HSi 溶血・洗浄液 HSi Hemolysis & Wash Solution
Contents
1. 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 Z N CAUTION E Use only in well ventilated areas In case of 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 s2. 1 3 HSI mo d 0018431 IHSi L 2000 mLX5 G7 G8 G9 0019550 HSi LL 4000 mLX2 G7 G8 G9 1 HLC 723G7 G7 HLC 723G8 G8 HLC 723G9 G9 4 30 4 4 30 4 25 3 5 s A 6 HPL
3. 4 Tk ay E e e DIRA WHAT SABES 0x3 e e e 15
4. 1 EUMDEM HH HH 2 Pee eee eee rere ere er reer errr ere err eer reer reer ere 3 A P AE R A T 4 TT ETE 5 cessssseccososososeccoosasoseccoosssssscocoosssosecoososs 6 OPT 7 cesesesocscoososssososoosssssesosossssseesoososs 8 Ph 9 CERIS ME SEED ESTEE 2011 6 2010 5 1 HLC 723G7 HLC 723G8 HLC 723G9 GHb N
5. e e e e i Ze yee A e e RHEN YRI EWO ZIRE L T IRN e e
6. HbA HbA 2 1 N fk HbA LAJ HbA s A HbAi LAi 1 3 s A L A s A LA s A s A 2
7. 9 1 2 3 4 XE HLC 723G7 HLC 723G8 HLC 723G9 TSKgel G7 HSi TSKgel G8 HSi TSKgel G9 HSi G7 HSi 1 2 S 3 S G8 HSi 1 S 2 3 S G9 HSi 1 S 2 S 3 S HSi 3 HSi
8. C 6 3 HbF s Ai Total A 7 HbA1c HbA1c HSi HSi 1 STOP 2 3 HSi 4 HSi 8 HLC 723G7 HLC 723G8 HLC 723G9
9. Rev DL005J030 DL005E020 HLC9 728 Tosoh Automated Glycohemoglobin Analyzer HLC 723 Series Instructions For Use HSi HSi Hemolysis amp Wash Solution Qo TOSOH e e e e e e e
10. an Francisco CA 94080 USA Phone 1 650 615 4970 Fax 1 650 615 0415 HLC TSKgel HLC and TSKgel are registered trademarks of TOSOH CORPORATION 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 subject to change without notice Printed in Japan T1109 5
11. bound to the and chains of human hemoglobin The most quantitatively prevalent complex is called HbA in which glucose binds to the N terminus of the 5 chain HbA is non enzymatically synthesized in two steps Step 1 The glucose aldehyde group reacts with the free amino group on the valine comprising the N terminus of the 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 amadori rearrangement Due to the fact that L A the intermediate product of this reaction changes rapidly in response to changes in whole blood glucose concentrations s A is increasingly being 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 Until recently it was difficult to achieve quick separation of L A and s A on a column therefore the pretreatment to remove L A is necessary before assaying s A The Tosoh Automated Glycohemoglobin Analyzers features quick separation of L A and S A on the column thus eliminating the need for treatment when assaying s A 2 Prior to Use Inspect the packaging and the exterior of the bottle for any signs of damage prior to use If any damages are visible contact your local Tosoh sales representative Confirm that the following document is included in the package Instruction
12. osoh Automated Glycohemoglobin Analyzer HLC 723G8 Columns TSKgel G7 HSi TSKgel G8 HSi TSKgel G7 Variant HSi TSKgel G8 Variant HSi TSKgel G7 f Thal HSi TSKgel G8 5 Thal HSi Elution Buffers G7 HSi Elution Buffer No 1 S No 2 S No 3 S G8 Elution Buffer HSi No 1 S No 2 S No 3 S G7 Variant Elution Buffer HSi No 1 S M No 2 S No 3 S G8 Variant Elution Buffer HSi No 1 S No 2 S No 3 S G7 Thalassemia Elution Buffer Kit G8 Thalassemia Elution Buffer Kit 2 Always return HSi Hemolysis amp Wash Solution to room temperature before use 3 Never used reagents that have exceeded the expiration date listed on their labels Assay results for expired reagents will not be reliable Also note that reagents must be used within three months after opening provided that the container is correctly maintained in vacuum state 4 Always replace with a new container when HSi Hemolysis amp Wash Solution is about to run out Avoid refilling leftover HSi Hemolysis amp Wash Solution containers as this can produce unreliable assay results TOSOH amex BR Y RTS 41 3 8 2 105 8623 TEL 03 5427 5181 FAX 03 5427 5220 ii 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 BIOSCIENCE INC 6000 Shoreline Ct Suite 101 South S
13. pattering of the product E Only use this product as intended This product is intended for in vitro diagnostic use for the measurement of Hemoglobin F A2 and HbA c in blood specimens B Proper disposal Dispose in accordance with local laws and regulations NOTE Keep this IFU with the product for future reference Symbols on the product labels Supplied by Manufacturer Supplied by In vitro diagnostic medical device Wi REF LOT Consult instructions for use Catalogue number Part number Batch code Lot number NET Temperature limitation Use by date Net volume after reconstitution for lyophilized material SO MANOA KR WD Introduction Prior to Use Assay Procedures Precautions for Use CONTENTS Warnings and Precautions eet eeee tees OOHteN 22202056 Storage and Stability een eeeeees Specimens Assay Principle Installation and Cali bration nn Revised in June 2011 1 Introduction Based on the principle of High Performance Liquid Chromatography assay the TSKgel G7 HSi and TSKgel G8 HSi column are designed exclusively for use with the Automated Glycohemoglobin Analyzer HLC 723G7 or Tosoh Automated Glycohemoglobin Analyzer HLC 723G8 They are not designed for and should never be used with any other type of system Glycohemoglobin GHb is a general term for whole blood glucose complexes that are non enzymatically
14. s 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 723 Series STD Mode Variant Mode Thalassemia Mode 3 Do not use this product beyond the expiration date 4 Content The following types of HSi Hemolysis amp Wash Solution are designed for exclusive use with the HLC 723G7 or HLC 723G8 analyzer Catalogue No Description Package contents Applicable analyzers HSi Hemolysis amp Wash 0018431 522000 mL HLC 723G7 HLC 723G8 Solution L HSi Hemolysis amp Wash 0019550 2X4000 mL HLC 723G7 HLC 723G8 Solution LL HSi Hemolysis amp Wash Solution contains deionized water EDTA and Triton X The solution contains less than 0 1 96 sodium azide as a preservative Assay mode STD Mode Variant Mode 5 Thalassemia Mode Applicable analyzers Automated Glycohemoglobin Analyzer HLC 723G7 Tosoh Automated Glycohemoglobin Analyzer HLC 723G8 5 Storage and Stability All unopened materials are stable until the expiration date on the label when stored at 4 C to 30 C The expiration date is listed on the package box and bottle labels Stable for 3 months after opening when stored at 4 C to 25 6 Specimens Whole blood samples 7 Assay Principle Separation using the TSKgel G7 HSi and TSKgel G8 HSi column is based on the High Performance Liquid Chroma
15. tography HPLC principle Cation exchange columns employ the differences in ionic interactions between hemoglobin components to separate them into a total of six fractions A step gradient featuring three elution buffers with differing salt concentrations is used to separate when assaying HbF s A Total A and HbA 8 Installation and Calibration Be sure to read the IFU included with the Columns Hemoglobin A1c Calibrator Set Hemoglobin A1c Control Elution Buffers and HSi Hemolysis amp Wash Solution as well as the Tosoh Automated Glycohemoglobin Analyzers HLC 723G7 HLC 723G8 Operator s Manual Installation of HSi Hemolysis amp Wash Solution 1 Press the STOP key on the system operation panel to enable the STAND BY state 2 Remove the cap from the bottle and place it in the designation location 3 Make sure to insert the suction tube in the HSi Hemolysis amp Wash Solution and tighten on the cap 4 Perform priming of the HSi Hemolysis amp Wash Solution line as necessary 9 Assay Procedures Refer to the Automated Glycohemoglobin Analyzer HLC 723G7 Tosoh Automated Glycohemoglobin Analyzer HLC 723G8 Operator s Manual for detailed instructions 10 Precautions for Use 1 The HSi Hemolysis amp Wash Solution is designed exclusively for use in combination with the analyzers elution buffers and columns listed below never in any other combination Analyzer Automated Glycohemoglobin Analyzer HLC 723G7 T
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