BD PhoenixSpec, Руководство пользователя, Страница: 2 / 13

INTENDED USE
The BD PhoenixSpec™ Nephelometer is a portable device designed to measure turbidity of
microbial suspensions equivalent to McFarland standards 0.10 to 4.50. The instrument may be
used for measurement of inoculum density for the BBL Crystal™ System and the BD Phoenix™
System. The instrument is battery operated or can be used with an AC adapter.
SUMMARY AND EXPLANATION
The visual comparison of organism suspensions to turbidity standards is an accepted method of
estimating organism densities. The most widely accepted standard is the McFarland standard. 1 A
McFarland standard is prepared by adding barium chloride to aqueous sulfuric acid. The density
of the resulting barium sulfate precipitate can be used to approximate the colony count of a
prepared suspension; e.g., McFarland 1 is the equivalent of approximately 3.0 x 10 8 colony
forming units (CFU)/mL of E. coli, ATCC™ 25922. Other standards have been used for density
measurements, including titanium dioxide 2 and latex particle suspensions. 3 The PhoenixSpec
Nephelometer uses latex particle suspensions as calibration standards that do not require
shaking before use.
The instrumented measurement of turbidity relies on the ability of particles to scatter light while
in suspension. The measurement of this scattered light is referred to as nephelometry. 4 In order
to obtain an accurate density measurement, a reliable method of calibration must be used.
PRINCIPLES OF THE PROCEDURE
The PhoenixSpec Nephelometer is a solid state instrument that uses a tungsten-filament lamp as
a light source, a 90° detector to monitor scattered light and a transmitted light detector. The
instrument’s microprocessor calculates the ratio of the signals for the 90° and transmitted light
detectors. The ratiometric technique compensates for color and/or light absorbing materials, and
for fluctuations in lamp intensity.
Before making measurements, the
PhoenixSpec instrument is calibrated with the PhoenixSpec
or PhoenixSpec AP Calibrator Kit. To determine the McFarland equivalent of a microbial
suspension, a tube is placed in the reading chamber and the test button is pressed. The results
are displayed on the LCD screen in McFarland units. On a daily basis, the 0.25 and 0.5 calibrators
in the PhoenixSpec Calibrator Kit, are read as a sample to assure proper operation. On a daily
basis, the 0.25, 0.5 and 2.0 calibrators in the PhoenixSpec AP Calibrator Kit, are read as a sample
to assure proper operation.
SPECIFICATIONS
Warnings and Precautions
For in vitro Diagnostic Use.
1. The BD PhoenixSpec Nephelometer is designed to work with BD “L” tubes (16 x 75 mm)
only. The minimum acceptable fill volume is 2.0 mL.
2. The BD PhoenixSpec Nephelometer is designed for use with BD Phoenix and BBL Crystal
Systems only.
PROCEDURE
Materials Provided: BD PhoenixSpec
Nephelometer, AC Adapter, PhoenixSpec Calibrator Kit
(0.25, 0.5, 1.0 and 4.0 McFarland Units), PhoenixSpec AP Calibrator Kit (0.25, 0.5, 1.0, 2.0 and 4.0
McFarland units), and 4 AA Alkaline batteries (not rechargeable).
Materials Required But Not Provided: Ancillary culture media and equipment required to
prepare a bacterial suspension.
Instructions:
BATTERY INSTALLATION AND REPLACEMENT – Remove the instrument and batteries from the
shipping box. Remove the battery compartment cover from the instrument bottom and install
the batteries. Correct battery polarity is shown on the battery holder. Reinstall the battery
compartment cover.
USING THE AC ADAPTER – Plug the adapter jack into the instrument’s connector. The AC Adapter
may be used with or without the batteries installed. The AC Adapter will not recharge the
installed batteries.
CALIBRATION PROCEDURE –
Notes:
• The instrument should be calibrated every three months, when the daily calibration verification
check of the 0.25, 0.5 and/or 2.0 PhoenixSpec Calibrators read outside the 0.23 – 0.27, 0.45 – 0.55
and 1.8 – 2.2 McFarland range, respectively, or as dictated by the laboratory’s experience or policy.
• Use only the PhoenixSpec or PhoenixSpec AP Calibrator Kit supplied for use with the
PhoenixSpec Instrument.
• Keep the PhoenixSpec Calibrators in the supplied packaging to avoid scratching the tubes, as
could happen in a metal test tube rack, for example. Scratches or dirt on the surface of the
tubes can affect readings.
• Do not use the PhoenixSpec Calibrators beyond the expiration date which appears on the label.
• The instrument should be placed on a stationary, level surface.
• If an error code flashes on the LCD screen during the procedure, refer to the TROUBLESHOOTING
section.
• The PhoenixSpec Calibrators do not require shaking before use.
1. Press the power button to turn instrument ON.
2. Insert the 0.25 PhoenixSpec Calibrator into the reading chamber. Press the Calibration
button.
3. The screen will flash S1 (Standard 1).
4. Press the Read button . The screen will count backwards from 10.
5. The screen will flash S2 . Remove the 0.25 Calibrator and insert the 1.0 Calibrator. Press the
Read button.
6. The screen will count backwards from 10, then flash S3 . Remove the 1.0 Calibrator, insert the
4.0 Calibrator and press the Read button.
7. The screen will count backwards from 10, then go back to S1 . Press the calibration
button.
8. Remove the 4.0 Calibrator. Calibration is now complete.
Note: If errors occur, refer to the TROUBLESHOOTING section.
TESTING PROCEDURES –
Notes:
•
The instrument should be placed on a stationary, level surface.
• On a daily basis, the 0.25 and 0.5 PhoenixSpec Calibrators for the PhoenixSpec Calibrator Kit
or the 0.25, 0.5 and 2.0 PhoenixSpec Calibrators for the PhoenixSpec AP Calibrator Kit must be
read as samples and the readings must fall between 0.23 – 0.27 (for the 0.25), 0.45 – 0.55 (for
the 0.5) and 1.8 – 2.2 (for the 2.0). If either reading falls outside its corresponding range,
recalibrate the PhoenixSpec instrument.
• The PhoenixSpec Calibrators do not require shaking before use.
1. Press the power button to turn the instrument ON.
2. Vortex the capped test sample and let bubbles disperse for 10 seconds.
3. Lift the lid, and insert the tube.
4. Press the Read button.
5. Read the display after the lamp symbol turns off.
Range ..............................McFarland 0.10 – 4.50
Accuracy ..........................0.5 ± 0.08 McFarland
2.0 ± 0.1 McFarland
Repeatability....................0.5 ± 0.04 McFarland
2.0 ± 0.1 McFarland
AC Mains Power................120 VAC ± 10%, 60 Hz
230 VAC ± 10%, 50 Hz
Battery..............................Four Size AA Alkaline Cells
Battery Life-
in-Use, # Tests ..................2300 Tests
Ambient Operating
Conditions ........................20 ° C to 30 ° C
0 to 90% RH at 30 ° C;
0 to 80% RH at 40 ° C;
0 to 70% RH at 50 ° C
Storage Temperature Range
Nephelometer: ................-40 ° C to 60 ° C (-40 ° F to 140 ° F)
Calibrators: ........................5°C to 60°C
Sample Tube Size ............ BD ”L”tube,
16 mm diameter,
75 mm height,
Lamp Life..........................~ 400,000 readings
0
PhoenixSpec
™
Nephelometer
User’s Guide
8 8012507
2011/05
English: pages 1 – 2 Italiano: pagine 5 – 7 Japanese: 10 - 11
Français : pages 2 – 4 Português: páginas 7 – 8
Deutsch: Seiten 4 – 5 Español: páginas 8 – 10