Hologic ThinPrep 5000 Operator'S Manual Download Page 16

Page: 16 / 346

ThinPrep™ 5000 System

Instructions for Use

English

AW-22289-001 Rev. 003 11-2021

10/36

Table 4: Two Category Diagnostic Classification Table, LSIL and More Severe Diagnoses

Conventional

NEG/ASCUS/

AGUS+

LSIL+

TOTAL

ThinPrep

NEG/ASCUS/

AGUS+

5985 125 6110

LSIL+

224

413 637

TOTAL

6209 538 6747

Table 5: Two Category Diagnostic Classification Table, ASCUS/AGUS and More Severe

Diagnoses

NEG

ASCUS/AGUS+

TOTAL

ThinPrep

NEG

5224 369 5593

ASCUS/

AGUS+

456

698 1154

TOTAL

5680 1067 6747

Summary of Contents for ThinPrep 5000

Page 1: ...Operator s Manual ThinPrep 5000 Processor with AutoLoader...

Page 2: ...0 442 9892 1 508 263 2900 Fax 1 508 229 2795 Web www hologic com Hologic BV Da Vincilaan 5 1930 Zaventem Belgium Australian Sponsor Hologic Australia and New Zealand Pty Ltd Suite 302 Level 3 2 Lyon P...

Page 3: ...ribed stored in a retrieval system or translated into any language or computer language in any form or by any means electronic mechanical magnetic optical chemical manual or otherwise without the prio...

Page 4: ...Clarify instructions Add instructions regarding reporting serious incidents Remove urine collection kit information AW 22290 002 Rev 002 4 2021 Replace CE mark Remove reference to hologic com package...

Page 5: ...This page intentionally left blank...

Page 6: ...Instructions For Use Instructions For Use...

Page 7: ...ThinPrep 5000 System Instructions for Use English AW 22289 001 Rev 003 11 2021 1 36 ThinPrep 5000 System Instructions for Use...

Page 8: ...immersed and rinsed in a vial filled with 20 ml of PreservCyt Solution PreservCyt The ThinPrep sample vial is then capped labeled and sent to a laboratory equipped with a ThinPrep 5000 Processor At th...

Page 9: ...n of cells in a defined circular area As with conventional Pap smears slides prepared with the ThinPrep 5000 System are examined in the context of the patient s clinical history and information provid...

Page 10: ...chnologists and pathologists who have been trained to evaluate ThinPrep prepared slides by Hologic or by organizations or individuals designated by Hologic Supplies used by the ThinPrep 5000 System ar...

Page 11: ...t the interference at his her own expense PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing must be stored between 15oC 59oF and 30oC 86oF and tested within 6 weeks of collec...

Page 12: ...75 After 1 hour 4 7 log reduction After 1 hour 5 7 log reduction Data is for 5 minutes Organisms were tested with similar organisms from the same genus to assess antimicrobial effectiveness Note All...

Page 13: ...of PreservCyt Solution At the laboratory the PreservCyt sample vial was placed into a ThinPrep 2000 Processor and a slide was then prepared from the patient s sample ThinPrep and conventional Pap sme...

Page 14: ...H1 Hospital 35 000 1 046 18 1 89 1 8 1 40 4 9 9 H2 Hospital 40 000 1 049 18 1 84 4 2 1 18 2 12 9 H3 Hospital 37 000 981 18 2 78 8 11 1 38 2 24 2 Clinical Study Results The diagnostic categories of The...

Page 15: ...0 0 0 0 0 0 0 TOTAL 5680 521 8 367 167 3 1 6747 Abbreviations for Diagnoses NEG Normal or negative ASCUS Atypical Squamous Cells of Undetermined Significance AGUS Atypical Glandular Cells of Undetermi...

Page 16: ...able LSIL and More Severe Diagnoses Conventional NEG ASCUS AGUS LSIL TOTAL ThinPrep NEG ASCUS AGUS 5985 125 6110 LSIL 224 413 637 TOTAL 6209 538 6747 Table 5 Two Category Diagnostic Classification Tab...

Page 17: ...rep LSIL Conventional LSIL x 100 Conventional LSIL For LSIL and more severe lesions the diagnostic comparison statistically favored the ThinPrep method at four sites and was statistically equivalent a...

Page 18: ...l at each site compared to the reference diagnosis of the independent pathologist provides the proportion of LSIL or more severe lesions Table 8 and the proportion of ASCUS AGUS or more severe lesions...

Page 19: ...ologist ThinPrep Positive Conventional Positive p Value Method Favored S1 92 72 68 0 900 Neither S2 101 85 59 0 005 ThinPrep S3 109 95 65 0 001 ThinPrep H1 170 155 143 0 237 Neither H2 171 143 154 0 3...

Page 20: ...er 155 2 3 285 4 2 Reactive Cellular Changes Associated with Inflammation 353 5 2 385 5 7 Atrophic Vaginitis 32 0 5 48 0 7 Radiation 2 0 0 1 0 0 Other 25 0 4 37 0 5 Epithelial Cell Abnormalities 1159...

Page 21: ...n and reactive cellular change Tables 12 13 and 14 show the specimen adequacy results for the ThinPrep method and conventional smear method for all of the study sites Of the 7 360 total patients enrol...

Page 22: ...0 1008 14 0 No Clinical History 12 0 2 6 0 1 Cytolysis 19 0 3 119 1 6 Other 10 0 1 26 0 4 Unsatisfactory for Evaluation 136 1 9 114 1 6 Air Drying Artifact 0 0 0 13 0 2 Thick Smear 0 0 0 7 0 1 Endoce...

Page 23: ...absence of Endocervical Component Table 15 shows the Satisfactory But Limited By category No ECC s for ThinPrep and conventional slides Table 15 Specimen Adequacy Results by Site SBLB Rates for no En...

Page 24: ...Component rate Direct to Vial HSIL Study Following initial FDA approval of the ThinPrep System Hologic conducted a multi site direct to vial clinical study to evaluate the ThinPrep 2000 System versus...

Page 25: ...suspected glandular abnormalities are identified their accurate classification as true glandular versus squamous lesions is important for proper evaluation and subsequent treatment e g choice of excis...

Page 26: ...needed Slides prepared for the study were from specimens processed within 6 weeks of specimen collection All study specimens were processed both on a ThinPrep 5000 processor and a ThinPrep 2000 system...

Page 27: ...least two 2 of the three 3 pathologists from a panel rendered an identical diagnosis In cases where consensus agreement was not achieved the panel members were brought together at a multi head micros...

Page 28: ...ASC US LSIL ASC H and HSIL Table 20 Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results for the Specimens with Reference Diagnosis of ASC US In the study there were 530 specimens with...

Page 29: ...l percentages are rounded to the nearest 0 1 LSIL Positive Percent Agreement Negative Percent Agreement Lab CT Pathologist ThinPrep 5000 95 CI ThinPrep 2000 95 CI Difference 95 CI ThinPrep 5000 95 CI...

Page 30: ...l percentages are rounded to the nearest 0 1 ASC H Positive Percent Agreement Negative Percent Agreement Lab CT Pathologist ThinPrep 5000 95 CI ThinPrep 2000 95 CI Difference 95 CI ThinPrep 5000 95 CI...

Page 31: ...e Percent Agreement Lab CT Pathologist ThinPrep 5000 95 CI ThinPrep 2000 95 CI Difference 95 CI ThinPrep 5000 95 CI ThinPrep 2000 95 CI Difference 95 CI 1 77 4 113 146 70 0 to 83 4 80 1 117 146 72 9 t...

Page 32: ...logist Pathologist Agreement All Results ASC H ThinPrep 2000 System Three lab CTs have read the same ThinPrep 2000 slide from a vial ASC H Three CTs had ASC H Two CTs had ASC H one had ASC H One CT ha...

Page 33: ...majority of laboratory CT Pathologists among all specimens of ASC H diagnosis with ThinPrep 2000 slides by a majority of laboratory CT Pathologists NPA is the negative percent agreement percent of spe...

Page 34: ...wo CTs had ASCUS and one had ASCUS 31 24 13 10 78 One CT had ASCUS and two had ASCUS 11 8 34 53 106 Three CTs had ASCUS 3 13 56 563 635 Totals 438 81 111 630 1260 ThinPrep 2000 System Three lab CTs ha...

Page 35: ...e instrument The slides were stained coverslipped and then reviewed by cytotechnologists The resulting diagnoses and specimen adequacy determinates are presented below Seventy eight 78 specimens had a...

Page 36: ...stem with results also presented below Table 29 Between Instrument Precision ThinPrep 5000 ThinPrep 2000 Percent of specimens that have three matching NILM replicates or three matching ASC US replicat...

Page 37: ...de s count value and the Test axis is the matching ThinPrep 5000 slide s count Deming regression analysis was performed and the slope was 0 98 with 95 CI 0 94 to 1 01 and the intercept was 300 with 95...

Page 38: ...Pap smear in a variety of patient populations and may be used as a replacement for the conventional Pap smear method for the detection of atypical cells cervical cancer or its precursor lesions as we...

Page 39: ...e filter Staining Racks pkg of 10 Absorbent pad for filter plug Absorbent pad for evaporative cover ThinPrep 5000 Processor with AutoLoader ThinPrep 5000 Processor with AutoLoader ThinPrep 5000 Proces...

Page 40: ...918 1995 3 American Cancer Society Cancer Facts and Figures 1995 4 Ashfaq R Gibbons D Vela C Saboorian MH Iliya F ThinPrep Pap Test Accuracy for glandular disease Acta Cytol 1999 43 81 5 5 Bai H Sung...

Page 41: ...800 442 9892 Fax 1 508 229 2795 For international or toll free blocked calls please contact 1 508 263 2900 Email info hologic com Hologic Inc 250 Campus Drive Marlborough MA 01752 1 800 442 9892 www h...

Page 42: ...n History Revision Date Description AW 22289 001 Rev 001 11 2020 Add Precision Study and Cell Count Study Information Add data in microbial viral organism table AW 22289 001 Rev 002 4 2021 Replace the...

Page 43: ...Table of Contents Table of Contents...

Page 44: ...Prep 5000 Hazards 1 15 SECTION E Disposal 1 22 Chapter Two INSTALLATION SECTION A General 2 1 SECTION B Action Upon Delivery 2 1 SECTION C Preparation Prior to Installation 2 1 SECTION D Storage and H...

Page 45: ...g Troubleshooting 4 6 Chapter Five NON GYNECOLOGIC SAMPLE PREPARATION SECTION A Introduction 5 1 SECTION B Required Materials 5 2 SECTION C Specimen Collection 5 3 SECTION D General Steps for Sample P...

Page 46: ...7 18 SECTION H Batch Complete 7 18 SECTION I Unload the ThinPrep 5000 Processor with AutoLoader 7 20 SECTION J Small Batch Mode 7 20 SECTION K Optional Instructions for Ancillary Testing 7 37 Chapter...

Page 47: ...TION D System Errors 9 18 Chapter Ten STAINING AND COVERSLIPPING SECTION A General 10 1 SECTION B Fixation 10 1 SECTION C Recommended Staining Guidelines 10 2 SECTION D Coverslipping 10 4 Chapter Elev...

Page 48: ...1 Introduction 1 Introduction...

Page 49: ...ture enables a batch in which 1 to 10 samples may be removed from the vial Urine specimens used in conjunction with Vysis UroVysion assay urine specimens One sample per vial may be processed in a batc...

Page 50: ...lides from ThinPrep PreservCyt vials for use as a replacement for the conventional method of Pap smear preparations for screening for the presence of atypical cells cervical cancer or its precursor le...

Page 51: ...ecimens as part of the ThinPrep system Not intended to be used for ThinPrep Pap testing For professional use The ThinPrep Pap Test The ThinPrep Pap test is a fluid based method for the collection and...

Page 52: ...ained by Hologic or by organizations or individuals designated by Hologic Evaluation of microscope slides produced with the ThinPrep 5000 system should be performed only by cytotechnologists and patho...

Page 53: ...tis and Neisseria gonorrhoeae testing using Hologic s APTIMA COMBO 2 CT NG assays and the Roche Diagnostics COBAS AMPLICOR assay should not be performed on a sample that has already been processed usi...

Page 54: ...rives inserted in a port Field service would be required Note also that the system cannot write data to a write protected USB key PreservCyt Solution was challenged with a variety of microbial and vir...

Page 55: ...Vial trays slide cassettes and filter trays are loaded into the instrument The carousel is placed into the ThinPrep 5000 processor compartment Fixative baths containing a staining rack and fixative al...

Page 56: ...into the car ousel and loads the carousel into the processor Pick up the first vial place it in the carousel and read the vial ID Pick a filter and put it in the carousel Check the vial and slide IDs...

Page 57: ...persion area Pick up the slide Once processing begins the system fetches subsequent vials filters and slides Disperse the vial contents Disperse the vial contents Uncap the vial Uncap the vial Place t...

Page 58: ...15 C 59 F and 30 C 86 F Do not use beyond the expiration date printed on the container Store PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing between 15 C 59 F and 30 C 86 F...

Page 59: ...rep filter tray bays 3 ThinPrep 5000 Processor with AutoLoader Processor User interface Carousel Baths door Filter waste bin Liquid waste bottle and slide waste bin behind door Laser fume extractor fi...

Page 60: ...57 inches 145 cm high x 54 inches 137 cm wide x 28 inches 71 cm deep Weight approximate 660 lbs 300 kg Waste bottle 17 inches 43 cm high x 6 inches 15 cm diameter Figure 1 5 ThinPrep 5000 Processor wi...

Page 61: ...at load Maximum 529 watts 1805 BTU hr or 1904 Joule hr Power Electrical Voltage frequency power 100 120 V 6A 50 60 Hz 220 240V 2A 50 60 Hz Fusing Two 6 3A 250V 5x20 mm SLO BLO Laser Type CW CO2 infrar...

Page 62: ...ctromagnetic radiation e g unshielded RF sources as these may interfere with the proper operation This product is in vitro diagnostic IVD medical equipment If this equipment is used in a manner not sp...

Page 63: ...der 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 the equipment may be impaired If...

Page 64: ...companying documents hologic com ifu Consult instructions for use Do not re use Fuse Waste Electrical and Electronic Equipment Do not dispose in municipal waste Contact Hologic for disposal of the ins...

Page 65: ...of manufacture Catalogue number Serial number Protective Conductor Terminal Power Switch On Power Switch Off Direction of flow Made in USA Information is applicable only in the USA and Canada Product...

Page 66: ...d experienced in the use of the product The ETL Mark is proof of product compliance to North American safety standards Authorities Having Jurisdiction AHJs and code officials across the US and Canada...

Page 67: ...rts Keep hands hair loose clothing jewelry etc clear Do not operate with the doors open WARNING Grounded Outlet To ensure safe operation of the equipment use a three wire grounded outlet Disconnection...

Page 68: ...e to organs Cannot be made non poisonous Keep away from heat sparks open flames and hot surfaces Follow the manufacturer s recommendations for reagent handling and cleanup of spills Refer to manufactu...

Page 69: ...uctions on replacing user accessible fuses Refer to Ordering Information for fuse specification and ordering WARNING Laser Device This product contains a Class 4 laser product Never operate the instru...

Page 70: ...guidelines As with all laboratory procedures universal precautions should be followed Used carbon filter from the fume extractor Dispose of as regular waste Used HEPA filter from the fume extractor Fo...

Page 71: ...MA 01752 USA 1930 Zaventem Tel 1 800 442 9892 Belgium 1 508 263 2900 Fax 1 508 229 2795 Web www hologic com Safety Data Sheet CytoLyt Solution PreservCyt Solution The Safety Data Sheet SDS for these s...

Page 72: ...INTRODUCTION 1 24 ThinPrep 5000 Processor with AutoLoader Operator s Manual 1 This page intentionally left blank...

Page 73: ...2 Installation 2 Installation...

Page 74: ...the packing cartons for Hologic service installation Store the instrument in a suitable environment until installation cool dry vibration free area PREPARATION PRIOR TO INSTALLATION Pre Installation...

Page 75: ...al ThinPrep 5000 Processor with AutoLoader CAUTION Route all connectors carefully to avoid pinching the cables To avoid tripping over or disconnecting cabling do not place cabling near foot traffic Ne...

Page 76: ...ystems Hologic can provide guidance on confirmation capabilities and constraints for setting up the LIS connection Hologic will validate the integrity of the instrument LIS interface The end user will...

Page 77: ...ain the instrument as described in the Maintenance chapter of this manual If the ThinPrep 5000 processor with AutoLoader is to be moved or shipped to a new location please contact Hologic Technical Su...

Page 78: ...r switch on the rear of the AutoLoader always leave that on and only power the entire system on or off via the switch on the processor portion of the instrument Figure 2 4 Power Switch The user interf...

Page 79: ...be set via the touch screen interface These settings may be reset at any time and any settings will persist even if the instrument is powered off and powered on again Set Time And Date page 6 25 Set...

Page 80: ...her let it finish or stop the batch To shut down touch the Admin Options button on the user interface and press the Shutdown button Figure 2 6 Shutdown Button Figure 2 7 Shutdown Confirmation A confir...

Page 81: ...ste bottle Maintenance chapter remove any items that may be on board and close all doors Follow the instructions for Normal Shutdown Completely remove power to the instrument by unplugging the power c...

Page 82: ...3 PreservCyt and CytoLyt Solutions 3 PreservCyt and CytoLyt Solutions...

Page 83: ...a have not been validated by Hologic Packaging Please refer to the Ordering Information in this manual for part numbers and detailed information regarding the ordering of solutions and supplies for th...

Page 84: ...cap with the mark on the vial as shown in Figure 3 1 to prevent leakage If the cap on the vial does not have a line ensure the cap is tightened securely Figure 3 1 Aligning the vial cap The shipping c...

Page 85: ...duction of viable organisms found after 15 minutes in the PreservCyt Solution As with all laboratory procedures universal precautions should be followed Organism Initial Concentration Log Reduction Af...

Page 86: ...roduct It may also be accessed at www hologicsds com Note All log reduction values with a designation yielded undetectable microbial presence after exposure to PreservCyt Solution The listed values re...

Page 87: ...Harmful if swallowed Harmful if inhaled Causes damage to organs Cannot be made non poisonous Keep away from heat sparks open flames and hot surfaces Storage Requirements Store the containers at 15 C...

Page 88: ...Operator s Manual 3 Handling Disposal Handle all chemical containing materials carefully in accordance with safe laboratory practices Safety Data Sheet The SDS for CytoLyt Solution is included in the...

Page 89: ...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 A...

Page 90: ...gs 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...

Page 91: ...e 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 interna...

Page 92: ...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 packag...

Page 93: ...on 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 o...

Page 94: ...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...

Page 95: ...tities 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 II...

Page 96: ...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 packagi...

Page 97: ...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...

Page 98: ...4 Gynecologic Sample Preparation 4 Gynecologic Sample Preparation...

Page 99: ...s from the ectocervix and the endocervix 1 Collection Deposit the specimen directly into a PreservCyt Solution vial Note Proper rinsing technique of the collection device is very important See specime...

Page 100: ...d to lubricate the speculum Even though lubricant jellies are water soluble excessive amounts of jelly may compromise the test and possibly lead to an unsatisfactory result Remove excess mucus or othe...

Page 101: ...the 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 p...

Page 102: ...brush as 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 Disc...

Page 103: ...Atiny amount of lubricant may be used just enough to sparingly coat the speculum with a gloved finger avoiding the tip of the speculum The Clinical and Laboratory Standard Institute Guidelines and ACO...

Page 104: ...te 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 3...

Page 105: ...oss 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...

Page 106: ...GYNECOLOGIC SAMPLE PREPARATION 4 8 ThinPrep 5000 Processor with AutoLoader Operator s Manual 4 This page intentionally left blank...

Page 107: ...5 Non Gynecologic Sample Preparation 5 Non Gynecologic Sample Preparation...

Page 108: ...rther sample processing to obtain better quality subsequent slides in these cases This chapter also provides an outline of various sample collection methods and the appropriate procedures for each Con...

Page 109: ...r more information about supplies and solutions from Hologic From Other Suppliers 50 mL capacity centrifuge free swing basket Centrifuge tubes 50 mL Plastic transfer pipettes 1 mL graduated Balanced e...

Page 110: ...a rapid analysis of specimen adequacy is required Mucoid Specimens Mucoid specimens are best collected into CytoLyt Solution If they are collected fresh CytoLyt Solution should be added as soon as po...

Page 111: ...f urine is required to perform the Vysis UroVysion assay Other Collection Media In cases where CytoLyt Solution is contraindicated balanced electrolyte solutions such as Plasma Lyte and Polysol may be...

Page 112: ...samples and after the addition of CytoLyt Solution When specified in the protocol centrifuge samples at 600 times normal gravity 600g for 10 minutes to force the cells in solution into a pellet at the...

Page 113: ...he radius of your centrifuge in the first column of Figure 5 2 Draw a line from the radius value through the 600 Gravities g column and into the rpm column Read the rpm value from the straight edge as...

Page 114: ...sample To do this invert the centrifuge tube 180 degrees in one smooth movement pour off all the supernatant and then return the tube to its original position as shown in Figure 5 3 1 Observe the cell...

Page 115: ...Figure 5 3 Pouring Off Supernatant After pouring off the supernatant place the centrifuge tube onto a vortexor and agitate the cell pellet for 3 seconds Manual vortexing may be achieved by syringing...

Page 116: ...ion wash See page 5 12 in this chapter Add 30 mL CytoLyt Solution Concentrate by centrifugation Pour off supernatant and vortex to resuspend cell pellet Cell pellet is mucoid not in liquid form To tes...

Page 117: ...oncentration of the sample If the supernatant is not completely poured off then additional drops of the sample may be required The total volume added to the vial must not exceed 1 mL Size of Cell Pell...

Page 118: ...overslips the slide according to the procedure in Chapter 10 Staining and Coverslipping When the slide is stained and coverslipped it is microscopically reviewed by a cytotechnologist or pathologist I...

Page 119: ...es Pouring off the supernatant and vortexing to resuspend the cell pellet One CytoLyt Solution Wash is usually adequate to clean most non gyn samples For particularly bloody or mucoid specimens additi...

Page 120: ...INES The following guidelines outline the preferred methods for preparing the different types of specimens The methods are described in general terms For more detailed information about each step refe...

Page 121: ...ssing techniques so use caution if you plan to use the specimen for other testing 2 Concentrate by centrifugation 600g for 10 minutes page 5 5 or 1200 g for 5 minutes 3 Pour off supernatant and vortex...

Page 122: ...eing used with respiratory mucoid samples add stock before agitation See the following page for preparation instructions 2 Mechanical agitation page 5 11 Note Vortex for a minimum of 5 minutes in hand...

Page 123: ...ssing Follow the steps for processing mucoid specimens on the previous page After sample collection Step 1 but prior to vortexing Step 2 add 1 mL of the stock DTT solution to the sample Proceed with t...

Page 124: ...extremely bloody fluids i e pericardial start with only 10 mL of fresh fluid 2 Concentrate by centrifugation 600g for 10 minutes page 5 5 or 1200 g for 5 minutes 3 Pour off supernatant and vortex to...

Page 125: ...h urine can be mixed with a 2 1 urine to PreservCyt Solution ratio and stored for up to 48 hours before processing Note Do not exceed a 2 1 ratio of urine to PreservCyt Solution If the urine volume ex...

Page 126: ...upernatant Resuspend cell pellet 5 Evaluate cell pellet appearance page 5 9 If the cell pellet is not free of blood add 30 mL of CytoLyt Solution and repeat from step 4 6 Add entire specimen to Preser...

Page 127: ...pecimen Collection 1 On the specimen collection cup record patient information in the space provided 2 Collect urine in a routine manner If urine volume exceeds 60 mL pour off excess The total volume...

Page 128: ...ibution of the cells in the cell spot that was not accompanied by a Sample Is Dilute message Uneven distribution in the form of a ring or halo of cellular material and or white blood cells A sparse ce...

Page 129: ...obvious halo of cellular material and or white blood cells 1 Dilute the sample 20 1 Use a calibrated pipette to add 1 mL of sample to a new PreservCyt Solution vial Prepare slide using sequence Non G...

Page 130: ...d vortex to resuspend cell pellet page 5 7 4 If the sample contains blood or non cellular debris Mix a solution of 9 parts CytoLyt Solution to 1 part Glacial acetic acid Add 30 mL of this solution to...

Page 131: ...pernatant and vortex to resuspend cell pellet page 5 7 7 Evaluate cell pellet appearance page 5 9 If pellet contains blood or protein repeat from step 4 8 Add specimen to PreservCyt Solution vial page...

Page 132: ...d pipette to add 1 mL of sample to a new PreservCyt Solution vial Prepare slide using Sequence Non Gyn If a halo is present on the new slide call Hologic Technical Service page 12 1 C Is the slide spa...

Page 133: ...number of drops by the volume in mL to get the number of drops that corresponds to 1 mL Use PreservCyt Solution rather than any other liquid so the drop size will be consistent with the sample drops...

Page 134: ...6 User Interface 6 User Interface...

Page 135: ...ent found in this chapter MAIN SCREEN INSTRUMENT IDLE 6 3 Status Bar 6 3 Status Indicators 6 5 Slides 6 6 Vials 6 8 Baths 6 10 Filters 6 14 Start Button 6 16 MAIN SCREEN DURING PROCESSING 6 16 Process...

Page 136: ...37 Configure Barcodes 6 44 Change Air Filter 6 64 Clean System 6 65 REPORTS AND LOGS 6 65 System Events 6 66 Batch Report 6 68 Find a Vial by ID 6 70 Save a Report to USB Key 6 73 Usage Details 6 75...

Page 137: ...vials filters and baths are present and match the sample type selected the status will be Ready Figure 6 2 System Status Ready If the system determines operator action is required a message is displa...

Page 138: ...sage window which lists all items to be seen to If the Start batch button is pressed the same message window will appear A batch will not start with unresolved issues Figure 6 3 System Status Not Read...

Page 139: ...een Status Indicators Status Icon Meaning Ready for processing Completed The batch has been paused Not ready or error Read the message in the status bar to know what issue needs to be resolved Warning...

Page 140: ...e Slides button or anywhere on the pane to open the Slides Details display Cassette 1 is selected as Gyn type slide and it is partially full Cassette 2 is selected as Non Gyn type slide and it is full...

Page 141: ...e screen The button label for that cassette will change to reflect the selection The types of microscope slides are Gyn ThinPrep microscope slides for gynecologic cytology Imager slides for use on the...

Page 142: ...l Details display Tray 1 is selected as Gyn sample type and it is ready for processing Tray 2 is selected as Non Gyn sample type and it is ready for processing Tray 3 is selected as UroCyte sample typ...

Page 143: ...with the ThinPrep Imaging System For running a tray of non gynecologic specimens Use blue ThinPrep non gynecologic filters and ThinPrep microscope slides For running a tray of urine specimens for use...

Page 144: ...h Details display How many baths are in the instrument ready to process How many baths are in the instrument that have completed slides and must be unloaded How many baths are in the instrument that n...

Page 145: ...selected bath Slide count The processor keeps track of the quantity of slides deposited in the slide rack in the selected bath First Slide ID The ID of the first slide in the slide rack for the selec...

Page 146: ...he bath compartment make sure the door is closed and press the Load Empty Baths button The system locks the door and moves an empty bath position in front of the door When the door unlocks open it and...

Page 147: ...ove completed fixative baths that are on board the instrument press the Remove Used Baths button The door locks and a completed bath is moved to the door The door unlocks Remove the bath and close the...

Page 148: ...ilters left OR if it finds an empty position If a filter tray is not present the status is No tray Touch the Filters button or anywhere on the pane to open the Filters Details display Tray 1 is select...

Page 149: ...samples Non Gyn Blue filters for general cytology UroCyte Yellow filters for use in conjunction with the Vysis UroVysion assay When a filter tray is empty the system will draw off of the next tray tha...

Page 150: ...atch Screen The carousel is rotated and every position is checked to make sure there are no vials on board Then every slide and filter slot is checked to ensure no material is in the carousel If the c...

Page 151: ...dy has a running slide count The progress bar indicates how many samples of the vial tray have been processed Figure 6 17 Processing Samples Screen When a tray has been completed the display will chan...

Page 152: ...e batch report press the View Report button The report will display and there is the opportunity to print the report or save it to USB key via that screen When the report screen is exited by pressing...

Page 153: ...he Done button Pause a Batch Figure 6 21 Pause Button Note The following steps are for operator initiation of a batch pause The system may initiate a pause if it detects low inventory of consumable it...

Page 154: ...he fixative bath s from the baths compartment New empty baths can be loaded Slides and filters can be replenished if necessary The types may be changed as long as there is the correct complement to co...

Page 155: ...igure 6 23 Stop Processing After Batch Pause SWITCH MODES When the instrument is in an idle state it can be switched to small batch mode for running 20 or fewer samples directly on the processing caro...

Page 156: ...touch screen for cleaning Empty the liquid waste bottle Configure the information etched onto the slide labels Configure the rules that the processor uses to check vial IDs and slide IDs Run an air fl...

Page 157: ...button is available for Hologic service personnel usage and it is password protected About Button Press the About button to display the serial number for the instrument as well as the software version...

Page 158: ...button Sound button Alert Tones button Done return to main screen Instrument Name button Lab Name button Vial Slide ID Pre match button Language button More settings shown below Install Printer butto...

Page 159: ...ld until the desired value is displayed Press the Save Changes button to return to the System Settings screen Press Cancel to cancel changes and revert to the previous setting See Figure 6 28 Figure 6...

Page 160: ...ld until the desired value is displayed For the meridian press the AM or PM button as appropriate Press the Save Changes button to save and return to the Systems Setting screen See Figure 6 30 Note De...

Page 161: ...but 20 characters are accepted in the field and will print on the reports Refer to Figure 6 32 To create a capital letter press the Shift button and then press the letter With the next letter the sys...

Page 162: ...ess the Shift button and then press the letter With the next letter the system reverts to lowercase Use the Space button for a space and the Delete button to remove entered letters Keyboard display Sh...

Page 163: ...rd and keypad as often as desired before saving changes Press the Save Changes button to save and return to the System Settings screen Figure 6 34 Edit Instrument Name Screen Set Sound Figure 6 35 Sou...

Page 164: ...o the System Settings screen Alert Tones Figure 6 37 Alert Tones Button Alert tones are audible alarms that sound upon batch completion or during an error condition Three sounds are offered for each S...

Page 165: ...he alert tone will sound once When an error condition occurs the alert tone will sound and then repeat every few seconds The error message window will have a Silence Alarm button that can be pressed t...

Page 166: ...and date format for that region to the language Press the Save Changes button to immediately apply the selected language and locale to the system Vial Slide ID Pre match Figure 6 42 Vial Slide ID Pre...

Page 167: ...e 6 43 Press Stop Processing to cancel the batch and unlock the doors so that the mismatches can be corrected The window will remain so that the vials and slides can be easily found Press Continue Pro...

Page 168: ...vials from the vial tray to the carousel The instrument can be configured to stop loading vials at an empty slot in the vial tray or to continue past empty slots in the vial tray When the setting is S...

Page 169: ...ystem is equipped with the optional LIS interface Batch reports can be uploaded to the NAS network attached storage Information from your laboratory information system can be included on the slide lab...

Page 170: ...in Chapter 8 Maintenance Empty Liquid Waste This is described in Chapter 8 Maintenance Batch reports will be copied to the NAS for access via the LIS server Note they will also reside in the system d...

Page 171: ...text choose lab name instrument name date time vial slide ID LIS Field 1 LIS Field 2 LIS Field 3 Vial Field 1 Vial Field 2 Vial Field 3 or do not select any field 4 Add lower text choose lab name ins...

Page 172: ...upported Code 128 Interleaved 2 of 5 Code 39 Code 93 Codabar or EAN 13 JAN or one of the two 2 D barcode symbologies supported DataMatrix or QR Code No OCR vial label formats may be used Figure 6 51 S...

Page 173: ...e the Review Design screen 2 D barcode format All characters are read from the vial barcode The data length for the slide ID must be a minimum of 5 characters The maximum length for the slide ID in a...

Page 174: ...f 14 digits including an optional check digit will fit on a slide 1 D Interleaved 2 of 5 Only digits are supported 5 7 9 or 11 characters 1 check digit is the format 1 D Code 39 Supported characters a...

Page 175: ...prompts you to select the type of data The Vial Field buttons are available only when the instrument is configured for a vial label that has additional information besides the accession ID Refer to C...

Page 176: ...der Operator s Manual 6 The data field under the slide ID can be a barcode or text The upper text and the lower text are each text fields Select the size for the text Figure 6 56 Select the size of te...

Page 177: ...ign and Save Changes When label type is selected from the Admin Options screen the current design will be etched onto the microscope slides Note This is only for the ThinPrep 5000 processor with AutoL...

Page 178: ...ilable for that particular instrument For example ThinPrep 5000 processors with a particular scanner installed cannot read 2 D barcodes on vial labels and a particular scanner reads a maximum of five...

Page 179: ...ple labels from a vial and or slide to check that the ThinPrep 5000 processor is configured to read the ID labels used in your lab The screen displays are designed to guide the operator through the se...

Page 180: ...Ds as 1 D barcodes or 2 D barcodes Select 1 D barcode or 2 D barcode and then select the type s of barcodes used for vial IDs at your facility Figure 6 61 Configure Vial ID barcode type s Note For bes...

Page 181: ...the sample accession ID configure the ThinPrep 5000 to recognize where the accession ID is within the vial ID Also configure the instrument to recognize additional information in the vial ID as one o...

Page 182: ...he text to open the keypad Enter the number or character and press Done to return to the Vial Information screen Press the Save Changes button to save and return to the Configure Vial ID screen The Co...

Page 183: ...y shows the number of sections and the position of the accession ID within the vial ID Figure 6 64 Accession ID and additional information within the vial ID Press Back to return to the previous scree...

Page 184: ...ck button To check that the vial ID configuration matches vial IDs in your laboratory press the Test Settings button Figure 6 65 Configure vial ID summary screen To test the vial ID configuration use...

Page 185: ...are required to etch the EAN 13 JAN and Codabar 1 D barcode types and the QR Code 2 D barcode type If the vial ID on the vial does not match the criteria configured for the vial ID the screen display...

Page 186: ...abel method Configure slide ID for laser etched slides The slide ID must be based on the vial ID There are four options for configuring laser etched slide IDs Combinations of the four options can be u...

Page 187: ...eave the Start at position field blank If the starting point is a certain position in the vial ID such as the fifth character use the Start at position setting A Touch the empty box to access the keyp...

Page 188: ...nding point of the segment of the vial ID used in the slide ID is a certain character touch the triangle next to Segment length to see the End at character field A Touch the name End at character to s...

Page 189: ...Press Save Changes to save the starting or inserted characters information Append characters The ThinPrep 5000 processor with Autoloader can be configured to etch slide IDs that are the vial IDs with...

Page 190: ...tton The OCR and 1 D barcode types often require shorter slide IDs than 2 D barcode types If the barcode configuration settings for the slide ID are likely to create a slide ID that is too long for th...

Page 191: ...arousel Close the doors and press Continue to scan The instrument moves the vial in slot 1 of the carousel and scans the vial ID The test not only checks that the vial ID scanned matches the vial ID c...

Page 192: ...gured return to the summary screen and save the changes Successful Slide ID configuration The vial ID configuration information matches the vial label that was scanned The slide ID for the sample in t...

Page 193: ...000 processor configure the type of barcode s used on the slide labels so that the ThinPrep 5000 processor recognizes the vial ID and slide ID from other information that may be printed on the labels...

Page 194: ...ext to continue To skip the next steps use the Review button to go directly to the last screen in the sequence the slide ID summary screen The All 1 D barcodes button selects all of the available 1 D...

Page 195: ...ID and the vial ID must share a unique portion of their IDs Specify whether they are identical or where the slide ID and vial ID differ so that the ThinPrep 5000 processor recognizes a match between t...

Page 196: ...t of the slide ID to use for matching the vial IDs and slide IDs The steps for configuring the instrument to recognize a segment of the vial ID and the slide ID with pre printed labels are the same as...

Page 197: ...the carousel and scans the slide ID The test checks that the vial ID scanned matches the vial ID configured that the vial ID scanned matches the slide ID scanned and that the slide ID scanned matches...

Page 198: ...r Filter This is described in Chapter 8 Maintenance Successful slide ID configuration for pre printed slides The vial ID and the slide ID in this example have the segment 9999 in common which can be c...

Page 199: ...do not interfere with the operation of the instrument The record of errors is retained for three years errors older than three years are purged Batch Reports displays the success or failure of sample...

Page 200: ...ment is not capable of recovering from without user intervention Instrument name if one has been set up Usage Summary tally of vials processed System Events button Batch button to view batch reports D...

Page 201: ...the event The Event Codes button displays a list of error codes that occurred for that batch Explanation of error codes is detailed in the Troubleshooting chapter Figure 6 82 shows an error codes lis...

Page 202: ...ch individual report is titled by a date and time stamp generated at the moment the batch completed See Figure 6 84 Figure 6 84 Batch Reports List Touch a report field to select it The report is displ...

Page 203: ...ed for the batch to run The status of the batch OK or an error code number which corresponds to a system error that ended the batch or operator cancellation of the batch The batch report lists every v...

Page 204: ...accession number Press the Find Vial by ID button ThinPrep 5000 Batch Report Start Time End Time Lab Instrument Serial number Sequence Status 10 21 2010 10 15 AM 10 21 2010 11 45 AM Hologic T5000 D002...

Page 205: ...ng searched for Figure 6 88 Enter Full or Partial Vial ID Press the Continue button to search all batch reports for the ID The report with that ID will be listed or a list of reports if a partial ID w...

Page 206: ...ue searched for the batch report is listed on the display Touch a report to open it The item s with the search value appear highlighted in green Search result found match Touch a batch report to view...

Page 207: ...ts CAUTION Always use the USB drive provided with the processor Never use a U3 Smart Drive While the system is able to write to this device there is a significant problem if the system is booted with...

Page 208: ...lly named by the convention of Report type Processor Name Date and Time XML This is illustrated below With each report type a style sheet file is also created so that when the report is viewed or prin...

Page 209: ...The usage history report header identifies The date and time of the report The lab name if one is used The processor name if one is used The usage history report identifies The number of slides succe...

Page 210: ...s generated at the con clusion of the run It is located on the Batch Reports screen Carousel Reports are only gener ated when using the AutoLoader Refer to Carousel Report Figure 6 96 The Carousel Rep...

Page 211: ...Waiting Return 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Carousel Position 1 Details Yes No Yes 1 1 Gyn Error Hold 74041829999 74041829999 Gyn Vial Status Vial ID Slide ID Slide Type Vial Pre...

Page 212: ...ins data for a vial until the vial tray is removed and replaced in the AutoLoader Figure 6 97 Vial Events Report Status This lists the code for the vial event Touch the code for information about the...

Page 213: ...Figure 6 99 Gather Diagnostics Button Gather Diagnostics is a function intended for instrument troubleshooting by Hologic Technical Support It gathers and zips the error history log and other instrum...

Page 214: ...ns from Hologic Technical Support Figure 6 100 Select the Option for Gathering Diagnostic Data Figure 6 101 Gather Diagnostics Screen The instrument operating information will be gathered into a folde...

Page 215: ...ThinPrep 5000 Processor with AutoLoader Operator s Manual 6 81 6 USER INTERFACE Clean Screen This is described in Chapter 8 Maintenance Empty Liquid Waste This is described in Chapter 8 Maintenance...

Page 216: ...USER INTERFACE 6 82 ThinPrep 5000 Processor with AutoLoader Operator s Manual 6 This page intentionally left blank...

Page 217: ...7 Operating Instructions 7 Operating Instructions...

Page 218: ...t is generated at the completion of each batch The report indicates the success or failure of processing each vial as well as any errors encountered The report may be viewed on the user interface or a...

Page 219: ...ssor with AutoLoader and depending on the process application there are three types of slides ThinPrep microscope slides for use with ThinPrep processors are for gynecologic or non gynecologic sample...

Page 220: ...The ThinPrep 5000 processor with AutoLoader also supports Interleaved 2 of 5 Code 39 Code 93 Codabar NW7 and EAN 13 JAN 1 D barcode symbologies The ThinPrep 5000 processor with AutoLoader also suppor...

Page 221: ...label over patient information multiple labels or on the torque features of the vial Do not place labels on the vial cap or on the bottom of the vial Sticking labels on incorrectly can cause a failur...

Page 222: ...rep 5000 instrument please note that if ancillary testing is to be performed read and understand the instructions in OPTIONAL INSTRUCTIONS FOR ANCILLARY TESTING on page 7 37 Figure 7 3 Load the Instru...

Page 223: ...the slide handler pick slides without binding Before loading a cassette with microscope slides gently wipe down the inside surface with a soft cloth to remove any glass dust from previous loads The m...

Page 224: ...Figure 7 4 Microscope Slides and Cassette Table 7 2 Load the Cassette with Slides 1 Unlatch the clasp that holds the slide cassette closed 2 Open the cassette and clean it 3 Open a box of microscope s...

Page 225: ...e cassette positions marked as bay 1 2 or 3 Push the cassette in all the way The cassette graphic will appear on the user interface when the sensor is activated by the presence of the cassette 4 Place...

Page 226: ...inPrep 5000 Processor with AutoLoader Operator s Manual 7 9 7 OPERATING INSTRUCTIONS Figure 7 5 Load Slide Cassettes The operator must identify the type of slides in each cassette See Slides on page 6...

Page 227: ...ial tray the instrument continues through all of the vial tray positions and loads any vial in the vial tray for processing When all of the positions in a vial tray have been searched the system will...

Page 228: ...nt and pull out a shelf Slide the filter tray onto the shelf and push it fully into the compartment The label on the filter tray must be facing out facing you Then close the compartment door The prese...

Page 229: ...STRUCTIONS 7 12 ThinPrep 5000 Processor with AutoLoader Operator s Manual 7 Figure 7 8 Robotic Arm Tray Search Pattern Start Start Finish or if configured at first empty position Finish or at first em...

Page 230: ...poration for a period of up to 72 hours Additionally if the instrument is left idle while containing eight baths it will rotate the bath carousel every 10 minutes so that no one particular bath is alw...

Page 231: ...and slide the tray into the center of the processing area It is properly in place when it stops against the rear wall The carousel does not have to be inserted with the number 1 position oriented in...

Page 232: ...7 12 Start Batch Button The doors will be heard to lock The processor checks for the presence of vials filters and slides The batch preparing to process screen displays See Figure 7 13 Figure 7 13 St...

Page 233: ...AutoLoader Operator s Manual 7 Figure 7 14 Processing Samples Screen Progress bar and tray position indicate how much of the vial tray has been processed Admin Options are available but some items are...

Page 234: ...isperser Pick up slide filter and vial and bring them to the dispersion area Pick up the slide Once processing begins the system fetches subsequent vials filters and slides Disperse the vial contents...

Page 235: ...When a single tray has completed the Processing Samples screen changes color to indicate that the vial tray is processed A View Report button becomes available for that vial tray The system continues...

Page 236: ...7 Examples of Processing Complete Screens The batch reports are available for viewing printing or saving to USB device Refer to Batch Reports on page 6 68 for complete details of interpreting a batch...

Page 237: ...sed slides If the slides will not be stained and coverslipped right away put the evaporative covers on the bath containers SMALL BATCH MODE Small batch mode processes sample vials directly from the ca...

Page 238: ...fore the system will begin processing a batch Touch the status indicator on the screen for a brief pop up explanation of what the status means A table of the status indicators is shown below Figure 7...

Page 239: ...ed or directly printed or etched onto the slide but make sure the contrast is sufficient for the scanner to read the label The barcode label must be one of the symbologies supported 1 D Code 128 1 D E...

Page 240: ...rmat used Figure 7 20 Examples of How Barcodes Fit onto a ThinPrep Slide The barcode must have a minimum height of 0 22 inch 5 88 mm and a maximum width no wider than 0 75 inch 19 05 mm Figure 7 21 Ba...

Page 241: ...coverslipping processes and be xylene resistant When adhering the labels be sure to apply them smoothly to the frosted area of the slide with no overhang or air bubbles Labels should be centered side...

Page 242: ...filter by grasping the sides of the cylinder Place it into the position with the membrane end down and the open end up Never touch the filter membrane or the inside of the cylinder Figure 7 24 Load Ca...

Page 243: ...s slides and vials can be loaded in any order that is convenient for loading filters then slides then vials as long as the patient ID labels match up Load the carousel into the processing area Refer t...

Page 244: ...n of Disable Slide ID Match which allows one sample to be run with the vial slide ID match turned off One vial of any sample type may be processed gynecologic non gynecologic or UroCyte A Chain of cus...

Page 245: ...ll doors 5 Press the Advanced button on the main screen 6 Press the Disable Slide ID Match setting button 7 Select the sample type that is to be processed and press the green OK button The display ret...

Page 246: ...sample has been processed the system reverts to Slide ID Match ON To process another sample without the vial slide ID match repeat the steps above Note Only one vial may be loaded into the carousel Pr...

Page 247: ...e adjacent filter and slide slots with the number of desired samples to be made from 2 to 10 3 Load a filled fixative bath with an empty slide rack into the baths compartment 4 Close all doors 5 Press...

Page 248: ...lides and a fixative bath is ready in the bath compartment select the sample processing sequence and press the Start button Figure 7 30 Figure 7 30 Start Batch Button The main door and bath door will...

Page 249: ...progress If a sample error occurs the batch continues but an error indicator is displayed on the batch screen as shown in Figure 7 32 Figure 7 32 Sample Errors During Small Batch Sample Processing Re...

Page 250: ...Completed slides may be unloaded by removing the fixative bath from the baths compartment If the batch will resume a fixative bath with no slides must be loaded Note If the fixative bath is slid out...

Page 251: ...e batch now The Batch Complete screen will display Refer to the next section Processing Complete When a batch has completed processing the processor returns to an idle state with a Processing Complete...

Page 252: ...also be done at a later time using the Reports function in Admin Options When the report screen is exited by pressing the Done button you return to the Batch Complete screen The screen will remain unt...

Page 253: ...CTIONS 7 36 ThinPrep 5000 Processor with AutoLoader Operator s Manual 7 The batch reports are the same as described for AutoLoader on page 6 68 except the carousel positions are listed instead of vial...

Page 254: ...lls may occur but 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 le...

Page 255: ...o 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...

Page 256: ...8 Maintenance 8 Maintenance...

Page 257: ...de cassettes the carousel and dispersion area Clean slide holder pneumatic suction cups at the slide cassette area and the processing area Check and empty the filter waste bin and the slide waste bin...

Page 258: ...y s protocols Clean the fixative bath containers covers and staining racks according to your laboratory s protocols Wipe Down Slide Cassette Before filling a slide cassette wipe down the inside using...

Page 259: ...arts 3 When the screen display says Follow instructions in manual for cleaning open the door s and perform the routine maintenance cleaning tasks Refer to Clean Around Carousel And Dispersion Areas on...

Page 260: ...nd touch the Continue button The instrument resets the mechanisms 5 Press Done to return to the Admin Options screen The Clean System fea ture allows the slide transport arm and the vial filter transp...

Page 261: ...ument mechanisms out of the way See Clean System on page 8 3 Figure 8 3 Carousel Sensors Clean around the dispersion well and the evaporative cover over the fixative bath Figure 8 4 Clean Dispersion W...

Page 262: ...let the suction cups dry 5 10 minutes before attempting to process slides on the instrument One set of slide holders is located on the slide pick arm in the slide cassette area Figure 8 6 Note that t...

Page 263: ...ns The right most cabinet of the AutoLoader is the waste area compartment Open this door to access the filter waste bin and the slide waste bin The liquid waste bottle and the fume extractor are also...

Page 264: ...ally in making sure it is positioned to receive filters from the waste chute directly above it The slide waste bin is in the same compartment to the left of the filter waste bin See Figure 8 8 The liq...

Page 265: ...ThinPrep 5000 Processor with AutoLoader Operator s Manual 8 9 8 MAINTENANCE Figure 8 8 Slide Waste Bin...

Page 266: ...gure 8 10 Or the waste may be emptied during routine maintenance of the instrument The waste bottle is located inside the waste cabinet the door on the right of the AutoLoader cart Figure 8 9 Waste Bo...

Page 267: ...0 Empty Liquid Waste Button and Message The system can be heard to vent which depressurizes the waste bottle It takes about 10 seconds Figure 8 11 Venting the Waste Bottle A message prompts for the op...

Page 268: ...he waste bottle while it is connected to the ThinPrep 5000 processor 6 To remove the waste cap rotate the waste cap with one hand while holding the waste bottle in place with the other hand If the was...

Page 269: ...sent clean the seal with water using a lint free wipe Apply a thin layer of vacuum grease to the O ring Figure 8 14 Inspect Waste Bottle O Ring Seal 10 Return the waste bottle back to its original loc...

Page 270: ...e tubing correctly 1 The waste bottle is located inside the waste cabinet door of the AutoLoader cart If for some reason the waste bottle is relocated outside of the cabinet the waste bottle should be...

Page 271: ...the connectors pop up outward with a click sound The L shaped connector should be pointed downward Yellow vacuum Blue waste No color pressure sensor CAUTION Do not mismatch tubing connections This may...

Page 272: ...the screen may be cleaned without inadvertently activating buttons or having to power off the instrument CLEAN INPUT CAROUSEL AND DUST COVER Input Carousel As needed clean the input carousel by wiping...

Page 273: ...anisms out of the way See Clean System on page 8 3 Replace the pads once a year or as desired The pads can be disposed of as regular waste unless they are dripping wet then dispose of as hazardous was...

Page 274: ...ide the waste cabinet door See Figure 8 20 The instrument will prompt the user if the HEPA filter needs to be changed The carbon filter may be changed on a yearly basis or more often as desired Figure...

Page 275: ...en the Fume Extractor Door Remove the two filters Note that they are labeled HEPA and Carbon and they indicate the direction of air flow See Figure 8 22 Remove each filter The carbon filter may be dis...

Page 276: ...e direction of air flow Figure 8 23 Fume Extractor Filter Labels Replace the filters Close the door to the cabin and return the retaining latch to the closed position From the message screen on the us...

Page 277: ...aning Wash them down with soap and water Allow them to dry thoroughly before returning them to the processor REPLACING THE USER ACCESSIBLE FUSES Processor fuses WARNING Instrument Fusing There are two...

Page 278: ...the metal ends 6 Using the flat head screwdriver press each fuse cover into the receptacle while turning clockwise 1 4 turn The fuse can be felt to engage with the catches and it will be slightly rece...

Page 279: ...wdriver pry the cover near the power cord receptacle open Pry out the fuse holder 4 Pull the two fuses out of the receptacles on the holder They may be discarded as regular waste 5 Insert two new 6 3A...

Page 280: ...er Operator s Manual 8 6 Push the fuse holder back into the AutoLoader Push the cover back into position 7 Reattach the power cord to the AutoLoader 8 Turn the processor power switch on If the instrum...

Page 281: ...r SlideWaste Bins page 8 7 Clean Carousel Dispersion Areas page 8 5 Clean Slide Holders page 8 6 Empty Waste Bottle page 8 1 0 Clean Touch Screen page 8 15 Clean Carousel and Dust Cover page 8 16 Chan...

Page 282: ...MAINTENANCE 8 26 ThinPrep 5000 Processor with AutoLoader Operator s Manual 8 This page intentionally left blank...

Page 283: ...9 Troubleshooting 9 Troubleshooting...

Page 284: ...rors occur when a sample vial is being processed They are sample specific and usually only affect the sample vial being processed A slide is not made and the operator must resolve the event and proces...

Page 285: ...s inadequate follow laboratory procedure for reporting unsatisfactory speci mens Non gyn slides If there is additional sample material available make another slide with more cells if possible 5001 Sam...

Page 286: ...3 Contact Technical Support if the problem persists 5004 Failed to Read Slide ID The slide ID could not be read or is an invalid format The sample was not processed and a slide was not made No slide...

Page 287: ...Per Vial Slide not present in carousel slot Slide leaning out of position in carousel slot Mechanical misalignment or failure of the slide gripper Confirm that a slide is present in the carousel and...

Page 288: ...the same ID as one that has already been processed in the batch The vial with the duplicate ID will not be processed Note In AutoLoader mode 1 vial tray is 1 batch in Small Batch mode 1 carousel is 1...

Page 289: ...ial to make sure it is not leaking Place sample into another vial if it is dam aged Check the fluid level in the vial Add PreservCyt Solution if the level is below the frosted line on the vial Do not...

Page 290: ...ient informa tion with the correct ID Rela bel if necessary Correct the slide ID barcode configuration on the instru ment Refer to Configure slide ID for pre labeled slides on page 6 59 5013 End of Vi...

Page 291: ...ee if it is missing dam aged or printed poorly Replace if necessary refer to Adhering Vial Labels on page 7 4 Make sure a slide is present and is labeled correctly Refer to Adhering Vial Labels on pag...

Page 292: ...formation must be checked and reconciled for both vials In Small Batch mode relabel the second slide and repro cess In AutoLoader mode check and correct the Label Design Correct the slide ID barcode c...

Page 293: ...slide and repro cess In AutoLoader mode check and correct the Label Design Correct the slide ID barcode configuration on the instru ment Refer to Configure Slide ID on page 6 51 5016 Sample Error Dur...

Page 294: ...rom Tray The mechanism failed to remove a vial from the vial tray Too many labels applied to the vial or labels applied such that the vial is stuck in the tray Possible malfunction of the mechanism Re...

Page 295: ...een put there from the user s database Verify the NAS is connected Verify that the file with this information was put there 5201 Failed to Read LIS file AutoLoader mode only Unable to access the LIS f...

Page 296: ...ch to begin If at least one bath is present and this error occurs contact Technical Support 4001 No Vial Detected Multiple Slides per Vial in small batch mode The system did not detect a vial in slot...

Page 297: ...xative bath to see if a slide was deposited into it and if there is a staining rack to hold it Add a staining rack if it is not present Contact Technical Support if a staining rack and slide are prese...

Page 298: ...hnical Support 4010 Bad Fluid Level Multiple Slides per Vial in small batch mode Fluid level is incorrect MSVP mode The system detected that the initial fluid level in the vial was more than the maxim...

Page 299: ...lots Available AutoLoader mode only Vials that have experienced a sample error will be placed into an empty carousel slot for reprocessing reconciliation when the batch is complete The number of sampl...

Page 300: ...o slides present Slides present with missing or damaged label In AutoLoader mode this may be due to laser not functioning properly Mechanical misalignment or failure of the reader If slides are presen...

Page 301: ...n the file The NAS network attached storage is not plugged in The file has not been put there from the user s database Verify the NAS is connected Verify that the file with this information was put th...

Page 302: ...nt cannot fully recover from an error condition the application will transition to restricted mode This allows the operator to access some functions but the system cannot process samples until the err...

Page 303: ...de screen appears contact Technical Support Clear Media For some system errors a Clear Media message dialog may display This prompts the operator to check the mechanisms along the processing path to r...

Page 304: ...to keep it from dropping To remove a filter that is left on the filter plug press the Release Filter button Then gently pull the filter off CAUTION Never forcibly remove a filter from the filter plug...

Page 305: ...trieve the vial if necessary Manually recap the vial See Figure 9 5 Release Slide Note Locate where the slide is before pressing the release button A slide might be located in the slide gripper of the...

Page 306: ...ft It can be retrieved from the waste tray at the bottom of the shaft CAUTION Empty the waste tray when the message appears on the instrument screen display Accumulation of media in the tray can obstr...

Page 307: ...ys the last 100 errors but keeps up to 3 years worth in the system database In most cases the Clear Media dialog box will display Check that the mechanisms are clear and begin a new batch If an error...

Page 308: ...10 Staining and Coverslipping 10 Staining and Coverslipping...

Page 309: ...The ThinPrep 5000 processor with AutoLoader deposits completed slides into a staining rack immersed in a fixative bath that contains 95 reagent alcohol or 95 ethyl alcohol Use the following procedure...

Page 310: ...n 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 res...

Page 311: ...glacial acetic acid 30 seconds with agitation 8 Distilled H2O dH2O 30 seconds with agitation 9 Bluing Reagent 10mg LiCarb 1L 30 seconds with agitation 10 50 Reagent Alcohol 30 seconds with agitation 1...

Page 312: ...ing media to ensure compatibility with ThinPrep slides Hologic also recommends that 24 mm x 40 mm or 24 mm x 50 mm glass coverslips be used Plastic coverslip material used with automated coverslipping...

Page 313: ...11 ThinPrep Pap Test Training Program 11 ThinPrep Pap Test Training Program...

Page 314: ...iew and application of cytology skills and knowledge A systematic approach allows for frequent assessment of an individual s understanding of the ThinPrep characteristics The training program incorpor...

Page 315: ...nterpret ThinPrep Pap test cases and to begin training additional cytotechnologists and pathologists in their laboratory under the supervision of the laboratory Technical Supervisor if needed Particip...

Page 316: ...Service Information Service Information...

Page 317: ...stomer Service Technical Support For technical support contact your local Hologic Technical Solutions office or your local distributor For questions about ThinPrep 5000 processor with AutoLoader issue...

Page 318: ...AutoLoader Operator s Manual 12 Protocol for Returned Goods For returns on warranty covered ThinPrep 5000 processor with AutoLoader accessory and consumable items contact Technical Support Service co...

Page 319: ...Ordering Information Ordering Information...

Page 320: ...p m EST Monday through Friday excluding holidays Customer Service Product orders which include standing orders are placed through Customer Service by phone during business hours Contact your local Hol...

Page 321: ...rack Staining racks case of 10 51873 001 Waste bottle Waste bottle plus cap 70028 001 Input carousel Package of 1 input carousel ASY 11050 Dust cover 1 dust cover for input carousels 71918 001 ThinPr...

Page 322: ...ices 70096 001 500 Cytobrush Spatula Collection Devices 70096 003 ThinPrep Pap Test Kit for use with the ThinPrep Imaging System Materials for 500 ThinPrep Pap Tests Contains 500 Vials of PreservCyt S...

Page 323: ...he ThinPrep Imaging System Contains 500 ThinPrep Pap Test Filters Clear 500 ThinPrep Imaging System Microscope Slides approximately 500 slides 70664 001 Broom Like Collection Devices Kit Contains 500...

Page 324: ...ttle Dispenses approximately 30 mL 50705 001 Non Gyn Filters Blue Box of 100 70205 001 ThinPrep UroCyte System Kit 100 ThinPrep UroCyte Filters Yellow 100 UroCyte microscope slides approximately 100 s...

Page 325: ...ORDERING INFORMATION 13 6 ThinPrep 5000 Processor with AutoLoader Operator s Manual 13 This page intentionally left blank...

Page 326: ...Index Index...

Page 327: ...7 37 ancillary testing 7 37 B barcode label format slide 7 22 vial 7 3 batch complete 6 18 7 18 7 34 batch processing errors 9 13 bath details 6 10 baths pane on main screen 6 10 bloody specimens non...

Page 328: ...etched slides 6 52 replace 6 54 segment 6 53 test settings vial ID 6 50 Configure slide ID 6 51 Configure vial ID 6 46 coverslipping 10 4 Customer Service 12 1 13 1 CytoLyt Solution 3 5 13 5 composit...

Page 329: ...ive bath status 6 11 fixative bath ordering 13 2 fluid specimens collection 5 3 preparation 5 17 FNA specimens collection 5 3 preparation 5 14 fuse 1 13 1 21 8 21 replacing 8 21 fuse ordering 13 2 G g...

Page 330: ...7 14 filters slides vials 7 25 load baths 6 12 slide cassette with slides 7 7 lubricant 4 2 4 5 M main screen during processing 6 16 processor idle 6 3 maintenance schedule 8 25 material safety data s...

Page 331: ...er on self test 1 15 power switch 2 5 PreservCyt Solution 3 1 13 5 antimicrobial properties 3 3 composition 3 1 packaging 3 1 stability 3 2 storage requirements 3 1 process sequences 6 9 processing co...

Page 332: ...ended 2 8 normal 2 7 silence alarm 6 31 slide details 6 7 slide ID duplicate 9 9 invalid 9 5 read error 9 3 9 8 slide ID format 6 38 1 D Barcode 6 39 2 D Barcode 6 39 configure barcodes 6 44 OCR Image...

Page 333: ...23 T Technical Solutions 12 1 Technical Support 12 1 ThinPrep Pap Test 1 3 ThinPrep Pap Test filters 7 2 13 3 ThinPrep Pap Test kit 13 3 time 6 26 touch screen cleaning 8 15 tray processing stop on em...

Page 334: ...th AutoLoader Operator s Manual V vial and slide ID pre match 6 32 vial details 6 9 vial labels 7 4 vials pane on main screen 6 8 voltage 1 13 W Warnings Cautions Notes 1 15 waste bottle 8 10 8 14 was...

Page 335: ...atus bar Vial tray cannot be processed missing or low inventory Full slide cassette or filter tray Partial slide cassette or filter tray Empty slide cassette or filter tray User action prompt Sample t...

Page 336: ...brane or inner surface of the filter Push filter trays fully into the bay to engage the tray present sensor If loading a partially used filter tray load it with the empty positions at the leading edge...

Page 337: ...20 Hologic Inc All rights reserved This guide is designed to be used in conjunction with but not to replace the ThinPrep 5000 Processor Operator s Manual As with all laboratory procedures universal pr...

Page 338: ...l Trays into the Instrument 2021 Hologic Inc All rights reserved This guide is designed to be used in conjunction with but not to replace the ThinPrep 5000 Processor with AutoLoader Operator s Manual...

Page 339: ...e the empty staining rack into empty fixative bath receptacle On the rack the words UP SIDE face the handle of the bath Push the rack down past the point of slight resistance Feel the rack snap into p...

Page 340: ...Dispersion Areas page 8 3 Clean Pneumatic Suction Holders page 8 4 Empty Waste Bottle page 8 6 Clean Touch Screen page 8 10 Clean Carousel and Dust Cover page 8 11 Replace Fume Extractor Filters page...

Page 341: ...he touch screen Checking and emptying material left in the robot arm elevator shaft Cleaning the carousel and the dust cover 2021 Hologic Inc All rights reserved Refer to the ThinPrep 5000 Processor O...

Page 342: ...1 1 ThinPrep 5000 Processor with AutoLoader Change the HEPA Filter English MAN 03931 001 Rev 004 Change the HEPA Filter ThinPrep 5000 Processor with AutoLoader 2021 Hologic Inc All rights reserved Re...

Page 343: ...emaining characters represent additional information about the mechanisms involved and their actions at the time of the error 2020 Hologic Inc All rights reserved This guide is designed to be used in...

Page 344: ...r Media Slides Move the slide handling arm gently toward the middle of the processing area for easier access Check two locations for a slide 1 Slide holder cups 2 Slide gripper fingers Hold the slide...

Page 345: ...Operator s Manual ThinPrep 5000 Processor with AutoLoader...

Page 346: ...Hologic Inc 250 Campus Drive Marlborough MA 01752 USA 1 508 263 2900 www hologic com MAN 07494 002 Rev 003 Hologic BV Da Vincilaan 5 1930 Zaventem Belgium...

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Summary of Contents for ThinPrep 5000

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Hologic ThinPrep 5000, Operator'S Manual, Page: 16 / 346

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Summary of Contents for ThinPrep 5000

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