Reagents for ABX analyzers

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1 TM Reagents for ABX analyzers ABX Pentra * 60, 60C, 60C *, 80 twbc + 5 part differential analysis Application Description Product Nr.. Pack size Diluent Diluid APR PC 20 L Lysing reagent CyMet APR CN Free PE 500 ml Lysing reagent for Eosinophils CyMet APR EO PE 1 L Lysing reagent for Basophils CyMet APR Baso II PE 1 L Cleaning, on line Detectoterge L Emergency Cleaning ProClean Plus ml Hypochlorite 0.5% L L Polycube Hematology Control 8 Parameter Control L/N/H 3427/3428/ ml ABX Micros 45 and Micros 60, 18 parameters twbc + 3 part differential analysis 3463/3464/ ml, pierceable 3701/3702/ ml Application Description Product Nr. Pack size Diluent Diluid III Diff L L Lysing reagent CyMet Micro ml L CyMet Micro CN Free L micros bottle Cleaning ProClean Extra L micros bottle Emergency Cleaning ProClean Plus ml Hypochlorite 0.5% L L Polycube Hematology Control 8 Parameter Control L/N/H 3427/3428/ ml 3463/3464/ ml, pierceable 3701/3702/ ml Hematology Control 3 Diff Control L/N/H 3433/3434/ ml 3820/3821/ ml Diluid, CyMet and ProClean are all trademarks of Avantor Performance Materials Inc. ABX, ABX Micros and ABX Pentra are trademarks of HORIBA. * For barcode procedures see page

2 Cross list: ABX reagents vs. J.T.Baker ABX ABX Nr. J.T.Baker J.T.Baker Nr. Pentra 60, 80 ABX Eosinofix, 1L CyMet APR EO 3478 ABX Diluent, 20L Diluid APR 3476 ABX Cleaner, 1L Detectoterge 3766 ABX Basolyse II, 1L CyMet APR Baso II 3479 ABX Alphalyse, 0.4L (contains CN) CyMet APR CN free 3417 ABX Lysebio, 0.4L, CN Free CyMet APR CN free 3417 Micros 60 ABX MiniClean 1L ProClean Extra 3867 Pack Micros LMG, 3360 ml diluent, 320 ml Lyse, 520 ml cleaner Diluid III Diff, CyMet Micro or CyMet Micro CN Free, ProClean Extra 3963, 3857 or 3852, 3867 ABX Minilyse, 1L ABX Minilyse LMG, 1L CyMet Micro or CyMet Micro CN Free 3857 or 3852 ABX Lysebio, 1L CyMet Micro CN Free 3852 ABX Minidil, 10L Diluid Azide Free 3958 ABX Minidil LMG, 10L Diluid III Diff 3963 Consumption of Reagents for ABX Counters Type Reagents Consumption per test Micros Diluid III Diff 22 ml CyMet Micro or CyMet Micro CN Free 0.56 ml ProClean 1 ml Pentra 60 reagent consumption Cycle Diluid APR CyMet APR Baso II ProClean Extra CyMet APR EO CBC 20,5 2,1 0,9 x 0,4 DIFF 25,6 2,1 0,9 1 0,4 Startup * 62 2,1 3,7 1 1,4 Shutdown 25,5 X 14 x 1 Prime Diluid APR 35,5 X X x X Prime ProClean Extra X X 25,8 x X Prime CyMet APR EO X X X 25,8 X Prime CyMet APR Baso II X 25,8 X x X Prime CyMet APR CN Free 2,5 X X x 4,2 Prime all Reagents 23, ,2 Autoclean cycle 12,5 X 6 x X Autocontrol cycle 24 X 1,4 x 1 CyMet APR CN Free TM 23 introduction MDC hycell hti hospitex erma drew diatron Benesphera beckman coulter bayer avl abx abbott

TM ABX Pentra 60: Optimizing performance JT Baker Reagents After several months of evaluation of our newly introduced reagents for the ABX Pentra 60 and 80 analyzers we like to share our findings

3 TM ABX Pentra 60: Optimizing performance JT Baker Reagents After several months of evaluation of our newly introduced reagents for the ABX Pentra 60 and 80 analyzers we like to share our findings with our distributors and customers. During this evaluation we focused on several technical observations, installation issues and reagents performance improvements. For ABX analyzers it is very important that the instrument maintenance is performed according the maintenance schedule mentioned in the service manual. Regular maintenance guarantees a good functionality of the analyzer, can avoid any problems during installation of our reagents and will prolong good instrument performance. CyMet APR EO: Stability and Black Dye In general it is advised to replace Diluids, CyMets and Cleaners three months after connecting to the analyzer. Our product CyMet APR EO ( PE) is an exception on this rule because of product characteristics and ingredients. CyMet APR EO contains an alcohol that vaporizes during use, resulting in an open bottle stability of 1 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. This dye does not affect any parts in the instrument. Also remarks were made about the possibility that contamination and colorization of the WBC Flow cell could occur. Due to the special hydrodynamic focusing technique in the ABX Pentra, Cymet APR EO is surrounded by Diluid APR in the Flowcell, which excludes any coloring of the Flowcell walls. CyMet APR Baso II: L1 flagging White Blood Cells and Basophils are measured in the same channel by means of the well-known impedance technique. Differentiation between Baso s and other leukocytes is obtained by means of CyMet APR Baso II. 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 print out of result). We have observed that the adjustment of the optimal positioning of the Leukocyte peek differs per instrument. Shift of the Leukocyte peak to the left, results in negative L1 flagging, causing NRBC / Platelet Aggregates alarms. Shift to the right of the Leukocyte peak, results in a higher Baso count. Print out of result When too many L1 flags are observed, optimization has to be done. To optimize the positioning of the Leukocyte peak, an electrical setting has to be changed on the Main Board. To access the main board, the left cover has to be removed from the instrument. The adjustment is made with the aid of a R134 potentiometer. Turning clockwise will shift the peak to the right and counterclockwise will shift the peak to the left. It is important to use fresh blood for this optimization (don t use blood samples older than 8 hours!). For location of R134 potentiometer on the main board see next photo. The original settings should be recorded before doing this adjustment! Mainboard CyMet APR EO: Positioning 4-part differential. The optimal positioning of the 4-part differential (LMNE Matrix) depends on several hardware settings that can only be adjusted by experienced users. During installation of JT Baker reagents we depend on the factorial settings and alignments of the instrument. For example the alignment of the Flow cell and the correct adjustment of potmeter R148 are critical for the correct Absorbance channel, but these are adjustments done by fully trained technical persons. See procedure in the Service Manual. JT Baker s CyMet APR EO is developed in a way that the positioning of the 4-part differential is almost equal compared to the original ABX reagents. The only difference we introduced is a small shift to the right of the Neutrophil and Monocyte clusters. The reason for this was to avoid too much negative ALY (Atypical Lymphocyte) flags. We have observed that the positioning (left to right) of the LMNE-matrix differs per instrument. For example: If the whole 4-part differential is shifted to the right, Neutrophils are counted as Monocytes and false Atypical Lymphocyte flags are shown. Satisfying 4-part differentials are obtained if the Neutrophil cluster is close to the Neutrophil/Monocyte separation in the LMNE Matrix (see print out of result). To optimize the positioning of this 4-part differential, an electrical setting has to be changed on the Main Board. The adjustment is made with the aid of a R136 potentiometer. Turning clockwise will shift all different WBC-clusters of the 4-part diff to the right and counterclockwise will shift the clusters to the left. For location of R136 potentiometer see the photo of the Main board. The original settings should be recorded before doing this adjustment! 24

TM introduction ABX Pentra 80 Barcode procedure: If new reagent bottles are connected to the analyzer the instrument requires to update reagent specifications: lot number and expiry date. J.T.Baker reagents for Pentra 80 do not have a barcode on the label so the barcode reader cannot be used.

4 TM introduction ABX Pentra 80 Barcode procedure: If new reagent bottles are connected to the analyzer the instrument requires to update reagent specifications: lot number and expiry date. J.T.Baker reagents for Pentra 80 do not have a barcode on the label so the barcode reader cannot be used. But it is easy to enter in the information manually. Following the reagent replacement procedure the screen below will show. 1. Type in the field Lot Nb the first 5 digits of the J.T.Baker lot number 2. Change the LEVEL in ml if necessary 3. Type in the expiration date 4. Press VALIDATE button to save the changes The reagent will be primed automatically by the system. ABX Pentra 60C, 60C + Barcode procedure: This procedure explains how to change manually reagents on the ABX Pentra 60C instruments. J.T. Baker reagents for ABX Pentra 60 do not have a barcode on the label. 1. Switch the computer on 2. In the Analyzer screen all reagents bottles are shown. Double click on the reagent you want to change. The reagent replacement screen appears. 3. In the Lot Number box, you have to replace the first two digits for a higher number (E.g. if the lotnumber in the box is I1 and you enter I1*, the Expiration Date will be The first two digits of each reagent correspond to the expiry year + one year. 4. This procedure can be done for all reagents. * If you accidently delete the whole lotnumber it is very important to enter the proper identification numbers in relation to the correct reagent. For Isoton (Diluid APR) please use H1 For Cleaner (Detectoterge) use I1 For Basolyse (CyMet APR Baso II) use I2 For Alphalyse (CyMet APR CN Free) use Y2 For Eosinofix (CyMet APR EO) use G1 25 MDC hycell hti hospitex erma drew diatron Benesphera beckman coulter bayer avl abx abbott

TM Priming and Calibration of ABX Analyzers ABX Pentra 60 Priming of ABX Pentra 60 1. Take the aspirating tubes from the ABX reagent cubitainers and bottles.

5 TM Priming and Calibration of ABX Analyzers ABX Pentra 60 Priming of ABX Pentra Take the aspirating tubes from the ABX reagent cubitainers and bottles. Don t lay the tubes on tissues or dusty surfaces. Place them in clean beakers. 2. It is important to rinse the outside surface of the aspirating tubes with distilled or de-ionised water to avoid any kind of reagent contamination. 3 For priming all reagents: press the <ESC> key to enter the main menu. Select option <3. Reagents> from the main menu. Then select option <3. Prime>. Then select option <6. All reagents>. Priming of all reagents is started. At first air is aspirated between ABX (Roche) and Avantor Performance Materials reagents. 4. Connect Avantor Diluid APR, Proclean Extra, CyMet APR BasoII, CyMet APR CN Free and CyMet APR EO to the corresponding aspiration tubes of the reagents. Note 1: Place the 500ml CyMet APR CN Free bottle at the left side in the reagent compartment (see picture). Otherwise the front door can t be closed. 5. After connection all installed reagents have to be updated. From the main menu select option <3. Reagents>. Then select <1. Level/Change> and use the h and i keys to display the <Change> key in reverse control. Or there is an option to change the coefficients directly when they are known. The Autocalibration is explained here. Please refer to the Operator Manual Chapter 3, Paragraph 5 for more detailed calibration information. 1. Press from the main menu <2.Calibration>. 2. Press <1. Autocalibration>. 3. Change the operator ID, lotnumber or expiration date if necessary. 4. Move to the <Target> field if the values have to be changed. If not press <ESC> directly. 5. Enter the new WBC target value if required and press <Enter>. The menu turns to the RBC target value. Repeat the same procedure for RBC, HGB, HCT and PLT. When the last value has been modified press <ESC>: the calibration result chart is displayed. 6. Run the blood control or calibrator at least 5 times. 7. The dot in the small square in front of the result indicates if a result is used in the statistical calculation. 8. Press <ESC> if all results are acceptable. If one of the results is given out, but in your opinion the result is satisfactory, move the cursor to the result line and press <. > to obtain a single square. In this way results can be included/excluded from the statistical calculation. 9. Press <Enter> to save the new coefficients or <Esc> to quit the calibration. 10. Press <Enter> to print the new coefficients. 11. The calibration is completed and press enter to quit the calibration chart table. video for the reagent you want to update. At first reagent installation perform this procedure for all 5 reagents. The reagent levels will be updated to 100%. 12. Run a blood control in the normal measurement mode to verify calibration. 6. Repeat step 3 two times, now with the reagents connected, to prime the Avantor reagents into the system. 7. Perform a START-UP by pressing the key <Start Up> to ensure correct operation. Note: When changing from Cyanide to Cyanide free reagents a recalibration for the Hb is required Calibration of ABX Pentra 60 On the Pentra 60 two calibration modes are available. You can perform an auto-calibration using a calibrator or blood 26

6 TM introduction ABX Pentra 60 Cleaning procedure: Some of our distributors have noticed higher WBC backgrounds on ABX Pentra 60 instruments when switching from original ABX reagents to JT Baker reagents. ABX reagents can introduce a so-called film/coating inside the tubing and counting chambers. This is flushed away when reagents from other sources are installed on the instrument. Please use next cleaning protocol in case of high WBC backgrounds. 1. Prepare a solution of 250ml hypochlorite 0.5% (3917) and 250ml distilled water. 2. Remove the tubing from the Basolyse and place the tubing in the prepared solution of hypochlorite. 3. Prime 3 times this solution: MAIN MENU, 3. REAGENTS, 3. PRIME and choose the Basolyse. 4. Leave it in for 30 minutes. 5. Remove the tubing from the hypochlorite solution and place it in a beaker with distilled water. 6. Prime again 3 times and connect the bottle of Basolyse. 7. Prime 3 times, perform a startup and background checks to ensure correct operation of the instrument. Repeat if necessary. ABX Pentra 60 and 80, WBC startup and background failures For many years we produce reagents for the 5-part differential Pentra instruments from ABX. Feedback from some of our distributors show that sometimes distributors run into problems installing JT Baker s reagents on the above instruments. Especially when they switch from other manufacturer s reagents to JT Baker s reagents, they observe high WBC Background counts after installation, priming and startups. Take notice that this problem will not occur on all Pentra 60 and 80 instruments in the field. Please note that as of June 2010 the cleaner advised in the Sales Manual Hematology Products has changed for this instrument line, from Proclean Extra ( PE) to Detectoterge (3766). The reason for this increase in WBC Background is the result of a chemical process in the WBC/Baso Counting Chamber. Due to long use of reagents of other manufacturers a small layer (film) of coating can be introduced in the flow circuit of above instruments and especially in the WBC/Baso counting chamber. After connection of our reagents and performing the priming protocol, as described in our Distributor s Catalogue Hematology, this layer slowly dissolves, resulting in an increased background of the WBC s during the startup procedure. Next procedure explains how you can solve this high WBC Background problem: 1. Prepare a beaker with 500ml Detectoterge (3763 or 3766). 2. Disconnect all reagent inlets from the reagent bottles and Diluid cubitainer. 3 Place them in an empty beaker. 4. Perform two times the Prime All reagents function from the reagent menu (with air). 5. Place all inlets in the beaker filled with Detectoterge. 6. Perform two times the Prime All reagents function from the reagent menu. 7. Wait for 2 hours (it is recommended to leave it in a longer period or overnight). 8. Remove all inlets from the Detectoterge beaker. 9. Prepare a beaker with 500ml distilled water. 10. Perform two times the Prime All reagents function from the reagent menu. 11. Remove all inlets from the distilled water to prime the instrument with air. 12. Perform two times the Prime All reagents function from the reagent menu. 13. Reconnect all reagents lines to their corresponding reagent bottles. 14. Perform two times the Prime All reagents function from the reagent menu. 15. Run startup procedures counts until background counts for WBC, RBC, HGB and PLT are acceptable. Monitor the WBC-background. If you have any questions or problems with the above procedure please contact your distributor or Avantor Performance Materials. 27 MDC hycell hti hospitex erma drew diatron Benesphera beckman coulter bayer avl abx abbott

7 TM ABX Micros Priming of ABX Micros Counter 1. Take the aspirating tubes from the HORIBA ABX SAS reagent cubitainers. Don t lay the tubes on tissues or dusty surfaces. Place them in clean beakers. 2. It is important to rinse the outside surface of the aspirating tubes with distilled or de-ionised water to avoid any kind of reagent contamination. 3 For priming all reagents: press the h or i to select option <4. SERVICE> from the main menu. Press <ENTER> to confirm. Then select option <3. PRIME> and press <ENTER>. Then choose option <1. ALL REAGENTS> from the menu and confirm with the <ENTER> key. Priming of all reagents is started. At first some air is aspirated between HORIBA ABX SAS and Avantor Performance Materials reagents. 4. Connect Avantor Diluid III Diff diluent, ProClean cleaning solution and CyMet Micro or CyMet Micro Cyanide free lysing reagent to the correspondng reagents aspiration tubes. 5. Repeat step 3 two times for all reagents. 6. Perform a START-UP by pressing the key <Start Up> to ensure correct operation. Note: When changing from Cyanide to Cyanide free reagents a recalibration for the Hb is required Calibration of ABX Micros 1. Press from the main menu <3> [Calibration]. 2. Press <2> [Coefficients]. 3. Press <1> [Calib Coeff.]. 4. Enter Password, by using numeric keys <1> <2> <3>, followed by <ENTER>. 5. Select the parameter, which needs to be calibrated by using the i key. 6. Enter the new calibration factor by using numeric keys, followed by <ENTER> 7. Select next parameter with the i key. Press finally <ESC> to exit the calibration menu. Press <ESC> a few times to return to the main menu. 28

Reagent pack installation procedure for ABX Micros * Installation of Avantor Performance Materials reagents

For example on the ABX Micros all reagents are included in one single pack.

In case of using such reagent packs it seems to be obvious that always such reagent packs are required to

Actually this is not true, because it s possible to connect separate reagent bottles to the ABX Micros

Switch the power of the instrument off. 2. remove the Micros CT pack.. 3. Remove the side cover.

The injection system is locked at with screws at the front and backside. 4.

The injection system is also locked with screws at the back. 5. Unscrew at the backside at given positions. 6.

The bottom part consists of a plastic block in which the injection needles are connected.

8 Reagent pack installation procedure for ABX Micros * Installation of Avantor Performance Materials reagents on ABX instruments ABX is using a typical injection system for their reagent bottles. For example on the ABX Micros all reagents are included in one single pack. A special bottle in this pack is reserved for waste collection. In case of using such reagent packs it seems to be obvious that always such reagent packs are required to operate the instrument. Actually this is not true, because it s possible to connect separate reagent bottles to the ABX Micros instruments. Next steps should be accomplished to operate single reagent packs. 1. Switch the power of the instrument off. 2. remove the Micros CT pack.. 3. Remove the side cover. It can easily be unscrewed. After removing this side cover the reagent injection system is seen. The injection system is locked at with screws at the front and backside. 4. Open the front door and remove the screws at given positions. The injection system is also locked with screws at the back. 5. Unscrew at the backside at given positions. 6. The top part with the two springs can now be removed. 7. The bottom part consists of a plastic block in which the injection needles are connected. Notice to which injection needle aspiration tubes of reagents are connected. 8. This plastic block should be turned upside down. Label the tubes of the reagents. Disconnect the tubes from the injection needles. When the tubes are pulled of the injection needles, a tube of equal diameter should lengthen them. 9. Finally install Avantor reagents with reference to our special priming and calibration procedures. TM 29 introduction MDC hycell hti hospitex erma drew diatron Benesphera beckman coulter bayer avl abx abbott

9 About Avantor Performance Materials Avantor Performance Materials manufactures and markets high-performance chemistries and materials around the world under several respected brand names, including the J.T.Baker, Macron Fine Chemicals, Rankem, Diagnova, BeneSphera, and POCH brands. Avantor products are used in a wide range of industries. Our biomedical and life science solutions are used in academic, industry and quality control laboratories for research, pharmaceutical production and medical lab testing, while our electronics solutions are used in the manufacturing of semiconductors and flat panel displays. Based in Center Valley, Pennsylvania (USA), Avantor is owned by an affiliate of New Mountain Capital, LLC. For additional information please visit or follow Ordering Information and Assistance Customer Service tel: fax: avantor.emea@avantormaterials.com AskAvantor Our Web site features ASK Avantor, which includes live chat capabilities with customer service representatives. Lit Number: 9052_E_Hematology_Products_Sales_Manual_13vs1_E 2012 Avantor Performance Materials, Inc. All rights reserved. Trademarks are owned by Avantor Performance Materials, Inc. or its affiliates unless otherwise noted. Corporate Headquarters Avantor Performance Materials, Inc Corporate Parkway Suite #200 Center Valley, PA USA Worldwide Locations China Malaysia North America India Mexico Poland Korea The Netherlands Taiwan For contact information at these locations, visit Us/Worldwide-Directory.aspx

Reagents for Diatron analyzers

Reagents for Diatron analyzers Diatron Abacus Junior 5 twbc + 5 part differential analysis Lysing reagent CyMet Abacus CN Free ** 3431.1000 1 L CyMet Abacus EO * 3444.1000PE 1 L not for software version