FACSPresto SVC - MNL-Distributor - NOT A Released Version

BD FACSPresto
Service Manual
Doc. Number 658892

Confidential Rev. 01
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every precaution to ensure accuracy, BD Biosciences assumes no liability for any errors or omissions, nor for any
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its products and services at any time to incorporate the latest technological developments. Although this guide
has been prepared with every precaution to ensure accuracy, BD Biosciences assumes no liability for any errors
or omissions, nor for any damages resulting from the application or use of this information. BD Biosciences
welcomes customer input on corrections and suggestions for improvement.
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ii BD FACSPresto Doc. Number 658892

Table of Contents
Safety
Safety Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Biological Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Theory of Operation
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Electrical System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Software Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Power On Self-Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Instrument Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Cartridge Quality Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Component Descriptions
Front Enclosure Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Rear Panel Enclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
CD4 Excitation Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Detection Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Chassis PCB Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Chassis, Fan, and Speaker Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
Installation
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Installing the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Doc. Number 658892 BD FACSPresto iii

Rev. 01 Confidential
Instrument Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Servicing Requirements
Service Tool Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

Servicing Safety and Precaution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Installing FACSPresto Final Test Software and Local Database . . . . . . . . . . . . .5-8
FACSPresto Final Test Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55
Replacement Procedures
Replacing the Rear Enclosure Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
Replacing the Excitation LED Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
Replacing the PCB Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6
Replacing the Fan and Speaker Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Replacing the Detection Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Replacing the Front Enclosure Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Troubleshooting
Error Log Software Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
GUI Troubleshooting Guide For IFU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26
Index
iv BD FACSPresto Doc. Number 658892

Safety – Safety Conventions
1
Safety
The Safety chapter consists of the following topics:
• Safety Conventions on page 1-1
• Limitations on page 1-1
• General Precautions on page 1-2
• Electrical Safety on page 1-3
• Biological Safety on page 1-4
Safety Conventions
The following hazard symbols are used in this manual or on safety labels to alert
you of a potential hazard.
Symbol Meaning
Caution alert
Identifies a hazard or unsafe practice that could result in data loss,
material damage, minor or severe injury, or death. When you see this
symbol, refer to the accompanying information about the caution.
Biological hazard
Risk of exposure to materials that are biological in nature.
Electrical hazard
Mechanical hazard, pinch points
Limitations
Intended Use
BD FACSPresto™ Near-Patient CD4 Counter is an automated system for in vitro
diagnostic use in performing the direct enumeration of CD4 absolute count, CD4
percentage of lymphocytes, and hemoglobin concentration in human whole blood.
Doc. Number 658892 BD FACSPresto 1-1

Safety – General Precautions
General Precautions
To prevent injury, carefully read the following safety precautions. Read all related
warnings and cautions before starting any procedure from this manual. Get
additional information from the BD Bioscience Employee Health and Services web
page (http://bdone.bdx.com/main.aspx?sid=196&cat=7207&d=1&id=11811).
Risk General system precautions
To prevent hazards, the BD FACSPresto instrument and attached

accessories must be used as specified by the manufacturer.
Always use universal precautions when handling biological specimens or

instruments that contact the specimen.
• Never pipette by mouth.
• Wear suitable pretective clothing, eyewear, and gloves.
• Handle all biological specimens and materials as if they are capable
of transmitting disease.
• Handle all biological specimens and materials in accordance with
applicable regulations and manufacturer specifications.
• Dispose of waste using proper precautions and in accordance with
local regulations.
Electrostatic discharge (ESD) is responsible for the spark generated
when you touch objects such as a doorknob on a dry day.
BD FACSPresto contains sensitive electronics susceptible to interference
from electrostatic discharge. ESD can cause temporary instrument
malfunction. Do not touch areas marked as ESD sensitive while the
instrument is in operation.
1-2 BD FACSPresto Doc. Number 658892

Safety – Electrical Safety
Electrical Safety
For protection against electrical shock, equipment should be connected to an

approved power source. Where applicable, a grounded outlet must be used.
Do not, under any circumstances, remove the grounding prong from the power
plug, if it is present. Do not use extension cords or daisy-chain powerstrips.
Powerstrips should be placed on a non-combustible surface such as a lab bench or
tile floor.
Warning: Electrical
Many portions of the electrical system, including the printed circuit boards, are at
a dangerous voltage level.
• To prevent shock injury, follow the electrical safety guidelines.
To prevent exposure to potential electrical shock hazards:

• Turn off the power switch and unplug the power cord before performing any
system maintenance on the instrument, unless otherwise noted. Remove the
internal rechargeable battery before attempting any other Service procedures.
• Connect the equipment only to an approved power source. Do not use extension
cords.
• Do not use damaged cords, plugs, or cables. Immediately replace any damaged
cords, plugs, or cables.
• Do not remove the grounding prong from the power plug. Have a qualified
electrician replace any ungrounded receptacles with properly grounded
receptacles in accordance with the local electrical code.
• Do not perform instrument maintenance or service procedures except as
specifically stated in the service manual.
• Make sure that the AC power cord for the BD FACSPresto system is accessible.
This will allow you to quickly disconnect power if an emergency arises.
• Do not defeat any safety interlocks on the instrument.

Safety – Biological Safety
Biological Safety
Warning: Biological
Treat all biological specimens and materials as if they could can transmit
potentially fatal disease.
• To prevent exposure to biohazardous agents, follow the biosafety guidelines.
Biosafety Guidelines
• Always use universal precautions when handling biological specimens or
instruments that contact the specimen.
• Handle all biological specimens and materials as if capable of transmitting
disease.
• Handle all biological specimens and materials in accordance with applicable
regulations and manufacturer specifications.
• Dispose of waste using proper precautions and in accordance with local
regulations.
• Never pipette by mouth.
• Wear suitable protective clothing, eyewear, and gloves.
• Expose waste container contents to bleach (10% of total volume) before
disposal.
For information on laboratory safety, refer to the following guidelines:
• Schmid I, Nicholson JKA, Giorgi JV, et al. Biosafety guidelines for sorting of
unfixed cells. Cytometry. 1997; 28:99-117.
• Protection of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline – Third Edition. Wayne, PA: Clinical and Laboratory
Standards Institute, 2005. CLSI document M29-A3.
• Procedures for the Handling and Processing of Blood Specimens; Approved
Guideline – Third Edition. Wayne, PA: Clinical and Laboratory Standards
Institute; 2004. CLSI document H18-A3.
The two CLSI documents listed above can be ordered online at www.clsi.org.
• European Council Directive on the protection of workers from risks related to
exposure to biological agents at work (90/679/EEC) and its relevant national
transpositions.

Biosafety Levels
There are four biosafety levels1 (BSL):
• BSL1 represents practices, safety equipment, and facility design for work done
with defined and characterized strains of viable microorganisms not known to
consistently cause disease in health human adults.
• BSL2 represents practices, equipment, and facility design where work is done
with the broad spectrum of indigenous moderate-risk agents that are present in
the community and associated with human disease of varying severity. This level
is appropriate when working with any human-derived blood, body fluids,
tissues, or primary human cell lines where the presence of infectious agent may
be unknown.
• BSL3 represents practices, safety equipment, and facility design where work is
done with indigenous or exotic agents with a potential for respiratory
transmission, and which may cause serious and potentially lethal infection.
• BSL4 represents practices, safety equipment, and facility design for work with
dangerous and exotic agents that pose a high individual risk of life-threatening
disease, which may be transmitted via the aerosol route and for which there is
no available vaccine or therapy.
This equipment is decontaminated internally and then sterilized externally (in a
vapor chamber) before being moved to a BLS2 environment for servicing.
Each of the four levels requires a different set of protective practices and lab
environment. Prior to working on any equipment, consider the guidelines for
working in the BSL2, BSL3, and BSL4 environments.
1. Reference Biosafety in Microbiological and Biomedical Laboratories 5th Edition - BMBL 5th Edition

BSL1 Environment
Consider the following guidelines when working in a BSL1 environment:
1 Is the equipment in an infectious environment?
• If yes, skip to BSL2 Environment on page 1-6.
• If no, continue to step 2.
2 Are there other hazards of concern?
• If yes, skip to BSL2 Environment on page 1-6.
• If no, perform the required service on the equipment.
BSL2 Environment
1 Is the equipment in a BSL2 environment?
• If yes, continue to step 2.
• If no, skip to BSL3 Environment on page 1-6.
2 Has the equipment been in contact with an infectious agent?
3 Will the lab decontaminate the equipment?
• If yes, and after decontamination, perform the required service on the
equipment.
• If no, contact BD Biosciences.
BSL3 Environment
1 Is the equipment in a BSL3 environment?
• If no, skip to BSL4 Environment on page 1-7.
• If yes, and after decontamination, continue to step 4.

4 Will the lab move the equipment to a BSL1 or BSL2 location?

• If yes, perform the required service on the equipment.
BSL4 Environment
• If yes, and after decontamination, continue to step 3.
• If no, do not service the equipment.
3 Will the lab move the equipment to a BSL1 or BSL2 location?
• If yes, contact BD Biosciences.
• If no, do not service the equipment.


Theory of Operation – System Specifications
2
Theory of Operation
The Theory of Operation chapter consists of the following topics:
• System Specifications on page 2-1
• Electrical Requirements on page 2-1
• Operating Environment on page 2-2
• System Overview on page 2-3
• Electrical System on page 2-8
System Specifications
Component Specification (W x D x H)
Dimensions 25.9 x 25.1 x 28.5 cm

(10.20 x 9.88 x 11.22 in.)
Crated Instrument 36.2 x 36.2 x 47.0 cm
Dimensions (14.3 x 14.3 x 18.5 in.)
Weight 6 kg
13.23 lbs.
Clearance requirement 1.27 cm
on the back side of the (0.5 in.)
equipment
Electrical Requirements
The system power supply has the following electrical power input requirements:
100–240 VAC, 50–60Hz.
The system power supply provides the following electrical power:
18 VDC, 3.3 A.

Theory of Operation – Operating Environment
Operating Environment
Item Requirement
Temperature Operating 10–40°C (50–104°F)

Storage 0–50°C (32–122°F)
at less than or equal to 2,500 meters above sea level
Humidity 10–95% non-condensing
Vibration Do not operate the instrument near a running vortexer,
centrifuge, or microfuge
Heat dissipation Up to 25 W

Theory of Operation – System Overview
System Overview
BD FACSPresto is a self-contained, portable system for analyzing absolute CD4

counts, CD4+ percent of lymphocytes, and hemoglobin (Hb) levels from peripheral
blood treated with fluorescent antibody-dye conjugates.
BD FACSPresto is capable of operating from an external power source or from its
internal rechargeable battery.
The system uses a Becton Dickenson (BD) proprietary single-use disposable
cartridge method of presenting a clinical sample of blood into the instrument for
analysis. This cartridge contains all the necessary reagents and Quality Control
(QC) features to automatically prepare a sample for analysis. Once the sample is
introduced into the cartridge, it can be sealed to prevent leakage and exposure risks
using its integral protection cap. The cartridge is then inserted into the instrument
where both QC and analysis are handled automatically without operator
intervention.
BD FACSPresto technology is based on fluorescent photo-microscopy and light
absorbance detection, on a multi-color platform. Samples are illuminated and the
resulting images are captured through a microscope lens system by a digital camera
assembly. The captured images are then analyzed by software and results are
reported to the operator. CD4 analysis uses photo-microscopy and multicolor
fluorescence for detection of lymphocytes while Hb analysis is performed using
light absorbance with a spectrophotometer.
BD FACSPresto performs self-tests of the system functions and system measurement
quality and then reports the results to the user. These tests are performed
automatically at instrument startup and prior to analyzing a sample or upon user
request via the touch screen. There are three instrument QC features co-located on
a single assembly:
• QC1 a glass window
• QC2 a set of bright field features also known as the “Starfield”
• QC3 a dual bandpass filter
QC1 and QC3 are used to calibrate the spectrophotometer and QC2 is used for
CD4 quality checks. The cartridge contains additional QC features for CD4. The
overall strategy provides full QC on both the instrument and the cartridge that is
transparent to the user.

Workflow
When a cartridge is inserted in the open cartridge slot at the front of the instrument,
the cartridge is captured and moved into the detection module and the slot is closed.
PRior to assay processing, the cartridge is illuminated by a white LED and the
barcode is imaged by the 2-D barcode camera and the image is sent to the user
interface module for processing and storage of the data. the cartridge QC beads are
also detected to ensure that the cartridge reagents are intact and the blood filled
completely.
The instrument performs a QC for CD4 using a built in test standard called a
“starfield” due to its fluorescent dot features. The starfield is illuminated from the
top side by the CD4 excitation module through two fiber optic bundles. The
imaging camera captures images through the appropriate filters and sends them to
the user interface module for processing and analysis.
The instrument also performs a QC for Hb using another built in test standard that
is illuminated from below by two LEDs; one white and one infrared (IR). The
imaging camera captures images through the appropriate filters and sends them to
the user interface module for processing and analysis.
Depending on the results of the QC, the cartridge is either processed or it is rejected,
and then ejected from the slot.
Cartridge processing follows the same optical excitation and collection steps for
CD4 and Hb as the QC. However, the cartridge is imaged instead of the test
standard and the image processing algorithm is looking for cells instead of QC
features. After a cartridge is processed, it is ejected.
Instrument QC is performed automatically during instrument startup or manually
via user input to the LCD touch screen.

BD FACSPresto Cartridge
1 2 3 4 5 6 7 8 9
10 11 4 12 13 14
Item 1 Cap Covers the inlet port and acts as a biohazard containment mechanism.
Item 2 Inlet port Receives blood or process control into the cartridge using the pipet or finger
stick.
Item 3 Channel Allows you to view the blood or process control in the cartridge before closing
the cap.
Item 4 Ridges Place to hold the cartridge.
Item 5 Insert blood Indicates the step to put blood into the cartridge.
Item 6 Barcode Scanned by the instrument to identify each cartridge.
Item 7 Incubate Indicates the step to incubate sample in the cartridge.
Item 8 Expiration date Date by which the cartridge must be used.
Item 9 Remove channel Indicates the step to remove the channel protector before inserting the
protector cartridge into the instrument.
Item 10 Containment zone Catches blood of process control that overflows from the inlet port.
Item 11 Patient number Indicates the space to write the patient ID or process control number before
putting blood or process control into the cartridge. Do not write on any other
part of the cartridge.
Item 12 Channel protector Protects the sample in the cartridge from light and dirt during incubation.The
channel protector must be removed before inserting the cartridge into the
instrument.
Item 13 Lot number Identifies the cartridge’s lot number. There are multiple cartridges per lot.
Item 14 Fill indicator Indicates the sample in the cartridge. The fill indicator should be ful of blood or
process control.
The assay cartridge is a one-time use disposable cartridge containing all the
necessary reagents, QC, and safety features. 25 µL of sample is introduced into a
chimney where it mixes with the reagents. A moat around the chimney contains
spill-off of up to 150 µL. The sealing cap is closed to seal the sample and any excess,
protecting both the user and the instrument from biohazard contamination.

Once the tear strip is removed, the following cartridge components are exposed:
• Central capillary channel which is optically transparent and contains 10 FOVs
for CD4 and Hb measurements
• An FOV containing a known quantity of stained QC beads
• A hemoglobin reference window for Hb QC
QC beads
FOV1 FOV10
Hb QC
Vent outlet Capillary stop

Central capillary channel
The Hb reference window is used by the instrument to locate the relative position of
all the imaging FOVs. If the Hb reference window is obscured, the cartridge will not
be read, and it will be ejected. The cartridge contains a capillary stop at the end of
the assay channel that prevents sample flow after the channel is full, but allows
continued filling of the main channel.
Optical System CD4 Measurement
CD4 Measurement
CD4 measurement is performed using photo-microscopy and multicolor
fluorescence. The sample is illuminated from above providing excitation
wavelengths for the fluorescent stains used in the immunophenotyping assay. Two
LEDs are used as the excitation sources, one green and one orange. To compute
CD4 measurements, the system analyzes color images of whole blood stained with
CD3 APC, CD4 PE-Cy5, CD14 PE, and CD45RA APC. CD45 is used to identify
the total population of all lymphocytes, while CD3 is used to identify the total
population of T- lymphocytes. Since monocytes may also express significant
amounts of the CD4 antigen, they are isolated via a CD14 antibody conjugate. This
enables a count of all CD4 positive cells and then subtracts the monocytes to yield
only CD4 positive T-lymphocytes.

Hb Measurement
Hemoglobin measurement is performed by measuring the absorption spectrum of
the whole blood compared to a reference baseline. The hemoglobin measurement is
made on un-lysed red blood cells and requires no chemistry. The sample is
illuminated from below through a slit using visible light from an LED. The light
passing through the sample is imaged onto a diffraction grating and the resulting
diffraction spectrum is recorded by the camera. By comparing the light intensities at
particular wavelengths with sample present to their intensities in the absence of
sample at the Hb reference window, the absolute concentration of hemoglobin may
be determined via Beer’s law using a factory-set calibration. A correction for light
loss due to scatter from cells in the blood sample is also derived from the
transmission spectrum of the white LED by analyzing light wavelengths outside the
absorbance bands of hemoglobin. The Hb excitation assembly also contains a NIR
LED that is currently not being used.

Theory of Operation – Electrical System
Electrical System
The electrical system is largely comprised of the Chassis PCBA assembly, which
includes a User Interface module and a Control module. Other small PCBs reside on
the Detection Module, Excitation LEDs, and touch screen that provide input to the
Chassis PCBA Assembly.
Software Systems
The BD FACSPresto system is composed of the following three software systems:

• Control board software system
- Provides low-level control of hardware interfaces
- Manages the power and battery sub-system
• DSP software system a sub-system that provides image processing
• UI software system
- Provides user interface

Theory of Operation – Power On Self-Test (POST)
- Provides high-level control during a cartridge run

- Master software system in the instrument
These software systems may be upgraded together via the front panel USB port with
a USB stick containing the new software package. This procedure is included in the
BD FACSPresto Instructions for Use.
Power On Self-Test (POST)
When the On/Off button is pressed to turn the instrument on, the instrument
automatically begins its POST procedure. This series of tests checks the instrument’s
basic functions and interfaces. The user interface module performs this function.
During POST, the following interfaces and functions are checked:
1 Perform ARM power up.
2 Perform database initialization.
3 Establish user interface module to control module communications.
4 Check ARM firmware version.
5 Check MSP430 firmware version.
6 Acquire real-time clock and set time.
7 Check cartridge transport motor calibration and position.
8 Check filter motor calibration and position.
9 Check focus motor calibration and position.
10 Establish communications with imaging camera.
11 Establish communications with barcode camera.
12 Establish communications with DSP.
13 Check DSP firmware version.
14 Perform Instrument QC (see Instrument Quality Control on page 2-9).
15 Check imaging camera for stuck-off CCD pixels.
16 Check imaging camera for stuck-on CCD pixels.
Instrument Quality Control
Instrument QC is included in the POST process and may additionally be run

manually upon user request from the touch screen. All of the following QC checks
describe the “pass” condition and are based upon analyses of images captured by
the imaging camera. Instrument QC consists of the following checks. Note that the
order shown does not represent the order in which the tests are performed.

Theory of Operation – Instrument Quality Control
Clear Window (QC1) Feature Tests Using the Spectrograph Image

1 Locate the zeroth order line and calculate the distance from the center to the
right edge of the spectrograph image and determine if it is within the specified
range.
2 Compute a focus score of the zeroth order line in a QC image, as the
Full-Width-Half-Max width of the slit in the image and determine if the value is
less or equal to the specified value.
3 Calculate and store the NIR LED coefficient and determine if it results in a peak
intensity within the specified range. Perform this step up to ten times if the
coefficient varies by greater than a specified percentage from the previously
calculated value stored in EEPROM.
4 Calculate and store the white LED coefficient and determine if it results in a
peak intensity within the specified range. Perform this step up to ten times if the
coefficient varies by greater than a specified percentage from the previously
calculated value stored in EEPROM.
5 Calculate the %CV uniformity and total uniformity in the CCD “Y” direction
of the slit area of a spectrograph image of the QC1 window using the NIR and
white LEDs and determine if the %CV uniformity is less than the specified value
and if the total uniformity is less than a specified value.
Starfield (QC2) Feature Test
CD4 Excitation LED Illumination Tests

1 Calculate and store the orange LED coefficient and determine if it is at either the
maximum or minimum specified value and that the measured QC2 intensity at
that level varies from the nominal by less than a specified tolerance. Perform this
step up to ten times if the coefficient varies by greater than a specified
percentage from the previously calculated value stored in EEPROM.
2 Calculate and store the green LED coefficient and determine if it is at either the
maximum or minimum specified value and that the measured QC2 intensity at
that level varies from the nominal by less than a specified tolerance. Perform this
step up to ten times if the coefficient varies by greater than a specified
percentage from the previously calculated value stored in EEPROM.
3 Calculate the illumination field curvature %CV for the best-fit second order
polynomial of the image target, over the masked image area for the orange LED
and determine if it is within the specified range.
4 Calculate the illumination field curvature %CV for the best-fit second order
polynomial of the image target, over the masked image area for the green LED

Theory of Operation – Instrument Quality Control
5 Calculate the polynomial fit of both the green and orange LED images and
determine if the error of either image is less than or equal to the specified value.
Resolution Test
Using the orange LED, calculate system resolution in terms of length of transition
from dark to light areas of the image and determine if it is less than or equal to a
specified value.
Imaging Camera Test

1 Locate at least three of five major QC2 features (corners and center) and
determine if the standard deviation of the individual magnification estimates is
less than the specified value.
2 Calculate the magnification offset of the imaging camera using the orange LED
Linear Y-stage Alignment

1 Using the orange LED, calculate the stage X direction offset using the vertical
center (image Y direction) of the center of the QC2 image and determine if it is
less than or equal to the specified value.
2 Using the orange LED, calculate the stage Y direction offset using the horizontal
center (image X direction) of the center of the QC2 image and determine if it is
less than or equal to the specified value.
Dual Bandpass Filter (QC3) Spectrographic Image Tests

1 Calculate the angle of the zeroth order line with reference to the right edge of
the spectrograph image and determine if it is less than or equal to the specified
value.
2 Calculate the maximum visible wavelength on the CCD image, by evaluating a
wavelength/pixel linear relation function at the left edge of the CCD image and
determine if it is greater than or equal to the specified value.
3 Calculate the pixel value of the zeroth order line on the spectrograph image and
determine if it is less than or equal to the value determined during factory test.
4 Calculate the pixel value of the first order line on the spectrograph image and
determine if it is less than or equal to the value determined during factory test.

Theory of Operation – Cartridge Quality Checks
Cartridge Quality Checks
Cartridge QC is included in the sample run process automatically after a cartridge

has been inserted into the instrument door. Cartridge QC consists of the following
checks:
1 Measure QC beads and determine if the fluorochrome counts fall within the
specified range.
2 Measure absorbance using the QC window and determine if the spectrograph
values fall within the specified range.
3 Check focus for each FOV and determine if it can be imaged successfully.
4 Locate the Hb QC feature and determine relative positions of the barcode and
cartridge FOVs.
5 Check the 2-D barcode and determine if the barcode is readable and if the
expiration date has not been reached.

Component Descriptions – Front Enclosure Module
3
The Component Descriptions chapter consists of the following topics:
• Front Enclosure Module on page 3-1
• Rear Panel Enclosure on page 3-2
• Battery on page 3-3
• Power Supply on page 3-3
• CD4 Excitation Module on page 3-3
• Detection Module on page 3-4
• Chassis PCB Module on page 3-6
• Chassis, Fan, and Speaker Module on page 3-7
Front Enclosure Module
The front enclosure module, consists of the following

components:
• Front panel
• LCD touch screen
• Cartridge door assembly
• Printer module
• Power on/off button
• Front panel USB port door

Component Descriptions – Rear Panel Enclosure
Touch Screen
The function of the touch screen is to provide a means
Touchscreen flex
for user input, display of instrument status, test status,
Backlight connector
and test results. The touch screen is an LCD color
display.
The LCD touch screen assembly consists of the LCD
with flex interconnect, touch screen, backlight with flex
connect, the LCD touch screen housing, and the
instrument chassis fan.
Fan
LCD flex interconnect
Fan power
Printer
The function of the printer is to provide a means to
print sample test results, instrument status, and
alerts.
The printer module is a self-contained unit with a
single connector on the back. The printer uses
thermal printing technology along with special
paper to produce reports. Thermal printing is a
digital printing process that produces an image by
selectively heating specially coated paper.
Rear Panel Enclosure
The rear enclosure module consists of the following

components:
• Rear panel
• Cover for the rear USB port and reset switch

Component Descriptions – Battery
Battery
The function of the battery pack is to provide a power

source to run the instrument when a hard-wire source is
not available, unstable, or the hard-wire source is lost.
The battery pack is a self-contained unit with a single
connector. It is accessible form the bottom of the
instrument, through a cover plate. The system may run
on a fully charged battery for up to six hours at typical
throughput.
Power Supply
The function of the power supply is to take the AC

voltage from any external source or from an inverter
supplying standard power from a battery and provides
18 VDC to the instrument. The power supply has a
detachable input power cord that can be replaced and
the available cord sets conform to the power
requirements of each country where BD FACSPresto will
be used.
CD4 Excitation Module
The function of the CD4 excitation module is to

provide illumination of the sample using two discrete
LEDs; one amber and one green.
• The amber LED is 618 nm
• The green LED is 536 nm
The LEDs are sequenced on individually during sample
analysis. The control module runs the LEDs. The CD4
excitation module is optically connected through two
fiber optic cable bundles to the detection module. An
integrated circuit (IC) on the CD4 excitation module
monitors temperature of the assembly and has an
EEPROM that stores factory data, which is used to
allow the modules to be interchangeable.

Component Descriptions – Detection Module
The CD4 excitation module consists of the PCB containing the excitation diodes, a
heatsink, an optical block coupling the light from the two LEDs to the fiber optic
bundles connecting to the detection module, and a cable with connector that
connects to the control module on the chassis PCB module.
Detection Module
The function of the detection module is to:

• Capture and position the sample cartridge to be
analyzed.
• Illuminate and image the cartridge 2-D barcode data
and provide images to the user interface module via
a LVDS interface.
• Illuminate the cartridge sample for Hb analysis.
• Optically filter light from the cartridge sample via
an internal filter wheel and motor assembly during
CD4 and Hb imaging. The wheel accommodates up
to six filters.
USB
connection • Image the cartridge sample for CD4 and Hb analysis
(top view) and provide images to the user interface module via
a USB interface.
• Imaging of internal test standards for instrument
QC.
The detection module includes the two fiber optic bundle cables, which in turn
connect to the CD4 excitation module. The detection module bellows connect to
the front of the enclosure and provide a seal that prevents external light and debris
from entering the detection module. This module contains a characterization
EEPROM that provides interchangeability for servicing.

Component Descriptions – Detection Module
Fiber optic bundle

Filter wheel assembly
Imaging camera
Filter wheel motor sensor assembly
Imaging camera
lens assembly
Fiber optic
bundle (end)
Instrument
QC features
2-D barcode
camera assembly
Cartridge
transport stage Cartridge
transport motor
Hb illumination
LED module
Filter Wheel Assembly
OD1 Open space The function of the filter wheel is to filter the collected
light that fluoresces off or passes through the sample
during imaging, depending on the illumination source.
OD4
Diffraction grating
650 nm LP
585 nm BP

Component Descriptions – Chassis PCB Module
Chassis PCB Module
User The chassis PCB module consists of the user interface

interface module and the control module.
module
Control module
Control Module
The function of the Control module is to provide:
• Instrument on/off control via the front enclosure On/Off switch.
• Regulation and distribution of instrument power from the external power
supply module to other modules.
• Power, LED temperature monitoring, and reading of factory stored EEPROM
data on the CD4 excitation module.
• Power and power monitoring for the Hb illuminator LEDs within the detection
module.
• Power and control of both the cartridge transport motor and optics filter wheel
motor within the detection module
• Automatic positioning and alignment of optical elements in the detection
module in conjunction with the user interface module.
• Interface to the user interface module via an I2C bus and discrete signal
interfaces.
• Power and control for the imaging camera fan within the detection module.
• Power and control for the chassis fan.
• Power and recharge control for the internal battery pack.
• Fault detection and performance of QC.
The Control module performs lower level functions for the system. These include
power regulation and distribution from external power supply, LED voltage and
current control, system temperature monitoring, fan power and control, various
motor controls, and the real-time clock.Data for up to 12,000 samples can be
stored in the instrument.

Component Descriptions – Chassis, Fan, and Speaker Module
Data can also be sent to the front panel USB for storage on a memory device in
response to user input via the LCD touch screen. Patient results records can also be
selectively deleted by the user.
This instrument is capable of operating from an external power source or its
internal rechargeable battery.
User Interface Module

The function of the User Interface Module is to provide:
• User input, instrument status, test status, and test results via the color Liquid
Crystal Display (LCD) touch screen.
• Processing of image data and providing camera control for the 2-D barcode
camera within the detection module via a Universal Serial Bus (USB) interface.
• Processing of image data and providing camera control for the imaging camera
within the detection module via a USB interface.
• Interface to the control module via an Inter-Integrated Circuit Bus (I2C) and
discrete signal interfaces.
• Automatic positioning and alignment of optical elements in the detection
module in conjunction with the control module.
• External storage of patient records, instrument logs, and camera images, as well
as installing system software upgrades via a front enclosure USB interface.
• System audio alerts via the internal speaker.
• Printing of sample test results, and instrument status and alerts via a self-
contained printer module.
• Instrument service data via a rear panel USB interface.
• Fault detection and performance of quality checks (QC)
BD FACSPresto is capable of performing self-tests of system functions and
measurement quality and reporting the results to the user. These tests are performed
at instrument startup, prior to analyzing a sample, and on demand.
Chassis, Fan, and Speaker Module
The function of the chassis, fan, and speaker module is

to provide staging areas for the fan, speaker, battery
door, detection module, and front enclosure on the
chassis.

Component Descriptions – Chassis, Fan, and Speaker Module
This page left blank intentionally.

Installation – Overview
4
Installation
The Installation chapter consists of the following topics:
• Overview on page 4-1
• Installing the Instrument on page 4-1
• Instrument Settings on page 4-2
Overview
The instrument will be shipped directly to customer’s site for them to perform the
installation as well as the performance verification. A product insert will ship with
each instrument that will include installation instructions.
Installing the Instrument
1 Stage the instrument on a level surface.

2 Remove the instrument cover from the instrument.
3 Plug the power supply into the instrument.
4 Plug the power cable for your country into the power supply.
5 Plug the power cable into a wall electrical outlet or other electric source, as
shown in the following figure.

Installation – Instrument Settings
Instrument Settings
Use these instructions to set up the instrument before running samples and to
change the settings later. The first time starting the instrument, specify the date,
time, brightness level, audio level, Hb unit, lab names, operator names, and process
control information.
Date Hb unit
Lab name
Time
Display Operator
brightnss
Audio level Quality control
1 Press the Settings tab.

2 Press the corresponding button to change one of the following settings:
• Date (year/month/day)
• Time
• Display Brightness
• Audio Level, from high to mute
• Hb Unit for the total hemoglobin result. Select grams per deciliter (g/dL) or
units per liter (g/L).
• Lab Name. Press Backspace to delete the default setting. Enter a lab name
from 1–20 characters.
• Operator. Press Backspace to delete the default setting. Enter an operator
name from 1–20 characters.
• Quality Control. Opens the Process Control Settings screen.
See the BD FACSPresto User’s Guide for setup instructions.
3 Press Accept to accept a setting.

Servicing Requirements – Service Tool Kit
5
Servicing Requirements
The Servicing Requirements chapter consists of the following topics:
• Service Tool Kit on page 5-1
• Servicing Safety and Precaution on page 5-1
• Decontamination on page 5-2
• Installing FACSPresto Final Test Software and Local Database on page 5-8
• FACSPresto Final Test Software on page 5-36
• Qualification on page 5-54
Service Tool Kit
BD No. Description
651067 Wiha 28502 Screwdriver Adj. Torque 5–10 in-lbs
651071 Wiha 28546 Blade Torque 2.0mm Hex 1.8N-m
657280 Manufacturing Test Cartridge
N.A. Hex wrench set, metric
N.A. Cable tie cutters
N.A. USB Type A-B cable
Servicing Safety and Precaution
Before completing any service procedure, remove power to the instrument prior to
performing the procedure. Where appropriate, before completing any service
procedure, verify that the Personal Health Information (PHI) is deleted from the
instrument. To remove PHI:
1 Turn the instrument on.
2 Press the Help tab
3 Press Delete All.
4 When the confirmation screen opens, press Accept.

Servicing Requirements – Decontamination
Decontamination
Decontaminate the BD FACSPresto instrument following exposure to biohazardous

samples and prior to working on the internal components of the instrument. The
level and extent of decontamination required will vary depending on the level of
work to be completed. For example, if the detection module is to be replaced and
discarded, it may not require disassembly and cleaning. Furthermore, disassembly
of the detection module for decontamination requires a full re-alignment and
calibration, which cannot be completed without special equipment at the factory.
Tools Required
• Hex tool sizes: 1.5 mm, 2 mm, 2.5 mm, and 3 mm
• Use either bleach diluted to 0.5% sodium hypochlorite concentration or 70%
isopropyl alcohol
• Disposable wipes and cotton tipped applicators
• Personal protective equipment including lab coat, gloves, safety glasses
• Biohazardous waste container
Basic Decontamination Procedure (External)
Note: Use this procedure prior to standard servicing including replacing full FRU
modules. This is the most common decontamination used outside
manufacturing facilities.
Wipe down the exterior of the instrument using disposable wipes and ethanol;
paying particular attention to the touch screen, cartridge insertion door, and bottom
of the instrument.
Extensive Decontamination Procedure
Note: This procedure requires re-alignment and recalibration at the factory. This
procedure is only required before rebuilding a Detection Module at the
factory.
1 Remove the Rear Enclosure assembly.

a Position the instrument face down on work bench.
b Using a 3 mm hex tool, remove the ten (10) screws that secure the rear skin
to the instrument.
c Remove the assembly from the instrument.
2 Remove LED Illuminator assembly.

a Using a 2.5 mm hex tool, remove the four (4) screws that secure the LED
Illuminator assembly to the chassis.
b Using a 1.5 mm hex tool, loosen the setscrews that secure the fiber optic
cable and slide the cable out.
c Disconnect the electrical connection going to the bottom of the LED assem-
bly and remove the assembly from the instrument.
Fiber optic setscrews
Electrical connection
3 Remove the Chassis PCBA assembly.

a Using a 2.5 mm hex tool, remove the six (6) screws that secure the PCBA
assembly to the Front Enclosure assembly and the Fan/Speaker Chassis
assembly.

b Disconnect all electrical connections and remove the assembly from the
instrument.
4 Remove the Fan/Speaker Chassis assembly.

a Using a 2.5 mm hex tool, remove the remaining two (2) screws that secure
the assembly to the Front Enclosure assembly.
b Pull the fiber optic cables and the five (5) grommets out of the chassis sup-
port bracket.
c Gently pull the assembly away from the Front Enclosure assembly while
pressing the black Rear Detection Module Supports through the white sup-
port retention bracket.
Press two supports

5 Remove the Detection Module assembly.

a Using a 2.5 mm hex tool, remove the two (2) retention brackets (each
bracket is secured by two screws).
b Slide the assembly out of the guides in the Front Enclosure assembly.
c Remove the rubber bellows from the assembly.
6 Use a cotton tipped applicator dipped in ethanol to wipe down the inside of the
Front Enclosure door.
Note: Pay particular attention to the complex curved levers used to open the door.

7 Separate the top and bottom portions of the Detection Module.

a Using a 2.5 mm hex tool, remove the six (6) screws that secure the detection
module halves together.
b Remove the gasket from the module.
Rubber bellows
8 Remove the sample cartridge (if present) and discard it in accordance with local
laws and regulations.
9 Decontaminate the Detection Module assembly.
Upper half of the cartridge
Gasket
Lower half of the cartridge
SS bracket
with 1 retention screw
a Using a 2.5 mm hex tool, remove the screw that secures the stainless steel
(SS) bracket from the lower half of the assembly.

b Remove the white cartridge detection flag.

Door
Cartridge rails
Detection flag
Door
c Use a cotton tipped applicator dipped in ethanol to clean the following com-
ponents:
• All surfaces of the gasket paying particular attention to the front facing
surfaces.
• All surfaces of the rubber bellows.
• The upper and lower halves of the cartridge opening at the front of the
Detection Module assembly.
• All surfaces of the stainless steel bracket paying particular attention to
the 6 detents on the under side of the bracket.
• The cartridge guide rails in the bottom half of the assembly paying
particular attention to the two detents close to the middle of the
assembly.
• The white cartridge detection flag.
10 Reassemble the instrument in reverse order.
Note: The Detection Module gasket has a top and bottom orientation such that the
“wings” point upward toward the front of the assembly when installed.

Servicing Requirements – Installing FACSPresto Final Test Software and Local Database
Installing FACSPresto Final Test Software and Local Database
Installing FACSPresto Final Test Software consists of first installing the local
database and other required drivers before finally installing the FACSPresto Final
Test Software. Obtain the latest version of FACSPresto Final Test software and
other required installers from SAP under 651000TP.
Install in the following order:
1 Ensure that .NET 4.5 or later is installed on the computer
2 Install the Local Database
3 Install the FDTI BUS driver
4 Install the PointGrey camera driver
5 Install FACSPresto Final Test Software
Installing a Local Database
Important: You will need Administrator’s privilege on the workstation computer

to install the software.
1 Download Microsoft SQL Server 2012 Express from the Microsoft website.
a Select the 32-bit English version.
b Download either Express with Tools or Express with Advanced Services.
2 Double-click the downloaded file to start the installation.

3 In the SQL Server Installation Center window, click New SQL Server stand-alone
installation or add features to an existing installation.

4 In the License Terms window, select I accept the license terms option and click
Next.

5 If the workstation is not connected to the internet, the following error will
occur. Ignore it and click Next.
6 In the Feature Selection window, click Select All, leave all other options as they
are, and click Next.

7 In the Instance Configuration window, change the instance name to BDDB, leave
other options as they are, and click Next.
8 In the Server Configuration window, leave all options as they are, and click
Next.

9 In the Database Engine Configuration window, make the following selections:

• Change Authentication Mode to Mixed Mode
• In the Enter Password and Confirm password fields, type BDIS or BDIS#111 if
the permission settings require a stronger password.
• In the Specify SQL Server Administrator menu, select the workstation to be
the administrator.
• Leave all other tabs as they are
• Click Next

10 In the Error Reporting window, leave all options as they are, and click Next.
11 The installation will start. Wait for installation to complete, then click Close.
12 Close the SQL Installation Center window also.

13 Select Start > All Programs > Microsoft SQL Server 2012 > SQL Server
Management Studio.
14 In Connect to Server window dialog box, leave all options as they are, and click
Connect.
15 Select Databases > System Databases.

16 Right-click the master database and select Tasks > Restore > Database.

17 In the Restore Database window, select Device then click the … button.
18 The Select backup devices window opens, click Add.
19 Navigate to the bddb_clean_20140109.bak file you saved (local hard drive or
thumb drive) and click OK.

20 In the Restore Database – bddb window, ensure that the bddb-Full Database
Backup option is selected.
21 In the Files tab of Restore Database – bddb window, select Relocate all files to
folder, and ensure that the data file folder and log file folder are in the following
location: C:\Program Files (x86)\Microsoft SQL Server\MSSQL11.BDDB\MSSQL\DATA

22 In Options tab of Restore Database – bddb window, select Overwrite the existing
database (WITH REPLACE) and click OK.
23 After the database is restored, the following dialog opens.

Create bddb Login and Associate to bddb Database for odbc Connection
1 In Microsoft SQL Server Management Studio, select File > Open > Files
2 In the resulting file browser, navigate to the bddb_create_login.sql file that you
previously stored (local hard drive or thumb drive).
3 Click the Execute button to execute script.

4 Verify that the script completed with no errors.
5 Select Security > Logins.
6 Right-click bddb and click Properties.

7 In the Password and Confirm password fields of the Login Properties – bddb
window, type bddb and click OK.

8 Select Start > Control Panel > System to obtain the computer name.
9 Add the Computer Name to the test station table in the bddb database.
a Select Databases > bddb > Tables.
b Right-click on the dbo.Test_Station table under the ‘bddb’ database and click
Edit top 200 rows.
c Type the computer name exactly as it was shown in the windows control
panel.

10 Select Start > All Programs > Microsoft SQL Server 2012 > Configuration Tools >
SQL Server Configuration Manager.
11 Right-click SQL Server Browser and click Properties.

12 In the SQL Server Browser Properties window, select the Service tab, Automatic
from the Start Mode menu, and click OK.
13 Right-click the SQL Server Browser again, and click Start.
Result: Verify the status changes to Running.

Setup the ODBC drive

1 Run the step applicable to the workstation operating system (OS):
• For Win7 64 bit OS, run odbcad32.exe from the following location:
C:\Windows\SysWOW64\ folder
• For Win7 32 bit OS or Windows XP system, select Control Panel >
Administrative Tools > Data Sources (ODBC).
The following ODBC Data Source Administrator window will open.
2 Select the System DSN tab, click Add.

The Create New Data Source window opens.

3 Select SQL Server from the menu and click Finish.

4 In the Name field, type bddb.
5 In the Server field, select the local server (computer name\BDDB) and click Next.
6 In the Create a New Data Source to SQL Server window, select the With SQL
Server authentication option, in the Login ID and Password fields type bddb,
and click Next.

7 In next window, leave all options as they are and click Next.
8 In next window, leave all option as they are and click Finish.

9 In next window, click Test Data Source.
The following dialog opens.
Installing the FDTI BUS Driver

1 Run the CDM20828_Setup.exe file.
2 Follow the prompts to complete the installation.
3 Accept all default settings.

Installing the PointGrey Camera Driver

1 Start the installer.
The installer dialog opens.
2 Click Next.
The FlyCapture License Agreement dialog opens.
3 Select the I accept the license agreement option and click Next.
The User Information dialog opens.

4 Enter the following information in the User Information dialog.
a In the Full Name field, enter your name

b In the Organization field, enter your organization.
c Select the Anyone who uses this computer option.
d Uncheck the Automatically register with PGR via the internet option.
e Click Next.
The Destination Folder option opens.
5 Click the Browse button to navigate to the location that you want the Point
Grey Camera driver to install.

6 Click Next.
The Select Installation Type dialog opens.
7 Select Minimal Installation and click Next.
The Interface Driver Selection dialog opens.

8 Ensure that all options are unchecked and click Next.
The Enhanced Halt State disable dialog opens.

9 Uncheck the FlyCapture will disable processor idle states while in use option and
click Next.
The Ready to Modify the Application dialog opens.
10 Click Next.

The Updating System dialog opens.
11 After some time the Internal Error 2753 dialog opens, click OK.
12 The Fatal Error dialog opens, click OK.
The installer closes.

13 Start the installer again, select Modify > Next when prompted for Application
Maintenance.
The Select Features dialog opens.

14 Select Executables > Next.
The Interface Driver Selection dialog opens.

15 Ensure that all options are uncheck and click Next.
The Enhanced Halt State Disable dialog opens.

16 Ensure that the FlyCapture will disable processor idle states while in use option is
unchecked and click Next.
Note: It is normal to wait several minutes when the installer indicates 0 seconds
remaining.
The successful installation dialog open.
17 Click Finish.

Servicing Requirements – FACSPresto Final Test Software
Installing FACSPresto Final Test Software

1 Obtain the latest version of FACSPresto Final Test Software by downloading the
FACSPresto Final Test Procedure and attachments from SAP.
2 Double-click the setup.exe file.
3 Follow the on-screen prompts and use the default entries.
FACSPresto Final Test Software
Final Test
Note: Touch the Abort/Stop button at any time and the test software will quit after
it finishes the current test step. Depending on what step the system is
currently in, software will respond to the stop request within 1–20 seconds.
The report file opens after a test is aborted, but the report will not contain all
of the test data.
1 After a successful POST completion, connect a USB cable to the service port on
the back of the instrument and connect the other end to the test computer.
2 Start the BD FACSPresto Final Test Application software.
Note: If a desktop shortcut does not exist, the software is installed in the following
directory: C:\Program Files (x86)\FACSPresto Final Test Application
When the software starts, the Final System Test Software GUI window opens.
Note: The window has been compressed to better fit on this page.

The program checks whether the instrument is powered on and connected to the
computer. If the connection check fails, the software opens the Connection
Failed dialog.
3 Click OK.
The test software quits.
4 Power on the instrument and connect the instrument to the computer via a USB
cable.
If the connection is successful, the COM/Camera Connected? LED turns green,
and the SN Input dialog opens.
Note: The software automatically populates the Instrument serial number, UI

board serial number, and the Control Board serial number fields with data
currently on the instrument.
5 Confirm that the instrument serial number matches the label on the back of the
instrument.

6 In the Operator field, type or select the operator’s name and click OK.
The software calculates the magnification offset by acquiring a QC2 image and
processing it and retrieves the firmware version in the instrument.
7 Confirm that all four corners are shown in the acquired picture, as shown.

The calculated result for Magnification Offset displays in the Testing Log and
must be between 1.6–1.8.
Note: There are two test modes available: Final Test and Debug Test. A Service tab
allows retrieval and editing of various instrument logs.
8 Click the Final Test > Start Test to start the automatic test.
The first step in final test is a graphical user interface (GUI) test. The test soft-
ware displays the following dialog.
9 Follow the instructions in the dialog and then click Proceed.

The following window opens.

10 Touch the first tab.
11 touch any one of the ten icons multiple times, making sure that the icon cycles
through the following three states.
In this example the third icon is cycled through its three states.
First state Second state Third state
12 Touch the fifth tab.

The following tab opens.
Date
Time
Brightness
Speaker volume
a Touch the corresponding icons to set the system date, time, brightness, and
speaker volume.
i. Touch Date icon.
The date modification window opens.
ii. Use the Up arrow to increase or the Down arrow to decrease the number.
Enter the date in the following format: year - month - day.
iii. Touch the green check button.
iv. The date modification window closes.
b Touch the Time icon.

The time modification window opens.
i. Use the Up arrow to increase or the Down arrow to decrease the number.
Enter the time in the following format: hour - minute - AM or PM.
ii. Touch the green check button.
The time modification window closes.
c Touch tab 6.
i. Make sure that the correct instrument serial number is shown on the
screen. After SN verification.
ii. Touch the Proceed button.
The Printer test starts automatically and tries to execute a print job.

13 The following printer test dialog opens. If the printer printed correctly, touch
Yes; if it did not, touch No.
Result: If printer test fails (for example, there is no paper installed), the software
skips all remaining test, and quits. Troubleshoot the problem, and re-start
the test. If the printer test passes, the speaker test starts automatically and
tries to make a sound from the speaker.
14 The following speaker test dialog opens. If the speaker functioned correctly,
touch Yes; if it did not, touch No.
Result: If the speaker test fails, the software will skip all remaining test, and quit.
Troubleshoot the problem, and re-start the test. If the speaker test passes,
the power test starts automatically.
15 The following power test dialog opens.

a Unplug the power supply to the instrument.
b Touch Proceed.
The software measures the battery discharging current, the value must be <0.

Result: If the test fails (for example, the power supply is not unplugged), software
gives you a chance to re-try.
c Touch Yes. Re-try to re-try the test (as many times as you want) until the test
passes or touch No. Preceed to Next Step if the test fails.
Result: Software will skip all remaining test, and quit. Troubleshoot the problem,
and re-try the test. The following power test dialog opens.
d Plug in the power supply to the instrument.

Software measures the battery charging current. The value must be 0.
Result: If it failed (for example, the power supply is not plugged in), software will
give you a chance to re-try.
e Touch Yes. Re-try to re-try the test (as many times as you want) until the test
passes or touch No. Preceed to Next Step if the test fails.

Result: If the test fails, software will skip all remaining test, and quit.
Troubleshoot the problem, and re-try the test. The cartridge test starts
automatically and the cartridge test dialog opens.
16 Insert the Final Test Cartridge and touch Proceed.
Note: If the cartridge is not inserted before touching Proceed, software will detect
the absence of the cartridge and keep prompting to insert the cartridge.
Note: Software starts the remaining tests automatically without any further user
interaction. As tests complete, new images display in the Camera Image field,
and the testing results show in the Testing Log filed user interface.

The Testing Log uses green, red, and black to indicate different states.
• Green indicates that the test results meet the specifications and the test
passed.
• Red indicates that the test results do not meet the specifications and the
test failed.
• Black indicates that the recorded information does not have a
specification.
Note: Some test steps include a re-try functionality. If the test fails, a dialog opens.
Touch Yes, re-try to re-try the test, or No, stop test to abort the test. You can
re-try the test as many times as you want until the test passes or you touch
No, stop test. If the test fails, the software will skip all remaining test, and
quit. Troubleshoot the problem, and re-do the test.
Note: It take approximately 3–5 minutes to finish all tests.
• Upon completion, the test software automatically prints a test report to

the test station’s default printer. Make sure there is a printer connected to
the test station, either directly or through a network.
• A soft copy of the test report (in PDF) is saved in the instrument Final
Test subfolder.
• During Final Test, all intermediate images taken are stored in a subfolder
under C:\Temp\Final\. The subfolder name is based on the instrument serial
number and the testing time. For example, for MG65100000041, and a
final test finished on 11/08/2013 9:15:05 AM, the full path for the test
result folder will be C:\Temp\Final\MG65100000041_20131108-091505. The
test report is saved in this folder, together with all PGM files.

• The Final Test Report opens automatically in the background in

Microsoft Word format. Populate the Qualification Form with
this data as appropriate.
The following cartridge test dialog opens.
17 Remove the cartridge and touch Proceed.

Note: The remove cartridge dialog box will continue to prompt you until the
cartridge is removed. After the cartridge is removed and Proceed touched,
software performs internal cleanup work (turn off all LEDs, move all motors
to home position, etc), and then quits.
Debug Mode
Touch the Debug Mode tab to access this mode. The debug mode provides the same
tests as Final Test, except that in debug mode, each test step can be performed and
recorded separately. It is useful for troubleshooting if the full automated test fails.
Touch the individual test button to run a specific test.
• Test results display in the Testing Log field and are recorded in a report.txt file.
In debug mode, this file will not be opened automatically after touching the
Abort/Stop button.
• Generated images display in the Camera Image field.
Note: The window has been compressed to better fit on this page.

The following table lists of the Debug Mode buttons and their functions.
Button Function
Eject Stage Eject the stage for insertion or removal of the test cartridge.
Home Stage Homes the stage and close the door.
Test Printer Tests the printer functionality.
Test Speaker Tests the speaker functionality. The user should hear a
sound from the speaker.
Find Door Close Tests the door close position and stores this value in test
Position report.
Battery Test Tests whether the battery charges and discharges correctly.
The software first tests the charging current by prompting
the user to plug in the power supplier, then it tests the
discharging current by prompting the user to unplug the
power supply. The passing conditions are:
• Charging current 0
• Discharging current <0
Barcode Test Performs the following tasks:
• Obtain a barcode image
• Obtain a barcode focus score
The passing condition is:
• Barcode image in focus
• Focus score >0
Barcode Decode/ Performs the following tasks:
Offset • Obtain a barcode image
• Decode the barcode image
• If there is a runtime error or if the barcode string is not
the right format, a dialog opens for manual input of
three offset values
Check X It performs the following tasks:
Alignment and • Take a test cartridge image at one location, and
Rotation calculate the deviation from the center.
• Take second test cartridge image at another location,
and calculate the deviation from the center.
• Deviation1 157 microns
• Deviation2 157 microns

Button Function
Check Diffraction Checks the diffraction grating alignment with respect to slit
Angle and CCD. It obtains an image and calculates the diffraction
angle.
Diffraction angle 2 degree
Set CD4 Intensity Optimizes the orange and green LED current setting. It
performs the following tasks:
• Turn Orange on Autofocus and obtain an image.
• Calculate normalized intensity.
• Adjust current setting until the normalized intensity
meets the specification.
• Repeat for Green LED.
• Orange LED current is between 300–1500 mA
• Orange normalized intensity is between (150–260)
*(1-Cover_Attenuation_Factor)
• Green LED current is between 300–1500 mA
• Green normalized intensity is between (175–300)
*(1-Cover_Attenuation_Factor)
Dark Image Long Obtains an image with all LEDs off and 1250 ms exposure
Exposure time. The purpose of this test is to screen for bad cameras
(too much noise).
• Dark image mean value <395.791
• Dark image std dev value <395.791
Check Y Steps Checks the repeatability of the stage motor by taking two
images at the same location and then examining the shift of
these two images.
• Shift in X direction is <50 microns
• Shift in Y direction is <50 microns

Service Functionality
The Service tab allows the user to manually update FRU (Field Replaceable Unit)
information in the instrument when a FRU module is replaced as well as read back
other information from the instrument.
Important: Do not press Mfg FRU Download as this will delete all instrument FRU
data and set all FRU counters to 1 with the current date. If you
accidentally click this button, press No on the confirmation screen to
back out.
Update FRU
In Service mode, manually update FRU information when an FRU is replaced.
1 From the Module to Update list, select the part and click Update FRU. The
following dialog opens.

2 Click Yes to update the instrument FRU information in software. If the update is
successful, the following dialog opens.
3 Click OK.
Get FRU Information
Click Get FRU Information to retrieve and display FRU information from
instrument. This file is also saved to a separate text file found in the following
location: C:\Temp\FRU_Information.txt
Note: During the execution of retrieving FRU information from instrument, the
Com/Camera Connected? LED will turn off temporarily and turn back on.
This is normal.
Get Instrument Name

Click Get Instrument Name to display the instrument, UI board, and control board
serial numbers in the Testing Log.

Get Service Log

Click Get Service Log this to display the service log from the instrument in the
Results textbox. This result is also saved to a separate text file found in the
following location: C:\Temp\ServiceLog.txt
Note: During the execution of retrieving service log information from instrument,
the Com/Camera Connected? LED will turn off temporarily, and turn back
on. This is normal.
Depending on how large the service log is, this operation may take some time.
Clear Service Log

1 Click Clear Service Log to clear the service log from the instrument.

Servicing Requirements – Qualification
2 Click Yes to clear the log. The following dialog opens.
Instrument Final Cleanup

1 Turn off the instrument.
2 Disconnect the USB cable and unplug the power supply.
3 Re-install the cover on the Service port panel of the instrument.
Qualification
1 Turn on the instrument and ensure that the POST sequence completes without
errors.
2 Run the Final Test. For instructions, see Final Test on page 5-36.

This page left blank intentionally.


Replacement Procedures – Replacing the Rear Enclosure Module
6
Replacement Procedures
This chapter includes the following component replacement procedures:
• Replacing the Rear Enclosure Module on page 6-1
• Replacing the Battery on page 6-2
• Replacing the Excitation LED Module on page 6-4
• Replacing the PCB Module on page 6-6
• Replacing the Fan and Speaker Module on page 6-14
• Replacing the Detection Module on page 6-15
• Replacing the Front Enclosure Module on page 6-18
Replacing the Rear Enclosure Module
Removal
1 Lay the instrument face down on a soft surface to access the back.

Replacement Procedures – Replacing the Battery
2 Remove the ten (10) screws that secure the rear enclosure module to the
instrument and remove the rear enclosure.
Installation
1 Stage the rear enclosure module on the instrument.
2 Install and tighten the ten (10) screws that secure the rear enclosure module on
the instrument to 12 in-lbs torque.
Replacing the Battery
Removal
1 Remove the Rear panel.
2 Remove the screw that secures the battery door cover to the instrument and
remove the panel.

Replacement Procedures – Replacing the Battery
3 Slide the battery out of the bottom of the instrument.
4 Disconnect the battery from J11 on the chassis PCB module.
Installation
Important: Install only BD-approved replacement batteries. Use of any other

battery than prescribed could result in risk of explosion, fire, or injury
to persons.
1 Connect the battery to J11 on the chassis PCB module.

2 Slide the battery in to the bottom of the instrument.
3 Stage the battery door cover on the instrument.
4 Install and tighten the screw that secures the battery door cover to the
instrument.
5 Install the Rear enclosure.

Replacement Procedures – Replacing the Excitation LED Module
Replacing the Excitation LED Module
Removal
1 Remove the rear enclosure module.
2 Cut the zip-tie that secures the LED wires to the battery housing.
3 Remove the four (4) screws that secure the excitation LED module to the
chassis.

Replacement Procedures – Replacing the Excitation LED Module
4 Loosen the two (2) setscrews that secure the fiber optic fibers to the excitation
LED module and slide the fibers out.
5 Insert a protective cap on the end of each fiber.

6 Disconnect the cable from the excitation LED module.
Installation
1 Connect the cable from the excitation LED module.
2 Loosely tie-wrap the cable to the battery enclosure and route the cable between
the two optical fiber mounts on the LED assembly.

Replacement Procedures – Replacing the PCB Module
3 Remove the protective caps and slide the optic fibers in to their mount.
Important: The optic fiber on the right of the detection module connects to the
right side LED sleeve. The left side optical fiber connects to the left
side LED sleeve.
4 Tighten the two (2) setscrews that secure the fiber optic fibers to the excitation
LED module to 7 in-lbs torque (0.79 Nm).
5 Stage the excitation LED module on the chassis.
6 Install and tighten the four (4) screws that secure the excitation LED module to
the chassis to 5 in-lbs torque (0.56 Nm).
7 Tighten the zip tie that secures the Excitation LED Cable assembly to the battery
housing keeping it separate from the other cables to prevent transfer of
electronic noise.
8 Install the rear enclosure module.
Replacing the PCB Module
Removal
1 Remove the rear panel and the Excitation LED assembly.
2 Remove the six (6) screw that secure the Chassis PCB module cover over the
PCB.

3 Disconnect the 15 cables from the two boards. Do not disconnect the fan cable.
Fan cable
Installation
1 Stage the PCB module on the front enclosure and connect the 15 cables to the
two boards in the following order:
J108 = Printer J119 J115

J105 = Display folded J110 J113
J113 = LCD backlight J105

J115 = LCD power J116
J116 = Speaker
J1 = Display fan
J6
J3 = Camera fan J108
J7 = Hb LED
J107 J1
J8 = Transport motor
(Y-stage) J10 J3
J9 = Filter motor
J13 J8
J13 = FLT IDC 10CND 0.5A
9.45 in. DBL F END J9
J4 = Excitation LED J7
J119 = Barcode camera
J11 J4
J110 = USB 2.0 S ML to ANG
Mini B ML 12 in.
J6 = Switch ON-OFF

2 When routing the cables, avoid the power supply area outlined in red to
minimize electromagnetic interference.
a Route the printer cable around the side of the printer (as shown), making
sure it is away from the fan.
b Route the speaker and Hb illuminator cable behind the battery enclosure
near the printer cable.
c Route the camera fan cable between the camera heat sink and the fiber
bundles.

d Zip-tie the camera fan cable, cartridge transport motor cable, and filter
wheel motor cable to the inner side of the zip-tie mount on top of the battery
enclosure as shown.
e Zip-tie the flat grey cable to the outer side of the zip-tie mount on top of the
battery enclosure as shown.

3 Install and tighten six(6) screws that secure the cover and module to the front
enclosure module. Make sure that the cables are not kinked or pinched.
4 Connect power to the instrument.
USB connection:
Type-B connector to the instrument
service port and Type-A connector
to the computer
Power connection
a Connect one end of instrument power adapter to the power connection in

the back of the instrument.
b Connect the other end of power adapter to an external power source or

surge protector.
5 Connect the USB cable with type-A male connector on one end, and type-B male
connector on the other end to the instrument.

a Connect the type-A connector to a spare USB port on the test computer.
b Connect the Type-B connector into the instrument service port.
Note: If service port is not accessible, remove the cover.
6 Press the power switch on the front panel to turn the instrument on.
After a short while, the touch screen turns on and prompts for calibration.
7 Follow the on-screen instructions and touch the symbol at each of the four
corners and center to finish the calibration procedure.
Symbol

8 When the following error is thrown, insert a USB software installer into the USB
port on the front of the instrument.
After a short while, the green check button is enabled.
9 Touch the green check button.

This starts the download of application software to the instrument. The soft-
ware installation also installs an empty database. Once the download completes,
the touch screen will display an icon to remove the USB and a green check icon.
Remove the USB
Green check

10 Remove the USB and touch the green check button.

The instrument will power off by itself.
11 Insert a USB stick containing the DebugCfg.xml file, which allows the instrument
to overwrite the database and create a new one.
12 Power on instrument again.
The instrument will skip the POST process, query all subsystem serial numbers,
and import all relevant EEPROM calibration data to populate the database. The
time for power up is approximately 1–2 minutes.
13 Once the instrument boots up, disconnect the USB and power off the
instrument. Power on the instrument again to complete the POST sequence.
Result: If the POST successfully completes, the instrument displays the splash
screen.
Result: If POST fails, reboot the instrument and allow POST to try again.
The system uses default start values for LED currents and allows ten
attempts to reach the target LED intensity. If the target cannot be reached
within ten attempts, POST will fail. The next POST sequence will attempts

Replacement Procedures – Replacing the Fan and Speaker Module
another ten times from where the previous POST ended and most likely
reach the LED target intensity values.
14 After a successful POST completion, go to the ? tab and enter the instrument
serial number. Then complete the final instrument qualification procedures. For
instructions, see FACSPresto Final Test Software on page 5-36.
Replacing the Fan and Speaker Module
Removal
1 Remove the Rear enclosure module.
2 Remove the battery.
3 Remove the Excitation LED module.
4 Remove the PCB module.
5 Remove the two (2) screws that secure the chassis fan speaker module to the
front enclosure module.
6 If you need to replace the camera fan, remove the four (4) screws that secure the
fan to its bracket.
7 If you need to replace the speaker, remove the four (4) screws that secure the
speaker to the bracket.
Installation
1 If you need to replace the speaker, stage the speaker on its bracket and install
and tighten the four (4) screws that secure the speaker to the bracket.

Replacement Procedures – Replacing the Detection Module
2 If you need to replace the camera fan, stage the fan on its bracket and install and
tighten the four (4) screws that secure the fan to the bracket.
3 Stage the Fan and Speaker module on the Front Enclosure and install and
tighten the two (2) screws that secure the Fan and Speaker module to the Front
Enclosure module.
4 Install the PCB module.
5 Install the Excitation LED module.
6 Install the battery module.
7 Install the Rear Enclosure module.
Replacing the Detection Module
Removal
1 Remove the Rear Enclosure module.
5 Remove the Chassis Fan Speaker module.
6 Remove the four (4) screws that secure the two detection cap mounts and
remove the mounts.

7 Slide the detection module out of the Front Enclosure module.
8 Make sure that the detection module bellows come out with the detection
module.

Installation
1 Install the bellows on the module. Make sure that the side labeled TOP is at the
top.
2 Remove the USB cable from the old module and install it on the new module.
3 Remove the grey flat cable from the old module and install it on the new
module.
4 Slide the Detection module in to the Front Enclosure module. Make sure that
the module tabs are flush the top of its mount.
Top of mount Tab
5 Install and tighten the four (4) screws that secure the two detection cap mounts
to 5 in-lbs torque (0.56 Nm).
6 Install the Chassis Speaker Fan module.
7 Verify that the nubs on the Detection Module vibration isolators are fully
inserted into the detection module mount.
10 Install the battery.

Replacement Procedures – Replacing the Front Enclosure Module
Replacing the Front Enclosure Module
Removal
1 Remove the Rear Enclosure module.

5 Remove the Detection module.
Installation
1 Install the Detection module.
4 Install the battery.

Replacing the Printer
Removal
1 Remove the Front Enclosure.
2 Disconnect the printer cable from the printer.
3 Remove the two (2) screws that secure the printer to the Front Enclosure
module and slide the printer out of the front of the module.
Installation
1 Stage the printer on the Front Enclosure and install and tighten the two (2)
screws that secure the printer to the module.
2 Connect the printer cable to the printer.
3 Install the Front Enclosure.
Replacing the Touch Screen
Removal
1 Remove the four (4) screws that secure the touch screen to the Front Enclosure.
2 Remove the touch screen cover and then the touch screen from the Front
Enclosure.

Installation
1 Make sure that the touch screen gasket is aligned on the two lower notches on
Front Enclosure module.
Side notch
Lower notches
2 Stage the touch screen on its three (3) notches on the Front Enclosure.
3 Transfer the two (2) cables from the old touch screen to the new touch screen.
4 Stage the cover on the touch screen.
5 Install and tighten the four (4) screws that secure the cover and touch screen to
the Front Enclosure module.

Troubleshooting – Error Log Software Specifications
7
Troubleshooting
The Troubleshooting chapter consists of the following topics:
• Error Log Software Specifications on page 7-1
• GUI Troubleshooting Guide For IFU on page 7-26
Error Log Software Specifications
MicroImager Software Systems

The MicroImager system is composed of the following three software systems:
• Control Board Software System
- Provides low-level control of hardware interfaces
- Manages the power and battery sub-system
• DSP Software System
- Image processing sub-system
• UI Software System
- Provides user interface
- Provides high level control during a cartridge run
- Master software system in the MicroImager
Non-critical Errors
Non-critical errors are generated by the system in response to events where the
system can continue to operating. The event may abort the current process being
performed by the device, but the device can recover from the error.
When a Non-critical error is detected by the system, the following actions are
performed:
• The error is logged into the device event log.
• If the error requires user interaction, a dialog is display to explain the action to
be performed by the user to recover from the error.
• In some cases the device enters a limited functionality mode. An example of this
would be if the printer is unavailable, the device can still process cartridges, but
report printing will be unavailable.

Non-critical Errors during Cartridge run
Error Description
Retry Run The device ejects the cartridge with a user prompt to fix the cartridge
(RR) issue. The user can re-insert the cartridge and the device will retry
processing without the user having to re-enter all information
associated with the cartridge.
Abort Run The device ejects the cartridge, transitions to the, “No Results”
(AR) screen, and displays the detected error code to the user. To re-process
the cartridge, the user must restart the cartridge processing from the
beginning.
Complete The device completes cartridge processing, displays the results, and
with Errors displays the error code associated with the detected Non-critical
(CE) error.
Complete The device completes cartridge processing with no indication that
Normal (CN) any error was detected by the system.
Non-critical, Non-Recoverable Errors (Limited Functionality Mode)

If the printer or battery fail without the cartridge runs being affected, a Non-critical
error is generated, even if the error is not recoverable by the user. The user will
always be notified of the error, but may continue processing cartridges. These errors
should indicate that the unit should be serviced, at the user’s convenience.
Error Description
Printer A printer error (e.g. the UI software cannot communicate with the printer),
the user may continue running cartridges, but the Print Report button will
display an error and be disabled. Results will display at the end of the run, be
stored in the database, where they can be viewed again, exported, and
printed in the event that the printer is repaired.
Battery A battery error (e.g. the battery is failing to recharge when connected to AC),
will cause the Battery icon will display an error. However, while connected to
AC, the user can continue to run cartridge samples.
Critical Errors
When a critical errors occurs, the device can not continue to operate and the
following actions are performed.
• The error is logged into the device log.
• The device is put into a safe state.
• A dialog displays the error code to the user.

• The device power must be cycled to attempt to recover from the error. If the
error is persistent, then the device must be sent back for service.
Error Ranges
The following table defines the range of error codes to log critical and Non-critical
error codes. Note codes 0x0000–0x3FFF are reserved for service Ids.
Error Type Error Range Description
Non-critical
Non-critical Errors
Errors
Common 0x4000–0x4FFF Error range for common non- critical errors

that can be logged by all software systems.
MSP 0x5000–0x54FF Error range for the MSP to log Non-critical
errors.
DSP 0x5500–0x5BFF Error range for the DSP to log Non-critical
errors.
UI 0x5A00–0x6FFF Error range for the UI to log Non-critical
errors.
Critical Errors Critical Errors
MSP Non- 0x7000–0x7FFF MSP errors that are Non-critical for the MSP
critical/System system, but are critical for the system.
critical
Common 0x8000 – 0x8FFF Error range for critical common errors that can
be logged by all software systems.
MSP 0xA000 – 0xAFFF Error range for the MSP to log critical errors.
DSP 0xB000 – 0xBFFF Error range for the DSP to log critical errors.
UI 0xC000 – 0xCFFF Error range for the UI to log critical errors.

Troubleshooting – Error Codes
Error Codes
Acronyms
CSR Workflow State, cartridge sample run.

POST Workflow State, Power On Self Test.
QCR Workflow State, QC Cartridge Run.
Common Software Errors

The following section defines common errors that can occur on all software
systems.
Non-critical Errors
The following section defines the common non-critical errors that can occur on all
processors. If three of these errors occur while the Control board is processing a
command from the UI board, the command fails and the UI system will report the
following critical error.
Error
Error Description Workflow
Code
0xC010 err_ui_pmp_comm_failure The UI software system cannot POST/CSR/

communicate to the Control QCR
Board.
Error
Code
0x4001 err_rx_unknown_msg The system received an Anytime

unknown message.a
0x4002 err_rx_large_msg The system received a message Anytime
a
that was too large to process .
Should only occur during
software development.
0x4003 err_tx_large_msg The transmit message was too Anytime
a
large to process .
0x4004 err_tx_msg_data An attempt to transmit a Anytime
message that has a NULL data
pointera.

Error
Code
0x4005 err_tx A transmit error was detected Anytime

when transmitting a message.
0x4006 err_rx_invalid_msg Invalid input message was Anytime
received.
0x4007 err_rx_crc_invalid The input message failed the Anytime
CRC check.
a.Should only occur during software development.
Critical Errors
The following section defines common critical errors in all software systems. The UI
system will display the Restart Error screen along with the error code listed in the
following table.
Error
Code
0x8001 err_fatal Generic fatal error code. The Anytime

file and line number provide
additional information about
the error.
0x8002 err_assert The software generated an Anytime
assert statement.
0x8003 err_default_case A default statement on a case Anytime
statement was taken.
0x8004 err_buffer_overrun A buffer overrun was detected. Anytime
Control Board Errors

The following section defines errors that are specific to the Control board system.
Most errors detected on the control software system are passed to the UI system for
processing. Only critical errors where the Control Board software system cannot
continue will cause the Control board to execute its critical error handler and reset
the system.

Critical Control Board Errors

The following table defines critical errors that are specific to the Control board. The
UI system will display the Restart Error screen along with the error code listed in
the following table.
Error
Code
0xA001 err_system_clock The Control board could not POST

configure the system clock.
0xA002 err_invalid_gpio_pin An invalid GPIO pin is trying POST
to be configured.
0xA003 err_unexpected_interrupt An unexpected interrupt was Anytime
detected on the Control Board.
Non-Critical Control Board Errors

The following section defines non-critical errors detected on the Control board
system. These errors are passed to the UI board for processing. There is an
additional comment in each table to identify the action taken by the system to the
error (Critical/Non-critical). All errors passed on the UI system are logged by the UI
system.
Communication Errors
The following section defines communications errors that the Control board can
generate. If three of the non-critical errors occur while the Control board is
processing a command from the UI board, the command fails and the UI system will
report the following critical error.
Error
Code
0xC010 err_ui_pmp_comm_failure The UI software system cannot POST/CSR/

communicate to the Control QCR
board.

Additional errors may be reported in the log file depending on the hardware device
involved.
Error System
Code Action
0x5010 err_serial_tx_overflow Serial input buffer overflow. Anytime Non-

critical
0x5012 err_serial_comm_err Corrupt communications Anytime Non-
message. critical
0x5013 err_spi_comm Communications error Anytime Non-
occurred on the SPI Bus. critical
0x5014 err_i2c_comm Communications errors Anytime Non-
occurred on the I2C Bus. critical
0x7001 err_barcode_gpio_com Communications error Anytime Critical
m communicating to the
barcode GPIO board.
0x7002 err_imaging_board_ee Communications error Anytime Critical
prom_comm communicating to the
imaging board EEPROM
0x7003 err_imaging_board_io Cannot communicate to the Anytime Critical
_comm I/O board.
0x7004 err_fan_comm Error communicating to the Anytime
fan controller. Critical
General Motor Controller Errors

The following section defines general errors associated with motor controllers.
Error System
Code Action
0x7020 err_motor_power Motor will not home to set Anytime Critical

position.
0x7021 err_motor_controller_i Failure when initializing the Anytime Critical
nit motor controller.
0x7022 err_motor_controller_ Failure when writing data to Anytime Critical
write the motor controller.
0x7023 err_motor_controller_r Failure when reading data Anytime Critical
ead from the motor controller.

Filter Wheel Errors

The following section defines errors associated with the filter wheel. If three non-
critical errors occur while a filter wheel command is being processed, the command
fails and the UI system will report the following critical error.
Error
Code
0xC052 err_filter_motor The filter motor was unable to POST/CSR/

move to the requested position. QCR
Error System
Code Action
0x5030 err_filter_wheel_move The filter wheel has a time- Anytime Non-

_timeout out before reaching the critical
requested position.
0x5031 err_filter_wheel_pos_s Error reading the filter wheel Anytime Non-
ensor position sensor. critical
0x5032 err_filter_motor_pos_s Error reading the filter wheel Anytime Non-
ensor motor position. critical
0x5033 err_filter_wheel_needs The filter wheel needs to be Anytime Non-
_cal calibrated. critical
0x5034 err_filter_motor_move Filter wheel move error. Anytime Non-
critical
0x5035 err_filter_motor_com Communications error with Anytime Non-
m the filter motor. critical
Slide Motor Errors

The following section defines Control board errors associated with the slide motor.
If three non-critical errors occur while a slide motor command is being processed,
the command fails and the UI system will report the following critical error.
Error
Code
0xC050 err_y_axis The cartridge stage was unable POST/CSR/

to move to the requested Y QCR
location,

Error UI
Code Action
0x5100 err_slide_move_timeou The slide motor has timed- POST/ Non-

t out before reaching the SCR/ critical
requested position. QCR/
Service
0x5101 err_slide_pos_sensor Error reading the slide POST/ Non-
position sensor. SCR/ critical
QCR/
Service
0x5102 err_slide_motor_comm Error communicating to the POST/ Non-
motor controller. SCR/ critical
QCR/
Service
0x5103 err_slide_motor_move Slide motor move error. POST/ Non-
SCR/ critical
QCR/
Service
0x5104 err_slide_motor_stalle The slide motor stalled. POST/ Non-
d SCR/ critical
QCR/
Service
0x5105 err_slide_motor_init There was an error POST/ *Non-
initializing the slide motor SCR/ critical
controller. QCR/
Service
0x5106 err_slide_motor Logged for general slide POST/ *Non-
motor errors. SCR/ critical
QCR/
Service
0x5107 err_slide_motor_needs The slide needs to be POST/ Non-
_cal calibrated. SCR/ critical
QCR/
Service
Note: When the UI system tries to calibrate the slide at start-up, the Control board
will return a failed status, which will cause the system to generate a Y motor
failure.

Focus Motor
The following section defines errors associated with the focus motor. If three non-
critical errors occur while a focus motor command is being processed, the command
fails and the UI system will report the following critical error.
Error
Code
0xC051 err_z_Axis The focus motor was unable to POST/CSR/

Error System
Code Action
0x5150 err_focus_motor_com There was an error POST/ Non-

m communicating to the focus SCR/ critical
motor. QCR/
Service
0x5151 err_focus_motor_move There was a time-out before Anytime Non-
_timeout the focus motor reached its critical
position.
Voltage/Power Monitoring Errors

The following section defines errors associated with monitoring power/voltage
supplies.
Error
Error Description Workflow UI Action
Code
0x710 err_power_sensor_com Communications error to Anytime Critical

1 m_system the system power sensor.
2 m_aux the auxiliary power sensor.
0x710 err_power_sensor_com Communications error Anytime Critical
3 m_3_3v_local interfacing to the 3.3 V
sensor.
0x710 err_power_sensor_5v Communications error to Anytime Critical
4 the 5 V sensor.
5 m_12v the 12 V sensor.

Error
Code

6 m_motor_power the motor power sensor.
7 m_0_9v the 0.9 V sensor.
8 m_1v the 1 V sensor.
9 m_1v_auto interfacing to the 1 V auto
sensor.
0 m_1_5v interfacing to the 1.5 V
sensor.
0x711 err_power_sensor_com Communication error Anytime Critical
1 m_1_8v interfacing to the 1.8 V
sensor.
2 m_3_3v_remote interfacing to the 3.3 V
remote sensor.
0x711 err_input_power Input power error. Anytime Critical
3
0x711 err_5v_bad 5 V power is bad. Anytime Critical
4
0x711 err_12v_bad 12 V power is bad. Anytime Critical
5
0x711 err_motor_power_goo Motor power error. Anytime Critical
6 d
0x711 err_integra_power_sup The Integra power supply is Anytime Critical
7 plies outside specification.

Battery Errors
The following section defines errors associated with the system battery. There are
no critical battery errors as the system can operate on AC power.
Error
Code
0x517 err_charger_comm Communication error to Anytime Non-

0 battery charger circuit. critical
0x517 err_battery_comm Error communicating to Anytime Non-
1 battery. critical
0x517 err_battery_end_of_lif Battery has reached end of Anytime Non-
2 e life. critical
0x517 err_battery_failure Battery failure. Anytime Non-
3 critical
0x517 err_charger_failure Charger failure. Anytime Non-
4 critical
LED Errors
The following section defines errors associated with LEDs.
Error
Code
0x715 err_led_temp_low The LED temperature is too Anytime Critical

0 low to calculate a valid
temperature.
0x715 err_led_temp_high The LED temperature is too Anytime Critical
1 high to calculate a
temperature.
Miscellaneous Errors
Error
Code
0x720 err_door_sensor The door sensor is not Anytime Critical

0 detecting the door open.
0x518 err_unknown_task_ms An unknown task sent a Anytime Non-
0 g message. Development only. critical

Error
Code
0x518 err_watchdog_reset The Control board was reset Anytime Non-

1 by a watchdog reset. The critical
system has already reset, so
log error.
0x518 err_unknown_reset An unknown condition Anytime Non-
2 caused the Control board to critical
reset.
0x720 err_eeprom_corrupt EEPROM error checking Anytime Critical
2 found a corruption.
DSP Errors
The following section defines the errors/warnings that are specific to the DSP
software system. Currently, no non-critical DSP errors are defined.
Critical Errors
The following section defines critical errors specific to the DSP software system.
Error
Code
0xB001 err_dsp_ctrl The DSP system task is Anytime

unresponsive.
0xB002 err_dsp_proc_err The DSP encountered a Anytime
condition where it cannot
continue. Examples are divide
by zero.
UI Errors
The following section defines the errors and warnings that are specific to the UI
software system.

Miscellaneous Critical Errors

The following table lists the miscellaneous critical UI errors. Currently there are no
non-critical miscellaneous defined.
Error
Code
0xC003 err_pwm_interface A write command to the PWM Anytime

interface for the buzzer or
brightness drivers failed.
0xC004 err_file_write An error writing to the log.txt Anytime
file occurred.
0xC005 err_debug_config An invalid debug configuration POST
file was found.
0xC006 err_gpio_if A write/read command to the Anytime
Linux GPIO driver failed.
0xC008 err_uncalibrated A manufacturing calibration POST
variable was found to be
uncalibrated.
0xC009 err_dsp_rev_mismatch The DSP software version does POST
not match the ARM.
0xC00A err_pmp_rev_mismatch The PMP software version POST
does not match the ARM.
0xC007 err_dsp_load_invalid The DSP Load is invalid. POST
0xC00B err_invalid_hb_file Invalid HB reference template POST
file.
0xC00C err_invalid_focus_file Invalid focus mask file. POST

Communication Errors
The following sections define the communication errors that are detected by the UI
system.
Non-Critical Errors
The following table lists fatal non-critical UI communications errors.
Error
Code
0x5A01 err_pmp_comm_timeout A message sent to the PMP was POST/CSR/

not acknowledged. The UI QCR
software had to re-send the
message.
0x5A02 err_dsp_comm_timeout A message sent to the DSP was POST/CSR/
not acknowledged. The UI QCR
software had to re-send the
message.
Critical Errors
The following table lists critical UI communications errors.
Error
Code
0xC011 err_ui_dsp_comm_failure The UI software system cannot POST/CSR/

communicate to the DSP QCR
software system.
0xC012 err_no_pmp_iface No PMP interface could be POST
createda.
0xC013 err_no_service_iface No service interface could be POST
a.
created
a. This should only occur in development mode when configured to override the default
PMP configuration.
Image Camera Errors

The following sections define errors associated with the image camera. Currently
there are no Non-Critical Imaging camera errors define.

Critical Errors
Error
Code
0xC031 err_no_image_buffer The image acquisition task POST/CSR/

timed out when waiting for an QCR/Service
image buffera.
0xC032 err_image_camera_comm Failure communicating to the POST/CSR/
imaging camera QCR
a. This should only occur in development mode when configured to override the default
PMP configuration.
Barcode Camera Errors

The following sections define errors associated with the barcode camera.
Non-Critical Errors
Error
Code
0x5A20 err_barcode_decode The device failed to decode the CSR/QCR

barcode.
Critical Errors
Error
Code
0xC039 err_barcode_camera The barcode camera has failed POST/CSR/

to receive data. QCR
Cartridge Processing Errors

The following are errors associated with cartridge processing.
Non-Critical Errors
Error
Code
0x5B02 err_door_open_during_run The cartridge door was open CSR/QCR

during a run.
0x5B03 err_expired_barcode The barcode is expired. CSR/QCR

Error
Code
0x5B05 err_position_unreachable A cartridge position was CSR/QCR

determined to be unreachable
after Y/Z adjustments for Y
calibration and focus height.
0x5B06 err_Y_autocal_failure The image processing routine CSR/QCR
to detect a known Y location
on the cartridge (the Hb
reference window) failed.
0x5B07 err_Y_slipPage Y stage slippage was detected CSR/QCR
on verify home.
0x5B08 err_focus_fit_fine If the R-sq value of the cubic CSR/QCR
fit is less than the fit goodness
threshold, the run will be
aborted with a focus fit error.
0x5B09 err_focus_z_range If the fine fit reports a peak CSR/QCR
focus score at a Z height <50
microns or >1450 microns, log
error and retry focus (coarse
plus fine). If the retry fails,
abort the sample run.
0x5B0A err_focus_min_score If final image sharpness score CSR/QCR
fails minimum value, log an
error and retry focus (coarse
plus fine). If the retry fails,
abort the sample run.
0x5B0B err_focus_z_ideal_bounds If the fine fit gives a Z height CSR/QCR
outside the ideal bounds
(between the 2nd and 4th
focus points) log an error and
retry focus (coarse plus fine). If
the retry fails, abort the sample
run.
0x5B0C err_cartridge_bow If the cartridge bow is >200 CSR
microns as calculated at
fiducial position 2, the run will
be aborted.

Critical Errors
Error
Code
0xC050 err_y_axis The cartridge stage was unable POST/CSR/

to move to the requested Y QCR
location.
0xC051 err_z_Axis The focus motor was unable to POST/CSR/
0xC052 err_filter_motor The filter motor was unable to POST/CSR/
0xC055 err_motor_control A motor controller error was POST/CSR/
detected by the device. QCR
0xc057 err_cartridge_load_error The device was unable to load CSR/QCR
the cartridge. Possible cause:
The cap is not closed.
Printer Errors
Non-Critical Errors
The following are non-critical errors associated with the printer.
Error
Code
0x5C01 err_printer_out_paper The printer is out of paper. CSR/QCR/

POST
0x5C02 err_no_printer Communication to the printer CSR/QCR/
over serial connection failure. POST
0x5C03 err_printer_door The printer door is open. CSR/QCR/
POST
0x5C04 err_printer_error A Printer error was detected. CSR/QCR/
Possible printer errors: POST
• Printer head over
temperature
• Voltage error

Thermal Errors
Non-Critical Errors
The following are non-critical errors associated with the thermal management.
Error
Code
0x6022 err_slide_temp The cartridge is over CSR/QCR

temperature.
Critical Errors
The following are critical errors associated with the thermal management.
Error
Code
0x7300 err_over_temperature The ambient temperature Anytime

inside the box is over
temperature.
0xC04 err_camera_temp The camera temperature is Anytime
1 over temperature.
Note: A critical temperature error is treated the same as a critical error in the
system, except that the Critical Temperature error screen is displayed to the
user, instead of the normal critical error screen.
USB Data Errors
Non-Critical Errors
The following are non-critical errors associated with the USB media.
Error
Code
0x5E01 err_usb_drive_full The connected USB device is Export

full. The export cannot be
saved.
0x5E02 err_usb_write_fail Writing to the USB device Export
failed for unknown reasons
(e.g. USB device is write-
protected).

Clinical Mode Errors
Non-Critical Errors
The following are non-critical errors that may occur when the device is booted up in
clinical data collection mode. These errors are associated with testing features
intended for use only during product development.
Error
Error Description Workflow Action
Code
0x5F00 err_runconfig_invalid Upon attempting to start a CSR/ Do not

run, the runconfig file on the QCR allow
USB drive was read and run to
determined to be invalid. start.
0x5F01 err_usb_not_enough_s There is not enough space on CSR/ Do not
pace the USB drive to save data QCR allow
associated with the cartridge run to
run. This error is logged if start.
the device is configured in
clinical collection mode, and
there is not enough room on
the USB drive to save the
image data associated with
the run.

Database Errors
The following section defines errors related to the SQLite database. There are no
non-critical data base errors.
Critical Errors
Error
Code
0xC080 err_database_corrupt The database file is corrupt. Anytime

0xC081 err_database_write A write/update to the database Anytime
failed.
0xC082 err_database_connect Cannot connect to the Anytime.
database.
0xC083 err_database_invalid The database is missing Anytime.
expected tables or columns.
Post/Instrument QC Errors
The following section defines errors related to QC tests. QC tests are run during
POST (at startup), and on demand during the instrument QC run.
Non-Critical Errors
Error
Code
0x6100 err_qc1_image_qual Combination of checks of the POST, QCR

Hb QC1 spectral image:
• Cannot find the zeroth
order line
• Cannot calculate intensity
uniformity
0x6101 err_qc2_image_qual Cannot find at least three of the POST, QCR
major QC2 features (corners
and center).
0x6102 err_qc3_image_qual Combination of checks of the POST, QCR
Hb QC3 spectral image:
• Cannot find the zeroth
order line
• Cannot calculate intensity
uniformity

Error
Code
0x6103 err_mag_offset Calculated magnification over POST, QCR

possible range of Z heights is
outside allowed limits.
0x6104 err_starfield_x_center Starfield center too far from POST, QCR
nominal X location (in image Y
direction).
0x6105 err_starfield_y_center Starfield center too far from POST, QCR
nominal Y location (in image X
direction).
0x6106 err_qc_count Normal or Low dot count is POST, QCR
out of tolerance.
0x6107 err_org_led_current Orange LED current is set at POST, QCR
physical limit and brightness is
still [above/below] nominal
[+20% / -20%].
0x6108 err_gre_led_current Green LED current is set at POST, QCR
physical limit and brightness is
still [above / below] nominal
[+20% / -20%].
0x6109 err_org_curvature Orange LED %CV is too high POST, QCR
(>10%).
0x610A err_gre_curvature Green LED %CV is too high POST, QCR
(>10%).
0x610B err_qc_resolution Measured resolution does not POST, QCR
meet specification.
0x610C err_slit_focus Slit focus score outside legal POST, QCR
range.
0x610D err_ir_led_current New IR LED calibration POST, QCR
coefficient gives brightness
outside of saturation range
(between 50–75%).
0x610E err_wht_led_current New white LED calibration POST, QCR
coefficient gives brightness
outside of saturation range
(between 50–75%).

Error
Code
0x610F err_hb_uniformity Zeroth order line variance or POST, QCR

%CV in CCD-Y direction
(stage-X direction) exceeds
tolerance.
0x6111 err_qc1dk_image_qual Dark Image quality error on POST, QCR
dark QC1 image.
0x6112 err_instrument_qc_hb_erro Instrument QC error. POST, QCR
r
0x6113 err_qc1dim_image_qual Combination of checks for HB POST, QCR
spectra.
Note: POST/QC errors tagged with CE, allow further sample runs, but an error
code is shown with results.
Critical Errors
Error
Code
0xC091 err_org_led_iteration Last computed orange LED POST/QCR

coefficient is more than 10%
away from previous coefficient
after 10 iterations.
0xC092 err_gre_led_iteration Last computed green LED POST/QCR
0xC094 err_slit_angle Zeroth order line too far from POST/QCR
vertical on CCD image.
0xC095 err_wave_pixel_max Max visible wavelength on POST/QCR
CCD is too low.
0xC096 err_ir_led_iteration Last computed IR LED POST/QCR
0xC097 err_wht_led_iteration Last computed white LED POST/QCR

Error
Code
0xC098 err_door_open_post_qc Cartridge door open during POST/QCR

POST/QC.
Sample Processing Errors

Sample processing errors can occur during the acquisition and analysis of patient
samples or process controls (CSR workflow). All sample processing errors are non-
critical (i.e. they do not put the system into a faulted state or require a system
reboot).
Non-Critical Errors
All algorithm errors are non-critical to the system, but they will result in one of the
following actions (as indicated in the table):
• AR action case: cause the cartridge run to be aborted
• CE action case: cause the sample result(s) to be suppressed and an error code to
be displayed
• CN action case: provide results as calculated and an error code to be displayed
Error Code Error Description
0x6B01 err_qc_frac_artifact_high Reagent QC FOV artifact area ratio to total

area exceeds threshold (in configuration file).
0x6B02 err_qc_bead_min_count This is the main condition to check.
0x6B04 err_hbref_image_qual Combination of checks of the Hb source
transmission image:
• Cannot find the zeroth order line
• Cannot find pass band lines
0x6B06 err_fovs_for_hbpc Hb Process Control FOVs #9 and #10 are
rejected during image processing (equivalent
to cartridge QC for Hb process control).
0x6B07 err_hb_insufficient_fovs Less than minimum number of FOVs for
producing the result.
0x6B09 err_hb_rep_range Hb reportable range is defined in software
requirements.
0x6B0A err_min_total_events Insufficient total events to proceed to gating
step. May be due to too many artifacts or very
low cell count.
0x6B0B err_too_few_gated_event Due to too few events in gates.
s

Error Code Error Description
0x6B0C err_pdf_no_intensity Due to flat intensity in histogram.

0x6B0D err_nonunif_cell_distrib_ Non uniform cell distribution along channel.
y
0x6B0E err_nonunif_cell_distrib_ Non uniform cell distribution across channel.
x
0x6B0F err_too_many_moving_ce Too many moving cells, too many green
lls channel, only events or CD4 channel too
noisy.
0x6B10 err_cd4_rep_range CD4/%CD4 reportable range is defined in
software requirements.
0x6B11 err_gaussian_corr CD4 numbers are suppressed.
0x6B15 err_hb_fov_qual Issue with one of the HB FOV where it is not
used in results calculation.
0x6B16 err_norm_image_qual After dividing QC3 by the source reference
image, check to ensure both pass bands can be
determined.
0x6B17 err_hbfovdk_image_qual Mean intensity is above maximum image
brightness threshold.

Troubleshooting – GUI Troubleshooting Guide For IFU
GUI Troubleshooting Guide For IFU
Restart Error Screen
Description Restart Error screen displays after a system critical error is

detected.
Recommendation Remove the USB drive if it is inserted into the USB port. If there
is a cartridge stuck in the door, do not try and remove it. Close
the cap if it is open. Shutdown the system by holding the Power
button, then restart the system. If an error occurs during startup,
contact BD Service.
Error Codes
Error Description
8001-8004 Software internal

A001, A002, A003 Control board
7001-7004 Communications
7020-7202 Instrument hardware
B002, B005 DSP processor
C003-C057 UI board
C080-C083 Database
C091-C098 POST / QC checks

Sample Run Error Screen
Description The Sample Run Error screen displays for an error requiring the
sample run to abort.
Recommendation If within two hours of incubation, unload and re-run the sample
cartridge. Otherwise prepare a new cartridge.
Error Codes
Error Description
5B02 Door Open

5B06, 5B07, 5A20 Cartridge detection
C039 Instrument hardware
5B08, 5B09, 5B0A, 5B0B, Internal checks
5B05, 5B0C

Cartridge Alert Screen
Description The Cartridge Alert screen displays if a problem occurs detecting

the cartridge loading or identification.
Recommendation Unload the cartridge and check for liquid or smears obscuring
the channel or barcode. Reload the cartridge to continue run.
Error Codes
Error Description
5B06 Cartridge detection

Sample Results Screen with Errors
Description The Sample Results screen displays suppressed results and error
codes.
Recommendation If within two hours of incubation, re-run the sample cartridge.

Otherwise prepare a new cartridge.
Error Codes
Error Description
5B03 Cartridge expired

6B01, 6B02 Reagent QC beads
6101, 6103 Internal checks
6B04, 6B07, 6B16, 6B17 Hb assay
6B0A, 6B0B, 6B0C, CD4 assay
6B0D, 6B0E, 6B0F, 6B11

Sample Results Screen Out of Reportable Range
Description The Sample Results screen displays results that have been
flagged as “out of reportable range”.
Recommendation Consult with the lab manager. If within two hours of incuba-
tion, re-run the sample cartridge. Otherwise prepare a new car-
tridge.
Error Codes
No error codes for reportable range.

POST/QC Results Screen with Error
Description The Instrument QC screen displays suppressed results and error

codes.
Recommendation Restart the instrument to determine if the errors are persistent. If

so, contact BD Service.
Error Codes
Error Description
6100–6113, 6B16 Calibration and operational checks

5B05, 5B08, 5B09, 5B0A, Internal checks
5B0B, 5B0C

Critical Temperature Error Screen
Description The Critical Temperature error screen displays specific to tem-

perature error with codes.
Recommendation Shutdown the instrument and wait for it to cool before restart-
ing. If an error is persistent, contact BD Service.
Error Codes
Error Description
7300, C041 Temperature too high

Index
B Error Codes, 7‐4
Error Log Software Specifications, 7‐1
Battery, 3‐3
Battery Errors, 7‐12 F
Biological Safety, 1‐4, 1‐5, 1‐6, 1‐7
Fan, 3‐7
Biosafety Guidelines, 1‐4
Filter Wheel Assembly, 3‐5
Biosafety Levels, 1‐5, 1‐6, 1‐7
Final Cleanup, 5‐55
Block Diagram, A‐2
Final Test, 5‐36
BSL1 Environment, 1‐6
Front Enclosure Module, 3‐1
BSL3 Environment, 1‐6 G
General Safety, 1‐2
C GUI Troubleshooting Guide For IFU
Cartridge Alert Screen, 7‐28
Cartridge, 2‐5
Critical Temperature Error Screen, 7‐32
CD4 Excitation Module, 3‐3
POST/QC Results Screen with Error, 7‐31
Chassis, 3‐7
Restart Error Screen, 7‐26
Chassis PCB Module, 3‐6
Sample Results Screen Out of Reportable Range,
Chassis, Fan, and Speaker Module, 3‐7
7‐30
Component Description, 3‐1
Sample Results Screen with Errors, 7‐29
Sample Run Error Screen, 7‐27
Battery, 3‐3
CD4 Excitation Module, 3‐3 I
Chassis PCB Module, 3‐6
Installation, 4‐1
Control Module, 3‐6
Installing the Instrument, 4‐1
User Interface Module, 3‐7
Instrument Settings, 4‐2
Chassis, Fan, and Speaker Module, 3‐7
Installing Service Software, 5‐8
Detection Module, 3‐4
Installing Service Software and Local Database, 5‐8
Filter Wheel Assembly, 3‐5
Installing the Instrument, 4‐1
Instrument Settings, 4‐2
Power Supply, 3‐3
Interconnect Diagram, A‐3
Printer, 3‐2
Touch Screen, 3‐2 L
Control Module, 3‐6 LED Errors, 7‐12
Create bddb Login, 5‐19 Levels, 1‐5
D Local Database, 5‐8
Debug Mode, 5‐48 O
Decontamination, 5‐2 Operating Environment, 2‐2
Detection Module, 3‐4 Optical System CD4 Measurement, 2‐6
Diagrams, A‐1
P
E POST, 2‐9
Electrical Block Diagram, A‐10 Power On Self-Test, 2‐9
Electrical Diagrams Power Supply, 3‐3
Electrical Block Diagram, A‐10 Printer, 3‐2
Interconnect Diagram, A‐3
System Block Diagram, A‐2 Q
Electrical Requirements, 2‐1 Qualification, 5‐55
Electrical Safety, 1‐3
Electrical System, 2‐8
Doc. Number 658892 BD FACSPresto Index-1

R Speaker Module, 3‐7
System Block Diagram, A‐2
Replacement Procedures, 6‐1
System Overview, 2‐3
Battery, 6‐2
System Specifications, 2‐1
Detection Module, 6‐15
Excitation LED Module, 6‐4 T
Fan and Speaker Module, 6‐14
Technical Description, 2‐1
Theory of Operation, 2‐1
PCB Module, 6‐6
Electrical Requirements, 2‐1
Printer, 6‐19
Electrical System, 2‐8
Touch Screen, 6‐19
Operating Environment, 2‐2
Replacing the Battery, 6‐2
Power On Self-Test, 2‐9
Replacing the Detection Module, 6‐15
Software Systems, 2‐8
Replacing the Excitation LED Module, 6‐4
System Overview, 2‐3
Replacing the Fan and Speaker Module, 6‐14
Cartridge, 2‐5
Replacing the Front Enclosure Module, 6‐18
Optical System CD4 Measurement, 2‐6
Replacing the PCB Module, 6‐6
Workflow, 2‐4
Replacing the Printer, 6‐19
System Specifications, 2‐1
Replacing the Speaker and Fan Module, 6‐14
Touch Screen, 3‐2
Replacing the Touch Screen, 6‐19
Troubleshooting, 7‐1
S Barcode Camera Errors, 7‐16
Cartridge Processing Errors, 7‐16
Safety, 1‐1
Clinical Mode Errors, 7‐20
Biological Safety
Biosafety, 1‐5 Communication Errors, 7‐15
Database Errors, 7‐21
Biosafety Guidelines, 1‐4
Error Codes, 7‐4
Biosafety Levels
BSL1 Environment, 1‐6 Battery Errors, 7‐12
Common Software Errors, 7‐4
Communication Errors, 7‐6
Control Board Errors, 7‐5
DSP Errors, 7‐13
Electrical Safety, 1‐3
Filter Wheel Errors, 7‐8
General Safety, 1‐2
Focus Motor, 7‐10
Service Functionality, 5‐51
General Motor Controller Errors, 7‐7
Service Software, 5‐36
LED Errors, 7‐12
Debug Mode, 5‐48
Miscellaneous Errors, 7‐12
Final Test, 5‐36
Slide Motor Errors, 7‐8
Service Functionality, 5‐51
UI Errors, 7‐13
Service Tool Kit, 5‐1
Voltage/Power Monitoring Errors, 7‐10
Servicing Requirements, 5‐1
Create bddb Login, 5‐19 Error Log Software Specifications, 7‐1
Decontamination, 5‐2 GUI Troubleshooting Guide For IFU, 7‐26
Installing Service Software and Local Database, Cartridge Alert Screen, 7‐28
Critical Temperature Error Screen, 7‐32
5‐8
Qualification, 5‐55 POST/QC Results Screen with Error, 7‐31
Service Software, 5‐36 Restart Error Screen, 7‐26
Debug Mode, 5‐48 Sample Results Screen Out of Reportable
Range, 7‐30
Final Cleanup, 5‐55
Final Test, 5‐36 Sample Results Screen with Errors, 7‐29
Service Functionality, 5‐51 Sample Run Error Screen, 7‐27
Service Tool Kit, 5‐1 Image Camera Errors, 7‐15
Servicing Safety and Precaution, 5‐1 Post/Instrument QC Errors, 7‐21
Servicing Safety and Precaution, 5‐1 Printer Errors, 7‐18
Software Systems, 2‐8 Sample Processing Errors, 7‐24
Thermal Errors, 7‐19
Index-2 BD FACSPresto Doc. Number 658892

USB Data Errors, 7‐19
U
User Interface Module, 3‐7
W
Workflow, 2‐4
Doc. Number 658892 BD FACSPresto Index-3

Index-4 BD FACSPresto Doc. Number 658892

FACSPresto SVC - MNL-Distributor - NOT A Released Version

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Copyright:

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FACSPresto SVC - MNL-Distributor - NOT A Released Version

Uploaded by

Copyright:

Available Formats

BD FACSPresto

Doc. Number 658892

Copyrights and Trademarks

ii BD FACSPresto Doc. Number 658892

Safety Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

Front Enclosure Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Doc. Number 658892 BD FACSPresto iii

Service Tool Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

Replacing the Rear Enclosure Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

Error Log Software Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

iv BD FACSPresto Doc. Number 658892

Mechanical hazard, pinch points

Doc. Number 658892 BD FACSPresto 1-1

Risk General system precautions

To prevent hazards, the BD FACSPresto instrument and attached

Always use universal precautions when handling biological specimens or

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For protection against electrical shock, equipment should be connected to an

To prevent exposure to potential electrical shock hazards:

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Doc. Number 658892 BD FACSPresto 1-5

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4 Will the lab move the equipment to a BSL1 or BSL2 location?

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Dimensions 25.9 x 25.1 x 28.5 cm

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Temperature Operating 10–40°C (50–104°F)

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BD FACSPresto is a self-contained, portable system for analyzing absolute CD4

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Vent outlet Capillary stop

Optical System CD4 Measurement

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The BD FACSPresto system is composed of the following three software systems:

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- Provides high-level control during a cartridge run

Power On Self-Test (POST)

Instrument Quality Control

Instrument QC is included in the POST process and may additionally be run

Doc. Number 658892 BD FACSPresto 2-9

Clear Window (QC1) Feature Tests Using the Spectrograph Image

Starfield (QC2) Feature Test

CD4 Excitation LED Illumination Tests

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Imaging Camera Test

Linear Y-stage Alignment

Dual Bandpass Filter (QC3) Spectrographic Image Tests

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Cartridge Quality Checks

Cartridge QC is included in the sample run process automatically after a cartridge

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Front Enclosure Module

The front enclosure module, consists of the following

Doc. Number 658892 BD FACSPresto 3-1

Rear Panel Enclosure

The rear enclosure module consists of the following

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