 7 Turn the ribbon feed knob in the direction of the arrow to tighten the ribbon clockwise Confirm that the printing ribbon is not routed below the ribbon separator Guide Tab Lock Print head Ribbon separator Ribbon feed knob Ribbon cartridge ...

Page 141: ...es as outlined below 1 Turn off the instrument 2 Remove the power cord from the wall outlet 3 Remove the power cord from the receptacle on the instrument WARNING Instrument Fusing 4 Using a small slotted screwdriver carefully pry open the cover of the power entry module as shown below 5 Gently pull down the cover It is hinged at the bottom end 6 Insert the screwdriver under the fuse holder to pull...

Page 142: ...d 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 10 Close the access cover Fuse holder ...

Page 143: ...TS 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 The printer paper is a thermal sensitive paper onto which the batch results are printed The rolls should be kept in a cool dark place Each roll is sealed in a light resistant plastic wrapper to protect it until use Do not open the package prior to installing the ...

Page 144: ...reen release lever down Pull the end of the paper out from under the platen Return the lever to the set position 3 Lift up the metal roll holder It is hinged on the left side 4 Remove the used paper roll from the metal roll holder and discard A translucent plastic washer at the left side of the roller keeps the roll of paper from skewing as it is used up Do not discard this plastic piece ...

Page 145: ...being pulled from the bottom of the roll 6 Lower the metal roll holder down 7 Insert the paper through the metal slot located directly in front of the metal roll holder as shown below The paper should unroll from the bottom The printer will auto advance a small amount of paper when it senses the leading edge beneath the platen 8 If the paper feeds crookedly through the roller press the left side o...

Page 146: ...e the paper three to four inches Lead it through the opening of the cover 12 Gently lower the lid back into place 13 Select Back to return to the main menu To test the legibility of the printer press Print Results to print a copy of the last batch report SET RELEASE Lube O Rings System Access Fixative System Main Menu Paper Advance Back C Y T Y C c o r p o r a t i o n ...

Page 147: ...6 INSTRUMENT MAINTENANCE 6 42 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 148: ...7 Troubleshooting 7 Troubleshooting ...

Page 149: ...ors and System Fault Errors This chapter addresses common error messages and corrective operator actions associated with each Note Regular instrument maintenance as described in Chapter 6 will reduce many instances of sample and system error Sample Errors 7 2 Special Sample Status Sample Is Dilute 7 4 Reprocessing Required Cap Tighten Failure 7 6 Duplicate Barcode 7 8 Filter Load Failure 7 10 Fixa...

Page 150: ...port Sample errors occur when a sample vial is being processed They are sample specific and usually only affect the sample vial being processed Sample errors are listed at the beginning of a batch report and can appear under two different head ings Special Sample Status or Reprocessing Required The reason for the error and the vial position are listed Additionally the vial position is marked with ...

Page 151: ...8376 A 7 000000018377 A 8 000000018378 A 9 000000018379 A10 000000018380 A11 000000018381 A12 A13 000000018383 A14 000000010525 A15 000000010532 A16 000000010533 A17 000000010534 000000010535 000000010536 A20 000000010537 A21 000000010538 A22 000000010539 A23 000000010540 A24 000000010541 A25 000000018384 518 Total Samples Processed No Barcode Date Instrument batch identification Software revision...

Page 152: ...t was collected rather than an issue with the instrument and its mechanisms A slide is made from the sample vial Possible Cause Low concentration of cells in the vial Pneumatic system failure Corrective Action 1 If the slide is satisfactory for screening purposes no further action is required 2 If the slide is inadequate follow laboratory procedure for reporting unsatisfactory specimens 3 If the e...

Page 153: ...ed Follow laboratory procedure for reporting unsatisfactory specimens Is the ThinPrep slide satisfactory No further action required Does the error message persist with subsequent samples Perform the pneumatic system test Did the pneu matic system test pass Contact Hologic Technical Support No further action required No Yes Yes No Yes No ...

Page 154: ...Cause The plastic outer packaging of the vial was not removed Vial labeling covers torque features The vial cap is damaged A mechanism fault Corrective Action 1 The batch report indicates the position of the vial under the Reprocessing Required listing as Cap Tighten Failure 2 Examine the vial cap and remove plastic outer packaging if it is present Examine the cap for defect or damage 3 Reprocess ...

Page 155: ...perator s Manual 7 7 7 Cap Tighten Failure Reprocessing Required No further action required Before reprocessing remove any extra outer packaging on the vial Does the message persist Reprocess the sample Contact Hologic Technical Support Yes No ...

Page 156: ...rence of the identical sample ID number will always be at an earlier tray position and a slide will have been made The patient information must be checked and reconciled for both vials 2 The second sample needs to be reprocessed as no slide was made Following the reconciliation of the patient information with the correct vials apply a new barcode label to the second vial and insert it into a new b...

Page 157: ... B18 000000010535 B19 000000010536 B20 000000010537 B21 000000010538 B22 000000010539 B23 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 Mark the tray position on each vial The slide that was processed is associated with the first sample vial i e the first vial with that barcode ...

Page 158: ...bricated A mechanism fault has occurred Corrective Action 1 The batch report indicates the position of the vial under the Reprocessing Required listing as Fil ter Load Failure 2 Look to see if there is a dropped filter or other cause for interference in the filter area 3 Perform the Lube O Rings maintenance taking care to lubricate the inner surface of the pneu matic test vial prior to testing Ref...

Page 159: ...Failure Reprocessing Required Filter Load Failure error Discard dropped filters Are dropped filters found in the filter area Contact Hologic Technical Support Perform Lube O Rings maintenance Reprocess the sample Does the message persist No further action required No Yes Yes No ...

Page 160: ...ay nozzle was not fully cleared by the previous maintenance Pneumatic system failure Corrective Action 1 Perform the fixative system preventative maintenance as described in FIXATIVE SYSTEM PRE VENTATIVE MAINTENANCE on page 6 5 2 When the spray is flowing freely reprocess the sample 3 If the fixative maintenance display appears even if the fixative seems to be flowing freely per form a pneumatic s...

Page 161: ...aintenance as described in Chap ter 6 Section B Perform a pneumatic system test Contact Hologic Technical Support Contact Hologic Technical Support No further action required Yes No Yes No No Yes No further action required Reprocess the sample Does the message persist Did the test pass Does the message persist Reprocess the sample ...

Page 162: ...lure has occurred WARNING Toxic Mixture Flammable Liquid and Vapor Corrective Action 1 The batch report indicates the position of the vial under the Reprocessing Required listing as Insufficient Vial Fluid Check the fluid level in the vial 2 Add additional PreservCyt Solution to the vial if fluid level is below the frosted area indicated on the vial Do not fill beyond the frosted area 3 Reprocess ...

Page 163: ...check the fill level of the vial Add PreservCyt Solution if needed Reprocess the sample Does the message persist Perform the pneumatic system test No further action required Contact Hologic Technical Support Contact Hologic Technical Support No further action required Did the pneu matic system test pass Reprocess the sample Yes No Yes No Yes No Does the message persist ...

Page 164: ...f a barcode label is present check the condition of the label A smudged wrinkled or torn bar code label may not be scanned Replace the label if this is the case Be sure to update the patient information with a matching label as well Reprocess the sample vial Note Do not stack labels Attempt to remove the old barcode label If it cannot be removed com pletely obliterate the barcode with a permanent ...

Page 165: ...e the patient information Check the orientation and condition of the label Replace if necessary Remove obliterate old barcode label Update the patient information Contact Hologic Technical Support No further action required Does the message persist Is the barcode label of the correct type for use with the TP 3000 Is there a barcode label adhered to the vial No No Yes Yes No Yes Reprocess the sampl...

Page 166: ...processing You may follow the screen prompts and load supplies into the instrument or you may press Cancel to end the batch The batch terminates and the last sample in process will not have a slide made It is listed on the batch report as Out of Consumables Possible Cause Instrument is out of ThinPrep Pap test filters Instrument is out of slides or cannot detect slide cartridges Staining racks are...

Page 167: ... below appears Note Only items needing attention will be listed The display may show some or all of the items listed below Press Continue Wait for the instrument to unlock the doors Load the supplies listed on the screen Close the doors and press Con tinue Press Cancel The batch will terminate The last sample in process will not have a slide made It will be listed on the report as Out of Consumabl...

Page 168: ...d a slide was not made Possible Cause The ThinPrep Pap test filter is damaged Pneumatic pressure is out of range Failure of instrument mechanisms Corrective Action 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 Sup...

Page 169: ...ual 7 21 7 Pneumatic Failure Reprocessing Required Perform a pneumatic system test Contact Hologic Technical Support Contact Hologic Technical Support No further action required Does the message persist Reprocess the sample Did the test pass No Yes No Yes ...

Page 170: ...sing Required listing as Slide Misprint Inspect the slide s in the slide waste bin If the printed text is too light the ribbon should be changed See REPLACING THE SLIDE PRINTER RIBBON on page 6 34 Reprocess the sample vial 2 If the slide s in the waste bin appear to be marred or defective check the slide cartridges to determine if other slides are defective If so replenish the cartridge with new s...

Page 171: ...r to Chapter 5 Section D Install the printer rib bon correctly Refer to Chapter 6 Section M Tighten the thumb screw Refer to Chapter 6 Section F Contact Hologic Technical Support Reprocess the sample Does the message persist Is the thumbscrew on the slide printer chassis secure Are the slides in the slide cartridges oriented cor rectly Is the printer ribbon installed correctly Is the printing on t...

Page 172: ... the Reprocessing Required listing as Too Much Vial Fluid Check the sample If the fluid level is above the frosted area of the vial remove excess fluid save it in an appro priate container and reprocess 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 p...

Page 173: ...e try and inspect it Remove excess fluid and store in an appropriate container Is the volume above the frosted area of the vial Did the pneumatic system test pass Contact Hologic Technical Support Does the message persist Contact Hologic Technical Support Perform the pneumatic system test No further action required Reprocess the sample Yes No Yes Yes No No ...

Page 174: ...vial under the Reprocessing Required listing as Vial Cap Too Tight 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 Provide the ThinPrep Pap Test Quick Reference ...

Page 175: ...7 7 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 message persist Yes Contact Hologic Technical Support No further action required No ...

Page 176: ... bottle fluid level Empty the waste bottle if fluid is above the maximum level line 2 Check the pinch valve tubing connection Reconnect the tubing if it is disconnected or connected to the wrong fitting 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 prompt...

Page 177: ...tle as described in Chapter 6 Section J Perform the pneumatic sys tem test Refer to Chapter 6 Section E Contact Hologic Technical Support No further action required Does the message persist Reconnect or replace the pinch tubing as described in Chapter 6 Section I Reprocess the sample Did the test pass Is the tubing damaged or discon nected Is it full No Yes Yes No No Yes Yes No Contact Hologic Tec...

Page 178: ...g 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 A message will appear on the display indicating the area of the error vial operation filter operation or slide operation Many of these conditions may be cleared by the operator and are described on the following pages SECTION C A C B ThinPrep Mi...

Page 179: ... trays and any prepared slides Was recovery successful The instrument displays a Check Mechanism message Close the doors and press Continue An Attempting Recovery message is displayed The instrument resets rehomes all mechanisms The doors unlock Perform a general check of the indicated area of error Look for a dropped filter or a jammed slide dropped sample vial etc Press Continue The instrument m...

Page 180: ...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 The vial is uncapped 5 The filter is introduced for cell collection 6 The vial is recapped 7 The sample vial is returned to the sample tray 005532 1 005532 2 3 4 5 6 005532 7 ...

Page 181: ...the audible beep can be stopped by pressing Alarm Off Press Continue The follow ing screen displays WARNING Sharp Edges Hot Surfaces 2 Open the front door when it unlocks 3 Remove the sample vial trays and look in the vial bay Area A to see if there is a dropped sample vial or a vial stuck in the sample processing station Retrieve the vial and cap for reprocessing System Fault Batch in Progress Vi...

Page 182: ...such as a piece of the collection device a piece of cap liner a piece of label etc Remove the object with tweezers for exam ple and reprocess the sample Inspect the vial for damage If the cap is defective discard it and replace it with a new cap from an unused PreservCyt vial Reprocess the sample 5 Replace the sample trays close the door s and press Continue The instrument will attempt recovery 6 ...

Page 183: ...nce If the system does not recover the following screen is displayed Any mechanical faults should be addressed by Hologic Technical Support If errors recur or do not appear as described here contact Hologic Technical Support System Fault Batch in Progress Filter Handling Error Alarm Off 15 XX XX XX x xx xx xx xx Continue Please Check Mechanism Continue ...

Page 184: ...he frosted area of the vial Retrieve and reprocess the sample Inspect the vial which was being han dled when the fault occurred Marked with an asterisk on the batch report The doors unlock Remove the sample trays and inspect the vial bay area Press Continue The instrument moves mechanisms to allow internal access The instrument halts with a display of Vial Handling Error The batch report prints Ye...

Page 185: ...load sample trays and staining racks Unprocessed samples go into a new batch for processing 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 Repeat the steps outlined above once more Press Continue See Filter Error Handling Section See Slide Error Handling Section Did it reco...

Page 186: ...ocessing arm retrieves the filter 4 The filter is brought to the sample processing station and introduced to the prepared sample 5 The sample processing arm rotates and precisely meets with the slide cell transfer arm bearing a slide Cell transfer occurs 6 The used filter is returned to the filter elevator for disposal 1 4 5 6 2 3 Disposal chute Filter elevator detail New filter position Used filt...

Page 187: ... fault Operator Corrective Action 1 If desired the audible beep can be stopped by pressing Alarm Off Press Continue The follow ing screen is displayed 2 Open the front door when it unlocks WARNING Sharp Edges Hot Surfaces 3 Remove the filter trays and look in the filter bay Area B to see if there are any filters lying in or near the filter tray area Discard any misplaced filters System Fault Batch...

Page 188: ...he new filter position of the filter elevator and verify that Gyn ThinPrep Pap test filters clear are loaded in the system Make sure the filter waste box is reasonably empty and that the used filters have room to drop in when they are disposed of 4 Replace the filter trays close the door s and press Continue The instrument will attempt recov ery 5 If your actions cleared the problem the following ...

Page 189: ...handled fil ters If the system does not recover the following screen is displayed 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 System Fault Batch in Progress Filter Handling Error Alarm Off 15 XX XX XX x xx...

Page 190: ...hanisms to allow internal access The doors unlock Remove the filter trays and inspect the filter bay area Replace filter trays into the machine Close the doors and press Continue The instrument will attempt recovery Discard filter s Remove the filter from the processing arm and discard Continued Remove the filter from the filter elevator and discard Are there any dropped filters Is a filter stuck ...

Page 191: ...nto a new batch for processing 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 See Slide Error Handling Section See Vial Error Han dling Section Repeat the steps outlined above once more Press Continue Did it recover Does Filter Handling Error display Does Vial Handling Erro...

Page 192: ...scanned from the sample vial is printed onto the slide along with the time date and facility name optional 4 The slide translator hands the slide off to the slide cell transfer arm 5 The slide cell transfer arm pivots to convey the slide to meet the ThinPrep Pap test filter for cell transfer 6 The slide cell transfer arm delivers the slide to the fixative dispenser where fixative is applied 7 The ...

Page 193: ... not clean enough error code 16 17 67 xx or 16 17 68 xx Slide not properly ejected into the staining rack Mechanism fault Corrective Action 1 If desired the audible beep can be stopped by pressing Alarm Off Press Continue The follow ing screen displays 2 Open the front door and top door when they are unlocked System Fault Batch in Progress Slide Handling Error Alarm Off 15 XX XX XX x xx xx xx xx C...

Page 194: ...ansfer Arm to see if a slide was not released from the slide clamps or is stuck due to fixative buildup To get a clearer view of this apparatus you may remove the staining racks fixative shield the filter trays and or the sample vial trays Press the OPEN prompt on the user interface to open the slide clamps of the slide cell transfer arm If a slide is present manually remove it Press the CLOSE pro...

Page 195: ...ide has collided with the printer or fallen off the track it may be above or below the print platform Loosen the thumbscrew and lift the slide printer assembly to look for a slide under neath Manually remove any slide located here Retighten the thumbscrew when done d Lift out the slide cartridges and see if a slide jammed while exiting the cartridge Manually remove the slide and check that the rem...

Page 196: ... 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 If your actions cleared the problem the following screen will be displayed 5 Press Continue The instrument will return to the System Ready screen Remove slides...

Page 197: ...ress 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 Please Check Mechanism Continue ...

Page 198: ...ide printer area for a jammed misplaced or broken slide Unfasten the assembly access thumbscrew and look under it as well Manually remove the slide Check to see that the slide printer ribbon is installed cor rectly and that the slide pick fin gers are clean of glass dust etc Press the Open prompt key Manually remove the slide from the arm Check to ensure that the mechanism is clean and free of fix...

Page 199: ...tridge and remove the jammed slides Refer to Chapter 5 Section D for correct placement of slides into the car tridges Batch Canceled Due to Slide Handling Error message Press Continue Unload sample trays and stain ing racks Unprocessed sam ples go into a new batch for processing Repeat the steps outlined above once more Press Continue See Vial Handling System Fault Section See Filter Handling Syst...

Page 200: ... Manual 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 ...

Page 201: ...tch Canceled Due To Slide Printer Ribbon Reprocessing Required Reason Position Slide Misprint A14 Slide Misprint A15 Sample ID Position 000000010526 A 1 000000010527 A 2 000000010528 A 3 000000010529 A 4 000000010530 A 5 000000010531 A 6 000000018376 A 7 000000018377 A 8 000000018378 A 9 000000018379 A10 000000018380 A11 000000018381 A12 000000018382 A13 000000018383 A14 000000010525 A15 Total Sam...

Page 202: ... the batch Failure to scan tray ID This is only if you are using Tray ID Barcode Scan mode The instrument failed to properly scan the sample vial tray barcode A sample vial tray did not have a barcode on it Filter load failure A filter was not properly pressed onto the sample processing arm See Filter Load Failure Reprocessing Required on page 7 10 Fixative clogged The fixative dispense system was...

Page 203: ...rror Three or more consecutive vial fluid level errors will cancel the batch Sample vials did not have enough fluid volume See Insufficient Vial Fluid Reprocess ing Required on page 7 14 Sample vials had too much fluid volume See Too Much Vial Fluid Reprocessing Required on page 7 24 ...

Page 204: ...7 TROUBLESHOOTING 7 56 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 205: ...8 Staining and Coverslipping 8 Staining and Coverslipping ...

Page 206: ...lines 8 2 SECTION C Coverslipping Recommendations 8 4 SECTION D Common Artifacts 8 5 INTRODUCTION 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 SECTION A...

Page 207: ...ate solu tion or Ammonium Hydroxide solution as the bluing solution Avoid the use of strong salt solutions like Scotts Tap Water Substitute Bath solution heights should completely cover the slides to reduce the chance of cell shedding during staining For optimal results slides should be agitated for at least 10 dips in each bath Below are the maximum concentrations to be used for the following sol...

Page 208: ...ith agitation 5 Clarifier 025 glacial acetic acid 30 seconds with agitation 6 Distilled H2O dH2O 30 seconds with agitation 7 Bluing Reagent 10 mg LiCarb 1 L 30 seconds with agitation 8 Distilled H2O 30 seconds with agitation 9 50 Reagent Alcohol 30 seconds with agitation 10 95 Reagent Alcohol 30 seconds with agitation 11 Richard Allan Cytology Stain 1 minute with agitation 12 95 Reagent Alcohol 60...

Page 209: ...ever Permount mounting media has been evaluated by Hologic and is recommended for use with 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 acc...

Page 210: ...ss slide Staining Artifact Some samples may display a staining artifact which mimics air drying in appearance This artifact appears as a red or orange central staining primarily in cell clusters or groups This artifact is due to incomplete rinsing of the counterstains Fresh alcohol baths or an additional rinse step after the cytoplasmic stains is required to reduce this artifact Edge of the Cylind...

Page 211: ...8 STAINING AND COVERSLIPPING 8 6 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 212: ...9 The ThinPrep Pap Test Training Program 9 The ThinPrep Pap Test Training Program ...

Page 213: ...program incorporates both pre and post tests in order to assess learning progress The training begins with the ThinPrep morphology lecture which is designed to familiarize the participants with the microscopic presentation of cervical samples prepared using the ThinPrep System The format summarizes the morphologic features common to specific diagnostic entities described in The Bethesda System for...

Page 214: ...or if needed Participants of the training program receiving less than 90 on the Final Assessment would require remedial training in their individual laboratories This training involves the screening diagnosing of an additional ThinPrep Pap Test slide module provided by Hologic and requires a score of 90 or better to complete Hologic s ThinPrep Pap Test Training Program Cytology Staff Training Holo...

Page 215: ...10 User Interface Screens 10 User Interface Screens ...

Page 216: ...ted by pressing the prompt keys The 42 character by 8 line message screen shows instrument information including setup operation status maintenance functions tests and error messages Most operator interaction is via the menu command trees listed on the following pages MENU TREES Main Menu Setup p 10 2 Main Menu Maintenance 10 4 Main Menu Status 10 5 Main Menu Test 10 6 Start Batch Address Items 10...

Page 217: ...10 USER INTERFACE SCREENS 10 2 ThinPrep 3000 Processor Operator s Manual Main Menu Setup Refer to Chapter 2 Sections H I J for operation ...

Page 218: ...USER INTERFACE SCREENS ThinPrep 3000 Processor Operator s Manual 10 3 10 Continued from previous page Only English is available at this time ...

Page 219: ...ay the results printer advances paper as long as the key is pressed Opens and closes the slide clamps on the Slide Cell Transfer Arm Use this function when cleaning the arm and troubleshooting slide release errors Opens and closes the pinch valve of the tubing connecting the pneumatic and waste systems Use this function when replacing the pinch valve tubing ...

Page 220: ...ERFACE SCREENS ThinPrep 3000 Processor Operator s Manual 10 5 10 Prints Error History Report View Error History on Screen Main Menu Status Useful for Technical Support Instrument Maintenance and Troubleshooting ...

Page 221: ...essor Operator s Manual OR These tests are for Field Service usage These tests are for Field Service usage Example only Contact Hologic Technical Support if the Pneumatic Test is not successful Main Menu Test Refer to Chapter 6 Section E for operation ...

Page 222: ...CREENS ThinPrep 3000 Processor Operator s Manual 10 7 10 Item s in Low Supply Item s Not Detected Doors Unlock Unlocks the Doors Items may be loaded Start Batch Address Items Refer to Chapter 5 Section D for operation ...

Page 223: ...10 USER INTERFACE SCREENS 10 8 ThinPrep 3000 Processor Operator s Manual OR Start Batch Pause Cancel Refer to Chapter 5 Section G H for operation ...

Page 224: ...perator s Manual 10 9 10 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 System Fault Refer to Chapter 7 Section C for Operation ...

Page 225: ...10 USER INTERFACE SCREENS 10 10 ThinPrep 3000 Processor Operator s Manual Mechanical Error Resolved Mechanical Error Encountered Continued from previous page System Fault ...

Page 226: ...Index Index ...

Page 227: ...ailure 7 6 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 6 6 Close Doors and Press Continue 5 17 common artifacts 8 5 completing a batch 5 18 coverslipping recommendations 8 4 Customer Service Service 1 D dimensions ThinPrep 3000 Processor 1 9 Disposal consumables 1...

Page 228: ...t 1 2 filters 5 15 fixative cap 5 16 Fixative Clog 7 12 fixative reservoir 6 32 fixative shield 5 16 6 33 Ordering 2 fixative system preventative maintenance 6 5 fuses 1 11 6 36 Ordering 3 G general cleaning 6 24 I Installation 2 1 instrument doors 5 4 instrument maintenance 6 1 Instrument systems overview 1 4 Insufficient Vial Fluid 7 14 Items Must be Addressed 5 15 L label locations instrument 1...

Page 229: ...7 18 P pausing a batch in process 5 22 pinch valve tubing Ordering 2 pinch valve tubing replacement 6 26 Please Address Items 5 17 Pneumatic Failure 7 20 pneumatic system test 6 13 pneumatic test vial 6 10 6 14 Ordering 2 power 1 11 2 4 Power On Self Test 1 12 PreservCyt Solution 1 2 3 2 6 29 printer paper 6 38 Ordering 3 R reading the batch report 5 20 replacing the fixative shield 6 23 Reprocess...

Page 230: ...2 silicone lubricant Ordering 3 slide cartridges 5 7 6 17 Ordering 2 slide cell transfer arm 6 19 slide clamps 6 19 Slide handling 7 44 slide handling error 7 45 Slide handling system 1 7 Slide Misprint 7 22 Slide printer output 2 10 slide printer ribbon Ordering 3 slide printer ribbon replacing 6 34 slide waste bin 6 9 Ordering 2 Special Sample Status 7 1 spray bottle Ordering 2 staining rack ada...

Page 231: ...Fluid 7 24 Troubleshooting 7 1 turn the processor off 2 5 turn the processor on 2 4 U User Interface Screens 10 1 V Versa Clean Solution 6 19 Ordering 3 Vial Cap Too Tight 7 26 Vial Handling 7 32 Vial handling error 7 33 Vial handling system 1 5 W Warnings Cautions and Notes 1 12 waste bin 5 16 waste bottle 5 16 6 28 Ordering 2 waste bottle transport cover 6 29 Ordering 2 Waste System Failure 7 28...

Page 232: ...INDEX Index 6 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 233: ...Service Information Service Information ...

Page 234: ... standing orders are placed through Customer Service by phone during business hours at 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 Technical Support For questions about ThinPrep processor i...

Page 235: ...turned warranty covered consumable items without this number The transportation of PreservCyt Solution and CellFyx Fixative Solution is regulated by the DOT and will not be guaranteed by air freight companies for second day or overnight delivery Asia 852 3526 0718 Netherlands 0800 022 6782 Australia 61 2 9888 8000 Norway 800 155 64 Austria 0800 291 919 Portugal 800 841 034 Belgium 0800 773 78 Spai...

Page 236: ...Ordering Information Ordering Information ...

Page 237: ...omer 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 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 c...

Page 238: ...mple vial trays 1 pkg 70264 001 Slide Cartridge Additional slide cartridge 1 70348 001 Staining Rack 4 pack Additional staining racks 1 pkg 70265 001 Staining Rack Adapters Attachment accessory Leica Sakura Shandon 1 1 1 02975 001 02994 001 02976 001 Slide Waste Bin Additional slide waste bin 1 50814 001 Waste Bottle and Harness Assembly Replacement waste bottle and harness assembly 1 70213 001 Wa...

Page 239: ...r Waste Box Liner Plastic bag insert for filter waste box See below for ordering specifications Fuse 5x20 mm 6 3 Amp time delay glass low break capacity replacement fuse 2 50077 021 Silicone Lubricant Silicone lubricant 2 oz tube 1 tube 51298 001 Sample Identification Barcode Labels Self adhesive barcode labels See next page for ordering specifications Slide Printer Ribbon Replacement printing rib...

Page 240: ...ailing alpha characters may be used The instrument will not print letters to the microscope slide Only the numeric accession number will be printed 3 Printed as both a barcode and a 0 10 in 0 25 cm high human readable number centered length wise on the label within 0 125 in 0 317 cm 4 Print quality must meet requirements outlined in ANSI X3 182 Label dimensions Vendors Label Arts Inc will take int...

Page 241: ...inPrep Imaging System microscope slides Collection devices Broom like collection devices or Cytobrush and plastic spatula 500 Tests 500 500 500 500 500 70662 001 70662 003 ThinPrep Pap Test Physician Office Kit Materials for the physician s office Vials of PreservCyt Solution for use with the ThinPrep Pap test Collection devices Broom like collection device or Cytobrush and plastic spatula 500 500...

Page 242: ...ORDERING INFORMATION Ordering 6 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 243: ...Safety Data Sheets Safety Data Sheets ...

Page 244: ... SDS 1 Safety Data Sheets PreservCyt Solution CellFyx 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 ...

Page 245: ...SAFETY DATA SHEETS SDS 2 ThinPrep 3000 Processor Operator s Manual This page intentionally left blank ...

Page 246: ...Appendix Appendix ...

Page 247: ...THINPREP 3000 PROCESSOR LABORATORY FLOW ThinPrep 3000 Processor Operator s Manual Lab Flow 1 ThinPrep 3000 Processor Laboratory Flow ...

Page 248: ...ls are loaded into the sample vial trays for processing The sample vial trays are loaded into the ThinPrep 3000 processor The ThinPrep 3000 processor prints the sample ID number that is read from the sample vial barcode label onto the slide then processes the sample The ThinPrep slide is stained and coverslipped Case report form and slide are paired by the sample ID numbers and forwarded to the cy...

Page 249: ...BARCODE LABEL SPECIFICATIONS FOR THE THINPREP 3000 PROCESSOR ThinPrep 3000 Processor Operator s Manual Barcode 1 Barcode Label Specifications for the ThinPrep 3000 Processor ...

Page 250: ...code 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 Barcode Requirements The barcode standard used is Code 128 Subset C with 013 X dimension narrow bar width 1 Black bars on blue white ...

Page 251: ...SAMPLE VIAL LABEL APPLICATION GUIDE ThinPrep 3000 Processor Operator s Manual Sample Vial 1 Sample Vial Label Application Guide ...

Page 252: ...g slide processing The following protocols recommend the best placement of labels on the PreservCyt Solution vial for use with the ThinPrep Pap Test Recommended Laboratory Protocol Place sample identification barcode labels lengthwise on the PreservCyt Solution vial Use the edge of the sample vial label as a guide for applying the labels If additional labels were placed onto the sample vial by the...

Page 253: ...01 Rev 002 Daily Maintenance Lubricate O Rings Lubricate the inner surface of the pneumatic test vial Load it into tray position A1 of an empty sample vial tray From the Maintenance menu select Lube O Rings Fixative Spray Preventative Maintenance When the fixative menu screen appears toggle the fixative dispense lever 3 4 times and press Spray Repeat as needed Empty Slide Waste Bin Remove the slid...

Page 254: ... notched end of the cartridge matches the notched area on the box of slides before flipping the slides into the cartridge Be sure the cartridge clicks shut entirely The slide should issue from the cartridge frosted side up the word ThinPrep reading left to right If slides jam when leaving the cartridge remove cartridge from the cartridge well and make sure there is no glass dust or debris impeding...

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