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LABORATORY PROCEDURE

BD Innova INTENDED USE The BD Innova instrument is intended to completely automate the front-end setup of liquid microbiology samples according to user-defined procedures and protocols. For Complete utomation !ode this includes opening and closing specimen container"s#$ and inoculating$ strea%ing and barcoding media plate"s#. &trea%-'nly mode is designed to strea% pre-inoculated media plates in a configured pattern. SUMMARY AND EXPLANATION OF THE TEST Complete utomation !ode includes opening and closing sample container"s#$ and inoculating$ strea%ing and barcoding media plate"s#. &trea%-'nly mode is designed to strea% pre-inoculated media plates in a configured pattern. PRINCIPLES OF THE PROCEDURE In Complete utomation mode$ the instrument performs the follo(ing) ccepts sample containers from the sample dra(ers Thoroughly agitates sample during transfer to processing area *eads sample barcode using camera 'ptionally notifies +I& of the sample,s receipt and e-change.transfer details 'pens "decaps# sample container using universal decapper mechanism /sing sensor$ detects liquid level in sample container to ensure sufficient volume is present /sing calibrated loop$ e-tracts fi-ed volume of liquid from sample container "based on pre-defined protocol# &elects appropriate agar type from input carousel "(hole or bi-plates# Inoculates media plate using loop. +oops are inspected before each inoculation &trea%s media plate in appropriate strea% pattern "based on pre-defined protocol# 0rints barcode label and applies to bottom of the media plate"s#. *eplica barcode$ date$ and time processed are printed on the label. dditional data$ including patient name$ age$ gender$ test type$ etc. can be printed if interfaced
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to the +I& &terili1es loop using incinerator &tac%s media plates in output carousel$ ready for transit to incubator

In &trea%-'nly mode$ the instrument performs the follo(ing) !oves pre-inoculated media plates into strea%ing station *emoves media plate lid and strea%s plate in customer defined pattern &terili1es loop using incinerator &tac%s plates into output carousel$ ready for transit to incubator

PRECAUTIONS Do not attempt to lift or move the instrument. The instrument must only be moved by a qualified BD representative$ or the instrument (arranty may be voided. ll users should become thoroughly familiar (ith all controls and indicators before attempting to operate the instrument. 2hen (or%ing on electrical devices$ +oc% 'ut and Tag as directed by the laboratory,s health and safety procedures. 'nly trained service personnel should open the service access doors at the front of the system. 3igh voltage terminals e-ist behind these doors. The %ey for this access should only be accessible to such personnel. The carousel access latch may contain sharp edges. Ta%e precaution (hen opening this door. The roller located under the instrument door may pose a trip ha1ard. 4nsure that long hair is tied bac% and that loose articles$ 5e(elry$ and clothing are restricted (hen (or%ing (ith the Innova instrument. 'bserve established precautions against microbiological ha1ards throughout all procedures. ll samples should be handled according to CDC-6I3 recommendations$ C+&I guidelines$ or local institution guidelines for any potentially infectious human serum$ blood$ or other body fluids. 0rior to discarding$ sterili1e sample containers and other contaminated materials by autoclaving. In addition to (earing gloves$ the use of disposable lab coats or go(ns and protective glasses or goggles is recommended (hen (or%ing around the instrument. 6ever leave foreign ob5ects "pens$ pencils$ etc.# resting on the bridge or the input.output.main carousels. The movement of those subsystems could cause the e5ection of that ob5ect.
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2hen operating the Innova instrument$ do not reach past the sample container trays. &tandard 0recautions 7 Consider all organisms as potentially infectious and handle according to standard microbiological practices$ special practices$ and safety equipment recommended for Biosafety +evel 8 "B&+-8# containment. B&+-8 practices include$ but are not limited to the follo(ing) 2ear gloves and lab coat (hen handling potentially infectious material or contaminated instrument components. 2ear any other personal protective equipment according to local policy. Decontaminate (or% surfaces after completion of (or% and after any spill or splash of potentially infectious material (ith appropriate disinfectant. Decontaminate all cultures$ stoc%s$ and other potentially infectious materials before disposal using an effective method.

0erform all procedures to minimi1e the creation of splashes and.or aerosols. +aboratory equipment should be routinely decontaminated$ as (ell as after spills$ splashes$ or other potential contamination. &pills involving infectious materials must be contained$ decontaminated$ and cleaned up by staff properly trained and equipped to (or% (ith infectious material. 4quipment must be decontaminated before repair$ maintenance$ or removal from the laboratory. Decontaminate and dispose of all potentially contaminated materials as regulated medical (aste in accordance (ith local$ state$ and federal regulations. Be cautious (hen handling trays. 4nd tabs may be sharp. &lamming either the sample dra(ers or main access door closed can cause the trays to slide out of place (hich may result in damage to either the trays or the instrument. 4nsure that sample dra(ers and main system access door are closed before starting any run.

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2hen the instrument notifies you of errors or faults$ you should immediately respond to the condition. Improper shutdo(n of the Innova instrument may cause soft(are file damage. ll maintenance and repair other than the procedures described in &ection 9) !aintenance must be performed by BD qualified service personnel. For troubleshooting instrument problems$ po(er should be removed and the po(er cord should be disconnected for safety$ unless you are instructed to leave the po(er on. &ome maintenance steps require the main access door to be open. Bumping this door (hile open may cause the sample trays to dislodge. Follo(ing any maintenance$ ensure the sample trays are properly loaded prior to starting a run. *efer to &ample +oading section of this procedure. Be especially careful around moving parts "carousels$ decapper$ printer and bridge# during cleaning procedures. During general machine cleaning it is advised to remove the loop"s# to prevent damage to the loop"s#. Follo( established laboratory &tandard 'perating 0rocedures "&'0s# for cleaning and sample handling and dispose of all used cleaning materials as per these procedures. 4-tra care should be ta%en in the event of bro%en glass containers. 2hen cleaning the upper grippers$ be careful of the sharp points of the grippers. Be a(are of the instrument frame (hen changing the inoculating loops to prevent head in5ury. Do not unt(ist the coils in the loop during loop alignment. If a loop becomes uncoiled$ do not use it on the Innova instrument. 'ver time$ a loop may become clogged (ith carbon build-up. Therefore$ the loop must be periodically chec%ed for its condition and calibration. Due to the fact that there are many factors affecting build-up$ the user must establish and follo( loop inspection and calibration procedures. Be cautious of paper cuts (hen inserting paper into printer. 2hen (or%ing near the sterili1er do not touch the surface. The temperature could be as high as :;;<C.

SPECIMEN COLLECTION AND PROCESSING The list belo( is a representative set of compatible clinical sample containers) BD grey top =acutainer tube ">?mm - @Amm - Bm+ BD =acutainer C C & transport tube for urine testing#$ or equivalent.
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&tarple-D +ea%Buster :;m+ specimen container cup$ or equivalent. BD (hite cap +iquid mies 4lution &(ab "4s(ab#$ or equivalent. BD BB+ clear glass tube (ith blac% cap$ or equivalent. !eridian 0ara-0a%D CC& "Culture and &ensitivity# tube "Cary-Blair container#$ or equivalent.

For questions regarding equivalent sample containers$ or containers not listed here$ contact BD Technical &ervice and &upport in 6orth merica at) :;;-9?:-:99? Use of inco !a"i#$e cons% a#$es inc$%&in' sa !$e con"aine(s ins"(% en" +a((an"), MATERIALS RE-UIRED &amples gar plates Inoculating loops Barcode label rolls a) voi& "*e

PROCEDURE 0re-start Inspection) !a%e sure all operators have been thoroughly trained and instructed on safety procedures and operation. !a%e sure the C po(er plug is connected to a grounded outletE the unit is connected to the lab,s ethernet net(or% via the net(or% 5ac% on the utility panel "if the Innova instrument is connected to the +I& or the BD 4piCenter Data !anagement &ystem#. !a%e sure the correct inoculation loops are loaded. !a%e sure the barcode printer is loaded (ith label rolls. 0roperly shut all doors.

0o(ering /p) Typically$ the Innova instrument (ill be po(ered on at all times$ ho(ever$ if the instrument has been po(ered off$ perform the follo(ing steps for po(ering on the instrument. Toggle the Innova !o+e( s+i"c* "s(itch above the 4mergency button# to the ON position.
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0ress the co !%"e( !o+e( button belo( the touchscreen monitor. 2ait for Innova soft(are to appear on screen. Input user name and pass(ord on the logon screen. 2hen logged on as a specific user$ the first eight characters of the user name appear on the user button on the bottom of the !ain *un Time display. 'ther(ise$ F/serG appears on the button.

'peration in Complete utomation !ode) &ample +oading >. 'pen desired dra(er. Dra(ers are opened by pressing the button on the top of the dra(er latches. 2hen loading samples$ slide dra(er fully out by pulling on the dra(erHs handle. 8. If trays are already present in the dra(er$ samples may be loaded. 4ach instrument dra(er holds A trays (here sample containers are placed by the operator. If no trays are present in a dra(er$ add trays to the dra(er$ or load sample containers into trays offline$ and then place filled trays into the dra(er. "*efer to &teps 9 and @ for instructions on loading trays.# ?. &ample containers fit in bet(een the (hite rollers in the trays. 4nsure that containers are seated properly "should be pushed do(n until the sample container touches the bottom of the tray#. B. 4ach tray can hold either : small containers or B large containers. 4ach tray may only contain one type of sample container. 'verall$ each dra(er can hold up to B; small containers or 8; large containersE the ma-imum instrument capacity is 8;; containers. +oad a !I6I!/! of T2' containers per tray. If loading four large containers$ they must be loaded into the >st$ ?rd$ 9th$ and :th slots of the tray. A. 4ach dra(er may only contain one type of sample containerE ho(ever those containers may contain different specimen types. 9. ny samples that are to be processed must be in sequence) start from the leftmost tray in the dra(er and fill from the front "near the operator# to(ards the bac% "a(ay from operator#. There should not be any empty or missing trays in bet(een trays for processing.

@. 4nsure that all trays are loaded properly into dra(er"s#. :. 'n the ends of the trays are tabs (hich loc% into place (ith spring-loaded latches on the dra(er mount. I. To load$ slide the tray for(ard until it pushes up the top bar on the latch and loc%s into place.

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>;. To release a tray$ press the tray J I6&T the dra(er mounted latch and release. The spring in the latch frees the tray. Do not try to pull the tray out of the latch. >>. 'nce the first plate is in place$ the remaining plates can all be inserted into the stac%. 0late +oading and Identification >. 4ach of the 9 input carousel stac%s can be loaded (ith a different type of agar$ or all stac%s can be loaded (ith the same type of plate. 4ach input carousel stac% holds up to BA agar plates. 8. Before placing the plates into the carousel$ ensure that they are not crac%ed$ have no bubbles or voids$ and are not cold$ fogged$ or (et. ?. *emove the plate topper from the input stac% by sliding the topper up until it is clear of the input stac%. B. +oad media plates (ith the agar side at the bottom$ facing up$ and the lids on top of the plate. A. To load fresh media plates in an input carousel stac%$ first place a single plate at the bottom of the stac%$ and ensure that it is sitting flat on the bottom. 9. 'nce the first plate is in place$ the remaining plates can all be inserted into the stac%. @. 2hen plates are loaded into the input stac%$ add the plate topper on top of the plate stac% by aligning the edges of the topper (ith the openings in the input carousel stac% and lo(ering the topper onto the plate stac%. 2hen a full stac% of plates is present in the input stac%$ the topper (ill sit above the top of the carousel. :. To identify the type of plate loaded into a given input carousel stac%$ select that stac% on the !ain *un Time display. I. 2hen the input carousel display is sho(n$ a list of agar plate types is sho(n. &elect the type of agar that (ill be placed into that carousel stac%. >;. The selected agar appears in the blue description bo- belo( the photo of the input carousel. To select a different type of agar plate for that stac%$ tap the FC+4 *G button or simply select a different type of agar from the list. >>. To enter plate type for other input carousel stac%s$ select the description bofor that stac% belo( the photo of the input carousel. >8. For input stac%s >-B$ tapping the F0 TT4*6G button and selecting a strea% pattern designates that stac% for &trea%-'nly mode. That stac% (ill be processed in &trea%-'nly mode only if the F&T*4 K '6+LG button is then selected on the !ain *un Time display. For more information on operation in &trea%-'nly mode$ refer to the 'peration in &trea%-'nly !ode section.
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>?. 2hen finished selecting agar plate types for the input carousel$ tap the F'KG button. The !ain *un Time display sho(s the selected agar types for the various input carousel stac%s.

'utput &tac% Tags >. If the administrator has set the output ordering to Jroup 0lates /sing 'utput &tac% 6ames$ the output stac%s must be assigned tags. These tag names are used by the instrument to %no( (here to place the finished plates for a given sample. 0lates are sorted into tagged output stac%s based on the protocol design. 8. This procedure is not performed if the output ordering has been set to !ar% 0lates as &eparate or Interleaved. ?. 2hen the output ordering is set to Jroup 0lates /sing 'utput &tac% 6ames$ fields associated (ith the output stac%s appear on the !ain *un Time display. These fields are (here the tags for each output stac% are entered. B. Tap the desired output stac% for tagging. 'nly output stac%s - D can have a tag assignedE the fifth output stac% "re5ect stac%$ F*G# cannot be tagged. A. If a batch is in process$ &teps 9-I cannot be performed and the instrument does not sho( the ne-t display. 9. 'n the ne( tag display$ all created tags appear in list form on the right side of the display. Tap the desired tag for that output stac% so that the name is highlighted. 'nce the desired tag is selected$ the alias appears in the output stac% field on the left side of the display. @. To enter tags for any other output stac%s$ tap the desired output stac% on the left side of the display and repeat step 9. !ore than one output stac% can be assigned the same tag. If an undesired tag is already assigned to an output stac%$ simply tap on that output stac% field$ then tap on a ne( tag name to change it$ or tap the FC+4 *G button and repeat step 9. :. Tagging or clearing an output stac% can only be done if the output stac% is empty of plates. If the stac% is not empty$ a popup message bo- appears to inform that only empty stac%s can be assigned or cleared. Tap the F'KG button to return to the !ain *un Time display and clear necessary output stac%s. I. Tap the F'KG button to continue and save output stac% tag assignments$ or FC 6C4+G to clear ne( assignments and return to the !ain *un Time display. 'nce output stac%s are assigned tags$ the aliases appear in the fields on the !ain *un Time display to sho( (hich output stac% is assigned (hich tag. 0rotocols
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The BD Innova instrument processes each sample based on a protocol. 0rotocols are defined based on the follo(ing criteria) Container type Barcode filter set 6umber of plates per sample &pecimen type.body site "+I& or 4piCenter Driven !ode# Inoculation volume +oop sterili1ation and cool do(n time gar type used Type of plate "(hole plate$ bi-plate$ etc.# 'utput ordering for plate delivery &trea% pattern

0rotocols are defined by an dministrator and based on the lab,s standard operating procedure "&'0#. 0rotocols can be changed at any time by the dministrator. During batch creation$ the batch protocols can either be assigned by the user for that batch "/ser Defined !ode# or selected by the instrument based on each sampleHs specimen type and.or body site "+I& or 4piCenter Driven !ode#. Batches and Batch Creation Innova processes samples in batches. 4ach dra(er is a separate batch and has a specific protocol assigned to it by the operator "/ser Defined !ode# or a protocol selected for each sample according to the specimen type and.or body site "+I& or 4piCenter Driven !ode#. Dra(ers are identified from top to bottom as 7 4. 'nce containers and plates have been loaded into the instrument$ the batch can be created on the !ain *un Time display. >. 'n the left side of the display$ select the desired dra(er. 8. If speciali1ed batch naming is required$ tap on the blue name bo-. ?. 'n the %eyboard display$ enter the desired batch name$ then tap either F46T4*G or F'K.G B. 2hen using the virtual %eyboard$ certain characters are grey and not active) T B$ +T$ CT*+$ G$ M$ N$ O$ P$ Q$ R$ H$ C$ S$ T$ U$ V$ W$ X$ Y$ Z. A. 'nce the desired batch name is accepted$ or if no naming convention is required$ tap the F64[TG button.
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9. &elect the sample container to be run on the dra(er. @. &elect the protocol that should be used to process this batch. :. The protocol selected must contain the same output ordering that is currently selected by the administrator. For e-ample$ if the administrator has Jroup 0lates /sing 'utput &tac% 6ames selected as the output style$ a protocol designed for !ar% 0lates as &eparate or Interleaved cannot be used. I. If a protocol (ith a different output style is selected$ a popup message boappears after the protocol is accepted (ith FInvalid 0rotocol &tac%ing &tyle.G Tap the F'KG button to ac%no(ledge this message. The batch icon turns orange. >;. 'nly certain protocols are available depending on the type of sample container selected. The protocol descriptions are displayed to the right of the protocol name. In addition$ batch processing can be assigned to be +I& Driven or /ser Defined.

>>. +I& Driven !ode - If the Innova instrument is enabled to run in +I& "or 4piCenter# Driven mode$ a protocol icon F+I& DrivenG "'r F4piCenter DrivenG# appears at the top of the list of protocols. &elect this icon to run the batch as +I& "or 4piCenter# Driven !ode) the +I& "or the BD 4piCenter Data !anagement &ystem# is queried for each sampleHs specimen type and.or body site for the appropriate protocol to run. +I& "or 4piCenter# Driven !ode still requires one sample container type per dra(er.batch. >8. /ser Defined !ode - The other protocols that are available for that sample container type are also listed (ith their administrator-defined names. To apply a particular protocol to all samples in that batch$ select the desired protocol "+I& or BD 4piCenter Data !anagement &ystem supplied information may be used for the plate label#. If the Innova instrument is not set up to run in +I& "or 4piCenter# Driven !ode$ these protocols are the only ones that appear. >?. Tap the F'KG button (hen finished. The batch starts processing automatically at this point. >B. In +I& "or 4piCenter# Driven !ode each sample containerHs barcode is read and verified$ then a request is sent to the +I& "or the BD 4piCenter Data !anagement &ystem# for patient and protocol information. The specimen type and.or body site received from the +I& "or the BD 4piCenter Data !anagement &ystem# must e-actly match a defined specimen type and.or body site already in the Innova instrument$ unless
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the FD4F /+TG option (as selected. 2hen the response is received$ the Innova protocol that matches the specimen type and.or body site is selected. fter the sample is processed$ a notification is sent to the +I& "or the BD 4piCenter Data !anagement &ystem# that the sample has completed successfully. >A. In /ser Defined !ode$ all samples in the batch are processed according to the protocol selected above. >9. If the plates required for the selected protocol are not configured.identified in the input stac%s on the !ain *un Time display$ the batch pauses and the !issing gars display appears. The missing agars are listedE once configured$ tap the F'KG button. >@. If output stac%s have not been assigned the tags required by the protocol$ the user is prompted to assign those tags. This only occurs if the administrator has set the output ordering to Jroup 0lates /sing 'utput &tac% 6ames$ 2hen the output stac%s have been assigned the missing tags$ tap the F'KG button. >:. If any tagged output stac%s are full$ a popup message bo- appears that no space is available and indicates (hich stac%s need to be cleared. 'pen the carousel door and empty any indicated output stac%s$ then tap the F'KG button or$ to terminate the batch$ tap the FC+4 *G button. This step only occurs if the administrator has set the output ordering to Jroup 0lates /sing 'utput &tac% 6ames. >I. 'nce a batch begins processing$ the dra(er in use is highlighted green. 8;. 2hen a batch is completed$ the dra(er turns dar% green. 8>. ne( batch can be created (hile another batch is being processed. To do so$ load samples into the ne-t empty dra(er then create the batch as described above.

88. 'nce created$ tap the F'KG button. The dra(er is highlighted blue$ and the batch is placed into the queue. 8?. The Innova instrument automatically begins processing the samples of subsequent batches (hen the batch before it has completed. 8B. The finished plates are placed into output stac%s based on the output ordering defined for the protocol. If all five instrument dra(ers are in queue$ the re5ect stac% may be used as an output stac% for the last dra(er to be processed. &ample 0rocessing s the Innova instrument begins processing samples in one of the A dra(ers$ it first selects the tray to the e-treme left "Tray >#. The first sample to be processed is the one closest to the operator "0osition >#. s a tray is selected$ the containers
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are agitated. fter agitation$ the tray enters the processing area and the processing of samples begins. >. To vie( the progress of a specific batch.dra(er$ select that dra(er from the main display by tapping on it. The Batch &tatus display appears as belo(. 8. dditionally$ plate status is presented on the !ain *un Time display. green plate indicates a successfully processed plate. Information for each output stac% is also presented) dra(er$ specimen number$ plate number$ barcode$ and processing times.

'peration in &trea%-'nly !ode) &trea%-'nly mode is used to strea% pre-inoculated plates in a pre-programmed pattern. /sers load plates into the input carousel and select the appropriate strea% pattern for each stac%. s processing begins$ the plate is transferred to the strea%ing area and the lid is removed. The inoculation area is detected by identifying the location of the barcode label and strea%ing begins in the same location each time. &trea%ed plates are then transferred to the output plate carousel. 0lacement of Inoculate Before using the Innova instrument to strea%$ the plates must be inoculated in a location on the plate that the system can properly detect. 0lates typically must be labeled before use in the system to properly %eep trac% of the sample. To ensure that the instrument does not recogni1e any e-isting frosted tabs$ if present$ the label must be placed directly over the tab. The sample is then inoculated on the plate. Different types of plates or strea%ing patterns require the label and inoculate to be placed in different locations. *efer to the diagrams belo( for ho( to label and inoculate. 4ach diagram sho(s the label and inoculate placement$ (hen vie(ing the plate from above (ith no plate lid. 2hole 0lates "4-cept (ith the Double &trea% 0attern# 2hole plates$ e-cept (ith the double strea% pattern$ have one label placed over the frosted tab$ then the inoculate added directly over the label location. Bi-0lates "4-cept (ith the *otated &trea% 0attern# Bi-plates$ e-cept (ith the rotated strea% pattern$ have one label centered across the plate division$ then inoculations added on each side of the plate by the label location. *otated &trea% 0attern on Bi-0lates
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The rotated strea% pattern on bi-plates has one label centered across the plate division$ then inoculations added across from each other$ I; degrees a(ay from the label location. Double &trea% 0attern on 2hole 0lates The double strea% pattern on (hole plates has t(o labels >:; degrees from each other$ then inoculations added over each label location. 'peration >. +oad pre-inoculated plates into stac%s >-B of the input carousel. Input carousel stac%s A and 9 C 66'T be used to load plates in &trea%-'nly mode. 0lates that require the same strea% pattern should be loaded into the same stac%. 8. To change modes$ select the carousel icon on the !ain *un Time display and tap the F&trea% 'nlyG button. ?. From the touchscreen$ select a stac% and select the desired strea%ing pattern. &trea%ing patterns available for &trea%-'nly mode are sho(n. B. &tac%s >-B can all have the same pattern "e.g.$ B \uad mode# or each stac% can be unique "e.g.$ ]ig1ag in stac% R>$ ? \uad in stac% R8$ B \uad in stac% R?#. A. 'nce the strea% pattern is selected$ the F'KG button appears. Tap F'KG to approve the stac% selection. 9. 'n the !ain *un Time display$ the stac%s (hich have been designated for processing appear under the diagram for the input carousel. @. fter processing is complete) &trea%ed plates from input stac% > are dispensed into output stac% . &trea%ed plates from input stac% 8 are dispensed into output stac% B. &trea%ed plates from input stac% ? are dispensed into output stac% C. &trea%ed plates from input stac% B are dispensed into output stac% D.

&topping and 0ausing) >. 2hen the BD Innova instrument completes all batches in the queue it automatically stops operation. lso$ if a batch requires operator input$ the system automatically pauses operation and a(aits a resume command to continue (ith the same batch. These t(o terms are defined as such) a. &T'0) The batch is completed and the active sample container tray is returned to the dra(er. The batch cannot be restarted. b. 0 /&4) The batch is only temporarily paused and the active sample container tray remains on the bridge. 2hen the reason for the pause
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has been managed operation is resumed and the batch continues at the sample on (hich it left off. 8. If the administrator has set the output to Jroup 0lates /sing 'utput &tac% 6ames$ the output stac%s can be re-assigned tag names (henever the instrument is paused. ?. ny time an instrument is paused$ the output stac%s can be emptied. *esponding to 6otifications) >. 6otifications occur (hen an action is required by the operator in order to continue processing the batch. 8. For each notification) 'peration of the Innova instrument pauses. n entry is added to the log file. n audible alert sounds. notification message appears on the !ain *un Time display.

?. 0resented in this section are the various notifications that may appear and information on responding to them. B. dditionally$ an online help guide via the user interface is available for each notification by selecting the help button on the notification display.

A. 2hen the instrument presents notifications$ you should immediately respond to the condition. 9. To silence the audible alert that accompanies the notification$ tap the touchscreen monitor. Input Carousel &tac%"s# 4mpty n Input Carousel &tac%"s# 4mpty notification occurs (hen a batch has been initiated and the e-pected agar plate type is not in the input carousel stac% position. dd gar 0lates to the Input Carousel &tac%"s# >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. 'pen the carousel door. ?. B. dd the appropriate agar plate type to the configured input carousel stac%"s# per the protocol. ny agar plates to be used (hich have been stored in a refrigerator should be removed and ta%en out of their plastic sleeve"s#$ if applicable$ to ensure they are not cold$ fogged$ or (et. This may ta%e more than > hour. 2hile
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plates are out$ protect them from light e-posure if they are light-sensitive. A. Close the carousel door. 9. Tap the F'KG button to clear the notification message. Configure gar 0late Types for Input Carousel &tac%"s# >. 'n the !ain *un Time display$ tap the corresponding input carousel stac% to invo%e the Input Carousel display. 8. 'n the Input Carousel display) a. Tap the agar plate type. b. Tap to select another input carousel stac%. c. *epeat to configure additional input carousel stac%s. ?. Tap the F'KG button to save the agar plate type configuration to the input carousel stac%s and return to the !ain *un Time display. B. Tap the F0+ LG button to resume processing the batch. A. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. 6o 'utput &tac% &pace vailable 6o 'utput &tac% &pace vailable notification occurs (hen a batch has been initiated and an output carousel stac%"s# is full (ith plates or has not been cleared on the !ain *un Time display by tapping the 4mpty &tac%s icon. >. 'pen the carousel door. 8. *emove the agar plates from the output carousel stac%"s#. ?. Close the carousel door. B. Tap the F'KG button on the notification message to resume processing the batch. A. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing and the output stac%s turn (hite to indicate they are empty +oop Inspection Failed +oop Inspection Failed notification occurs if only one calibrated loop is loaded in the automated loop mechanism or if a calibrated loop in the automated loop mechanism becomes misaligned or bent during normal operations. >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. 'pen the main system access "sample# door.

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?. If there is only one loop$ add another calibrated loop for appropriate sample protocol"s#. B. 0erform the +oop Inspection and lignment 0rocedure "&ee &ection @.?.A) +oop Inspection and lignment 0rocedure# to ensure that both loops in the automated loop mechanism are aligned. A. Close the main system access "sample# door. 9. Tap the F0+ LG button to resume processing the batch. @. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. Invalid +oop n Invalid +oop notification occurs (hen the (rong volume loop is loaded in the automated loop mechanism for the sample protocol"s# for batch processing. >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. =erify the correct loop si1e "volume# for the current batch,s protocol) Blac% loop handle ^ > _+ Blue loop handle ^ >; _+ *ed loop handle ^ ?; _+ ?. 'pen the main system access "sample# door. B. *emove the incorrect loop from the automated loop mechanism. A. *eplace (ith the correct loop volume for the current batchHs sample protocol. 9. Close the main system access "sample# door. @. Tap the F0+ LG button to resume processing the batch. :. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. Tray Detected on Bridge Tray Detected on Bridge notification occurs (hen a tray has been left on the bridge "e.g.$ after user activity inside the instrument#. >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. 'pen the main system access "sample# door. ?. &lide the tray on the bridge to(ard you. B. +ift the tray from the bridge hoo% to remove it from the bridge.
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A. +ocate an empty tray lane in a dra(er by loo%ing at the inside of the main system access "sample# door. 9. Close the main system access "sample# door. @. 'pen the dra(er in (hich the empty lane (as located. :. 0lace the tray you removed from the bridge into the empty lane position and ma%e sure it is properly latched. I. Close the dra(er. >;. Tap the F0+ LG button to resume processing the batch. >>. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. 4-&top.!ain &ystem ccess Interloc% ctivated n 4-&top.!ain &ystem ccess Interloc% ctivated notification occurs (hen the 4mergency &top button is depressed or (hen the main system access "sample# door is open (hen a batch is initiated. >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. 0erform the follo(ing chec%s to determine the cause of the notification) a. Chec% to see if the main system access "sample# door is open. If it is$ close it. b. Chec% to see if the 4-&top button is depressed. If it is$ rotate the button cloc%(ise to resume po(er. ?. Tap the F0+ LG button to resume processing the batch. B. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. Carousel Door Interloc% ctivated Carousel Door Interloc% ctivated notification occurs (hen the carousel door is open (hen a batch is initiated. >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. Close the carousel door. ?. Tap the F0+ LG button to resume processing the batch. B. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. 0rinter 4rror and +abel pplication 4rror 0rinter 4rror notification occurs (hen the printer has run out of labels$ a roll of
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labels has not been loaded into the printer$ the printer door has not been shut properly or the printer is not po(ered on. +abel pplication 4rror notification occurs (hen the label roll has run out of labels or the printer is not able to apply the labels correctly to the plates. The response to either of these notifications is the same. >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. 'pen the main system access "sample# door. ?. 'pen the main printer door by pushing in on the door and lifting up on the green plastic latches. B. 4nsure that labels are (ithin the green label hoo%s. A. Inspect the roll of labels. If the labels have run out$ replace the label roll. If the label roll is not installed properly$ re-install the label roll. 9. Clean the printer sensors$ as dust can accumulate. @. Close the main printer door. !a%e sure that you hear a clic% sound after the printer door is closed$ and that the printer light "located on the main printer door# is green. a. If the printer light is red$ then either the printer door is still open or the printer needs to be reset. b. Close the main printer door again. c. To reset the printer$ turn it off and on again using the blac% s(itch on the side of the printer. !a%e sure the printer light turns green. :. Tap the F'KG button to clear the notification message. I. 0rint a test label to ensure that the labels are printing correctly. a. lign one of the main carousel holes (ith the top of the printer. b. Tap the FToolsG button on the !ain *un Time display. c. Tap the F dvance +abelG button on the Tools display. >;. Chec% to see if the test label prints properly (ith all lines of configured te-t visible on the label. *epeat printing a test label if necessary. >>. Tap the FC 6C4+G button to e-it the dvance +abel display. >8. Chec% for and remove any labels that may be stuc% under the main carousel. >?. Close the main system access "sample# door. >B. Tap the F0+ LG button to resume processing the batch.

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>A. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. >9. In the event that printer error or label application error persists$ contact BD Technical &ervice and &upport at >-:;;-9?:-:99? or your local BD representative for assistance. !a-imum Bi-plate Failures !a-imum Bi-plate Failures notification occurs (hen a batch has been initiated and bi-plates are e-pected for the sample protocol but (hole plates are loaded in the input carousel stac%. The instrument generates this notification only after a pre-defined number of (hole plates in a ro( are detected. >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. 'pen the carousel door. ?. *emove the (hole plates from the input carousel stac%"s#. B. *eplace (ith bi-plates. A. ny agar plates to be used (hich have been stored in a refrigerator should be removed and ta%en out of their plastic sleeve"s#$ if applicable$ to ensure they are not cold$ fogged$ or (et. This may ta%e more than > hour. 2hile plates are out$ protect them from light e-posure if they are light-sensitive.

9. Close the carousel door. @. Tap the F0+ LG button to resume processing the batch. :. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. !a-imum !ar%ers Failures !a-imum !ar%ers Failures notification occurs in &trea%-'nly mode (hen there are no labels over the frosted tab on the agar plate or there are too many labels over the frosted tab on the agar plate. The Innova instrument generates this notification only after a pre-defined number of mar%er failures in a ro( are detected. >. Tap any(here on the screen to ac%no(ledge the message and silence the audible alert. 8. 'pen the carousel door. ?. *emove the plates from the *e5ect stac% of the output carousel. B. pply labels to plates if no labels are present or ensure that only one label is over the frosted tab on each agar plate. &ee 0lacement of Inoculate section for information on placing labels on the agar plate.

A. +oad plates into input carousel"s#.


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9. Close the carousel door. @. Tap the F0+ LG button to resume processing. :. The batch header and batch dra(er on the !ain *un Time display turn light green to indicate the batch has resumed processing. *e5ected 0lates The re5ect stac% contains any re5ected plates. plate is Fre5ectedG if it is not processed correctly. *e5ected plates must be removed from the re5ect stac% and either re-loaded into the instrument or strea%ed manually. *e5ected plates can be vie(ed by tapping the re5ect stac% symbol "letter F*G# on the output carousel. red re5ected plate indicates a processed plate "may or may not have a plate label#$ and a (hite re5ected plate indicates an unprocessed plate. nytime the carousel access door is opened$ the user must confirm the contents of each stac% are correct before restarting processing. 4nd of *un 'perations) 2hen a run is complete and the instrument is finished processing all batches in queue$ perform the follo(ing functions to finish processing samples and prepare the instrument for the ne-t set of runs. Clear Input &tac%s If needed$ clear any unused plates remaining in the input stac%s) >. 'pen the carousel door. 8. *aise the plate topper off of the stac% of plates and remove it from the input stac%. ?. *emove plates and store per the manufacturerHs instructions. B. *eplace the plate topper in the input stac% or store as needed. Clear 'utput &tac%s There are t(o options for clearing output stac%s) >. /se the Tools display a. &elect the FToolsG button from the !ain *un Time display. b. &elect the FClear 'utput &tac%sG button. c. popup message appears (ith instructions to open the carousel door and clear all the output stac%s. ny plates from the *e5ect output stac% can be discarded.

d. 'nce all output stac%s are emptied$ tap the F'KG button on the popup message. 8. 'n the !ain *un Time display use the 'utput &tac%s icon. This button is
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utili1ed differently depending on (hich output option is selected by the administrator. ?. !ar% 0lates as &eparate or Interleaved) a. Tap the center Fempty stac%sG icon. b. popup message bo- appears (ith instructions to open the carousel door and empty all output stac%s. ny plates from the *e5ect output stac% can be discarded.

c. 'nce the output stac%s are emptied$ tap the F'KG button on the popup message. d. 'n the !ain *un Time display$ all output stac%s turn (hite. B. Jroup 0lates /sing 'utput &tac% 6ames) a. Tap the desired output stac% to empty. n output stac% icon (ith finished plates appears light blue$ and (hen selected$ turns dar% blue. If an empty output stac% is selected "(hite# a popup message bo- indicates that stac% is empty. b. Tap the center Fempty stac%sG icon. c. popup message bo- appears (ith instructions to open the carousel door and empty that stac%. The tag for the selected output stac% is provided.

d. 'nce the selected output stac% is emptied$ tap the F'KG button on the popup message. e. 'n the !ain *un Time display$ the selected output stac% turns (hite. Clear Batches 2hen a batch is complete$ or if in queue and no longer needed$ it can be cleared from the !ain *un Time display. >. Tap the dra(er for the batch to be cleared on the !ain *un Time display. 8. 'n the &tatus display that appears$ tap FC+4 *.G Incubate 0rocessed 0lates For all plates that have been successfully strea%ed and removed from the output stac%"s#$ incubate according to the laboratoryHs standard operating procedures. !aintenance 0erform any necessary maintenance steps. Complete &hutdo(n) 'ccasionally$ the Innova instrument may need to be completely shutdo(n for e-tended periods of inactivity. 3o(ever$ to ensure that the Innova instrument is
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accessible for diagnostics and data collection "for e-ample$ if the Innova instrument is lin%ed to a BD ssurity +inc &ystem#$ the instrument should be left on unless instructed by BD service personnel. I !(o!e( s*%"&o+n of "*e Innova ins"(% en" To completely shutdo(n Innova) >. fter the last sample has been processed$ tap F0'24*G on the !ain *un Time display. This turns off the soft(are. popup appears to confirm the shutdo(n. &elect F'KG to proceed or FC 6C4+G to return to the /ser display. a) ca%se sof"+a(e fi$e &a a'e,

8. If po(er is not removed (ithin a fe( minutes$ press the computer po(er button on the front of the system belo( the touchscreen. This po(ers do(n the computer. ?. Toggle the Innova po(er s(itch to the 'FF position. To restart after a complete shutdo(n) >. *efer to the 0o(ering /p section of this procedure. RESULTS The BD Innova instrument is intended to completely automate the front-end setup of liquid microbiology samples according to user-defined procedures and protocols$ and does not perform testing that produces patient results. -UALITY CONTROL There are no defined user quality control procedures.

ADDITIONAL NOTES BD calibrated nichrome loops inoculate volumes of >$ >; and ?; _+. ll containers must be barcoded in order to be processed. The barcode label must be applied to the sample container such that the label is applied vertically "(ith the barcode lines hori1ontal#. The barcode that is printed for the plate label uses code>8: symbology regardless of the barcode symbology used on the sample container. Therefore$ the barcodes may visually appear different bet(een the sample container and the plate. 4ach dra(er may only contain one type of sample containerE ho(ever those containers may contain different specimen types. Compatible media plates must conform to the follo(ing measurements) 0late lid diameter) I8 ` 8 mm$ 0late height) >B.A - >9 mm$ 0late lid recess) a > mm The BD Innova instrument has been optimi1ed using BD BB+ 0repared 0lated !edia.
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/se of incompatible consumables including sample containers may void the instrument (arranty.

TECHNICAL INFORMATION pproved by)bbbbbbbbbbbbbbbbbbbbbbbbb Date 4ffective)bbbbbbbbbbbbbbbbbbbbbbbb &upervisor)bbbbbbbbbbbbbbbbbbbbbbbbbbbDate)bbbbbbbbbbbbbbbbbbbb Director)bbbbbbbbbbbbbbbbbbbbbbbbbbbbbDate)bbbbbbbbbbbbbbbbbbbb *evie(ed)bbbbbbbbbbbbbbbbbbbbbbbbbbbb ?.8;>? BD is a trademar% of Becton$ Dic%inson$ and Company.

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