BD Phoenix M50 System Manuale utente

BD Phoenix™ M50 System Quick Reference Guide
Phoenix™ M50 System
Quick Reference Guide
Icon Reference
Panel Login
QC Panel Testing
Preparing Panels
Preparing Emerge Panels
Results
Reports Overview
Needs Attention
Isolation Mode
Maintenance
Error Codes
Organism Barcodes
Before using this Guide, it is important that all users review the
BD Phoenix™ M50 System User’s Manual and package inserts for
comprehensive operating instructions, including important
warnings relating to operator safety.
Becton, Dickinson and Company
7 Loveton Circle
Sparks, Maryland 21152 USA
Australian Sponsor:
Becton Dickinson Pty Ltd.
66 Waterloo Road
Macquarie Park NSW 2113
Australia
New Zealand Sponsor:
Becton Dickinson Limited
14B George Bourke Drive
Mt. Wellington Auckland 1060
New Zealand
Made in USA
500004680(04) 2021-06
443894

BD Phoenix™ M50 System Quick Reference Guide
CHANGE HISTORY
Revision Date Change Summary
03 2020-04 Added a second option for Preparing Emerge Panels.
Added codes regarding instrument identification: W900; W901; W904; and
W905 to Error Codes Table. Updated Australia Sponsor address.
04 2021-06 Added New Zealand sponsor address.
Modified instructions for Preparing Emerge Panels.
Removed EU authorized representative address.
ATCC®is a trademark of American Type Culture Collection.
BD, the BD Logo, BBL, CrystalSpec, EpiCenter, EMERGE, Phoenix, and PhoenixSpec are trademarks of Becton, Dickinson and Company
or its affiliates. © 2021 BD. All rights reserved.
No part of this publication may be reproduced, transmitted, 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 USA.
2

BD Phoenix™ M50 System Quick Reference Guide
STATUS SCREEN
Results *Finalization Inventory Reports
Icons
Collapsed Expanded Enabled Print Help
Log in/Log Out Silence Alarm Status Panel Login
* Icon does not appear when connected to BD EpiCenter™.
3

BD Phoenix™ M50 System Quick Reference Guide
ALERTS/NOTIFICATIONS STATION STATUS
*Cannot Finalize System Alert Special Message Blocked Station Empty Station
PANELS NEEDS ATTENTION
Ongoing
Panel
Removable
Panels,
Complete
Final ID
Edited, AST
Result
Edited
*Resistance
Marker
Rapid
Complete
Active
Alert
No Active
Needs
Attention
Active
Needs
Attention
* Icon does not appear when connected to BD EpiCenter™.
4

BD Phoenix™ M50 System Quick Reference Guide
INSTRUMENT STATUS
Door Locked Door Unlocked Idle Processing Data Warming Up Temperature
Testing Instrument
Number
Light Source
Adjustment
(RGB, UV)
Inventory Scan Isolation Recovery
(Uploading Data)
**BD EpiCenter™
Configured and
Connected
**BD EpiCenter™
Configured but
not Connected
*LIS Configured
and Connected
*LIS Configured
but Disconnected
Instrument
Connection Status
– Connected
(All-in-One PC to
Instrument)
Instrument
Connection Status
– Disconnected
(All-in-One PC
to Instrument)
* Icon does not appear when connected to BD EpiCenter™.
** Icon does not appear when in standalone mode.
5

BD Phoenix™ M50 System Quick Reference Guide
Panel Login
1 Press the Panel Login tab and select Clinical.
2 To receive special notification when results are obtained, select Critical.
3 In the Accession Number field, type in/scan an accession number.
4 In the Sequence Number field, type in/scan the panel’s sequence number.
5 The Isolate Number field defaults to isolate number 1. Type in the isolate number. Valid isolate numbers are 1 to 20.
6 If only the ID or AST portion of a combination panel is being used, disable the part of the panel not being used.
7 If ID is disabled, or if an AST only or BD Phoenix™ EMERGE™ panel is not being used, the Organism ID field appears.
8 For Yeast panels, select the media type in the media field.
9Save the information.
10 Insert the panel in the instrument (refer to Section 5.2.3 of the BD Phoenix™ M50 System User’s Manual).
Panel Login
6

BD Phoenix™ M50 System Quick Reference Guide
To Test QC Panels
1
2
Inoculate a panel with one of the organisms listed in the package insert.
To log the panel in as a QC panel:
a Press the Panel Login tab.
b Select QC panel.
c If desired, in the Accession Number field, type in/scan an accession number.
d In the Sequence Number field, type in/scan the panel’s sequence number.
e If a combination panel is being used, both ID and AST are automatically enabled.
f The Isolate Number field defaults to 1. Valid isolate numbers are 1 to 20.
g Select QC organism selection box in the Test Strain field. Highlight the desired QC organism or scan the appropriate barcode provided in
this guide.
h For Yeast ID panels, select the media field to the right of the isolate number. Select the desired media type.
i In the Tech ID field, enter the identification for the technologist performing the QC test.
j In the Panel Lot Number field, type in or scan the panel’s lot number (completed automatically when Panel Lot feature is enabled and
panel sequence barcode is scanned).
k In the first Panel Lot Number Expiration Date field, enter the expiration day, month, or year (depending on the configuration). If the Panel
Lot feature is enabled, this field is completed automatically when the panel sequence barcode is scanned.
l The ID Broth lot number is optional. If desired, in the ID Broth Lot Number field, type in or scan the broth lot number. If a lot number is
entered, an expiration date must be entered also.
m The AST Broth lot number is optional. If desired, in the AST Broth Lot Number field, type in or scan the broth lot number. If a lot number is
entered, an expiration date must be entered also.
n The Indicator Lot number is optional. If desired, in the Indicator Lot Number field, type in or scan the lot number. If a lot number is entered,
an expiration date must be entered also.
oSave the information.
3
4
Place the panel in the instrument.
When panel testing is complete, review the results for accuracy in the Panel Results display.
QC Panel Testing
7

BD Phoenix™ M50 System Quick Reference Guide
Preparing Panels
1 Confirm the isolate’s Gram stain reaction.
2 Remove the appropriate panel from the pouch.
Use panel within 2 hours of removal from pouch.
3 Place the panel on the Inoculation Station with the inoculation ports on top.
4 Label a BD Phoenix™ ID Broth tube with the patient’s specimen number. Using aseptic technique, pick colonies of the same morphology with the tip of a sterile cotton
swab or a wooden applicator stick from the media.
5 Suspend the colonies in the BD Phoenix™ ID/Inoculum broth.
6 Cap the tube and vortex for five seconds.
7 Allow approximately ten seconds for air bubbles to surface.
8 Insert the tube as far as it will go into the BD BBL™ CrystalSpec™/BD PhoenixSpec™ Nephelometer.
9 If the Inoculum Density is configured for 0.5, read the tube to confirm 0.5 McFarland (0.50–0.60 is acceptable). If the Inoculum Density is configured for 0.25, read the tube
to confirm 0.25 McFarland (0.20–0.30 is acceptable). Yeast ID panels must be inoculated using a 2.00–2.40 McFarland inoculum density. SMIC and SMIC/ID panels must
be inoculated using a 0.50 McFarland inoculum density. If the density of organisms is low, the user can add colonies from the isolate. Re-vortex the sample and reread. If
the inoculum concentration in the tube exceeds the acceptable range, refer to Section 6.2.3, Step 10 of the User’s Manual for instructions.
!
Confirm settings for Inoculum Density BEFORE inoculating panels. Refer to the manual for instructions on Inoculum Density Flexibility.
Standardized bacterial suspension in ID broth must be used within 60 minutes of preparation.
10 If identification only is being performed, proceed to Step 15 and continue.
11 Label a BD Phoenix™ AST Broth tube (8.0 mL) with the patient’s specimen number. Add one free-falling drop of AST Indicator solution to the AST broth tube. Invert to
mix. DO NOT VORTEX.
Tubes must be used within 2 hours after the addition of AST Indicator solution if exposed to light (8 hours if stored in dark).
12 Using a pipettor, transfer the following amounts of bacterial suspension from the ID tube into the AST broth tube: for Inoculum Density of 0.5 McFarland, transfer 25 µL;
for Inoculum Density of 0.25 McFarland, transfer 50 µL.
Panels must be inoculated within 30 minutes of the time that the AST broth inoculum is prepared.
13 Cap the AST tube and invert several times to mix. DO NOT VORTEX.
14 Wait a few seconds for air bubbles to surface.
15 Pour the ID tube inoculum into the fill port on ID side of the panel. DO NOT overfill the panel. Allow the fluid to traverse down the tracks before moving it. If an AST
(only) panel is being used, DO NOT inoculate the ID side of the panel. Retain the ID tube for an optional purity check.
16 Pour the AST broth inoculum into the fill port on the AST side of the panel. DO NOT overfill the panel. Allow the fluid to traverse down the tracks before moving it.
17 Before placing panel closures, check for droplets of inoculum on the edge of the fill port. Remove with absorbent material if present.
18 Fully snap on the panel closures. Ensure that the closures are fully seated.
19 Visually inspect panels to be sure each of the wells is full. Look at both sides of the panel. Make certain that the wells are not overfilled. If any of the wells are improperly
filled, reinoculate a new panel.
Panels must be loaded into the instrument within 30 minutes of inoculation.
Panel Prep
8

BD Phoenix™ M50 System Quick Reference Guide
Preparing BD Phoenix™ EMERGE™ Panels
Option 1: Two tubes of AST broth will be required.
1 Follow Steps 1–10 (refer to Section 6.2.3 General Panel Preparation of the BD Phoenix™ M50 System User’s Manual) to prepare the suspension
of bacteria.
2 Label two BD Phoenix™ AST Broth tubes (8.0 mL) with the patient's specimen number. Add one drop of the BD Phoenix™ AST Indicator to each
AST broth tube. Invert to mix. DO NOT VORTEX.
3 Transfer 25 μL (50 μL if low inoculum option is used) of the suspension to two BD Phoenix™ AST Broth tubes. Cap and gently invert.
4 Using sterile technique, remove 3.5 mL of broth from one of the inoculated BD Phoenix™ AST Broth tubes and discard in an appropriate container.
5 Pour the remaining 4.5 mL into the left side of the BD Phoenix™ EMERGE™ panel. Allow the fluid to traverse down the tracks before moving the
panel.
6 Pour the other BD Phoenix™ AST Broth tube into the right side of the BD Phoenix™ EMERGE™ panel. Allow the fluid to traverse down the tracks
before moving the panel.
7 Snap on the panel closures and follow the normal panel login procedure.
Option 2: BD Phoenix™ EMERGE™ AST Broth (12.5 mL) and BD Phoenix™ EMERGE™ AST Indicator are required.
1 Follow Steps 1–10 (refer to Section 6.2.3 General Panel Preparation of the BD Phoenix™ M50 System User’s Manual) to prepare the suspension
of bacteria.
2 Label a BD Phoenix™ EMERGE™ AST Broth tube (12.5 mL) with the patient's specimen number. Add one drop of BD Phoenix™ EMERGE™
AST indicator into the Emerge AST Broth, cap and gently invert to mix. DO NOT VORTEX.
3 Transfer 39 μL (78 μL if low inoculum option is used) of the suspension to the BD Phoenix™ Emerge AST broth with indicator. Cap and invert
several times to mix. DO NOT VORTEX.
4 Pipette 4.5 mL of inoculated AST broth into the 51-well side (left side) of the BD Phoenix™ Emerge panel. Allow the fluid to traverse down the
tracks before moving the panel.
5 Pour the remaining inoculated Emerge AST broth into the 85-well side (right side) of the BD Phoenix™ Emerge panel. Allow the fluid to traverse
down the tracks before moving the panel.
6 Snap on the panel closures and follow the normal panel login procedure.
9
BD EMERGE™ Panel Prep

BD Phoenix™ M50 System Quick Reference Guide
Results
MIC
For test panels
? MIC determination is pending (SIR values remain blank)
X MIC value cannot be produced; or Final ID is not claimed in the Taxa listing for AST testing; or the panel’s drug dilution series does
not cover the BD Phoenix™ reportable MIC range; or for additional causes see Special messages
> Growth occurred for all concentrations of antimicrobial
≤No growth occurred in any concentration of antimicrobial
C Rapid Complete (MIC is pending, BDXpert SIR is based on ID and completed drug and/or resistance marker results). Replaced by
actual MIC values as they are determined.
For QC panels
P Actual MIC value within expected MIC range
F Actual MIC value not within expected MIC range (or is “X”)
Blank No range defined for antimicrobial/organism combination
Interpretations
S Susceptible
I Intermediate
R Resistant
N Not Susceptible (Indicates that the antimicrobial/organism does not have an upper breakpoint. When there is no upper breakpoint
there are no criteria for calling an organism intermediate or resistant. This often occurs when there is an absence of or rare
occurrence of resistant strains of an organism. In this case, if the MIC is below the lower breakpoint the SIR results can be reported
as susceptible but if the MIC is above the lower breakpoint the only result that can be reported is N or not susceptible.)
X Cannot produce interpretation
Blank No SIR (missing or invalid Final ID; MIC = ?, C, or X; unclaimed organism for Final ID)
10
Results
Indice
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