TOSOH CORPORATION
Contents
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3. 2 RA 3 11 HLC 723GX oz o i OO xs 0 40 ddH E 9 LV aH EB 7d vS 8S L V38w 1Y101 GZ 6I9L ZO L 1 6 ov es s 690 6 b OLVS EL 7Z GS O S 40L 1 92 Zi Zh 0 0 3 ve Zt ze 0 L 0 aly v t tz 0 L 0 viv 00 C 02 0 0 0 dd VIV 3411 SWYN OZpL O XESLL L DP 1VO LO S000 QI 10 S000 81 vLOO ON 00 LOA NOIIVd0dd09 HOSOL SL E0 0 10 1102 HOSOL 1MOd3H NI80190N3H09A19 o o SL 0 9 0 JaH 9 9 vaH 4E S OLVGAH 6p 99L v3uv 1vV101 90 zybL Z0 L EZ6 0v 89 g 790 E S 9LVS 09 Z SS O Vv 917 v9 6 tro 80 3 zg El lero 6 0 gly B6 9 2 0 vr o viv 00 0 00 0 0 0 d v3uv 3Nil 3WVN c09E 0 X69hL L f Z0 000 01 ZO E000 81 ZZ00 ON 00 LOA NOIIVHOdGNOO HOSOL 6Z2 EL 8L 0L 0L0Z HOSOL LHOdIY NISO 190N3HO2A 9 12 lt Total Area f R FP NI x 0 1 13 1 HbA1c Level 2 s A
4. e e 15 OBR Mee amp Bel ie ARDS ET IS 1 oo 1 2 Pere eee reer reer rere eee ere ere rere eee errr 2 9 ANS m aesti asic UR 2 4 eH Henn 2 5
5. w N 5 6 1 2 CE 7 HLC 723GX HbAlc J 9 HLC 723GX 10 D HLC 723GX UTE GX Y Bi Jg A BOT 1
6. AS A 0 i y 1 005x 0 014 aie Ua i 0 999 Press arte e pa pia e pe po ep e 20 40 60 8 0 10 0 12 0 14 0 16 0 HLC 723G8 HLC 723GX HLC 723G7 16 0 14 0 12 0 10 0 8 0 6 0 4 0 2 0 bee ence A mu eter eee a a y 1 006 x 0 072 r 0 999 n 101 2 0 40 60 80 10 0 12 0 14 0 16 0 HLC 723G7 14 1 n 10 3 s A n 10 Low Medium High Mean 5 00 7 53 10 06 SD 0 00 0 05 0 05 CV 0 0 0 7 0 5 2 n 10 2 1 1 sA Low High Mean 4 94 9 96 SD 0 05 0 05 CV 1 0 0 5 10 15 1 1 1000 mg dL L Ai 4 s Ai
7. 4 30 7 bei FB dita AK HEY GX DW 1 15 30 2 4 3 1
8. fk HbA LAJ HbA s A HbAi LA 1 3 s A LA s A 2 2 97 A a SHE PB 2 4 2 A s A
9. GX 1 HLC 723GX STOP OK gt C N XA SA C GX 1 HLC 723GX STOP 2 3 4
10. 5 H W 6 OK 1 2 3 4 1 1 STATUS CE 4
11. Total Area 700 4500 800 4000 Total Area s Ax 493 53 9 9 986 09 9 9 1492 07 10 0 1933 15 10 0 2427 67 10 1 2907 35 10 1 3403 81 10 1 3803 19 10 1 4292 48 10 1 4698 64 10 2 2 2 sAi SA 0 10 24 1 9 41 4 0 103 2 8 5 8 5 7 102 3 T 74 7 3 101 4 6 8 9 8 9 100 5 5 10 7 10 6 101 6 4 12 5 12 2 102 7 3 14 0 13 9 101 8 2 15 5 15 5 100 9 1 17 3 17 1 101 10 0 18 8 3 HLC 723GX HLC 723G8 HLC 723GX HLC 723G7 s A HLC 723GX HLC 723G8 HLC 723GX HLC 723GX 16 0 14 0 12 0 10 0 8 0 6 0 4 0 2 0
12. 3 HbE s A HbE s A 4 sACQQ 3 1 Area 700 2 s Ai 3 s A 16 EDTA NaF 25 24 4 14 Safety Precautions To help protect you and or your property from potential damage and ensure personal safety please read this IFU thoroughly before using the product Notational Convention Notation Explanation Indicates a hazard with a low level of risk which if not ZNCAUTION avoided could result in minor or moderate injury ZN CAUTION E Use only in well ventilated areas In case of
13. oh 2 6 eee eee eee eee eee eee eee eee eee eee 3 T sesesssesossossoosessossososesssossosesosssesoseeee 3 8 a 3 9 AS ss d ars LT 5 10 A 5 11 eee Hee 7 12 ESAS SA ais isi VS UN 7 13 A A 8 14 RAR E ER e ERN 10 15 TT 11 16 Visus Sine einn PENIS O 13 2011 9 2011 1 1 HLC 723GX HLC 723GX GHb N HbA LIENT T HbA 2 1 N
14. gently squeeze the elution buffer pack by hand to remove all excess air and tighten the cap firmly to create a vacuum that will prevent air from entering during operation 23 5 Never use reagents that have exceeded the expiration date printed on their labels Assay results for expired reagents will not be reliable Also note that reagents must be used within four months after opening provided that the container is correctly maintained in vacuum state 6 When there is leftover elution buffer in the aluminum pack that must be removed from the analyzer and stored again gently squeeze the elution buffer pack by hand to remove all excess air and tighten the cap firmly to create a vacuum that will prevent air from entering during storage and store between 4 and 30 C This product is stable for four months after opening 7 Always replace with an aluminum pack when elution buffer is almost empty Avoid refilling leftover elution buffer into aluminum pack as this can produce unreliable assay results GX Hemolysis amp Wash Solution 1 Always return GX Hemolysis amp Wash Solution to 15 to 30 C before use 2 Assay results for expired reagents will not be reliable Also note that reagents must be used within four months after opening provided that the container is correctly maintained in vacuum state 3 This product is stable for four months after opening when stored at4to 30 C 4 Alway
15. 32 13 66 47 49 ou par e mail l adresse info raga eu tosoh com Version Actuelle GXV 01000 A Haszn lati utas t s t bb nyelven el rhet websz jtunkon www tosohbioscience eu a Service amp Support Szolg ltat s s T mogat s szekci alatt Nyomtatott valtozat ig nyelhet faxon a 32 13 66 47 49 es telefonsz mon vagy e mailben info raqa eu tosoh com Aktu lis V ltozat GXV 01000 Istruzioni per l Uso in diverse lingue sono disponibili sul nostro sito web www tosohbioscience eu alla sezione Service amp Support Versione cartacea pu essere richiesta via fax al 32 13 66 47 49 o via e mail a info raqa eu tosoh com Versione Attuale GXV 01000 I Naudojimo instrukcijas vairiomis kalbomis galite rasti m s tinklalapio www tosohbioscience eu skyriuje Service amp Support Popierin versij galite gauti faksu 32 13 66 47 49 arba el pa tu info raqa eu tosoh com Naujausia Versija GXV 01000 Instrukcja U ytkowania w r nych j zykach jest dost pna na naszej stronie internetowej www tosohbioscience eu w zak adce Service 8 Support Serwis i Wsparcie O wersj papierow mo na pyta pod nr faksu 32 13 66 47 49 lub e mailem info raqa eu tosoh com Aktualna Wersja GXV 01000 As instrug es de utilizag o encontram se disponiveis em diversos idiomas no nosso sitio www tosohbioscience eu na sec o Service amp Support Servi
16. 4 30 4 30 4 GX 4 30 4 30 4 6 sA 7 HPLC 2 2 6 3 GX YAR GX TEE 1 GX 18 2 GX 3 HbF 5 s A Total A 8 TSKeel GX GX HbAlc J HbAle 2 HLC 723GX
17. For specified column lot only Manufacturer Authorized representative in the European Community Consult instructions for use In vitro diagnostic medical device LOT Batch code Lot number Temperature limitation SN NET Serial number Column number Net volume after reconstitution for lyophilized material CONTENTS 4 Introduction DE 18 2 Prior to Use EE 19 3 Warnings and Precautions mE 19 4 Content oo 19 5 Related Components DE 20 6 Storage and Stability DE 20 TE Specimens DIE 20 8 Assay Principle EE 20 9 Installation IEEE 21 10 Assay Procedures DE 22 11 Precautions for Use IDEM 23 12 Reference Data Porra rc hh nnn 25 13 Measurement Values DP 25 14 Evaluation of Results DE 25 15 Expected Values DE 26 16 Performance Characteristics 88n 27 17 Precision DE 29 18 Interferences DE 29 19 Specimen Collection and Handling 8 31 Published in September 2011 1 Introduction The GX Assay Kit is designed exclusively for use with the Tosoh Automated Glycohemoglobin Analyzer HLC 723GX referred to as HLC 723GX in the IFU which is based on the principle of High Performance Liquid Chromatography assay It is not designed for and should never be used with any other type of system The GX Assay Kit is intended for in vitro diagnostic use for the measurement of Hemoglobin A HbA in blood specimens Hemoglobin A measurements are used in the clinical management of diabetes to assess the
18. Ref American Diabetes Association Standards of medical care for patients with diabetes mellitus Diabetes Care 2000 23 Suppl 1 S32 42 The values referred to within this IFU have been determined with a NGSP certified method It is known that the relationship between HbA results from the NGSP network and the IFCC network mmol mol is expressed by using the following equation See http www ifcchba1c net IFCC_08 asp NGSP 0 09148 X IFCC 2 152 26 16 Performance Characterestics 1 Dilution Linearity The tests were performed with Hemoglobin A1c Control diluted with various percentage factors to determine the effect on the s A value Linearity was observed for the Total Area in the 700 to 4500 range and measurements in the range of 800 to 4000 are recommended to give more reliable results Total Area S A 96 493 53 10 3 986 09 10 4 1492 07 10 5 1933 15 10 5 2427 67 10 5 2907 35 10 5 3403 81 10 6 3803 19 10 6 4292 48 10 6 4698 64 10 6 2 Recovery The table below shows the recovery ratios for two types of samples mixed in different percentage factors High s A Low s A Measurement Theoretical Recovery sample sample value value ratio ratio S A 96 S A 96 96 0 10 2 7 1 9 4 5 4 4 102 2 8 6 2 6 1 102 3 7 7 9 7 8 101 4 6 9 4 9 5 99 5 5 11 3 11 2 101 6 4 13 1 12 9 102 7 3 14 7
19. 8 0 7 0 6 0 0 200 400 600 800 1000 mg dL 2 25 mg dL L Aj 6 s Ai 8 0 r r 7 r DNE NM NE INIRE e a oes eee as C 0 5 10 15 20 25 mg dL 3 25 mg dL L A 4 s Ai 8 0 r 70 m Mm Hb d o sa S Atc G L A 96 0 5 10 15 20 25 mg dL 4 s A Q0 19 mg dL 20mg dL FLU 1 500 KILLY Y v WE 50 mg dL 2 1 HbD HbS HbC s A 2 HbF sA
20. Connect the outlet side flow tube 10 Assay Procedures Refer to the HLC 723GX Operator s Manual for detailed instructions 22 11 Precautions for Use 1 Carefully read the instructions contained in this IFU and related Instructions For Use provided with HLC 723GX TSKgel GX Hemoglobin A1c Calibrator Set Hemoglobin A1c Control Set Hemoglobin A1c Control Set 2 GX Assay Kit is designed exclusively for use in combination with the HLC 723GX and TSKgel GX never in any other combination 3 For safe waste disposal it is recommended that each laboratory complies with established laboratory procedures and local state and federal regulations GX Elution Buffer 1 Return the elution buffer to 15 to 30 C before use 2 Always use the GX Elution Buffer in combination with the TSKgel GX of the identical lot number The column lot number is indicated by a single uppercase alphabetical character A B etc on the label of column box The Elution Buffer label displays an alphabetic character corresponding to the column lot number as shown below Zot ot Rolin ON 3 Always use GX Elution Buffers from the same GX Assay kit number The GX Assay kit number is indicated by 2 digits and two uppercase alphabetical characters A01K A02M etc on the aluminum pack label as shown below KIT A01 K 4 When first opening the aluminum pack to insert the suction tube
21. os e Assist ncia Pode ainda obter uma versao em papel atrav s do fax 32 13 66 47 49 ou do email info raqa eu tosoh com Versao Actual GXV 01000 Instructiuni de utilizare in diverse limbi sunt disponibile pe site ul nostru www tosohbioscience eu la sec iunea Service amp Support Service si asisten tehnic O versiune pe hartie poate fi obtinuta comandand o prin fax la 32 13 66 47 49 sau prin e mail la info raqa eu tosoh com Versiune Actual GXV 01000 Ve jezi na navodila za uporabo so na voljo na na i spletni strani www tosohbioscience eu v razdelku Service amp Support Servis in podpora V papirni obliki jih lahko prejmete po faksu 32 13 66 47 49 ali elektronski posti info raqa eu tosoh com Aktualna Razli ica GXV 01000 N vod na pouzitie vo viacerych jazykoch je dostupny na na ej web str nke www tosohbioscience eu v sekcii Service amp Support Vytla en verziu mono z ska faxom 32 13 66 47 49 alebo cez e mail info raga eu tosoh com Aktu lna Verzia GXV 01000 Bruksanvisning pa flera spr k finns att tillg pa var webbplats www tosohbioscience eu under rubriken Service amp Support En pappersversion kan erh llas per fax 32 13 66 47 49 eller e post info raga eu tosoh com Aktuell Version GXV 01000 Symbols on the product labels CE European Conformity Catalogue number Part number Use by date For ot column ON gt
22. insufficient ventilation flammable and toxic solvents can cause fire explosion or poisoning E First Aid Skin exposure Wash exposed area with plenty of soap and water Eye exposure Open eyes as wide as possible and wash with clean water for at least 15 minutes Immediately call for medical attention Ingestion Please wash mouth with excess water and immediately call for medical attention E Do not spill solvents Spillage and leakage can cause fire electric shock poisoning injury and corrosion Wear appropriate protective gear when cleaning up a spill E Wear eye protection and protective gloves Organic solvents and acids are harmful and should not come in direct contact with the skin E Handle package with care Inappropriate handling may cause rupturing and or spattering of the product E Only use this product as intended This product is intended for in vitro diagnostic use for the measurement of HbA in blood specimens E Proper disposal Dispose in accordance with local laws and regulations NOTE Keep this IFU with the product for future reference EU rev GXV 01000 Emponeiickw norpeGurenu Evrop t z kazn ci Europ iske kunder Europ ische Kunden European customers Eupwrraioi mehdres Clientes europeos Euroopa kliendid Consommateurs europ ens Eur pai gyfelek Clienti europei Europos klientai Eiropas klienti Klienci europejscy Clientes europeus Clienfii europeni Evropski kupci Eur pski z k
23. long term efficacy of diabetic control Glycohemoglobin GHb is a general term for complexes where the whole blood glucose is non enzymatically bound to the or B chains of human hemoglobin Within these complexes HbA which is a complex of glucose and the N terminus of the 5 chain is the most prevalent HbA is non enzymatically synthesized in two steps Step 1 The glucose aldehyde group reacts with the free amino group on the valine at the N terminus of the 5 chain to form the Schiff base labile HbA L A Step 2 Stable ketoamine stable HbA s A is then formed by a reaction known as the amadori rearrangement Due to the fact that L A the intermediate product of this reaction changes rapidly in response to the changes in whole blood glucose concentrations S A is now generally used to measure HbA It provides the best indication of average glucose levels over the most recent 1 to 3 month period because it does not fluctuate in response to physiological factors In the past it was difficult to achieve quick separation of L A and S A4 on a column therefore sample pretreatment to remove L A was necessary before assaying s A The HLC 723GX is featured by quick separation of L A and s A on the column 2 2 min with no need for sample treatment when assaying s A 18 The hemoglobin found in a normal adult is hemoglobin A which comprises about 97 of the total hemoglobin On the other h
24. 0 05 sodium azide as a preservative GX Hemolysis amp Wash Solution contains detergent and less than 0 1 sodium azide as preservative Applicable analyzers Tosoh Automated Glycohemoglobin Analyzer HLC 723GX 5 Related Components Catalogue No Hemoglobin A1c Calibrator Set 0018767 Hemoglobin A1c Control 0019405 Hemoglobin A1c Control Set 0021974 TSKgel GX 0023160 6 Storage and Stability GX Elution Buffer No 1 No 2 No 3 All unopened materials are stable until the expiration date on the label when stored at 4 to 30 C The expiration date is indicated on the package and aluminum pack label Stable for 4 months after opening when stored at 4 to 30 C GX Hemolysis amp Wash Solution All unopened materials are stable until the expiration date on the label when stored at 4 to 30 C The expiration date is listed on the bottle label Stable for 4 months after opening when stored at 4 to 30 C 7 Specimens Whole blood samples in primary tubes containing EDTA 8 Assay Principle The HLC 723GX is based on the High Performance Liquid Chromatography HPLC principle with a cation exchange column employing the differences in ionic interactions between hemoglobin components to separate them in a span of 2 2 min 20 A step gradient elution is used to separate HbF s A Total A and Hb variants with a set of Elution Buffers GX Elution Buffer No 1 2 and 3 of different salt concentrations 9
25. 14 6 101 8 2 16 3 16 3 100 9 1 18 1 18 0 101 10 0 19 7 27 3 Correlation Correlations 1 between the HLC 723GX and the HLC 723G8 and 2 between the HLC 723GX and the HLC 723G7 are shown in the graphs below 1 Correlation between the HLC 723GX and the HLC 723G8 HLC 723GX 16 0 14 0 12 0 10 0 8 0 6 0 40 2 0 A nn O A ES y 1 000x 0 065 r 1 000 n 101 M APP t i i i i i i 20 40 60 80 100 120 140 160 HLC 723G8 2 Correlation between the HLC 723GX and the HLC 723G7 HLC 723GX 16 0 14 0 12 0 10 0 8 0 6 0 4 0 2 0 cd N tee ce doce ead feo y 1 014x 0 014 r 0 999 L pee n 100 20 40 60 8 0 10 0 12 0 14 0 16 0 HLC 723G7 28 17 Precision 1 Intra assay n 10 The intra assay precision n 10 of the s A for three types of control samples are shown below Low Medium High Mean 5 40 7 99 10 50 SD 0 00 0 03 0 00 CV 0 0 0 4 0 0 2 Inter assay n 10 The inter assay precision n 10 measured once a day for a 10 day period of s A 96 for two types of control samples are shown below Low High Mean 5 34 10 42 SD 0 05 0 06 CV 96 0 9 0 6 18 Interfere
26. HLC 723GX HbD HbS HbC A s A 2 GX YHA GX GX Jr s 1 3 m od W 0023161 GX GX 1 800 mLX1 GX T amp BIER 98 2 800 mLX1 GX 3 800 mLX1 GX 2000 mLX2 2 2 HLC 723GX 4 HbA1lc HbA1c TSKgel GX 5 r1 HH J 0018198 0021974 0023160 GX 1 2 3
27. Installation Be sure to read the IFU included with the TSKgel GX GX Assay Kit Hemoglobin A1c Calibrator Set Hemoglobin A1c Control Hemoglobin A1c Control Set as well as HLC 723 GX Operator s Manual Installation of GX Elution Buffer 1 Press the STOP key on the HLC 723GX system operation panel to enable the STAND BY state 2 Remove the cap from the elution buffer pack 3 Make sure to insert the tube matching the color of the elution buffer pack being installed 4 Gently squeeze the elution buffer pack by hand to remove all excess air and tighten cap firmly into place to create a vacuum that will prevent air from entering during operation 5 Press the MAINTE key and then the REAGENT CHANGE key 6 Press the keys of the reagents to be replaced on the REAGENT CHANGE screen 7 Press the CHANGE key A confirmation message will be displayed If everything is all right press the OK key Installation of GX Hemolysis amp Wash Solution 1 Press the STOP key on the HLC 723GX system operation panel to enable the STAND BY state 2 Remove the cap from the GX Hemolysis amp Wash Solution bottle 3 Insert the tube into the new bottle and screw cap back on 4 Press the MAINTE key and then the REAGENT CHANGE key 5 Press the H W key on the REAGENT CHANGE screen 6 Press the CHANGE key A confirmation message will be displayed If everything is all right press the OK key 21 Installation of Printer Paper 1 Lif
28. Rev DL028J010 DLO28E000 HLC 723GX Tosoh Automated Glycohemoglobin Analyzer HLC 723GX Instructions For Use GX GX Assay Kit CE TOSOH CORPORATION TOSOH
29. and various hemoglobin variants have also been reported in different regions especially in areas with a large immigrant population Abnormal hemoglobins or hemoglobin variants are eluted out together with other Hb components and can lead to misinterpretation of s A values The HLC 723GX with the TSKgel GX and the GX Elution Buffers will not be affected by most commonly known hemoglobin variants in reporting s A values 2 Prior to Use Inspect the packaging and the exterior of the aluminum pack for any signs of damage prior to use If any damages are visible contact your local Tosoh sales representative Confirm that the following documents are included in the package Instructions For Use 1 copy 3 Warnings and Precautions 1 This product is for in vitro diagnostic use only 2 This product is intended for use on the Tosoh Automated Glycohemoglobin Analyzer HLC 723GX only 3 Do not use this product beyond the expiration date 4 Content The GX Assay Kit contains the listed products below Catalogue No Description Package contents 0023161 GX Assay Kit GX Elution Buffer No 1 1x800 mL GX Elution Buffer No 2 1x800 mL GX Elution Buffer No 3 1x800 mL GX Hemolysis amp Wash Solution 2x2000 mL Printer Paper 2 Filter Element 2 The following types of elution buffers are designed for exclusive use with the HLC 723GX 19 GX Elution Buffers are organic acid buffers Each contains less than
30. azn ci Europeiska kunder E MHcTpykunn sa ynorpe6a Ha pa3MuHM esnyn ca Ha pasnonoxeHne Ha Hawna ye6cajir www tosohbioscience eu a pasgena Momou n nonnpbxka Service amp Support XaDTMeHO konne Moxe na 69e nonyueHo Ha fax 32 13 66 47 49 unu e mail info raqa eu tosoh com AkTyanHa Bepcua GXV 01000 Lieto anas instrukcijas da d s valod s ir pieejamas m su interneta vietn www tosohbioscience eu sada Service amp Support Apkalpo ana un Atbalsts Druk tu versiju iesp jams sa emt pa faksu 32 13 66 47 49 vai e pastu info raqa eu tosoh com Aktu l Versija GXV 01000 N vod k pou it v r zn ch jazycich je dostupn na na ich webov ch str nk ch www tosohbioscience eu v sekci Service amp Support Ti t nou verzi m ete obdr et faxem slo 32 13 66 47 49 nebo e mailem info raqa eu tosoh com Aktu ln Verze GXV 01000 Flersprogede brugsanvisninger findes p vores hjemmeside www tosohbioscience eu under Service amp Support sektionen Trykte brugsanvisninger kan rekvireres pr fax 32 13 66 47 49 eller e mail info raqa eu tosoh com Nuveerende Version GXV 01000 Bedienungsanleitungen in verschiedenen Sprachen sind auf unserer Webseite www tosohbioscience eu Im Kapitel Service amp Support erh ltlich Ein Papierexemplar erhalten Sie auf schriftliche Anfrage an Faxnummer 32 13 66 47 49 oder per E Mail an info raqa eu tosoh com Aktuel
31. ct to change without notice HLC TSKgel HLC and TSKgel are registered trademarks of TOSOH CORPORATION Printed in Japan T1111 500
32. le Version GXV 01000 Oa BpglTg ric OSnyigc xprjonc oe ToAAEc YAOoogc orn DiadIKTUAK toTroBec a pa www tosohbioscience eu OTnV zv rnra Service amp Support Mrrope te va A fere TNV vrumm Hop urroB AAovrag a tnon LEcw pag otov apigu 32 13 66 47 49 fj p ow nAEKTPOVIKOU Tayubpousiou info raqa eu tosoh com Tpgxouoa EK6oon GXV 01000 Instructions For Use in multiple languages are available on our website www tosohbioscience eu under the Service amp Support section A paper version can be obtained by fax 32 13 66 47 49 or e mail info raqa eu tosoh com Actual Version GXV 01000 Las instrucciones de uso est n disponibles en diferentes idiomas en nuestra pagina web www tosohbioscience eu en la secci n de Service amp Support Servicio y Soporte Tambi n podemos enviarle una versi n impresa a trav s del fax 32 13 66 47 49 o por correo electr nico info raqa eu tosoh com Versi n Real GXV 01000 Eri keeltes kasutusjuhendid on saadaval meie veebilehel www tosohbioscience eu alajaotuses Service amp Support Paberkandjal versiooni saab tellida faksinumbril 32 13 66 47 49 v i e posti teel info raqa eu tosoh com Kehtiv Versioon GXV 01000 Les instructions d utilisation sont disponibles en plusieurs langues sur notre site web www tosohbioscience eu dans la r brique Service amp Support Vous pouvez obtenir un exemplaire papier par fax au n
33. lo x E ci Sample oo e NO o CO e LE oc woowoccos a a O e es e res NE e Cc ON a gt N a NOYO Lu e 10 so z M Ye z oz om C SO s c e oro oc reoccocer lt D a lt o oc Neo y o NODO 3 0 ar T Owore Ir D o x s e ss I o cocorwnr e OC o o NO gt zoo 0g E e oocz a o S w oo u oce c ZU ALLAN 13 Measurement Values Measurement values on the above report the second column indicate the percentage of each peak in relation to the Total Area excluding the front peak FP after calibration Note the minimum unit of measurement displayed is 0 1 14 Evaluation of Results Quality Control In order to monitor and evaluate the precision and analytical performance it is recommended that control samples should be assayed daily If one or more control sample value s is out of the acceptable 25 range it is necessary to investigate the validity of the calibration curve before reporting patient results Standard laboratory procedures should be followed in accordance to the strictest regulatory agency under which the laboratory operates 15 Expected Values Reference ranges nondiabetic HbA s A 4 0 6 0 mean 5 0 SD 0 5
34. nces A substance is considered to interfere when the recovery of a known specimen falls outside a 10 96 acceptable range 1 No effect was observed up to 10 g L for glucose 0 25 g L for sodium cyanate and 0 25 g L for acetaldehyde Glucose 8 0 7 0 6 0 5 0 S E 40 E 3 0 2 0 1 0 0 0 0 2 4 6 8 10 Control Concentration g L 29 Sodium cyanate 8 0 2o so 5 0 EE NY A E e RN 3 0 o Lue IE Le Hb 96 SY o EE To i E E iuter O LAict Lj 0 0 L L 0 00 0 05 0 10 0 15 0 20 0 25 Control Concentration g L Acetaldehyde 8 0 ol ees MEE ME MN MON opm de dus POM lo PE SEE aaa x A os H i 30 p eseses 1 2 0 1 i 1 0 1 0 0 f 1 f i 0 00 0 05 0 10 0 15 0 20 0 25 Control Concentration g L 2 No effect was observed for the following agents up to the concentrations indicated in the table Free bilirubin to 0 19 g L Conjugated bilirubin to 0 20 g L Chyle to 1500 Formazine turbidity Aspirin to 0 50 g L Triglyceride to 20 g L 3 The presence of HbD HbS and HbC does not interfere with the assay High HbF may interfere with the assay 4 HbE may interfere with assay In the presence of HbE a sh
35. oulder or small peak may be observed behind s A peak 30 5 Since a high number of Hb variants is observed worldwide care should be taken when interpreting the results Designation of a particular name cannot exclude the presence of other variants 6 Low concentrations of hemoglobin may cause the Total Area of the chromatogram to be lt 700 7 A reduced concentration of HbA may be observed in patients due to limited life span of red blood cells interpret clinical results with caution 8 Hemolysis does not interfere with HbA assay results 19 Specimen Collection and Handling A whole blood sample is required for the assay No special preparation is necessary A venous blood sample is collected aseptically The blood samples in primary tubes containing EDTA may be stored at 25 C for 24 hours prior to analysis or at 4 C for 14 days 31 TOSOH wsmsx 3 8 2 105 8623 TEL 03 5427 5181 FAX 03 5427 5220 MI TOSOH CORPORATION BIOSCIENCE DIVISION Shiba Koen First Bldg 3 8 2 Shiba Minato ku Tokyo 105 8623 Japan Phone 81 3 5427 5181 Fax 81 3 5427 5220 TOSOH EUROPE N V Transportstraat 4 B 3980 Tessenderlo Belgium Phone 32 13 66 88 30 Fax 32 13 66 47 49 This manual may not be reprinted or copied in whole or in part without written consent of TOSOH CORPORATION The contents of the manual are subje
36. s replace with a new container when GX Hemolysis amp Wash Solution is about to run out Avoid refilling leftover GX Hemolysis amp Wash Solution containers as this can produce unreliable assay results Filter Element 1 Place the new filter element with great care of filter surface The gray colored surface is the outlet up side 2 As once the filter element is tightened it is deformed it cannot be used again 3 The used filter element has been in contact with blood sample Wear protective clothing glasses gloves mask etc and take sufficient care to prevent potential infection during installation and handling 24 12 Reference Data from the HLC 723GX Assay Control no m gt e re e NG nu 5d te o wo worn TTC cts e a Oo EN EE we ee 05 rM e oo 4OO Otct tNcOG B c eo o ul c eo eu o ac N y q S_1 Ds oz UY ON NAO Da lt pa ON x 2 ae wo o gt o aca el S Y V exo wo e ox e gt e NODO ccaonwnmor Lu Y BOO Poo o o c T 5 gt 200 CN 9 e e co lt gt o ad e cocz 09 rw e5 Led a w oo u lt a Dro E I sof lt lt E ZO Zu u
37. t the printer cover upper lid to open and push the paper holding lever down to the very front and wrap the remaining paper onto the roll 2 Lift the roll up and remove the mandrel 3 Insert the mandrel into the new roll and set it with great care for the direction 4 Return the paper holding lever to the very back and insert the paper into the printer The paper will automatically be fed Installation of Filter Element 1 Confirm that analyzer system eluent delivery has been terminated STAND BY is displayed on the Main screen first screen Then remove the filter outlet top flow line 2 Turn the top of the filter holder assembly by turning it counterclockwise and remove the filter holder by pulling it straight out 3 Lightly press the top of the holder to take out the used filter element 4 Place the new element with great care of surface of filter The gray colored surface is the outlet up side 5 Firmly tighten the top of the filter holder assembly by hand until no further tightening is possible 6 Press the arrow key at the bottom right of the Main screen first screen to show the Main screen second screen Press the pump key on the Main screen second screen to start the pump and check the eluent flows through the filter outlet top Then stop the pump by pressing the pump key again Take special care that eluent coming from the tube does not spill onto the analyzer unit by preparing wiping paper beforehand 7
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