Procedure Manual-English
Contents
1. Slip the FastPack IP into the external printer from the left side with the label side up and the label facing towards the rear of the external printer Printer will print and release the FastPack IP automatically It is important to insert the FastPack IP from the left side of the printer to avoid tangling or twisting the printer ribbon Remove the FastPack IP from the left side of the external printer It is important to remove the FastPack IP from the left side of the printer to avoid tangling or twisting the printer ribbon Find the result printed on the FastPack IP peel off label Control Result Units Date of Test Instrument Serial 26 All the necessary information for Quality Control is now included on the peel off label FastPack IP Label after Printing FastPack IP Expiration Lot Number Date EXP 2016 06 21 0802027 7 1 8 ng ml 10 05 15 0207 Patient ifl nu Pazlente Paciente Lot Control Date of Instrument Operator Result Test Serial Initials 65000159 Rev 007 06 15 Action Match each control lot number from the Control Range Card with the lot number on the control vials If each of these lot numbers match then verify that the result printed on the FastPack IP is within range for the appropriate control Instrument Control Testing Procedure Information If a control is outside of the acceptable range repe2. 65000159 Rev 007 06 15 Action Instrument Procezsing AA remaining Control Testing Procedure Illustra Information The screen will display test status and time remaining XX REMAINING om When test is complete analyzer will beep Example B mgsml iezh ie Lr or Sel rege ml ziii ii 13 00 The analyzer will provide the test result on the display The result will remain displayed for one minute after the door is opened or until another test is run When a new test is run the previous test result is erased from the analyzer memory and display 24 ng ml 06 21716 1 00PM Open the analyzer door 65000159 Rev 007 06 15 Inzert FasiPack IF in Printer Analyzer will start beeping and display Insert FastPack in Printer until result is printed 25 Control Testing Procedure Action Remove and inspect the FastPack IP Check the inside of the Analyzer door for fluid If there is fluid on the FastPack IP or Analyzer disregard the result and properly dispose of the pack Implement the cleaning procedure Instrument Information Ensure that all chambers have burst Fluid should easily flow between all chambers Observe that most of the fluid in the FastPack IP is yellow If there is no yellow fluid disregard the result and rerun FastPack IP Illustration
3. thm ddl uu and time digit with the RED bittor hh mm xi If English 2 or a European language has been chosen date is in Day Month Year format and time is in 24 hour format If English 1 is Sr chosen date is in Month Day Year format and time is in 12 hour format See Troubleshooting if a date or time error occurs Approve each date time digit and move ahead to demme ug the next digit by pressing Hmm the BLUE button Setting Analyzer for External Printer Use If the display shows COM1 Computer the system is already configured for an external printer Selecting this choice vvill change it to be configured for output to an external computer Scroll to COM1 Printer by pressing the RED button L hi Printer on the analyzer 65000159 Rev 007 06 15 7 FastPack IP System Set Up Action Press the BLUE button to select the COM1 Printer menu option Instrument C rli Frinter Information Illustration Scroll to Exit by pressing the RED button Exit Select EXIT by pressing the BLUE button Connecting the External Printer Attach small ferrite core to the large end of the Serial Printer Cable The ferrite core is found in the packaging of the Printer Further instruction and illustration can be found in the External Printer User s Manual Note External Printer User s Manual indicates the use
4. FastPackp System PROCEDURE MANUAL Qualigen Table of Contents ES V FastSteps for Vitamin Du es ans s vil Welcome oo e ERR I aa T 1 What the FastPack IP System 065 1 About This Manual enr REN 1 RENATA E M M 2 Electrical nanenane M 2 Nemko Mark Label lagen ir ER EYE EE ree e seg ace 2 Other Symbols 5 cete ee e get Dis De ee ette aent 2 Biomedical Fabel sic entornos e e r s b y DARE iso 2 Attention Labeli onien a a NE ER n EHE RE 2 CE Mark Label soli a 2 IVD Label ann essen en initiieren r re 2 Setting Up the FastPack IP System usnasnvoenvevnvevnrrvnrnrnrernesnnesnnrsnnnssnesnnesenennnsnennevnsnvnssvnssnnssnnssnnessnessenssnssnnsee 3 What iis Ineluded 0 22 222 NR IE ao eae eE o Eor OOE 3 FastP cke IP System Set Up iie eee i e EO EE AR R tee eb SUP A ETE ER ie Vei irae eus 3 Unpacking the FastPack Pye 3 Getting Power to the FastPack IP System 4 Turning ON the System Analyzer ssrranennnrnnnrnvnrnnnrnenrnnnnsnensnnnsnenenevenenensesnensnrssnrssnnesnnesnnesnensnsnsnsnee 4 Nass e E 5 Fang age
5. 1 Write the Patient s Name ID and the operator s initials on the FastPack IP label 29 All samples must be pretreated by diluting 1 3 with FastPack Vitamin D Pretreatment Buffer 1 part sample 2 parts pretreatment buffer Eject sample into the tube pre loaded with 200 uL Pretreatment Buffer by pressing down on the pipette plunger to the first stop Replace the screw cap tightly onto the buffer tube Tip is fully seated A Tip is 5 visible 13 Be certain not to unseat the pipette tip from the injection port The tip acts as a plug to seal the sample in the FastPack IP If you observe a leak properly dispose of the pack and begin the procedure with a new FastPack IP 2 Press and hold the pipette plunger down completely so that the metal grippers are extended and open as shown in Figure 1 DN 8 Invert the buffer tube at least 3 times to thoroughly mix together the sample and buffer The act of mixing the sample and buffer releases the vitamin D present therefore making it available for the assay 14 Place the FastPack IP on the door of the analyzer Align the pins on the door with the holes in the FastPack IP Close the analyzer door 3 While holding the plunger down firmly press the pipette into the pipette tip until it snaps in place then release the plunger 9 Withdraw the sample from the pre treatment buffer tube using the sa
6. IP System Procedure Action Verify that the analyzer is in Ready mode Instrument Ready Information Remove the FastPack IP from its box Check to make sure it is the correct test type Ensure there are no external fluid leaks or any burst chambers on the FastPack IP Always keep FastPacks stored in the refrigerator in the upright position indicated on the box at 2 8 C 36 46 F prior to use FastPacks can be taken directly from the refrigerator and used in the analyzer Write the Patient s Name ID and the operator s initials on the peel off FastPack IP label This information is important for quality control Closely follow FastSteps 2 through 5 from your FastSteps Guide 48 Use only Qualigen recommended pipette tips The tips are available through your local distributor or Qualigen Be sure that the pipette operates smoothly and does not stick It is very important that the tip is properly seated on the pipette If it is not there is a high likely hood of short sampling which will directly affect patient results 65000159 Rev 007 06 15 Action Closely follow FastSteps 6 through 10 from your FastSteps Guide STOP The Following two steps are for FastPack IP Vitamin D Eject the sample into the pre treatment buffer tube by pressing down on the pipette plunger to the first stop Replace the screw
7. IP System Set Up Information This mode is not accessible when a test is in progress Illustration button Units Press the BLUE button to select the Languages Units menu category The analyzer allows the selection from nine English 1 languages and units English Z English 1 Espanol English 2 Scroll through the Portugues Spanish language options by Italiano repeatedly pressing the GE m Portuguese SITZT RED button Bunt Italian Francais Heder lands German Suedizh French Dutch Svvedish 65000159 Rev 007 06 15 FastPack IP System Set Up Action Select your language by pressing the BLUE button Setting Date and Scroll to Date Time by pressing the RED button Time Instrument HatesTime Information Testosterone units will display as ng dL when English 1 is selected Illustration Press the BLUE button to select Date Time menu category If date is correct press the BLUE button to accept this date ame dd yy The analyzer has an internal clock that allows it to print the date for each test result To maintain optimum quality control it is important this is set correctly 65000159 Rev 007 06 15 FastPack IP System Set Up Action Instrument Information Illustration If date is incorrect press RED button to change this date Scroll to the correct date
8. cap tightly onto the buffer tube Instrument FastPack IP System Procedure Information Use serum plasma calibrators or controls only Always wear gloves when handling samples It is very important that the pipette tip is firmly placed in the injection port If any sample leaking is detected immediately dispose of the FastPack IP and begin again with a new FastPack IP and sample Each patient sample calibrator or control must be thoroughly mixed with the FastPack Pre treatment buffer before running a FastPack IP Vitamin D assay Illustration Users Only 65000159 Rev 007 06 15 Invert the buffer tube at least 3 times to thoroughly mix together the sample and buffer The act of mixing the sample and buffer releases the vitamin D present therefore making it available for the assay Follow the FastSteps for Vitamin D Guide steps 9 and 10 to complete sample delivery to the FastPack IP 2 8 49 FastPack IP System Procedure Running Patient Samples Continued Action Instrument Information Illustration Open the FastPack IP analyzer door Place FastPack IP on the door Align the pins on the door with the holes in the FastPack IP It is only possible to align the FastPack IP inone direction Close the analyzer door If the door is not closed the analyzer will not run Press the BLUE button 50 Ready The
9. Units aske ude eine 5 Setting Date nd Time bola R R SARS a a YR voles etta EYE ENS PE e ele dde 6 Setting Analyzer for External Printer 1 5 7 Connecting the External Printer eese on onen 8 Calibrating the FastPack IP System eese on o nn 11 When to Calibrate E os 11 What You Need etse e ERO soiuda stent tages vecessestt nia 11 Calibration davor edic TN 12 FastPack IP Vitamin D Users ONLY Sample Pretreatment 14 A Word about 19 Purpose ss R E E E EE E ASEARA 19 Gener l Proceduren au tirer RO i ee MES 19 Preparing a FastPack IP with a Calibrator Sample eese eene 19 Preparing to Calibrate your Analyzer eronnnrnononenonenenrrnnrsnnrennrenrrnnrrnsrrnsnensnensnensnesenessnesenesnnesnnsennr 19 Running the Calibrator FastPack IP 19 When is Calibration Required isione eoira aiaee ainan Ea ara AE A EE E E 19 1 When Attempting to Use New Lots of FastPacks or Calibrators 19 2 When it s Time to Recalibrate 19
10. a light tight seal around the pack during the test process The FastPack IP System analyzer performs a comprehensive self diagnostic test each night at 12 00 am The same test is performed when Run Diagnostic is selected in the set up menu Throughout testing the analyzer monitors temperature air pressure background light system power and force profiles of seal ruptures and clamps Limitation of Procedure Please read the information packaged in the FastPack IP Reagent Kit regarding up to date product specifications and limitations Warranty For U S Only Qualigen FastPack IP System Limited 1 year Warranty Qualigen warrants to the original purchaser that the FastPack IP System will be free from defects in materials and workmanship for a period of one year from the date of purchase Qualigen s liability for all matters arising under this warranty shall be limited solely to the repair or in Qualigen s sole discretion replacement of the product If Qualigen reasonably determines that a repair or replacement is covered by this warranty Qualigen shall bear the cost of shipping the repaired or replacement product to the customer Risk of loss or damage during shipments under this warranty shall be the responsibility of the party shipping the product If product shipped to Qualigen under this warranty is not suitably packaged for shipment any physical damage present to the product on receipt by Qualigen and not previously rep
11. and write CAL 1 or CAL 2 or CAL 3 for the Vitamin D assay and the operator s initials on the peel off label 2 Gently invert the calibrator vial several times before drawing a sample from it Inverting this vial should be done each time you draw a sample 3 Filla FastPack IP with the calibrator sample following the instructions found in your FastSteps guide Preparing to Calibrate your Analyzer 1 Takethe calibration card from the calibration kit 2 Placethe calibrator card in your analyzer by aligning the holes in the card with the pins in the analyzer door Press the BLUE button The analyzer will read the calibration card information 30 sec Cu Re 09 The analyzer should read Insert Cal Press Start 6 Remove the calibration card Running the Calibrator FastPack IP 1 Place the calibrator filled FastPack IP into the analyzer and push the BLUE button 2 The analyzer will process this pack and when complete will display Cal X Pass 3 Remove the processed FastPack IP from the analyzer and place in the printer 4 Placethe printed label onto the Label Record in the appropriate assay section of your Quality Assurance Log 5 Repeatthe Calibration Procedure The analyzer will display an alert when calibration is required See the Calibration Process Tree on Page 20 which illustrates the messages shown on the analyzer display 6 Placethe calibration card back into the Calibration Kit for storage When
12. door will lock and the analyzer will run the test All the test information is read by the analyzer from the bar code on the FastPack IP label Refer to the Troubleshooting section if an error message is displayed 65000159 Rev 007 06 15 Action Instrument Processing AR min remain FastPack IP System Procedure Information The screen will display test status and time remaining Press the Cancel button if test needs to be stopped in an emergency Illustra PROCESSING XX REMAINING When test is complete analyzer will beep The analyzer will provide the test result on the display Example Sel rage ml d XA LIP or ut l ngz4mL za in iE RII The result will remain displayed for one minute after the door is opened or until another test is run When a new test is run the previous test result is erased from the analyzer memory and display 2 1 ng ml 05 25 08 1 00PM Open the analyzer door 65000159 Rev 007 06 15 Inzert FasiPack in Printer The analyzer will start beeping and display Insert FastPack in Printer until result is printed 51 FastPack IP System Procedure Action Remove and inspect the FastPack IP Check the inside of the analyzer door for fluid If there is fluid on the FastPack IP or the analyzer disregard the
13. is not completely closed Close Door Tate Error A date that is not possible has been entered Re enter correct date Hoor Failure Bar code window installed incorrectly Door latch has failed Remove the bar code window Verify that edges of silicone shield are flush with back plate Contact System Support Expired Pack 65000159 Rev 007 06 15 FastPack IP has passed expiration date or system date is incorrect Verify system date is correct f correct obtain new lot of FastPack IP 57 Troubleshooting the FastPack IP System Display Unable to Read Barcode Cause Bar code label is illegible Reader non functional Action Check to see if bar code is defaced Reposition barcode label approx inch lower and re try e If Plexiglas barcode window is present use a standard flat head screwdriver to remove the window and re try inualid Label Hnkran Test Wrong test type pack Correct software version not installed Z22222244222222 Verify that FastPack IP and Calibrator card are of the same test type Contact System Support Restricted test type due io temp Operator attempted to run a FastPack test that is incompatible with the temperature of the analyzer Attempt to run the FastPack on an analyzer that is temperature compatible Missing Pack There is no pack in t
14. of FastPack IP tests please refer to the current direction insert posted on the Qualigen Inc website at www qualigeninc com If you have questions or concerns about the FastPack IP System please contact your local distributor or call Qualigen Inc Toll Free 1 877 770 6127 What the FastPack IP System Does The FastPack IP System performs immunoassays on serum and plasma samples Refer to the Principle of Operation for a detailed description Immunoassay tests help physicians diagnose and monitor a range of disease states About This Manual Action Instrument Information Illustration This column provides This column represents This column shows what F our action the analyzer displays additicnalinftormatign y y about the action This is the Ready Mode of the instrument i e the Press the BLUE button Ready analyzer is ready to perform a test 65000159 Rev 007 06 15 1 Safety Features Electrical The FastPack IP Analyzer must be connected to a properly grounded outlet Nemko us Electrical Safety UL 61010 1 Other Symbols Nemko Mark Label The application of the Nemko mark denotes that the FastPack IP System meets all requirements for electrical safety and is approved for use in the field All symbols discussed on this page can be found on the inside door plate of the FastPack IP Analyzer Sm B Biomedical Label This sym
15. rateur Beciene Operatore Operador Operario JOHN DOE JKL FastPack PSAPV Test Po Name Type Initials Patient Date 65000159 Rev 007 06 15 Action Peel off the label and place it in the patient record Instrument FastPack IP System Procedure Information Illustration Discard the FastPack IP into a Biohazard container 65000159 Rev 007 06 15 53 54 65000159 Rev 007 06 15 Cleaning the FastPack IP System Note Always wear protective gloves when cleaning or disinfecting the analyzer The FastPack IP System analyzer is completely self enclosed and only requires periodic cleaning to remove excess sample Use a damp cloth to wipe down the entire exterior and interior compartment of the analyzer Do not use solvents to wipe down the exterior of the analyzer If a FastPack IP has leaked inside the FastPack IP analyzer perform the following cleaning procedure FastPack IP System Cleaning Procedure Action Illustration Wipe the inside of the door panel with a soft cloth soaked with a mild disinfectant or any hospital grade disinfectant to remove any potential contaminant that may impact performance of the analyzer Note Do not press too hard as the silicone membrane can be torn with excessive force Wipe the membrane side of the analyzer chamber with a mild disinfectant to eliminate any potential active chemiluminescence chemicals that may i
16. result and properly dispose of the pack Implement the cleaning procedure Instrument Information Confirm that all chambers have burst Fluid should easily flow between all chambers Observe that most of the fluid in the FastPack IP is yellow If there is no yellow fluid disregard the result and rerun a new FastPack IP Illustration Slip the FastPack IP into the external printer from the LEFT SIDE with the label side up and the label facing towards the rear of the external printer Be sure that the edge of the FastPack IP goes to the far edge of the external printer The printer will print and release the FastPack IP automatically It is important to insert the FastPack from the left side of the printer to avoid tangling or twisting the printer ribbon Remove the FastPack IP from the LEFT SIDE of the external printer It is important to remove the FastPack IP from the left side of the printer to avoid tangling or twisting the printer ribbon Find the result printed on the FastPack IP peel off label Patient Result Units Date of Test Instrument Serial 4 52 All the necessary information for Quality Control is now included on the peel off label FastPack IP label after Printing Result FastPack IP Expiration Instrument Lot Number Date Serial Number 0802027 7 amp EXP 2016 06 21 1 2 ng ml 10 05 15 0207 Patien Patl ntPazlente Packente Operator Bedlener Op
17. 011 USA For Technical Support P 877 770 6127 F 760 579 6900 systemsupport qualigeninc com Qualigen www qualigeninc com 65000159 Rev 007 06 15 vii Figure 1 Metal tip in pipette extended to Figure 2 IMPROPERLY vs PROPERLY seated grip the pipette piston pipette tip on the pipette Figure 3 Inserting the filled pipette tip into the injection port Figure 4 Pipette tip properly Figure 5 Pipette tip seated into the improperly seated injection port into the injection port FastSteps Vit D M061 001 viii 65000159 Rev 007 06 15 Welcome The FastPack IP System provides lab quality immunoassay performance in a design ideal for the physician s office or small laboratory The small system utilizes advanced technology to provide an immediate result yet it is very simple to use The FastPack IP System includes the FastPack IP Analyzer and External Printer The FastPack IP System requires a disposable single use FastPack IP for each test The operator simply loads the sample into the FastPack IP places the FastPack IP in the Analyzer and presses the start button When the test is complete the Analyzer displays the result The FastPack IP System is for in vitro diagnostic use only This manual contains all of the information needed to operate and care for the FastPack IP System Please read this entire manual before you operating For information on the performance
18. 06 15 Control Testing When to Control Test Control testing ensures that you are running the test correctly and that your FastPack IP System is working properly When control testing is performed two control levels must be used Qualigen recommends that users run controls whenever Patient testing is performed A calibration is performed Repair maintenance is performed Improper storage or handling of FastPacks is suspected Questionable patient results are obtained Users should follow proper state and federal quality control guidelines Review the Individualized Quality Control Plan IQCP Guidelines implemented by CMS These guidelines are based on individual risk factors involved in the performance of each test run in your laboratory IQCP is voluntary and provides laboratories with flexibility in customizing QC policies and procedures based on the unique aspects and test systems found in your laboratory and may allow for the reduction in the frequency of control testing required Visit www qualigeninc com for additional regulatory information What You Need 1 2 e sau Control Range Card Pipette Tips FastPack IP System FastPack IP FastPack IP Control Kit Control Vials 2 Pipette Medical Gloves used to avoid contact with biohazard materials such as human blood etc Control Ranges for FastPack Total PSA Kit L N 0805019
19. 901 4 Control L N Mean ng mL Range ng mL CI 0801056 20 11 29 C2 0801057 116 8 6 14 6 65000159 Rev 007 06 15 21 FOR FASTPACK IP VITAMIN D USERS ONLY 8 Pretreatment Buffer Control Testing Procedure Action Instrument Information Illustration Keep the Control Range Open the FastPack IP Card in a place easily Control Kit Remove retrieved for reference contents possibly in your Quality Assurance Log Write CX depending upon the Control Vial used and lot number and the operator s initials on the peel off FastPack IP label E g C1 for Control Level 1 or C2 for Control Level 2 Invert Control Vial 6 8 times before opening 22 65000159 Rev 007 06 15 Action Closely follow FastSteps 2 through 5 from your FastSteps Guide Instrument Control Testing Procedure Information Utilize only Qualigen recommended pipette tips The tips are available through your local distributor or Qualigen Be sure that the pipette operates smoothly and does not stick It is very important that the tip is properly seated on the pipette If it is not there is a high probability of short sampling which will directly affect control results Illustration Closely follow FastSteps 6 through 10 from your FastSteps Guide FastPack IP Vitamin D Users ONLY Eject the control sample into the pre treatment buffer tube by pressing down on the pipette plunger t
20. FastPack IP System Analyzer Calibration Process Tree 20 Control ME iim 21 VVhen to Control Test eee a ee tiae A ER kennen 21 What YOu NGG I 21 65000159 Rev 007 06 15 i Control Testing PAPE dad LER ERR REDE EE EVE E ERE Lond vs 22 FastPack IP Vitamin D Users ONLY Sample Pretreatment 23 Sample Dilution heben lu delene RC 29 VVhen to Dilutea Test Sample erkennt SERERE ers A stone 29 What Vol NEAR 29 Diluting Sampler tes nn 30 Setting Dilution Mode 5 reed ie ke 31 Dil tion Mode or Rp pere taedia aii tao ien 31 Enable Dilution Modes hCG s esse en ree he e eie re eren engen d 31 Disable Dilution Mode hCG ie tt oe teer e veris nin RR EE ERES 32 Testing with the FastPack IP System in Dilution Mode 33 Testing a Neat Sample in Dilution Mode eese nennen nennen ethernet nnne 33 Testing an hCG 1 100 Diluted Sample in Dilution 34 Testing an hCG 1 10000 Diluted Sample in Dilution Mode eee 35 WHO International Standard 5 AO 37 WHO International Unit Mode
21. Illustration Spin tube in a high speed microcentrifuge If using a high speed microcentrifuge such as a StatSpin For plasma centrifuge at setting 120 takes 2 minutes Be sure not to remix the sample while removing the tube from the centrifuge For serum after complete clot formation has occurred centrifuge at setting 120 Refer to the FastPack IP Kit Direction Insert for additional information about sample processing and storage Closely follow FastSteps 2 through 5 from your FastSteps for Vitamin D Guide 44 Use only Qualigen recommended pipette tips The tips are available through your local distributor or Qualigen Be sure that the pipette operates smoothly and does not stick It is very important that the tip is properly seated on the pipette If it is not there is a high likelihood of short sampling which will directly affect patient results 65000159 Rev 007 06 15 Sample Collection and Delivery Vitamin D Only Action Instrument Follow steps 6 through 9 from your FastSteps for Vitamin D Guide Information When testing for Vitamin D it is necessary to treat each sample with pre treatment buffer prior to putting the sample into the FastPack IP Illustration Closely follow steps 10 through 13 from your FastSteps for Vitamin D Guide 65000159 Rev 007 06 15 Use serum plasma calibrators or controls only Always wear g
22. Pack IP in one direction Calibration Procedure Illustration Close the analyzer door If the door is not closed the analyzer will not run Press the BLUE button Insert Cal Prezz Start The door will lock and the analyzer will run the test INSERT CAL PRESS START 65000159 Rev 007 06 15 AA remaining The screen will display test status and time remaining PROCESSING XX REMAINING Calibration Procedure Action Instrument Information P When calibration is complete analyzer will beep Dal Fasz ale 1500 or Cal Am Fail 1005216 11 00 The result will remain The display will confirm er displayed for one minute whether calibration passed after the door is opened or failed and display date Lal Fail and time uu m See Troubleshooting if 119516 1 00 calibration fails Insert FP in Printer Open the analyzer door Analyzer vvill start beeping and display Insert FastPack in Printer until result is printed Remove and inspect the FastPack IP Check the inside of the analyzer door for fluid If there is fluid on the FastPack IP or analyzer disregard the result and properly dispose of the pack Implement the Cleaning Procedure 16 Ensure that all chambers have burst Fluid should easily flow between all chambers Obser
23. Qualigen Inc 65000159 Rev 007 06 15 69 Manufactured By 70 Qualigen Inc 2042 Corte del Nogal Carlsbad CA 92011 0 1 760 918 9165 PH 0 1 760 918 9127 FX Toll Free 1 877 709 2169 www qualigeninc com systemsupport qualigeninc com 65000159 Rev 007 06 15 Notes 65000159 Rev 007 06 15 71 72 65000159 Rev 007 06 15 Qualigen 2042 Corte del Nogal Suite B Carlsbad CA 92011 PH 877 709 2169 760 918 9165 FX 760 918 9127 www qualigeninc com
24. Verify that the correct Control vial was used Both Controls lut of Range High or low Reagents have been stored at room temperature Re calibrate and run Controls Problem with Calibration Reset Calibration Both Controls fit of Range One high and the other low Problem with Sample filling Check pipette for proper operation See section titled Troubleshooting FastPack IP Injection Port and Pipette 60 Unrefrigerated FastPacks IP Delayed Delivery Refrigerator Malfunction a a a aa aaa aa Contact Qualigen System Support Contact Qualigen System Support 65000159 Rev 007 06 15 Troubleshooting the FastPack IP Injection Port and Pipette Important Note Proper performance of the pipette is critical to obtain accurate test results If at any time you note the pipette plunger sticking or if plunger operation feels rough replace with a new pipette Problem Pipette does not draw up or dispense any sample Cause Pipette tip may not be properly seated The white piston inside the pipette tip should move up and down when the plunger is depressed If it does not the tip is not properly seated or the piston is warped Action Eject the pipette tip Seat a new pipette tip properly Refer to the FastSteps proper techniques for sampling Sample is leaking from the injection port 65000159 Rev 007 06 15 The pipette i
25. at the test If the retest is still outside of the acceptable range call Qualigen System Support at 877 770 6127 Illustration a LOT 0801056 Match Control Lot Numbers Control Ranges for FastPack Total PSA Kit L N 0805019 901 Control LAN ng mL Range ng mL c 0801056 2 0 1 1 2 9 ca 0801057 11 6 8 6 14 6 Result must be within range Lot 0803097 B Exe 2016 06 21 1 8 ng ml atana Parto Pacha Opora och e Lot 0801056 JKL FastPack PSA Apply the Control Label onto the Label Record in the appropriate assay section of your Quality Assurance Log Important control information is now included in your Quality Assurance Log T zu Discard the used FastPack IP into a Biohazard container The FastPack IP analyzer requires testing with two levels of controls Repeat the control procedure as needed 65000159 Rev 007 06 15 Discard both control vials when one vial is empty or when the control kit has expired into a Biohazard container Order a new control kit from your local distributor or Qualigen Inc 27 28 65000159 Rev 007 06 15 Sample Dilution hCG When to Dilute a Test Sample Samples can be accurately measured for hCG if it is within the analytic range of 1 8 1000 mIU mL However in some instances the analyte level in patient samples may
26. ay G pue p s n i4 umop Aem y je s bunid 0j uod uonoefui eyedid su sseJd uonoui eu olul pajeas si snonulluoo euo ul 6 di ay eins ag g 5 v 9964 Z Qnbl4 Jed ayjadid ay jo pue 9 uo Ayedoud pajees si dn eyedid euns eg R Ang si dik NOILVYVdAMd di oMIVdlSVI Q1Nbl4 Jed uedo pue papuapxa eje sjeddub jeyew JeBunjd au se j USYJ goed ui sdeus y jun di n did v ayedid au ay jeu os jejejdul09 sjenu 5 sseJd Au umop 1eBunjd umop Jabunjd l pue JI OUJEN eu ulplou SIIUM v plou pue SSG Z sjuaned eui SUM NOlIYMVYd3dd EL PE E 8 I N lt 2 3 sdajsjseg 65000159 Rev 007 06 15 LO0 LEON od uonoalul v ojul dy n did u Sum sul eJnBi4 od UOIJO9 LI au ojui pajeas AH do dulu di uod uonoefui au ojur pejees Ausdoud di n did py 94NGI 4 B dij n did pejees A TH3dOMHd SA ATH3dOMdMWI Z pieg sd s 65000159 Rev 007 06 15 uojsid y dub o p pu yx apadid ul dn JeyoW eanBi4 vi FastSteps for Vitamin D FEPS For FASTPACK IP VITAMIN D IMMUNOASSAY USERS ONLY
27. ay section of your Quality Assurance Log Instrument Information Important calibration information is now included in your Quality Assurance Log Illustration Em 773 Mile cs aor ne Discard the FastPack IP into a Biohazards container Repeat the Calibration Procedure All calibrations require that TWO 2 calibrations be run with the calibrator The exception is the FastPack IP Vitamin D Immunoassay which requires THREE 3 calibrations All calibrations must PASS for a successful calibration See the Calibration Process Tree on Page 20 which illustrates the messages shown on the analyzer display See Direction Insert for the test being calibrated 18 Discard all expired calibrator material in stoppered vials into a Biohazard container Order a new Calibration Kit from your local distributor or Qualigen Inc 65000159 Rev 007 06 15 A Word about Calibration Purpose The purpose of this section is to concisely define how and when calibrators are run for the various assays used in the FastPack IP System General Procedure The calibration kit contains a calibration card and 1 vial of calibrator The calibration card is used to communicate to the analyzer that the next test run will bea calibration Please follow these steps carefully Preparing a FastPack IP with a Calibrator Sample 1 Remove a FastPack IP from the kit
28. bol indicates the area in the analyzer that may contain potentially infectious human serum or blood products Healthcare personnel should always wear disposable gloves when handling blood products Adhere to state and federal infection control guidelines All blood specimens should be handled at the Biosafety Level 2 as recommended for any potentially infectious material in the Centers for Disease Control National Institutes of Health manual Biosafety in Microbiological and Biomedical Laboratories 1988 Attention Label Attention Important information that must be read is located both in the Procedure Manual as well as in the directional inserts for all assays performed on the FastPack IP System CE Mark Label This label signifies that the FastPack IP System conforms with all applicable health safety and environmental protection standards of the European Union IVD Label The FastPack IP System is an In vitro diagnostic medical device 65000159 Rev 007 06 15 Setting Up the FastPack IP System What is Included FastPack IP Analyzer External Printer AC Povver Cords 2 Desktop Power Supply 2 a A U ND Procedure Manual QA Manual US Only QA Log US Only FastPack IP System Set Up Unpacking the FastPack IP System Action Instrument Information Procedure anual FastPack System Illustration Remove all components of Keep shipping boxes and the FastPack IP Sy
29. d antibody to bind to the analyte in a sandwich format This mixture is then brought into contact with the coated paramagnetic particles which bind to the capture antibody and thus the analyte The amount of labeled antibody bound to the paramagnetic particles is directly proportional to the analyte concentration in the sample 68 65000159 Rev 007 06 15 For the competitive type assays an immuno reactive form of the analyte is bound to the paramagnetic particles Initially the sample is mixed with a labeled antibody and this mixture is added to the analyte bound paramagnetic particles The analyte in the sample competes with the particle bound analyte for the labeled antibody The amount of labeled antibody which binds to the paramagnetic particles is inversely proportional to the analyte concentration in the sample For both assay formats the antibody bound paramagnetic particles are processed the same in the analyzer The analyzer uses a magnet to hold the paramagnetic particles with their attached labeled antibody complex while they are washed repeatedly The wash removes any unbound antibody Finally a substrate solution is added which reacts with the labeled antibody to emit light During the entire run of the FastPack IP temperature control of 37 to 45 C 0 5 C for the FastPack IP is achieved by heating metal plates that adjoin the FastPack IP The light produced is read by a photomultiplier tube The analyzer provides
30. d Sample in Dilution Mode To learn more about hCG sample dilution go to www qualigeninc com hcgdilution Insert the sample filled FastPack IP into the analyzer NOTE In this scenario the sample will have been diluted 1 100 prior to filling into the FastPack Press the BLUE button 34 Sample Dilution RedzFez Blus Ho This prompt is questioning whether or not the current test sample is diluted To test a diluted sample respond with Yes A No response indicates a neat sample is to be tested 65000159 Rev 007 06 15 Testing in Dilution Mode Testing an hCG 1 100 Diluted Sample in Dilution Mode Continued Action Instrument Information Illustration Badzis 100 This prompt is asking for Press the RED button the dilution factor of the Blue izi sample 1 1 10 This prompt is asking for Press the RED button Red STOP Blue confirmation Processing 0 0 Press the BLUE button The test is initiated ii min remain Testing an hCG 1 10000 Diluted Sample in Dilution Mode To learn more about hCG sample dilution go to www qualigeninc com hcgdilution NOTE In this scenario the sample will have been FastPack IP into the diluted 1 10000 prior to analyzer filling into the FastPack Insert the sample filled 65000159 Rev 007 06 15 35 Testing in Dilution Mode Testing an hCG 1 10000 Di
31. de get feri Ee npe R reete aree nga 63 What You Need nu nina EE X 63 Upgrade Pr cedur ususkun ansiennitet innt 63 Calibration Reset e LR Ste ete Adra ANN Deep 65 Calibration Reset Procedure enr ertet e DO RR Re ve et a lien 65 ii 65000159 Rev 007 06 15 Other Iformatloh n SEL HE cosh eO REPRE Hints 67 Upgrading Flash Memory vs ee ne ERE Pr 67 Downloading Data ur nnno nere RU EY REX Po NER in FEE Fee e vere rien 67 FastPack IP System Product 67 Storage Conditions epe Ie ER P R R RI A 68 Statement of Comphlince 5 dede cunts mais eee I a ERE uneven R Y 68 Disposal 22i vetu diee e i DER ER Eo eee ER Ee 68 Principle Of Operation He UC REO Zaha 68 Limitation of Proced re 2 eite terere eee En eas ae PE VE R ine al e EUR souks 69 Warranty For US Only ss a Ip eee pP eves saat ve es i i D Dub ep 69 Support Services Supplies iere RER Ri nn eaa 69 IECUR 70 Nono e a O 71 65000159 Rev 007 06 15 iii 65000159 Rev 007 06 15 FastSteps yoeg s pJ099J juened ay ul ql eoejd pue l qe y yo eed PL g aunBi4 18 94 MD 14 pinoys uod uonoefu dl exoediseJ 84 0ju dy n
32. did pally SY yesur saund eu yo Jo uy ino YJIM Z ew 3 Woo ouluabijenb yoddnswajsks qel payoeye y UO snse1 juud pue dl 49 q se4 M AOUI M SI 59 Joop 1ez jeue au uedo EL Jez jeue y uo uognq pes an q au ssaud ZL 1531 3 9NINYO4J43d ejduies y ui s lqqnq Jie OU 9JE 919U eJns SYEU o dy spadid su 1 edsu au Buiseejel jwo s q ejduies MEJPYJIM pue eqni ajdwes ay d eyedid ay eoejd USYL ploy pue dojs 191 eui o umop JaBunjd syad d y ssaud Ayusg 9 yedoud pejees jou SI uojsid y ji In990 Aew yol alq pne uy Buiseajo pue 4015 19 ay o umop jeBun d 91 Buisseid Ausb q payeas Auedoud 51 dy n did ay jeu Alle G Joop Jez eue ay SOl dl gioegiseJ SU ui S9jou 34 uj JOOP eui uo suid y ufiy 19Z jeue y JO Joop y uo dl q m wov 2uuabenb mmm xe4 0069648097 Ud 2219047448 6 LLOZ6 VO 49 6 g eins ep 9902 2702 ou ua eno dl eoedise Mau E UJIM enpeooud dij y did u pue yoed u Joafa jjeoneuojne u Jo esodsip yuedoud pue dl eXoediseJ yea e nof JI di d se FUJ ui ejduies y eas o Bnid e se spe dy uod uonoefui eu WO di ayedid ay jeesun 0 jou ureyeo eg 0L u o ul ejduues au joefui Alsnoaueynuis IM UONDE SIY dojs puooes
33. e Diluting a Sample Illustration Setting Dilution Mode Dilution Mode This mode enables the analyzer to calculate and output results for hCG samples that have been diluted prior to testing This affects hCG tests only The analyzer outputs the calculated result based on the operator selected dilution factor A D or X will be printed to the left of the result if a sample was tested in Dilution Mode D indicates that a sample was tested at a 1 100 dilution X indicates that a sample was tested at a 1 10 000 dilution D or X will likewise appear on the second character row of the analyzer screen under the same testing conditions With Dilution Mode disabled the analyzer will immediately initiate an hCG test with no dilution prompts and results will be output with no dilution correction and no indication that the tested sample had been diluted Setting Dilution Mode Enable Dilution Mode hCG Action Press RED button several times to scroll through the menu till you see Set Dilution ON 65000159 Rev 007 06 15 Instrument Set Dilution M Information Illustration 31 Setting Dilution Mode Enable Dilution Mode hCG Continued Action Press the BLUE button to accept Instrument Ask Dilution is OH Information This action enables the Dilution Mode Illustration Disable Dilution Press RED button several times to sc
34. ear to the left ofthe result when results are printed in this same mode There are no additional steps required for using the WHO unit mode aside from enabling or disabling this mode To learn more about WHO standardization and Hybritech standardization go to www qualigeninc com WHO Enable WHO Unit Mode Total PSA WHO Unit Mode Action Instrument Information Illustration Press the RED button several times until the display reads Set WHO unit ON This action enables the it are CN Press the BLUE button HHO unit are M WHO unit MODE The analyzer display will Readu return to the Ready screen 65000159 Rev 007 06 15 37 Disable WHO Unit Mode Total PSA WHO Unit Mode Action Press the RED button several times until the display reads Set WHO unit OFF Instrument Information Illustration Press the BLUE button HHO unit are OFF This action disables the WHO unit MODE 38 Ready The analyzer display will return to the Ready screen 65000159 Rev 007 06 15 Sample Collection and Delivery into the FastPack IP What You Need 1 Pipette available from Qualigen 2 Pipette Tips available from Qualigen 3 Sample patient plasma or serum calibrator or control o 4 FastPack IP o igen l l INN 5 Microcentrifuge required fo
35. exceed the assay range of 1000 mIU mL In these cases the assay must be run again using a diluted sample in order to determine the actual quantitative hCG concentration What You Need Pipette Pipette Tips Patient Sample o FastPack hCG Sample Diluent Kit FastPack IP for hCG Microcentrifuge NY AANA UU DND Medical Gloves used to avoid contact with biohazard materials such as human blood etc 65000159 Rev 007 06 15 29 Diluting a Sample Action Using a NEW pipette tip draw a fresh 25 uL patient sample Information It is IMPORTANT to use a new unused pipette tip in order to create an accurate dilution Illustration Add this sample to a Sample Diluent tube Replace the cap and gently mix by inverting the tube back and forth several times This will create a 1 100 diluted sample Using a NEW pipette tip draw a 25 uL sample from the mixture in the Sample Diluent tube 30 It is IMPORTANT to use a new unused pipette tip in order to maintain an accurate dilution E G 7 65000159 Rev 007 06 15 Action Place this sample into a fresh FastPack IP Instrument Information This is now your 1 100 diluted patient sample that you will run through the FastPack IP System analyzer To create a 1 10 000 diluted sample repeat the above steps using your 1 100 diluted sample as your patient sampl
36. he analyzer Insert FastPack IP Motor Failure Motor has failed Run diagnostic If it fails contact System Support PHT Background High 2 _ PMT background reading is high during self diagnostic or at beginning of a test This may result from contamination leakage of ambient light in the analyzer or attempting to use a previously used FastPack IP Ensure that the used FastPack IP is not still in the Instrument Ensure that the instrument is not in direct sunlight Follow cleaning procedure Run self diagnostic Contact System Support if message persists PHT Failure PMT Failure Light Leak Ensure that the analyzer is not in direct sunlight Contact System Support Shutter Failure Shutter Failure Contact System Support Pressure Failure System has a severe pressure leak Air pump not functioning Contact System Support 58 Hemoue FaztPack A FastPack IP is in the analyzer when attempting to run diagnostics Remove FastPack IP Upon closing door diagnostics will automatically begin 65000159 Rev 007 06 15 Troubleshooting the FastPack IP System Display Cause Action Close door Recheck after 5 minutes Temperature too low may occur if door is left open for long duration If problem persists contact System Support Lemperatdre 8 baa sees scree sess gh aar nm 777 7 Move analy
37. her analyzer results and to the master curve established by the manufacturer Additional information about calibration can also be found in the Direction Insert for each FastPack IP product as well as in the A Word About Calibration section found in the procedure manual What You Need 1 FastPack IP System 2 FastPack IP 3 FastPack IP Calibration Kit a Calibration Card b Vial of Calibrator 1 4 Pipette available from Qualigen 5 Pipette Tips available from Qualigen 6 Medical Gloves used to avoid contact with biohazard materials such as human blood etc SU FOR FASTPACK IP VITAMIN D USERS ONLY 7 Pretreatment Buffer 65000159 Rev 007 06 15 11 Calibration Procedure Action Instrument Information Illustration Open the FastPack IP Be sure to refer to the Calibration Kit Remove Direction Insert for the test contents type being calibrated Calibration Kit Lot Number Expiration Date 0811035 EXP 2016 06 21 Important quality control information is now included in your Quality Assurance Log B LOT 0805030 FastPack PSA Calibrator Lot Test Type The analyzer will read the Place Calibration card on bar code on this card to the door Align the pins on perform the calibration If the door with the holes in the calibrator has expired the FastPack IP the analyzer will not Operate The door will lock and the as
38. htning Surge Immunity RF Common Mode Immunity Voltage Dips amp Short Interruptions 72 23 EEC Safety Requirements TEC 100 4 4 and IEC 1000 4 6 were passed under criterion C Disposal This product contains recyclable materials Do not dispose of this product as unsorted waste Please contact your local dealer or Qualigen Inc for disposal instructions Principle of Operation Sample is added to the FastPack via the injection port The FastPack contains all the premeasured reagents in sealed chambers necessary to perform the desired test The pack label contains a bar code with all necessary information required by the analyzer to run the test The FastPack IP System analyzer performs the test by automatically mixing and moving the sample and reagents within the pack The sample and reagents are moved from one chamber to another by applying uniform pressure to the compartment by means of internal pressure pads extended from the analyzer The pressure pads are driven by compressed air supplied by a small air compressor in the analyzer The FastPack IP System analyzer is capable of running both sandwich and competitive formatted immunoassays For the sandwich type assays the chemical principle is as follows A sample of unknown analyte concentration is mixed with an excess amount of known concentration of capture and labeled antibody solution This mixture is incubated for a preset time to allow the capture antibody and the labele
39. is Calibration Required The analyzer display will prompt you automatically when a calibration is due This prompt will occur for two reasons 1 When Attempting to Use New Lots of FastPacks or Calibrators 2 When it s Time to Recalibrate Calibration expires every 31 days for the following assays Vitamin D PSA hCG aGST hsCRP Calibration expires every 15 days for the following assays TSH Free T4 Testo When either of these two scenarios occurs Run two calibrations for the following assays TSH FreeT4 PSA Testo hCG aGST hsCRP Runthree calibrations for the Vitamin D immunoassay 65000159 Rev 007 06 15 19 FastPack IP System Analyzer Calibration Process Tree Calibration Pass Calibration Pass Display Cal X Fass Fun Another Cal Calibration Fail Display Cal W Pass Cal Complete Calibration Fail Calibration Pass Display Cal Fail Fun Another Cal Calibration Pass Display Cal X Fasz Cal Complete Calibration Fail Display Cal Fail Restart Cal Calibration Pass Display Cal Fail Run Another Cal Display Cal X Pass Fun Another Cal Calibration Fail Display Cal X Pass Cal Complete Calibration Fail Calibration Pass Display Cal X Fail Restart Cal Display Cal Fail Fun Another Cal Display Cal x Pass Cal Complete Calibration Fail Display Cal Fail Restart Cal 20 65000159 Rev 007
40. ll be Serial Comm RS232 Baud Rate 9600 Parity None Data bits 8 Stop bits 1 Recall last result sends this information out to PC for the last test run FastPack IP System Product Specifications FastPack IP System Analyzer Ambient Operating Temperature 15 C 59 F to 32 C 90 F Operating Humidity 10 to 80 relative humidity Operating Altitude lt 2000 m 6562 ft Pollution Degree 2 Installation Category II Display Output 2 line alphanumerical display Data Output RS232 9600 baud ASCII text Field Service Options ROM card firmware upgrade Electrical Requirements 100 240 10 VAC 1 9A Power Consumption 100 Watts maximum Size 13 x 9 x 12 inches 33 x 23 x 30 cm Weight 28 64 lbs 12 99 kg This product is intended for indoor use only 65000159 Rev 007 06 15 67 Storage Conditions FastPack IP System Analyzer Storage Temperature Humidity Stacking Limits Statement of Compliance FCC Sec 15 EN 61326 1 IEC 1000 3 2 IEC 1000 3 3 IEC 1000 4 2 IEC 1000 4 3 IEC 1000 4 4 IEC 1000 4 5 IEC 1000 4 6 IEC 1000 4 11 Low Voltage Directive EN 61010 1 EN 61010 2 UL 61010 1 CSA 22 2 NO 61010 1 CSA 22 2 NO 61010 2 15 C 59 F to 32 C 90 F 10 to 80 relative humidity Not to exceed four high Class A Radiated Conducted Emissions Class A Radiated Conducted Emissions Powerline Harmonics Test Powerline Flicker Test ESD Immunity Radiated Susceptibility EFT Immunity Lig
41. loves when handling samples It is very important that the pipette tip is firmly placed in the injection port If any sample leaking is detected immediately dispose of the FastPack IP and begin again with a new FastPack IP and sample 45 46 65000159 Rev 007 06 15 Running Patient Samples When to Run a FastPack IP The FastPack IP System analyzer is ready to run a FastPack IP at any time as long as it is turned on has reached operating temperature and pressure and has been calibrated Ifthe analyzer is not at operating temperature the analyzer will not operate and the BLUE button will not function Leave the analyzer turned on 24 hours a day so that it will always be at operating temperature The analyzer performs a comprehensive Self Diagnostic test every midnight to ensure the system is functioning properly When the Self Diagnostic test is running the analyzer door will be locked shut What You Need 1 FastPack IP System 2 Microcentrifuge required for patient samples only FastPack IP for the specific assay to be tested Pipette available from Qualigen D Pipette Tips available from Qualigen na A c Patient Sample serum or plasma depending on the assay 7 Medical Gloves used to avoid contact with biohazard materials such as human blood etc FOR FASTPACK IP VITAMIN D USERS ONLY 8 Pretreatment Buffer 65000159 Rev 007 06 15 47 FastPack
42. luted Sample in Dilution Mode Continued Action Instrument Information Illustration This prompt is questioning whether or not the current NC test sample is diluted Sample Dilution P Federer BluezMa Press the BLUE button To test a diluted sample respond with Yes A No response indicates a neat sample is to be tested adsl 100 This prompt is asking for imd the dilution factor of th Press the RED button Bluestein e dilution factor of the sample nili dana n This prompt is asking for Press the BLUE button RedsSTOP Blue G0 confirmation Processing Press the BLUE button The test is initiated il min remain 36 65000159 Rev 007 06 15 WHO International Standard The World Health Organization WHO has established International Biological Reference Preparations to serve as reference sources for defining biological activity expressed in an internationally agreed upon unit of measure The FastPack IP System provides the user the option of displaying results for Total PSA based on the WHO standard WHO International Unit Mode This mode enables the analyzer to output WHO standardized Total PSA results as an alternative to the default Hybritech standardized results No other tests are affected An uppercase W will appear in the second character row of the analyzer display when the WHO Unit Mode is enabled The uppercase W will also app
43. ly affect calibration results Illustration Closely follow FastSteps 6 through 10 from your FastSteps Guide FastPack IP Vita Eject the calibrator sample into the pre treatment buffer tube by pressing down on the pipette plunger to the first stop Replace the screw cap tightly onto the buffer tube Use serum plasma calibrators or controls only Always wear gloves when handling samples It is very important that the pipette tip is firmly placed in the injection port If any sample leaking is detected immediately dispose of the FastPack IP and begin again with a new FastPack IP and sample min D Users ONLY Sample Pretreatment Each patient sample calibrator or control must be thoroughly mixed with the FastPack Pre treatment buffer before running a FastPack IP Vitamin D assay Invert the buffer tube at least 3 times to thoroughly mix together the sample and buffer The act of mixing the sample and buffer releases the vitamin D present therefore making it available for the assay Follow the FastSteps for Vitamin D Guide steps 9 and 10 to complete sample delivery to the FastPack IP 14 65000159 Rev 007 06 15 Calibration Procedure Continued Action Open analyzer door Place FastPack IP on the door Align the pins on the door with the holes in the FastPack IP Instrument Insert Cal Press Start Information It is only possible to align the Fast
44. me pipette tip as before and following the same technique as in Step 6 above 15 Press the blue Start button on the analyzer 4 Be sure the pipette tip is seated properly on the end of the pipette as seen in Figure 2 U 10 with your finger off the pipette plunger fully insert the filled pipette tip into the FastPack IP Injection Port It should fit tightly Refer to Figure 3 16 Open the analyzer door when the test is complete Remove the FastPack IP and print the results on the attached label A quick reference guide to using the FastPack jp System 5 Verify that the pipette tip is properly seated by gently pressing the plunger down to the first stop and releasing An audible Click may occur if the piston is not seated properly 11 Be sure the pipette tip is seated properly into the injection port Refer to Figures 4 and 5 17 Peel off the label and place it in the patient record 6 Gently press the pipette plunger down to the first stop and hold Place the pipette tip into the sample tube withdraw sample by slowly releasing the plunger Inspect the pipette tip to confirm there are no air bubbles in the sample 12 In one continuous motion quickly press the pipette plunger all the way down This action will simultaneously inject the sample into the FastPack IP and automatically eject the pipette tip SUPPORT Qualigen Inc Carlsbad CA 92
45. mpact performance 65000159 Rev 007 06 15 55 56 65000159 Rev 007 06 15 Troubleshooting Troubleshooting the FastPack IP System Analyzer These messages are possible errors that may occur The FastPack IP System analyzer will sound with a beep each time an error message is displayed If a problem persists please contact your local distributor or call Qualigen Inc System Support at 877 770 6127 or e mail System Support at systemsupport qualigeninc com Display Cause Action Check for obstruction and try FastPack Bar code reader has failed or door bar IP or card again Bar Code Failure code label is obstructed or defaced Contact System Support Re run a new calibrator sample and be certain the FastPack IP has a proper fill If error persists perform a Calibration Reset then re calibrate the analyzer Calibrator result is outside of the Fail is acceptable range hen Lot Use the same FastPack lot previously Requires Calibration Different lot of FastPacks is being used used or re calibrate the analyzer for the new lot of FastPacks Time to Re Calibrate Time between calibrations has expired Run calibration for desired assay n Calibrator Expire Calibrator has passed expiration date or system date is incorrect Verify system date is correct f correct obtain a new Calibration Kit Clase Daa Door
46. o the first stop Replace the screw cap tightly onto the buffer tube 65000159 Rev 007 06 15 Use serum plasma calibrators or controls only Always wear gloves when handling samples It is very important that the pipette tip is firmly placed in the injection port If any sample leaking is detected dispose of the FastPack IP and begin again with a new FastPack IP and sample Sample Pretreatment Each patient sample calibrator or control must be thoroughly mixed with the FastPack Pre treatment buffer before running a FastPack IP Vitamin D assay 23 Control Testing Procedure Action Invert the buffer tube at least 3 times to thoroughly mix together the sample and buffer The act of mixing the sample and buffer releases the vitamin D present therefore making it available for the assay Follow the FastSteps for Vitamin D Guide steps 9 and 10 to complete sample delivery to the FastPack IP Control Testing P Open analyzer door Place FastPack IP on the door Instrument rocedure Continued Information It is only possible to align Illustration Align the pins on the door Ready the FastPack IP in one with the holes in the direction FastPack IP If the door is not closed Close analyzer door the analyzer will not run The door will lock and the Press the BLUE button Ready 777 24 analyzer vvill run the test
47. of the large ferrite core You should use the small ferrite core Serial Interface Cable 65000159 Rev 007 06 15 Action Connect the large end of the Serial Printer Cable to the rear of the external printer with a screwdriver or tighten screws by hand Instrument FastPack IP System Set Up Illustration Information Analyzer should be turned on and in Ready position Connect the other end of the Serial Printer Cable to the analyzer at the port labeled COM1 Plug the Desktop Power Supply into the back of the External Printer Plug the AC Power Cord into the Desktop Power Supply Plug the AC Power Cord into the wall socket External Printer operates with input voltage of 100 240 10 VAC and 50 60 Hz Press the Printer s ON switch located on the left side 65000159 Rev 007 06 15 FastPack IP System Set Up Action Remove the printer cover Unwrap and insert the printer ribbon cartridge into the printer Instrument Information Follow all instructions found in the printer manual Illustration 10 You are now ready to calibrate the analyzer You can only run a FastPack IP on the analyzer if it has been calibrated for that test 65000159 Rev 007 06 15 Calibrating the FastPack IP System When to Calibrate Calibration ensures that each individual analyzer results are identical to all ot
48. orted shall be presumed to have occurred in transit and will be the responsibility of the customer The customer must obtain a Return Authorization from Qualigen prior to shipping the product back to Qualigen Qualigen shall not be obligated under this warranty if the need for repairs or replacements directly or indirectly results from customer s i failure to use or store the product as specified by Qualigen ii failure to properly perform the services or maintenance required in the Operator s Manual for a product iii repairs to a product by persons other than Qualigen service personnel iv replacement of parts with other than Qualigen genuine parts v negligence or negligent operation of any product or vi alterations or modifications of any product without authorization from Qualigen THIS WARRANTY TOGETHER WITH ANY OTHER WRITTEN WARRANTY THAT MAY BE ISSUED BY QUALIGEN IS THE SOLE AND EXCLUSIVE WARRANTY AS TO QUALIGEN PRODUCTS EXTENDS ONLY TO THE CUSTOMER AND IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY AGAINST INFRINGEMENT Note Qualigen does not warranty the StatSpin centrifuge Please check with StatSpin for warranty information Support Services Supplies For questions concerning the FastPack IP System or if supplies or services are needed contact your local FastPack IP System dealer or
49. press the Example RED button again Release the RED button when the beeping stops Erase After Erase tPSA Cal is APSA displayed the screen will toggle between different displays This will erase the Example calibration Press the BLUE button PSA has Follow the Calibration Procedure to re calibrate the analyzer been erased 66 65000159 Rev 007 06 15 Other Information Upgrading Flash Memory The FastPack IP System analyzer is equipped with a Smart Media Card Reader that is used to install periodic software upgrades to the system As software upgrades become available Qualigen Inc will provide a Smart Media Card containing the upgrade ready to be installed on to your FastPack IP System Downloading Data The FastPack IP System when COM1 is configured for a computer allows for the output of test results to a personal computer PC Data is automatically output through an RS232 connection found on the back ofthe FastPack IP System analyzer at the completion of each test To obtain data connect a serial cable from the FastPack IP System analyzer RS232 port to the computer and configure COM1 on the analyzer for a computer The output data is ASCII text with the following comma delimited fields Result Value numerical or pass fail for calibrator or controls Units Date Time Instrument Serial Number SW Revisions Test Type The communications protocol wi
50. r analyzer will read the Press the BLUE button Ready Y MS calibration card This will take about 30 seconds 12 65000159 Rev 007 06 15 Action Open the analyzer door Remove the calibration card Store card in Calibration Kit Instrument Insert Cal Start Press Information Calibration Procedure Illustration Remove the FastPack IP from its box Check to make sure it is the correct test type Always keep FastPack IP stored in the refrigerator in the position indicated on the box at 2 8 C 36 46 F prior to use FastPacks can be taken directly from the refrigerator and used in the analyzer Write CAL 1 or CAL 2 or CAL 3 for the Vitamin D assay along with the operator s initials on the peel off FastPack IP label Invert the calibrator vial 6 8 times before opening 65000159 Rev 007 06 15 Follow this procedure each time you run a sample 13 Calibration Procedure Action Closely follow FastSteps 2 through 5 from your FastSteps Guide Instrument Information Use only Qualigen recommended pipette tips The tips are available through your local distributor or Qualigen Be sure that the pipette operates smoothly and does not stick It is very important that the tip is properly seated on the pipette If it is not there is a high likely hood of short sampling which will direct
51. r patient samples only 6 Medical Gloves used to avoid contact with biohazard materials such as human blood etc IMPORTANT When using FastPack IP Vitamin D for calibration controls or running patient samples you must pre treat each sample with the FastPack Pretreatment Buffer See the section on Sample Collection Pretreatment and Delivery into the FastPack IP Vitamin D Testing Only 65000159 Rev 007 06 15 39 Sample Collection and Delivery Action For patient samples collect 2 4 mL of blood in a 5 mL tube Instrument Information Refer to specific direction insert for sample collection and handling Illustration Spin tube in a high speed microcentrifuge If using a high speed microcentrifuge such as a StatSpin For plasma centrifuge at setting 120 takes 2 minutes Be sure not to remix the sample while removing the tube from the centrifuge For serum after complete clot formation has occurred centrifuge at setting 120 Refer to the FastPack IP Kit Direction Insert for additional information about sample processing and storage Closely follow FastSteps 2 through 5 from your FastSteps Guide 40 Use only Qualigen recommended pipette tips The tips are available through your local distributor or Qualigen Be sure that the pipette operates smoothly and does not stick It is very important that the tip is p
52. roll through the menu till you see Set Dilution OFF Ready Mode hCG Sek Dilution OFF The analyzer display will return to the Ready screen Press BLUE button 32 Ask Dilution iz OFF This action disables the dilution mode 65000159 Rev 007 06 15 Setting Dilution Mode Action Instrument Information Illustration The analyzer display will Readu return to the Ready screen Testing with the FastPack IP System in Dilution Mode Testing in Dilution Mode Testing a Neat Sample in Dilution Mode Action Instrument Information Illustration Insert the sample filled FastPack IP into the analyzer This prompt is questioning whether or not the current E test sample is diluted Sample Dilution RHedzFez Blus Ho Press the BLUE button To test a neat sample respond with No A Yes response indicates test sample is diluted 65000159 Rev 007 06 15 33 Testing in Dilution Mode Testing a Neat Sample in Dilution Mode Continued Action Press the BLUE button Instrument H Dilution Used Red 5TOF Blus Information This prompt is asking for confirmation that you are testing a neat sample Illustration Press the BLUE button Fracessing li min remain The test is initiated Testing an hCG 1 100 Dilute
53. roperly seated on the pipette If it is not there is a high likelihood of short sampling which will directly affect patient results 65000159 Rev 007 06 15 Action Closely follow FastSteps 6 through 10 from your FastSteps Guide 65000159 Rev 007 06 15 Instrument Sample Collection and Delivery Information Use serum plasma calibrators or controls only Always wear gloves when handling samples It is very important that the pipette tip is firmly placed in the injection port If any sample leaking is detected immediately dispose of the FastPack IP and begin again with a new FastPack IP and sample Illustration 41 42 65000159 Rev 007 06 15 Sample Collection and Delivery into the FastPack IP Vitamin D Testing Only What You Need 1 Pipette available from Qualigen 2 Pipette Tips available from Qualigen 3 Sample patient plasma or serum calibrator or control 4 FastPack Pretreatment Buffer D 5 FastPack IP for Vitamin D 6 Microcentrifuge required for patient samples only 7 Medical Gloves used to avoid contact with biohazard materials such as human blood etc 65000159 Rev 007 06 15 43 Sample Collection and Delivery Vitamin D Only Action For patient samples collect 2 4 mL of blood in a 5 mL tube Information Refer to specific direction insert for sample collection and handling
54. s s ed dee eie e s s esed e gere venas 37 Enable WHO Unit Mode Total PSA 37 Disable WHO Unit Mode Total PSA 38 Sample Collection and Delivery into the FastPack IP 39 What You Need nase Ke 39 Sample Collection and Delivery S Dee a 40 Sample Collection and Delivery into the FastPack IP Vitamin D Testing Only 43 What YouNeed utere utens eue 43 Sample Collection and Delivery Vitamin D 44 Running Patient Samples ee pe ee e qn dee ql eee ieh RU teten 47 When to Ruma FastPackQ9 IP z ATR eid 47 What You Need s S s s s ere Cus Ine Pee dev 47 FastPack IP System Procedu re 5 oie eese etr tear vere donee dre ede ge eR insbe ebenen 48 Cleaning the FastPack IP System ssrannrnnranvnrnnrrnnnensnenenensnesenenenesenssnnesnnrsnnansrsnsrsesnensnensnensnesenesenesenesnnesnnesnne 55 FastPack IP System Cleaning Procedure eese eene nene nennen nennen nennen snnt 55 Troubl sho oting swiss vase ene es aan IR iittala thee NT 57 Troubleshooting the FastPack IP System Analyzer eese eene nennen ener nenne 57 Troubleshooting the FastPack IP Injection Port and Pipette esee 61 Analyzer Software Upgrade ect etre he i gr
55. s not properly seated in the injection port Discard the leaking FastPack and start with a new unused FastPack When inserting the pipette tip into the injection port ensure that the tip is fully inserted all the way into injection port so that it is properly seated After injecting the fluid and ejecting the pipette tip make sure you do not inadvertently pull out the tip This will cause the pipette tip and or the white internal piston to be unseated and potentially allow leakage of sample Contact System Support 877 770 6127 61 62 65000159 Rev 007 06 15 Analyzer Software Upgrade What You Need 1 FastPack IP System analyzer 2 Smart Media Card I Action Instrument With the analyzer on and in Ready mode insert the Smart Media Card into the port on the back of the analyzer labeled SMART MEDIA CARD Readu Information The gold side of the Smart Media Card should face up The notch on the Smart Media Card will be inserted first Upgrade Procedure Illustration Scroll to Upgrade Software by pressing the RED button on the analyzer Upgrade Software Press the BLUE button to select the Upgrade Checking Software menu option 65000159 Rev 007 06 15 The unit will start by checking the software and finish by going through Self Diagnostics The entire sequence should take about 2 minutes If the analyzer should get stuck at an
56. stem internal packaging in case from their boxes units have to be returned Place analyzer on Analyzer is designed to be countertop set on a table top 65000159 Rev 007 06 15 FastPack IP System Set Up Getting Power to the FastPack IP System Action Plug Desktop Power Supply into the analyzer Plug AC Power Cord into Desktop Power Supply Turning ON the S Plug AC Power Cord into the wall socket Turn analyzer on using power button located on back of unit Attention Leave analyzer on at all times Instrument ystem Analyzer Information Power Supply operates with input voltage of 100 240 10 VAC and 50 60 Hz Illustration un Software uu Ready The analyzer will beep once and display the internal software version for 5 seconds Analyzer will now perform a self diagnostic check and it will not function until operating temperature is reached It takes 40 60 minutes to reach operating temperature During this time the display will show two sets of temperature readings The analyzer will beep twice and display Ready when operating temperature is reached om 65000159 Rev 007 06 15 Set Up Menu Action Enter the Set Up Menu for the analyzer by pressing the RED button Language Units Scroll to Languages Units by pressing the RED Instrument Languages FastPack
57. ve that most of the fluid in the FastPack IP is yellow If there is no yellow fluid disregard the result and rerun a FastPack IP 65000159 Rev 007 06 15 Calibration Procedure Action Slip the FastPack IP into the external printer from the left side with the label side up and the label facing towards the rear of the external printer Instrument Information Printer will print and release the FastPack IP automatically It is important to insert the FastPack IP from the left side of the printer to avoid tangling or twisting the printer ribbon Illustration Remove the FastPack IP from the left side of the external printer t is important to remove the FastPack IP from the left side of the printer to avoid tangling or tvvisting the printer ribbon fi N N Find the result printed on the FastPack IP peel off label Calibrator Pass Fail Calibration Lot Date of Test Instrument Serial Allthe necessary information for Quality Control is now included on the peel off label FastPack IP Expiration Lot Number Date 0802027 7 EXP 2016 06 21 Cal BPass 0805030 10 05 15 0207 Cal Pass Date Instrument or Fail Serial Calibrator Operator Lot Initials Peel off the label 65000159 Rev 007 06 15 17 Calibration Procedure Action Place the printed Calibration label on a Label Record in the appropriate ass
58. y step call Qualigen System Support If an error message is displayed DO NOT turn off the machine Follow the instructions on the display If the error persists call Qualigen System Support 63 Upgrade Procedure Action When the analyzer returns to Ready mode press the EJECT button next to the port and remove the Smart Media Card Return the Smart Media Card after the upgrade is complete 64 Instrument Ready Information After the software is completely installed Software VX XX appears in the display and the self diagnostics will run automatically Once the diagnostics are complete Ready will appear on the screen It is acceptable to remove the card at this time Illustration 65000159 Rev 007 06 15 Calibration Reset Calibration Reset Procedure Action Instrument Information Illustration Readu Place the Calibrator Card for the test type calibration you want to erase on the door Align Readu the pins on the door with the holes in the Calibration Card Close the analyzer door Inzert Cal Press the BLUE button iid Fress Start 65000159 Rev 007 06 15 65 Calibration Reset Procedure Action Instrument Information Press and hold the RED Analyzer will beep four button times If you do not want to erase the calibration
59. zer to a cooler location or wait approximately 15 minutes Qui of Range between runs Temperature too high may occur if room temperature is too warm gt 32 C or 90 F If problem persists contact System Support Temp of Range Temperature has exceeded correct Discard pack Retry test If problem Invalid Test range during a test persists contact System Support Wadi dioc ilias ada Cancelling a test will require the use of a Test Cancelled P P i new FastPack IP and new sample Thermistor Failure Thermistor has failed Contact System Support A time that is not possible has been Re enter correct time entered Time Error A Report result as gt XX units FastPack IP Test result is higher than sas units the maximum reportable result If desired send sample to reference lab for confirmation FastPack IP Test result is lower than the SRA units Report result as units minimum reportable result 65000159 Rev 007 06 15 59 Troubleshooting the FastPack IP System Display ine Control fit of Range Cause Full volume of Control not filled into FastPack IP Wrong Control used Action Re run Control Verify that the correct range is being read for the Control lot being used Verify the expiration date on the vial of the Control being used Verify that the Controls were stored and used properly
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