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Assay Value Sheet

1. Diluent Sheath 03H79 01 Diluid Sheath 3200 4000 3832 9020 HGB NOC Lyse 03H80 02 CyMet 3200 CN Free 3823 1000 WBC Lyse 03H78 01 LeucoLyse 3475 5000PC Reticulocyte reagent 03H40 01 RetiCount CD 3777 Enzymatic Cleaner 3902 01 00PE Abbott Cell Dyn 3000 Diluent 99231 01 Diluid ST1600 2000 3976 HGB WIC Lyse 99431 01 CyMet 3000 3469 9010PC Sheath 99311 01 Sheath Fluid 3000 3500 3471 9020PC Enzymatic Cleaner 99644 01 ProClean CD 3902 0100PE Abbott Cell Dyn 1800 1700 1600 1300 1700 1800 series Diluent 99220 01 Diluid ST1600 2000 3976 99226 01 08H17 04 Lytic agent 99420 01 CyMet ST1600 2000 CN Free 3759 1000 99435 01 CyMet ST1600 2000 3775 1000 08H19 01 1700 1800 Lyse CN Free 03H59 01 CyMet ST1600 2000 CN Free 3759 1000 07H84 01 1700 1800 detergent 08H18 02 Blanking solution ST1600 2000 3947 Enzymatic Cleaner 99644 01 ProClean CD 3902 0100PE Abbott Cell Dyn Emerald 18 Emerald 18 Diluent 09H48 01 Diluid III Diff 3963 09H49 02 Emerald 18 Lyse 09H47 02 CyMet IIl Diff CN Free 3511 1000 Emerald 18 Cleaner 09H46 01 ProClean 3900 8 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of AWANTOR PERFORMANCE MATERIALS Abbott Analyzers Reagent Consumption An indication of the consumption of reagents per test is sh
2. PERFORMANCE MATERIALS Product CE Product CE J T Baker Product Number Pack Size mark J T Baker Product Number Pack Size mark Lyzerglobin 3769 6 15 Hematology Controls Lyzerglobin PCE 3771 15 8 Parameter Control L N H 3427 3428 3429 2 5 ml CE uc e oooi E 3463 3464 3465 2 5 ml CE RBCLyse G 3518G 1000PE 1L CE 3701 3702 3703 4 5 ml CE WBCStabilise 3514 0500 500 ml 8 Parameter Control L N H 3746 3x2 5 ml GE Reticulocyte Re y agents 8 Parameter Control 4xN 3747 4x2 5 ml CE RetiClear MHG 3493 1000PE 11 8 Parameter Control 1xL 4xN 1xH 3751 6x2 5 ml CE RetiCount 3774 30 ml CE 8 Parameter Control extended L N H 3633 3634 3635 2 5 ml CE RetiCount AS 2953 0210PE 210 ml CE 8 Parameter Control VET L N H 2904 2905 2906 2 5 ml RetiCount CD 3777 15 x 3 5 ml CE i 3 Diff Control L N H 3433 3434 3435 2 5 ml RetiCount G 3494 0200PE 200 ml CE 3502 3503 3504 4 5 ml CE Cleaners r 3 Diff Control 4xL 3466 4x 2 5 ml CE Blanking Solution Hgb 3507 9020 CE 3 Diff Control 4xN 3467 4 2 5 ml CE Blanking Solution 1600 2000 3947 CE 3 Diff Control 4xH 3468 4x2 5 ml CE DetectoTerge 3763 CE zy E 3 Diff Control extented L N H 3421 3422 3423 2 5 ml CE 5D Control L N H 3681 3682 3683 5 0 ml GE DetectoTerge BS 2970 0900PE CE ADV Diff Control L N H 3684 3685 3686 3 5 ml CE HyClean BS34 2907 5000PC BC Diff 5 Control L N H 3613 3614 3615 3 0 Hypoch
3. Diluent Sheath 01H73 01 Diluid Sheath 3200 4000 3832 9020 WBC Reagent part A 01H77 01 CyMet ASA 2950 2500PE WBC Reagent part 01H78 01 CyMet ASB 2951 0500 Sapphire reticulocyte reagent 1H76 01 RetiCount AS 2953 0210PE Enzymatic Cleaner 99644 01 ProClean CD 3902 0100PE Abbott Cell Dyn 3700 3500 Diluent 99231 01 Diluid ST1600 2000 3976 HGB WIC Lyse 99431 01 CyMet 3500 3839 5000PC 03H62 01 CyMet 3500 CN Free 3825 Sheath 9931 1 01 Sheath Fluid 3000 3500 3471 9020PC Reticulocyte reagent 03H40 01 RetiCount CD 3777 3500 3700 detergent 99321 01 Blanking solution ST1600 2000 3947 Abbott and Cell Dyn and its subsidiary products are trademarks of Abbott Laboratories Corporation The information contained herein has not been approved by Abbott Laboratories Corporation Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 7 Part of PERFORMANCE MATERIALS Abbott Analyzers Cross List continued Abbott Nr J T Baker Product Abbott Product J T Baker Nr Abbott Cell Dyn Ruby Diluent Sheath 01H73 01 Diluid Ruby 2987 9020PC HGB NOC Lyse 03H80 02 CyMet Ruby CN Free 2988 5000PC WBC Lyse 08H52 01 Leuco Ruby 2989 5000PC Reticulocyte reagent 03H40 01 RetiCount CD 3777 ProClean CD 3902 0100PE Enzymatic Cleaner 99644 01 Abbott Cell Dyn 3200
4. IMPORTANT NOTE For Reticulocyte parameters D0000824 AHTO 2 use the XERet control PN 3652 3653 3654 Version 8 0 EE PTE Assay values XE Diff Controls LOT 232 Avantor Performance Materials BV Box 1 7400AA Deventer The Netherlands 2014 11 19 Tel 31 0 570 687500 The devices as mentioned in this insert comply with the In REF 3731 3732 3733 Vitro Diagnostic Medical Devices Directive 98 79 EC Assay values and expected ranges for Sysmex Instruments XT 1800i and XT 2000i LOW 3731 NORMAL 3732 HIGH 3733 Parameters Mean Range Mean Range Mean Range WBC 10 NEUT 4 10 LYMP 1071 MONO 10 I EOS 1071 BASO 10 Open sampling 109 NEUT 4 107 LYMP 1071 MONO 1071 EOS 109 1 BASO 109 1 Closed sampling Both modes MCH Open Sampling fmol MCHC g dl mmol l 10 HGB g dl mmol l HCT 1 1 MCV fl MCH pg fmol MCHC g dl mmol l Closed sampling RDW SD fl RDW CV PLT 1071 PLT cl 107 MPV fi PLT O op 10 I PLT O cl 10 PCT ml l PDW fl Op open mode cl closed mode Op open mode cl closed mode ch ch ch ch Open sampling amp Closed sampling RBC O 1077 RBC X ch RBC Y ch XE diff must be analyzed in the instrument e Check Quality Control mode Not available for the Sysmex XT 1800i 4 When using CD ROM for Assay values setup s
5. 20000809 Version 6 0 167001 220 1832 2014 00 167001 III Levell LOW 167001 19 12 2 lilii WBC pem 740 0 6 44 0 10 0 NE 00 167001 4 0 44 0 1 7 gt J pe 47 0 10 0 DOO 47 0 1 8 LD s c Mos ETTI E00 187001 1 6 5 0 3 E Tn a Rec 260 012 Goo 167001 2 60 6 8 21 3 he a 213 5 167001 82 0 26 2 31 9 1 1 10 10000 400 167001 0 068 16 7 Notes Ranges must be entered manually inte the Coulter control files Barcodes can mol be used for the GENS LH500 and LH759 A ANTOR Ae Te Avanior Performance Materials B V il P O Box 1 7400 Deventer Holland c Tei 31 0570 687600 I C The deveces as mentioned in thia insert with the lin 4 Varo Diagnostic Medical Devices Directive BR TINEC SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 69 Part of _A ANTOR PERFORMANCE MATERIALS J I Baker Assay Value Sheet Assay values 5 D Controls Coulterf 5 107 167002 55 18 12 2014 DERT Level NORMAL Mean Ranget WBC 0 99 123 NES 9 _ 520 90 Neg 51 09 37 0 9 0 LYa 37 09 3 5 35 1 BAN x10 L RBC xo 418 HGS
6. 210 2015 02 19 RBC 1071 Hb g dl Hb mmol l Hct MCHC mmol l RDW SD fl RDW CV Pits 10 MPV fl PCT ml l PDW SD fl PDW CV Medonic CA530 CA620 LYMP MONO GRAN LYMP MONO GRAN JT Baker reagents CyMet Abacus Diluid Abacus Use Reagent Code 2 in service settings Parameters WBC 1071 LOW NORMAL HIGH Mean Range Mean Range Mean Range RBC 10 2 l Hb g dl Hb mmol l Hct Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW 96 Pits 1071 MPV fl LYMP MONO GRAN LYMP MONO GRAN Inmesco HM1060 Rayto RT 7600 HTI Micros CC 20 Plus LOW NORMAL HIGH Mean Range Mean Range Mean Range Parameters WBC 10 RBC 1071 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV 96 RDW SD fl Pits 10 MPV fl PCT ml l PDW LYMP GRAN LYMP MONO GRAN Box 1 7400 Deventer The Netherlands Tel 31 0 570 687500 devices as mentioned in this insert comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC Parameters WBC 1071 Avantor BeneSphera H32 LOW NORMAL HIGH Mean Range Mean Range Mean Range RBC 1071 Hb g dl Hb mmol l Hct MCHC mmol l RDW CV RDW SD fl Pits 10 l Parameters WBC 1071 ERMA PCE 170 ERMAX 18 PCE 210 LOW NORMAL HIGH Mean Range
7. RDW 96 15 Plts x 1071 1 1 MPV 1 1 Abbott Cell Dyn Series not for 5 part diff WBC x 10 228 012 RBC 1071 6 0 0 4 Hb g dl 17 3 1 5 96 76 4 MCV fl 26 3 2 4 34 6 3 0 67 15 Plts x 10 10 5 1 5 MPV 0 07 0 02 WBC 109 1 WBC x 10 1 9 0 4 RBC 10771 RBC 1071 2 28 0 12 Hb g dl 6 0 0 4 j Hct 96 17 8 1 5 MCV fl 78 4 MCH pg 26 3 24 g dl 33 7 3 0 1 1 Plts x 1071 13 8 2 0 1 MPV fl Plts x 1074 89 15 Nihon Kohden Celltac and MEK series MPV fl 6 1 1 5 WBC x 10 RBC x 10 Hb g dl Hct 96 MCV fl MCH pg MCHC g dl Pits x 107 Mindray BC series WBC x 10 1 RBC x 10 7 Hb g dl Hct 96 MCV fl MCH pg MCHC g dl Pits x 1071 All Drew MWI Models except Excell 22 Orphee Mythic 18 WBC x 1071 RBC x 10 7 Hb g dl Hct 96 MCV fl WBC 1071 1071 Plts x 107 fl WBC x 10 1 9 RBC 10 Z l 2 25 012 6 0 0 4 16 7 1 5 4 Plts x 10 MPV fl Plts x 107 MPV fl Avantor Performance Materials B V 1 7400 Deventer Netherlands Tel 31 0570 687500 devices as mentioned this insert comply with Vitro Diagnostic Medical Devices Directive 98 79 EC 8 C 2 C 58 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Assay Value Sheet J I Bak
8. ASANTOR PERFORMANCE MATERIALS Cleaning and Rinsing Solutions Avantor offers different types of J T Baker brand cleaners and rinsing solutions suitable for use with many popular brands of hematology instruments Below is an overview of the different types of cleaners available and their properties For information on specific applications refer to the analyzer pages J T Baker Cleaners Selection Guide J T Baker Product Product Nr Pack Size Principle Blanking Solution HgB 35079020 Colorless 1 On line li Chemical u Blanking Solution ST1600 2000 3947 20 L Colorless On line Chemical DetectoTerge 3763 5 L Green On line Chemical 3766 1L DetectoTerge BS 2970 0900PE 900 ml Green On line Chemical HyClean 2907 5000PC 21 Colorless On line Hypochlorite HypoChlorite 0 5 3917 5000 5L Colorless Emergency On line Hypochlorite 3917 1L HypoChlorite NR 3941 5000PC 5L Colorless On line Hypochlorite 3941 1000PE 1L 3941 0100PE 100 Emergency ProClean 3900 5L Purple On line Enzymatic 3768 1000 1 L micros ProClean Abacus 3432 5000 5L Purple On line Enzymatic 3432 1000PE 1L ProClean CD 3902 0100PE 100 Yellowish Emergency Enzymatic ProClean Extra 3862 5000 5L Colorless On line Enzymatic 3862 1000 1L 3867 1000PE 1L micros ProClean MX5 3498 1000PE 1L Colorless On line Enzymatic ProClean Plus 3901 100 ml Colorless Emergency Enzymatic Rinse
9. SALES MANUAL HEMATOLOG Y PRODUCTS Edition 2015 foe AVANTOR PERFORMANCE MATERIALS PRODUCT 5 DATA 5 5 SDS ARE AVAILABLE REQUEST PLEASE SEE PRODUCT SDS FOR COMPLETE INFORMATION REGARDING PRODUCT SAFETY AND APPROPRIATE PRECAUTIONS AND LEGAL REQUIREMENTS TO BE TAKEN WITH RESPECT TO PRODUCT HANDLING USE AND DISPOSAL ALL REFERENCES HEREIN WITH RESPECT TO WORDS SUCH AS NON HARMFUL NON TOXIC ETC ARE INTENDED AS GENERAL REFERENCES AND SHOULD ONLY BE INTERPRETED IN THE CONTEXT OF THE COMPLETE PRODUCT SDS www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of AWANTOR PERFORMANCE MATERIALS CONTENTS General Information 1 Declaration of CE Conformity 2 ISO Certifcates 3 Hematology Analyzers Reagents and Controls Product List 4 Abbott Analyzers 6 ABX Analyzers 14 Avantor Performance Materials Analyzers 20 AVL Analyzers 22 Bayer Analyzers 23 Beckman Coulter Analyzers 24 Diatron Analyzers 26 Drew Analyzers 29 Erma Analyzers 31 Hospitex Analyzers 33 HTI Analyzers 34 MDC Analyzers 35 Medonic Analyzers 36 Melet Schloesing Analyzers 38 Mindray Analyzers 39 Nihon Kohden Analyzers 42 Orphee Analyzers 46 Seac Analyzers 48 Swelab Analyzers 50 Sysmex Analyzers 51 Urit Analyzers 54 Cleaning and Rinsing Solutions 55 Hematology Controls 56 Assay Value Sheets 58 Stains and Dyes Giemsa and May Gr nwald 86 Stains and Dyes Leishman 88
10. 3000 3469 9010PC 10L Scatter reagent Sheath Fluid 3000 3500 3471 9020PC 20L Emergency Cleaner ProClean CD 3902 0100PE 100 ml 6 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of PERFORMANCE MATERIALS ASANTOR Description JT Baker Product _ProductNr Pack Size Abbott Cell Dyn 1800 1700 1600 1300 Diluent Diluid ST1600 2000 3976 201 Lyse CyMet ST1600 2000 3775 1000 1L CyMet ST1600 2000 CN Free 3759 5000 3759 1000 1L Rinse online Blanking Solution ST1600 2000 3947 20L Emergency Cleaner ProClean CD 3902 0100PE 100 ml Hypochlorite 0 596 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Abbott Cell Dyn Emerald 18 Lyse CyMet III Diff CN Free 3511 5000 5L 3511 1000 1L Cleaner ProClean 3900 5L Hematology Control 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Abbott Analyzers Cross List An overview of comparable Abbott brand and J T Baker brand reagents is shown in the table below When replacing Abbott reagents with reagents information about priming and calibration can be found on the next pages Abbott Nr J T Baker Product J T Baker Nr Abbott Product Abbott Cell Dyn Sapphire 4000
11. ASANTOR PERFORMANCE MATERIALS Beckman Coulter Analyzers Cross List An overview of comparable Beckman Coulter brand and J T Baker brand reagents is shown in the table below When replacing Beckman Coulter reagents with J T Baker reagents information about calibration can be found on the next pages Beckman Coulter Product Beckman Coulter Nr J T Baker Product J T Baker Nr Beckman Coulter AcT 5 Diff Diluent 8547169 Diluid APR 3476 9020PC HGB Lyse 8547168 CyMet APR CN Free 3417 0500PE Fix 8547171 CyMet APR EO 3478 1000PE WBC Lyse 8547170 CyMet APR Baso II 3479 1000PE Rinse 8547167 DetectoTerge 3766 Beckman Coulter AcT Diff 2 Diff Pack Reagent kit 8547134 Diluid III Diff 3963 CyMet III Diff CN Free 3511 1000 Rinse 8547113 ProClean 3900 Beckman Coulter Analyzers Calibration Calibration of Beckman Coulter AcT Diff Cleaning Procedure 1 Run 3 hematology controls or 5 reference patient The cleaning procedure is advised to perform in case samples of error messages on the impedance aperture or WBC differential issues 2 Take the current calibration factors from the memory of the instrument using the following buttons Procedure 1 Mix in a 1L beaker 500ml distilled water and 500ml Hypochlorite 0 5 2 Connectthis solution to the ProClean line Clenz line Fig 9 Buttons to enter c
12. LOW NORMAL HIGH LOW NORMAL HIGH Mean Range Mean Range Mean Range Mean Mean Range Mean Range WBC 10 L WBC WOC 10 L LYM WIC 1091 MID NEU 10 L GRAN 96 NEU 96 LYM 1071 I LYM 1071 MID 10 L LYM GRAN 10 L 10 L RBC 1071 MONO HGB g dL EOS 1071 HGB mmol L 5 Hct 96 BASO 10 L HCT L L BASO MCV fL RBC 10 7 L MCH pg 2 HGB g dL fmol HGB mmol L MCHC g dL 1 Het 96 MCHC mmol L 2 HCT L L RDW MCV fL Pits 1071 MCH pg MPV fL U MCH fmol Abbott Cell Dyn 1300 1600 2000 series MCHC g dL LOW NORMAL HIGH MCHC mmol L Mean Range Mean Range Mean Range RDW Pits 10 L MPV fL Parameters Parameters Abbott Cell Dyn 4000 Abbott Sapphire LYM 10 L LOW NORMAL Parameters MID 1091 Range Mean Range GRAN 1071 i WBC 10 Other CBC Parameter NEU 10 L NEU 96 LYM 1091 LOW NORMAL HIGH LYM Mean Mean Mean Range 10 L WBC WOC 10 L WBC NOC 10 g EOS 10 L NEU 1071 5 NEU 96 BASO 10 L LYM 10 L BASO LYM RBC 10771 MONO 1071 f RBCo 10 7 L MONO g dL EOS 1071 HGB mmol L EOS i BASO 1071 HCT L L BASO 96 MCV fL RBC 107
13. fl 78 4 MCH fmol 1 62 0 15 MCHC mmol l 20 7 1 9 RDW 13 8 2 0 Plts x 107 89 15 MPV fl 6 1 1 5 Sysmex F series K series KX 21 and X series CBC mode WBC x 10 2 0 0 4 RBC x 1071 2 33 0 12 Hb mmol l 3 8 0 2 Het I I 0 177 0 015 MCV fl 76 4 MCH fmol 1 63 0 15 MCHC mmol l 21 4 1 9 Pits x 10 71 15 MPV fl 8 4 1 5 ABX Micros Pentra 60 80 and 120 cbc mode Bayer Advia 60 WBC x 1071 1 9 0 4 RBC 10 1 2 25 0 12 Hb mmol l 3 7 0 2 Hct I I 0 167 0 015 MCV fl 74 4 MCH fmol 1 65 0 15 MCHC mmol l 22 2 1 9 Plts x 107 73 15 Diatron Abacus Arcus WBC x 107 1 7 0 4 RBC x 1071 2 33 0 12 Hb mmol l 3 9 0 2 Het I I 0 192 0 015 MOV fl 82 4 MCH fmol 1 65 0 15 MCHC mmol l 20 1 1 9 Plts x 10 69 15 MPV fl 7 8 1 5 Avantor Performance Materials B V mw P O Box 1 7400AA Deventer The Netherlands Tel 31 0570 687500 The devices as mentioned in this insert comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC Qd c x 107 71 15 MPV fl 8 4 1 5 Medonic Series Analys Series WBC x 1071 1 8 0 4 18 6 2 0 x 1071 2 28 0 12 i 5 61 0 18 Hb mmol l 3 5 0 2 j 10 7 0 4 Het I I 0 178 0 015 1 0 527 0 030 1 78 4 94 4 fmol 1 53 0 15 1 91 0 19 MCHC mmol l 19 6 1 9 20 3 1 9 Plts x 107 75 15 425 50 MPV fl 7 4 1 5 8 1 1 5 Nihon Kohden Celltac and MEK series WBC 10 RBC 10 Hb mmol l Hct I I MCV fl MCH fmol
14. 2000 Kohden Celltac F MEK 8222K X c MEK 8118K QA 810V ES MEK 7300 E MEK 7222K Celltac a MEK 6450 6420 MEK 6410 MEK 6400 MEK 6318K MEK 6108 Orphee Mythic 18 Rayto RT 7600 SEAC H20 Genius H12 H8 Swelab 970 AC920e0 X 910 900 X Sysmex SF3000 4500 1000 21 21 XE2100 XT2000i XT1800i XS1000i x Urit 3010 2900 The information contained herein has not been approved by listed instrument manufacturer Always refer to the user manual provided with the equipment at issue 56 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of A NTOF PERFORAAANCE AAATERIALS The J T Baker hematology controls are available in Low Normal and High levels Product numbers packaging stability and ordering frequency information can be found in the table below J T Baker Hematology Controls Overview Open vial Ordering frequency per year Control Number Stability months stability J T Baker Product Level Volume Pack type L N H 3463 3464 3465 2 5ml Pierceable cap 4 4 4 L N H 3701 3702 3703 4 5 Pierceable cap 4 4 4 L N H 3746 3 2 5 ml Screw 4 4 4 4xN 3747 4x2 5 ml Screw cap 4 4 4 1xL 4xN 1xH 3751 6x2 5ml Screw cap 4 4 4 8 Parameter Control extended L N H 3633 3634 3635 2 5 ml Screw cap 6 4 4 8 Parameter Control VET L N H 290
15. MPV fL PCT 96 PCT ml L PLT 10 uL NORMAL HIGH Mean Range Mean Range Mean Range Parameters WBC 10 L NEU 1071 NEU 96 LYM 4 1091 LYM 96 10 EOS 10 L 5 BASO 1071 BASO WBC 10 L LYM 1091 LYM MONO 10 L MONO EOS 10 L EOS BASO 1071 BASO NEU 10 L NEU Parameters WBC 107 NEU 10 uL LYM 10 uL MONO 1071 EOS 10 uL BASO 10 uL NEU 96 LYM MONO EOS BASO NORMAL HIGH Mean Mean Range Mean RBC 10 2 L HGB g dL HGB mmol L MCHC g dL MCHC mmol L RDW 96 RBC 10 yL HGB g dL HGB mmol L Hct HCT L L MCV fL PLT 10 PCT MPV fL PDW CV Check Manuals Celltac E and ES for FL SD adjustment for CONTROL mode Celltac F CONTROL setup FS 1 0 FL 1 3 and SD 1 5 PLT 10 uL PCT Avantor Performance Materials B V 8 C P O Box 1 7400AA Deventer The Netherlands 4 29 Tel 31 0 570 687500 devices mentioned this insert comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC 76 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Range Range Assay Value Sheet Part of AWANTOR PERFORMANCE MATERIALS AVYANTOR PERFORMANCE MATERIALS Assay values K Diff Controls Combined Units LOT REF Assay values and expected range
16. Stains and Dyes Wright 90 Stains and Dyes RetiCount 92 SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of foe PERFORMANCE MATERIALS General Information Introduction The manufacturing and purifying expertise of Avantor Performance Materials forms the basis of a comprehensive range of diluting reagents lysing reagents cleaning reagents and hematology controls Avantor understands not just cell lysing and chemical interference of compounds on cell membranes but also the characteristics of these compounds in aqueous solutions and their long term behavior in the presence of other chemicals Production Avantor s J T Baker brand reagents are produced using advanced production techniques in modern certified manufacturing facilities to ensure minimal impurities Both the high quality water and solvents used by Avantor in the manufacturing process help to improve the overall quality of the solutions produced The products are bottled under controlled conditions to prevent contamination and degradation assuring maximum purity and stability Quality Control Every reagent batch is use tested and released in accordance with ISO 9001 regulations Our knowledgeable staff of specialists working in well equipped R amp D and QC laboratories assure lot to lot consistency and provide technical customer support Validation
17. Undiluted May Gr nwald 3 May Gr nwald working solution 5 Move slides gently Sorensen buffer pH 7 20 blood smears 25 bone marrow cytology Move slides gently in Giemsa working solution Flush in tap or deionized water e Traditional method according to Pappenheim for whole blood smears 1 Prepare S rensen buffer solution pH 7 Dilute 100 ml of the concentrated S rensen phosphate buffer with 1 9L deionized water 2 Prepare the Giemsa working solution Dilute 25 ml Giemsa solution with 475 ml Serensen buffer solution pH 7 3 Proceed according to the table below Reagent sequence Minutes Undiluted May Gr nwald 3 Flush in deionized water 1 Move slides gently in Giemsa working solution 20 Flush tap or deionized water 86 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of f PERFORMANCE MATERIALS Quick staining method for whole blood smears Quick staining method for whole blood smears 1 Prepare S rensen buffer solution pH 7 1 Prepare S rensen buffer solution pH 7 Dilute 100 ml of the concentrated Sorensen Dilute 100 ml of the concentrated Sorensen phosphate buffer with 1 9L deionized water phosphate buffer with 1 9L deionized water 2 Prepare the Giemsa working solution 2 Prepare the Giemsa working solution Dilute Giemsa solution 1 to 6 up to 1 to 8 with Dilute Giemsa solution 1 to 6 up to 1 to 8 with S rensen buf
18. and HIV 1 2 Each unit is also negative by a immunoassay test for Syphilis without losing product integrity The stability period of opened vials is guaranteed when the hematology controls are used in accordance with the instructions for use Because no test method can offer complete assurance Ordering information that infectious agents are absent this material should The J T Baker hematology controls are manufactured be handled as potentially infectious When handling or delivered four or six times per year see the table above for disposing of vials follow precautions for patient specimens ordering frequency information as specified in local biosafety procedures Information about the test methods is available on request Abbott and Cell Dyn are trademarks of Abbott Laboratories Corporation ABX Pentra and Micros are trademarks of HORIBA ABX SAS Avantor Performance Materials BeneSphera are trademarks of Avantor Performance Materials Inc is manufactured by Roche Diagnostics Corporation Bayer and Advia are trademarks of Bayer Corporation Beckman Coulter Diff ACT Diff 27 AcT10 AcT8 AcT5 STKS GenS LH780 LH750 LH500 HmX MaxM are trademarks of Beckman Coulter Inc Diatron is manufactured by Diatron MI PLC Drew is manufactured by Drew Scientific Ltd Erma is manufactured by Erma Inc Hospitex is manufactured by Hospitex Diagnostics HTI is a tradema
19. lt Main gt Select option lt Special protocols gt Select two times option lt More gt Connect J T Baker Diluid ST1600 2000 Blanking Solution ST1600 2000 CyMet ST1600 2000 CN Free to the corresponding aspiration tubes Select option lt Reagent prime gt to prime Diluid ST1600 2000 and Blanking Solution ST1600 2000 Select option Lyse priming to prime CyMet ST1600 2000 Repeat step 8 at least 4 times and step 9 at least 6 times Select option Main and then Run An auto startup prime cycle and background check will be completed Review the displayed data Acceptable values are as follows Parameter Background WBC lt 0 5 x 10 L RBC lt 0 05 x 107 L HGB 0 2 g dL PLT lt 10x 10 L When acceptable background values are displayed the priming is successful If not repeat steps 8 9 again 12 Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Note When changing from cyanide containing to cyanide free reagents a recalibration for the Hemoglobin is required Calibration of Abbott Cell Dyn 1700 1600 1300 Two calibration options are available Select option lt Auto Calibrate gt to run an automatic calibration or follow the manual calibration process as follows Open mode 1 Selectoption Calibration from the main menu The calibration menu displays the calibration fact
20. samples the values to use during calibration Remove the aspirating tubes from the Abbott reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Select option lt Special protocols gt from the main menu Select option lt Reagent reservoir gt Select option lt Empty gt to empty the reservoir from the reagent to be replaced Wait till Fill gt toggles Connect the reagents to the corresponding aspiration tubes Select option Fill gt Perform steps 4 8 for all three reagents Abbott and Cell Dyn and its subsidiary products are trademarks of Abbott Laboratories Corporation The information contained herein has not been approved by Abbott Laboratories Corporation Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 11 Part of AWANTOR J T Baker PERFORMANCE MATERIALS 10 Select option lt Special protocols gt from the main 11 12 13 14 15 Note When changing from cyanide containing to cyanide free menu then select option lt More gt and select option lt Daily shutdown gt Wait till the Standby status has been achieved Select option lt Run gt to perform a prime cycle and achieve Ready mode Perform at least 3 blank counts Review the displayed data Ac
21. x current calibration factor mean value new calibration factor Select option lt New factors entry gt Enter the new calibration factors Continue to the next parameter using key Select option lt Activate gt to save and activate the new factors 10 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of foe PERFORMANCE MATERIALS Priming of Abbott Cell Dyn 3700 3500 3000 1 10 11 12 13 14 Run 3 hematology controls or 5 reference patient samples Keep the values to use during calibration Remove the aspirating tubes from the Abbott reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Select option lt Special protocols gt from the main menu Select option lt Empty reag reservoir gt to empty all reagent reservoirs on the Cell Dyn 3000 or select option lt Empty reservoir gt for each separate reagent reservoir on the Cell Dyn 3500 and Cell Dyn 3700 Select option Fill reag resv to empty the aspiration tube The instrument will give a fault alarm Connect the reagents to the corresponding aspiration tubes Select option Clear fault All J T Baker reagents will be aspirated into the reagent reservoirs Repeat steps 5 6 at least 3 times Select option Main and then Run Perform at least 3 blank co
22. 251 CyMet ASB 2951 0500PE 500 ml CyMet AS CN Free 2952 9010PC 10L Reticulocyte reagent RetiCount AS 2953 0210PE 210 ml Emergency Cleaner ProClean CD 3902 0100PE 100 ml Hematology Control CD Diff Control L N H 3452 3453 3454 3 0 ml Abbott Cell Dyn 3700 3500 Lyse CyMet 3500 CN Free 3825 SE CyMet 3500 3839 5000PC 5L Scatter reagent Sheath Fluid 3000 3500 3471 9020PC 20L Rinse on line Blanking Solution ST1600 2000 3947 20L Reticulocyte reagent RetiCount CD 3777 15x3 5 ml Emergency Cleaner ProClean CD 3902 0100PE 100 ml Abbott Cell Dyn Ruby Diluent Diluid Ruby 2987 9020PC 20L Lyse CyMet Ruby CN Free 2988 5000PC 5L Scatter reagent Leuco Ruby 2989 5000 5L Reticulocyte reagent RetiCount CD 3777 15x3 5 ml Emergency Cleaner ProClean Plus 3901 100 ml Hematology Control Abbott Cell Dyn 3200 CD Diff Control L N H 3452 3453 3454 3 0 ml Diluent Diluid Sheath 3200 4000 3832 9020 201 Lyse CyMet 3200 CN Free 3823 1000 1L Scatter reagent LeucoLyse 3475 5000PC 5L Reticulocyte reagent RetiCount CD 3777 15x3 5 ml Emergency Cleaner ProClean CD 3902 0100PE 100 ml Hematology Control Abbott Cell Dyn 3000 CD Diff Control L N H 3452 3453 3454 3 0 ml Diluent Diluid ST1600 2000 3976 20L Lyse CyMet
23. 3 1 9 Plts x 1071 75 15 240 30 425 50 MPV fl 7 4 1 5 8 0 1 5 8 1 1 5 Nihon Kohden Celltac and MEK series WBC x 1071 2 2 0 4 10 6 1 0 RBC x 10 7 2 36 0 12 4 56 0 15 Hb mmol l 3 9 0 2 8 5 0 3 Het I I 0 191 0 030 0 411 0 030 MCV fl 81 12 90 7 MCH fmol 1 65 0 15 1 86 0 17 MCHC mmol l 20 4 1 9 20 7 1 9 Plts 107 1 77 15 261 30 Mindray BC series WBC x 10 1 8 0 4 RBC x 10 7 2 26 0 12 Hb mmol l 3 8 0 2 Hct I I 0 192 0 030 MCV fl 85 12 MCH fmol 1 68 0 15 MCHC mmol l 19 7 1 9 x 107 75 15 Drew MWI Models except Excell 22 Orphee Mythic 18 WBC x 1071 2 0 0 4 10 5 1 0 x 10 2 23 0 12 4 47 0 15 Hb mmol l 3 5 0 2 8 3 0 3 Het I I 0 183 0 030 0 402 0 030 MCV fl 82 12 90 7 MCH fmol 1 59 0 15 1 86 0 17 MCHC mmol l 19 3 1 9 20 7 1 9 Plts x 10 75 15 235 30 MPV fl 7 9 1 5 8 0 1 5 Part of AASANTOR PERFORMANCE AAATERIALS Assay Value Sheet Z ANTOR BEROP a i E Assay values 8 Parameter Control Vet LOT 218 2015 01 19 Avantor BeneSphera H 32 VET QC MODE NORMAL J Ho Parameters WBC x 10 RBC x 10 Hb g dl Hct fl MCH pg MCHC g dl Plts x 10 l MPV fl Avantor BeneSphera 3 H32 VET DOG MODE LOW NORMAL WBC 10 7 2 0 0 5 RBC x 10 2 l 2 47 0 15 Hb g dl 6 2 0 4 Hct 19 7 1 5 Parameters fl 79 7 5 MCH pg 25 1 2 4 MC
24. 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Drew Excell 18 BT2100 Diluent Diluid III Diff 3963 20L Lyse CyMet III Diff 3964 JE 3968 1L CyMet III Diff CN Free 3511 5000 51 3511 1000 11 Cleaner ProClean 3900 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Drew is manufactured by Drew Scientific Ltd The information contained herein has not been approved by Drew Scientific Ltd Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 29 Part of fae AVANTOR PERFORAAANCE AAATERIALS Drew Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type J T Baker Product Drew Excell 22 Diluid Ill Diff Consumption Per Test CyMet Ill Diff Sheath D Drew D3 Diluid III Diff CyMet Ill Diff ProClean Drew is manufactured by Drew Scientific Ltd The information contained herein has not been approved by Drew Scientific Ltd Always
25. 8 AcT 10 LOW NORMAL Mean Range Mean Range Please refer to Table AcT Diff for CBC parameters LYMP 53 3 6 0 24 4 4 0 LYMP 1 1 0 2 1 9 0 4 Parameters Nihon Kohden Celltac and MEK series not for 5 part dif LOW Mean Range NORMAL Mean Range Parameters WBC 1071 HIGH Mean Range 11 4 4 0 2 4 0 8 HIGH Mean Range 1071 Hb g dl Hb mmol l Hct 96 Het I I MOV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW 96 Pits 109 1 MPV fl LYMP MONO GRAN LYMP MONO GRAN LOW Mean Range NORMAL Mean Range Parameters WBC 1071 Danam Drew Excel18 MWI BT2100 D3 Orphee Mythic 18 Abbott Emerald 18 HIGH Mean Range RBC 1071 Hb g dl Hb mmol l Hct 96 Het I I fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW Pits 109 1 AVL Contraves AVL 818 LOW Mean Range NORMAL Mean Range Parameters Please refer to Table Coulter Counters for CBC parameters HIGH Mean Range SALES MANUALHEMATOLOGY PRODUCTS www avantormaterials com 63 Part of fae AVANTOR PERFORAAANCE AAATERIALS Assay Value Sheet JVANTOR Assay values 3 Diff Controls D0000803 Combined US and SI Units Avantor Performance Materials B V Version 22 0 TRECE rna ESL LOT Diatron Abacus Abacus 3 Abacus Junior Arcus Erba Elite 3 LOW NORMAL HIGH Mean Range Mean Range Mean Range Parameters WBC 10
26. Assay Value Sheet ANVANTOR 2 PERFORMANCE MATERIALS 3940 Cal Set 1 Calibration Set 3940 Calibration Entry Worksheet LOT 268 Instrument Performed by EE 2015 01 19 Date Table 1 Determination of Mean Value Cal Set 1 WBC RBC HGB x 10 10 2 g dl or mmol l old calibration factor Assigned Value Mean value x old calibration factor Table 3 Verification of Calibration Cal Set 1 x 10 l 10 2 Difference between Mean Value and Assigned Value Tolerance Limits HCT versus MCV fl case of Toa Sysmex and BioChem analysers Hematocrit is used for calibration instead of MCV MCV is coverted to by RBC 10 x MCV fl HCT 10 MCV and HCT are directly related to each other This means the change in MCV is directly proportional to the change in HCT Hb mmol l In case Hb is measured as mmol l the value listed in g dl has to be multiplied by the factor 0 6206 Hb mmol l Hb g dl x 0 6206 82 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of f AVANTOR PERFORMANCE MATERIALS Assay Value Sheet ZANTOR RE 390 BEF Cina a CE A A TE N a E LOT 268 3940 Cal Set 1 Calibration Set EE 2015 01 19 Table 4 Cal Set 1 Assigned values HGB Instrument type mmol l 0 1 1 N Coulter Counter Models semi automates S Plus Il Il IV V VI JR JS JT ST STKR MD AcT MAXM STKS HmX Gen S Av
27. DetectoTerge 3763 5L Sheath Fluid Sheath D 3495 9010PC 10L Bayer ADVIA 60 Diluent Diluid III Diff 3963 20L Lyse CyMet Micro CN Free 3863 1000 1 L micros bottle Cleaner ProClean 3768 1000 1 L micros bottle Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 11 Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Bayer ADVIA 120 Reagents not available Hematology Control ADV Diff Control 3684 3685 3686 3 5 Bayer and Advia are trademarks of Bayer Corporation The information contained herein has not been approved by Bayer Corporation Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 23 Part of PERFORMANCE MATERIALS Beckman Coulter Analyzers Beckman Coulter Analyzers Reagents Description J T Baker Product Pack Size Beckman Coulter AcT 5 Diluent Diluid APR 3476 9020PC 20L Lyse CyMet APR CN Free 3417 0500PE 500 ml Lyse for Eosinophils CyMet APR EO 3478 1000PE 1L Lyse for Basophils CyMet APR Baso II 3479 1000PE 1L Cleaner on line DetectoTerge 3766 1L Emergency Cleaner ProClean Plus 3901 100 ml Hy
28. Dutch Ministry of Health CE marking requires some additional information on the label Symbols instead of text will be used to express some data VD For in vitro diagnostic use Expiry date month year Store temperature 8 m 8 Manufactured by C8 TA CE registered product Product Number Lot Number yyddd12345 The lot numbering system for hematology reagents except hematology controls has the following system for traceability purposes and shows the manufacturing date yy year of production day of production 12345 production number Hematology controls have a 3 digit lot number like 110 111 112 Each new batch has the subsequent lot number SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 1 Part of gt AVANTOR PERFORMANCE MATERIALS Diluid 610 me 3969 201 Documentation g zoo For more information about our product program advised 1 protocols and troubleshooting visit our website at in d dmm 4 eren m 2 IT www avantormaterials com B Rn aro qu Ripe SSS ME Sami mam ML num j Lg LL ER FED 1 dV um SI arama OL Dann eee D U ELEM mamam Hi mam wunumptum ar man huba enan um ciim saran
29. Hb mmol l 3 8 0 2 10 9 0 4 Het 0 177 0 030 1 0 508 0 030 MCV fl 76 18 89 8 MCH fmol 1 63 0 15 1 91 0 19 MCHC mmol l 21 4 1 9 21 4 1 9 Plts x 10 1 71 15 475 50 fl 8 4 1 5 i 9 2 1 5 Micros Pentra 60 80 120 cbc mode Bayer Advia 60 WBC x 107l 1 9 0 4 10 3 1 0 RBC x 10 l 2 25 0 12 4 54 0 15 Hb mmol l 3 7 0 2 8 3 0 3 Het 0 167 0 030 0 380 0 030 fl 74 12 84 7 fmol 1 65 0 15 1 82 0 17 MCHC mmol l 22 2 1 9 21 7 1 9 Plts x 107 73 15 247 30 Diatron Abacus Arcus WBC x 107l 10 7 RBC x 10 233 012 4 71 015 Hb mmol l 3 9 0 2 8 4 0 3 0 192 0 030 0 433 0 030 fl 82 12 92 7 fmol 1 65 0 15 1 78 0 17 MCHC mmol l 20 1 1 9 19 3 1 9 Plts x 10 69 15 262 30 MPV fl 7 8 1 5 8 2 1 5 P O Box 1 7400 Deventer The Netherlands Tel 31 0570 687500 The devices as mentioned in this insert comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC 8 C Avantor Performance Materials B V 2 C SALES MANUALHEMATOLOGY PRODUCTS www avantormaterials com 61 Plts x 1071 71 15 243 30 MPV fl 8 4 1 5 8 4 1 5 Medonic Series Analys Series WBC 10 7 10 4 18 6 2 0 RBC x 1071 2 28 0 12 4 51 0 15 5 61 0 18 Hb mmol l 3 5 0 2 7 9 0 3 10 7 0 4 Het 0 178 0 030 0 392 0 030 0 527 0 030 fl 78 12 87 7 94 7 MCH fmol 1 53 0 15 1 76 0 17 1 91 0 19 MCHC mmol l 19 6 1 9 20 2 1 9 20
30. I NOTE Mean 2015 04 19 Range NORMAL Mean Range Coulter Counter Models with Ill Diff option for ACT see separate table Please refer to next page for Erma Values LOW HIGH Mean Range Parameters WBC 109 1 Mean Range Mean Range Mean Range RBC 107 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW 96 1071 Hb g dl Hb mmol l Hct Hct I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW Pits 109 1 MPV fl Pits 109 1 MPV fl PDW LYMP MONO GRAN LYMP MONO GRAN Parameters WBC 1071 Mean LOW Range ABX Roche Micros 60 Micros ES 60 Bayer Advia 60 NORMAL Mean Range HIGH Mean Range LYMP MONO GRAN LYMP MONO GRAN Parameters Coulter Counter AcT 8 AcT 10 LOW Mean Range NORMAL Mean Range Please refer to Table AcT Diff for CBC parameters LYMP LYMP Parameters WBC 10 53 3 1 1 6 0 0 2 LOW Mean Range 24 4 1 9 4 0 0 4 Nihon Kohden Celltac and MEK series not for 5 part diff NORMAL Mean Range HIGH Mean 11 4 2 4 Range 4 0 0 8 HIGH Mean Range RBC 1071 Hb g dl Hb mmol l Hct Hct I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW 1071 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg
31. J T Baker Product Consumption Per Test Diatron Abacus Junior 5 Diluid Abacus 40 ml CyMet Abacus CN Free 0 5 ml CyMet Abacus EO 2 ml CyMet Abacus Baso 3 ml ProClean Abacus 3 Diatron Abacus Diluid Abacus 30 ml CyMet Abacus CN Free 0 9 ml ProClean Abacus 0 6 ml Diatron analyzers Priming and Calibration Priming of Diatron Abacus 10 Run 3 hematology controls or 5 reference patient samples Keep the values to use during calibration Remove the aspirating tubes from the Diatron reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Select option 3 Maintenance Select option 2 Priming Select option Prime diluent to empty the system Connect J T Baker Abacus to the corresponding aspiration tube Select option Prime diluent at least 3 times To prime CyMet Abacus CN Free ProClean Abacus proceed as described above for the Diluent Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Note All reagents can be primed in one cycle Select option Prime all gt Calibration of Diatron Abacus Two calibration options are available see below information on auto calibration and factorial manual calibration Auto calibration
32. MCH fmol MCHC g dl MCHC mmol l RDW 96 Pits 109 1 MPV fl Pits 10 l MPV fl LYMP MONO GRAN LYMP MONO GRAN Parameters WBC 10 Mean Abbott Cell Dyn 1300 1500 1600 1700 1800 series LOW Range NORMAL Mean Range HIGH Mean Range LYMP MONO GRAN 96 LYMP MONO GRAN Danam Drew Excel18 MWI BT2100 D3 Orphee Mythic 18 Abbott Emerald 18 Parameters WBC 10 LOW Mean Range NORMAL Mean Range HIGH Mean Range RBC 107 Hb g dl Hb mmol l Hct Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l Pits 109 1 MPV fl RBC 1071 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW LYMP 96 MID 96 Orphee MYTHIC 18 Please refer now to Danam Drew table Pits 109 1 MPV fl LYMP MONO GRAN LYMP MONO GRAN 66 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of f AVANTOR PERFORMANCE MATERIALS Assay Value Sheet Assay values 3 Diff Controls Extended 00000840 Combined US and SI Units Avantor Performance Materials Version 12 0 JAVANTOIR E Ha 144 TRIN Box 1 7400 Deventer The Netherlands Tel 31 0 570 687500 LOT 210 2015 04 19 Diatron Abacus Abacus 3 Abacus Junior Arcus Erba Elite 3 Parameters WBC 107
33. Mean Range Mean Range RBC 1071 Hb g dl Hb mmol l Hct Hct I I MCHC mmol l RDW Pits 1071 MPV fi PDW LYMP MONO GRAN LYMP Urit 2900 Plus Parameters WBC 1071 LOW NORMAL HIGH Mean Range Mean Range Mean Range RBC 1071 Hb g dl Hb mmol l Hct 96 MCHC mmol l RDW CV 96 RDW SD fl Pits 10 1 MPV fl PCT PCT ml l PDW LYMP GRAN LYMP MONO GRAN 64 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Assay Value Sheet AGANTON ELELE LOT Mindray 3200 3000 Parameters Mean WBC 10 210 2015 02 19 LOW Range Assay values 3 Diff Controls Combined US and SI Units NORMAL HIGH Mean Range Mean Range RBC 1071 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV RDW SD Pits 109 1 MPV fi LYMP MONO GRAN LYMP MONO GRAN Mindray BC 2800 BC 2600 software version 2 0 or higher NORMAL HIGH Mean Range Mean Range Parameters Mean WBC 10 LOW Range RBC 107 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV RDW SD Plts 10 MPV fl PCT PCT ml l PDW fl LYMP MONO GRAN LYMP Mindray BC 3600 BC 3300 Parameters Mean WBC 109 1 LOW Range NORMAL HIGH Mean Range Mea
34. ProClean 3900 5L Emergency Cleaner Hypochlorite 0 596 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml HTI and its subsidiary products are trademarks of High Technology Inc The information contained herein has not been approved by High Technology Inc Always refer to the user manual provided with the equipment at issue 34 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of A NTOF PERFORAAANCE AAATERIALS MDC Analyzers MDC Analyzers Reagents Description J T Baker Product C ProduutN Pack Size MDC AL Medicon 4000 AL series 902 18 902 20 300 916 Diluent Diluid III Diff 3963 20L Lyse CyMet AL 3499 1000 N Cleaner Blanking Solution HgB 3507 9020 20L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 596 3917 5000 5L 3917 1L MDC its subsidiary products are manufactured by AL Systeme The information contained herein has not been approved by AL Systeme Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 35 Part of PERFORMANCE MATERIALS Medonic Analyzers Medonic Analyzers Reagents Descriptio
35. RDW SD Plts 107 MPV fl PCT 96 Pits 1071 MPV fl LYMP MONO GRAN LYMP LOW Mean Range Parameters WBC 109 1 LOW NORMAL HIGH Mean Range Mean Mean Range Parameters WBC 1071 RBC 107 Hb g dl Hb mmol l RBC 1071 Hb g dl Hb mmol l Hct 96 Het I I fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV RDW SD Hct 96 Het I I fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV RDW SD Plts 107 MPV fl LYMP Pits 1071 MPV fi PCT PCT ml l PDW fl MONO GRAN LYMP MONO LYMP MONO GRAN LYMP old series s n A59xxx Hb mmol l MCH pg MCH fmol MCHC g dl MCHC mmol l Mindray BC 3600 BC 3300 LOW NORMAL HIGH Parameters Mean Range Mean Range Mean Range Mindray BC 2300 BC 2100 Parameters LOW NORMAL HIGH RBC 1071 Hb g dl Hb mmol l Hct Het 1 1 MCV fl MCH pg MCH fmol g dl MCHC mmol l RDW CV RDW SD Mean Range Mean Mean Range WBC 1071 RBC 107 Hb g dl Hb mmol l Hct 96 Het I I fl MCH pg MCH fmol MCHC g dl MCHC mmol l Pits 1071 MPV fl PCT 96 RDW CV RDW SD Pits 10 MPV fl PCT PCT mi l PDW fl LYMP MONO GRAN LYMP MONO GRAN 68 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of v A MAGA VANTO R PERFORMANCE MATERIALS Assay Value Sheet
36. Select option lt Enter gt to save Select option lt Select gt select option lt Yes gt and select option lt Enter gt Select option lt Select gt to print the new calibration factors Press lt C9 0 gt to enter the service mode for the calibration of the other parameters Select option lt Select gt Select option lt 9 Service gt Select option lt 3 Settings gt Select option lt 2 Change gt Select option lt 1 Calibration gt Calculate new calibration factors for the other parameters reference value new calibration factor x current calibration factor mean value Select the parameter to be calibrated and enter new calibration factors Continue to the next parameter using key Put the cursor on the bottom line and use key to show the parameters to be changed Select option lt Set gt to save the calibration factors and return to the Ready mode Sysmex KX21 WBC startup and background failures Ifa high WBC background is measured after switching to 1 reagents then use the next cleaning protocol 1 Prepare a solution with 500 ml Hypochlorite 0 596 and 500 ml distilled water 2 Remove the aspirating tube from the diluent cubitainer and connect to the hypochlorite solution 3 Select option Select and select option lt 5 Auto Rinse gt Wait for 30 minutes 4 Select option Select and select option lt 5 Au
37. cleaning protocol be used 1 Filla beaker with 500 ml DetectoTerge 2 Remove the aspirating tubes from the reagent cubitainers and bottles and put them in clean beakers 3 Press Esc to enter the main menu 4 Select option 3 Reagents from the main menu 5 Select option 3 Prime 6 Selectoption 6 All reagents 7 Repeat steps 3 6 8 Putallaspirating tubes in the DetectoTerge solution 9 Prime2 times following the procedure in step 3 6 10 Wait for at least 2 hours and remove all aspirating tubes from the DetectoTerge solution 11 Prepare a beaker with 500 ml distilled water 12 Prime 2 times following the procedure in steps 3 6 18 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS 13 14 15 16 17 Part of foe AVANTOR PERFORMANCE MATERIALS Remove all aspirating tubes from the distilled water to prime the instrument with air Prime 2 times following the procedure in steps 3 6 Reconnect all aspirating tubes to their corresponding reagent bottles Prime 2 times following the procedure in steps 3 6 Perform a startup and background check Repeat if necessary Priming of ABX Micros 10 11 12 Run 3 hematology controls or 5 reference patient Samples Keep the values to use during calibration Remove the aspirating tubes from the Abbott reagent cubitainers and bottles and put them in clean beakers R
38. has been performed under the The audit hus been performed under the a H ae Lars af Veldkamp Faget Lend Auditor Mariagenien Reprexentative T 1 8222 Lack of fulfilment of conditions as set aut in the Certification Agreement may render this Certificate invalid z 5 2 dae beest tuned 5 6 aaa cse far mire Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid HEM OFFICE Da Wash Vena AB Vertisves 1 1322 Face ey TATA OTST T Sur di cain USIT DET NORSKE LOFRTIEICATICN BOY wor sewer 1 2994 LB BARENDRECIT THE NXTHESi AV DS TEL 83 08 12202 2600 www dnvba com Fig 2 ISO 9001 2008 Fig 3 ISO 13485 2003 Certification guarantees continous total quality Especially for diagnostic products DIN V DNV BUSINESS ASSURANCE MANAGEMENT SYSTEM CERTIFICATE Certificate No 122475 2012 AE NLD RvA This is to certify that Avantor Performance Materials B V Teugseweg 20 7418 Deventer The Netherlands has been found to conform to the Management System Standard ISO 14001 2004 This certificate is issued on basis of the ISO 14001 certification scheme from SCCM and is valid concerning activities related io Design development production sales and supply of high purity chemicals for hematology histopathology laboratories research centers bio pha
39. methanol fix for 1 minute wash off the fixative with distilled water and drain 3 Prepare the Leishman Buffer solution Dilute 50 ml Leishman solution with 250 ml Sorensen buffer solution pH 7 4 and allow to stand for 10 minutes 5 Proceed according to the table below Reagent sequence Minutes Undiluted Leishman 1 Leishman Buffer solution 6 Buffer 1 Buffer 1 Rinse in running tap water 2 Dry Note times as listed the tables are approximate and can be adjusted to suit personal preferences Staining solutions will lose their staining power when heavily used and the staining times should be longer or fresh solutions should be used 88 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of Ne AVANTOR PERFORMANCE MATERIALS Performance Characteristics Red blood cells red to yellowish red Neutrophils dark purple nuclei pale pink cytoplasm reddish lilac small granules Eosinophils blue nuclei pale pink cytoplasm red to orange red large granules Basophils purple to dark blue nucleus dark purple almost black large granules Lymphocytes dark purple to deep bluish purple nuclei sky blue cytoplasm Platelets violet to purple granules Parasites Dark blue black Leishmania malaria etc Troubleshootings Red cells are blue and nuclei are deeply stained Fig 12 Leishman stain 100x Prolonged staining Inadequate washing Excessively alkal
40. procedure In keeping with the high quality standards that J T Baker brand reagents are known for newly developed reagents for hematology analyzers are tested to meet or exceed the performance of those currently on the market All new reagents undergo stringent tests including e Chemical specification e Correlation e Reproducibility e Linearity e Performance hematology controls Stress testing Long term stability ISO 9001 Avantor s ongoing pursuit of total quality has resulted in a NEN EN ISO 9001 2008 certified quality system for Avantor s facilities in Deventer the Netherlands The NEN EN ISO 9001 2008 certification includes design development production and supply of the products ISO 13485 Avantor s facility in Deventer the Netherlands has been ISO 13485 2003 certified since January 2012 ISO 13485 covers the design development production sales and supply of high purity chemicals and kits for clinical diagnostics ISO 14001 Avantor s facility in Deventer the Netherlands has been NEN EN ISO 14001 2004 certified since January 2004 ISO 14001 is ISO s environmental management system that describes the efforts taken to minimize harmful effects to the environment CE Mark European IVD Directive 98 79 EC Most of Avantor s hematology and histopathology products are CE marked Avantor has completed the technical dossiers of these hematology products and registered these products at the competent authority the
41. r dL 11 8 05 37 4 2 0 28 2 1 8 160 85 PLT x10 83 20 0210 00580 POW 12167 90 Notas Ranges must be entered manually Into the Coulter conirol files Barcodes can not ba used for the GENS LH500 and LH 50 Avantor Performance Materials B V Box 1 7400AA Deventer Holland Tel 41 0 570 687500 The devices as mentioned in this insert comely with the In Vitro Diagnostic Medical Devices Directive TT CDI Assay values for Coulter instruments STKS MAXM Hmx GENS LH500 1 750 30000809 Version 6 0 BOO 167002 18 12 2014 IIIIIIIIIIIIIIAI C00 167002 9 9 52 0 5 1 TURAE TEIL NE a G00 167002 4 18 11 8374 ll lili UL 100 167002 16 0 258 8 3 IIIIIIIIIIIIIIIIII 100 187002 0210 16 7 _ i EUER iE FE da TE EWI di L 5 a CE 70 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of CF VANTO R PERFORMANCE MATERIALS Assay Value Sheet DODDOH YE Version 6 0 per Coulter STKS f MAXM J H HmX I GENS LH500 LH750 L tor 167003 T 222 19 12 2014 ADO 167003 REF 3683 Nek Ti N D00 187003 24 0 5 4 6 5 00 167003144009 NM UON FOO 167003 1 0 0 2 ES M GOO
42. steps 8 9 Select option 4 Calibration Select option 3 Calibration settings Select option Calibration with three measures Go back to the Main menu Select option 4 Calibration Select option 1 Calibrate gt Define target values using the 3 Diff or 8 parameter assay value sheets Select Ok If a parameter should not be calibrated keep the target value O Select y for calibration measurement Run 3 times a hematology control Select y to accept results 10 Select to accept the new calibration factors Diatron and its subsidiary products are manufactured by Diatron MI PLC The information contained herein has not been approved by Diatron MI PLC Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 27 J I Baker Part of AWANTOR PERFORMANCE MATERIALS Factorial manual steps pa Select option lt 4 Calibration gt Select option lt 3 Calibration settings gt Select option lt Factorial Calibration gt Go back to the main menu Select option lt 4 Calibration gt Select option lt 1 Calibrate gt Calculate new calibration factors assigned value new calibration factor mean value x current calibration factor Enter new calibration factors between 0 8 and 1 2 Select Ok Priming of Diatron Abacus Junior 5 10 Run 3 hematology controls or 5 reference patien
43. times 5 Select option Sel to manually include or exclude results from the statistical calculation 6 Default all parameters are selected to be calibrated Select option Calibration Manual calibration steps 1 Login into the advanced setup menu with default password 123 2 Select option Calibration factors to enter new calibration factors 3 Calculate new calibration factors reference value new calibration factor x current calibration factor mean value 4 Select option Valid to accept the new factors or select option Esc to exit without any modifications Orph e S A is manufactured by The Cormay Group Mythic and its subsidiary products are trademarks of Orphee S A The information contained herein has not been approved by The Cormay Group or Orphee S A Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 47 Part of PERFORMANCE MATERIALS Seac Analyzers Seac Analyzers Reagents Description J T Baker Product C ProduutN Pack Size SEAC H20 Genius Diluent Diluid III Diff 3963 20L Lyse CyMet H20 3853 1000 11 Cleaner ProClean 3900 5L DetectoTerge 3763 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 596 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H
44. 08 140012004 amp 134852007 C Deventer the Melheranda 900123008 149012004 amp 134852003 india 9001 5308 ANVANTOR PERFORMANCE MATERIALS
45. 1 Note Reagent Card for MS4 and 59 is not available via Avantor Performance Materials B V Melet Schloesing MS9 MS4 MS8 MS8 VET are trademarks of Melet Schloesing Laboratories The information contained herein has not been approved by Melet Schloesing Laboratories Always refer to the user manual provided with the equipment at issue 38 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of AVANTOR PERFORMANCE MATERIALS Mindray Analyzers Mindray Analyzers Reagents Description JT Baker Product Product Pack Size Mindray BC 5380 BC 5300 Diluent Diluid M5 3419 9020PC 20 L Lyse CyMet MD I 53 2984 1000PE 1L CyMet MD II 3488 0500PE 500 ml CyMet LH 53 2985 1000PE 11 Cleaner ProClean MX5 3498 1000PE 1L Hematology Control BC Diff 5 Control L N H 3613 3614 3615 3 0 ml Mindray BC 3200 BC 3000 Plus BC 2800 Diluent Diluid Mindray 3439 9020PC 20L CyMet Mindray CN Free 3440 0500PE 500 ml Rinse Rinse Mindray 3442 5000PE 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 11 Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Mindray BC 2300 BC 2000 Diluent Diluid Mindr
46. 1 LOW NORMAL HIGH Range Mean Range Mean Range Mean RBC 107 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW SD fl RDW CV Pits 1071 MPV fl PCT ml l PDW SD fl PDW CV LYMP MONO GRAN LYMP MONO GRAN JT Baker reagents CyMet Abacus Diluid Abacus Use Reagent Code 2 in service settings AVL Contraves AVL 816 Parameters Mean LOW NORMAL HIGH Range Mean Range Mean Range Please refer to Table Coulter Counters for CBC parameters Parameters Mean LOW NORMAL HIGH Range Mean Range Mean Range Please refer to Table Coulter Counters for CBC parameters Inmesco HM1060 Rayto RT 7600 HTI Micros CC 20 Plus Parameters Mean WBC 10 LOW NORMAL HIGH Range Mean Range Mean Range RBC 107 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV RDW SD fl Pits 10 MPV fl PCT PCT PDW LYMP GRAN LYMP The devices as mentioned in this insert comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC Avantor BeneSphera H32 LOW NORMAL Mean Range Mean Range Parameters WBC 10 HIGH Mean Range RBC 107 Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV RDW SD fl Pits 10 MPV fl PCT ml l PDW LYMP GR
47. 1 HGB g dL HGB mmol L Hct 96 MCHC mmol L HCT L L RDW MCV fL i NRBC 10 L MCH pg 100 WBC fmol 1 PLT 10 g dL PLTi 109 L MCHC mmol L MPV fL RDW PCT PLT 10 PCT mi L MPV fL PDW Parameters Avantor Performance Materials B V 8 P O Box 1 7400AA Deventer The Netherlands 4 Tel 31 0 570 687500 29C devices as mentioned in this insert with the In Vitro Diagnostic Medical Devices Directive 98 79 EC SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 75 J I Baker Part of _A ANTOR PERFORMANCE MATERIALS Assay Value Sheet mm RGGU H Lud HN ide Assay values CD Diff Cell Dyn Controls LOT 211 REF 3452 3453 3454 3838 2014 11 16 Human HumaCount 5L software version 1 5 1829 0 and higher LOW NORMAL HIGH Mean Range Mean Range Mean Range Parameters WBC 10 uL NEU 10 uL LYM 10 uL MONO 10 uL EOS 10 uL BASO 10 SEAC Heco5 Heco5Plus Parameters RBC 10 L HGB g dL HGB mmol L Hct 96 HCT L L MCV fL MCHC mmol L 00000806 Version 12 0 LOW NORMAL HIGH Mean Mean Range Mean RBC 10 uL HGB g dL HGB mmol L Hct 96 HCT L L fL MCH pg MCH fmol MCHC g dL MCHC mmol L RDW SD fL RDW CV 96 PLTi 1071
48. 187003 541 17 2557 n 167003 103 0 31 8 30 9 HU NH ii iii 100 167003 13 8 4658 4 l noe 3s as EU 138 50 400 167003 0 400 16 7 s 91 Notes Ranges must be entered manually into the Coulter control files Barcodes can not be used for the GENS LH500 and AVYANTOR Avanior Performance Materials B V Box 1 740044 Deventer Holland B C _ Tal 31 20570 687500 T C devices as mentioned in this insert comply wah fhe In Vitro Diagnasbc Medical Devices Directive BB TINEC SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 71 Part of foe AVANTOR PERFORAAANCE AAATERIALS Assay Value Sheet D0000829 A MTOR Version 2 0 BGR PS Ci Jai n b ll Assay values ADV Diff Controls LOT 157 REF 3684 3685 3686 55 222 2014 12 19 Assay values and expected ranges for Bayer ADVIA 120 2120 Instruments LOW 3684 NORMAL 3685 HIGH 3686 Parameters Mean Range Mean Range Mean Range WBC 1091 WBCP 10711 RBC 107 HGB g dl mmol l 1 1 fl pg fmol g dl mmol l g dl mmol l g dl mmol l 10 fl 1071 1071 1071 109 1 1071 Parameters HIGH 8686 Mean Range Avantor Performance Materials B V P O Box 1 7400AA Deventer The Netherlands 8 C
49. 33 3634 3635 Avantor BeneSphera H 32 HUMAN User and QC Mode Avantor BeneSphera H 32 VET ONLY QC MODE NORMAL WBC 10 20 0 4 1 0 Parameters RBC x 1077 2 26 0 12 Hb mmol l 3 8 0 2 Hct 0 181 0 030 fl 80 12 fmol 1 68 0 15 MCHC mmol l 20 9 1 9 RDW 96 16 8 2 0 RBC x 1077 2 30 0 12 0 15 Hb mmol l 3 8 0 2 0 3 Het I I 0 189 0 015 0 024 MCV fl 82 12 7 fmol 1 65 0 15 0 17 MCHC mmol l 20 1 1 9 1 9 RDW 17 8 2 0 2 0 Plts x 10 l 75 15 MPV fl 7 9 1 5 S Plus Heco Vet Vet C Vet S Plus vet WBC 107 Plts 1071 73 15 30 MPV fl 10 9 1 5 1 1 5 Abbott Cell Dyn Series not for 5 part diff WBC x 107 10 3 1 0 RBC x 1071 228 012 Hb mmol l 3 7 0 2 Hct I I 0 173 0 030 MCV fl 76 12 MCH fmol 1 63 0 15 MCHC mmol l 21 5 1 9 x 10 2 230 015 4 50 0 15 Hb mmol l 3 8 0 2 8 3 0 3 Het 0 186 0 030 0 405 0 030 fl 81 12 90 7 MCH fmol 1 65 0 15 1 83 0 17 MCHC mmoll 20 3 1 9 20 4 1 9 Plts x 1071 67 15 MPV fl 10 5 1 5 Pct 0 70 0 20 Swelab Auto Counter Series 3 part diff AC series WBC x 1071 1 9 0 4 RBC 1071 2 28 0 12 Hb mmol l 3 7 0 2 Het 0 178 0 030 MCV fl 78 12 MCH fmol 1 62 0 15 MCHC mmol l 20 7 1 9 RDW 96 13 8 2 0 Plts x 1074 89 15 MPV fl 6 1 1 5 Sysmex F series K series KX 21 and X series CBC mode WBC x 10 19 4 2 0 RBC x 10 l 233 012 5 70 0 18
50. 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml CD Diff Control L N H 3452 3453 3454 3 0 ml SEACH12 Diluent Diluid III Diff 3963 20L Lyse CyMet H12 CN Free 3841 1000PE 1 E Cleaner ProClean 3900 5L DetectoTerge 3763 sib Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 596 3917 5000 21 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml SEAC H8 Diluent Diluid III Diff 3963 20L Lyse CyMet III Diff 3964 SE 3968 1L Cleaner ProClean 3900 5L DetectoTerge 3763 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 596 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml 48 www avantormaterials om SALES MANUAL HEMATOLOGY PRODUCTS Part of A NTOF PERFORAAANCE AAATERIALS Seac Analyzers Cross List An overview of comparable Seac brand and brand reagents is shown in the table below J T Baker Product SEAC Product SEAC H12 J T Baker Nr Isotonic solution 3 Diluid III Diff 3963 Lyse 3 CyMet H12 CN Free 3841 1000PE Detergent ProClean 3900 DetectoTerge 3763 SEAC H8 Isotonic solution 3 Diluid III Diff 3963 Lyse 3 CyMet III Diff 3968 Detergent ProClean 3900 DetectoTerge 3763 Seac Analyzers Reagent Consumption An indication of the
51. 4 1000PE 11 CE Diluid NR 3483 9020PC CE CyMet 3488 0500PE 500 ml CE Diluid Ruby U CyMet MH CN Free 34970500 500 ml CE Diluid Sheath 3200 4000 3832 9020 CE CyMet Micro 38521000 1L CE Diluid ST1600 2000 3976 CE CyMet Micro CN free 3863 1000 1 Lmicros CE Sheath D 3495 9010PC CyMet Mindray 3441 0500PE 500ml CE Sheath Fluid 3000 3500 3471 9020PC CE CyMet Mindray CN Free 3440 0500PE CE Lyses CyMet NR III 3484 1000PE CE CN free Lyse Diff AC 200 2 CyMet NR III CN Free 3486 1000PE CE CyMet 1000 CN free 3744 CE CyMet NR V 3485 1000PE CE CyMet 22 2986 0500PE E CyMet Ruby CN Free 2988 5000PC CE CyMet 3000 3469 9010PC CE QyMet SF Baso 3480 5000PC CE CyMet 3200 CN free 3823 1000 CyMet SF Diff 1 3481 5000PC CE CyMet 3500 3839 5000PC 2 CyMet SF Diff 2 3482 0500PE CE CyMet 3500 CN free Pens CyMet ST 1600 2000 3775 1000 CE CyMet 4500 CN free 3773 5000 cE CyMet ST 1600 2000 CN free 3759 5000 CE CyMet 530 CN free 3975 CE 3759 1000 CE CyMet 590 CN free 3971 CE CyMet STX STL 3788 CE CyMet 610 CN free 3970 CE LeucoLyse 3475 5000PC CE 3977 CE LeucoLyse Ruby 2989 5000PC 5L CE CyMet Abacus Baso 3445 1000PE CE Lyzerglobin CE Part of A ANTOR J I Baker
52. 4 2905 2906 2 5 ml Screw cap 4 4 4 3 Diff Control L N H 3433 3434 3435 2 5 ml Screw cap 4 3 4 L N H 3502 3503 3504 4 5 ml Pierceable cap 4 3 4 4xL 3466 4 2 5 ml Screw 4 3 4 4 3467 4 2 5 ml Screw 4 3 4 4xH 3468 4 2 5 ml Screw 4 3 4 3 Diff Control extented L N H 3421 3422 3423 2 5 ml Screw cap 6 3 4 5D Control L N H 3681 3682 3683 5 0 ml Pierceable cap 3 2 6 ADV Diff Control L N H 3684 3685 3686 3 5 ml Screw cap 3 2 6 BC Diff 5 Control L N H 3613 3614 3615 3 0 ml Pierceable cap 3 2 6 CD Diff Control L N H 3452 3453 3454 3 0 ml Pierceable cap 3 2 6 2xL 2xN 2xH 3838 6x3 0ml Pierceable cap 3 2 6 K Diff Control L N H 3455 3456 3457 2 5ml Screw cap 4 3 4 SF Diff Control L N H 3693 3694 3695 4 5 Pierceable 3 2 6 XE Diff Control L N H 3731 3732 3733 4 5 ml Pierceable cap 3 2 6 Cal Set 1 3940 2x 2 5 ml Screw cap 3 2 4 Platelet Extended value 3424 5x3ml Pierceable cap 3 2 6 WBC Reduced RBC L H 3698 3699 3 0 ml Pierceable cap 3 4 6 Biosafety information Stability Each human donor unit used in the preparation of the To guarantee the stability in the table above the hematology products listed above has been tested by a United States controls have to be stored upright at 2 8 C when not in use Food and Drug Administration licensed method test and The vials may be stressed for 48 hours at 18 C maximum found to be negative or non reactive for the presence of HBsAg Anti HCV 1 HCV RNA
53. 8 1000PE Lyse for Basophils CyMet APR Baso II 3479 1000PE 11 Cleaner on line DetectoTerge 3766 1L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml ABX Micros 60 560 45 Diluent Diluid III Diff 3963 20L Lyse CyMet Micro 3852 1000 1L CyMet Micro CN Free 3863 1000 11 micros bottle Cleaner ProClean Extra 3867 1000PE 1 L micros bottle Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 596 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml For barcode procedures for ABX Pentra 80 60C and 60C see the following pages ABX Analyzers Cross List An overview of comparable ABX brand and J T Baker brand reagents is shown in the table below When replacing ABX reagents with J T Baker reagents information about priming and calibration can be found on the next pages ABX Product ABX Nr J T Baker Product J T Baker Nr ABX Pentra 80 60 60C 60C Eosinofix 0206010 CyMet APR EO 3478 1000PE Diluent 0901020 Diluid APR 3476 9020PC Cleaner 0903010 DetectoTerge 3766 Basolyse 0906003 CyMet APR Baso ll 3479 1000PE Lyse
54. AN LYMP MONO GRAN 170 18 210 LOW NORMAL Mean Range Mean Range Parameters WBC 10 HIGH Mean Range RBC 107 Hb g dl Hb mmol l Hct Het I I MCH pg MCH fmol MCHC g dl MCHC mmol l RDW Pits 10 MPV fl PDW LYMP MONO GRAN LYMP MONO GRAN Urit 2900 Plus LOW NORMAL Mean Range Mean Range Parameters WBC 10 HIGH Mean Range RBC 10721 Hb g dl Hb mmol l Hct MCHC mmol l RDW CV RDW SD fl Pits 10 MPV fl PCT PCT ml l PDW LYMP MONO GRAN LYMP MONO GRAN SALES MANUALHEMATOLOGY PRODUCTS www avantormaterials com 67 J I Baker Part of AWANTOR PERFORMANCE MATERIALS Assay Value Sheet JAVANTOR EI az s Ha WI La B Pili B LOT 1 210 2015 04 19 Mindray 3200 3000 Parameters WBC 109 1 LOW Mean Range NORMAL HIGH Mean Range Mean Range Hct I I Assay values 3 Diff Controls Extended D0000840 Combined US and SI Units Version 12 0 Mindray BC 3000 s n A75xxx BC 2900 BC 1800 Hemolux LOW NORMAL HIGH Parameters Mean Range Mean Mean Range WBC 1071 RBC 107 Hb g dl Hb mmol l MCV fl RBC 1071 Hb g dl Hb mmol l Hct 96 Het I I fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV RDW SD MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV
55. Bayer Advia 120 1650 2150 Beckman Coulter GenS 1535 1895 Sysmex XE XT 1430 1830 Note Assay means and range values may exceed manufacturer s linearity claims Linearity must be verified by the user INTENDED USE Platelet Control Extended is a control for use in monitoring values from hematology instruments that provide Platelet determinations Refer to the Assay table for specific instrument models Avantor Performance Materials B V Mall P O Box 1 7400AA Deventer The Netherlands Tel 31 0 570 687500 8 C The devices as mentioned in this insert comply with the In 4 Vitro Diagnostic Medical Devices Directive 98 79 EC 29C SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 85 Part of fae AVANTOR PERFORAAANCE AAATERIALS Stains Dyes Giemsa and May Gr nwald Ordering Information Product Product Number Packaging May Gr nwald 3855 0500 500 ml May Gr nwald 3855 1000 1L May Gr nwald 3855 2500 2 5 L Giemsa 3856 0500 500 ml Giemsa 3856 1000 1L Giemsa 3856 2500 2 5 S rensen buffer concentrate 3716 10 x 100 ml Introduction May Grunwald and Giemsa stains are used for tissue sections cytology smears blood smears and bone marrow J I Baker brand stains have optimized formulations resulting in balanced colors with easy adaptable tones and an avoidance of crystallization The purple color of cell nuclei is due to molecular interactio
56. HC g dl 31 5 3 0 Plts x 10 47 25 MPV fl 5 9 2 0 Avantor BeneSphera 3 H32 VET HORSE MODE WBC x 10 RBC 10771 Hb g dl Hct MCV fl MCH pg MCHC g dl Plts x 10 MPV fl INTENDED USE For Veterinary Use Only D0000871 Version 1 0 REF 2904 2905 2906 Avantor BeneSphera 3 H32 VET CAT MODE T mer 000 Parameters WBC x 107 x 10 2 Hb g dl Hct 96 fl MCH pg MCHC g dl Plts x 107 MPV fl Avantor BeneSphera 3 H32 VET CATTLE MODE WBC x 10 RBC x Te z Hb g dl Hct MCH pg g dl Plts x 10 MPV fl 8 Parameter Control VET is a control designed to monitor accuracy precision the QC Mode of the BeneSphera 32 Vet hematology analyzer Indicated Assay Value Means Ranges for Dog Cat Horse and Cattle are derived using reference methods Customers are final responsible for Animal Mode calibration and to verify measured animal values Avantor Performance Materials B V P O Box 1 7400AA Deventer The Netherlands Tel 31 0570 687500 8 C FOR VETERINARY USE ONLY 2 C 62 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of J I Baker AWANTOR PERFORMANCE MATERIALS Assay Value Sheet PWANTOR Assay values 3 Diff Controls Combined US and SI Units 200 Fr EL LOT T Coulter Counter Model
57. I Tel 31 0 570 687500 2 C The devices as mentioned in this insert comply with the In C Vitro Diagnostic Medical Devices Directive 98 79 EC Both Reagents QC Mode SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 73 Part of fae AVANTOR PERFORAAANCE AAATERIALS Assay Value Sheet D0000834 A ZANTO R Version 8 0 PERFORMANCE MATERIALS Assay values and expected ranges for Mindray Instruments BC 5380 Parameters LOW 3613 NORMAL 3614 HIGH 3615 Parameters Mean Range Mean Range Mean Range WBC 10 l U NEUT 102 10 l 10 l 10 l 10 l 10 g dl Both Reagents QC Mode 109 1 fl Assay values and expected ranges for Mindray Instruments BC 5300 BC 5300Vet BC 5100 BC 5100Vet LOW 3613 NORMAL 3614 HIGH 3615 Parameters Mean Mean Range WBC 10 l l U NEUT 102 10 l 1071 1071 109 1 O gt 2 2 c D c O m 74 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of f AVANTOR PERFORMANCE MATERIALS Assay Value Sheet 00000806 Version 12 0 ARP izi a TE PR i h Assay values CD Diff Cell Dyn Controls LOT 211 2014 11 16 REF 3452 3453 3454 3838 Abbott Cell Dyn 1700 1800 series Abbott Cell Dyn 3000 no WIC 3500 and 3700 series
58. MCHC mmol l Pits x 107 Mindray BC series WBC x 1071 10 2 RBC x 1071 226 4 59 E Hb mmol l 3 8 0 2 8 6 0 3 Het 1 0 192 0 015 0 431 0 024 MCV fl 85 4 94 4 MCH fmol 1 68 0 15 1 87 0 17 MCHC mmol l 19 7 1 9 19 8 1 9 Plts x 1071 75 15 220 30 All Drew MWI Models except Excell 22 Orphee Mythic 18 WBC x 10 RBC x 1071 Hb mmol l Het I I fl MCH fmol MCHC mmol l x 107 MPV fl SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 59 Part of ATA TOR amp PERFORMANCE AAATERIALS Assay Value Sheet D0000867 Version 50 WERAIHM LLHMOLE ATEN LALLE Assay values 8 Parameter Controls Extended US Units n amp 3633 3634 3635 LOT 218 52 2015 03 19 Avantor BeneSphera H 32 HUMAN User and QC Mode Avantor BeneSphera 32 VET ONLY QC MODE Coulter Counter Models Erma Models PCE170 PCE210 Seac 10 12 and Genius series All AVL Contraves Models Parameters NORMAL baker 1963 Range NORMAL EH Parameters WBC x 10 RBC x 10 Z Hb g dl Hct MCV fl MCH pg g dl RDW RBC x 1071 Hb g dl fl MCH pg MCHC g dl RDW Plts x 107 1 MPV fl WBC x 1071 Plts x 1074 MPV fl Abbott Cell Dyn Series not for 5 part diff WBC x 1071 RBC x 10727 Hb g dl Hct 96 MCV fl MCH pg MCHC g dl 10727 H
59. MEK 7222K Diluent Diluid NR 3483 9020 201 CyMet NR III CN Free 3486 1000PE 1L CyMet NRV Cleaner DetectoTerge 5 L Hypochlorite NR 3941 5000PC 5L 3941 1000PE 1L Emergency Cleaner Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml Nihon Celltac MEK 8118K QA 810V CD Diff Control L N H 3452 3453 3454 3 0 ml Diluent Diluid NR 3483 9020PC 20L Lyse CyMet NR III 3484 1000PE 1L CyMet NR V 3485 1000PE 11 Cleaner DetectoTerge 3763 Hypochlorite NR 3941 5000PC 5L 3941 1000PE 1L Emergency Cleaner Hypochlorite 0 596 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml CD Diff Control L N H 3452 3453 3454 3 0 ml Nihon Kohden Celltac a MEK 8118K MEK 6450 MEK 6420 6410 MEK 6400 MEK 6108 QA 610 Diluent NR 3483 9020PC 20L Lyse CyMet NR III CN Free 3486 1000PE 1L Cleaner DetectoTerge 3763 Hypochlorite NR 3941 5000PC 5L 3941 1000PE 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial Nih
60. Mindray 3442 5000 5L Colorless On line Chemical Rinse VET 3438 5000PC 5L Colorless On line Chemical 3438 1000PE 1L SALES MANUALHEMATOLOGY PRODUCTS www avantormaterials com 55 Part of PERFORMANCE MATERIALS Hematology Controls Avantor offers different types of J T Baker hematology controls suitable for use with many popular hematology instruments Below is an overview for what instrument the controls can be used J T Baker Hematology Controls Selection Guide Platelet Instrument Abbott Cell Dyn Sapphire Ruby 4000 3700 3500 Cell Dyn 3200 and 3000 Cell Dyn 1800 1700 1600 and 1300 Cell Dyn Emerald 18 ABX Pentra 80 60 60 60C 60 5 60 5 Micros 60 ES60 45 gt Avantor Performance BeneSphera H34 H32 3 part diff Materials BeneSphera H32 3 part diff VET X AVL 818 816 Advia 120 AcT Diff ACT Diff 2 AcT10 AcT8 AcT5 STKS GenS LH780 LH750 LH500 HmX MaxM Beckman Coulter 2111111111 1114113 2 x x x x gt lt x x Diatron Abacus Junior 5 Abacus Abacus Junior Drew D3 Excell 18 Erma PCE 210 PCE 170 HTI Micros CC20 CC18 Medonic CA620 20 CA620 16 CA610 CA600 CA570 CA530 16 CA590 CA580 CA530 9 Mindray BC 5380 BC 5300 3200 BC 3000 2800 2300
61. Pentra 60 two calibration modes are available An auto calibration can be performed using a calibrator or a hematology control In addition the coefficients can be changed manually Auto calibration steps 1 Selectoption 2 Calibration from the main menu 2 Select option 1 Auto calibration gt 3 Change per parameter WBC RBC HGB HCT and PLT the operator ID lot number or expiration date if necessary by entering the Target field with the respective target values and select option Enter After entering the values or when no changes are required press Esc The calibration result chart is displayed 4 Run the hematology control calibrator at least 5 times 5 Press Esc to accept the results To manually include or exclude results from the statistical calculation move the cursor to the result line and press to obtain a single square 6 Selectoption Enter to save the new coefficients or Esc to quit the calibration 7 Selectoption Enter to print the new coefficients 8 Thecalibration is completed Select option Enter to quit the calibration chart table 9 Runahematology control in the normal measurement mode to verify calibration Note Please refer to the operator manual for more detailed calibration information ABX Pentra 80 60 WBC startup and background failures In case a high WBC background is measured after switching to J T Baker reagents next
62. RIBA ABX SAS The information contained herein has not been approved by HORIBA ABX SAS Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 45 PERFORMANCE MATERIALS Orphee Analyzers Orphee Analyzers Reagents Description JT Baker Product ProductNr Pack Size Orphee Mythic 22 Diluent Diluid 22 2990 901 0PC 10L Lyse CyMet 22 CN Free 2986 0500PE 500 ml Cleaner ProClean 3768 1000 1 Lmicros bottle Orphee Mythic 18 Diluent Diluid Diff 3963 20L Lyse CyMet IIl Diff CN Free 3511 5000 5L 3511 1000 1L Cleaner ProClean 3900 5L Hematology Control 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Orphee Analyzers Cross List An overview of comparable Orphee brand and brand reagents is shown in the table below When replacing Orphee reagents with J T Baker reagents information about priming and calibration can be found on the next pages Orphee Nr J T Baker Product Orphee Product J T Baker Nr Orphee Mythic 22 Diluent for Mythic 22 22 003 22 2990 9010 Onlyone Lyse 22 002 CyMet 22 CN Free 2986 0500 Cleaner for Mythic 22 HM22 001 ProClean 3768 1000 Orphee Mythic 18 Diluent for Mythic 18 HM18 009 Diluid III Diff 3963 Cyanide Free Lytic Solution for Mythi
63. Reagents gt Select option lt Prime all gt to remove remaining liquids Place the J T Baker CyMet 22 CN Free and the ProClean in the reagent compartment Place the J T Baker Diluid 22 at the same level as the analyzer to avoid aspiration of air bubbles Connect the J T Baker reagents to the corresponding aspiration tubes Select option Diluent and enter lot number the expiry date and the container capacity Select option Change reagent to validate the new entry Select option Prime diluent and select option Valid To prime the other reagents proceed as described above for the diluent In the Main menu select option Start up When a fault alarm is shown repeat Start up Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Calibration of Orphee Mythic 22 Two calibration options are available see below information on auto calibration and manual calibration For more information refer to the Mythic 22 User Manual Auto calibration steps 1 Select option Calibration in the Main menu to get information about the last calibrator control used 2 Select option Change to enter the required data of the calibrator control to be used 3 Select option Result and Tools to show print the calibration result chart 4 Runthe hematology control or calibrator at least 5
64. Tel 31 0 570 687500 4 devices mentioned this insert with the 2 C Vitro Diagnostic Medical Devices Directive 98 79 EC 72 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of foe AVANTOR PERFORMANCE MATERIALS Assay Value Sheet D0000834 ZX NTO EJ Version 8 0 am Pak di d TUS AO Assay values BC Diff 5 Controls LOT 158 EE 2014 11 19 REF 3613 3614 3615 Instruments BC 5500 BC5200 LOW 3613 NORMAL 3614 HIGH 3615 Mean Range Mean Range Mean Range 1 00 0 70 0 70 0 70 0 45 0 08 e 8 0 8 0 8 0 5 0 1 0 ES 1 0 0 7 0 7 0 7 0 5 1 0 4 8 0 8 0 8 0 Mindray Reagents Mode 7 1 5 0 5 2 5 2 JT Baker Reagents Mode 4 57 0 24 13 6 0 6 8 4 0 4 38 4 2 0 Mindray reagents 0 384 0 020 41 3 2 0 JT Baker reagents 0 413 0 020 MCV fl 84 0 5 0 MCV fl 90 4 5 0 MCH pg 29 8 2 5 fmol 1 85 0 20 MCHC g dl 35 4 3 0 MCHC mmol l 22 0 2 0 MCHC g dl 32 9 3 0 MCHC mmol l 20 4 2 0 RDW CV 11 5 3 0 RDW SD fl 32 0 8 0 PLT 10 255 40 fl l 9 0 3 0 0 230 0 100 16 2 3 0 Controls have to be measured in QC Mode ForMindray reagents measured value is artificially set to zero Avantor Performance Materials B V 52 Box 1 7400 Deventer Netherlands
65. Wright Buffer solution 1 Prepare S rensen buffer solution pH 7 Dilute 100 ml of the concentrated S rensen phosphate buffer with 1 9L deionized water Do not use tap water 2 Prepare a cytospin slide or smear of sample Blood smears may be pre fixed with methanol for 30 seconds 3 Prepare the Wright Buffer solution Dilute 50 ml Wright solution with 250 ml S rensen buffer solution pH 7 Mix and allow to stand for 10 minutes 4 Proceed according to the table below Reagent sequence Minutes Undiluted Wright 3 Wright Buffer solution 6 Buffer 2 Rinse in running tap water 2 Dry e Method using more diluted Wright Buffer solution 1 Prepare S rensen buffer solution pH 7 Dilute 100 ml of the concentrated S rensen phosphate buffer with 1 9L deionized water Do not use tap water 2 Prepare a cytospin slide or smear of sample Blood smears may be pre fixed with methanol for 30 seconds 3 Prepare the Wright Buffer solution Dilute 1 ml Wright solution with 400 ml S rensen buffer solution pH 7 Mix and allow to stand for 10 minutes 4 Proceed according to the table below Reagent sequence Minutes Undiluted Wright 5 Wright Buffer solution 3 Rinse with buffer 20 sec Dry Note The times as listed in the tables are approximates and can be adjusted to suit personal preferences Staining solutions will lose their staining intensity when heavily used and the staining tim
66. alibration factors 3 Perform a shutdown procedure 3 times 3 Calculate new calibration factors 4 Wait for 15 minutes assigned value 5 Connect a beaker with distilled water to the ProClean new calibration factor gt x current calibration factor line mean value 4 Enter new factors on the calibration factors screen 6 Perform a shutdown procedure 3 times 7 Perform a prime cycle for all reagents 8 Perform a startup Fig 10 Calibration screen Beckman Coulter AcT Diff ACT Diff 2 AcT8 AcT10 STKS GenS LH780 LH750 LH500 HmX MaxM and its subsidiary products are trademarks of Beckman Coulter Inc The information contained herein has not been approved by Beckman Coulter Inc Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 25 Part of PERFORMANCE MATERIALS Diatron Analyzers Diatron Analyzers Reagents Description J T Baker Product C ProduutN Pack Size Diatron Abacus Junior 5 Diluent Diluid Abacus 3430 9020 20 L 3430 9010 10L Lyse CyMet Abacus CN Free 3431 1000 1L CyMet Abacus EO 3444 1000PE 1L Cleaner ProClean Abacus 5L T Diatron Abacus Diluent Diluid Abacus 3430 9020 20L 3430 9010 10L Lyse CyMet Abacus CN Free 3431 1000 1L Cl
67. als Analyzers Priming and Calibration Please refer to the separate user manuals of the 5 H34 H32 and H32 VET 3 Part Differential Analyzers for information about priming and calibration 1 Ig Fig 8 BeneSphera H32 3 Part Differential analyzer SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 21 Part of TOR PERFORMANCE MATERIALS AVL Analyzers AVL Analyzers Reagents Description JT Baker Product ProductNr Pack Size AVL 818 816 Diluent Diluid III Diff 3963 201 Lyse CyMet ST1600 2000 CN Free 3759 5000 5L 3759 1000 1L Cleaner ProClean 3900 5L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml AVL is manufactured by Roche Diagnostics Corporation The information contained herein has not been approved by Roche Diagnostics Corporation Always refer to the user manual provided with the equipment at issue 22 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of ASANTOR PERFORMANCE MATERIALS Bayer Analyzers Bayer Analyzers Reagents Description J T Baker Product ProductNre Pack Size Bayer ADVIA 70 Diluent Diluid III Diff 3963 20 L Lyse CyMet III Diff 3964 5L 3968 1L Cleaner
68. antor BeneSphera H 32 Models 170 210 Sysmex series K series F series and X series CBC mode KX 21 Drew Danam MWI All models except Excell 22 N p co 1 gt 00 Swelab Autocounter 3 part diff series AC900 AC920 AC970 Medonic series CA series SEAC H8 H10 H12 Genius SEAC HeCo Systems including Vet i Abbott Cell Dyn series semi automates CD1300 CD1600 CD1700 CD2000 series semi automates automated series ABX Micros Pentra 60 80 120 CBC Mode Bayer Advia 60 co series Abacus Arcus gt AVL Contraves series Digicell 500 800 AVL 808 AVL 816 AVL 818 Mindray BC Series Avantor Performance Materials B V Box 1 7400 Deventer The Netherlands Tel 31 0570 687500 devices as mentioned this insert comply with the Vitro Diagnostic Medical Devices Directive 98 79 EC 4 SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 83 Part of foe AVANTOR PERFORAAANCE AAATERIALS Assay Value Sheet 00000827 E Version 3 0 PERFORMANCE MATERIALS Assay values WBC Reduced RBC Control LOT 160 REF 3698 3699 2015 01 19 Assay values and expecte
69. ate reagent data manually replacement screen appears Replace the first two digits in the Lot Number box by a higher number E g if the lot number the box is 140103 1 enter 150103H1 see table below The reagent will be primed automatically by the Enter the analyzer screen where all reagents are shown Double click on the reagent to be changed The reagent replacement screen fig 7 appears Enter the first 5 digits of the lot number in the field Lot Nb Enter the volume in the field level in ml Enter the expiration date Select y to save the changes The reagent will be primed automatically by the system E ia u lass E fene ence tata ae annm k s k n Fig 7 Barcode procedure screen system Code J T Baker Product 1 Diluid APR Y2 CyMet APR CN Free G1 CyMet APR EO 12 CyMet APR Baso 11 DetectoTerge Note The identification numbers per reagent are the last 2 digits of the above lot number ABX Analyzers Priming and Calibration Priming of ABX Pentra 60 1 Run3hematology controls or 5 reference patient samples Keep the values to use during calibration 2 Remove the aspirating tubes from the Abbott reagent cubitainers and bottles and put them in clean beakers 3 Rinsethe aspirating tubes with distilled or de ionized water to avoid reagent contamination 4 Press Esc to en
70. atology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml Swelab Analyzers Cross List An overview of comparable Swelab brand and J T Baker brand reagents is shown in the table below Swelab Product J T Baker Nr Swelab AC900 series AutoTon 1504103 Diluid AC900 3996 AutoLyze 1504114 CN Free Lyse Diff AC900 3998 AutoTergent 1504105 DetectoTerge 3763 Swelab Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type J T Baker Product Consumption Per Test Swelab AC910 Diluid AC900 16 ml CN Free Lyse Diff AC900 4 ml Swelab and its subsidiary products are trademarks of Boule Medical AB The information contained herein has not been approved by Boule Medical AB Always refer to the user manual provided with the equipment at issue 50 www avantormaterials om SALES MANUAL HEMATOLOGY PRODUCTS Part of ASANTOR PERFORMANCE MATERIALS Sysmex Analyzers Sysmex Analyzers Reagents Description J T Baker Product C ProduutN Pack Size Sysmex SF3000 Diluent Diluid 100 Plus 3961 20 L Lyse CyMet 1000 CN Free 3744 5L CyMet SF Diff 1 3481 5000 Sil CyMet SF Diff 2 3482 0500PE 500 ml Lyse for Basophils CyMe
71. ay 3439 9020PC 20L Lyse CyMet Mindray for BC 2300 3441 0500PE 500 ml Lyzerglobin PCE for BC 2000 3771 10x 10 ml Cleaner ProClean Extra 3862 5000 5L 3862 1000 1L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Mindray and its subsidiary products are trademarks of Shenzhen Mindray Bio Medical Electronics Co Ltd The information contained herein has not been approved by Shenzhen Mindray Bio Medical Electronics Co Ltd Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 39 Part of foe AVANTOR PERFORAAANCE AAATERIALS Mindray Analyzers Cross List An overview of comparable Mindray brand and J T Baker brand reagents is shown the table below When replacing Mindray reagents with reagents information about priming and calibration can be found on the next pages J T Baker Product Diluid Mindray Mindray Product J T Baker Nr Mindray BC 3000 Plus M 30 Diluent 3439 9020PC M 30 CFL Lyse CyMet Mindray 3441 0500PE CyMet Mindray CN Free 3440 0500PE M 30 Rinse Rinse Mindray 3442 5000PE M 30 E Z Cleanser ProClean Plu
72. b g dl Hct MCV fl MCH pg MCHC g dl Plts x 10 MPV fl Pct Swelab Auto Counter Series 3 part diff AC series WBC x 109 1 RBC x 10 7 Hb g dl Hct 96 MCV fl MCH pg MCHC g dl RDW Plts x 107 1 RBC x 1071 Hb g dl Hct 96 MCV fl MCH pg MCHC g dl Pits x 10 I REG gt TE Hb g dl Hct fl x 1071 Hb g dl Hct MCV fl Plts x 107 1 MPV fl Avantor Performance Materials B V P O Box 1 7400AA Deventer The Netherlands Tel 31 0570 687500 The devices as mentioned in this insert comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC 2 C 8 C Plts x 1074 MPV fl Medonic Series Analys Series WBC x 10 107 Hb g dl Hct MCV fl Plts x 10 MPV fl WBC 10 l 10 Hb g dl MCV fl BBC TOUR Hb g dl Hct MCV fl BBC i9 Hb g dl Hct 96 fl MCH pg MCHC g dl Plts x 107 MPV fl 60 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Assay Value Sheet EVANTOR E BP OSE CE Te LL Assay values 8 Parameter Controls Extended SI Units LOT 218 52 2015 03 19 Coulter Counter Models 170 210 Seac H8 10 12 and Genius series All AVL Contraves Models M NORMAL WBC x 107 l 2 0 0 4 Parameters J I Baker PERFORAAANCE AAATERIALS D0000867 Version 5 0 REF 36
73. bio CN Free 0906013 CyMet APR CN Free 3417 0500PE 14 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of A NTOF PERFORAAANCE AAATERIALS Analyzers Cross List continued ABX Product uu ABX Nr J T Baker Product J T Baker Nr ABX Micros 60 45 MiniClean 0403010 ProClean Extra 3867 1000PE Pack Micros LMG diluent lyse cleaner 0602050 Diluid III Diff CyMet Micro CN Free 3963 3852 1000 or 3863 1000 ProClean Extra 3867 1000PE Minilyse LMG 0702010 CyMet Micro CN Free 3852 1000 or 3863 1000 Lysebio 0906012 CyMet Micro CN Free 3852 1000 Minidil LMG 0802010 Diluid III Diff 3963 Minoclair 0401005 Hypochlorite 0 5 3917 ABX Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type J T Baker Product Consumption Per Test ABX Pentra 80 60 Diluid APR 25 6 ml CyMet APR EO 1 ml CyMet APR Baso II 2 1 ml CyMet APR CN Free 0 4 ml DetectoTerge 0 9 ml Micros 60 45 Diluid III Diff 22 ml CyMet Micro CN Free 0 6 ml ProClean Extra 1ml ABX Pentra Micros and its subsidiary products are trademarks of HORIBA ABX SAS The information contained herein has not been approved by HORIBA ABX SAS Always refer to t
74. c 18 HM18 008 CyMet III Diff CN Free 3511 1000 Enzymatic Cleaning Solution for Mythic 18 HM18 007 ProClean 3900 Orphee Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type J T Baker Product Consumption Per Test Orphee Mythic 22 Diluid 22 21 ml CyMet 22 CN Free 0 9 ml ProClean 0 5 ml Orphee Mythic 18 Diluid III Diff 12 8 ml CyMet III Diff CN Free 0 3 ml ProClean 0 4 ml Orph e S A is manufactured by The Cormay Group Mythic and its subsidiary products are trademarks of Orphee S A The information contained herein has not been approved by The Cormay Group or Orphee S A Always refer to the user manual provided with the equipment at issue 46 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of foe PERFORMANCE MATERIALS Orphee Analyzers Priming and Calibration Priming of Orphee Mythic 22 1 10 11 12 13 14 Run 3 hematology controls or 5 reference patient samples Keep the values to use during calibration Remove the aspirating tubes from the Orphee reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination In the Main menu select option lt
75. c gt to return to the main menu ABX Pentra Micros and its subsidiary products are trademarks of HORIBA ABX SAS The information contained herein has not been approved by HORIBA ABX SAS Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 19 Part of PERFORMANCE MATERIALS Avantor Performance Materials Analyzers BeneSphera Analyzers BeneSphera Product ProdutNr Description Pack Size BeneSphera analyzers 3 part differential H34 3 Part Differential 1 unit 3 part differential H32 3 Part Differential 1 unit 3 part differential for veterinary use H32 VET 3 Part Differential 1 unit 5 Analyzers Reagents Description BeneSphera Product 1 ProductNr Pack Size BeneSphera H34 Diluent Diluid BS34 2901 9010PC 10L Lyse CyMet BS34 CN Free 2902 1000PE 1L Cleaner HyClean 534 2907 5000PC 5L Reagent Pack Reagent Pack BS34 Diluid BS34 2910 1 pack CyMet BS34 CN Free HyClean 534 Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3503 4 5 ml BeneSphera H32 Diluent Diluid III Diff 3963 20L Lyse CyM
76. ceptable values are as follows Parameter Background WBC lt 0 5 x 10 L RBC lt 0 05 x 10 2 L HGB lt 0 2 g dL PLT lt 10x 10 L When acceptable background values are displayed the priming is successful If not repeat steps 4 8 again Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed reagents a recalibration for the Hemoglobin is required Calibration of Abbott Cell Dyn Ruby 3200 Two calibration options are available Select option lt Auto Calibrate gt to run an automatic calibration or follow the manual calibration process as below i Select option lt Calibration gt from the main menu The calibration menu displays the calibration factors Select option lt Open sampler gt or lt Closed sampler gt Select option lt Print screen gt to printout the factors Calculate new calibration factors assigned value new calibration factor x current calibration factor mean value Press F12 and then F1 to enter new dilution factors Continue to the next parameter using key It is advised to enter the factors for both open and closed modes Press Return to leave the dilution factor menu Optimization of WOC Channel performance of Abbott Cell Dyn 3700 3500 3200 3000 and Ruby The following procedure describes the optimization of the White Optical Count WOC channel by adjusting the
77. certify that This is to certify that ihe Management System of Avantor Performance Materials B V Avantor Performance Materials B V Teugseweg 20 7418 DEVENTER Netherlands Teugseweg 20 7418 AM Deventer The Netherlands has been found to conform to the Management System Standard has been found o conform to the standard ISO 9001 2008 180 13485 2003 This Certificate is valid for ihe following product or service ranges This Certificate is valid for the following scope Design development production sales and supply of high purity chemicals and kits for clinical diagnostics Design development production sales and supply of high purity chemicals for hematology histopathology laboratories research centers bio pharma phetovoltaic and the microelectronics industry Initial Certification date Place and date 30 January 2012 Havik 30 January 2012 ais for the Accredited Unit This Certificate i DET NORSKE VERITAS 30 January 2015 j u CERTIFICATION AS NORWAY Certification date Place date 28 December 1994 Barendrechi 17 September 2012 for the Accredited Unit This Certificate is valid untit DET NORSKE VERITAS CRRTIFICATION B V 15 September 2015 Tor Ke aa r L 1 1 1 di NORWEGIAN kasimo 2 supervision of ACCREDITATION a B Poldermans Mors 002 Eugenie Winger Husebye Lead Auditor Management Representative The audit
78. consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type J T Baker Product Consumption Per Test SEAC H12 Diluid III Diff 40 DetectoTerge ProClean 40 ml for daily shutdown SEAC H8 Diluid III Diff 40 ml CyMet III Diff 1 ml DetectoTerge ProClean 40 ml for daily shutdown Seac and its subsidiary products are manufactured by RADIM Spa The information contained herein has not been approved by RADIM Spa Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 49 Part of _A ANTOR PERFORMANCE MATERIALS J I Baker Swelab Analyzers Swelab Analyzers Reagents Description _J I Baker Product ProductNr Pack Size Swelab AC970eo AC920eo Diluent Diluid AC900 3996 201 Lyse CN Free Lyse Diff AC900 3998 5L Lyse for Eosinophils EO Reagent Autocounter 3842 1000 1L Cleaner DetectoTerge 3763 BE Emergency Cleaner ProClean Plus 3901 100 ml Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml Swelab AC910 AC900 Diluent Diluid AC900 3996 20L Lyse CN Free Lyse Diff AC900 3998 5L Emergency Cleaner ProClean Plus 3901 100 ml Hem
79. d ranges Low Abnormal 3698 High Abnormal 3699 Parameter Mean Range Mean Range Flow Cytometer WBC 10 L 21 7 16 2 27 2 Nageotte Chamber WBC 10 L 18 5 13 0 24 0 Product Description WBC reduced Control is used as process control to monitor white blood cell reduced products including the dilution and staining process method set up and WBC enumeration WBC reduced RBC Control is a reliable product that provides means of determining the precision accuracy of analytical procedures that measure the residual leucocytes in blood products It is tested in the same manner as blood products used for transfusion purposes Avantor Performance Materials B V bill P O Box 1 7400AA Deventer The Netherlands Tel 31 0 570 687500 8 C The devices as mentioned in this insert comply with the In V C 2 2 C Vitro Diagnostic Medical Devices Directive 98 79 EC 84 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of fae AVANTOR PERFORMANCE MATERIALS Assay Value Sheet 00000818 Version 9 0 ZXVANTOR FERPA TEA Li Assay values Platelet Control Extended LOT 167 REF 3424 2014 12 19 Assay values expected ranges for Platelet Control Extended PLT x 10 L Mean Range Abbott Cell Dyn Sapphire 1475 1815 Abbott Cell Dyn 3500 3700 1600 2000 ABX Micros 60 1590 2090 ABX Pentra 80 Rev 1 11 0 1430 1990
80. eaner ProClean Abacus 3432 5000 5L 3432 1000PE 1L Hypochlorite 0 596 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial Diatron Abacus Junior Diluent Diluid Abacus 3430 9020 20L 3430 9010 10L Lyse CyMet Abacus CN Free 3431 1000 1L Cleaner ProClean Abacus 3432 5000 5018 3432 1000 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3503 4 5 ml Diatron Abacus Junior VET Diluent Diluid Abacus 3430 9020 20L 3430 9010 10L Lyse CyMet Abacus CN Free 3431 1000 1L Cleaner ProClean Abacus 3432 5000 Sle 3432 1000PE 1L Rinse Rinse VET 3438 5000PC 5L 3438 1000PE 1L Emergency Cleaner Hypochlorite 0 5 3917 5000 5L Not for software version 2 17 and higher Note To achieve optimal performance with J T Baker reagents all mentioned Diatron analyzers reagent code 2 should be selected in the software settings 26 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of foe PERFORMANCE MATERIALS Diatron Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type
81. ed herein has not been approved by Abbott Laboratories Corporation Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 9 J I Baker Part of AWANTOR PERFORMANCE MATERIALS Abbott Analyzers Priming and Calibration Priming of Abbott Cell Dyn Sapphire 4000 1 10 11 12 13 14 15 16 17 Run 3 hematology controls or 5 reference patient samples Keep the values to use during calibration Remove the aspirating tubes from the Abbott reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Select option lt Analyzer gt and selection option lt Special protocols gt Select option lt Empty Dil1 gt to empty the reservoir Wait till the selected procedure stops Connect Diluid Sheath 3200 4000 to the aspiration tubes of the Diluent Select option lt Fill Dil1 gt Wait till the selected procedure stops Select option lt Empty DIL2 gt to empty the reservoir Waittill the selected procedure stops Select option Fill DIL2 gt to fill the reservoir Select option Empty HGB to empty the reservoir Wait till the selected procedure stops Connect CyMet AS CN Free to the aspiration tube of HGB Select option Fill HGB Wait till the selected procedure stops Select option Empty WBC A a
82. er 9 PERFORMANCE MATERIALS J D0000801 2 PERFORCE MAATIAIALE Assay values 8 Parameter Controls SI Units LOT 218 52 2015 01 19 Coulter Counter Models 170 PCE 210 Seac H8 10 12 and Genius series All AVL Contraves Models NORMAL EN MN WBC x 10 7 2 0 0 4 Parameters REF 3463 3464 3465 361 9 3620 3621 3701 3702 3703 3746 3747 3749 3751 3427 3428 3429 Avantor BeneSphera H 32 HUMAN User and QC Mode Avantor BeneSphera H 32 VET ONLY QC MODE EN NORMAL EN _ Parameters WBC x 107 RBC x 10 1 2 26 0 12 Hb mmol l 3 8 0 2 Het I I 0 181 0 015 fl 80 4 MCH fmol 1 68 0 15 MCHC mmol l 20 9 1 9 RDW 96 16 8 2 0 RBC x 10 I Hb mmol l Het fl MCH fmol MCHC mmol l RDW Plts x 10 75 15 MPV fl 7 9 1 5 Seac 5 Plus Heco Vet Vet C Vet S Plus vet WBC 1071 Plts x 10 l MPV fl Abbott Cell Dyn Series not for 5 part diff WBC x 107 RBC 1071 228 Hb mmol l 3 7 0 2 Het I I 0 173 0 015 fl 76 4 MCH fmol 1 63 0 15 MCHC mmol l 21 5 1 9 RBC x 1071 230 bu Hb mmol l 3 8 0 2 Het I I 0 186 0 015 fl 81 4 MCH fmol 1 65 0 15 MCHC mmol l 20 3 1 9 Plts x 107 67 15 MPV fl 10 5 1 5 Pct ml L 0 70 0 20 Swelab Auto Counter Series 3 part diff AC series WBC x 10 1 9 0 4 RBC 1071 2 28 0 12 Hb mmol l 3 7 0 2 Het I I 0 178 0 015
83. es should be longer or fresh solutions should be used 90 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of er AVYANTOR 4 9 PERFORMANCE MATERIALS Performance Characteristics Red blood cells red to pink Neutrophils dark purple nuclei pale pink cytoplasm reddish lilac small granules Eosinophils blue nuclei pale pink cytoplasm red to orange red large granules Basophils purple to dark blue nucleus dark purple almost black large granules Lymphocytes dark purple to deep bluish purple nuclei sky blue cytoplasm Platelets violet to purple granules Troubleshootings Red cells are blue and nuclei are deeply stained Prolonged staining Fig 13 Wright stained blood cells 100x Inadequate washing Excessively alkaline stain or stain buffer mixture pH of buffer too high Excessive redness of red cells and poor staining of nuclei Inadequate staining Excessive washing Excessively acid stain or stain buffer mixture pH of buffer too low SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 91 Part of foe AVANTOR PERFORAAANCE AAATERIALS Stains and Dyes RetiCount Ordering Information Product Product Number Packaging Reticount 3774 30 Introduction J I Baker Reticount is a special hematology stain intended for the identification of reticulocytes in blood smears and for counting the number of reticulocytes per 1000 erythr
84. et BS3 CN Free 2982 0500PE 500 ml Cleaner DetectoTerge BS 2970 0900PE 900 ml Emergency Cleaner Hypochlorite 0 596 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3503 4 5 ml BeneSphera H32 VET Diluent Diluid BS3 VET 2974 9010PC 10L Lyse CyMet BS3 VET CN Free 2975 0500PE 500 ml Cleaner DetectoTerge BS 2970 0900PE 900 ml Emergency Cleaner Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control VET L N H 2904 2905 2906 2 5 ml vial 20 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of ASANTOR PERFORMANCE MATERIALS Avantor Performance Materials Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type Consumption Per Test BeneSphera H34 3 part Differential Diluid BS34 5 ml CyMet BS34 CN Free 1 ml HyClean BS34 2 ml BeneSphera H32 3 part Differential Diluid III Diff 15 5 ml CyMet BS3 CN Free 0 6 ml DetectoTerge BS 1 2 ml BeneSphera H32 VET 3 part Differential Diluid BS3 VET 15 5 ml CyMet BS3 VET CN Free 0 4 0 7 ml DetectoTerge BS 1 2 ml Avantor Performance Materi
85. fer solution pH 7 Sorensen buffer solution pH 7 3 Proceed according to the table below 3 Proceed according to the table below Reagent sequence Minutes Reagent sequence Minutes Undiluted May Gr nwald 2 3 Undiluted May Gr nwald 223 Move slides gently in Sorensen buffer pH 7 1 Flush in tap or deionized water 1 Move slides gently in Giemsa working solution 4 5 Giemsa working solution 4 5 Flush in tap or deionized water Flush in tap or deionized water Note The times as listed in the tables are approximate and can be adjusted to suit personal preferences Staining solutions will lose their staining power when heavily used so the staining times should be longer or fresh solutions should be used Performance Characteristics Type Blood cell Amount Characteristics RBC 4 6 x 10 liter Pink brown discs clearer in the middle due to their concave structure PLT 0 2 0 3 x 10 liter Purple colored granules much smaller then RBC NEUT 50 70 96 Transparent pink blue cytoplasm 2 5 lobed bright purple nucleus EO 2 4 Typical pink orange granulated cytoplasm generally 2 lobed purple nucleus LYM 20 40 Transparent purple cytoplasm one large purple pink nucleus MONO 3 896 Largest of the leukocytes transparent pink blue cytoplasm with horseshoe shaped pink purple nucleus BASO 0 5 1 0 96 Granulo rich cytoplasm exhibiting dark blue stain overruling the dark blue nucleus stain From total WBC populatio
86. gent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type J T Baker Product Consumption Per Test Medonic CA610 600 series Diluid 610 45 ml CyMet 610 CN Free 5 ml DetectoTerge 1 5 ml Medonic CA530 16 Diluid 610 19 ml CyMet 610 CN Free 9 ml Medonic and its subsidiary products are manufactured by Boule Medical AB The information contained herein has not been approved by Boule Medical AB Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 37 Part of PERFORMANCE MATERIALS Melet Schloesing Analyzers Melet Schloesing Analyzers Reagents Description JT Baker Product ProductNr Pack Size Melet Schloesing MS9 MS4 Diluent Diluid III Diff 3963 201 CyMet Ill Diff 3964 5L 3968 1L Cleaner Blanking Solution ST 1600 2000 3947 20L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5 3917 11 Melet Schloesing MS8 MS8 VET Lyse CyMet III Diff 3964 5E 3968 11 CyMet III Diff CN Free 3511 5000 5L 3511 1000 1L Cleaner DetectoTerge 3763 5L ProClean 3900 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5 3917 1
87. he next messages appear No diluent No lysing reagent No detergent Select option lt Clean gt to complete the priming Priming is completed when the message Ready appears 11 Perform at least 3 blank counts 12 Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Note When changing from cyanide containing to cyanide free reagents a recalibration for the Hemoglobin is required Calibration of Nihon Kohden Celltac a MEK 6318K Select option Menu 2 Select option Calibration 3 Select option Norm for calibration in normal mode To switch to the capillary mode select option Cap 4 Run3hematology controls normal level The measurement result appears on the Cal result screen 5 Calculate new calibration factors reference value new calibration factor x current calibration factor mean value 6 Select option Calibration The Cal Normal screen appears The latest measured values and previous calibration coefficients are displayed 7 Selectthe parameter to be calibrated and enter new calibration factors between 100 and 2000 Select option Next to change other parameters 8 Select option Enter to save Select option to return to the Menu screen ABX Pentra Micros and its subsidiary products are trademarks of HO
88. he hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed 44 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of AVANTOR PERFORMANCE MATERIALS Calibration of Nihon Kohden Celltac a MEK 8118K Select option lt Calibration gt Run 3 hematology controls and calculate new calibration factors reference value new calibration factor O x current calibration factor mean value Select the parameter to be calibrated and enter new calibration factors Select option lt gt to change other parameters Select option lt Enter gt to save Select option lt Quit gt and select option lt Menu gt to return to the Menu screen Priming of Nihon Kohden Celltac a MEK 6318K 10 Run 3 hematology controls or 5 reference patient Samples Keep the values to use during calibration Remove the aspirating tubes from the Nihon Kohden reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Select option lt Menu gt Select option lt Other gt Select option lt Drain all gt Select option lt Yes gt key to drain all reagents Wait till the message press the Clean key appears Connect the reagents the aspiration tubes Select option lt Clean gt to prime and drain Wait till t
89. he user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 15 Part of AWANTOR PERFORMANCE MATERIALS J I Baker Analyzers Performance Information ABX Pentra 60 EO reagent Stability and black dye J T Baker CyMet APR EO contains an alcohol that vaporizes during use resulting in an open bottle stability of one month After one month of utilization CyMet APR EO should be replaced CyMet APR EO contains a black dye The intense black color is seen in the tygon tubing containing CyMet APR EO Contamination and colorization of the WBC flowcell will not occur due to the special hydrodynamic focusing technique in the ABX Pentra CyMet APR EO is surrounded by Diluid APR in the flowcell which prevents coloring of the flowcell walls ABX Pentra 60 EO reagent Positioning 4 part differential When connecting J T Baker CyMet APR EO a small shift to the right of the neutrophil and monocyte clusters can be seen compared to ABX reagents The positioning left to right of the 4 part differential may differ per instrument False atypical lymphocyte flags are shown when the whole 4 part differential is shifted to the right as when neutrophils are counted as monocytes Satisfying 4 part differentials are obtained if the neutrophil cluster is close to the neutrophil monocyte separation in the LMNE Matrix see fig 5 To optimize this positioni
90. herein has not been approved by Nihon Kohden Corporation Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 43 Part of gt AVANTOR PERFORAAANCE AAATERIALS Nihon Kohden Analyzers Priming and Calibration Priming of Nihon Kohden Celltac F MEK 8222K 10 11 12 13 14 Run 3 hematology controls or 5 reference patient samples Keep the values to use during calibration Remove the aspirating tubes from the Nihon Kohden reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Select option lt Menu gt Select option lt Other Operations gt Select option lt Drain all gt Select option lt Yes gt key to drain all reagents Wait till the analyzer is in the Ready mode Connect the J T Baker reagents to the aspiration tubes Select option lt Menu gt Select option lt Other Operations gt Select option lt Prime on installation gt Select option lt Yes gt to prime all reagents Wait till the analyzer is in the Ready mode Perform at least 3 blank counts Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Calibration of Nihon Kohden Celltac F MEK 8222K Select option Menu Select op
91. in negative L1 flagging causing NRBC platelet aggregates alarms Shift to the right of the leukocyte peak results in a higher basophil count To lower L1 flags optimization can be done To optimize the positioning of the leukocyte peak an electrical setting has to be changed on the main board The adjustment can be done with the R134 potentiometer 1 Usefresh max 8 hours blood for this optimization 16 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of foe AVANTOR PERFORMANCE MATERIALS Remove the left cover to get access the main board Locate the R134 potentiometer on the main board see fig 6 Record the original settings Turn clockwise to shift the peak to the right and counterclockwise to shift the peak to the left ABX Pentra 60C 60C Barcode procedure 60C and 60C require barcode reading when new reagent bottles are connected J T Baker reagents for 60C and 60C do not have an instrument accepted barcode on the label The instrument requires the user to update reagent data manually 1 Enterthe analyzer screen where all reagents are shown 2 Doubleclick on the reagent to be changed The reagent ABX Pentra 80 Barcode procedure Pentra 80 requires barcode reading when new reagent bottles are connected J T Baker reagents for Pentra 80 do not have an instrument accepted barcode on the label The instrument requires the user to upd
92. ine stain or stain buffer mixture pH of buffer too high Excessive redness of red cells and poor staining of nuclei Inadequate staining Excessive washing Excessively acid stain or stain buffer mixture pH of buffer too low SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 89 Part of gt AVANTOR PERFORAAANCE AAATERIALS Stains Dyes Wright Ordering Information Product Wright Product Number Packaging 3878 1000 1L Serensen buffer concentrate 3716 10 x 100 ml Introduction Wright s stain is used for blood smears and bone marrow It is generally used for differential blood picture staining and is based on eosin methylene blue The Wright Giemsa formulation results in an intense differential stain for blood smears bone marrows mast cells and FNA s The purple color of cell nuclei is due to molecular interaction between eosin Y and an azure B DNA complex The intensity of the staining depends on the azure B content and on the ratio azure B eosin Y Composition Wright is alcohol based and contains Giemsa s azure eosin methylene blue Wright stain and methanol Stability and Storage Wright staining solution is stable for one year when the bottles are kept closed and stored at room temperature 18 30 Products that are past their shelf life must be disposed of according to local disposal guidelines Procedure e Method using a concentrated
93. ing of Sysmex KX21 1 3 hematology controls or 5 reference patient 6 Select option lt 5 Auto Rinse gt to prime the reagents samples Keep the values to use during calibration and repeat 4 times 2 Remove the aspirating tubes from the Sysmex reagent 7 Runthe hematology controls or reference patient cubitainers and bottles and put them in clean beakers samples from step 1 again Compare the values and N zz 2 check if any calibration is needed 3 Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination 4 Selectoption Select and select option 5 Auto Calibration of Sysmex 21 Rinse Wait till the instrument will give a fault alarm 1 Select option Select 5 Connect the reagents to the corresponding aspiration tubes 2 Select option 3 Calibration 52 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS 10 11 12 13 14 15 16 17 18 Part of foe AVANTOR PERFORMANCE MATERIALS Select option lt 2 Manual Cal gt to change calibration factors for hemoglobin or hematocrit Calculate new calibration factors for hemoglobin or hematocrit reference value new calibration factor x current calibration factor mean value Select the parameter to be calibrated and enter new calibration factors The new value can differ maximum 5 repeat when a higher differentiation is required
94. inse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Press and to select option lt 4 Service gt from the main menu Select option lt Enter gt to confirm Select option lt 3 Prime gt and select option lt Enter gt Select option lt 1 All reagents gt and select option lt Enter gt Remaining liquids are now removed from the tubes Connect the J T Baker reagents to the corresponding aspiration tubes Repeat step 3 twice now with the reagents connected to prime the reagents into the system Select option Start Up to perform a start up Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Note When changing from cyanide containing to cyanide free reagents a recalibration for the Hemoglobin is required Calibration of ABX Micros Select option lt 3 Calibration gt from the main menu Select option lt 2 Coefficients gt Select option lt 1 Calibration Coefficients gt Enter password followed by lt Enter gt Calculate new calibration factors assigned value new calibration factor x current calibration factor mean value Select the parameter which needs to be calibrated by using Enter the new calibration factor followed by lt Enter gt Continue to the next parameter with Press lt Esc gt to exit the calibration menu Press lt Es
95. ith the 3693 3694 3695 Vitro Diagnostic Medical Devices Directive 98 79 EC Assay values and expected ranges for Sysmex Instruments SF 3000 Manual mode Parameters LOW 3633 NORMAL 3694 HIGH 3695 Mean Range Mean Range Mean Range WBC 107 107 HGB g dl mmol l HCT fl MCH pg fmol MCHC g dl mmol l RDW SD fl RDW CV 96 PLT 10 PDW fl MPV fl P LCR NEUT 107 LYMP 109 1 MONO 10 EOS 107 BASO 10 NEUT LYMP MONO LOW 3693 NORMAL 3694 HIGH 3695 Parameters Mean Range Mean Range Mean Range WBC 107 107 HGB g dl mmol l HCT 9 fl MCH pg fmol MCHC g dl mmol l RDW SD fl RDW CV PLT 10 PDW fl MPV fl P LCR NEUT 10 LYMP 109 1 MONO 1071 EOS 10 BASO 109 NEUT 4 8 C LYMP 1 4 96 29C EOS IVD 78 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of foe AVANTOR PERFORMANCE MATERIALS Assay Value Sheet PWANTOR PP LIN Be Assay values XE Diff Controls LOT 232 54 2014 11 19 3731 3732 3733 Assay values expected ranges for Sysmex Instruments XE 2100 LOW 3731 Range REF Mean WBC 107 NEUT 4 10 LYMP 1071 MONO 1071 EOS 109 1 BASO 107 Open sampling 00000824 IMPORTANT NOTE For Reticulocyte parameters Versi
96. lar interaction between eosin Y and an azure B DNA complex The intensity of the staining depends on the azure B content and on the ratio azure B eosin Y Composition Leishman contains Leishman stain and methanol Stability and Storage Leishman staining solution is stable for five years when the bottles are kept closed and stored at room temperature 18 30 Products that are past their shelf life must be disposed of according to local disposal guidelines Procedure e Method using a concentrated Leishman Buffer solution 1 Prepare S rensen buffer solution pH 7 Dilute 100 ml of the concentrated S rensen phosphate buffer with 1 9L deionized water Do not use tap water 2 Prepare the Leishman Buffer solution Dilute 50 ml Leishman solution with 150 ml S rensen buffer solution pH 7 3 Mix and allow to stand for 10 minutes 4 Proceed according to the table below Reagent sequence Minutes Undiluted Leishman 1 Leishman Buffer solution 7 Rinse in distilled or deionized water Few sec Buffer 2 Rinse in distilled or deionized water Few sec Dry e Method using a more diluted Leishman Buffer solution 1 S rensen buffer solution pH 7 Dilute 100 ml of the concentrated S rensen phosphate buffer with 1 9L deionized water Do not use tap water 2 Prepare a cytospin slide or smear by gently lowering the slide into a coplin jar of acetic alcohol 396 acetic acid in 9596
97. lorite 0 596 3917 5000 3317 Cal Set 1 3940 2x 2 5 ml CD Diff Control L N H 3452 3453 3454 3 0 CE Hypochlorite NR 3941 5000PC CD Diff Control 2xL 2xN 2xH 3838 6 x 3 0 ml CE 3941 1000PE K Diff Control L N H 3455 3456 3457 2 5 ml GE 3941 0100PE Platelet Control Extended value 3424 5 x 3 0 ml CE ProClean 3900 CE SF Diff Control L N H 3693 3694 3695 4 5 ml CE 3768 1000 micros CE WBC Reduced RBC L H 3698 3699 3 0 ml CE ProClean Abacus 3432 5000 5 L CE XE Diff Control L N H 3731 3732 3733 4 5 CE 3432 1000PE 11 E 4 tains and Dyes ProClean CD 3902 0100PE 100 ml CE y Giemsa 3856 2500 2 51 ProClean Extra 3862 5000 BL CE 3856 1000 1L CE 3862 1000 1L CE 3856 0500 500 ml CE 3867 1000PE micros CE 3856 0100 100 ml CE ProClean MX5 3498 1000PE 1L CE Leishman 3879 1000 1L CE ProClean Plus 3901 100 ml CE May Gr nwald 3855 2500 2 5 L Rinse Mindray 3442 5000 5L CE 3855 1000 1L CE Rinse VET 3438 5000PC 5L 3855 0500 500 ml CE 3438 1000PE 1L S rensen buffer 3716 10 x 100 ml Wright 3878 1000 1L CE SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 5 Part of PERFORMANCE MATERIALS Abbott Analyzers Abbott Analyzers Reagents Description J T Baker Product C ProduutN Pack Size Abbott Cell Dyn Sapphire 4000 Diluent Diluid Sheath 3200 4000 3832 9020 20L Lyse CyMet ASA 2950 2500PE
98. me the Diluent into the baths Perform at least 5 blank counts Review the displayed data Acceptable values are as follows Parameter Background WBC lt 0 5 x 10 L RBC lt 0 05 x 107 L HGB 0 2 g dL PLT lt 10x 10 L When acceptable background values are displayed the priming is successful If not repeat step 6 9 Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Select option lt Calibration gt from the Main menu Select option lt Manual calibration gt and select lt Enter gt to show the calibration factors Calculate new calibration factors reference value new calibration factor x current calibration factor mean value Enter new factors on the calibration factors screen and confirm Mindray and its subsidiary products are trademarks of Shenzhen Mindray Bio Medical Electronics Co Ltd The information contained herein has not been approved by Shenzhen Mindray Bio Medical Electronics Co Ltd Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 41 Part of PERFORMANCE MATERIALS Nihon Kohden Analyzers Kohden Analyzers Reagents Description JT Baker Product ProductNr Pack Size Nihon Kohden Celltac F MEK 8222K Celltac ES MEK 7300 Celltac
99. mp B gt to empty the reservoirs Wait till the selected procedure stops Connect both CyMet ASA and CyMet ASB to the aspiration tubes of WBC A reagent and WBC B reagent Select option Fill WBC A amp B gt Wait till the selected procedure stops Select option Analyzer and selection option Special protocols Select option Prime to perform a prime cycle and achieve Ready mode 18 Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Priming of Abbott Cell Dyn Sapphire 4000 for Reticulocyte reagent 1 Remove the aspirating tube from the Abbott Reticulocyte reagent bottle and put it in a clean beaker Remove Abbott Reticulocyte reagent bottle Rinse the aspirating tube with distilled or de ionized water to avoid reagent contamination Select option Run open tube select Specimen type Background and select Sub type RETC gt Select OK Press the Sample aspiration button to perform a background The instrument will give a fault alarm Connect RetiCount AS to the aspiration tube Repeat steps 4 5 at least 7 times Calibration of Abbott Cell Dyn Sapphire 4000 1 Select option lt Analyzer gt selection option lt Calibration gt Select option lt Calibration factors gt Select option lt Print screen gt to printout the factors Calculate new calibration factors assigned value
100. n generally 5 7 x 10 cells liter Troubleshooting bone marrow cytology samples and blood smears Insufficient color development of leucocytes Prepared smears not completely dried Glass slides used are not degreased or pre treated Exhausted May Grunwald or Giemsa working solution Too much erythrocyte fragments Specimen older than 12 hours P JU 2 3 Blood smear dried at ambient temperature gt 30 x B a Prepared smear not completely dried P uw 1 6 Color too much blue and red N Fig 11 May Gr nwald stained blood cells 100x Too long staining in May Gr nwald and Giemsa Too short color development in Sorensen buffer or deionized water Ambient temperature gt 30 SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 87 Part of fae AVANTOR PERFORAAANCE AAATERIALS Stains and Dyes Leishman Ordering Information Product Product Number Packaging Leishman 3879 1000 Serensen buffer concentrate 3716 10x 100 ml Introduction Leishman s stain is used for blood smears and bone marrow It is generally used to differentiate and identify leucocytes malaria parasites and trypanosomas unicellar parasitic protozoa It is based on a mixture of methylene blue and eosin J T Baker brand stains result in optimized color intensity for clear results in most testing procedures The purple color of cell nuclei is due to molecu
101. n JT Baker Product ProductNr Pack Size Medonic CA620 20 CA620 16 CA530 16 Diluent Diluid 610 3969 20L Lyse CyMet 610 CN Free 3970 10L 3977 51 Emergency ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Medonic CA610 CA600 CA570 Diluent Diluid 610 20L Lyse CyMet 610 CN Free 10L 5L Cleaner DetectoTerge 5L Emergency Cleaner ProClean Plus 100 ml Hematology Control 3 Diff Control L N H 2 5 ml vial Medonic CA580 CA590 Diluent Diluid 590 3954 20L Lyse CyMet 590 CN Free 3971 5L Cleaner DetectoTerge 3763 5 L Emergency Cleaner ProClean Plus 3901 100 ml Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml Medonic CA530 9 mimer Diluent Diluid 590 3954 20L Lyse CyMet 590 CN Free 3971 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml Medonic VET Diluent Diluid CA VET 2980 9010PC 10L Lyse CyMet CA VET 2981 5000PC 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 1L 36 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of AVYANTOR PERFORMANCE MATERIALS Medonic Analyzers Rea
102. n Range RBC 107 Hb g dl Hb mmol l Hct Hct I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV RDW SD Pits 109 1 MPV fi PCT SALES MANUALHEMATOLOGY PRODUCTS www avantormaterials com 65 Part of J I Baker 00000803 Version 22 0 Mindray BC 3000 Plus s n A75xxx BC 2900 BC 1800 Hemolux NORMAL Mean Ranget HIGH Mean Range Mean Range WBC 109 1 RBC 107 Hb g dl Hb mmol l Hct 96 Het I I fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW CV Pits 109 1 Mindray BC 3000 with CyMet Mindray CN free old models s n A59xxx LOW NORMAL Mean Mean Range HIGH Mean Range Parameters WBC 10 RBC 107 Hb g dl Hb mmol l Hct Hct I I MCV fl MCHC g dl MCHC mmol l RDW CV RDW SD Pits 1071 MCHC mmol l Mindray BC 2300 BC 2100 HIGH Mean Range LOW NORMAL Mean Range Mean Range Parameters WBC 10 RBC 107 Hb g dl Hb mmol l MCHC mmol l RDW CV RDW SD Pits 109 1 AWANTOR PERFORMANCE MATERIALS Part of foe AVANTOR PERFORAAANCE AAATERIALS Assay Value Sheet D0000840 8 C Version 12 0 4 C Assay values 3 Diff Controls Extended N NTO v Combined US and SI Units HUE mus ESSA 2 C REF 3421 3422 3423 Coulter Counter AcT diff AcT diff 2 LOW LOT 210 NORMAL HIGH MELET MS9 Parameters WBC 10
103. n between eosin Y and an azure B DNA May Gr nwald s eosin methylene blue and Giemsa s azure eosin methylene blue are intended to be used for staining of blood and bone marrow smears and cytological specimens such as urine sediment or sputum For staining of most histology specimens mostly gastric sections Giemsa is used S rensen buffer solution can be used for easy diluting Composition May Gr nwald is alcohol based and contains May Gr nwald s eosin methylene blue and methanol 285 Giemsa is alcohol based and contains Giemsa s azure eosin methylene blue methanol 25096 and glycerol Stability and Storage May Gr nwald and Giemsa are stable for five years when the bottles are kept closed and stored at room temperature 18 30 Products that are past their shelf life must be disposed of according to local disposal guidelines Procedures for bone marrow cytology samples and blood smears General method for bone marrow cytology specimen or for whole blood smears 1 Prepare S rensen buffer solution pH 7 Dilute 100 ml of the concentrated S rensen phosphate buffer with 1 9L deionized water 2 the May Gr nwald working solution Dilute 250 ml May Gr nwald solution with 250 ml Sorensen buffer solution pH 7 3 Prepare the Giemsa working solution Dilute 50 ml Giemsa solution with 450 ml Serensen buffer solution pH 7 4 Proceed according to the table below Reagent sequence Minutes
104. ng of the 4 part differential an electrical setting has to be changed on the main board MERZ n ji we bi we HUB B Hal H T 8 257 171 it HCM 2 11 A li ERT EM 12 7 x PLT pP Hu Fl PCT 18 8 x Lia 288 1 87 18 7 H 7 Sk Birik ds ALFE 1 1 dod 1 0 ds wa E mad Fig 5 LMNE matrix The adjustment can be done with the R136 potentiometer 1 Usefresh max 8 hours blood for this optimization 2 Remove the left cover to get access the main board 3 Locate the R136 potentiometer on the main board see fig 6 4 Record the original settings 5 Turn clockwise to shift the clusters to the right and counterclockwise to shift the clusters to the left Fig 6 Main board ABX Pentra 60 Baso reagent L1 flagging White blood cells and basophils are measured in the same channel by means of the impedance technique Differentiation between basophils and other leukocytes is obtained by means of J T Baker CyMet APR Baso The total number of leukocytes is represented by the total number of cells between threshold 1 and 3 Basophils are located after threshold 2 see fig 5 Adjustment of the optimal positioning of the leukocyte peek differs per instrument Shift of the leukocyte peak to the left results
105. ntormaterials com 51 Part of fae AVANTOR PERFORAAANCE AAATERIALS Sysmex Analyzers Cross List An overview of comparable Sysmex brand and J T Baker brand reagents is shown in the table below When replacing Sysmex reagents with J T Baker reagents information about priming and calibration can be found on the next pages J T Baker Product Sysmex Product J T Baker Nr Sysmex 5 3000 Diluid 100 Plus 3961 Stromatolyser 3WP CyMet 1000 CN Free 3744 Stromatolyser FD I CyMet SF Diff 1 3481 5000PC Stromatolyser FD II CyMet SF Diff 2 3482 0500PE CyMet SF Baso 3480 5000PC Stromatolyser FB Sysmex K series Cellpack Diluid 100 Plus 3961 Sulfolyser CyMet 1000 CN Free 3744 CyMet 4500 CN Free 3773 5000PC Stromatolyser WH CyMet KX CN Free 3425 0500 Cellclean Hypochlorite 0 5 3917 Sysmex Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type Consumption Per Test Sysmex K4500 Diluid 100 Plus 30 ml CyMet 4500 CN Free 2 ml Sysmex K1000 Diluid 100 Plus 30 ml CyMet 1000 CN Free 2 ml Sysmex KX21 Diluid 100 Plus 34 CyMet KX CN Free 1 ml Sysmex Analyzers Priming and Calibration Prim
106. ocytes by microscopic analysis An erythrocyte will be counted as reticulocyte when it contains 2 or more blue stained granules Composition RetiCount is water based and contains potassium oxalate sodium chloride and brilliant cresyl blue Stability and Storage RetiCount is stable for 2 years when the bottles are kept closed and stored at room temperature 18 30 C Products that are past their shelf life must be disposed of according to local disposal guidelines Procedure Single slide dip technique 1 Mix in a plastic test tube 1 drop of RetiCount with 3 drops of fresh whole human blood anticoagulated with EDTA or citrate Heparin interferes with RetiCount and should not be used 2 Incubate 15 minutes at room temperature 3 Mix the content after incubation 4 Make a smear of this mixture on a slide 5 Air dry the smear before microscopic examination 6 Examine the object at a microscopic magnification of 1000 10x ocular and 100x oil immersion objective 7 The erythrocytes are homogeneous pale blue coloured A reticulocyte contains 2 or more blue stained particles 8 Calculate the reticulocyte percentage according to laboratory procedures 92 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS LM Philip un NJ 90012008 14001 2004 Gliwice Poland 90012008 amp 170252005 Par KY SOOT 2008 Selangor Malaysia 90012008 y Messco 9001 2008 Dehradun Indias 9001 20
107. ome instruments read MCHC incorrectly IVD 80 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of foe AVANTOR PERFORMANCE MATERIALS Assay Value Sheet D0000824 A Version 8 0 LI asa ie E HALA BI SSK L ili Assay values XE Diff Controls LOT 232 Avantor Performance Materials Box 1 7400 Deventer Netherlands 52 2014 11 19 Tel 31 0 570 687500 devices mentioned this insert comply with the REF 3731 3732 3733 Vitro Diagnostic Medical Devices Directive 98 79 EC Assay values and expected ranges for Sysmex Instruments 5 1000 LOW 3731 NORMAL 3732 HIGH 3733 Mean Range Mean Range Mean Range Parameters WBC C 1071 WBC D 10 107 g dl mmol l 1 1 fl pg fmol MCHC g dl mmol l RDW SD fi RDW CV 96 1071 NEUT 4 10 LYMP 10 MONO 109 1 EOS 109 1 BASO 107 Manual sampling LOW 3731 NORMAL 3732 HIGH 3733 Parameters Mean Range Mean Range Mean Range WBC 109 1 WBC D 107 10 g dl mmol l fl pg fmol MCHC g dl mmol l RDW SD fi RDW CV 96 PLT 10 MPV fl NEUT 107 LYMP 1071 MONO 1071 EOS 109 1 BASO 107 Manual sampling ec zc c SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 81 Part of foe AVANTOR PERFORAAANCE AAATERIALS
108. on 8 0 use the XERet control PN 3652 3653 3654 ji Avantor Performance Materials BV Box 1 7400AA Deventer The Netherlands Tel 31 0 570 687500 The devices as mentioned in this insert comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC NORMAL 3732 Mean Range HIGH 3733 Mean Range WBC 10i NEUT 4 10 LYMP 1071 MONO 1071 EOS 109 1 BASO 1071 Closed sampling Both modes MCV MCH Open sampling fmol MCHC g dl mmol l 10 HGB g dl mmol l HCT MCV fl MCH pg fmol MCHC g dl mmol l 9 oO 9 RDW SD fl RDW CV 9 PLT op 1071 PLT cl 1071 MPV fl PLT O op 1071 PLT O cl 1091 mi l PDW fl IPF op open mode cl closed mode op open mode cl closed mode NRBC 1071 NRBC IMIZ X 1064 IG op 1071 IG cl 10 IG open mode cl closed mode DIFF X ch DIFF Y ch BASO X ch BASO Y ch IMIDC fl IMIRF fl NRBC X ch NRBC Y ch Open sampling amp Closed sampling RBC O 10 RBC X ch RBC Y ch XE diff must be analyzed in the instrument e Check Quality Control mode 2 C When using CD ROM for Assay values setup some instruments read MCHC incorrectly SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 79 Part of foe AVANTOR PERFORAAANCE AAATERIALS Assay Value Sheet
109. on Kohden Celltac MEK 6318K 3502 3503 3504 4 5 ml Diluent Diluid NR 3483 9020PC 20L Lyse CyMet NR III 3484 1000PE 1L CyMet NR III CN Free 3486 1000PE 1L Cleaner DetectoTerge 3763 5L Hypochlorite NR 3941 5000PC 5L 3941 1000PE 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml 42 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of A NTOF PERFORAAANCE AAATERIALS Nihon Kohden Analyzers Cross List An overview of comparable Nihon Kohden brand J T Baker brand reagents is shown in the table below When replacing Nihon Kohden reagents with J T Baker reagents information about priming and calibration can be found on the next pages Nihon Kohden Product Nihon Kohden Nr J T Baker Product J T Baker Nr All series Diluent Isotonac 37 T436D Diluid NR 3483 9020PC Hemolynac 37 T489 CyMet NR III 3484 1000PE Hemolynac 3N CN Free T498 CyMet NR III CN Free 3486 1000PE Hemolynac 5 T496 CyMet NRV 3485 1000PE Cleanac 37 T438D Hypochlorite NR 3941 5000PC Cleanac 7438 DetectoTerge 3763 Nihon Kohden Celltac and its subsidiary products are trademarks of Nihon Kohden Corporation The information contained
110. on ProClean 3900 Hypochlorite 0 5 3917 Erma and its subsidiary products are manufactured by Erma Inc The information contained herein has not been approved by Erma Inc Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 31 Part of fae AVANTOR PERFORAAANCE AAATERIALS Erma Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Consumption Per Test Analyzer Type J T Baker Product Erma PCE 210 Diluid ERMA 29 ml CyMet ERMA III Diff 0 7 ml Erma and its subsidiary products are manufactured by Erma Inc The information contained herein has not been approved by Erma Inc Always refer to the user manual provided with the equipment at issue 32 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of ASANTOR PERFORMANCE MATERIALS Hospitex Analyzers Hospitex Analyzers Reagents Description J T Baker Product ProductNre Pack Size Hospitex Hemascreen 18 Diluent Diluid III Diff 3963 20L Lyse CyMet III Diff 3964 5L 3968 1L CyMet III Diff CN Free 3511 5000 51 3511 1000 11 Cleaner DetectoTerge 3763 5 L Rinse Blanking Solution ST1600 2000 3947 20 L Emergency Cleaner ProClean Plus 3901 100 ml Hypochl
111. orite 0 5 3917 5000 5L 3917 1L Hospitex Analyzers Cross List An overview of comparable Hospitex brand and J T Baker brand reagents is shown in the table below Hospitex Product HosptexNr J T Baker Product J T Baker Nr Hemascreen 18 Differential isotonic solution 70010070 Diluid III Diff 3963 CyMet III Diff 3964 3968 CyMet III Diff CN Free 3511 5000 351 1 1000 DetectoTerge 3763 Differential lysing solution 70010075 DetectoTerge 70010085 Hospitex Analyzers Reagent Consumption An indication of the consumption of reagents per test is shown in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type J T Baker Product Consumption Per Test Hospitex Hemascreen 18 Diluid Diff 10 ml CyMet III Diff CN Free 0 6 ml Hospitex and its subsidiary products are manufactured by Hospitex Diagnostics The information contained herein has not been approved by Hospitex Diagnostics Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 33 J I Baker Part of _A ANTOR PERFORMANCE MATERIALS Analyzers Analyzers Reagents Description JT Baker Product ProdutN Pack Size HTI micros CC18 Diluent Diluid III Diff 3963 20L Lyse CyMet III Diff 3964 5L 3968 1L Cleaner
112. ors 2 Calculate new calibration factors assigned value new calibration factor x current calibration factor mean value 3 Selectoption Enter factor to enter new calibration factors Continue to the next parameter using key 4 Selectoption Return to leave the calibration menu Closed mode Select option lt Calibration gt from the main menu 2 Enter 94043 The menu displays the dilution calibration factors 3 Calculate new calibration factors assigned value new calibration factor x current calibration factor mean value 4 Select option Enter factor to enter new dilution factors Continue to the next parameter using key 5 Select option Return to leave the calibration menu Abbott and Cell Dyn and its subsidiary products are trademarks of Abbott Laboratories Corporation The information contained herein has not been approved by Abbott Laboratories Corporation Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 13 Part of PERFORMANCE MATERIALS Analyzers ABX Analyzers Reagents Description J T Baker Product Pack Size ABX Pentra 80 60 60C 60 60 5 Diluent Diluid APR 3476 9020PC 20L Lyse CyMet APR CN Free 3417 0500PE 500 ml Lyse for Eosinophils CyMet APR EO 347
113. own in the table below The actual consumption value can change due to necessary priming and cleaning steps Analyzer Type Consumption Per Test Abbott Cell Dyn Sapphire Rev 2 3 Diluid Sheath 3200 4000 47 7 ml 57 3 ml incl reticulocytes count CyMet ASA 3 5 ml CyMet ASB 0 4 ml CyMet AS CN Free 9 6 ml RetiCount AS 0 9 ml Abbott Cell Dyn 4000 Rev 9 2 9 3 Diluid Sheath 3200 4000 47 ml 55 ml incl reticulocytes count CyMet ASA 3 6 ml CyMet ASB 0 4 ml CyMet AS CN Free 11 ml RetiCount AS 0 7 ml Abbott Cell Dyn 3500 SL Diluid ST1600 2000 35 4 ml CyMet 3500 CN Free 0 8 ml Sheath Fluid 3000 3500 14 4 ml Blanking Solution ST1600 2000 18 3 ml Abbott Cell Dyn Ruby Diluid Ruby 50 ml CyMet Ruby CN Free 1 3 ml Leuco Ruby 5 5 Abbott Cell Dyn 3200 SL or CS Diluid Sheath 3200 4000 46 6 ml CyMet 3200 CN Free 0 6 ml LeucoLyse 1 4 ml Abbott Cell Dyn 3000 SL Diluid ST1600 2000 32 ml CyMet 3000 8ml Sheath Fluid 3000 3500 14 ml Abbott Cell Dyn 1800 Diluid ST1600 2000 34 2 ml CyMet ST1600 2000 CN Free 1 ml Blanking Solution ST1600 2000 16 Abbott Cell Dyn 1700 Diluid ST1600 2000 36 ml CyMet ST1600 2000 CN Free 1 ml Blanking Solution ST1600 2000 15 ml Abbott and Cell Dyn and its subsidiary products are trademarks of Abbott Laboratories Corporation The information contain
114. pier WEE ac ID cum RUE ura ham eo Dum Declaration of CE Conformity LI teu eom ies Hin jee 4 o UD gea Ia gas KEM EN AI ki if pe m T u cum ser zr a Avantor Performance Materials B V reg no 38013066 who is an established manufacturer of Hematology C 4 Reagents Stains Controls and Calibrators and products for Histopathology located at Teugseweg 20 7418 AM Deventer The Netherlands Fig 1 Example of the label Products that are not CE marked are not IVD s according to herewith declares the following the definition of the directive E g the Rinsing Solution VET The reagents see attached list are labeled with the J T Baker label and have the CE mark on the label where applicable The devices comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC and the conformity assessment procedure according to Annex III The is not CE marked It is e notfor medical purposes e not designed to provide information about a physiological or pathological state or to monitor therapeutic measures or about a congenital abnormality not specific for human samples BeneSphera 3 Part Diff Analyzer H32 is in compliance with IEC 61010 Safety Requirements for Electrical Equipment for Training possibilities Measurement Control and Laboratory Use Avantor has several options to train distributors and ser
115. pochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml Beckman Coulter AcT Diff ACT Diff 2 Diluent Diluid III Diff 3963 20L Lyse CyMet III Diff 3964 2 3968 1L CyMet III Diff CN Free 3511 5000 5L 3511 1000 1L Cleaner ProClean 3900 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Reagent Card C Card AcT Diff 3793 For 1000 tests Beckman Coulter 8 107 Diluent Diluid III Diff 3963 20L Lyse CyMet III Diff 3964 5L 3968 1L CyMet III Diff CN Free 3511 5000 5L 3511 1000 1L Cleaner ProClean 3900 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml Reagent Card C Card AcT Diff 3793 For 1000 tests Beckman Coulter STKS GenS LH780 LH750 LH500 HmX MaxM Reagents not available Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 5D Control L N H 3681 3682 3683 5 ml 24 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of
116. refer to the user manual provided with the equipment at issue 30 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of A NTOF PERFORAAANCE AAATERIALS Erma Analyzers Erma Analyzers Reagents Description J T Baker Product ProdetNr Pack Size Erma PCE 210 Diluent Diluid ERMA 3459 9020 20L Lyse CyMet ERMA III Diff 3416 0500 500 ml Cleaner ProClean 3900 5L Emergency Cleaner Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Erma PCE 170 Diluent Diluid ERMA 3459 9020 201 Lyse Lyzerglobin PCE 3771 10x 10 ml Cleaner ProClean 3900 5L Emergency Cleaner Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Erma Analyzers Cross List An overview of comparable Erma brand and J T Baker brand reagents is shown in the table below Erma Product J T Baker Nr PCE 210 Diluent solution Diluid ERMA 3459 9020 Hemolysis CyMet ERMA III Diff 3416 0500 Cleaner solution 3900 PCE 170 Diluent solution Diluid ERMA 3459 9020 Hemolysis PCE Lyzerglobin PCE 3771 Cleaner soluti
117. rk of High Technology Inc Medonic is manufactured by Boule Medical AB S A Mindray is a trademark of Shenzhen Mindray Bio Medical Electronics Co Ltd Nihon Kohden is a trademark of Nihon Kohden Corporation Orph e S A is manufactured by The Cormay Group Mythic is trademark of Orphee S A Rayto is manufactured by Rayto Life and Analytical Sciences Co Ltd Seac is manufactured by RADIM Spa Swelab is a trademark of Boule Medical AB Sysmex is a trademark of Sysmex Corporation Urit is manufactured by Urit Medical Electronic Co Ltd SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 57 Part of AVYANTOR PERFORMANCE MATERIALS Assay Value Sheet F 00000801 PWANTOR Version 190 ATELE REF Assay values 8 Parameter Controls US Units 3463 3464 3465 3619 3620 3621 3701 3702 3703 3746 3747 3749 3751 3427 3428 3429 LOT 218 52 2015 01 19 Coulter Counter Models Erma Models 170 210 Avantor BeneSphera H 32 HUMAN User and QC Mode Seac H8 10 12 and Genius series All AVL Contraves Models Avantor BeneSphera H 32 VET ONLY QC MODE A NORMAL Low NORMAL HIGH Parameters Parameters Mean Ranget Mean t Mean WBC x 10 2 0 0 4 WBC x 1071 x 10 l 2 26 0 12 10 6 1 0 4 1 Hb g dl 18 1 1 5 j i 80 4 MCV fl 27 0 2 4 MCH pg 33 7 3 0 g dl 16 8 2 0
118. rma photovoltaic and the microelectronics industry Init Certification date Place and date itDecember2003 _ Barendrechi 17 September 2012 15 September 2015 for the Accredited Unit Phis Certificate is velid atit i i Dir NORSKE VERITAS CERTIFICATION B V RR The audit has been performed under the MT 3 a core supervision af Veldkamp Petar Lead Auditor Management Representative Lack of fulfilment of conditions as sel out in the Certification Agreement may render this Certilicate invalid Fig 4 SO 1 400 1 2004 AC RHDITHI M NET NGZSKE VERIPAS ER ATHY IEW 1 LIL NETHEBI AND VL 137 0 1 222600 www dnyba com Ce rt f Ca t g h g h t 5 n e S S a n d care for the environment SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 3 Part of J I Baker A ANTOR PERFORMANCE MATERIALS Hematology Analyzers Reagents and Controls Product List 4 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS BeneSphera Product Number Pack Size J T Baker Product Number Pack Size mark Hematolog
119. s with III Diff option for see separate table Please refer to next page for Erma Values NORMAL HIGH Mean Rangez Mean Range MELET MS9 Parameters WBC 1071 NOTE Mean 3433 3434 3435 3466 3467 3468 3502 3503 3504 210 2015 02 19 LOW Range RBC 1071 Hb g dl Hb mmol l Hct Hct I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW Pits 109 1 ABX Roche Micros 60 Micros ES 60 Bayer Advia 60 Parameters WBC 1071 Mean LOW NORMAL HIGH Mean Range Mean Range Range 1071 Hb g dl Hb mmol l Hct Het I I fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW 96 109 1 Abbott Cell Dyn 1300 1500 1600 1700 1800 series Parameters Mean LOW Range NORMAL Mean Range HIGH Mean Range RBC 1071 Hb g dl Hb mmol l Hct 96 Het I I fl MCH pg MCH fmol MCHC g dl MCHC mmol l Pits 109 1 AVL Contraves AVL 816 Parameters Mean LOW Range NORMAL HIGH Mean Range Mean Range Please refer to Table Coulter Counters for CBC parameters I 8 C 2 C Coulter Counter AcT diff AcT diff 2 LOW Range NORMAL Parameters Mean Range Mean WBC 1071 D0000803 Version 22 0 CE HIGH Mean Range 10 l Hb g dl Hb mmol l Hct 96 Het I I MCV fl MCH pg MCH fmol MCHC g dl MCHC mmol l RDW 96 Pits 107 Coulter Counter AcT
120. s 3901 M 30 Probe Cleanser Hypochlorite 0 5 3917 40 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of f AVANTOR PERFORMANCE MATERIALS Mindray Analyzers Priming and Calibration Priming of Mindray BC 3000 Plus 1 10 12 13 14 Run 3 hematology controls 5 reference patient samples Keep the values to use during calibration Calibration of Mindray BC 3000 Plus Two calibration options are available Follow the manual calibration process as outlined below For automatic calibration or more information consult the Mindray Remove the aspirating tubes from the Mindray reagent cubitainers and bottles and put them in clean beakers BC 3000 Plus user manual Manual calibration steps Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Select option Service from the main menu 2 Select option Maintenance and select Enter 3 Select option Diluent prime followed by Enter to empty the tube Move the sensor up to stop the reagent alarm Connect Diluid Mindray to the corresponding 4 aspiration tube Select option Diluent prime followed by Enter To prime the other reagents proceed as described above for the Diluent Select option Empty baths followed by Enter to empty the diluent from the WBC and RBC baths Press Enter to pri
121. s for Toa Sysmex K800 K1000 K4500 WBC 10 00000808 Version 9 0 166 2014 12 19 3455 3456 3457 LOW 3896 NORMAL 3897 3898 Range Mean Range Mean Range 107 g dl mmol l 1 1 fl pg fmol g dl mmol l MCV MCH MCHC RDW CV Pits 1071 fl W SCR LYMPH W MCR MXD W LCR NEUT W SCC LYMP W MCC MXD W LCC NEUT Assay values and expected ranges for Toa Sysmex KX21 WBC 10 LOW 3896 NORMAL 3897 HIGH 3898 Mean Range Mean Range Mean Range 1071 g dl mmol l 1 1 pg fmol g dl mmol l fl MCHC RDW SD RDW CV Pits 1071 fl W SCR LYMPH W MCR MXD W LCR NEUT W SCC LYMP W MCC MXD W LCC NEUT Avantor Performance Materials B V P O Box 1 7400AA Deventer The Netherlands Tel 31 0 570 687500 8 C IVD devices mentioned in this insert comply with the In Vitro Diagnostic Medical Devices Directive 98 79 EC 29C 4 SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 77 Part of PERFORMANCE AAATERIALS Assay Value Sheet D0000828 Version 3 0 AWANTOR Per ee E Be Sk N Assay values SF Diff Controls LOT 158 Avantor Performance Materials B V P O Box 1 7400AA Deventer The Netherlands 55 5 2014 11 19 431 0 570 687500 devices mentioned this insert comply w
122. software settings Select option Diagnostics press F1 F12 and select option Print screen to printout the WOC gains from the set point entry screen Select option Quality Control and select option X B to printout the actual WOC channel settings Calculate new WOC gains per parameter for Neu 0 Neu 10 Neu 90 and Neu 90 D Target parameter value x Actual WOC gain new WOC gain Actual parameter value The following target parameter values have to be used Parameter New WOC gain NEU 0 160 WOC 0D NEU 10 149 WOC 10D NEU 90 125 WOC 90D NEU 9090 21 WOC 90DP Select option Diagnostics and enter the calculated new WOC gains in the set point entry screen Note Changing WOC will be valid for both Neu 0 and Lym 0 changing WOC 100 will be valid for both Neu 10 and Lym 10 Select option Set analyzer to activate the new gains Priming of Abbott Cell Dyn 1700 1600 1300 1 Run 3 hematology controls 5 reference patient samples the values to use during calibration Remove the aspirating tubes from the Abbott reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination 12 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS 10 11 12 13 14 Part of foe PERFORMANCE MATERIALS Select option
123. t SF Baso 3480 5000PC 5L Cleaner Hypochlorite NR 3941 1000PE 1L Hematology Control SF Diff Control L N H 3693 3694 3695 4 5 ml Sysmex K4500 Lyse CyMet 4500 CN Free 3773 5000PC Emergency Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 3701 3702 3703 4 5 ml Sysmex K1000 Diluent Diluid 100 Plus 3961 20L Lyse CyMet 1000 CN Free 3744 5L Emergency Cleaner Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml K Diff Control L N H 3455 3456 3457 2 5 ml Sysmex KX21 KX21 N Diluent Diluid 100 Plus 3961 20L Lyse CyMet KX CN Free 3425 0500 500 ml Emergency Cleaner Hypochlorite 0 5 3917 5000 5L 3917 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2 5 ml vial 3463 3464 3465 2 5 ml 3701 3702 3703 4 5 ml K Diff Control L N H 3455 3456 3457 2 5 ml Sysmex XE2100 XT2000i XT1800i XS1000i Reagents not available Hematology Control XE Diff Control L N H 3731 3732 3733 4 5 ml Sysmex and its subsidiary products are trademarks Sysmex Corporation The information contained herein has not been approved by Sysmex Corporation Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www ava
124. t samples Keep the values to use during calibration Remove the aspirating tubes from the Diatron reagent cubitainers and bottles and put them in clean beakers Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination Select option 1 Maintenance Select option 2 Priming gt Select option Prime diluent to empty the system Connect Diluid Abacus to the corresponding aspiration tube Select option Prime diluent gt at least 3 times To prime other J T Baker reagents proceed as described above for the diluent Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Note All reagents be primed in one cycle Select option Prime all gt Diatron and its subsidiary products are manufactured by Diatron MI PLC The information contained herein has not been approved by Diatron MI PLC Always refer to the user manual provided with the equipment at issue Calibration of Diatron Abacus Junior 5 Two calibration options are available see below information on auto calibration and factorial manual calibration Auto calibration steps 8 9 Select option lt 2 Calibration gt Select option lt 3 Calibration settings gt Select option lt 5 Three measurements gt Go back to the Calibration menu Select option lt 1 Calibration gt Define targe
125. t values using the SF Diff assay value sheets If a parameter should not be calibrated keep the target value 0 Select Ok for calibration measurement Run 3 times a hematology control Select to accept results Select Ok to accept the new calibration factors Factorial manual steps Select option lt 2 Calibration gt Select option lt 3 Calibration settings gt Select option lt 3 Factorial calibration gt Go back to the Calibration menu Select option lt 1 Calibration gt Calculate new calibration factors assigned value new calibration factor x current calibration factor mean value Enter new calibration factors between 0 8 and 1 2 Select lt Ok gt 28 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of AVANTOR PERFORMANCE MATERIALS Drew Analyzers Drew Analyzers Reagents Description Drew Excell 22 J T Baker Product ProductNre 5 Diluent Diluid III Diff 3963 20L Lyse CyMet III Diff 3964 5L 3968 1L Cleaner DetectoTerge 3763 5L Sheath Fluid Sheath D 3495 9010PC 10L Drew D3 Diluent Diluid III Diff 20L Lyse CyMet III Diff 5L 1L Cleaner ProClean 3900 5L Emergency Cleaner ProClean Plus 3901 100 ml Hypochlorite NR 3941 5000PC 5L 3941 1000PE 1L Hematology Control 8 Parameter Control L N H 3427 3428 3429 2
126. ter the main menu 5 Select option 3 Reagents from the main menu 6 Select option 3 Prime 7 Select option 6 All reagents ABX Pentra and Micros and its subsidiary products are trademarks of HORIBA ABX SAS The information contained herein has not been approved by HORIBA ABX SAS Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 17 Part of gt AVANTOR PERFORAAANCE AAATERIALS 8 Remaining liquids are now removed from the tubes 9 Place the 500 ml CyMet APR CN Free bottle at the left side in the reagent compartment 10 Connect the J T Baker reagents to the corresponding aspiration tubes 11 Select option 3 Reagents from the main menu 12 Select option 1 Level Change 13 Usethe f and keys to select the Change key 14 Perform this procedure for all 5 reagents The reagent levels will be updated to 10096 15 Repeat 2 times steps 4 7 now with the reagents connected to prime the reagents into the system 16 Select option Start Up to perform a start up 17 Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Note When changing from cyanide containing to cyanide free reagents a recalibration for the Hemoglobin is required Calibration of ABX Pentra 60 On the ABX
127. tion Calibration Select option Closed or select option Manual or select option lt gt to start calibration in the desired mode Run 3 hematology controls normal level 5 Calculate new calibration factors reference value new calibration factor x current calibration factor mean value 6 Selectoption Calibration 7 Selectthe parameter to be calibrated and enter new calibration factors between 100 and 2000 Continue to the next parameter using key 8 Select option Enter to save 9 Select option OK to return to the Calibration screen Priming of Nihon Kohden Celltac a MEK 8118K 1 Run 3 hematology controls or 5 reference patient samples Keep the values to use during calibration 2 Remove the aspirating tubes from the Nihon Kohden reagent cubitainers and bottles and put them in clean beakers 3 Rinse the aspirating tubes with distilled or de ionized water to avoid reagent contamination 4 Connect J T Baker Diluid NR to the aspiration tube 5 Select option Function Check and select option Priming 6 Select option Clean and select option Meas Continue to aspirate air in the lyse and detergent tubes 7 Connect CyMet NR III CN Free and DetectoTerge to the aspiration tubes 8 Select option Clean and select option Meas Continue to start priming Repeat 5 times 9 Runt
128. to Rinse 5 Prepare a beaker with 500 ml distilled water and connect to the diluent aspiration tube 6 Select option Select and select option 5 Auto Rinse and repeat 7 Connect J T Baker Diluid 100 Plus to the diluent aspiration tube 8 Select option lt Select gt and select option lt 5 Auto Rinse gt and repeat 9 Performa startup and background check Repeat if necessary Sysmex and its subsidiary products are trademarks Sysmex Corporation The information contained herein has not been approved by Sysmex Corporation Always refer to the user manual provided with the equipment at issue SALES MANUAL HEMATOLOGY PRODUCTS www avantormaterials com 53 J I Baker Part of _A ANTOR PERFORMANCE MATERIALS Urit Analyzers Urit Analyzers Reagents Description JT Baker Product ProductNr Pack Size Urit 3010 2900 Diluent Diluid III Diff 3963 201 CyMet III Diff 3964 5L 3968 1L Cleaner ProClean Extra 3862 5000 5L 3862 1000 1L Hematology Control 3 Diff Control L N H 3433 3434 3435 2 5 ml vial 3502 3503 3504 4 5 ml Urit and its subsidiary products are manufactured by Urit Medical Electronic Co Ltd The information contained herein has not been approved by Urit Medical Electronic Co Ltd Always refer to the user manual provided with the equipment at issue 54 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of
129. unts Review the displayed data Acceptable values are as follows Parameter Background WBC lt 0 5 x 10 L RBC lt 0 05 x 10 L HGB 0 2 g dL PLT lt 10x 10 L When acceptable background values are displayed the priming is successful If not repeat steps 5 6 again Run the hematology controls or reference patient samples from step 1 again Compare the values and check if any calibration is needed Note When changing from cyanide containing to cyanide free reagents a recalibration for the Hemoglobin is required Calibration of Abbott Cell Dyn 3700 3500 3000 Two calibration options are available Select option lt Auto Calibrate gt to run an automatic calibration or follow the manual calibration process as below 1 Select option lt Calibration gt from the main menu calibration menu displays the calibration factors Select option lt Open sampler gt or lt Closed sampler gt Select option lt Print screen gt to printout the factors Calculate new calibration factors assigned value new calibration factor x current calibration factor mean value Select option lt Enter factor gt to enter new calibration factors Continue to the next parameter using key It is advised to enter the factors for both open and closed modes Press lt Return gt to leave the calibration menu Priming of Abbott Cell Dyn Ruby 3200 1 Run 3 hematology controls 5 reference patient
130. vice The products are not part of List A and List B of Annex ll of the IVD Directive 98 79 EC but are subject to self registration engineers on the proper use of our products including e Education of our reagent line e Technical experience with a number of cell counters e Installation of reagents on cell counters This declaration is valid for all the IVD medical devices Calibration of cell counters described above and which are placed on the market by Reagent trouble shooting ourselves on or after the date hereof and which bear the CE Complaint handling marking e Assistance by one of our product specialists with y P P Deventer the Netherlands reagent installation at the first key customer s or August 26 2014 reference laboratories at the customer s site if necessary A full reagent training session as described above is conducted over two or three days A full training session for instrument maintenance can be completed in one day per instrument line and includes preventive maintenance technical issues and troubleshooting J Mittendorf Manager Quality and Assurance 2 www avantormaterials com SALES MANUAL HEMATOLOGY PRODUCTS Part of ASANTOR PERFORMANCE MATERIALS ISO Certificates ____ DNV BUSINESS ASSURANCE MANAGEMENT SYSTEM CERTIFICATE Certificate No 109338 2012 AQ NLD NA DNV BUSINESS ASSURANCE MANAGEMENT SYSTEM CERTIFICATE Certificate 122474 2012 AQ NLD RvA This is to
131. y Analyzers CyMet Abacus CN free 3431 1000 1 H34 3 Part Differential 2973 1 unit CE CyMet Abacus EO 3444 1000PE 1L CE H32 3 Part Differential 2983 unit CE CyMet APR Baso Il 3479 1000PE 1L CE H32 VET 3 Part Differential 2977 1 unit CyMet APR CN free 3417 0500PE 500 ml CE CyMet APR EO 3478 1000PE 11 CE I CE CyMet ASA 2950 3800PE 3 81 CE Product Number Size mark CyMet ASB 2951 0380PE Diluents CyMet AS CN free 2952 9010PC CE Diluid 100 Plus 3961 CyMet Automated 3755 Diluid 22 2990 9010PC CF QyMet BS3 CN free 2982 0500PE CE Diluid 590 3954 CF QyMet BS34 CN Free 2902 1000PE CE Diluid 610 3969 CF QyMet BS3 VET 2975 0500PE Diluid Abacus 3430 9020 CyMet CA VET 2981 5000PC 51 3430 9010 CF GyMet Ill Diff 3964 5L CE Diluid AC 900 3996 CE 3968 1L CE Diluid APR 3476 9020PC CyMet IlI Diff CN free 3511 5000 5L CE Diluid Azide free 3957 35111000 1L CE Diluid BS34 2901 9010PC CE CyMet Erma 3416 0500 CE Diluid BS3 VET 2974 9010PC CyMet H12 CN Free 3841 1000PE 1L CE Diluid CA VET 2980 9010PC CyMet H20 3853 1000 1L CE Diluid III Diff 3963 CE CyMet KX CN Free 3425 0500 500 ml CE 3963 9010 53 29851000PE 11 CE Diluid Erma 3459 9020 CE CyMet MBA 34891000PE 1L CE Diluid 5 3419 9020PC CE CyMet MD I 3418 1000PE 11 CE Diluid Mindray 3439 9020 Jr CyMet MD I 53 298

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