US IVD HCCA portioned – Instructions for Use
Contents
1. for example CHROMASOLV LC MS solvents The procedures below are used for identification of test organisms using the MALDI Biotyper CA System Direct Transfer sample preparation method 1 Select two positions on a US IVD 48 Spot Target cross joint positions are recommended Inoculate 1 uL of US IVD BTS solution onto each position 2 Smear a thin film of each test organism onto an unoccupied US IVD 48 Spot Target position using a sterile wooden stick Make sure that each sample is from an isolated colony 3 Overlay each sample spot with 1 uL US IVD HCCA solution Note Make sure that the screw cap tube containing US IVD HCCA solution is tightly closed after use to minimize evaporation 4 Allow the matrix overlaid sample spots to dry at room temperature A homogeneous preparation should be observed for each test organism 5 Perform MALDI Biotyper CA identification in accordance with the instructions in the MALDI Biotyper CA System User Manual extended Direct Transfer sample preparation method The extended Direct Transfer method can be used to reanalyze test organisms that deliver a log score of lt 2 0 using the Direct Transfer method 1 Select two positions on a US IVD 48 Spot Target cross joint positions are recommended Inoculate 1 uL of US IVD BTS solution onto each position 2 Smear a thin film of each test organism onto an unoccupied US IVD 48 Spot Target position using a sterile wooden stick Make sure that eac2. 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 8 US IVD HCCA portioned Instructions for Use Revision D Bruker Daltonics Inc 4 Preparation of US IVD HCCA Solution Chemicals and Materials Required e Standard solvent acetonitrile 50 water 47 5 and trifluoroacetic acid 2 5 from Sigma Aldrich which has been tested by Bruker and is recommended for use when dissolving US IVD HCCA Equipment and Tools Required but not Provided e Vortex mixer pipettes pipette tips Preparation of US IVD HCCA solution 1 Add 250 uL standard solvent to the screw cap tube containing US IVD HCCA final concentration 10 mg US IVD HCCA mL and close the tube 2 Shake and vortex until completely dissolved 3 Shake the contents down 4 Store at controlled room temperature for up to 1 week Revision D US IVD HCCA portioned Instructions for Use Page 5 of 8 Bruker Daltonics Inc 5 US IVD HCCA Sample Preparation Procedure Note Poor sample preparation will impact product performance and will result in low resolution and poor reproducibility The generation of ions through MALDI depends on the presence of an optimal ratio of matrix substance to analyte For best results use all materials as directed and use only chemicals recommended for use by Bruker
3. BRUKER Instructions for Use US IVD HCCA portioned Purified matrix substance for use with MALDI Biotyper CA Systems IVD Language US en Revision D July 2015 Bruker Daltonics Inc 1 OAR cot a a ci sn vases ees snes 2 2 Product DESCri peli s sssicsiisissssiinnisnninsnannn puana naasna ainaani niaaa aonadan uana Nansenia aaae KanN iait 2 3 Inspection Storage and Stability ccsseeeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeesaaeeeeeeeeeeeeeeenneees 3 3 1 Inspection upon Receipt sseessnsssrrssrresttertnnttrnsrrssttnsrnntttnntrnsttnnsntnnnnnntnnn ennenen ennenen 3 3 2 Stor ge On Arrival rsecrsiinreke nie ekna E E EEN EEE E EE 3 3 3 Storage after Solubilization eee cece ee eeeee eee e eee e eet anaaeeeee seen eeaaaaaaaaaeeeeeeeeeeenaaaaes 3 3 4 Risk and safety iInOrnNavlOnccisceveriasessseci cocderivacsseecameenete suse dnedeniveaesedemmeemeehaceunens 4 4 Preparation of US IVD HCCA Solution cccctcceeeseeeeeneeeeeeeeeeeneeeeeeeeeeeeeeeesaseeeeeeeeeeeeeeeneees 5 5 US IVD HCCA Sample Preparation Procedure eccccceeeseeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeenneees 6 6 VTA TAGUUR EE a2 ten cissaae ete ce ces aececen cease cen ceceeee cast actectisceencestectantescceanseScatbeboopenssssbhauatecatenarebeans 8 1 Intended Use US IVD HCCA portioned is an in vitro diagnostic product which must be used when processing test organisms for identification on the MALDI Biotyper CA System US IVD HCCA po
4. h sample is from an isolated colony 3 Overlay each sample spot with 1 uL 70 aqueous formic acid solution and allow the sample spot to dry at room temperature 4 Overlay each sample spot with 1 uL US IVD HCCA solution Note Make sure that the screw cap tube containing US IVD HCCA solution is tightly closed after use to minimize evaporation Page 6 of 8 US IVD HCCA portioned Instructions for Use Revision D Bruker Daltonics Inc Allow the matrix overlaid sample spots to dry at room temperature A homogeneous preparation should be observed for each test organism Perform MALDI Biotyper CA identification in accordance with the instructions in the MALDI Biotyper CA User Manual Extraction sample preparation method The Extraction method can be used to reanalyze test organisms that deliver a log score of lt 2 0 using the Direct Transfer method The Extraction method must be used to reanalyze test organisms that deliver a log score of lt 2 0 using the Direct Transfer and extended Direct Transfer methods 1 Select two positions on a US IVD 48 Spot Target cross joint positions are recommended Inoculate 1 uL of US IVD BTS solution onto each position For each test organism pipette 1 uL of test organism extract prepared in accordance with the instructions in the MALDI Biotyper CA System User Manual onto an unoccupied US IVD 48 Spot Target position Allow the sample spots to dry at room temperature Overlay each sample s
5. pot with 1 uL US IVD HCCA solution Note Make sure that the screw cap tube containing US IVD HCCA solution is tightly closed after use to minimize evaporation Allow the matrix overlaid sample spots to dry at room temperature A homogeneous preparation should be observed for each test organism Perform MALDI Biotyper CA identification in accordance with the instructions in the MALDI Biotyper CA System User Manual Revision D US IVD HCCA portioned Instructions for Use Page 7 of 8 Bruker Daltonics Inc 6 Manufacturer Bruker Daltonics Inc 40 Manning Road Manning Park Billerica MA 01821 USA Support E mail ms support us bruker com Phone 1 877 410 2211 access code 724 Fax 1 978 667 5993 Internet www bruker com Sales Information E mail ms sales bdal bruker com Phone 1 978 663 3660 Web www bruker com care Hours Monday Friday 5 am 12 midnight EST Weekends Holidays 9 am 9 pm EST For consumables orders PO questions and Service Contract quotes please call 1 877 442 2231 during business hours Ordering Information Product Part Number US IVD HCCA portioned 604531 604531 Descriptions and specifications supersede all previous information and are subject to change without notice Copyright 2015 Bruker Daltonics Inc Page 8 of 8 US IVD HCCA portioned Instructions for Use Revision D
6. rdous 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 biohazardous material H315 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 ftume 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 Calla POISON CENTER or doctor
7. rtioned must be dissolved in accordance with the instructions provided using the recommended solvent Caution Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner 2 Product Description US IVD HCCA portioned referred to as US IVD HCCA HCCA a Cyano 4 hydroxycinnamic acid enables easy and convenient preparation of MALDI matrix solution for MALDI Biotyper CA measurement and identification of test organisms US IVD HCCA is soluble in standard solvent see section 4 Each tube contains 2 5 0 3 mg matrix enabling fast preparation of the desired concentration simply by adding the recommended volume of standard solvent Page 2 of 8 US IVD HCCA portioned Instructions for Use Revision D Bruker Daltonics Inc 3 Inspection Storage and Stability 3 1 Inspection upon Receipt Check the US IVD HCCA package upon receipt If the tubes are damaged do not use 3 2 Storage on Arrival 8 C US IVD HCCA is shipped at ambient temperature but must be stored at 2 8 C Do not use beyond expiration date noted on the package 2 C 3 3 Storage after Solubilization 25 C Dissolved US IVD HCCA solution is stable at controlled room temperature 20 25 C for up to one week 20 C Revision D US IVD HCCA portioned Instructions for Use Page 3 of 8 Bruker Daltonics Inc 3 4 Risk and safety information US IVD HCCA is classified as a haza
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