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14

 

SECTION 1 

INTRODUCTION 

 

1.1 Instrument Overview  

Table 6: Explanation of Symbols 

 

Alternating Current (AC) 

 

Authorized Representative in the European Community

 

 

 

 

Batch Code 

 

 

Biological Hazards (Biological Risks) 

 

 

 

Catalog Number (Model Number) 

 

 

 

 

 

Caution, Consult Accompanying Documents (Attention, see instructions for use) 

 

 

 

CE Mark, product meets the essential requirements designated in Annex I of the 

In Vitro Device Directive (IVDD) 98/79/EC 

 

 

 

 

Consult Instructions For Use 

 

 

Do Not Reuse 

 

 

 

Do not use if package is damaged 

 

 

 

Fragile, Handle with Care 

 

 

 

Fuse 

 

 

 

General Symbol for Recovery, Recyclable 

  

 

In vitro Diagnostic Device (In vitro Diagnostic Medical Device)

 

 

 

Keep away from sunlight (Keep away from heat) 

 

 

Manufacturer 

 

 

 

Waste Electrical and Electronic Equipment 

 
 

Reagent stable after opening for number of months specified 

Содержание AEROSPRAY 7122

Страница 1: ...AEROSPRAY HEMATOLOGY STAT MODEL 7122 Applications Manual SLIDE STAINER CYTOCENTRIFUGE...

Страница 2: ...AEROSPRAY HEMATOLOGY STAT SLIDE STAINER CYTOCENTRIFUGE Model 7122 Applications Manual 57 2000 02C Last Revision 01 08 2021...

Страница 3: ...Cytopro are trademarks of ELITechGroup Inc Other trade names used in this manual are trademarks of their respective owners used here for information only ELITechGroup Inc makes no express or implied...

Страница 4: ...r Interface 21 Table 8 Front Panel Main Screen Function Keys 21 Table 9 System Setup Keys 22 Table 10 Maintenance Function Keys 24 Section 2 Setup and Preparation for Operation 2 1 Instrument Setup 25...

Страница 5: ...de Reader 48 Manually Entering Specimen information 49 Manually Entering Reagent Information 50 3 3 The Help Menu 51 Using Help 51 Section 4 Operating the Stainer 4 1 Operating Instructions 52 Suggest...

Страница 6: ...ormance 6 1 Nozzle Disassembly and Cleaning 68 Nozzle Disassembly 68 Nozzle Cleaning 68 6 2 Nozzle Reassembly 69 6 3 Manual Priming 70 6 4 Performing the Volume Test 71 Table 12 Volume Test Tolerances...

Страница 7: ...o Cytocentrifuge 8 1 Cytopro Cytocentrifuge Information 88 Functional Description 88 Key Features 88 Cytopro Rotor 88 Appendix A Critical Reagent Components 89 Appendix B Risk and Safety Phrases 91 Ap...

Страница 8: ...h the documents shipped with this device NOTE This equipment complies with the emission and immunity requirements described in the IEC 61326 series Understanding Warnings This manual uses three warnin...

Страница 9: ...a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference CAUTION To avoid serious instrument damage always use reagents supplied...

Страница 10: ...e automatic alcohol fixation function to fix specimens Reagent and waste level monitoring Log files 10 Stain Intensity Settings The correct accessory must be used for each function The Cytopro Cytocen...

Страница 11: ...nection Connector on rear panel accepts male connector attached to vinyl drain tube 1 8 meters 6 ft length supplied Ventilation Air is exhausted from the stainer via a female inch SAE pipe thread fitt...

Страница 12: ...ts REF numbers for this stainer start with one of the following SS 035 SS 049 SS 135 SS 149 SS 048 or SS 148 A Rinse B Thiazin Stain Blue C Eosin Stain Red D Methanol or Aerofix Note Methanol must be...

Страница 13: ...ual cycle times may vary Staining Mode Medium Dark Setting 5 Fixation Pump D 0ptional 102 Eosin Stain Pump C 21 Thiazin Stain Pump B 33 Rinse Pump A 27 High Speed Dry 33 Total without fixation in minu...

Страница 14: ...ro Applications Manual RP 517 Rotor Carousel Maximum rpm Maximum Capacity Maximum Sample Volume 12 Slide Carousel AC 188 1000 rpm 12 each 26 mm x 76 mm 1 x 3 inch microscope slides N A Cytopro Cytocen...

Страница 15: ...ns for use CE Mark product meets the essential requirements designated in Annex I of the In Vitro Device Directive IVDD 98 79 EC Consult Instructions For Use Do Not Reuse Do not use if package is dama...

Страница 16: ...emperature Limitation indicates high and low limits Normal room temperatures are specified for all ELITechGroup Reagents Use By Volume Control General Warning Caution Risk of Danger Warning Biological...

Страница 17: ...ure 1 Front and Right Side Panels 1 Front Panel with Touch Screen Display 2 Bowl 3 Carousel 4 Lid with Safety Lock 5 Right Side Panel with Label Indicating Reagent Positions A Rinse B Thiazin C Eosin...

Страница 18: ...er to Front Panel Main Screen Function Keys Section 1 3 Table 8 for more information Figure 3 Rear Panel 1 USB Ports 2 Network Ethernet Connection 3 Exhaust Vent 4 Rear Panel Label 5 Biohazard Warning...

Страница 19: ...ption Figure 4 Stainer Bowl Components 1 Nozzle D Methanol or Aerofix 2 Nozzle C Eosin stain 3 Nozzle B Thiazin stain 4 Nozzle A Rinse 5 Drive Hub Figure 5 Nozzle Diagram 1 Compression Screw 2 Swirl C...

Страница 20: ...mps Silicon Grease Lubricates the nozzle threads for easy assembly Nozzle Wire Cleans nozzle housing orifices Nozzle Cleaning Strainer Strains the nozzle parts to prevent them from going down a drain...

Страница 21: ...cts reagents while performing the Volume Test Nozzle Maintenance Tube Stand Holds Nozzle Cleaning Tubes large tube and Volume Test Tubes small tube Nozzle Cleaning Tubes large tube For soaking nozzles...

Страница 22: ...ne priming Pattern Test Volume Test and B Line Flush functions Clean Performs the Clean cycle Cyto Enters the Cytocentrifuge mode System Information Shows the system information including serial numbe...

Страница 23: ...to create edit and delete stain programs Cyto Programs Allows users to create edit and delete cytocentrifuge programs Reagents Allows users to edit reagent information Users Allows users to create and...

Страница 24: ...ogramming mode for creating staining and cytocentrifuge programs Also allows the system administrator to authorize new users Allows manual entry of slide or specimen information Delete Erase Remove De...

Страница 25: ...s are clear of debris and spraying properly Volume Test Performs Volume Test to verify the selected nozzle volume is within the correct range 60 Sec Prime Runs the pumps for 1 minute and primes the li...

Страница 26: ...boxes match the packing lists for the instrument and accessories 3 Open the instrument lid and remove the cardboard tube that protects the hub NOTE Keep the box and packaging material to repack the in...

Страница 27: ...t the drain tube to the waste container If using a waste bottle with level detect REF AC 182 4 Connect the waste monitoring cable to the rear panel receptacle 5 Connect the waste monitoring cable to t...

Страница 28: ...shown at left 1 Place each 500 mL reagent bottle in the correct position A Rinse B Thiazin Stain C Eosin Stain D Methanol NOTE See Appendix A for complete identification of all reagents used in this...

Страница 29: ...odes This allows easy reagent and specimen information tracking If a barcode reader is not installed reagent and specimen information can be entered manually Section 3 2 Installing the Barcode Reader...

Страница 30: ...return it to the original position during reassembly 3 Place a carousel on the stainer hub to prevent stain from entering the motor shaft CAUTION Fluid from priming can flood and damage the motor if t...

Страница 31: ...me all lines at the same time press ABCD The pumps will run for 1 minute and prime all the lines Follow instructions on the screen NOTE To prime individual lines press the appropriate individual prime...

Страница 32: ...l loaded with specimens in the instrument for a clean cycle including placing the instrument in standby mode Specimens will be damaged if they contact reagents sprayed from the nozzles when you press...

Страница 33: ...E The instrument must be installed on a flat level surface for accurate reagent monitoring CAUTION This system is designed to warn you when the reagent level is getting low The instrument will continu...

Страница 34: ...level detect is not reporting correctly If zeroing does not correct the problem recalibrate the Level Detect function Section 7 3 1 Press Information 2 Press System Setup 3 Press Level Detect to ente...

Страница 35: ...Start NOTE Vibrations or bumps to the instrument or lab bench can cause inaccuracies in zeroing or calibration 6 After zeroing press OK Press the Back button to exit to the System Setup menu 7 Return...

Страница 36: ...ging beeper settings Setting the date and time Restoring default settings Accessing the System Setup Menu 1 Press System Information from the Main menu 2 Press System Setup Stain Programs Stain Progra...

Страница 37: ...and enter the desired name on the keypad 4 Press Enter on the keypad The display returns to the Stain Programming Menu 5 Select Intensity From the Stain Programming Menu Select the desired stain inten...

Страница 38: ...tor account and multiple up to 50 user accounts The Administrator controls access to the system by adding and editing user accounts Users cannot edit System Settings unless permitted by the Administra...

Страница 39: ...r Accounts Note This function is available only if an administrator account has been created 1 Press System Setup 2 Enter the Administrator password 3 Press Enter 4 Press Users to reveal the Manage Us...

Страница 40: ...with user selectable time options See User Login Logout below Enable Run Login requires the current user to enter a password to run a Stain or Cytocentrifuge cycle Global Login must be enabled to use...

Страница 41: ...Enter the correct passcode for the selected user and press Enter 4 Once Login is complete the display advances to the Main screen and the instrument is ready for programming and staining A Logout butt...

Страница 42: ...ent 6 Scan the reagent bottle barcodes Section 3 2 or manually enter the reagent information in the correct fields 7 Press Save for each reagent Modifying Level Detect Functions The Level Detect funct...

Страница 43: ...e 1 From System Setup press Set Date Time 2 Select 12 for a 12 hour clock or 24 for a 24 hour clock 3 Use the up and down arrows to modify the time and date 4 Press Save System Log The instrument reco...

Страница 44: ...into the right USB port 3 Press Export NOTE The log files are exported to the Flash Drive as a CSV file that can be used in spreadsheet software programs Controlling Beeper Alerts 1 From System Setup...

Страница 45: ...able Stain Slide Tracking 3 Press Back twice to return to the main screen Verify that the Start Button on the main screen reads Load Slides NOTE Selecting Enable Stain Slide Tracking changes the Start...

Страница 46: ...ypad limited to 24 characters Enable Preventive Maintenance Tracking To activate the tracking prompts for Preventive Maintenance Tracking use the following steps 1 From System Setup select QC Maintena...

Страница 47: ...System Settings will delete all user names and passwords Restoring Stain Settings will delete all stain programs and restore the default programs Restoring Cytocentrifuge Settings will delete all cyt...

Страница 48: ...Stain Slide Tracking changes the Start button on the Main menu to Load Slides 3 Press Back twice to return to the Main menu 4 Press Load Slides on the Main menu The Scan and Load Slides menu will appe...

Страница 49: ...select QC Maintenance Tracking 2 Select Enable Reagent Tracking for each desired reagent A B C D 3 Press Back to return to the System Setup menu 4 Press Reagents to reveal the Reagent Information scr...

Страница 50: ...nu where you can scan or manually enter reagent information by pressing Change Manually Entering Specimen Information With Stain Slide Tracking and Manual Entry enabled in the QC Maintenance menu 1 Pr...

Страница 51: ...ation 1 Press Reagents from the System Setup menu or press the reagent status icon on the Main menu to reveal the Reagent Information menu 2 Select the desired reagent and press Change 3 Select the de...

Страница 52: ...jects Help Screens Basic Operation Loading the Carousel Programming Number of Slides Select Intensity Setting Correct Reagents and Locations Selecting a Staining Program Touchscreen Calibrating the To...

Страница 53: ...enabled enter the number of slides on the Main menu Perform a stain cycle Unload the carousel Performing a Hub Pattern Test Use the Hub Pattern Test to ensure the nozzles are clear of debris and spra...

Страница 54: ...re is no guarantee of staining performance when dissimilar specimens are used 1 Remove the carousel from the bowl and place it on a solid level surface 2 Remove the carousel lid by pressing the button...

Страница 55: ...rst slide in position 1 the second in position 2 and so on NOTE A warning will sound during the staining cycle if the carousel is unbalanced Figure 9 Loading the Carousel Figure 10 Specimen Placement...

Страница 56: ...en slides and close the instrument lid 2 If you have not enabled Slide Tracking select the number of slides to be stained Slide selection defaults to full carousel at the end of the run after pressing...

Страница 57: ...ogy stained can be stained with the Hematology Stat Stainer Adjust stain settings to maximize staining quality for each specimen type see Section 3 1 4 Press Start The display shows the progress of th...

Страница 58: ...d to the actual level in the bottles Never allow a reagent to run dry When the reagent level is near empty replace the reagent bottle with a new one see below Never allow the waste container level to...

Страница 59: ...ong term storage 3 Open the Reagent Information menu by pressing the reagent bottle icon on the right side of the Main menu 4 Select the desired reagent and press Change 5 If you are using reagent tra...

Страница 60: ...the nozzle openings 5 At the end of the day Place an empty carousel in the bowl and close the lid Press Standby Ready on the front panel and wait until the end of the automatic cleaning process Spray...

Страница 61: ...ve Maintenance Tracking enabled the PM Log provides a convenient and structured means of recording important maintenance and QC functions The system allows you to set up timely prompts that require re...

Страница 62: ...dip tube from the bottles 3 Place the end of the dip tube in a bottle of methanol 4 Flush at least 250 mL of methanol through each reagent line by priming all lines simultaneously Leave the alcohol i...

Страница 63: ...wer OFF the instrument 2 Disconnect the power cord from the power outlet and the rear panel of the instrument 3 Open the fuse cover by inserting a screwdriver in the slot on the right side of the cove...

Страница 64: ...quipment WARNING If potentially infectious liquid is spilled on the instrument the instrument must be disinfected in accordance with all applicable local regulations Refer to Decontaminating the Stain...

Страница 65: ...including gloves and eye protection when handling reagents WARNING Authorized and trained personnel wearing appropriate protection equipment should perform the decontamination procedure in a well vent...

Страница 66: ...instrument in a biological safety hood or well ventilated area 4 Spray the inner bowl and inner lid with a decontaminating solution such as REF SS 133 5 Repeat the spray treatment every 2 or 3 minute...

Страница 67: ...ll decontamination solution 10 Immerse or generously spray the carousel and lid with decontaminating solution Allow the solution to react for 20 minutes 11 Thoroughly rinse the carousel and lid with d...

Страница 68: ...amination performed by ELITechGroup CAUTION Ship the instrument or carousels in containers comparable to the original packaging Hazard Free Certification The operating authority must print and complet...

Страница 69: ...ozzle Diagram in Section 1 3 If you will be storing the nozzle parts in Nozzle Cleaning solution longer than one hour remove the o ring 4 Place the nozzle parts minus the o ring if required in a 50 mL...

Страница 70: ...bricant REF AC 103 to the compression screw threads 7 Reassemble the nozzle by placing the compression screw on the nozzle disassembly tool then inserting the swirl cone into the compression screw NOT...

Страница 71: ...Press Maintenance from the Main menu 6 Press Volume Test 7 Press the desired prime button to start the reagent pump 8 Run the reagent into the tube until the fluid is free of bubbles then press Stop W...

Страница 72: ...rough 5 for each nozzle 7 Compare collected nozzle volumes with the following table Table 12 Volume Test Tolerances Nozzle Reagent Line Minimum Maximum A B C 9 0 mL 11 0 mL D 8 5 mL 10 5 mL NOTE The s...

Страница 73: ...Volume Test 8 Prepare the Maintenance Kit for future use Empty the contents of the tubes into the stainer bowl Rinse the tubes with water Put the tubes back into their original place in the Maintenan...

Страница 74: ...nt of positions 1 and 2 2 Load the carousel into the stainer and close the lid 3 From the Main menu press Maintenance 4 Press Pattern Test 5 Press the corresponding prime button for the reagent line t...

Страница 75: ...uges refrigerators air conditioners or other motorized equipment If the above steps do not solve the problem consult the Aerospray Service Manual or contact your dealer or ELITechGroup for assistance...

Страница 76: ...e carousel is properly loaded on the drive hub In staining mode the instrument detects whether the staining carousel is present before proceeding In cytocentrifuge mode the instrument will stop if it...

Страница 77: ...carousel position sensor Consult the Aerospray Service Manual or contact your dealer or ELITechGroup for assistance If the cycle continues this indicates an electronic problem see below Abnormal stai...

Страница 78: ...load the slides in the correct positions as indicated by the markings on the carousel see Section 4 1 Verify that each reagent pump is primed by opening the lid and pressing the corresponding prime b...

Страница 79: ...ng to a fresh bottle of stain While transferring remaining stain saves stain it eventually concentrates the precipitates to the point they appear on the slide Staining intensity is too weak Granulatio...

Страница 80: ...the instrument 2 If the problem recurs install a computer type surge protector to isolate the instrument 3 If possible connect the stainer to a power circuit not shared by centrifuges refrigerators ai...

Страница 81: ...the thicker regions while the thinner monolayered regions remain usable Severe tearing that starts in the thick region may also extend into the monolayer Dirty Slides Dirty slides are a major source...

Страница 82: ...dry for 2 to 3 minutes before staining Wipe Carousel Chamber Dry Between cycles leave the stainer lid open to dry out the bowl If necessary wipe the interior of the carousel chamber dry to reduce the...

Страница 83: ...et sit for 20 minutes 3 Flush each affected reagent line with 150 mL of deionized water 4 Reprime the stainer with fresh reagents see Section 2 2 and clean nozzles according to instructions in Section...

Страница 84: ...rument may require service Contact your dealer or ELITechGroup for assistance A reagent line leak between the pump outlet and the nozzle will cause fluid to leak into the interior of the stainer housi...

Страница 85: ...Unstable If movement was detected on bottles while calibrating zeroing the display shows an error message NOTE While zeroing or calibrating do not bump the instrument or lab bench Ensure that no near...

Страница 86: ...in place 500 mL bottles of reagent placed in the correct tray positions due to different densities of each reagent type 6 Place the correct reagent bottles in all enabled positions and press Start NOT...

Страница 87: ...appears 2 Press the center of the target with a finger stylus or similar tool Another target will appear in a different location 3 Continue to press the center of the targets until you have pressed a...

Страница 88: ...dealers offer full local service and support ELITechGroup Inc 370 West 1700 South Logan Utah 84321 8212 USA Telephone 800 453 2725 United States Canada 1 435 752 6011 International calls Fax 1 435 75...

Страница 89: ...Single Dual and Cytopro Magnum chambers Reusable or disposable chambers single and dual Eight slides and chambers User programmable memory locations for settings speed acceleration rate and time Easy...

Страница 90: ...de 0 1 Tergitol TMN 100X SS 048 or SS 148 as diluted SS 148 EU Aerofix Fixative High Humidity contains 95 Methyl Alcohol 4 Ethylene Glycol 2 Polyvinylpyrrolidone PVP 1 Azure B SS 049A SS 049A EU or SS...

Страница 91: ...tains 55 70 Ethylene Glycol 30 45 Polyvinylpyrrolidone PVP 1 Azure B SS 148 or SS 148 EU Aerofix Fixative Concentrate High Humidity contains 40 50 Methyl Alcohol 1 5 Oxalic Acid SS 029C Nozzle Cleanin...

Страница 92: ...ionary statements The associated Signal word is Danger H225 Highly flammable liquid and vapor H301 H311 H331 Toxic if swallowed in contact with skin or if inhaled H370 Causes damage to organs P210 Kee...

Страница 93: ...hot surfaces sparks open flames and other ignition sources No smoking P309 P311 If exposed or if you feel unwell Call a POISON CENTER or doctor physician P304 P340 IF INHALED Remove person to fresh ai...

Страница 94: ...vapors spray mist fume P280 Wear protective gloves eye protection protective clothing P302 P352 IF ON SKIN Wash with plenty of water SS 103 O ring Nozzle Thread Grease is associated with no Hazard an...

Страница 95: ...ses serious eye irritation H314 Causes severe burns and eye damage P280 Wear protective gloves protective clothing eye protection P303 P361 P353 IF ON SKIN or hair Take off immediately all contaminate...

Страница 96: ...S 135 149C SYSTEM Surfactant used with SS 135 A B C SS 135S Reagent D Aerofix Fixative High Humidity 500 mL SS 048 Aerofix Additive for Reagent D Methanol 135 mL SS 148 or SS 148 EU Reagent A Basofix...

Страница 97: ...ELITechGroup Inc 370 West 1700 South Logan Utah 84321 8212 USA 800 453 2725 1 435 752 6011 WWW ELITECHGROUP COM...

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