Instructions for Use - IVD Matrix HCCA-portioned
Contents
1. 6 Solubilization of IVD HCCA Chemicals and materials required e Standard solvent acetonitrile 50 water 47 5 and trifluoroacetic acid 2 5 from Sigma Aldrich 19182 which has been tested by Bruker Daltonik GmbH and is recommended for solubilization of IVD HCCA e MALDI target plate of the type selected for your workflow Equipment and tools required Vortex mixer pipettes pipette tips Solubilization procedure The procedure for solubilization of IVD HCCA depends on the type of MALDI target plate to be used For BigAnchor targets 1 Add 500 uL standard solvent to the screw cap tube containing IVD HCCA final concentration 5 mg IVD HCCA mL and close the tube 2 Shake the screw cap tube and use a vortex mixer to completely dissolve IVD HCCA at room temperature Finally shake the contents down For all other targets approved for your workflow 1 Add 250 uL standard solvent to the screw cap tube containing IVD HCCA final concentration 10 mg IVD HCCA mL and close the tube 2 Shake the screw cap tube and use a vortex mixer to completely dissolve IVD HCCA at room temperature Finally shake the contents down Revision 1 IVD Matrix HCCA portioned Instructions for Use Page 5 of 7 Bruker 7 Sample preparation using IVD HCCA The procedures below can be used for the classification and identification of microorganisms through MALDI TOF MS Direct Transfer sample preparation method 1 Transfer biologica2. Standard onto a MALDI target plate position 2 Allow the sample spot to dry at room temperature 3 Overlay the sample spot with 1 uL IVD HCCA solution Note Make sure that the screw cap tube containing IVD HCCA is tightly closed after use to minimize solvent evaporation 4 Allow the matrix overlaid sample spot to dry at room temperature A homogenous preparation should be observed 5 Perform MALDI TOF MS measurement Page 6 of 7 IVD Matrix HCCA portioned Instructions for Use Revision 1 Bruker 8 Manufacturer Bruker Daltonik GmbH Fahrenheitstrasse 4 28359 Bremen Germany Support E mail biotyper support bdal de Phone 49 421 2205 1401 Fax 49 421 2205 106 Sales Information E mail care bdal de Phone 49 421 2205 1402 Web www bruker com care Your local Bruker representative Bruker Pty Ltd 1 28a Albert Street Preston Victoria 3072 Australia Support hardware and software Phone 1800 171 247 Email service_aus_ nz bruker com Sales Phone 1800 278 537 Fax 03 9474 7070 Email sales aus nz bruker com 8290200 or 290200 Descriptions and specifications supersede all previous information and are subject to change without notice Copyright 2014 Bruker Daltonik GmbH Revision 1 IVD Matrix HCCA portioned Instructions for Use Page 7 of 7
3. high throughput method for the classification and identification of microorganisms 1H315 Causes skin irritation P264 Wash hands thoroughly after handling P280 Wear protective gloves protective clothing eye protection face protection P302 P352 IF ON SKIN Wash with soap and water P321 Specific treatment see First aid measures in the MSDS P332 P313 If skin irritation occurs Get medical advice attention P362 P364 Take off contaminated clothing and wash it before reuse H319 Causes serious eye irritation P264 Wash hands thoroughly after handling P280 Wear protective gloves protective clothing eye protection face protection P305 P351 P338 IF IN EYES Rinse cautiously with water for several minutes Remove contact lenses if present and easy to do continue rinsing P337 P313 If eye irritation persists get medical advice attention H335 May cause respiratory irritation P261 Avoid breathing dust fume gas mist vapors spray P271 Use only outdoors or in a well ventilated area P304 P340 IF INHALED Remove victim to fresh air and keep at rest in a position comfortable for breathing P312 Call a POISON CENTER or doctor physician if you feel unwell P403 P233 Store in a well ventilated place Keep container tightly closed P405 Store locked up P501 Dispose of contents container in accordance with local regional national international regulations Page 4 of 7 IVD Matrix HCCA portioned Instructions for Use Revision 1 Bruker
4. age following the guidelines outlined in the Material Safety Data Sheet for the product and contact Bruker Daltonik GmbH Service Department biotyper support bdal de for a replacement 3 2 Storage on arrival 8 C IVD HCCA is shipped at ambient temperature The expiry date on the package is valid for the product when stored in a refrigerator at 2 C to 8 C on arrival 3 3 Storage after solubilization 25 C Dissolved IVD HCCA is stable at controlled room temperature 20 25 C for up to one week Revision 1 IVD Matrix HCCA portioned Instructions for Use Page 3 of 7 Bruker 4 Risk and safety information IVD Matrix HCCA portioned is classified as a hazardous chemical WARNING H315 H319 H335 For more information read the Material Safety Data Sheet available for download at www bruker com care Additional chemicals may be required for procedures described in these Instructions for Use Carefully read the Material Safety Data Sheet provided by the supplier and follow general safety regulations when handling chemicals or biohnazardous material 5 Field of application IVD Matrix HCCA portioned enables easy and convenient preparation of HCCA matrix solutions The matrix is soluble in standard solvent see section 6 is easy to handle and enables highly sensitive MALDI TOF MS measurement of peptides and proteins from 0 7 to 20 kDa MALDI TOF MS using HCCA as a matrix has been shown to be a reliable
5. ee ee cece ceeeeeeeseeeeees 5 7 Sample preparation using IVD HCCA ooa a aaa aaa aaa aaao ccc cece eee cee eee ceeceeeeeeees 6 8 Manufacturer _ 2 2 0 2 0 eee eee eee bee eee eee nec e eee e eee ee seen eeeeeees T 1 Intended use IVD Matrix HCCA portioned is an in vitro diagnostic product which is intended to be used for MALDI TOF MS after solvent addition 2 Product description IVD Matrix HCCA portioned referred to as IVD HCCA HCCA a Cyano 4 hydroxycinnamic acid enables easy and convenient preparation of MALDI matrix solution for MALDI TOF MS measurement of peptides and proteins Each tube contains 2 5 0 3 mg matrix enabling fast preparation of the desired concentration simply by adding the relevant volume of solvent Synonyms 2 Cyano 3 4 hydroxyphenyl acrylic acid Molecular formula C H NO Structural formula HO Molecular weight 189 17 g mol CAS number 28166 41 8 EC number 248 879 1 Melting point 245 250 C Content 2 5 mg IVD HCCA tube This kit is an in vitro diagnostic device Page 2 of 7 IVD Matrix HCCA portioned Instructions for Use Revision 1 Bruker Ordering information Product Part Number IVD Matrix HCCA portioned 10 tubes 8290200 or 290200 3 Inspection storage and stability 3 1 Inspection on arrival Check the IVD HCCA package on arrival If it is damaged check the tubes If the tubes are damaged the IVD HCCA must not be used Dispose of the IVD HCCA tubes and pack
6. l material for example a single bacterial colony as a thin film directly onto a MALDI target plate position 2 Overlay the sample spot with 1 uL IVD HCCA solution Note Make sure that the screw cap tube containing IVD HCCA is tightly closed after use to minimize solvent evaporation 3 Allow the matrix overlaid sample spot to dry at room temperature A homogeneous preparation should be observed 4 Perform MALDI TOF MS measurement extended Direct Transfer sample preparation method Note The extended Direct Transfer method is not included in the VD MALDI Biotyper User Manual but has been fully validated for use in IVD MALDI Biotyper workflows 1 Transfer biological material for example a single bacterial colony as a thin film directly onto a MALDI target plate position 2 Overlay the sample spot with 1 uL 70 formic acid and allow to dry at room temperature 3 Overlay the sample spot with 1 uL IVD HCCA solution Note Make sure that the screw cap tube containing IVD HCCA is tightly closed after use to minimize solvent evaporation 4 Allow the matrix overlaid sample spot to dry at room temperature A homogeneous preparation should be observed 5 Perform MALDI TOF MS measurement Extraction sample preparation method IVD Bacterial Test Standard or Bruker Bacterial Test Standard solution sample preparation 1 Deposit 1 uL of extract from biological material or 1 uL IVD Bacterial Test Standard or 1 uL Bruker Bacterial Test
7. we wre CATC of our customers BRUKER Instructions for Use IVD Matrix HCCA portioned Purified matrix substance for matrix assisted laser desorption and ionization time of flight mass spectrometry MALDI TOF MS CARE products are designed to support our worldwide customers with high quality consumables accessories and dedicated kits The CARE product range is specifically optimized and certified for use with all Bruker Daltonics systems www bruker com care Language en AU Revision 1 September 2014 Bruker 1 Intended SS sors ee ee et oe eS ne eee cose eee eeateeaee 2 Product description 2 00000000000000 0000000000000000 a000 a 00000A D DLLD DDALL a2 anora 2 Inspection storage and stability 0 0000000000000000000000000000000000000000000 eee cece oro eeeceeeseenees 3 3 1 Inspection on arrival 2 22 0 aaan aoaaa oaaao aaa aa eee eee cee cece cece eee ec eee ee cee eeceeeeeseeeeseeseeseesees 3 3 2 Storage on arrival 2 lec c ccc ccc ccc ccc cece e cece cee ceeceeceeccceceeceeceeccucceeceeceeceeseeeees 3 3 3 Storage after solubilization 0222 2 cence nce c ee eee cece cece cece cece eeeeeeeseeeeeeees 3 4 Risk and safety information 2 0 00a00000a0000000000000 0000000000000000 0000o o anoano noanoa aonan oann aonann 4 5 Field of application __ 22 2 2 oie ee eee eee eee eee cece eee eee eeeseeceeeeseeseesees 4 6 Solubilization of IVD HCCA ooo oie cc cece cece cece e
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