ࡱ> '` 2bjbjDD *&&) " " " 6 :::8:$:L6 JWR<R<(z<z<z<*>D> P>VVVVVVV$NYh[V" ?>"&>??V z<z<WDDD?* z< 8z<VD?VDD6#N Pz<F< }:@OPW0JW Pj\Ahj\8Pj\" PLX>>>,D>$>X>X>X>VVMD^X>X>X>JW????6 6 6 d(46 6 6 46 6 6  This procedure is valid for the following chemistry analyzers: AU400/AU400eAU640/AU640eAU480AU680AU600AU2700/AU5400 Prepared ByDate AdoptedSupersedes Procedure # Review DateRevision DateSignature Distributed to# of Copies Distributed to# of Copies PRINCIPLE: Bilirubin is an end product of hemoglobin catabolism. It is conjugated with glucuronic acid in the liver, and the conjugated form is cleared from the circulation by excretion in the bile. Both conjugated (direct) and unconjugated (indirect) forms of bilirubin circulate loosely bound to albumin. The assessment of direct bilirubin is helpful in the determination of hepatic disorders. The increase in the total bilirubin associated with obstructive jaundice is primarily due to the direct fraction. Both direct and indirect bilirubin are increased in the serum with hepatitis. In the newborn patient with hemolytic jaundice and neonatal jaundice, the increase in the total bilirubin is primarily due to the indirect bilirubin fraction. Causes of this jaundice condition include Rh, ABO, or other blood group incompatibilities, by hepatic immaturity, or by hereditary defects in bilirubin conjugation.1 INTENDED USE: System reagent for the quantitative determination of Direct Bilirubin in human serum or plasma on BECKMAN COULTER AU Clinical Chemistry analyzers. Direct Bilirubin reagent OSR6511 is for use on the AU680, AU2700, and AU5400 systems only. METHODOLOGY: This Beckman Coulter AU System Direct Bilirubin Reagent utilizes a variation of the classical method developed by Van den Bergh and Mueller.2 Direct (conjugated) bilirubin couples directly with a diazonium salt of 3,5-dichloroaniline (DPD) in an acid medium to form azobilirubin. The direct bilirubin in serum is directly proportional to the color development of azobilirubin which is measured bichromatically at 570/660 nm. Bilirubin + 3,5-Dichlorophenyl Diazonium (BF)4 Azobilirubin SPECIMEN: Patient Preparation: None required. Additional instructions for patient preparation as designated by this laboratory: Type: Serum or heparinized plasma samples, free from hemolysis, are the recommended specimens. Protect specimen from light and assay as soon as possible. Additional type conditions as designated by this laboratory: Handling Conditions: Exposure to direct sunlight can decrease bilirubin in samples by 50% within one hour. When well protected from light, bilirubin in serum is stable for up to 3 days at 2 - 8C and for approximately three months when stored at <-20C.1 Additional handling conditions as designated by this laboratory:  EQUIPMENT AND MATERIALS: Equipment: Beckman Coulter AU400/AU400e, AU480, AU600, AU640/AU640e, AU680, AU2700, and AU5400 analyzers. Materials: Beckman Coulter AU System Direct Bilirubin Reagent Final concentration of reactive ingredients: 3, 5-Dichlorophenyldiazonium tetrafluoroborate0.09 mmol/LHydrochloric acid84 mmol/LSulfuric acid37%Also contains preservatives. Reagent storage location in this laboratory: Test tubes 12 -16 mm in diameter or sample cups (Cat No. AU1063). Storage location of test tubes or sample cups in this laboratory: Beckman Coulter Chemistry Calibrator (Cat. No. DR0070) Storage location of the calibrator in this laboratory: Precautions: 1. For in vitro diagnostic use. WARNING CORROSIVE! Causes sever burns. Contains Sulfuric and Hydrochloric acids. Do not pipet by mouth. Avoid contact with eyes, skin or clothing. In case of contact, immediately flush affected areas with plenty of water for 15 minutes. Obtain medical attention immediately for eye contact or ingestion. WARNING: POTENTIAL BIOHAZARDOUS MATERIAL. The calibrator is manufactured from human serum. No test method can offer complete assurance that HIV- 1/2, HCV, Hepatitis B, or other infectious agents are absent from biological materials, all calibrator material should be handled at the Biosafety Level 2 as recommended for any infectious human serum or blood specimen in the CDC/National Institutes of Health manual, Biosafety in Microbiological and Biomedical Laboratories, 1993. Preparation: The Beckman Coulter AU System Direct Bilirubin Reagent is liquid, ready for use. No preparation is necessary. The Beckman Coulter Chemistry Calibrator reconstitution: Remove the vials of calibrator and diluent from storage and let stand at room temperature (15-25(C) for 5 minutes. Remove the cap and stopper from the vials of the lyophilized serum and reconstituting diluent. Using a volumetric pipette or a calibrated air-displacement pipettor, add exactly 5.0 mL of reconstituting diluent to DR0070 lyophilized serum vial. DO NOT pour directly from the reconstituting diluent vial. Replace the cap and stopper to the vial of lyophilized serum immediately after adding the diluent Allow the calibrator to stand for 5-10 minutes. Gently swirl the contents until completely dissolved. Storage Requirements: 1. The unopened reagents are stable until the expiration date printed on the label when stored at 2 - 8C. 2. Opened reagents are stable for 21 days when stored in the refrigerated compartment of the analyzer. Protect from light. Un-reconstituted calibrator and diluent are stable until the expiration date stated on the label when stored at 2 - 8C. For Direct Bilirubin, reconstituted calibrator materials are stable for 4 days from the date of reconstitution when stored at 2 - 8C. The materials should be capped and stored upright 2 - 8C when not in use. Additional storage requirements as designated by this laboratory: Indications of Deterioration: Discoloration of the reagent, visible signs of microbial growth, turbidity or precipitation in reagent may indicate degradation and warrant discontinuance of use. PERFORMANCE PARAMETERS: The following data was obtained using this Direct Bilirubin Reagent on Beckman Coulter AU analyzers according to established procedures. Results obtained in individual laboratories may differ. Precision:7 Estimates of precision, based on CLSI recommendations6, are consistent with typical performance. The within run precision is less than 4%CV or SD ( 0.04 and total precision is less than 5%CV or SD ( 0.07. Assays of control sera were performed and this data reduced following CLSI guidelines. N=100Within runTotalMean, mg/dLSDCV%SDCV%0.40.00.00.00.01.5650.0140.90.0432.7 Method Comparison: 7 Patient samples were used to compare this Direct Bilirubin. Representative performance data on AU analyzers is shown in the next table. Y MethodAU640/AU640eX MethodAU600Slope0.9996Intercept-0.006Correlation Coeff. (r)0.9996No. of Samples (n)180Range (mg/dL)0.01 - 6.03 Sensitivity: Typical change in absorbance per minute for 1 mg/dL of Direct Bilirubin is 23 mAbsorbance. CALIBRATION: Standard Preparation: Perform a one-point calibration (AB) using a water blank (blue rack) and the appropriate calibrator in a yellow calibration rack. The frequency of calibration is every 7 days. Calibration of this direct bilirubin procedure is accomplished by use of the Beckman Coulter Chemistry Calibrator (Cat No. DR0070), which is traceable to the National Institutes of Standards and Technology (NIST) Standard Reference Material (SRM) 916a. Calibration Procedure: Recalibration is required when any of the following conditions exist: A reagent lot number has changed or there is an observed shift in control values. Major preventative maintenance was performed on the analyzer. 3. A critical part was replaced. QUALITY CONTROL: During operation of the Beckman Coulter AU analyzer at least two levels of appropriate control material should be tested a minimum of once a day. In addition, controls should be performed after calibration, with each new lot of reagents, and after specific maintenance or troubleshooting steps described in the appropriate AU Users Guide. Quality control testing should be performed in accordance with regulatory requirements and each laboratorys standard procedure. Location of controls used at this laboratory. ANALYZER PARAMETERS: A complete list of test parameters and operating procedures can be found in the appropriate Users Guide at www.beckmancoulter.com. CALCULATIONS: For SI units (mol/L), multiply the results by 17.1. REPORTING RESULTS: Reference Ranges: Adults5: 0.03 - 0.18 mg/dL Expected values may vary with age, sex, diet and geographical location. Each laboratory should determine its own expected values as dictated by good laboratory practice. Expected reference ranges in this laboratory:  Procedures for Abnormal Results: Abnormal results are flagged by the listed analyzers according to the normal values entered by the user into the instrument parameters. Reporting Format: Results are automatically printed for each sample in mg/dL at 37o C. Additional reporting information as designated by this laboratory: LIMITATIONS: The Beckman Coulter AU System Direct Bilirubin procedure is linear from 0 up to 10 mg/dL. Samples exceeding the upper limit of linearity should be diluted and repeated. The sample may be diluted, repeated and multiplied by the dilution factor automatically utilizing the AUTO REPEAT RUN. Interfering Substances: Results of studies3 show that the following substances interfere with this direct bilirubin assay. The criteria for no significant interference is recovery within 10% of the initial value. Hemolysis:No significant interference up to 25 mg/dL Hemolysate Lipemia:No significant interference up to 300 mg/dL Intralipid*.* Intralipid, manufactured by KabiVitrium Inc., is a 20% IV fat emulsion used to emulate extremely turbid samples. The information presented is based on results from Beckman Coulter AU studies and is current at the date of publication. Beckman Coulter Inc., makes no representation about the completeness or accuracy of results generated by future studies. For further information on interfering substances, refer to Young4 for a compilation of reported interferences with this test. Laboratory specific procedure notes:  REFERENCES: 1. Tietz, N.W.(editor), Fundamentals of Clinical Chemistry, Third Edition, W.B. Saunders, 1987. 2. Van den Bergh, A. and Mueller, P., Biochem Z, 77: 90, 1916. 3. CLSI/NCCLS, Interference Testing in Clinical Chemistry, EP7-P, 1986. 4. Young, D.S., Effects of Drugs on Clinical Laboratory Tests, Fifth Edition, AACC Press, 2000. 5. Beckman Coulter Inc. data on samples collected from 200 blood donors in North Texas. 6. CLSI/NCCLS, Evaluation Protocol EP5-T2, 1992. 7. Data is on file for specific AU analyzers.      Procedure: DIRECT BILIRUBIN OSR6111, OSR6211, and OSR6511 Beckman Coulter, Inc. 2010 Page  PAGE 1 of  NUMPAGES 11 All printed copies are considered to be copies of the electronic original. Rev #1, Dec 01, 10 ?KLXY}& ; = O P c bc &(#$+3DVvOf hX,6]hX,5>*\ hX,6hPZ h(eEHh(e hX,>* hX,5H*jhX,5UmHnHuh( hX,H* hX,5hX,OJQJ hcfiEHhcfihX,>?@MZ[agVkd$$Ifl0hJxj t644 laytX,! 8h<$If^`gdcfi122ghn|}~90 ! & F^Vkd$$Ifl0hJxj t644 laytX,! 8h<$If^`gdcfiVkdj$$Ifl0hJxj t644 laytX,~tnnn$Ifkd>$$IflF ,"  n 0    4 la$IfUPJJJ$If !kd$$IflF ,"  n   0    4 lapyyy$Ifkd$$IflF ,"  n 0    4 laZTTT$Ifkd$$IflF ,"  n   0    4 lapZTTT$Ifkd$$IflF ,"  n   0    4 lapZTTT$Ifkd$$IflF ,"  n   0    4 lapZTTT$Ifkd$$IflF ,"  n   0    4 lap  ZXRRIIRR $$Ifa$$Ifkd$$IflF ,"  n   0    4 lap  & ' ( ) * + ~~~~ $$Ifa$nkd$$Ifl4\ "n  4 laf4 $$Ifa$+ , - . / 0 `WWWW $$Ifa$kd $$Ifl4\ "n    (4 laf4p(0 1 2 3 4 5 `WWWW $$Ifa$kd $$Ifl4\ "n    (4 laf4p(5 6 7 8 9 : `WWWW $$Ifa$kd $$Ifl4\ "n    (4 laf4p(: ; G o n `^\\^\\^\\kd! $$Ifl4\ "n    (4 laf4p( HIJKLMS$%&ikdK$$IflZ,"!   04 lap "$If&'()>(ijklm$Ifikd$$IflZ,"!   04 lap "$If mno1^$Ifgd(eikd$$IflZ,"!   04 lap  cJkd$$Ifl0h4b4 la$IfJkdU$$Ifl0h4b4 la"$IfJkd$$Ifl0h4b4 la\$If"$Ifnkd$$IflZ,"!   04 lap $If"$Ifikd/$$IflZ,"!   04 lap $DvUb ~z & F & F ikd$$IflZ,"!   04 lap fxyghjklxy&'  *:=>EFk; = D E n p w x ! ! !!!!!!!!!!!:!;!L!ߴߟߟߟߟߟ *hL hehL *hL5 hL5CJhehL5CJ jhX,h()] hX,H*hLhLH*hlC hX,6hL jhX, hcfi>* hX,>*h(hX,hcfi<bv 'ikd$$IflZ,"!   04 lap "$If & F ]kd9$$Ifl4F<p 4K  t0v    4 laf4ytL $$Ifa$gdX, !! ! !!!Bkd$$Iflr<p  4F t0v4 laytL $$Ifa$gdX,!!!!!%!+!/!Bkd$$Iflr<p  4F t0v4 laytL $$Ifa$gdX,/!5!9!:!;!P!!B@>5h^hgdlCkd$$Iflr<p  4F t0v4 laytL $$Ifa$gdX,L!M!O!w!y!!!!!!!!"" " """"" "7"=">"?"R"U"V"W"_"`"f"k"l"n"p"q"r"s"t"v"#$%%%%''''S(W(m((())**++/+A+B+I+b,c,u,v,,+- hX,6hj[S hX,EH hX,H* hPZ>*hPZhX,OJQJhcfi hOf5 hw hOfhOfhLhLH*hX,G!!!!!!!ptkd$$Ifl0l  04 laXytX, $$Ifa$gdX, $IfgdX,gdOf!"" "u $$Ifa$gdX, $IfgdX,tkdH$$Ifl0l  04 laXytX, """"u $$Ifa$gdX, $IfgdX,tkd$$Ifl0l  04 laXytX," "7">"u $$Ifa$gdX, $IfgdX,tkd$$Ifl0l  04 laXytX,>"?"R"V"u $$Ifa$gdX, $IfgdX,tkd$$Ifl0l  04 laXytX,V"W"f"r"u $$Ifa$gdX, $IfgdX,tkd$$Ifl0l  04 laXytX,r"s"t"u"v""""#$$ %^%%%{{y & F tkdY$$Ifl0l  04 laXytX,%%'''''''o(}((((())))Dkd$$IflD !   4 lap $If"$If]gdW_)))))))))}***+++++ikdb$$IflZ,"!   04 lap "$If++++++K,c,, -+-b- $IfgdX,ikd$$IflZ,"!   04 lap "$If +-b-l-------M._...M/N/j0p011j1p1111111111111111122"2+2,23242:2;2<2=2A2B2L2M2O2P22222222222񸲸 hcfi0Jh()]0JmHnHu hX,0JjhX,0JU hX,\hX,B*ph hX,5jDhcfiUh ajh aU hX,H*hcfihX,hPZ hG<hPZ?b-c-l---..///XVVVPP"$IfOkd($$Ifl0hf!4 laytX, $IfgdX,Mkd$$Ifl0hf!4 laytX, /////////$0c00 1c1111ikd$$IflZ,"!   04 lap "$If111111111122222222 $dN(/ =!"#$% h$$If!vh5x5j#vx#vj:V l t65x5jaytX,h$$If!vh5x5j#vx#vj:V l t65x5jaytX,h$$If!vh5x5j#vx#vj:V l t65x5jaytX,$$If!vh5 5 5n #v #v #vn :V l05 5 5n / / 4 $$If!vh5 5 5n #v #v #vn :V l  05 5 5n /  / 4p$$If!vh5 5 5n #v #v #vn :V l05 5 5n / / 4$$If!vh5 5 5n #v #v #vn :V l  05 5 5n / 4p$$If!vh5 5 5n #v #v #vn :V l  05 5 5n / 4p$$If!vh5 5 5n #v #v #vn :V l  05 5 5n / 4p $$If!vh5 5 5n #v #v #vn :V l  05 5 5n / / 4p $$If!vh5 5 5n #v #v #vn :V l  05 5 5n /  / 4p$$If!vh5n 55 5#vn #v#v #v:V l45n 55 5/ / / / / 4f4$$If!vh5n 55 5#vn #v#v #v:V l4  (5n 55 5/ / / 4f4p($$If!vh5n 55 5#vn #v#v #v:V l4  (5n 55 5/ / / 4f4p($$If!vh5n 55 5#vn #v#v #v:V l4  (5n 55 5/ / / 4f4p(($$If!vh5n 55 5#vn #v#v #v:V l4  (5n 55 5/  / /  / 4f4p($$If!vh5!#v!:V l   05!/ 4ap $$If!vh5!#v!:V l   05!/ 4ap $$If!vh5!#v!:V l   05!/ 4ap b$$If!vh55b#v#vb:V l55b4ab$$If!vh55b#v#vb:V l55b4ab$$If!vh55b#v#vb:V l55b4a$$If!vh5!#v!:V l   05!/ 4ap $$If!vh5!#v!:V l   05!/ 4ap $$If!vh5!#v!:V l   05!/ 4ap $$If!vh5!#v!:V l   05!/ 4ap $$If!vh545K 5 #v4#vK #v :V l4 t0v545K 5 4af4ytL$$If!vh545F555#v4#vF#v#v#v:V l t0v545F5554aytL$$If!vh545F555#v4#vF#v#v#v:V l t0v545F5554aytL$$If!vh545F555#v4#vF#v#v#v:V l t0v545F5554aytL$$IfX!vh5 5 #v #v :V l05 5 4aXytX,$$IfX!vh5 5 #v #v :V l05 5 4aXytX,$$IfX!vh5 5 #v #v :V l05 5 4aXytX,$$IfX!vh5 5 #v #v :V l05 5 4aXytX,$$IfX!vh5 5 #v #v :V l05 5 4aXytX,$$IfX!vh5 5 #v #v :V l05 5 4aXytX,$$IfX!vh5 5 #v #v :V l05 5 4aXytX,j$$If!vh5!#v!:V lD   5!4p $$If!vh5!#v!:V l   05!/ 4ap $$If!vh5!#v!:V l   05!/ 4ap h$$If!vh55#v#v:V l554aytX,l$$If!vh55#v#v:V l554aytX,$$If!vh5!#v!:V l   05!/ 4ap 2Dd yrI0  # A"B]I_ST.@=B]I_ST.Рo##Px]=\GO㕔n)$C.@TP&hLABE -DDE@~/9x47gݹF~ޟ{;sjY-/q|,onY_kr⭫Uq|fY\5w_Yq+q|8~to]/xO:>+q0<ѣݻwqΝO>5_ٳgܼޭ[nkx޽{>3>|x3ms wl{EV~iq|n Edߓ'O,}3Zk\5}l=on[t4d*d[&^^mkׅ>+Zk.av9 DW{̗.h q%O$on_s{ļi-5o%Uqî,})^G8@5Zx4ۚh,m o55cFCgiod1xY,Ibp1|^+q[s>"g?kqε#vնo]S pKgȾ#Q_PnIY$Ǹ^kBGQlKydcE 8]crl@+)~ƭힺ΍-$EtƭXiM\ =K,j{ %'K{}HqksGθ1޺3l{O{.Z9:nZ`4vF:){m;RꍛM]8CYZH|I?aRV7KYs6\ƚr'^YOzFݙ~:YD_z<מdbgZmE Ew]-sͽ zr*yI{9MH>yj_@v3_k+~QZ4ܦ5XS\\c_#3Ͻ&}tqY/`YmѨi{əzXx״Kמo޹osO@"1W֤X,|o.H$a{D"؃l_9˚O7?|;r׿ݿ=tY^RLvD-Wϰ{,9L9lo&o~+&18Wmg|[;7ḡQgv—GZZtV,H}7˿nu.se>z^hgK2'7!vߣ{q*7z ԺH3 ONiQ7]~]~̲OSiF ϑ|H-akpzzT';4_{x>'D Z@%ctOE.u!YҺ8۲?s.+ҙV!^X_tO܊oeG{tI7i%;Ճ,[{{ {zcgyv|mD.nӽu,KTQ_ˉRx%ŨzF+ِr~7rR~/ةl5u>ZtT:`)/cn/<ɿro޼pl'6ޖ[,-cgpנ6Ek$U?koZ6~˵F j^El6 B|o;]aGe)'ߏ[_Q^K!)Og-Xsr-ζh88;ZSR}KflYkh}nlD.|-^KFt?~kۥM'*_f=[>s#~v[[u.fԉK`3=dz',)ҵ8\+YlNqM9ySKt2>0eUm#Ι8NHu.ڒ Y`R]'ky뭕tum{G#r#Z֬r}Fa6 NHBpϵ|}~;{=ݰ9ycgul׽noiJܖ|9LnmDI>mO-^^;lpLbxkxk%$ƤĞ<~(;:Ϳ|4Nv_ w%ᶧoAOO1p{1,>w}#1n썗yDx^BZ޺3NDq#mSr؆v5 O_)(׹%^~q޺3)VQJ<ĪkRo{uKMZj4R+Cu/?c#{H:jFulZ!q IJ0Z-aCzdHZ +(텺$]-F[d:E=JNRҒceZŵZ8,Vw'^sN8f[bg-jŸ]l\.WoOhܽ؈>g$z_Y-q;Dy%NJźWV0u郟[^˺w{TLRl9c\mUl2{mu|5vk+Xbg*.Tz&gFzp/{tw{ۣb Ҿ}>=>;WcRU>r=gb ->>Sgti}Ǽ{\j]˚3<3u9̔o[60P_sd3 \>+Qu6@"a嬩.aSGE1C_δ::HxQGu&[rc4!=:Y}k1xpFKHlkX羅g;}|~"^nxǩ|޷]؇xbo^O7GN' FSH[szu|/H=USzso`B\NGu78$>{[5xM.ڧ8gP 'ֻ/;K Tڭl9;K$FαߑLoDb H )_c'3ë)u8Wup40gMqy^wH"%fR||Ƴ>`Gs9kܦ%sN^xb"q.: {v%knA뽚Ȟ^י|dʝqT֣!p܃5S=DbvDu-hh}Vu5J;!N^xK:DX-(d'P sՖ`H$iDr{.}[dmYҸ" wgےuKqr,Cs}K3S t1n/9&)}npkE=ϒӉ8EpكN$x)FJ$~=0e%o iw'q~`$1nW"Xokq:Tgg',#\@\ Normal,BodydxxCJOJQJ_HmH sH tH R@R Heading 1$&d@&5CJ KHOJQJX@X Heading 2$hd@&^h5:CJOJQJP@P Heading 3<@&^56OJQJ@@@ Heading 4$@& 5OJQJ>@> Heading 5$$@&a$5H@H Heading 6$h@&`h 5OJQJDA@D Default Paragraph FontVi@V  Table Normal :V 44 la (k@(No List 8@8 Header  !OJQJ< @< Footer  ! CJOJQJ.)@. Page NumberfP@"f Body Text 2.$ d^`a$OJQJFO2F Heading 2 Texthd,^hR@B Body Text Indent 2G$ ,p@ P !$`'^a$OJQJS@R Body Text Indent 3O$ ,p@ P !$`'^`a$OJQJfB@bf Body Text:$ /@p@ P !$`'a$ROrR Table Text<< 8OJQJ8Oq8 Table Header5HO1H Heading 3 Text 8@^LOL Heading 3 Text #8^8`TO1T Heading 2 Text # 88^8`VOV Heading 3 Text Alpha 8@^XOX Heading 1 Tex # $ hh^h`a$>O> Heading 1 Textd,JOJ Procedure $a$5B*CJOJQJXfOf Heading 3 Bullets)! & F h88d<^8@O"@ Additional"-D CJ**?@MZ[aghn|}~  &'()*+,-./0123456789:;GonHIJKLMS$ % & ' ( ) > ( i j k l m n o 1 ^       \      $ D vUb ~zbv '  %+/59:;P  7>?RVWfrstuv ^o } !!!!!!!!!!!!}"""########+#K$c$$ %+%b%c%l%%%&&'''''''''''$(c(( )c)))))))))))))*******00 !0  !0 0  !0  !0 0  !0  !0 0 !00 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000 00 00 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00;0;0000000000"0"0"0"0"0 0 00M"0M"0M"0M"0M"0M 0M 00) "0) "0) "0) "0) 0)  0)  0) 00o 0 0o 0 0 0  0  0  0  0  0  0  0  0  0 "0 "0 "0 "0 "0  0  0 "0 "0 "0 0  0  0 "0 "0 0 0  0  (0 0 0 0 0o 0U0U 0U 0U 0U 0U 0U(0U0z0z 0z 0z 0z"0z"0z"0z"0z"0z 0z (0U0 00000000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00070707 07 07 07 07 07 07 07 07 07 07 07 07 07 07 07 07 07 07 07 07 070707(070r00000 0 0000"0"000 0 000000000"0"0"0"0"0"0"0 0 00000"0"0"0"0"0"0"0 0 000000 0 0 0 0 0 000"0"0"0"0"0"0"0 0 0"00'0'0'0'0'0'00'0@000@000@000@000@0@0@0@000000\MMZ[aghn|}   9:  >?VWrso b%c%%%*@ !0 @ !0 @0 @ !0 @ !0 @0 @ !0 @ !0 @0 00t2:@A,200t2:@A,200t2:@A,2 @000000000000000 00000000000000000000 000 0 000 0 000&0'0&00&000000l@0 00l@0 00 KKfL!+-239Dg~ + 0 5 : &m !/!!! "">"V"r"%)+b-/12 !"#$%&'()*+,-./01245678:;<=>?@ABCEFG2mtv{!@  @H 0(  (  NB  S DB S  ?*t OLE_LINK1a*f*y\Ry/yPyR V)* a)*9*urn:schemas-microsoft-com:office:smarttagsplace=*urn:schemas-microsoft-com:office:smarttags PlaceName=*urn:schemas-microsoft-com:office:smarttags PlaceType hmP ,QS`o{ ,1V%`%c%j%%%J(Q())))))))))))***S`m ' * -c$$$$&&''))))))))))))***333333333333PcMM      yghjk:=;=np;LzzuvvS m !!####B#I#w$w$$%&&j(p())j)p)))))))))))))*"*+*,*-*-***************))))))))))))*** 8a8T.pn n_?/r6dcC@e(Ixu%}Lv})RX:qY_R:M`ĔE}H!0} 88^8`o(.88^8`o(.^`. L ^ `L.  ^ `.xx^x`.HLH^H`L.^`.^`.L^`L.88^8`o(.@^`.88^8`o(.^`. L ^ `L.  ^ `.xx^x`.HLH^H`L.^`.^`.L^`L.h 88^8`OJQJo(h ^`OJQJo(oh   ^ `OJQJo(h   ^ `OJQJo(h xx^x`OJQJo(oh HH^H`OJQJo(h ^`OJQJo(h ^`OJQJo(oh ^`OJQJo(@^`.88^8`o(.88^8`o(. hh^h`OJQJo(@^`.8aqY_E}0}0}0[P6dcC6dcC[PM`)RX)RXP_?/(Ipn %}L<[P @^`.[P@^`.P @^`.         R                   L( aOfX,lCj[S()]cfi(eW_PZ e@MZ[aghn|}~ &'()*+,-./0123456789:;LMS( ) > ( m n 1 ^   \   b   %+/59:L  7>?RVWfrs !!!""##c$w$ %+%b%c%l%%%&''')))))**@}T*@UnknownGz Times New Roman5Symbol3& z Arial?& Arial BlackC"UniversArialMCentury Schoolbook?5 z Courier New;Wingdings"1hB{&l&nRS 3<#K<#K4d))2QHP ? e2 Prepared By&Technical Operations & Product SupportBeckman Coulter User8         Oh+'0 <H h t   Prepared By(Technical Operations & Product Support Normal.dotBeckman Coulter User12Microsoft Office Word@@lM4y@@қ}<#՜.+,0 hp  Olympus America Inc.K)'  Prepared By Title  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHJKLMNOPQRSTUVWXYZ[\]^_`acdefghijklmnopqrstuvwxyz{|}~Root Entry FK}Data Iv11Tableb\WordDocument*SummaryInformation(DocumentSummaryInformation8CompObjq  FMicrosoft Office Word Document MSWordDocWord.Document.89q