BD MicroProbe™ Processor Instrument User`s Manual
Contents
1. 2 2 2 3 2 Setting Up the 2 5 2 3 3 Installing the 2 6 2 3 4 Installing the Program 2 7 2 4 Powering On and Off the Instrument 2 8 2 41 POWER OM eee nes 2 8 2 4 2 Power 2 9 2 4 3 Shut down Procedure Preparation for Storage or Shipping 3550 0 2 0 2 tote fed ess 2 9 2 5 Repacking the 2 10 iv MA0106 D Preface Operation 3 1 lt 3 1 3 2 Processor Components and Functions 3 1 3 2 1 Processor Base 3 1 3 2 2 Robotic Arm and 3 1 3 2 8 Cassette 3 2 3 2 4 Program 3 2 3 2 5 Program Card 3 2 3 2 5 User Control 3 3 3 3 User Control Panel Functions 3 3 3 3 1 Keys i oci sands 3 3 3 3 2 RUN Key ass ete eee eei ili liie 3 3 3 3 3 HELP 3 3 3 342. 2 5 2 3 Installing the Transformer 2 6 2 4 Installing the Program 2 8 2 5 Power On and Standby 2 9 3 1 User Control Panel Controls and Indicators 3 4 3 2 Cassette 3 7 Bibliography Disinfecting Agents recommended in CLSI document M29 A3 2005 Approved Guideline Protection of Laboratory Workers from Occupationally Acquired Infections vi MA0106 D Introduction 1 4 General This section provides introductory information on the BD MicroProbe Processor The following major topics are included Intended Use of the Processor Section 1 2 Description and Principles of Operation Section 1 3 System Section 1 4 Use of this Section 1 5 Notes Cautions and Warnings Section 1 6 Summary of Cautions and Warnings Section 1 7 1 2 Intended Use of the Processor The BD MicroProbe Processor is used in the Automated Processing portion of the Affirm Microbial Identification Test procedure The BD MicroProbe Processor is required for ALL Affirm tests and together they work as a SYSTEM This User s Manual describes the installation and operation of the Processor only Refer to your Affirm Test kit package
3. WARNING THE POWER PLUG ON THE TRANSFORMER MUST BE CONNECTED TO A GROUNDED POWER SOURCE DO NOT USE AN ADAPTER TO CONNECT THE POWER PLUG TO AN OUTLET FOR WHICH IT IS NOT DESIGNED DO NOT UNDER ANY CIRCUMSTANCES OPERATE THE SYSTEM UNTIL AN ELECTRICAL GROUND IS PROVIDED AND THE POWER CORD IS PROPERLY CONNECTED TO GROUND Insert the transformer pin connector into the keyed port on the back of the processor aligning the notch on the connector to the key at the top of the port Then insert the end of the power cord into an outlet of appropriate voltage Transformer pin in keyed Transformer Figure 2 3 Installing the Transformer Rear View of the Processor 2 6 MA0106 D Installation Installing the Program Card CAUTION Position the instrument in a place where the program card port on the front of the instrument is protected from dirt or liquids If spillage occurs contact your Technical Services representative before using the processor or installing the program card CAUTION Handle the program cards carefully to prevent damage Store the card in the plastic case when not installed in the instrument The program card contains the specific processor operating software for a particular Affirm test Confirm that the description on the card matches that on the Affirm test kit package insert 1 Make sure the system is set to STANDBY the green LED is NOT lit If ON pres
4. mode when the operator is ready to continue The blinking double arrow gt gt on the display always prompts the operator to press RUN to continue 3 3 3 HELP Key Pressing the blue HELP key causes the system to display more information about the prompt on the display HELP is available to the operator any time before the start of automated processing To exit the HELP mode simply press RUN to continue 0106 3 3 BD MicroProbe Processor Instrument User s Manual 3 3 4 Power Indicator The green light LED next to the ON STANDBY key is illuminated when the BD MicroProbe Processor is powered up and ON the transformer is connected to processor unit and plugged into the power supply the ON STANDBY key has been pressed to the ON position The green LED is not lighted when the system is set to STANDBY 3 3 5 Display The lighted display prompts the operator during test setup and provides test status messages during operation Displaying up to 20 characters at a time the vacuum fluorescent display will wrap around and repeat messages until the operator presses the RUN key or presses the HELP key The display is only lighted or active when the system is ON and a program card is installed RUN Key HELP Key Green Blue Figure 3 1 User Control Panel Controls and Indicators 3 4 User Prompts and Responses The BD MicroProbe Processor is designed to be easy to use by both new and exper
5. be easily moved on and off the processor Care should be taken not to bump the caddy when it is being installed with open cassettes and samples to avoid splash over between wells When replacing the caddy onto the processor be sure that it is securely positioned on all four locator pins 3 5 2 Positioning the Cassettes for Processing When less than six samples are processed position the reagent cassettes closest to the center first and then distribute evenly on each side moving from the center outward The PAC arms on the processor will move each 3 6 0106 Operation PAC into the proper position when it is picked up As a double check observe the PACs at the start of processing to make sure they are parallel with the cassette wells and at even height along the bottom 7 WELL 7 1 WELL 1 Figure 3 2 Cassette Positions 3 5 3 Cassette Positions Although the PACs should not be manipulated during operation small adjustments can be made if done very carefully If one or more PACs are significantly out of position at the start of a run you may stop the run and restart as follows support the arm while setting the power to STANDBY Release the PACs into well 1 and lift the robotic arm to remove the caddy from the processor Check that nothing has fallen into any of the wells in the reagent cassettes Turn the power ON wait for the arm to home and begin the run again 3 5 4 Turning the Processor Off
6. cover when not in use will prevent exposure to dirt and spills 4 4 Disinfection Decontamination 4 4 1 BD MicroProbe Processor Base Unit 1 Set the unit to STANDBY and disconnect the power Immediately remove the spilled material by wiping with a soft absorbent cloth or paper and dispose in a biohazard container 2 Wipe down all contaminated surfaces with a germicidal detergent and wipe with a moist cloth to remove all organic material Germicidal detergents are listed in CLSI M29 A3 2005 Approved Guideline Protection of Laboratory Workers from Occupationally Acquired Infections 3 Wipe all surfaces with a 10 96 bleach solution and allow to air dry CAUTION Make certain the 10 bleach solution does not come into contact with the program card If you suspect any liquid material has spilled onto the program card or into the program card port contact BD Technical Services or an authorized distributor for assistance Do NOT use the system if such a spill is suspected 0106 4 3 BD MicroProbe Processor Instrument User s Manual 4 After the disinfection time is complete wipe the processor thoroughly with a moist cloth to remove the residual disinfectant 5 Finally wipe the surfaces with 7096 isopropyl alcohol and allow to air dry NOTE This procedure must be followed prior to shipping the unit back to BD for repair 4 4 2 Cassette Caddy The cassette caddy may be disinfected
7. 106 Limited Warranty This warranty gives you specific legal rights Additionally you may have other rights that vary from state to state and country to country The BD MicroProbe Processor is warranted to be free of defects in material and workmanship Full responsibility is assumed by the manufacturer for servicing any instrument or its components which under normal operating conditions prove to be defective within one year of delivery BD will furnish new or remanufactured components upon its option All replacements shall meet new part specifications Defective components become the property of BD It is understood that the equipment covered by this agreement has been installed in accordance with the recommendations and instructions in the BD MicroProbe Processor User s Manual Any damage to the BD MicroProbe Processor resulting from the negligence of the owner or operator to maintain reasonable care and precautions in the operation and maintenance of the system will void this warranty and terminate the obligations of the manufacturer as stated herein MA0106 D A 1 BD MicroProbe Processor Instrument User s Manual This warranty is in lieu of all other warranties whether express or implied including but not limited to warranties of merchantability or fitness for a particular use In no event will BD be liable for indirect or consequential damages Service The BD MicroProbe Processor is not designed to be r
8. 37 1200 Fax 52 5 237 1287 Akasaka D S Bldg 5 26 Akasaka 8 chome Minato ku Tokyo 107 Japan Tel 81 3 54138181 Fax 81 3 5418144 MA0106 D BD MicroProbe Processor Instrument User s Manual C 2 0106 BD Instrument User s Manual For use with BD Affirm VPIII Microbial Identification Test Printing Specifications DO NOT PRINT THIS PAGE As per Vendor Specification 50208 Internal Pages Paper 5016 White Offset 5 2 x 8 72 Black ink both sides Front and Back Cover Paper 1001 White Card Stock 5 77 x 8 75 Outside surfaces to be dull coated Artwork Front Cover use artwork on Section 10 page 1 Back Cover blank Binding GBC Punch Comb 3 8 White
9. All maintenance and repair other than the procedures described in Section 4 Maintenance must be performed by BD qualified service personnel 1 6 MA0106 D Introduction e Always set the Processor to STANDBY and disconnect the power supply before performing cleaning disinfection or maintenance procedures e Do not use organic solvents such as acetone or petroleum based products to clean the painted plastic instrument case Do not use bleach on or near metal components Do not store reagents on the instrument Wipe all reagent spills immediately e Do not immerse the BD MicroProbe Processor or power transformer in liquid e certain the 10 percent bleach solution does not come into contact with the program card MA0106 D 1 7 BD MicroProbe Processor Instrument User s Manual 1 8 MA0106 D Installation 2 1 General This section provides specifications for installation and setup of the BD MicroProbe Processor The following major topics are included Instrument Specifications Section 2 2 Instrument Installation Section 2 3 Powering On and Off the Instrument Section 2 4 Repacking 00 e Section 2 5 2 2 Instrument Specifications 2 2 1 Operating Specifications Dimensions Height 6 in 16 cm Width 10 in 26 cm Depth 9 in 24 cm Weight 18 165 8 kg MA0106 D 2 1 BD MicroProbe Processor Instrument User s
10. Always remove any PACs and cassettes and press RUN before turning the processor power OFF so that the PAC arms can return to the home position If the caddy will be stored off the processor it is easier to remove it before setting the instrument power to STANDBY MA0106 D 3 7 BD MicroProbe Processor Instrument User s Manual 3 8 0106 Maint nance 4 1 General The BD MicroProbe Processor requires little cleaning and maintenance from the user to provide reliable performance Procedures are described in this section Cleaning and Maintenance Section 4 2 General Section 4 3 Disinfection Decontamination Section 4 4 WARNING THE BD MICROPROBE PROCESSOR CONTAINS NO USER SERVICEABLE PARTS ALL MAINTENANCE AND REPAIR OTHER THAN THE PROCEDURES DESCRIBED IN SECTION 4 MAINTENANCE MUST BE PERFORMED BY BD QUALIFIED SERVICE PERSONNEL WARNING ALWAYS SET THE PROCESSOR TO STANDBY AND DISCONNECT THE POWER SUPPLY BEFORE PERFORMING CLEANING DISINFECTION OR MAINTENANCE PROCEDURES MA0106 D 4 1 BD MicroProbe Processor Instrument User s Manual 4 2 Cleaning and Maintenance No special maintenance procedures are required other than wiping reagent spills and periodic surface cleaning to remove any dirt or grime Because of the possibility of blue colored reagent deposits as a result of reagent reactions
11. BD MicroProbe Processor Instrument User s Manual For use with BD Affirm VPIII Microbial Identification Test icroProbe mice amp BD Document No MA0106 ud Becton Dickinson and Company Revision D 7 Loveton Circle 250100 Sparks MD 21152 USA Tel 800 638 8663 www bd com ds Benex Limited C Rineanna House Shannon Free Zone Shannon County Clare Ireland BD MicroProbe Processor Instrument User s Manual System Software Notice This manual includes instructions for installing and operating the BD MicroProbe Processor as it is used with the BD Affirm VPIII Microbial Identification Test kits Each Affirm Microbial Identification Test requires specific system software to be installed in the Processor Please refer to the test kit package insert for the correct software version and the specific test procedures ii MA0106 D Preface Change History REVISION DATE PAGES REASON New 1 99 All New Product Release A 4 99 All CE Marking B 7 99 1 2 50 52 Codification C 1003 All CE Marking Update Format Photos and AR Address Change Update ambient D 2010 10 All operating temperature in Section 2 2 1 Update unpacking instructions in Section 2 3 1 BD BD Logo MicroProbe and Affirm are trademarks of Becton Dickinson and Company Copyright Becton Dickinson and Company 2010 All rights reserved No part of this publication may be reproduced transmit
12. Manual Power Voltage Selectable by Transformer 120 10 220 240 VAC 100 VAC 10 50 60 Hz 10 Maximum Input Current 1A Environmental Indoor Use Ambient Temperature 22 28 C Ambient Humidity 10 85 Altitude 2000 m maximum Installation Category II Pollution Degree 2 as per IEC 664 Regulatory Compliance Designed to meet UL CSA and IEC standards 2 2 2 Calibration The BD MicroProbe Processor is factory calibrated No further calibration or alignment is required under conditions of normal use 2 3 Instrument Installation 2 3 4 Unpacking the Processor 1 Place the shipping container in the upright position Open the top of the container and remove the product literature and the top foam packing block 2 Remove the accessories The power transformer 120 V or 220 240 V or 100 V lysis block thermometer program card and cassette caddy 2 2 MA0106 D Installation 3 Carefully lift the processor in the protective bag out of the box and place it on a level surface 4 Remove the clear plastic bag then remove the protective foam insert covering the robotic arm CAUTION Do not use the robotic arm as a handle to lift or move the processor Always lift from the bottom of the base unit 5 Remove the power transformer program card and cassette caddy and make certain the program card matches the Affirm test you intend to use NOTE Retain the BD MicroProbe Processo
13. ON ON AN ACTIVITY WHICH POTENTIALLY COULD CAUSE INJURY TO THE USER IS PRESENTED AS A WARNING MA0106 D 1 5 BD MicroProbe Processor Instrument User s Manual 1 7 Summary of Cautions and Warnings Do not use the robotic arm as a handle to lift or move the processor Always lift from the bottom of the base unit To raise the robotic arm grasp it near the PAC arms and move it upward using even but firm pressure Do not use the PAC arms to raise the robotic arm The power plug on the transformer must be connected to a grounded power source Do NOT use an adapter to connect the power plug to an outlet for which it is not designed Position the instrument in a place where the program card port on the front of the instrument is protected from dirt or liquids If spillage occurs contact your Technical Services representative before using the processor or installing the program card Handle the program cards carefully to prevent damage Store the card in the plastic case when not installed in the instrument The robotic arm automatically rises when the power is turned ON and drops when the power is set to STANDBY Keep hands and other objects clear of the arms when turning power ON or setting to STANDBY Do not add or remove reagent cassettes or attempt to install or remove the cassette caddy when the processor is in operation homing or processing PACs The BD MicroProbe Processor contains no user serviceable parts
14. Power 3 4 5255 3 4 3 4 User Prompts and Responses 3 4 3 5 Setting Up and Processing Samples 3 6 3 5 1 Using the Cassette 3 6 3 5 2 Positioning the Cassettes for Processing 3 6 3 5 3 Cassette 3 7 3 5 4 Turning the Processor 3 7 Maintenance 4 1 General eue OR 4 1 4 2 Cleaning and Maintenance 4 2 4 3 General 4 2 4 4 4 3 4 4 1 MicroProbe Processor Base Unit 4 3 4 4 2 Cassette 4 4 4 4 3 Program 4 4 MA0106 D BD MicroProbe Processor Instrument User s Manual Troubleshooting 5 7 Generale eee esee een een estende 5 1 Warranty Replacement Parts International Contacts List of Illustrations Figure Title Page 1 1 The BD MicroProbe 1 2 2 1 Unpacking the 2 4 2 2 Setting Up the
15. epaired by the user Any service or repair work must be done by BD authorized service personnel only Contact your BD Technical Services representative or authorized distributor if you believe your Processor requires service or repair MA0106 D Repl cdient Ordering Information To order additional accessories or replacement parts contact your BD Affirm VPIII Microbial Identification Test distributor representative Affirm Microbial Identification Test Kits and Sample Collection Sets may be ordered through your BD Affirm VPIII Microbial Identification Test distributor representative Replacement Items 211901 Sterile Affirm thermometer 212992 Replacement kit PAC clips individual clips x 6 441864 Replacement kit PAC clips single bar MA0106 D B 1 BD MicroProbe Processor Instrument User s Manual B 2 MA0106 D Interfhational Contacts Becton Dickinson and Company 7 Loveton Circle Sparks MD 21152 Tel 1 800 638 8663 www bd com ds Rineanna House Shannon Free Zone Shannon County Claire Ireland Tel 353 61 47 29 20 Fax 353 61 47 29 07 2771 Bristol Circle Oakville Ontario Canada L6H 6R5 Voice 905 855 5550 800 268 5430 30 Tuas Avenue 2 Singapore 639461 Tel 65 8610633 Fax 65 8601590 Rua Alexandre Dumas 1976 04717 004 Sao Paulo S P Brazil Tel 55 11 5459833 Fax 55 11 2478644 Monte Pelvoux 111 9th Floor Col Lomas de Chapultepec 11000 Mexico D F Tel 52 5 2
16. he alarm beeps Possible Cause Power surge or interruption or system problem Corrective Action If the PAC is in wells 2 to 7 Support the robotic transport arm to keep it from dropping and set the system to STANDBY Lift the robotic arm and carefully remove the PACs from the PAC arms Discard the PACs Carefully retrieve ALL of the sample from each well 1 with a disposable pipette and place the samples into well 1 of a new reagent cassette Discard the partially processed reagent cassettes and place the new cassettes into the caddy on the instrument Process the sample with new PACs after adding substrate to well 7 of the new reagent cassettes SYMPTOM UNIT STOPS PROCESSING AT START OF RUN Instrument stops processing at the start of a run well 1 and the alarm beeps Possible Cause Power surge or interruption or system problem Corrective Action If the PAC is still in well 1 sample well Support the robotic arm to keep it from dropping and set the instrument to STANDBY 0106 5 3 BD MicroProbe Processor Instrument User s Manual Release the PACs from the clips into reagent cassette well 1 Lift the robotic arm and remove the caddy with the PACs in the cassettes Turn the instrument ON to reset and wait for it to home Place the caddy with PACs positioned in the reagent cassettes on the processor Move through the prompts to start automated processing 5 4 0
17. ienced operators A series of prompts on the display guides the user through the various set up steps in the test 3 4 0106 Operation A HELP mode is available for new or infrequent users See Section 3 3 3 The HELP prompts can be accessed any time before the start of automated processing by pressing the blue HELP key Pressing the green RUN key will exit HELP and continue to the next step In all instances the appearance of a blinking double arrow gt gt on the display tells the user to press the RUN key While each test uses test specific software all BD MicroProbe Processor software follows the same general operating principles Examples are given below Please refer to the user instructions packaged with each test kit for the specific prompts and procedures DISPLAY OPERATOR ACTION Wait until the next prompt appears on the PLEASE WAIT display The instrument may be moving or homing during this time Add reagent as called out in the test kit package insert Press the RUN key when the reagent addition is complete The ADD SUBSTRATE gt gt mode contains additional information Press RUN to exit HELP and continue with the assay steps Using the test kit to prepare the sample ADD SAMPLE gt gt place the prepared sample into well 1 of the reagent cassette Replace the caddy onto the processor taking care not to splash the reagents or samples Ensure that
18. insert to perform the test If the processor is used in a manner not specified the protection afforded by the processor may be impaired MA0106 D 1 1 BD MicroProbe Processor Instrument User s Manual The BD MicroProbe Processor is pictured below Individual components are listed below Figure 1 1 The BD MicroProbe Processor The BD MicroProbe Processor Components BD MicroProbe Processor Base Unit Cassette Caddy Probe Analysis Cards PACs Reagent Cassettes Robotic Arm PAC Arms Program Card 1 2 MA0106 D Introduction 1 3 Description and Principles of Operation The BD MicroProbe Processor is a compact robotic unit that automatically controls the reagent and sample mixing and incubation timing of the Affirm Microbial Identification Tests The Affirm tests use specialized beads coated with microbe specific DNA probes to qualitatively identify the presence of selected target microorganisms clinical samples Each test consists of a panel of organism specific probe beads plus a specificity control negative bead and a procedural control positive bead The beads are all located on a single test card called a Probe Analysis Card PAC The identification reaction takes place on the beads as the processor moves the PACs through a series of incubations with sample and reagent resulting in a blue colored bead if the test is positive The BD MicroProbe Processor consists of a base
19. material This is very important as the custom packaging foam supports the Processor components in the proper position during shipment 3 Place the shipping box on a level surface with only the bottom packing foam in place All other pieces of foam must be removed 4 With the instrument in the home position PAC arms to the rear carefully position the protective foam insert to cover the robotic arm 5 Place the processor into the protective plastic bag and carefully lower it into the foam support in the box supporting the unit at the bottom if necessary DO NOT use the robotic arm as a handle 2 10 MA0106 D Installation 6 Place all accessories into the shipping box Cover with top foam piece See Figure 2 1 for placement of packing materials 7 Close the box and seal with shipping tape MA0106 D 2 11 BD MicroProbe Processor Instrument User s Manual 2 12 MA0106 D 3 1 General This section describes the routine operation of the MicroProbe Processor The following major topics are discussed Processor Components and Functions Section 3 2 User Control Panel Functions Section 3 3 User Prompts and Responses Section 3 4 Setting Up and Processing Samples Section 3 5 3 2 Processor Components and Functions 3 2 1 Processor Base Unit The base unit houses the mechanical and electronic components positions the cassette caddy and
20. nt cassettes or attempt to install or remove the cassette caddy when the processor is in operation homing or processing PACs 3 2 4 Program Card The Affirm program card functions in a manner similar to a computer floppy disc supplying the operating software for a particular application Program cards are assay specific 3 2 5 Program Card Port The program card is inserted into this specialized port which is the horizontal slot located on the lower right front of 3 2 0106 Operation the instrument The instrument must be set to STANDBY green LED NOT lit when the card is inserted or removed to avoid damage to the program card 3 2 5 User Control Panel Includes the ON STANDBY RUN and HELP keys 20 character vacuum fluorescent display and LED power indicator 3 3 User Control Panel Functions 3 3 1 ON STANDBY Key Pressing the red ON STANDBY key allows the system to be powered up ON or set to STANDBY from the control panel The green LED is illuminated only when the system is ON Always install the program card before turning the instrument power to ON If the green LED is lighted and a card is not installed set the system to STANDBY before installing the card 3 3 2 RUN Key Pressing the green RUN key causes the system display to prompt the user to complete the next step in the test sequence and also starts the automatic processing cycle The RUN key is used to exit the HELP
21. ower strip If a power strip is used make sure it is ON Press the ON STANDBY key to continue operation If the unit still will not operate call for assistance SYMPTOM UNIT WILL NOT OPERATE Instrument display does not light and the robotic arm does not move Green LED light indicates power is ON Possible Cause Program card not installed or program card not seated properly Corrective Action Set the system to STANDBY by pressing the ON STANDBY key Check to see that a program card is installed in the port on the front of the unit If not install the card If program card is in place set the power to STANDBY and carefully reseat the program card until it clicks into the port Press the ON STANDBY key to continue operation If the unit still will not operate call for assistance SYMPTOM UNIT WILL NOT RESPOND The display is locked on a prompt or the unit does not respond to pressing the RUN or HELP key during test set up Possible Cause Power surge or interruption or a system problem A system reset is required Corrective Action Press the ON STANDBY key to reset the system and continue with test setup 5 2 0106 Troubleshooting If resetting the system does not cause the processor to operate correctly contact your BD Technical Services representative for assistance SYMPTOM UNIT STOPS PROCESSING IN MID CYCLE Instrument stops processing PACs mid cycle wells 2 to 7 and t
22. plies for the particular assay 1 4 4 Affirm Sample Collection Kits Specimen collection materials such as swabs or aspiration tubes are packaged for user convenience in the test kits or in separate sample collection kits 1 4 5 Lysis Block A heating block Lysis Block with thermometer is supplied 1 5 Use of this Manual This users manual is designed as a reference tool for technologists supervisors and other personnel who operate and maintain the BD MicroProbe Processor on a regular basis 1 4 MA0106 D Introduction Every attempt has been made to include information which would be required during normal use and maintenance of the instrument Should a question arise which is not answered in this manual please contact the following parties USA For assistance in North America 2 Technical Services 1 800 638 8663 International contacts are listed in Appendix C or contact your local BD representative 1 6 Notes Cautions and Warnings Throughout this manual important information is presented in boxes offset from the regular text and is labeled as either a NOTE CAUTION or WARNING These messages are formatted as shown below and bear the following significance NOTE Important information about instrument use worthy of special attention is presented as a NOTE CAUTION Information on an activity which potentially could cause damage to the instrument is presented as a CAUTION WARNING INFORMATI
23. provides a port for inserting the system software program card 3 2 2 Robotic Arm and PAC Arms The only moving parts on the processor the robotic arm and the PAC arms work together to pick up the PACs Probe Analysis Cards supplied in the Affirm VPIII test kits at the start of the run and move them through the reagent wells MA0106 D BD MicroProbe Processor Instrument User s Manual presenting them to the operator when processing is completed The robotic arm supports and positions the PAC arms and controls the up and down motion of the PACs in the reagent cassettes When the power is ON the robotic arm is always raised up and drops when the power is set to STANDBY This arm should not be used to lift the processor but it can be raised gently to install the caddy when the power is set to STANDBY The PAC Arms right and left move forward and back carrying the PACs through the cassette wells The PAC arms are carefully aligned to the reagent cassette wells Care must be taken not to bump or manipulate these arms in a way that may cause them to become misaligned 3 2 3 Cassette Caddy The cassette caddy is the tray that holds the reagent cassettes during processing The caddy is easily removed for set up and transport of multiple reagent cassettes When the caddy is installed it rests in the caddy bay on the locator pins at each side level with the surface of the base unit CAUTION Do not add or remove reage
24. r shipping container and all packing materials for later transport or shipment 6 To complete the installation verify that all parts are present see steps 1 5 above and Figure 2 1 and inspect for any damage If any parts are missing or damaged contact BD Technical Services 1 800 638 8663 or your local BD representative 0106 2 3 BD MicroProbe Processor Instrument User s Manual Foam Top Cassette Caddy Product Literature BD MicroProbe Unit _ Program Card BY Transformer Foam Insert Lysis Block Robotic Arm DO NOT USE TO LIFT PROCESSOR Figure 2 1 Unpacking the Processor NOTE The plastic bag that covers the instrument is not pictured here 2 4 MAO106 D Installation 2 3 2 Setting Up the Processor CAUTION To raise the robotic arm grasp it near the PAC arms and move it upward using even but firm pressure Do not use the PAC arms to raise the robotic arm 1 Place the processor on a clean level surface away from liquids or mechanical equipment that may interfere with the operation of the instrument 2 Gently raise the robotic arm to install the cassette caddy Rest the caddy on the locator pins on each side of the instrument level with the surface of the base unit Locator Pins Figure 2 2 Setting up the Processor 0106 2 5 BD MicroProbe Processor Instrument User s Manual 2 3 3 Installing the Transformer
25. rs NOTE The robotic arm will drop when the power is set to STANDBY Lift the robotic arm to install or remove the cassette caddy when the power is set to STANDBY ON STANDBY key Power indicator Processor Red Green LED display Figure 2 5 Powering Up the Processor 2 4 3 Shut down Procedure Preparation for Storage or Shipping 1 Remove any reagent cassettes or PACs from the instrument Remove the caddy and store it in the original shipping box 2 Make sure the system is in the home position with the PAC arms to the rear The processor will go to the home position when the instrument is first turned ON and prepared to run a test or when the RUN key is pressed at the end of an assay 0106 2 9 BD MicroProbe Processor Instrument User s Manual 3 Press the ON STANDBY key on the control panel The green LED will go out and the display will become dark Disconnect the electrical plug from the power outlet and the transformer pin connector from the processor 4 Carefully remove the program card from the port on the front of the instrument and place it in the plastic storage box 5 The system may be stored covered or repacked for shipment 6 Prior to shipping use the disinfecting procedure in Section 4 4 2 5 Repacking the Processor 1 Check that you have completed the shut down procedure before repacking the processor 2 Retrieve the original shipping box and packing
26. s the ON STANDBY key to set the Processor to STANDBY NOTE Do not insert or remove the program card while the processor is turned ON or in operation 2 With the label up insert the card in the direction of the arrows into the program card port on the lower right front of the instrument You will feel the card seat firmly in the port when it is properly installed MA0106 D 2 7 BD MicroProbe Processor Instrument User s Manual Figure 2 4 Installing the Program Card 2 4 Powering On and Off the Instrument WARNING THE ROBOTIC ARM AUTOMATICALLY RISES WHEN THE POWER IS TURNED ON AND DROPS WHEN THE POWER IS SET TO STANDBY KEEP HANDS AND OTHER OBJECTS CLEAR OF THE ARMS WHEN TURNING POWER ON OR SETTING TO STANDBY 2 4 1 Power On When the unit is connected to the transformer and the power outlet press the red ON STANDBY key on the front left side of the control panel The green LED on the panel will light and will remain lit whenever the power to the system is ON When a program card is installed the user prompts will appear on the display A program card must be in place to light the display 2 8 MA0106 D Installation 2 4 2 Power Standby The processor may be set to STANDBY by pressing the red ON STANDBY key on the control panel The green LED is not illuminated when the power is set to STANDBY It is recommended that the instrument be set to STANDBY if it will be idle for more than 24 hou
27. spills and splatters should be wiped up immediately to prevent staining Use the following cleaning procedures with the BD MicroProbe Processor on an as needed basis for general cleaning or to remove clean liquid spills Good laboratory practice calls for treating any specimen spill as a potential biohazard Therefore use the procedure for disinfection if contamination is suspected CAUTION Do not use organic solvents such as acetone or petroleum based products to clean the painted plastic instrument case Do not use bleach on or near metal components CAUTION Do not store reagents on the instrument Wipe all reagent spills immediately CAUTION Do not immerse the BD MicroProbe Processor or power transformer in liquid 4 3 General Cleaning The BD MicroProbe Processor base unit and reagent caddy should be cleaned periodically with a detergent to keep the surfaces clean Make sure the unit is set to STANDBY and disconnected from the power supply while cleaning Wipe all surfaces with a mild detergent and then wipe with a moist cloth to remove any residual detergent Finally wipe the 4 2 MA0106 D Maintenance surfaces with 7096 isopropyl alcohol and allow to air dry Cleaning monthly should be sufficient for most laboratories however more frequent cleaning will not harm the system The program card may be wiped carefully with 7096 isopropyl alcohol and allowed to air dry Storing the card in the protective plastic
28. ted transcribed stored in retrieval systems or translated into any language or computer language in any form or by any means electronic mechanical magnetic optical chemical manual or otherwise without the prior written permission of BD 7 Loveton Circle Sparks Maryland 21152 United States of America MA0106 D iii BD MicroProbe Processor Instrument User s Manual Table of Contents Introduction Alt Generals sen NINH NS 1 1 1 2 Intended Use of the 1 1 1 3 Description and Principles of Operation 1 3 1 4 System Components 1 4 1 4 1 BD MicroProbe 1 4 1 4 2 Program 1 4 1 4 3 Affirm Microbial Identification Test Kits 1 4 1 4 4 Affirm Sample Collection Kits 1 4 1 45 LYSIS onn eats 1 4 1 5 Use of this 4 1 4 1 6 Notes Cautions and Warnings 1 5 1 7 Summary of Cautions and Warnings 1 6 Installation 2 4 eet et LINE 2 1 2 2 Instrument 2 1 2 2 1 Operating 222 2 1 222 Calibration eee edes 2 2 2 3 Instrument 222 22 2 2 2 3 1 Unpacking the
29. the caddy is placed securely on all four locator pins PLACE CADDY Open one PAC for each sample being run PLACE PAC gt gt and place it in Well 1 with the beads in the solution and the microorganism names facing forward TO START PRESS Press the RUN button to start automated RUN gt gt processing 0106 3 5 BD MicroProbe Processor Instrument User s Manual The prompts will continue to direct the operator through the assay procedure with HELP available at each step until automated processing starts When automated processing is complete the system will present the PACs to the operator NOTE Always remove the completed PACs when they are presented and be sure PACs are removed before pressing the RUN key 3 5 Setting Up and Processing Samples The following general tips are intended to help all BD MicroProbe Processor users Each Affirm Microbial Identification Test has specific sample preparation requirements and procedures Please refer to the package insert packaged in each test kit before processing samples 3 5 1 Using the Cassette Caddy The cassette caddy is designed to be a workstation for setting up Affirm tests It is easier to add substrate solution and prepared samples while the caddy is off the processor When power is set to STANDBY lift the robotic arm gently and slide the caddy out When the power is ON the arm remains in a raised position so the caddy can
30. unit with removable tray called the cassette caddy which holds from one to six reagent cassettes The PAC arms on the robotic arm pick up the PACs and move them through a series of reagents in reaction wells in the reagent cassettes The precise timing of incubations in the reaction wells is under software control as the PACs are automatically cycled first into the sample well then through the reagent wells Depending on the test the reaction is complete approximately 30 minutes The BD MicroProbe Processor is very simple to operate Once started the system automatically completes the test procedures without any further operator attention A HELP mode is available to assist new or infrequent users The system software is on a program card selected to match the specific test 0106 1 3 BD MicroProbe Processor Instrument User s Manual 1 4 System Components 1 4 4 BD MicroProbe Processor BD MicroProbe Processor Base Unit Cassette Caddy Power Transformer selectable for voltage User s Manual 1 4 2 Program Card The test specific program card must be matched to the test Your Processor will initially arrive with a program card included Please confirm that you have the correct software for the test you wish to run 1 4 3 Affirm Microbial Identification Test Kits Each Kit contains e Reagent Cassettes e PACs Probe Analysis Cards Reagent Bottles e Miscellaneous sample collection and processing sup
31. using the same procedure as the processor base unit steps 1 through 5 above 4 4 3 Program Card Disinfect the program card using the same procedure as the processor base unit steps 1 through 5 above DO NOT GET THE ELECTRICAL CONTACTS INSIDE THE PROGRAM CARD WET Allow the surface of the program card to dry thoroughly before installing the card in the base unit 4 4 MA0106 D Troub 5 1 General This troubleshooting guide describes the symptoms possible causes and corrective actions that an operator should take in case of a problem These are listed in order from the most simple problem to the most complex Please follow directions carefully and note the result of any corrective actions which have been attempted in case telephone assistance is required If none of the recommended corrective actions are successful contact your BD Technical Services representative or authorized distributor for assistance Please have available your processor serial number and type of software being used when calling for assistance SYMPTOM NO POWER TO UNIT Instrument does not respond to pressing the ON STANDBY key green LED does not light Possible Cause Unit not receiving power Corrective Action Check that the transformer is connected to the instrument Make sure the connection is firm MA0106 D 5 1 BD MicroProbe Processor Instrument User s Manual Check that the transformer is connected to a live wall outlet or p
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