Innova CLSI Procedure

8/13/2019 Innova CLSI Procedure

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LABORATORY PROCEDURE

BD Innova

INTENDED USEThe 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 tostrea% 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 echangetransfer 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$ etracts fied 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 eachinoculation

&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 eist behind these doors. The %ey for this access should only beaccessible 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 anypotentially 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 theinstrument.

6ever leave foreign ob5ects "pens$ pencils$ etc.# resting on the bridge or the

inputoutputmain carousels. The movement of those subsystems could causethe 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$ andsafety 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 orcontaminated 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 andor 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 theinstrument.

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. Fortroubleshooting instrument problems$ po(er should be removed and the

po(er cord should be disconnected for safety$ unless you are instructed toleave 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. 4tra 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 andfollo( 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 :;;


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&tarple +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% C& "Culture and &ensitivity# tube "Cary-Blaircontainer#$ 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 a) voi& "*e

ins"(%en" +a((an"),

MATERIALS RE-UIRED

&amples

gar plates

Inoculating loops

Barcode label rolls

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 4piCenterData !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

ONposition.

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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$ /serGappears 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 loadsample 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 samplecontainer touches the bottom of the tray#.

. 4ach tray can hold either : small containers or large containers. 4ach tray

may only contain one type of sample container. 'verall$ each dra(er can

hold up to ; small containers or 8; large containersE the maimuminstrument 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 left-

most tray in the dra(er and fill from the front "near the operator# to(ards thebac% "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-loadedlatches on the dra(er mount.

. 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 JI6&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 A 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%.. +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 plateat 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 theplate 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 thecarousel.

:. To identify the type of plate loaded into a given input carousel stac%$ select

that stac% on the !ain *un Time display.

. 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

C+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 bo

for that stac% belo( the photo of the input carousel.

>8. For input stac%s >-$ tapping the 0TT4*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 &T*4K '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 '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 protocoldesign.

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.

. Tap the desired output stac% for tagging. 'nly output stac%s - D can have atag assignedE the fifth output stac% "re5ect stac%$ *G# cannot be tagged.

A. If a batch is in process$ &teps 9- cannot be performed and the instrument

does not sho( the net display.

9. 'n the ne( tag display$ all created tags appear in list form on the right side ofthe 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 tochange it$ or tap the C+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 toinform that only empty stac%s can be assigned or cleared. Tap the 'KG

button to return to the !ain *un Time display and clear necessary output

stac%s.

. Tap the 'KG button to continue and save output stac% tag assignments$ orC6C4+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 (hichtag.

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 typebody 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 standardoperating 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 forthat batch "/ser Defined !ode# or selected by the instrument based on each

sampleHs specimen type andor 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 aspecific protocol assigned to it by the operator "/ser Defined !ode# or a protocol

selected for each sample according to the specimen type andor 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

46T4*G or 'K.G

. 2hen using the virtual %eyboard$ certain characters are grey and notactive) TB$ +T$ CT*+$ G$ M$ N$ O$ P$ Q$ R$ H$ $ S$ $ U$ V$ W$ X$ Y$ Z.

A. 'nce the desired batch name is accepted$ or if no naming convention is

required$ tap the 64[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 iscurrently selected by the administrator. For eample$ if the administrator

has Jroup 0lates /sing 'utput &tac% 6ames selected as the output style$ aprotocol designed for !ar% 0lates as &eparate or Interleaved cannot beused.

. If a protocol (ith a different output style is selected$ a popup message bo

appears after the protocol is accepted (ith Invalid 0rotocol &tac%ing

&tyle.G Tap the 'KG button to ac%no(ledge this message. The batch iconturns orange.

>;. 'nly certain protocols are available depending on the type of sample

container selected. The protocol descriptions are displayed to the right ofthe 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 +I& DrivenG "'r 4piCenter

DrivenG# appears at the top of the list of protocols. &elect this icon to runthe batch as +I& "or 4piCenter# Driven !ode) the +I& "or the BD

4piCenter Data !anagement &ystem# is queried for each sampleHs

specimen type andor body site for the appropriate protocol to run. +I& "or4piCenter# Driven !ode still requires one sample container type per

dra(erbatch.

>8. /ser Defined !ode - The other protocols that are available for that sample

container type are also listed (ith their administrator-defined names. Toapply 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 isnot set up to run in +I& "or 4piCenter# Driven !ode$ these protocols are

the only ones that appear.

>?. Tap the 'KG button (hen finished. The batch starts processingautomatically at this point.

>. 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. Thespecimen type andor body site received from the +I& "or the BD

4piCenter Data !anagement &ystem# must eactly match a defined

specimen type andor body site already in the Innova instrument$ unless

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the D4F/+TG option (as selected. 2hen the response is received$ the

Innova protocol that matches the specimen type andor body site is

selected. fter the sample is processed$ a notification is sent to the +I& "orthe BD 4piCenter Data !anagement &ystem# that the sample has

completed successfully.

>A. In /ser Defined !ode$ all samples in the batch are processed according tothe protocol selected above.

>9. If the plates required for the selected protocol are not configuredidentified

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 onceconfigured$ tap the '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 theadministrator 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 'KG button.

>:. If any tagged output stac%s are full$ a popup message bo appears that nospace 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 'KG

button or$ to terminate the batch$ tap the C+4*G button. This step onlyoccurs if the administrator has set the output ordering to Jroup 0lates

/sing 'utput &tac% 6ames.

>. '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 net empty dra(er then create the batch asdescribed above.

88. 'nce created$ tap the '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 ofsubsequent batches (hen the batch before it has completed.

8. 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 inqueue$ 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$ itfirst selects the tray to the etreme 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 batchdra(er$ select that dra(er fromthe 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 thentransferred 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 belabeled before use in the system to properly %eep trac% of the sample. To ensure

that the instrument does not recogni1e any eisting frosted tabs$ if present$ the

label must be placed directly over the tab. The sample is then inoculated on theplate.

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 andinoculate. 4ach diagram sho(s the label and inoculate placement$ (hen vie(ing

the plate from above (ith no plate lid.

2hole 0lates "4cept (ith the Double &trea% 0attern#

2hole plates$ ecept (ith the double strea% pattern$ have one label placed over

the frosted tab$ then the inoculate added directly over the label location.Bi-0lates "4cept (ith the *otated &trea% 0attern#

Bi-plates$ ecept (ith the rotated strea% pattern$ have one label centered acrossthe 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$ ; 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 eachother$ then inoculations added over each label location.

'peration

>. +oad pre-inoculated plates into stac%s >- of the input carousel. Input carousel

stac%s A and 9 C66'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 &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.. &tac%s >- can all have the same pattern "e.g.$ \uad mode# or each stac% can

be unique "e.g.$ ]ig1ag in stac% R>$ ? \uad in stac% R8$ \uad in stac% R?#.

A. 'nce the strea% pattern is selected$ the 'KG button appears. Tap 'KG toapprove 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% 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$ thesystem 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 isreturned 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.

. 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 thetouchscreen monitor.

Input Carousel &tac%"s# 4mpty

n Input Carousel &tac%"s# 4mpty notification occurs (hen a batch has beeninitiated and the epected 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 theaudible alert.

8. 'pen the carousel door.

?. dd the appropriate agar plate type to the configured input carouselstac%"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 eposure if they are light-sensitive.

A. Close the carousel door.

9. Tap the '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 'KG button to save the agar plate type configuration to the inputcarousel stac%s and return to the !ain *un Time display.

. Tap the 0+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 clearedon 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.

. Tap the '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 outputstac%s turn (hite to indicate they are empty

+oop Inspection Failed

+oop Inspection Failed notification occurs if only one calibrated loop is loadedin the automated loop mechanism or if a calibrated loop in the automated loopmechanism 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#.

. 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 0+LG button to resume processing the batch.

@. The batch header and batch dra(er on the !ain *un Time display turn


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.


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.

. *emove the incorrect loop from the automated loop mechanism.

A. *eplace (ith the correct loop volume for the current batchHs sampleprotocol.

9. Close the main system access "sample# door.

@. Tap the 0+LG button to resume processing the batch.

:. The batch header and batch dra(er on the !ain *un Time display turn


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 theaudible alert.


?. &lide the tray on the bridge to(ard you.

. +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 positionand ma%e sure it is properly latched.

. Close the dra(er.

>;. Tap the 0+LG button to resume processing the batch.

>>. The batch header and batch dra(er on the !ain *un Time display turn


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.


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 itis$ 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 0+LG button to resume processing the batch.

. The batch header and batch dra(er on the !ain *un Time display turn


Carousel Door Interloc% ctivated

Carousel Door Interloc% ctivated notification occurs (hen the carousel dooris open (hen a batch is initiated.


audible alert.

8. Close the carousel door.

?. Tap the 0+LG button to resume processing the batch.

. The batch header and batch dra(er on the !ain *un Time display turn


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 oflabels 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.


?. 'pen the main printer door by pushing in on the door and lifting up on the

green plastic latches.

. 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 orthe 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 'KG button to clear the notification message.

. 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 ToolsG button on the !ain *un Time display.

c. Tap the dvance +abelG button on the Tools display.

>;. Chec% to see if the test label prints properly (ith all lines of configured

tet visible on the label. *epeat printing a test label if necessary.

>>. Tap the C6C4+G button to eit 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.

>. Tap the 0+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


>9. In the event that printer error or label application error persists$ contactBD Technical &ervice and &upport at >-:;;-9?:-:99? or your local BD

representative for assistance.

!aimum Bi-plate Failures

!aimum Bi-plate Failures notification occurs (hen a batch has been initiatedand bi-plates are epected 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.


audible alert.


?. *emove the (hole plates from the input carousel stac%"s#.. *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 ensurethey are not cold$ fogged$ or (et. This may ta%e more than > hour. 2hile

plates are out$ protect them from light eposure if they are light-sensitive.


@. Tap the 0+LG button to resume processing the batch.

:. The batch header and batch dra(er on the !ain *un Time display turn


!aimum !ar%ers Failures

!aimum !ar%ers Failures notification occurs in &trea%-'nly mode (henthere 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( aredetected.


audible alert.


?. *emove the plates from the *e5ect stac% of the output carousel.

. 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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@. Tap the 0+LG button to resume processing.

:. The batch header and batch dra(er on the !ain *un Time display turnlight green to indicate the batch has resumed processing.

*e5ected 0lates

The re5ect stac% contains any re5ected plates. plate is re5ectedG if it is not

processed correctly. *e5ected plates must be removed from the re5ect stac% andeither re-loaded into the instrument or strea%ed manually.

*e5ected plates can be vie(ed by tapping the re5ect stac% symbol "letter *G# on

the output carousel. red re5ected plate indicates a processed plate "may or maynot 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 net 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.

. *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 ToolsG button from the !ain *un Time display.

b. &elect the Clear 'utput &tac%sG button.

c. popup message appears (ith instructions to open the carouseldoor 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 'KG button on thepopup 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 empty stac%sG icon.

b. popup message bo appears (ith instructions to open thecarousel 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 'KG button on the

popup message.

d. 'n the !ain *un Time display$ all output stac%s turn (hite.

. 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 messagebo indicates that stac% is empty.

b. Tap the center empty stac%sG icon.

c. popup message bo appears (ith instructions to open the

carousel door and empty that stac%. The tag for the selected outputstac% is provided.

d. 'nce the selected output stac% is emptied$ tap the '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 clearedfrom 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 C+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

etended periods of inactivity. 3o(ever$ to ensure that the Innova instrument is

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accessible for diagnostics and data collection "for eample$ 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" a) ca%se sof"+a(e fi$e &aa'e,

To completely shutdo(n Innova)>. fter the last sample has been processed$ tap 0'24*G on the !ain *un

Time display. This turns off the soft(are. popup appears to confirm theshutdo(n. &elect 'KG to proceed or C6C4+G to return to the /ser

display.

8. If po(er is not removed (ithin a fe( minutes$ press the computer po(erbutton 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$ anddoes 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 ofthe 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 thosecontainers may contain different specimen types.

Compatible media plates must conform to the follo(ing measurements) 0late lid

diameter) 8 ` 8 mm$ 0late height) >.A - >9 mm$ 0late lid recess) > 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)Date 4ffective)

&upervisor)Date)

Director)Date)*evie(ed)

?8;>?

BD is a trademar% of Becton$ Dic%inson$ and Company.

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Documents

Innova CLSI Procedure