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QBC STAR™ System Operator`s/Service Manual

1. 12 1 52 HGB g dL 1 48 PLT x 10 L 1 00 GRAN x 10 L LYMPH MONO x 109 L 10 10 9 10 10 9 10 L 10 9 WBC x de 10 L E 9 10 E 10 9 10 10 9 Variability between runs during the same days Variability between tubes on the same run during the same day error df degrees of freedom 0 00 denotes a negative variance estimate Accuracy The performance of the QBC STAR system is based on data from venous blood samples collected in VACUTAINER brand col lection tubes containing K EDTA anticoagulant Venous blood samples provide a more stable test system than capillary blood for comparing results from multiple methods While skin puncture samples provide clinically relevant results they are subject to more variation due to the nature of the sampling technique Two QBC STAR tubes were prepared on each of approximately 323 blood samples and analyzed on both the QBC STAR system and either the Coulter STKS or Sysmex K1000 analyzers The correlation coefficients for the WBC Gran L M Hct and Hgb and PLT parameters were 0 95 or greater Complete statistical results are presented on following page 5 2 L 000867 A 5 Performance and Limitations Cor Cell Number cept Mean Values of Sam Mean ples Parameter relation Slope Inter QBC Counter Range of Coeffi cient I 5 2 Hemoglobin g dL 0 982 0 387 12 1 12 0 x 638 Platelet x 10 L 0 962 0
2. 935 17 701 23 913 Granulocyte x 0 8 Ll u u N Lymph Mono 0 8 The hematocrit results shown above reflect the calibration methods of the Coulter or Sysmex analyzers used in the correlation study The QBC STAR software has been calibrated to match the international reference standard for microhematocrit MHCT technology The data shown in the table below were obtained by comparing the QBC STAR results against the microhematocrit reference method Cell Counter Rangeof Number of Mean Values Samples Mean Correlation QBC Parameter Coefficient Slope Intercept Microhematocrit 15 7 Products of Coulter Electronics Hialeah FL and TOA Medical Electronics Kyoto Japan Interfering Substances e Hemolysis Do not perform tests on visibly hemolyzed blood specimens e Bilirubin No effects on test results have been observed at bilirubin concentrations up to 20 mg dL e Triglycerides No effects on test results have been observed at triglyceride concentrations up to 1 800 mg dL e Coumadin Anticoagulant therapy has been shown to have no clinically significant effect on performance e Doxorubicin Treatment with the anthracyclic drug Doxorubicin does not appear to interfere with the QBC test method e Other Drugs The effects of other potentially interfering drugs and their metabolites on QBC tests have not been established 1 L 000867 A 5 3 QBC STAR System Operator s Service Manual Limitations Quality medi
3. Operation Steps Routine operation of the QBC STAR Hematology System consists of the following steps e Turn the instrument on e Print out save electronic controls e Fil tube with blood e Mix the tube of blood e Place the cap onto the tube e Place the tube into the instrument e Close door and ensure it is latched e Push the Star button to start the test cycle e Obtain the results from the printer e Dispose of the QBC STAR tube in a biohazard container Each of these steps is described below L 000867 A 4 1 QBC STAR System Operator s Service Manual JTurn Instrument Power on Turn on the QBC STAR instrument power if necessary Turn power on by placing the power switch on the rear of the instrument in the On position The instrument performs a self test which can take a few minutes During this time the mes sage System Check In Progress Please Wait is displayed When the self test is complete and the system is ready the following message appears on the LCD readout Ready Insert Sample Close Door Press Star Note that if power is left on continuously the power on self test occurs automatically once per 8 hours when the door is closed Electronic controls print out automatically after the self test is complete Save for control re cords O Prepare the QBC STAR tube For additional information on preparing the QBC STAR tube refer to the package insert in the tube carton The blood sourc
4. Se R oos oos J White Blood Cells WBC 1 6 x 10 L 99 9 x 10 L male Et ENT MA AR BEE External Connections The following external connections are located on the rear of the QBC STAR instrument and are shown in Figure 4 e AC power input e Serial Port for connecting the instrument to a Laboratory Information System LIS or PC e Barcode Scanner Port for connecting a barcode scanner e Parallel Port for connecting a full size printer e Keyboard Port for connecting a full size keyboard Connecting an External Printer You can attach a full size external printer to the QBC STAR instrument to print results on standard letter or A4 size paper You may print either in black and white or color If you enable color printing errors and out of range parameters are printed in red ink You can also leave the internal instrument printer enabled even if you attach an external printer If you do results print on the internal printer first Press the Star button to reprint results on the external printer For information on what makes and models of printers can be used contact QBC Diagnostics Technical Services 2 4 L 000867 A 2 Installation and Setup Figure 4 External Connections On Left AC power connection On Right Top to Bottom Serial Port connection Bar code Port connection Parallel Port connection Keyboard Port connection Required Materials Compatible external printer Standard Centronics
5. door is locked electromechanically when it is unsafe to open the door such as when a QBC STAR tube is being centrifuged Pressing the door release latch at such a time has no effect Liquid Crystal Display LCD All system prompts instructions for use are presented on the Liquid Crystal Display also called the LCD or LCD Readout In addition the test results are shown on the LCD If any errors occur during the system s self tests or during operation of the unit this information too is shown on the LCD See Figure 6 LCD Readout Printer Star Button Door Release Latch Floppy Disk Drive Figure 6 QBC STAR Controls and Indicators 3 2 L 000867 A 3 Controls and Indicators Printer Test results print automatically at the end of the testing cycle The printer is located on the top panel of the instrument on the right side Samples of test results printouts are shown in Section 4 Operation See Figure 6 for the printer s location See Figure 7 for printer controls To access printer controls lift the rear of the printer panel and remove it from the unit Paper Release Lever The paper release lever is located on the right side of the printer Pull the lever forward to enable load ing paper When the lever is forward the manual advance wheel below is operational Push the lever toward the rear to lock the paper in place Manual Advance Wheel The manual paper advance is located on the right side of th
6. during each sample run The built in checks confirm that the QBC STAR tube has not been previously processed and is correctly assembled Tests confirm that the cap is present the tube assembly is the proper length the float is present and the correct length and the tube is filled with the correct amount of blood 5 Reagent QC during each sample run These built in checks evaluate reagent integrity using the data from the optical scan This includes tests for fluorescent signal intensity interface sharpness and the reproducibility of scans around the tube Results are reported only if all of the internal quality control requirements have been satisfied Internal Electronic Quality Control Label An internal quality control label designed to simulate 3 hematology specimens is automatically read every 8 hours as part of the instrument self test The instrument prints the hematology values obtained from reading the tri level electronic QC control label at the end of the self test These values are available to plot and evaluate shifts and trends The label is also read with each patient sample run The instrument compares the electronic QC values measured during self test and during patient sample runs to factory established limits Recovery of any value outside of the established limits will result in an instrument shutdown until the problem is corrected and a valid self test is performed The internal electronic QC label tolerances are shown
7. electronic QC results Stopping the Centrifuge If for some reason you must stop the test before it is complete press the Star key to stop the instru ment Note that you cannot reuse or reanalyze a partially processed tube It is perfectly normal for the analyzer to make clicking noises during the testing process This does not indicate an abnormal condition The system automatically stops testing if a power failure or system error occurs or the unit breaks down If this occurs a message appears on the LCD display Emergency Door Unlock In the event of a power failure or the failure of certain components you may be unable to open the door with the door release latch If this occurs you can still open the door Emergency door unlock is performed by tripping the internal latch with a screwdriver To unlock the door 1 Make sure the power switch is in the Off position O and the power cord is disconnected from the instrument 2 Lift the front of the instrument and rest the QBC STAR instrument on its rear panel 3 Locate the door latch access hole in the bottom of the instrument It is almost directly below the door release latch See Figure 21 4 Insert a small diameter screwdriver that has a shaft at least 2 inches long 5 Press down against the internal latch by pivoting the screwdriver handle upward This step may require a moderate amount of pressure 6 When the door pops open remove the screwdriver and pla
8. enough paper to clear the printer cov er N Flip the paper release lever backward 8 Replace the printer panel feeding the new strip of paper through the slot Insert paper between two rollers f i od Feed paper from bottom manual advance wheel rearward 13 Flip paper release lever forward Flip lever backward Figure 22 Replacing Printer Paper 6 2 L 000867 A 6 Maintenance Replacing Fuses WARNING BEFORE BEGINNING TO CHANGE THE FUSES MAKE SURE THE UNIT S POWER IS TURNED OFF AND DISCONNECT THE INSTRUMENT POWER CORD FROM THE POWER SOURCE There are two fuses in the power entry module The fuses are located in a holder just above the power cord plug See Figure 23 F These fuses are Diameter 5 x 20 mm F3 15A 250V Indicated by the symbol 250 V 3 15A To replace the fuses 1 Lift the small tab at the bottom of the fuse holder with a thumbnail or small screwdriver 2 Slide the fuse holder out of the instrument 3 Remove the fuses and examine the fuse elements to see which of the fuses has blown You only have to replace the blown fuse s 4 Make sure the good fuses are the same voltage and current rating as the bad ones 5 Place the good fuses back in the holder and slide the holder back into the power module Make sure the holder CLICKS into place 6 Reconnect the power cord and turn instrument power back on Lift tab with thumbnail __ slide fuse
9. h S q Bu a ke Suku aus 3 4 Floppy Disk dica o dl el ide Sed be tie 3 4 Floppy Disk Eject BUTTON ccoo cocodrilos dnuennatehaeerksihbsneneadancenens 3 4 O a 35 ES ciao 3 5 Be KEYS huuu a e ee una Oe de ende 3 5 S SS AG a REICHEN el dol os o tened hdd deco Dedo tedioso e a 3 5 Key Het hi hofi e ukasa tn a ers eo il had a 3 5 A ia ne ae nee 4 1 summary of Operation StepSx ua a HE a Buna aa eh 4 1 Turn Ihstrument Powenon u up n Het meines ee eae 4 2 Prepare the OBC STARtubez eu A L SSS CS SD a L Aaa 4 2 Pa kap aaa a kuma h Mid a Beek au pale aera 4 4 TIE UDG a dr tos pah Acad colt dl o mdd need dt meno hai dL u A 4 5 E O 4 5 Insert the tube into the instrument 4 senmenennnenennnennnnnnennnnnennnnnennneennnnnenrnnen rn 4 6 Glose the instr ment doorsz ntai A Sua ergy 4 6 Started tio AA td e dl e cad add dsc 2 evo Lo eli add e oA 4 6 Printing OF results ii A Qha tapa masipa ibid 4 7 NS IO 4 10 ROWERDOWN Q ka id liado usss 4 10 Stopping the Centrtuge s a dd eh iw kata 4 10 Emergency Door Unlock a ENT e h puti O u N 4 10 5 Performance and Limitations rra 5 1 Operating Ranges aara t k ib 5 1 PrECISION uu Sa us io 5 1 ACCUTANE 5 2 Interfering SUBSTANCES iaci a a eos 5 3 LIMITATIONS ae aan Oia 5 4 Expected Vallesa nn ee a ee ea e ea 5 4 Controls Besen huu mu Ne Ue Mee a kaa EN u aka Stam 5 5 ntermal Ouality Entra ate a 5 5 Internal Electron
10. in the table below L 000867 A 5 5 w o o HCT HGB g dL MCHC g dL PLT x 109 L un N WBC x 109 L N N w w GRAN x 109 L GRANL w N gt N L M x 109 L u gt p y w o N gt u gt o Ww 3 g w L M External liquid controls QBC Controls are available for additional performance monitoring of the QBC STAR system You must run liquid controls and document the results before you begin testing with a new lot or newly received shipment of QBC STAR tubes You must run liquid controls and document the results with each instance of instrument relocation or repair Consult the package insert accompanying the controls for preparation instructions and expected results You must also follow any quality control requirements from your regulatory or accreditation agencies Proficiency Tests Proficiency testing is an external evaluation of the quality of a laboratory s performance Laboratories enrolled in a proficiency testing program for the QBC STAR System will receive five unknown specimens three times each year These specimens are run in the same way that patient specimens are tested Results are submitted to the proficiency testing program for comparison to results obtained by other laboratories using the QBC STAR System A partial list of organizations that may offer proficiency testing for the QBC STAR System is shown below American Proficiency Institute API American Co
11. name or ID number In addition the date and time and the electronic QC status Pass Failed are printed Electronic QC values are only printed every 8 hours and at startup The system only prints the actual measured or calculated results with no interpretations or normal values The following hematology results are reported 4 7 QBC STAR System Operator s Service Manual 4 8 Reported Results Parameter abbreviation Hematocrit Hct Percentage Hemoglobin Hgb g dL Mean Corpuscular Hemoglobin Concentration MCHC g dL White Blood Cells WBC Lymphocytes Monocytes 10 L Percentage Platelets 10 L Any results that are out of the reporting range specified in Section 2 are shown on the display with dashes instead of actual numerical values On the printout out of range readings are indicated as greater than or less than the maximum or min of Operating Range prints Calculated values based on Report If the electro optical verifications fail an error m imum value Also the message Out out of range readings print as No essage is displayed Any errors that might occur are both displayed and printed on the results printout Refer to Section 6 Troubleshooting for causes of errors and corrective actions Test results are printed when the electronic QC checks have been successful This is indicated on the results printout as Electronic QC Passed A sample results printout is
12. other device to pick up any glass or plastic fragments Dispose of in a biohazard sharps container 2 Clean any contaminated surfaces with 10 solution of household bleach 1 part bleach to 9 parts water Allow to stand 5 minutes then rinse thoroughly with water and dry Household bleach is effective against bacteria spores and viruses However it is an oxidizing agent and is corrosive to metal alloys Bleach must be thoroughly wiped off the instrument with a damp cloth and dried It should never be used if there is surface damage to any metal parts For any other cleaning methods you must contact QBC Diagnostics to verify that the proposed method does not damage the QBC STAR instrument CAUTION Do not immerse the QBC STAR instrument in water or other liquid L 000867 A 6 1 QBC STAR System Operator s Service Manual Replacing Printer Paper When the printer paper is nearly exhausted a colored edge appears on the roll of paper You should replace paper at this time to avoid running out while printing patient test results See Figure 22 To replace printer paper 1 Remove the printer panel and remove the old roll of paper Peel off the beginning of the new roll of paper Place the paper in the instrument with the paper feeding up from the bottom 2 3 4 Insert the paper between the two black rubber rollers on the printer 5 Flip the paper release lever forward 6 Roll the manual paper advance wheel rearward Advance
13. selected press le on the keypad When you select a different language another window pops up that lets you select the time format you want English defaults to a 12 hour time format i e 12 00 a m to 11 59 p m The other lan guages default to a 24 hour format i e 00 00 to 23 59 If you want to change the time format use the or key to move the arrow cursor to the other format Press on the keypad to save that format Internal Printer Internal Printer lets you enable or disable the QBC STAR system s built in printer When you select the option a sub menu titled INTERNAL PRINTER appears When the printer is ENABLED the menu lets you disable the printer by selecting option 1 When the built in printer is ENABLED option 1 reads Disable Printer You can disable the printer by confirming that the arrow cursor is pointing to option 1 and pressing theke key A mes sage appears stating Internal Printer Is Disabled When the built in printer is DISABLED you can enable it by selecting option 1 When the printer is disabled option 1 reads Enable Printer You can enable the printer by confirming that the arrow cursor is pointing to option 1 and pressing the key A message appears stating Internal Printer Is Enabled L 000867 A 2 9 QBC STAR System Operator s Service Manual 2 10 External Printer External Printer lets you ena
14. shown in Figure 19 A sampl 20 e results readout is shown in Figure You can print additional copies of the results report by pressing the Star button after the first printout completes You must reprint the report BEFORE opening the door L 000867 A QBC STAR Hematology Results Patient Date DEC 10 1998 Time 2 37 pm Software Version 12 20 98 3 00XX Instrument S N XXXXXXX Hematocrit Hemoglobin MCHC Total WBC Granulocytes Granulocytes Lymph Monos x10 L Lymph Monos Platelets x10 L g dL g dL x109 L x109 L Electronic QC Passed Figure 19 Sample Results Printout lematocrit 45 5 Hemoglobin el CHE 29 2 Gf Ola Total WBC 7 9 10 Granulocytes a B O Granulocytes 62 3 Lymph Monos 30 xO All Lymph Monos 38 Platelets SUSO Ie Figure 20 Sample Results Readout L 000867 A 4 9 QBC STAR System Operator s Service Manual C Tube Disposal After the results have been printed and you have reviewed the printout s for clarity open the instru ment door by pressing the door release latch Remove the QBC STAR tube Discard the tube in a biohazard container O Power Down If desired after testing is completed you can turn instrument power off by placing the power switch in the off O position Note that if you leave the power on continuously the instrument will perform a power on self test every eight hours and print
15. the POWER SOURCE Do not attempt to move the instrument rotor by hand Moving the rotor manually can cause damage to the instrument L 000867 A 1 7 2 Installation and Setup Unpacking and Setup The QBC STAR instrument weighs approximately 30 pounds Use caution when lifting and moving the instrument Carefully unpack the QBC STAR instrument noting any damage to the shipping carton If damage is ob served notify the carrier immediately After unpacking remove the instrument from the plastic bag and place it on a level stable working surface free of holes Remove the packaging material cardboard and foam block from inside the instrument door A clearance envelope should be marked 11 8 in 300 mm from each side of the unit The operator should not stand within the clearance envelope longer than necessary for operational purposes Proceed with electrical connection described below Electrical Connection Connect the female end of the power cord to the QBC STAR instrument see Figure 4 Connect the male end of the power cord to the main AC power source To avoid electrical shock connect the power cord only to an approved power source such as a 3 wire grounded receptacle If a 2 wire receptacle is all that is present have it replaced with a properly grounded 3 wire receptacle in accordance with the National Electrical Code WARNINGS IF THE EQUIPMENT IS USED IN A MANNER NOT SPECIFIED BY THE MANUFAC TURER THE PRO
16. to open Defective lid solenoid or internal Request authorized service parts L 000867 A 7 1 QBC STAR System Operator s Service Manual Error Codes and Messages EXX System Error POSSIBLE CAUSES All the E type error codes for example E02 E13 etc indicate either software or hardware problems These problems can cause the instrument to be inoperative Some errors indicate that a component has failed or is near failure When E type errors occur all instrument operations cease The E code is displayed and the system prompts you to press the Star key to continue CORRECTIVE ACTIONS Note the error number Press the Star key when prompted This causes the instrument to start a self test The instrument will attempt to confirm any detected abnormalities Follow the instructions on the LCD If the problem persists contact QBC Diagnostics Inc for assistance Fill Error POSSIBLE CAUSES The tube s fill volume was incorrect CORRECTIVE ACTIONS Tube that caused error must be prepared and tested again To prevent error fill all tubes between the two black fill lines on the tube Sample Already Processed POSSIBLE CAUSES The system has detected one of two conditions 1 The tube placed in the instrument has already been tested 2 The tube was not placed in the instrument promptly after filling within 15 minutes of filling 3 The sample leaked into the plastic safety sleeve CORRECTIVE
17. valve will stop any blood from flowing into the adapter If necessary insert other tubes in the proper order and repeat the collection procedure Gently remove the needle from the venipuncture site Apply sterile gauze to the site while keeping the arm extended Keep pressure on the site for at least 2 minutes Ensure that bleed ing has stopped and apply a bandage over the site Instruct the patient to wear the bandage for at least 15 minutes Gently invert any tube s containing anticoagulant or clot activators as in SST Brand tubes five to ten times to mix the blood with the additive Do not shake the tube vigorously because this will damage the blood cells and possibly lead to erroneous test results 9 Dispose of needle s in a sharps container Dispose of gloves and gauze in an appropriate biological hazard container Wash hands Collecting Multiple Specimens from a Single Venipuncture When drawing more than one tube of blood from a single venipuncture using evacuated tubes with various additives use the tubes in the following order e Blood culture e Red Stopper or Red Gray SST Brand tube e Blue Stopper e Green Stopper e Lavender Stopper e Gray Stopper Areas to Avoid When Drawing Venous Specimens e Scarred areas such as healed burns e Thrombosed veins These veins feel thick and cord like and tend to roll e Bruised areas If you cannot avoid collecting from a bruise site then draw the specimen from the
18. ACTIONS Remove incorrect tube from instrument Place correct tube in instrument and press Star key to begin testing If problem recurs rerun test with new tube If tube was not previously tested and was prepared in a prompt time frame ensure proper technique in capping the sample Sample Cap Not Seated POSSIBLE CAUSES The system has detected that the tube cap is not seated properly on the tube CORRECTIVE ACTIONS Press firmly to seat caps in place Replace tube in instrument and press Star key to begin testing Sample Error XX POSSIBLE CAUSES Note the error number if you must contact QBC Diagnostics Inc for assistance All the sample errors indicate that the readings obtained from the blood sample were out of the acceptable range It is possible that the sample was drawn or processed incorrectly CORRECTIVE ACTIONS Rerun test with new tube and sample If problem recurs perform the assay by a different method and contact QBC Diagnostics Inc Sample or Cap Not Present POSSIBLE CAUSES The Star key was pressed but there is no tube in the instrument or no cap on the tube CORRECTIVE ACTIONS Insert tube in instrument and press Star key to begin testing If tube was present but cap was missing do the following 1 Locate cap 2 Place cap firmly on end of tube 3 Place tube in instrument 4 Press Star key to begin testing Tube Error XX POSSIBLE CAUSES Note the error number if you must contact QB
19. C Diagnostics Inc for assistance The system has detected a physical problem with the tube itself Possible causes include blood leakage tube breakage etc 7 2 L 000867 A 7 Troubleshooting CORRECTIVE ACTIONS Rerun test with new tube and sample If problem recurs perform the assay by a different method and contact QBC Diagnostics Inc Unit is too hot to operate POSSIBLE CAUSES The internal temperature of the instrument exceeds 45 C CORRECTIVE ACTIONS Make sure there are at least 2 inches of clearance around the instrument for airflow Make sure instrument s environmental conditions meet the requirements specified in Section 2 If they do and unit continues to issue heat warnings contact QBC Diagnostics Inc for assistance External Printer Problem POSSIBLE CAUSES There is a problem with the external printer Problem could be paper supply is exhausted paper jam exists cable has become disconnected power is not turned on or other problem CORRECTIVE ACTIONS Check paper supply to the printer paper jam condition cable connection to the printer power to the printer If these are okay check printer s status lights and refer to the printer s operating instruc tions Internal Printer Problem POSSIBLE CAUSES There is a problem with the internal printer Problem could be paper supply is exhausted or paper jam exists Paper release lever could be in open forward position CORRECTIVE ACTIONS Check paper
20. IN ADDITION TO WEARING GLOVES THE USE OF DISPOSABLE LAB COATS OR GOWNS AND PROTECTIVE GLASSES OR GOGGLES IS RECOMMENDED WHEN WORKING AROUND THE INSTRUMENT L 000867 A E 1 QBC STAR System Operator s Service Manual Venous Blood Collection Venipuncture Supplies e Disposable gloves e Tourniquet e Alcohol pads e Sterile gauze e Bandage e VACUTAINER Brand or other evacuated blood collection system Tubes containing EDTA anticoagulant lavender top Needles Needle holder adapter e Sharps container e Marking pen Procedure 1 Identify the patient by having him or her or a guardian state his full name 2 Select the appropriate blood collection supplies Establish the order of evacuated tubes if multiple specimens are drawn 3 Label all evacuated blood collection tubes with the patient s name and the time and date the speci men is drawn 4 Position the patient with the elbow extended and the arm supported Have the patient make a fist but avoid vigorous pumping or other hand exercise 5 Apply the tourniquet about 3 4 inches above the venipuncture site Do not stop the blood flow for more than one minute before the blood is drawn If necessary release and reapply the tourni quet 6 Select the venipuncture site The median antecubital and cephalic veins are most commonly used 7 Clean the venipuncture site with an alcohol pad making one smooth circular pass of the veni puncture site Allow th
21. QBC STAR System Operator s Service Manual a a Diagnostics 2006 02 QBC Diagnostics Inc Document Number L 000867 200 Innovation Blvd Suite 212 Revision A State College PA 16803 USA 877 231 3115 QBC Star System Operator s Service Manual Reason Updates for software version 3 0 QBC QBC Star are registered trademarks of QBC Diagnostics Inc Adams and Vacutainer are regis tered trademarks of BD Copyright QBC Diagnostics Inc 2006 All rights reserved No part of this publication may be repro duced transmitted transcribed stored in retrieval systems or translated into any language or computer language in any form or by any means electronic mechanical magnetic optical chemical manual or otherwise without the prior written permission of QBC Diagnostics Inc 200 Innovation Blvd Suite 212 State College PA 16803 United States of America VS 0226 ii L 000867 A Contents T Introducti no nee oe een ee ee 1 1 laia A nasuta aS tdt u ayata 1 1 EA Test anon EA ae fe ee ete hele A nerd au tose mete et dhe lite 1 1 SYSCEMMOVERVICW wish bccn dde aida 1 2 OBC STAR Blood Collection Tubes l m Lu a a ua SS t ea dica adas 1 2 QBE STAR IHStTUMENT se a o demi ea de de 1 3 Instrument Self Testing and Calibration_ an onn conocia 1 4 MANUALS TUCU A aa 15 a 15 Os AIM obs teh 15 A A 1 6 Symbols Used n the EQUIPMENT 1 6 Notes Cautions and Warnings noei eraren E
22. TECTION PROVIDED BY THE EQUIPMENT MAY BE IMPAIRED DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUND PRONG FROM THE INSTRUMENT POWER PLUG Should the power cord or plug become cracked frayed broken or otherwise damaged replace them im mediately see Appendix B for part number Never attempt to override electrical safety interlocks of the instrument L 000867 A 2 1 QBC STAR Specifications Height loading door open 16 3 in 41 4 cm 16 in 40 6 cm 16 3 in 41 4cm Clearance 11 8 in 30 cm Electrical Specifications Voltage 100 240 VAC 10 Frequency Current less than 4 amperes 185 watts nominal 285 watts peak 293 BTU 3 tests per hour L 000867 A gt N 2 Installation and Setup Environmental Specifications Non Operating Storage j I Humidity 10 95 non condensing Operating 16 C 32 C unrestricted at 32 C 37 C Temperature use may be limited by instrument temperature shutdown or some results may be suppressed Humidity 10 95 non condensing Ambient Light 15 150 ft candles lt 70 db 3 ft Up to 2 000 m 2 any direction without restraint 10 any direction with restraint Surface Inclination Decontamination 10 dilution of Household bleach solution IEC 664 Pollution Degree Category 2 IEC 663 Installation Category II L 000867 A 2 oO QBC START System Operator s Service Manual Reporting Ranges
23. aAa ar EA AAN E ai aE AE a aA ieia ea 1 6 Summary of Warnings and Cautions enenenmnseennennnnnenmennnnenennnneennne nennen 1 7 2 installation and Setup nenne aan ie 2 1 Unpacking and Setupu q e ea reta el od RL 2 1 Electrical Connection a eier 2 1 QBC STAR Specifications lu S a Ss 2 2 External Connections ad 2 4 Gonnecting an ExternaliPrintersnse ee 2 4 Updating System Software 6 Bandes Ei seine 2 6 System setup and Ulsa HE 2 6 RR A Bn id alles 2 6 LEDICONtraS tinc dd test ee en yaku s a nn dl hulu os Denies de TE 2 7 Date and Mera A AA A a 2 7 DIEE ENAKE PACE o DE E E ea aaa elta een 2 8 A 2 8 RAINE Data ES na m aye ce bind ttc cota AO Meca Lcda tea calla mm eh Bann all eta lees En ei SUR 2 8 A an 2 8 MOS OPUS ea u Au 2 8 3 Controls and Indicators u u 3 1 General Deuss Oey cre AA andere di la a a anne uot ed MUSE 3 1 Power pea hence tn Su Se EI Qa asta oc om kau aa aka Su Ma tes chi qa saat Je cour Note a Pt W 3 1 A A A E EEE AA A O Merten salva Meee S uk I apa Ca uqa as sa 3 2 Door Release Lat e A Se cue ne eo e AS ca EAS 3 2 Liguid Grystal Dd cor ua sya 3 2 L 000867 A iii QBC Star System Operator s Service Manual Contents ATA AEAEE e dd de nd eo Ou aa un h kta tad Rs aA do 3 3 Paper Release Leven a ea um med a dd dos en e le o nahe 3 3 Manual Advance Wheel Bam eat edie did at 3 3 Floppy Disk Drive ann aa e ah hee Saa
24. avented plug at the end of the tube e atube carrier 3 Glass Tube Carrier Plastic Sleeve Cap Assembly S Eyi s Seal Fill Lines Vented Plug Figure 1 QBC STAR Blood Collection Tube Tubes are filled by capillary action with 65 to 75 uL of whole blood This is the volume when the tube is filled between the 2 fill lines marked on the QBC STAR tube The blood can come directly from a fingerstick or from a VacutainerTM brand blood collection tube or equivalent lavender top only The plug has a vent allowing air to escape during filling of the tube The vent closes off when the tube is capped After the tube assembly is filled with blood the tube is mixed and the cap assembly is placed on the tube The cap consists of the following components e A precision molded plastic float e Alloat holder e The cap 1 2 L 000867 A 1 Introduction Placing the cap on the tube performs two actions simultaneously e It seals the tube carrier e It inserts the float into the QBC STAR tube The density of the float is matched to the density of the buffy coat so that it centers itself in that region The float expands the buffy coat by a factor of ten during centrifugation If a tube breaks during centrifugation blood and glass are fully contained within the capped tube carrier This design provides a high degree of user and instrument protection from exposure to blood and aerosols QBC STAR Instrument The QBC STAR Instrument is a com
25. ble or disable a printer that would be attached to the printer port on the back of the instrument It also lets you enable or disable color printing to the external printer When you select the option a sub menu titled EXTERNAL PRINTER appears Enable Disable External Printer When the printer is ENABLED the menu lets you disable the printer by selecting option 1 External printing is disabled by default When the printer is enabled option 1 reads Disable Printer You can disable the printer by confirming that the arrow cursor is pointing to option 1 and pressing the Le key A message appears stating External Printer Is Disabled When the printer is DISABLED you can enable it by selecting option 1 When the printer is disabled option 1 reads Enable Printer You can enable the printer by confirming that the arrow cursor is pointing to option 1 and pressing the ke key A message appears stating External Printer Is Enabled Enable Disable Color Printing When color printing is ENABLED the menu lets you disable it by selecting option 2 Color print ing is enabled by default When color printing is enabled option 2 reads Disable Color You can disable color printing by confirming that the arrow cursor is pointing to option 2 and pressing the lt d key A message appears stating Color Disabled When color printing is DISABLED you can enable it
26. by selecting option 2 When color printing is disabled option 2 reads Enable Color You can enable color printing by confirming that the arrow cursor is pointing to option 2 and pressing the key A message appears stating Color Enabled SI STD Units SI STD Units lets you select whether certain results are reported in Sl units millimoles per Liter or STD units grams per deciLiter The results that are affected are Hemoglobin and MCHC When SI units are selected menu option 4 reads STD Units You can select STD units by using the a or key to move the arrow cursor up or down the list until it is pointing to option 4 Then press te on the keypad A message appears stating STD Units Selected When STD units are selected menu option 4 reads SI Units You can select SI units by using the a or key to move the arrow cursor up or down the list until it is pointing to option 4 Then press el on the keypad A message appears stating SI Units Selected L 000867 A 3 Controls and Indicators General Discussion The QBC STAR Hematology System has been designed so that there are only two routine user controls the Star Button which has several functions that are described below and the Door Release Latch which is only used to open the door to insert or remove QBC STAR Blood Collection Tubes All the instrument controls buttons s
27. cal care requires that laboratory values be correlated with each patient s symptoms and signs by a trained prac titioner Operating Ranges lists the validated upper and lower limits of the operating range Values above and below these validated ranges are not displayed and should be confirmed by an alternate method The QBC STAR reagent tube has been formulated to provide optimum packing and layering of normal cells In a small number of patients however the system cannot read certain parameters and will not report a value User errors in processing or use of outdated or inappropriately stored tubes can also result in non reported results Practitioners must not assume that unreported values are normal further testing with an alternative method is essential Automated granulocyte and lymphocyte monocyte differential counts cannot replace the conventional manual differential Due to the grouping by density of the cell populations by the QBC test method the system cannot discriminate between normal and abnormal cell types in disease states characterized by the presence of abnormal white cell types or nucleated red blood cells If abnormal cell populations are suspected verification of QBC test results or testing and diagnosis by alternative methods is essential The combined lymphocyte monocyte count should not be used to test for lymphocytopenia in evaluating patients with known or possible immunodeficiencies Further evaluation of lymphocyte monocy
28. ce the QBC STAR instrument in its normal upright position 4 10 L 000867 A Bottom of instrument Figure 21 Door Unlatch Access Hole L 000867 A 4 11 5 Performance and Limitations Operating Ranges Hematology parameters measured with the QBC STAR system are valid over the following range of values Hematocrit 15 65 Hemoglobin 5 0 20 0 g dL Platelet Count 20 999 x 10YL WBC Count 1 6 99 9 x 10 L Granulocyte Count 0 8 70 0 x 10 L Lymph Mono Count 0 8 99 9 x 10 L Results that fall outside these ranges may be confirmed by alternate methods Precision Data on typical within run precision tests on QBC STAR tubes tested in the QBC STAR system are shown in the two tables below The precision data represents the analysis of ten whole blood specimens each assayed in replicates of 10 Whole Blood Total Imprecision Parameter Mean Value Mean CV Parameter Range Max S D L 000867 A 5 1 QBC STAR System Operator s Service Manual In a separate precision study intra and inter run precision were assessed using a dual level QBC Control 424304 The controls were assayed on multiple days at three sites using QBC STAR tubes and the QBC STAR system The results of this study are presented in the table below Control Precision Control Level 1 Control Level 2 Intra Day Intra Run Intra Day Intra Run Parameter CV df CV 0 28 1 58 HCT 1 37 1 66 0 73 1
29. ce the natural sepa ration properties of a whole blood sample when it is centrifuged A special coating in the QBC STAR tube stains the two white blood cell populations granulocytes appear orange yellow and lymphocytes monocytes appear green and the platelet layer platelets appear yellow orange The ability to quantify the cells is also enhanced by the insertion of a precision plastic float into the QBC STAR tube that mechanically expands the buffy coat layers The hematocrit white blood cell counts and platelet count are directly measured from the cell layers The float whose density approximates the buffy coat cells will also penetrate the red blood cell layer The QBC STAR hemoglobin measurement is directly related to the density of the red blood cells and is based on the depth of penetration of the float into the red blood cell layer Mean corpuscular hemoglobin concentration MCHC is electronically calculated using the standard formula HGB HCT 100 The QBC STAR tube is also internally coated with anticoagulants that allow collection of capillary blood directly from a skin puncture site The QBC STAR System is intended for in vitro diagnostic use WARNING CAREFULLY OBSERVE ALL WARNINGS AND PRECAUTIONS IN THIS MANUAL AND ON LABELING OF QBC STAR TUBES CONCERNING THE SAFE HANDLING OF BLOOD AND BLOOD DERIVED PRODUCTS L 000867 A 1 1 QBC STAR System Operator s Service Manual System Overview The QBC STAR Hematolog
30. ct another item use the or key to move the arrow cursor up or down the list When the desired option is selected press on the keypad When you press the menu disappears and the cursor appears next to the item you selected Press the a or key to increase or decrease the value When the desired value is shown press Le To return the original value press ESC L 000867 A 2 7 perator s Service Manual DATE amp TIME 1 Year 2 Month 3 Date 4 Hour 5 Minute 6 AM or PM 7 EXIT Disable Auto LCD Contrast As the QBC STAR instrument is used it may warm up several degrees This can cause the LCD screen contrast to change The instrument monitors operating temperatures and automatically adjusts the contrast The Disable Auto LCD Contrast option lets you enable turn on or disable turn off the automatic contrast adjustment of the LCD screen When you select the option a message tells you whether the auto contrast is currently enabled or disabled Press the or key to change the status from enabled to disabled or vice versa When the desired status is shown press Save Data This option is for factory use only Print Data This option is typically used to help QBC Diagnostics Inc personnel to troubleshoot possible problems When selected Print Data sends raw scan data from tube readings and diagnostic para
31. e alae ha 4 5 Inserting the Tube into the Instrument n anna rra 4 6 Sample Results PriNTO T tias dile Ri 4 9 ASS n sssnnrssnsssrssssssssrsssssss 4 9 Door Unlateh Acc ss Helea coa sense dde entidad ella ad 4 11 Replacing Printer Paper a a e ad e y Sua 6 2 Replacing FUSES vt a er keine 6 3 L 000867 A QBC STAR System Operator s Ser ice Ma ual BC Diagnostics Inc 1 Introduction Intended Use The QBC STARTM Centrifugal Hematology System provides a diagnostic hematology profile on venous or capillary blood providing values for e Hematocrit e Hemoglobin e Mean Corpuscular Hemoglobin Concentration MCHC e Platelet count e White blood cell count e Granulocyte count and number Lymphocyte monocyte count and number Principles of the Test It has been known for many years that the grayish white layer buffy coat that appears above the red blood cells in a hematocrit tube contained packed layers of leukocytes white blood cells and thrombo cytes platelets gt The QBC STAR Centrifugal Hematology System uses technologies that make it possible to quantify the buffy coat cells When the QBC STAR tube is filled with blood and placed into the QBC STAR instrument the tube is spun at a high rate of speed causing the different types of cells in the blood to separate into layers or bands from the heaviest to the lightest The QBC STAR System uses a special tube designed to enhan
32. e can be either a capillary fingerstick drop of blood or a source of anticoagulated ve nous blood such as a VacutainerTM tube lavender top only The QBC STAR tube fills itself by capillary action That is when you touch the collection tip of the tube to the blood sample it is drawn into the tube automatically NOTES Use only QBC STAR tubes in the QBC STAR instrument Place the tube into the instrument within 15 minutes of filling Whatever blood source you use make sure you touch just the collection tip of the tube to the blood For Venous Blood Samples It is important that you gently mix the blood sample immediately before filling the QBC STAR tube Invert the capped sample tube 12 15 times as shown in Figures 10 and 11 As an alternative you can mix the sample on a mixer such as the Adams Nutator WARNINGS DO NOT HANDLE THE QBC STAR TUBE BY THE GLASS COLLECTION END OF THE TUBE DO NOT USE ANY QBC STAR TUBE IF ANY PART OF THE CARRIER OR TUBE IS CHIPPED OR CRACKED 4 2 L 000867 A 4 Operation Figure 10 Sample Vial Figure 11 Inverting the Sample Vial Open the QBC STAR tube package by placing a fingernail between the foil seal and the molded plastic packaging and lifting and peeling the foil layer away After mixing tilt the sample vial to bring the blood up to the open end Place the collection tip of the QBC STAR tube in contact with the blood as shown below Figure 12 shows a venous blood
33. e printer It is a knurled wheel Rotate the wheel toward the rear to advance paper when loading Rotate the wheel forward to retract paper for example to unjam a paper jam Figure 7 Printer Controls L 000867 A 3 3 QBC STAR System Operator s Service Manual Floppy Disk Drive The floppy disk drive is used primarily for software updates It is located on the front panel of the instrument at bottom right To access the drive flip the top of the access door downward Disks should be inserted with the shutter first and the label upward See Figure 8 for disk controls and indicators Floppy Disk Indicator The Floppy Disk Drive Indicator light is toward the left side of the drive below the insertion slot When off it indicates that no activity is occurring in the drive When on or flashing it indicates that the disk drive is accessing a floppy disk Do not attempt to eject a floppy disk while this indica tor is lit Floppy Disk Eject Button The floppy disk drive eject button is located toward the right side of the drive below the insertion slot When a floppy disk is inserted fully into the slot this button extends itself To remove a disk fully depress the eject button Do not attempt to eject a floppy disk while the floppy disk indicator is lit Figure 8 Floppy Disk Drive Controls and Indicators 3 4 L 000867 A 3 Controls and Indicators Setup Keypad The setup keypad is located to the front of the pr
34. e skin to dry to prevent hemolysis and to prevent the patient from having a burning sensation when the needle is inserted Do not touch the vein site after cleaning it 8 Perform the venipuncture a Wearing gloves gently grasp the patient s arm near the venipuncture site using the thumb to draw the skin tight b With the needle bevel facing up line up the needle with the vein Penetrate the skin and en ter the vein at an angle of approximately 15 30 degrees Holding the flange of the needle adapter push the evacuated tube forward allowing the back end of the needle to puncture the stopper to engage the vacuum E 2 L 000867 A E Blood Collection and Handling As the blood begins to flow into the tube release the tourniquet and open the patient s fist to avoid bleeding at the puncture site Keep constant forward pressure on the tube to prevent the shutoff valve from closing and stopping the flow of blood Allow tubes containing an anticoagulant to fill until the vacuum is exhausted and blood flow ceases assuring the correct ratio of blood to anticoagulant If a blood sample cannot be obtained change the position of the needle If the needle has penetrated too far into the vein pull it back a bit If it has not penetrated far enough move it further into the vein but do not probe with the needle You may need to try another tube Remove the tube from the needle adapter when the blood stops flowing The automatic shut off
35. esennesemnenensnennenenennnnnnnnen E 3 Errors to Avoid in Venous Blood Collection 24420sensensnneennnnnennnnnennnnnen nenne E 4 Capillary Blood Collect iba E a tido tiara date A da E 4 Suppl es uy 2 O TE de e E a to Ed BE Sa O E 4 Pr cedure naar Ad ii is E 4 Avoiding Hemolysis during Capillary Blood Collection as E 5 F Bibliography as nina F 1 L 000867 A V QBC Star System Operator s Service Manual Vi Figure 1 ON DWM UN Figures Description Page QBC STAR Blood Collection Tuben rs area a nn 1 2 OBE ST R INStEUMENE a He taw eur E a 1 3 Symbols Used on the QBC STAR Instrument rear ooooconnnccccooocccoonncconnnnonononononnnononononononcnnno 1 6 EXtErnal COnmections Mr nen een ces Oe 2 2 5 Power switch iei rsang a ea e a a a ae rae laea ea E EGTE 3 1 QBC STAR Controls and IRdicatorS a a a u e a E R ai 3 2 Printer Controls ern A nee 3 3 Floppy Disk Drive Controls and Indicators 2 4onesenesenenennennenennennennne 3 4 A AT 35 O e Sa a Bk 4 3 lnverting the Sample Vial sh iia 4 3 Filling a Tube from Venous Blood nnnennennneenmenennenenennennnnerneenne 4 3 Fili g ar Tube trom Capillary Bled uum ala 4 4 Mixing thes AAA Skid a oe ee cab ee Se dd 4 4 Tilingsthe TUD s a ee AA A a aa ea 4 5 WHEADPIRG he TUDO ca ctra des A EATE a A lated a od Oh A A E 4 5 Seating the Cap and Floats rinnen ade e
36. ffice name and a return phone number 7 4 L 000867 A CBC Complete Blood Count CCD Charge Coupled Device linear array photo detector gs Unit of acceleration 1g acceleration of gravity Gran Granulocytes Hgb Hemoglobin Hct Hematocrit L M Lymphocytes and Monocytes Lymph Monos Lymphocytes and Monocytes MCHC Mean Corpuscular Hemoglobin Concentration Pit Platelets rpm Revolutions per minute WBC White blood cell count L 000867 A G 1 A Limited Warranty This warranty gives you specific legal rights Additionally you may have other rights that vary from region to region The QBC STAR Centrifugal Hematology System is warranted to the original purchaser to be free from defects in materials and workmanship for a period of twelve months following installation QBC Diagnostics Inc sole responsibility under this warranty shall be to repair or replace any in strument or its components except for expendable supplies such as printer paper which under normal operating conditions prove to be defective within twelve months of delivery QBC Diagnostics Inc will furnish new or remanufactured components upon its option All replace ments shall meet new part specifications and shall be warranted as above for the remainder of the twelve month period Replaced components become the property of QBC Diagnostics Inc It is understood that the equipment covered by this Agreement has been insta
37. he instrument and how to set it up for operation e Read Section 3 Controls and Indicators It explains the lights readouts buttons switches etc that are found on the instrument e Read Section 4 Operation It tells you how to perform routine system operations Use of this Manual This Operator s Service manual is designed as a reference tool for personnel who operate the QBC STAR Hematology System on a regular basis Every attempt has been made to include all information which would be needed during normal use and maintenance of the system Should a question arise which is not answered in this manual please contact the following USA Technical Services 1 866 265 1486 Contact s are listed in Appendix D You can send in your comments or recommendations on this Operator s Service manual on the postage paid Reader Comment Card at the end of the manual If you prefer you can send e mail to qocsupport qbcdiag com Other documentation that may be of interest includes L 000867 A 1 5 QBC STAR System Operator s Service Manual QBC STAR Tube Package Insert This document contains important information on specimen prepa ration and the use storage and limitations of the tubes A package insert is included with each box of tubes and is available upon request from QBC Diagnostics Inc QBC STAR Tube Quick Reference Guide This document contains a summary of steps for preparing venous and capillary specimens and testing t
38. hem on the QBC STAR instrument Conventions Symbols Used on the Equipment The following symbols appear on the back of the QBC STAR instrument F Ten 250 V 3 15A Figure 3 Symbols Used on the QBC STAR Instrument rear Top figure Left Symbol for electrical hazard Right Symbol for refer to accompanying documenta tion specifically the user s manual for instructions Bottom figure Symbol for fuse Notes Cautions and Warnings Throughout this manual important information is presented in boxes offset from the regular text and is labeled as either a NOTE CAUTION or WARNING These messages are formatted as shown below and bear the following meaning NOTE Important information about system use worthy of special attention is pre sented as a NOTE CAUTION Information on an activity that potentially could cause damage to the instru ment or system is presented as a CAUTION WARNING INFORMATION ON AN ACTIVITY THAT POTENTIALLY COULD CAUSE INJURY TO THE USER IS PRESENTED AS A WARNING 1 6 L 000867 A 1 Introduction Summary of Warnings and Cautions Carefully observe all warnings and precautions in this manual and on labeling of QBC STAR tubes concern ing the safe handling of blood and blood derived products If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired Do not under any circumstances remove the ground prong f
39. holder out Replace bad fuse s Return holder Figure 23 Replacing Fuses L 000867 A 7 Troubleshooting If the QBC STAR instrument fails to operate properly consult the guides below DO NOT ATTEMPT TO PERFORM ANY SERVICE OR REPAIR THAT DOES NOT APPEAR IN THIS MANUAL Refer service problems to the Technical Service Department of QBC Diagnostics Inc 1 866 265 1486 USA Otherwise contact your nearest QBC Diagnostics Inc office for assistance The General Problems section presents some general symptoms that you might notice It also suggests cor rective actions These problems do not cause error codes to appear on the LCD or printout The Error Codes sections presents problems that DO cause error codes If any of these error messages appear use the chart to find the possible causes and corrective actions General Problems Consult the table below for general problems not reported by error codes messages General Instrument Problems Symptom Possible Causes Corrective Actions Power cord not plugged into unit or receptacle Door not latched Close door and latch securely Replace fuse s by following instructions in Section 5 Instrument vibrates Foam pads worn or missing on excessively bottom of instrument Plug cord into unit and receptacle Instrument fails to operate Line fuse blown Call Technical Services Use emergency door unlock procedure in Section 4 Power has failed Lid fails
40. ic Quality Control Label 000sssensnnsennennennnenennnnnen nn en nn 5 5 External UI Controls en eo rend 5 6 Proficiency Testi Hr ante iaa s 5 6 iv L 000867 A Contents 6 Maintenance nn ee ee ee 6 1 O A A na ee ee 6 1 Bisintactioni al a e eto dl A ct ated ua une kakak a a ten sehe nee 6 1 Replacing Printer Paper ss a e EE AE A m a ll adn nt um ee 6 2 REPIAEINGSEUSESE i eet na ae e e o dd eed led ada e O 6 3 7 Troubleshooting cnn cnn rra 7 1 GENErAlIPLODIEMS a smua m A ateo o a cd dan ral al ll ea o anna lana 7 1 Error Codes and Messages u tr een endet ala Beedle a aiaa rE aaea 7 2 G A G 1 A Limited Warranty u u u A 1 B Parts and Accessories cnn cnn narrar B 1 C Software Update Log morral taa C 1 D Contact ee ae een D 1 E Blood Collection and Handling J u E 1 GenheraliGommentsa asta Ae e OL ox Rd Re e na E 1 Universal Precautions for Specimen Handling enemnenenenmenenennnnnernennnne E 1 Venous Blood Collection Venipuncture 204seensennneensnnennennnnnennenennnennenennenneernenne E 2 Supplies A A uD Uu tattle a ate aS attach es A She Se LOE aaa pa E 2 Collecting Multiple Specimens from a Single Venipuncture nennenenmenmnnenne E 3 Areas to Avoid When Drawing Venous Specimens en
41. inter beneath the printer access panel It is used to enter setup information into the computer such as the date and time LCD contrast etc The setup keypad keys are described below Setup functions are described in Section 2 Installation and Setup ESC Key Press this key to cancel an action or to return to a previous menu a Key Press this key to increase a value or scroll upward in a list v Key Press this key to decrease a value or scroll downward in a list lt i Key Press this key to select a menu option Figure 9 Setup Keypad L 000867 A 3 5 WARNINGS BLOOD AND BODY FLUIDS MAY CONTAIN THE HEPATITIS B VIRUS HBV HEPA TITIS C VIRUS HCV HUMAN IMMUNODEFICIENCY VIRUS HIV OR OTHER DISEASE CAUSING AGENTS HANDLE ALL PATIENT SPECIMENS AS POTENTIAL BIOHAZARDS CAPABLE OF TRANSMITTING INFECTION WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT INCLUDING LABORATORY GLOVES WHEN COLLECTING HANDLING AND PROCESSING BLOOD AND BODY FLUIDS IN ADDITION TO WEARING GLOVES THE USE OF DISPOSABLE LAB COATS OR GOWNS AND PROTECTIVE GLASSES OR GOGGLES IS RECOMMENDED WHEN WORKING AROUND THE INSTRUMENT ACRIDINE ORANGE REAGENT MAY BE TOXIC DO NOT INGEST AVOID CON TACT WITH SKIN EYES AND CLOTHING IF A TUBE BREAKS IN THE UNIT CAREFULLY REMOVE THE TUBE WITH A HE MOSTAT OR OTHER DEVICE USING PUNCTURE RESISTANT UTILITY GLOVES CONTACT TECHNICAL SERVICES FOR ADDITIONAL INFORMATION Summary of
42. ll through the menu until you get to a selection labeled Print Data eOnce you are at Print Data press the Enter Key left bent arrow located on the far right of the keypad The printer will be activated and it will print 3 boxes with some graphical information followed by a block of numbers ePress the Escape Key to return to the regular sample testing mode 3 If using the internal printer the Diagnostic Scan printout will need to be sectioned and placed on a sheet of 8 Y x 11 paper prior to faxing to QBC Diagnostics Note the sheet may need to be photocopied in order to achieve satisfactory transmission results and to prevent jamming the facsimile machine 4 Fax the Diagnostic Scan information to QBC DiagnosticsTM Inc Technical Services 814 342 2449 Prior to faxing the scans please call QBC Diagnostics Technical Services Department 1 866 265 1486 Inform one of the Technical Specialists that you are faxing Diagnostic Scan information for review 5 Please provide the following information with the fax Lot Number and Expiration Dates of the QBC STARTM tube being used The QBC STARTM Serial Number which is located on the rear data label and inside the access door covering the diskette drive Additionally please include the sample type being tested i e QBCTM Control or other vendor s control Proficiency Test or patient blood sample Please use a coversheet that includes your name o
43. lled in accordance with the recommendations and instructions in the QBC STAR System Operator s Service Manual Any damage to a QBC STAR system resulting from the insertion or removal of cables that connect this instrument to systems other than those approved or supplied by QBC Diagnostics Inc or the failure of the owner to maintain reasonable care and precautions in the operation and mainte nance of the system will void this warranty and terminate the obligations of the manufacturer as stated herein The warranty stated herein shall extend to the original consumer only and not to any subsequent consumer of the instrument This warranty is in lieu of all other warranties whether express or implied including but not limited to warranties of merchantability or fitness for a particular use In no event will QBC Diagnostics Inc be liable for indirect incidental special or consequential damages regardless of whether QBC Diagnostics Inc has been advised of such L 000867 A A 1 B Parts and Accessories Item Catalog Number Paper Printer 3 pk 429580 Fuses 250V 3 15A 5x20 mm 5 pk 429581 QBC STAR Tubes box 100 429625 Power Cord U K 421554 Power Cord Europe 421551 Power Cord USA 421634 L 000867 A B 1 C Software Update Log Whenever you receive a software update please take a moment to log it below This can assist you and QBC Diagnostics Inc personnel in identifying software revision levels potential s
44. llege of Phycisians ACP 1159 Business Park Drive 2011 Pennsylvania Ave NW Traverse City MI 49686 Suite 800 800 333 0958 Washington D C 20006 800 338 2746 American Academy of Family Physicians College of American Pathologists CAP PT Program Coordinator Surveys Department 11400 Tomahawk Creek Parkway 325 Waukegan Road Leawood KS 66211 Northfield Illinois 60093 800 274 7911 800 323 4040 American Association of Bioanalysts AAB 205 West Levee Brownsville Texas 78520 800 234 5315 5 6 L 000867 A WARNINGS THE USER SHOULD NOT PERFORM ANY SERVICING EXCEPT AS SPECIFICALLY STATED IN THIS MANUAL REFER OTHER PROBLEMS TO TRAINED PERSONNEL OR RETURN THE INSTRUMENT TO QBC DIAGNOSTICS FOR REPAIR TURN INSTRUMENT POWER OFF AND UNPLUG THE POWER CORD BEFORE SERVICING Cleaning You should occasionally wipe interior and exterior surfaces of the QBC STAR instrument with a damp cloth You can use a mild detergent to remove stains Keeping these parts clean helps prolong the life of the instrument Disinfection Ifa QBC STAR tube breaks while in the instrument the spread of blood and glass is substantially contained by the capped tube carrier This device design provides a high degree of user and instrument protection from exposure to blood and aerosols If blood or glass should escape the plastic protective tube clean and disinfect the QBC STAR instrument as follows 1 Put on puncture resistant gloves Use a hemostat or
45. me testing The system can detect if a sample has already been tested If this occurs the message Sample already processed appears on the LCD The readout prompts you to remove the sample tube and unlocks the door to enable removal A previously processed sample can not be processed or analyzed a second time The instrument mixes the tube contents for as long as 30 seconds using a low speed spin The float descends from the top of the tube toward the closure end of the tube This mixes the blood and reagents in the tube A countdown displays the time remaining in the cycle After mixing is complete the centrifuge accelerates to high speed to separate and pack the cell populations into distinct cell bands A countdown displays the time remaining in the cycle Finally a series of readings is taken The messages Reading Cycle In Progress Scanning QBC Sample and Analyzing QBC Scan Data are displayed while tests are being performed It is normal for clicking sounds to be heard during the testing process O Printing of results When the test is complete the results are automatically displayed and printed L 000867 A NOTE DO NOT OPEN THE INSTRUMENT DOOR UNTIL THE RESULTS ARE REVIEWED AND PRINTED Test results are cleared from the display when the instrument door is opened You must manually keep track of link between the test results and the patient A space is provided on the printout for writing the patient
46. meters to the selected printer The information is useful only to QBC Diagnostics Inc technical personnel in trying to determine the source of errors that may occur Shipping Prep This option prepares the instrument to be physically shipped It performs three functions First it al lows the rotor to spin freely Second it moves the optics carriage back so that protective foam can be inserted Third it unlocks the door for the insertion of the foam After you select this option a message advises you to turn off instrument power prior to inserting the foam More Options If you select number 7 More Options a new menu appears with additional selections See the sample graphic on following page L 000867 A 2 Installation and Setup MORE OPTIONS gt 1 Set Language 2 Internal Printer 3 External Printer 4 SI Units 5 EXIT Set Language Set language lets you select from the following languages German Deutsch English Spanish Espa ol French Francais Italian Italiano When you select the option a sub menu titled LANGUAGES appears It lists these language selections The arrow cursor gt points to the item that is currently selected When you first access the menu the cursor points to the first item Deutsch To select the current item press ke on the keypad To select another item use the or key to move the arrow cursor up or down the list When the desired option is
47. nd motors are fully functional Should you choose to leave the system on continuously the test will automati cally be repeated every 8 hours A tri level internal electronic quality control label electronic QC label designed to simulate 3 hematology specimens simulating low cell counts normal cell counts and elevated cell counts tests the system s optics against values established at the time of manufacture At the end of the self test the instrument prints the hematology values obtained from reading the electronic QC label The hematology values may be plotted to evaluate for shifts or trends in the data The instrument will flag any results that are outside the set limits print an error code and automatically shut down operation of the instrument until the problem is corrected and a valid self test is performed 3 Electronic QC during each sample run The tri level electronic QC label is re checked during each sample run The instrument will recognize any results that are outside the set electronic QC limits print an error code and automatically shut down operation of the instrument until the problem is corrected and a valid self test is performed Additional built in checks include tests for proper centrifuge speed optical focus and internal temperature When these quality control checks are successfully completed the status of the electronic QC is printed on the patient record as Electronic QC Passed 4 Sample Preparation QC
48. not press or scrape the collection device on the skin e To avoid clotting in capillary blood collection Keep the puncture site clean by wiping off excess blood on skin around puncture Touch collection device only to drop of blood as it exits the puncture site Do not scoop off skin L 000867 A E 5 Wintrobe M M 1933 Macroscopic Examination of the Blood American Journal of Medicine SC 185 58 71 Olef I 1937 The Determination of Platelet Volume Journal of Laboratory and Clinical Medicine 23 166 178 Bessis M 1940 Une m thode permettant L isolement des diff rents l ments figur s du sang Sang 14 262 Davidson E 1960 The Distribution of the Cells in the Buffy Layer in Chronic Myeloid Leuke mia Acta haemat 23 22 28 Zucker R M and Casse B 1966 The Separation of Normal Human Leukocytes by Density and Classification by Size Blood 34 5 591 600 Jackson J F 1961 Supravital Blood Studies Using Acridine Orange Fluorescence Blood 17 643 17 643 649 Wardlaw S C and Levine R A Quantitative Buffy Coat Analysis JAMA 5 617 620 1983 Data on file at Becton Dickinson Biosciences Division Sparks MD 21152 Young D S Pestaner L C and Gibberman V 1975 Effects of Drugs on Clinical Laboratory Tests Clinical Chemistry 21 313D 3454D 346D 390D 391D 392D Elking M P and Kabat H 1968 Drug Induced Modifications of Laborato
49. nstrument Insert the tube into the QBC STAR instrument oriented as shown in Figure 18 The tube must be inserted into the instrument within 15 minutes of being prepared and capped The best way to insert the tube is to first place the uncapped end into place then pivot the capped end of the tube down into the recessed area If the bottom end is not seated correctly the tube will not pivot down into place If this hap pens just lift the tube out make sure the cap is seated fully and place the tube back into the instrument as described above O Close the instrument door Make sure the door clicks into place Figure 18 Inserting the Tube into the Instrument O Start the test To start the test press the Star button The system automatically locks the door electromechanically This prevents it from being opened during high speed centrifuge operations The system initially performs several checks on the sample If it detects that a cap is not seated properly the message Sample Cap Not Seated is shown If this happens the system unlocks the door to enable removal You can reseat the cap place the tube back in the instrument and press the Star button to resume testing 4 6 L 000867 A If there is no tube in the rotor or if the cap is not present the message Sample or Cap Not Present appears To proceed place the cap on the tube or place the tube in the instrument and press the Star button to resu
50. oftware problems etc Date Software Date Installed Received Version Installed L 000867 A C 1 QBC Diagnostics Inc 200 Innovation Blvd Suite 212 State College PA 16803 USA Voice 814 231 7660 e Fax 814 231 3118 Toll Free Technical Services 1 866 265 1486 Customer Service 1 877 231 3115 www qbcdiagnostics com L 000867 A D 1 E Blood Collection and Handling General Comments The quality of a test is only as good as the quality of the specimen The following guidelines help ensure the quality of the blood specimens collected in your office as well as the safety of the staff performing the tests These specimen collection guidelines are derived fromthose recommended bythe National Commit tee for Clinical Laboratory Standards NCCLS in the specimen collection section of the Physician s Office Laboratory Guidelines NCCLS Document POL1 and POL2 For more information contact NCCLS at 771 East Lancaster Avenue Villanova PA 19085 215 525 2435 Universal Precautions for Specimen Handling WARNINGS BLOOD AND BODY FLUIDS MAY CONTAIN THE HEPATITIS B VIRUS HBV HEPA TITIS CVIRUS HCV HUMAN IMMUNODEFICIENCY VIRUS HIV OR OTHER DISEASE CAUSING AGENTS HANDLE ALL PATIENT SPECIMENS AS POTENTIAL BIOHAZARDS CAPABLE OF TRANSMITTING INFECTION WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT INCLUDING LABO RATORY GLOVES WHEN COLLECTING HANDLING AND PROCESSING BLOOD AND BODY FLUIDS
51. pact portable centrifugal hematology analyzer The instrument contains a single tube centrifuge for sample mixing and for separating the blood into the various cell populations Analysis of the sample occurs in the centrifuge rotor while the centrifuge is running See Figure 2 A single filled QBC STAR tube is placed into the rotor the door is closed and the Star button pressed to start the test process The centrifuge cycle mixes and then separates the blood into distinct cell layers The instrument initially spins slowly for 8 to 12 seconds typically up to 30 seconds allowing the blood in the tube to mix Once mixing is done the centrifuge accelerates to a higher speed which is maintained for 4 minutes This stage separates the blood cell populations into distinct packed cell bands After the cell populations have been separated the centrifuge decelerates to measure the band lengths Analysis of the tube occurs at the illumination read station This station consists of a dual light source and optical detector system Figure 2 QBC STAR Instrument L 000867 A 1 3 QBC STAR System Operator s Service Manual Hematological results are shown on the Liquid Crystal Display Results are also automatically printed by the internal thermal printer onto a 2 25 inch paper tape The instrument contains the following subsystems e The centrifuge for mixing and separating the blood sample e An embedded microprocessor for machine cont
52. parallel printer cable or IEEE 1284 Centronics parallel printer cable 10 ft or less 8 x 11 letter or A4 paper no envelopes labels or custom sizes of paper How to attach an external printer 1 O vw A Q Unpack and set up the printer according to the manufacturer s operating instructions Connect the printer to the QBC STAR instrument s printer parallel port see Figure 4 using the cable specified above Verify that any printer cartridges are installed and that the correct size paper is present Turn on power to the QBC STAR instrument first Turn on power to the external printer second Go to the printer setup menu see below More Options and make sure you a disable the internal printer if you do not want to continue using it b enable the external printer and c enable or dis able color printing When turning power off turn off the printer first then the QBC STAR instrument L 000867 A 2 5 QBC STAR System Operator s Service Manual Updating System Software Updated versions of the QBC STAR Hematology System software may be provided to you from time to time You should install new software as soon as you receive it You should also log the update on the form in Appendix C of this manual Updated software is provided on 3 floppy disk labeled QBC STAR Software Version y yyz Y yy is the actual software version number and z is the revision letter To install a software upda
53. rol blood sample analysis and communications Memory to store the operating system and application software e A3 5 oppy drive for software updates e An internal printer e A Liquid Crystal Display to show results prompts and messages e Data ports for communication with optional external devices such as a keyboard bar code wand full size external printer Instrument Self Testing and Calibration Whenever instrument power is turned on or once every 8 hours if power is left on continuously the sys tem software performs a self test to verify proper operation The self test checks such things as centrifuge motor at various speeds emission Iter assembly optics assembly light source xenon ash lamp timing control optical clarity and focus internal printer rotor timing setup keypad An internal quality control label and rotor timing target are xed in place on the rotor assembly These items help the system verify that the optical measurement and centrifuge subsystems are functioning properly See paragraph 2 on Internal Quality Control Printout occurs automatically The instrument runs a built in calibration check every time a sample is processed Sample integrity checks include statistical matching of bandlengths ratios and absolute values for signal levels ratios that are used to evaluate the quality of interfaces measurement of oat length veri cation of optics and sensors measurement and evaluation of sample Il volume Addi
54. rom the instrument power plug Blood and body fluids may contain the Hepatitis B virus HBV Hepatitis C virus HCV human immunode ficiency virus HIV or other disease causing agents Handle all patient specimens as potential biohazards capable of transmitting infection Wear appropriate personal protective equipment including laboratory gloves when collecting handling and processing blood and body fluids In addition to wearing gloves the use of disposable lab coats or gowns and protective glasses or goggles is recommended when working around the INSTRUMENT ACRIDINE ORANGE REAGENT MAY BE TOXIC DO NOT INGEST AVOID CONTACT WITH SKIN EYES AND CLOTHING If a tube breaks in the unit carefully remove THE TUBE with a hemostat or other device using puncture resistant utility gloves CONTACT TECHNICAL SERVICES FOR ADDITIONAL INFORMATION Do not handle the QBC STAR tube by the glass collection end of the tube Do not use any QBC STAR tube if any part of the carrier or tube is chipped or cracked The user should not perform any servicing except as specifically stated in this manual Refer other problems to trained personnel or return the instrument to QBC Diagnostics for repair Turn instrument power off and unplug the power cord before servicing Do not immerse the QBC STAR instrument in water or other liquid Before BEGINNING to change the fuses MAKE SURE THE UNIT S POWER IS TURNED OFF AND disconnect the instrument POWER CORD from
55. ry Test Values American Journal of Hospital Pharmaceuticals 25 485 Williams W J Beutler E Lichtman M A Coller B S Kipps T J Ed Hemotology 5th ed New York McGraw Hill Co 1995 p 9 National Committee for Clinical Laboratory Standards Approved Standard H7 A 1985 Pro cedure for Determining Packed Cell Volume by the Microhematocrit Method Wintrobe M M 1981 Clinical Hemotology 8th Ed Lea amp Febiger Phila PA 1981 p 1885 1889 L 000867 A F 1
56. sample Figure 13 shows a capillary blood sample Figure 12 Filling a Tube from Venous Blood L 000867 A 4 3 QBC STAR System Operator s Service Manual Figure 13 Filling a Tube from Capillary Blood Fill the QBC STAR tube to the second black fill line Blood must always be filled to at least the first black line This results in a blood volume of between 65 and 75 microliters The instrument automatically identifies the tube type and detects if the fill volume is correct JMix the tube Rock the QBC STAR tube back and forth at least four times to mix the blood with the orange coating Do not allow the blood to touch the white plug at the end of the tube Note allowing the blood to flow from the collection end toward the plug end of the tube and back is equal to one rock Figure 14 Mixing the Tube 4 4 L 000867 A 4 Operation O Tilt the tube Tilt the QBC STAR tube as shown and allow the blood to move down the tube toward the center of the tube See Figure 15 Figure 15 Tilting the Tube C Cap the tube Remove the cap from the tube by pulling it straight off Place the cap over the collection end of the tube by guiding the glass end of the tube into the center of the cap Push the cap on firmly See Figures 16 and 17 r Figure 16 Uncapping the Tube Figure 17 Seating the Cap and Float L 000867 A 4 5 QBC START System Operator s Service Manual O Insert the tube into the i
57. site farthest away from the bruised area e The arm on the side of a prior mastectomy Because this surgery results in lymphostasis specimen collection may be difficult e The arm that has the A V shunt in a dialysis patient e Arecent IV site or the same side of the body as the IV site L 000867 A QBC STAR System Operator s Service Manual Errors to Avoid in Venous Blood Collection Do not underfill the tube This may result in excess anticoagulant interfering with the test result or cause hemolysis of the specimen Completely mix the tube to avoid clot formation in specimens collected in tubes containing anti coagulants Do not mix the specimen too vigorously Overly vigorous mixing may result in cell damage and hemolysis Do not overfill evacuated tubes when adding blood with a syringe This could adversely affect the ratio of blood to anticoagulant Overfilling anticoagulant tubes can also lead to excess pressure causing the stoppers to come off Capillary Blood Collection Supplies Disposable gloves Lancet with blade no longer than 2 0 2 4 mm Alcohol swab or pad Sterile gauze Bandage Sharps container QBC STAR tube Procedure E 4 Identify the patient by having him or her or a guardian state his full name Select and organize the appropriate blood collection supplies Select a puncture site With older children and adults use the third or fourth finger of the non dominant hand Choose a punct
58. supply to the printer or paper jam condition Verify that paper release lever is in closed rear position If these are okay contact QBC Diagnostics Inc for assistance For troubleshooting purposes refer to 7 4 to print a diagnostic scan for technical services to interpret L 000867 A 7 3 QBC STAR System Operator s Service Manual mm MA 2 A m G wasip a u a Diagnostics Date Issued 01 2006 Product QBC STARTM Model 429000 Subject Printing Diagnostic Scans Troubleshooting Tool Only 1 Diagnostic Scans can be obtained after allowing the QBC STARTM to process the sample and print the QBCTM Hematology results Blood samples from Patients QBCTM Controls amp Proficiency Test material can be evaluated using this procedure and are for troubleshooting purposes only 2 When the report has finished printing perform the following steps in order to print the Diagnostic Scan the sample can be printed as long as no other samples have been run prior to printing the Diagnostic Scan information eL ift the printer cover to expose the keypad underneath From Left to Right you will see the following touch pad buttons ESC Escape Up Arrow Down Arrow and the Enter Key left bent arrow located on the far right of the keypad See appropriate section in the Operator s Service Manual for additional details ePress the ESC key in order to access the Menu area eUsing the Down Arrow scro
59. te 1 Be sure the instrument is empty no tube in the rotor 2 Turn the instrument power off 3 Flip the floppy disk access door down Insert the software update disk in the floppy disk drive Insert the disk with the shutter first and with the label facing upward 4 Turn the power on The updated system software loads automatically When it is complete remove the software update disk and store it in a safe place in case the software ever has to be installed again System Setup and Utilities Before using the QBC STAR instrument for sample testing you should review system setup parameters to see if they are suitable for your laboratory These parameters include e LCD Contrast e Date and Time e Disable Auto L CD C ontrast e More Options includes Set Language and time format Internal External Printer SI Units In addition several utility functions can be performed through Setup These utilities are e Save Data e Print Data Shipping Prep Any changes to configuration parameters are in effect from the time of the change forward Also note that any changes you make cannot be cancelled per se if you change a value you must manually change the new value back to its previous state To Enter Setup Mode Lift and pull back the printer access panel Insure the instrument door is closed and latched Turn on instrument power with the power switch on the rear of the instrument Figure 5 BR Q N After the instr
60. te counts in relevant situations must include a manual differential and lymphocyte subset analysis The presence of abnormally sized platelets may lead to discrepancies between the QBC test method platelet count which is based on platelet mass and results obtained with an impedance counter which are based on measurement of particle number Expected Values The following table provides normal ranges reported in the literature 3 Offices or laboratories may choose to develop normal hematology ranges based on the characteristics of their patient population Parameter Range Hematocrit Males 42 0 50 0 Hematocrit Females 36 0 45 0 Hemoglobin Males g dL 14 0 18 0 Hemoglobin Females g dL 12 0 16 0 MCHC g dL 31 7 36 0 Platelet Count x10 L 140 440 WBC x10 L 4 3 10 0 Granulocyte Count x10 L 1 8 7 2 Lymphocyte Monocyte Count x10 L 1 7 4 9 5 4 L 000867 A 5 Performance and Limitations Controls Internal Quality Control The QBC STAR Centrifugal Hematology System has multiple built in quality control QC systems that maintain the overall system integrity and the quality of the test results it produces The QBC STAR System has five internal quality control elements 1 Factory calibration System calibration is set during manufacture and cannot be altered by the user 2 Instrument self test This test assures that each time the instrument is turned on the computer memory optics a
61. tional tests performed as part of each assay cycle include centrifuge speed and electro optical veri cation Results are reported on tube tests only if all veri cation and integrity tests pass The power on self test and sample integrity tests provide veri cation of instrument parameters such as timing speed disposable integrity reagent stability etc In addition to these checks the system monitors the temperature inside and outside the instrument before and during each test The system will not allow operation of the instrument if the temperature is higher than 40 C This threshold ensures that the sample temperature does not exceed 45 C during the assay when temperatures can rise Although the QBC STAR instrument contains a centrifuge it is not necessary to periodically test the rotor Centrifuge speed measurements are veri ed each time a sample is processed If any part of the self testing or calibration process fails a message is displayed and printed Con rmation of the success of self tests is provided by the Ready message In addition each results printout indicates the outcome of electronic QC If the calibration tests fail an error message is reported 1 4 L 000867 A 1 Introduction Manual Structure This Operator s Service manual contains the following sections Section 1 Introduction provides an overview of the QBC STAR hematology system its major com ponents and its uses in the laboratory An o
62. ument completes a self check and the door unlocks press the ESC key on the setup keypad 5 Amenu appears listing all the setup functions 2 6 L 000867 A 2 Installation and Setup OPTIONS gt 1 LCD Contrast 2 Date and Time 3 Disable Auto LCD 4 Save Data 5 Print Data 6 Shipping Prep 7 More Options 8 EXIT The arrow cursor points to the option that is currently selected When you first access the menu the first option LCD Contrast is selected To adjust the option that is selected press le on the keypad To select another option use the or key to move the arrow cursor up or down the list When the desired option is selected press on the keypad to adjust the setting Each of the setup options utilities is described below LCD Contrast The LCD Contrast option lets you adjust the contrast of the LCD screen This can help improve the readibility of the screen Press the or key to increase or decrease the display contrast When you reach the desired contrast press le Date and Time The Date and time option lets you adjust the date and time that is printed on results reports When you select the option a sub menu shown below appears The arrow cursor points to the item that is currently selected When you first access the menu the first item Year is selected To adjust the current item press e on the keypad To sele
63. ure site halfway between the center of the finger pad and the outer edge of the finger For infants punctures may be performed on the outer or inner portion of the plantar surface of the heel Make sure the site to be punctured is not cyanotic edematous or cold If cyanotic or cold cover the puncture site with a warm moist towel for at least three minutes before puncture Clean the puncture site with an alcohol pad To prevent hemolysis allow the site to dry Wearing gloves puncture the finger with a sterile lancet Wipe away the first drop of blood to avoid diluting the specimen with excess tissue fluid Apply slight pressure above the puncture site Avoid squeezing directly atthe puncture area because that may cause cell damage as well as dilute the specimen with tissue fluid Fill the QBC STAR tube by placing the collection end of the tube directly in contact with the finger puncture blood Fill the QBC STAR tube to a level between the two black fill lines When collection is complete apply slight pressure with sterile gauze pad and elevate the puncture site Bandage if necessary Dispose of lancet s in a sharps container Dispose of gloves and gauze in an appropriate biological hazard container Wash hands L 000867 A E Blood Collection and Handling Avoiding Hemolysis during Capillary Blood Collection e Allow the puncture site to dry after cleaning with alcohol Do not squeeze the puncture site excessively Do
64. verview of this manual s structure and conventions is also included Section 2 Installation and Setup gives specifications for installation of the QBC STAR system and instructions for instrument installation and setup Section 3 Controls and Indicators explains the use and meaning of all controls and indicators of the system Section 4 Operation provides instructions for routine operation Section 5 Performance and Limitations provides information on instrument performance such as operating ranges precision accuracy interfering substances expected values etc Section 6 Maintenance explains all user system maintenance Section 7 Troubleshooting provides a convenient guide identifying errors and suggesting corrective actions The Glossary explains several terms used in this manual as well as abbreviations The Appendices contain supplemental information such as warranty list of parts and accessories a software update form a listing of national contacts specimen collection and bibliography Getting Started The QBC STAR system has been designed and tested for ease of use However before you begin to use the instrument you will find it advantageous to familiarize yourself with the material in this manual es pecially e Be sure to read the Summary of Warnings and Cautions on page 1 7 e Refer to the material in Section 2 Installation and Setup for information on where to place t
65. witches etc and indicators readouts lights etc are described below The following items are discussed Power Switch Star Button Door Release Latch Liquid Crystal Display Printer Floppy Disk Drive Setup Keypad Power Switch The power switch is located on the rear panel of the QBC STAR instrument on the left side It is a two position rocker switch Place the switch in the position to turn instrument power on Place the switch in the O position to turn instrument power off QBC Diagnostics recommends that you turn the power off at the end of the days testing See Figure 5 Figure 5 Power Switch toward left L 000867 A 3 1 QBC STAR System Operator s Service Manual Star Button The Star Button is located on the top of the QBC STAR instrument toward the right side It is teal colored See Figure 6 This button has several functions e Start Testing when an untested tube is in the analyzer e Abort Testing when the instrument is in the process of testing e Reprint Test Results after automatic test results printout before opening door The button will only perform these functions at the times described above Door Release Latch The door release latch is located on the front panel of the QBC STAR instrument just below the door It is used to pop open the door on the top of the instrument The door can only be opened when the system determines that it is safe to do so The
66. y System is a self contained whole blood automated hematology system Reported results include hematocrit hemoglobin total white blood cell count combined lymphocyte and monocyte count granulocyte count platelet count and Mean Corpuscular Hemoglobin Concentration MCHC The test can be performed from either venous or capillary blood specimens The system is factory preset and user calibration is NOT required The system is powered by a universal voltage internal power supply that plugs directly into an AC power source The QBC STAR Hematology System performs all tests using the QBC STAR tube The QBC STAR tube is described below When the QBC STAR tube is placed into the instrument it is automatically centrifuged and analyzed The results are computed displayed and printed on the internal printer QBC STAR Blood Collection Tubes The QBC STAR Tube is a two component device The tube assembly represents the first component It consists of a precision glass QBC tube and the plastic sleeve that serves as a carrier for the tube A cap and float assembly comprise the second component The float expands the buffy coat region by a factor of ten It does this by reducing the cross section area of the tube See Figure 1 The QBC STAR tube is preassembled and consists of the following components e 3 long precision bore glass tube with dried coatings of acridine orange heparin K EDTA potas sium oxalate monoclonal antibody and reagents e

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