D-10 HEMOGLOBIN TESTING SYSTEM

Bio-Rad Laboratories
Diagnostics Group
4000 Alfred Nobel Drive
Hercules, California 94547
USA

TECHNICAL ASSISTANCE

Toll Free 1-800-2BIORAD (224-6723)

Bio-Rad provides a toll free line for technical assistance,

available 24 hours a day, 7 days a week.

DRAFT

The toll free number is available for use only in the United States of America and Puerto
Rico. Outside the U.S.A., please contact your regional Bio-Rad office for assistance.

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D-10 HEMOGLOBIN TESTING SYSTEM

Multiple Language CD
This manual includes a multiple language CD-ROM in the following languages:
English, German, French, Spanish, Italian, Portuguese, Swedish and Danish.

DRAFT

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WARNING: ELECTRIC SHOCK HAZARD

Do not remove cover.
There are no user-serviceable parts inside.
Refer servicing to Bio-Rad Personnel.
The D-10 Hemoglobin Testing System was designed and certified to meet
IEC61010 safety standards. Certified products are safe to use when
operated in accordance with the instruction manual. This safety certification
does not extend to other equipment or accessories not IEC61010 certified,
even when connected to the D-10 Hemoglobin Testing System.
This instrument should not be modified or altered in any way. Alteration of
this instrument will void the warranty, void the IEC61010 certification, and
create a potential safety hazard for the user.
Bio-Rad is not responsible for any injury or damage caused by the use of
this instrument for purposes other than for which it is intended or by
modifications of the instrument not performed by Bio-Rad or an authorized
agent.
IEC61010 is an internationally accepted electrical safety standard for
laboratory instruments.

CAUTION

BIOHAZARD
DRAFT
Please read through and familiarize yourself with the contents of the
operation manual before using the system for the first time.
All personnel using the D-10 should wear standard laboratory safety
apparatus (e.g., safety glasses, laboratory coat, gloves).
All reference material (i.e., calibrators, controls) and patient samples should
be considered as biohazardous material and must be handled with caution.
Waste material contains sample waste plus reagents; treat and dispose of
as directed by your laboratory safety guidelines or by local ordinance.

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Graphic Conventions
Throughout the text, icons and signal words appear where the nature of the
information warrants special attention. The following is a list of hazard
conventions used in this manual.

CONVENTION DESCRIPTION
NOTE: Note statements alert you to important
information that is relevant to the current
subject matter.

WARNING: Warnings appear adjacent to an

important point of information which can
cause potential physical hazards.

CAUTION: This signals a condition that

may cause damage to equipment or
data.

WARNING: This warning alerts you to a

condition that may result in an electrical
shock that may cause personal injury or
death.

DRAFT
BIOHAZARD: This warning alerts you to
a potentially biohazardous condition.

Trademarks and References

D-10 and Lyphochek are trademarks of Bio-Rad Laboratories, Inc.
All other trademarks are the property of their respective companies.

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Table of Contents
Graphic Conventions........................................................................................................ 1-iii
Trademarks and References............................................................................................ 1-iii
1. Introduction ......................................................................................................... 1-1
General Description.......................................................................................................... 1-1
Principles of Operation..................................................................................................... 1-2
2. System Description ........................................................................................... 2-1
Overview ........................................................................................................................... 2-1

DRAFT
System Status................................................................................................................... 2-2
System Components........................................................................................................ 2-2
User Interface ................................................................................................................... 2-3
Run Screen ............................................................................................................ 2-4
Data Screen ........................................................................................................... 2-7
Settings Screen ...................................................................................................... 2-10
Lot Info Screen ....................................................................................................... 2-12
Maintain Screen....................................................................................................... 2-17
Sample Processing Compartment .................................................................................. 2-20
Sample Analysis Compartment ....................................................................................... 2-22
Side View, Right ...................................................................................................... 2-23
Side View, Left ........................................................................................................ 2-24
Rear View............................................................................................................... 2-25

3. Installation ........................................................................................................... 3-1

Installation Requirements................................................................................................. 3-1
Unpacking and Inspection ............................................................................................... 3-2
Set Up .............................................................................................................................. 3-4
Reagent Lines ........................................................................................................ 3-4
Waste Line ............................................................................................................. 3-4
Power Cord ............................................................................................................ 3-5
Install the Printer Paper ............................................................................................. 3-5
Prime the Reagent Lines ............................................................................................ 3-5
Install the Cartridge .................................................................................................. 3-6

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Assess the Check Valves ...........................................................................................3-8

Perform the Update Kit Procedure................................................................................3-8
Enter Control Values .................................................................................................3-9
Barcode Labels.........................................................................................................3-10
Performing Test Runs .......................................................................................................3-10
Perform a Prime Run.................................................................................................3-10

4. Operation .............................................................................................................4-1
General Information ..........................................................................................................4-1
Routine Processing For Whole Blood Samples From Primary Tubes .....................................4-1
Routine Processing For Pre-diluted Samples Using Sample Vials .........................................4-2
Urgent Sample Processing .........................................................................................4-2
Emergency Shut Down ..............................................................................................4-2
Pre-run Checklist ..............................................................................................................4-3
Check the Method Setting..........................................................................................4-3
Check the Buffers and Wash/Diluent Solution Levels.........................................................4-3
Check the Number of Injections on the Cartridge .............................................................4-4
Check the External Waste Tank Level............................................................................4-6
Check the Pressure ..................................................................................................4-6
Check for Leaks.......................................................................................................4-7
Check the Printer Paper Supply ...................................................................................4-7
Changing Methods ...........................................................................................................4-7
Change Reagents ....................................................................................................4-7
Install a New Cartridge and System Software ..................................................................4-7

DRAFT
Perform a System Flush.............................................................................................4-7
Select a New Method................................................................................................4-8
Performing a Run ..............................................................................................................4-8
Setting Up a Sample Rack..........................................................................................4-8
Loading Samples .....................................................................................................4-8
Analyzing Samples ...................................................................................................4-8
Interrupting a Run ....................................................................................................4-9
Reviewing Data .................................................................................................................4-9
Exporting Data ........................................................................................................4-10
Post-Run Checklist ...........................................................................................................4-10
Store or Discard Samples...........................................................................................4-10
Wipe Up Spills and Decontaminate Surfaces...................................................................4-10
Long-Term Shut Down ..............................................................................................4-10

5. Maintenance .......................................................................................................5-1
Monthly Maintenance .......................................................................................................5-1
Exterior Surface Cleaning ...........................................................................................5-1
Interior Surface Cleaning ............................................................................................5-1
Clean/Decontaminate Sampling Fluid Path .....................................................................5-2
Clean the Dilution Well...............................................................................................5-2
Clean Internal Waste Bottle.........................................................................................5-2
Clean and Inspect Sample Racks .................................................................................5-3
Periodic Maintenance .......................................................................................................5-3
Replace the Sample Probe .........................................................................................5-3

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6. Troubleshooting ................................................................................................. 6-1

General Troubleshooting.................................................................................................. 6-2
Hardware Error Codes ..................................................................................................... 6-9
Checking for Leaks or Blockages ................................................................................. 6-11
Replace the Fluid Lines ............................................................................................. 6-11

A. System Specifications ...................................................................................... A-1

General Specifications ..................................................................................................... A-1
Visible Wavelength Detector Specifications.................................................................... A-2
Pump Unit Specifications................................................................................................. A-2
Pressure Sensor Specifications....................................................................................... A-2
Degasser Unit Specifications........................................................................................... A-2
Injection Valve Specifications........................................................................................... A-2
Sample Handling .............................................................................................................. A-3
Sample Identification........................................................................................................ A-3
Reagent Bottle Bay........................................................................................................... A-3
Waste Tank Unit, external ................................................................................................ A-4
System Controller............................................................................................................. A-4
User Interface ...................................................................................................................A-4

DRAFT
Cartridge Holder ............................................................................................................... A-4
B. Replacement Parts ............................................................................................ B-1
C. Maintenance Logs ............................................................................................. C-1
Daily Log
Monthly Maintenance Log
Periodic Maintenance Log

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 D-10 HEMOGLOBIN TESTING SYSTEM

List of Figures &

Tables
Figure 1-1 The D-10 Hemoglobin Testing System .............................................................................. 1-1
Figure 2-1 D-10 Front View ................................................................................................................ 2-2
Figure 2-2 User Interface/Run Screen ................................................................................................ 2-3
Figure 2-3 Run Screen, Sleep State ................................................................................................... 2-4
Figure 2-4 Run Screen, Start Up Sequence ....................................................................................... 2-4

DRAFT
Figure 2-5 Run Screen, Standby State ............................................................................................... 2-5
Figure 2-6 Run Screen, Eject Button .................................................................................................. 2-6
Figure 2-7 Keypad ............................................................................................................................. 2-7
Figure 2-8 Data Screen ...................................................................................................................... 2-7
Figure 2-9 Data/Print Menu ................................................................................................................ 2-8
Figure 2-10 Data/Export Menu ............................................................................................................ 2-9
Figure 2-11 Data/Change View ............................................................................................................ 2-9
Figure 2-12 Data/Change View/View Chrom. ....................................................................................... 2-9
Figure 2-13 Settings Screen ................................................................................................................ 2-10
Figure 2-14 Settings/General Settings ................................................................................................. 2-10
Figure 2-15 Settings/Print Settings ...................................................................................................... 2-11
Figure 2-16 Settings/Archive Settings .................................................................................................. 2-11
Figure 2-17 Settings/Levels ................................................................................................................. 2-11
Figure 2-18 Settings/Alert Settings ...................................................................................................... 2-12
Figure 2-19 Lot Info Screen ................................................................................................................. 2-12
Figure 2-20 Lot Info/Update Kit Screen ................................................................................................ 2-13
Figure 2-21 Lot Info/Low Control Screen ............................................................................................. 2-13
Figure 2-22 Lot Info/Low Control/Select Method Screen ..................................................................... 2-13
Figure 2-23 Lot Info/High Control Screen ............................................................................................. 2-14
Figure 2-24 Lot Info/Calibrator 1 Screen .............................................................................................. 2-14
Figure 2-25 Lot Info/Calibrator 2 Screen .............................................................................................. 2-14
Figure 2-26 Lot Info/Buffer 1 Screen .................................................................................................... 2-15

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Figure 2-27 Lot Info/Buffer 1/Reset Level Screen ................................................................................. 2-15

Figure 2-28 Lot Info/Buffer 2 Screen .................................................................................................... 2-15
Figure 2-29 Lot Info/Wash Reagent Screen ......................................................................................... 2-16
Figure 2-30 Lot Info/Wash Reagent Screen ......................................................................................... 2-16
Figure 2-31 Maintain Screen ................................................................................................................ 2-17
Figure 2-32 Maintain/View Log ............................................................................................................. 2-18
Figure 2-33 Maintain/Service Screen .................................................................................................... 2-19
Figure 2-34 Sample Processing Compartment ..................................................................................... 2-20
Figure 2-35 Sample Rack with Sample Vial Adapters ........................................................................... 2-21
Figure 2-36 Sample Analysis Compartment ......................................................................................... 2-22
Figure 2-37 D-10, Perspective View ..................................................................................................... 2-23
Figure 2-38 Display Contrast Knob ...................................................................................................... 2-23
Figure 2-39 Right Side, Lower Compartment (panel door open) ........................................................... 2-24
Figure 2-40 Left Side View ................................................................................................................... 2-24
Figure 2-41 Rear View ......................................................................................................................... 2-25
Figure 3-1 D-10 Carton and Pallet ..................................................................................................... 3-2
Figure 3-2 Unpacking the D-10 .......................................................................................................... 3-2
Figure 3-3 Sampling Arm Shipping Lock ............................................................................................ 3-3
Figure 3-4 D-10 Accessories ............................................................................................................. 3-3
Figure 3-5 Fluid Connections, Rear Panel .......................................................................................... 3-4
Figure 3-6 Display Contrast Knob ...................................................................................................... 3-5

DRAFT
Figure 3-7 Priming the Reagent Lines ................................................................................................ 3-6
Figure 3-8 Sample Analysis Compartment ......................................................................................... 3-6
Figure 3-9 Cartridge Heater ............................................................................................................... 3-7
Figure 3-10 Placement of Cartridge Holder .......................................................................................... 3-7
Figure 3-11 Purging Air from the Check Valves .................................................................................... 3-8
Figure 3-12 Lot Info/Update Kit Screen ................................................................................................ 3-9
Figure 3-13 Lot Info/Low Control Screen ............................................................................................. 3-9
Figure 3-14 Lot Info/High Control ......................................................................................................... 3-9
Figure 4-1 Lot Info/Update Kit Screen ................................................................................................ 4-4
Figure 4-2 Lot Info Screen ................................................................................................................. 4-4
Figure 4-3 Sample Analysis Compartment ......................................................................................... 4-5
Figure 4-4 Cartridge Heater ............................................................................................................... 4-5
Figure 4-5 Placement of Cartridge Holder .......................................................................................... 4-6
Figure 4-6 Sample Chromatogram ..................................................................................................... 4-10
Figure 5-1 Sample Probe, Home Position .......................................................................................... 5-3
Figure 6-3 D-10 Fluid System ............................................................................................................ 6-11

Table 6-1 General Troubleshooting .................................................................................................... 6-2

Table 6-2 Troubleshooting Hardware ................................................................................................. 6-9

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 Section

1
Introduction
General Description
The Bio-Rad D-10™ Hemoglobin Testing System is a fully automated
analyzer consisting of a single module that provides an integrated method for
sample preparation, separation, and determination of specific hemoglobins

DRAFT
in whole blood. The system is a mid-volume analyzer that can accommodate
1 to 10 samples per run.
Application (program) information is not included in this manual; please refer
to the appropriate method instruction manual.

Figure 1-1: The D-10 Hemoglobin Testing System

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INTRODUCTION D-10 • Section 1
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The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the
separation and determination of the relative percent of specific hemoglobins (A2, F, A1c)
in whole blood. The separation is based on the principles of high performance liquid
chromatography.
The D-10 Hemoglobin Testing System is intended for use only with Bio-Rad reagent kits.

Principles of Operation
The D-10 Hemoglobin Testing System uses the principles of high performance liquid
chromatography (HPLC). A single dual-piston, low pulsation HPLC pump with a
proportioning valve delivers the buffer solution to the analytical cartridge and detector.
Whole blood samples undergo an automatic two-step dilution process and are then
introduced into the analytical flow path. Pre-diluted samples are identified based upon
the use of a sample vial adapter in the sample rack, and the automatic dilution step is
omitted. Pre-diluted samples are aspirated directly and introduced into the analytical
flow path. Between sample injections, the sample probe is rinsed with Wash/Diluent
Solution to minimize sample carryover.
A programmed buffer gradient of increasing ionic strength delivers the sample to the
analytical cartridge, where the hemoglobins are separated based upon their ionic
interactions with the cartridge material. The separated hemoglobins then pass through
the filter photometer flow cell where changes in the absorbance are measured at 415 nm.
The software performs a reduction of raw data collected from each analysis that may
include use of a calibration factor. A sample report and chromatogram are generated for
each sample.

DRAFT

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 Section

2
System
Description
Overview
DRAFT
The D-10 Hemoglobin Testing System is a single module designed for
hemoglobin analysis in mid-volume laboratories. The D-10 is a fully
integrated system for sample dilution, processing and analysis of
hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10
incorporates the use of a dedicated software system for instrument control,
data collection and analysis.
The proprietary analytical cartridge is disposable and easy to change. The
total number of analyses that can be performed on a single cartridge
depends upon the method. The software tracks the number of injections
remaining on the installed cartridge. For specific method information, please
refer to the appropriate instruction manual.

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SYSTEM DESCRIPTION D-10 • Section 2
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System Status
The D-10 has six main states.
• Sleep – All hardware components are switched off, the instrument front door is locked,
the rack door is closed and a run cannot be initiated from this state. Operators can
access and use features of the user interface while in the Sleep state. The system
enters the Sleep state if a run is not initiated from the Standby state before the
Shutdown TimeOut period expires (see Settings/General Settings for Shutdown
TimeOut).
• Standby – All hardware components are warmed up and ready to begin a run. In the
Standby state, the instrument door is locked. The rack door is open if no rack is
installed. When a rack is installed, the door closes. The system enters the Sleep state
if a run is not initiated before the Shutdown TimeOut period expires (as selected in the
Settings screen). A time bar at the bottom of the user interface displays the remaining
time before the system transitions to the Sleep state. When the system first enters the
Standby state from Sleep state, the pumps are not running. When the system enters
the Standby state after performing a run, Buffer 1 is pumped through the cartridge at a
very low flow rate. This flow continues until either the system returns to Sleep or
another run is initiated.
• Running – The system is performing a run. This includes any priming or wash
sequences. In the Running state, the instrument door is locked to protect the operator
from potential hazards presented by the sample probe. The rack door is closed. The
system enters the Standby state when a run is completed.
• Manual – The operator is manually performing an action, such as performing a system
flush. In this state, the instrument door is locked. Upon completion of the manual
action, the system enters the Standby state.

DRAFT
• Waiting – The system is transitioning between different states. In this state, the
instrument door is locked. The rack door is closed.
• Fault – The system has detected a critical fault and is unable to perform normal
operations.

System Components
Front View

 User Interface

 Sample Processing
Compartment

Sample Analysis
Compartment

Figure 2-1: D-10 Front View

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SYSTEM DESCRIPTION

User Interface
The user interface uses a liquid crystal display (LCD) touchscreen that displays one of five
main screens and a status bar. The five main screens (Run, Data, Settings, Lot Info,
Maintain) consist of worklists, subscreens and/or buttons.
CONVENTION: For ease of reference, subscreen figures shown in this manual are written
with the name of the main screen first, followed by the subscreen name. The main screen
and subscreen names are separated by a forward slash (/), (e.g., Settings/General
Settings).
In cases where a subscreen includes a menu or other screen, another forward slash
followed by the menu or other screen name denotes the relation to the main screen (e.g.,
Settings/General Settings/Service Menu).
In this section, figures of screens and subscreen elements appear with numbered
callouts that correspond to a description in a table immediately following the figure (e.g.,
). Additional figures and tables are included when a subscreen element requires
further descriptions; for these related figures, a letter follows the element number (e.g.,
 ), denoting the relation to the main screen or subscreen.

DRAFT

Figure 2-2: User Interface/Run Screen

No. Description Function

 Screen Selection Tabs The tabs allow the operator to navigate between the
main screens. The highlighted tab indicates which
screen is currently displayed. The main screen displays
one of five choices: Run, Data, Settings, Lot Info and
Maintain.

 Main Screen Display Items displayed on the main screen depend on which
screen tab is selected.

Status Bar The status bar is always displayed at the bottom of the
user interface. The status bar indicates: when it is safe to
open the instrument door; the active assay; the system
state; remaining time and a time bar to visually indicate
remaining time of current operation; and, the current
date and time.

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Run Screen
The Run Screen, in the Sleep state, consists of a Start Up and a Shut Down button.

Figure 2-3: Run Screen, Sleep State

No. Description Function

 Start Up Button Initiates the Start Up sequence which the instrument

performs to enter the Standby state.

 Shut Down Button Closes the software to safely power down the system.

While the Start Up sequence is being performed, the system displays the status of the

DRAFT
following items.










Figure 2-4: Run Screen, Start Up Sequence

No. Description Function

 Buffer 1 Indicates that there is sufficient Buffer 1 to complete the

number of samples indicated in the Settings/Levels (4 of
5) screen.

 Buffer 2 Indicates that there is sufficient Buffer 2 to complete the

number of samples indicated in the Settings/Levels (4 of
5) screen.

Wash Indicates that there is sufficient Wash/Diluent Solution to

complete the number of samples indicated in the
Settings/Levels (4 of 5) screen.

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SYSTEM DESCRIPTION

 Waste Indicates that there is sufficient space in the external

waste container to complete the number of samples
indicated in the Settings/Levels (4 of 5) screen.

 Cartridge Indicates that there are sufficient injections remaining on

the cartridge to complete the number of samples
indicated in the Settings/Levels (4 of 5) screen.

 Temperature Indicates that the system has reached the correct

temperature to perform the assay.

 Calibration Indicates that the system has been calibrated for the
selected method.

 Internal Waste Bottle Indicates that the internal waste bottle is sealed correctly.

Once the Start Up sequence is completed, the system enters the Standby state. The
worklist, Start/Stop button, Sleep button, and Edit button are then displayed. The Start
Up sequence takes approximately 5 minutes.




DRAFT


Figure 2-5: Run Screen, Standby State

No. Description Function

 Worklist The worklist includes the injection number, sample

identification (ID), the analyte result(s) and a flag field.
Any empty slots in the sample tray are reflected in the
worklist as a blank line. Blank lines may also occur if the
barcode reader is unable to read a label.
The injection number is composed of the daily
incremental injection number, the day, the month and the
year of analysis. For example, injection number “13/20-
05” would indicate the 13th injection performed on May
20.
The sample identification is entered automatically by the
barcode reader. This field can also be edited by the
operator prior to starting a run. To edit, the operator
touches the sample ID and a keypad is displayed. The
operator uses the alphanumeric keypad to edit the
sample ID, then selects “Done” when complete.

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 Worklist (continued) During a run, the sample currently being analyzed is

highlighted.
The analyte result(s) are entered into the worklist as
analysis is completed for each sample. The flag field will
include an asterisk (*) when a result is flagged, indicating
that the operator should refer to the printed results for
additional information (e.g., sample exceeds normal
range).

 Start/Stop Button The Start button Initiates the process to begin an

analytical run. When pressed, it toggles to become the
Stop button.
The Stop button stops the run in progress.

Sleep Button Transitions the system into the Sleep state. The
transition includes the execution of required shutdown
actions, such as cartridge flush.

 Edit Button Displays the keypad which allows the manual entry of
sample IDs.

When a rack is inserted into the system, the barcode reader scans the tubes and enters
the barcode numbers into the sample ID field. The Eject button is displayed. The Eject
button is pressed to remove the rack from the system.

DRAFT
Eject Button

Figure 2-6: Run Screen, Eject Button

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SYSTEM DESCRIPTION

In the Run/Edit screen, the Keypad includes an ID field, arrow keys, alphanumeric
keypad, Done button, Cancel button, and Clear button.




 


Figure 2-7: Keypad

No. Description Function

 ID Field
In

The ID Field is divided into 20 boxes; each box

accomodates one alphanumeric character for a
maximum of 20 characters per ID.

 Arrow Keys Scrolls the alphanumeric keys to the left or right,

displaying up to 12 characters at one time.

Done Button Returns to the Run screen and enters the new sample ID
into the worklist.

 DRAFT
Cancel Button

Clear Button

Data Screen
Returns to the Run screen without entering a new
sample ID into the worklist.

Deletes the alphanumeric characters from the ID Field.

The Data screen consists of the Results Table, Print button, Export button, View
Chromatogram button, Change View button, and scroll buttons. The Data screen can be
accessed at any time, with the system in any state.




Figure 2-8: Data Screen

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No. Description Function

 Results Table
In

Displays all stored data for the selected assay. The most
recently analyzed data is displayed at the top of the
table.
Includes the injection number, sample ID, the analyte
result(s) and a flag field. Any blank lines that appeared in
the worklist are eliminated from the results table.

 Print Button Accesses the print menu where operators select the
data to be printed. See 2A below for additional
information.

Export Button The Export button accesses the export menu, where the
operator selects the location for data export. See 3A on
page 2-9 for additional information.

 Change View Button The Change View button toggles the placement of the
screen buttons from the right side to the bottom of the
screen, and back again. See 4A and 4B on page 2-9 for
additional information.

 Scroll Buttons The scroll buttons allow the operator to move up and
down the table rows.

Data Screen
DRAFT Description

 Print Menu
Selected Samples – prints sample reports the operator has
indicated in the results table, prior to pressing the Print button.
Daily Report – prints the complete reports for all samples run
that day. Complete reports include a chromatogram for each
sample analysis.

Calibrator Report – prints the most recent calibration data,
including the slope and intercept, or correction factor.
After indicating choices, the pressing the Print button
completes the print process. Pressing the Exit button closes
the print menu without completing the print process.

Figure 2-9: Data/Print Menu

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SYSTEM DESCRIPTION

Export Menu
Sample report files can be exported to either a floppy disk in
the A-drive or to a LAN* in the form of PDF files. After
indicating choices, the operator presses the Export button to

complete the upload process. Pressing the Exit button closes
the export menu without completing the export process.
Export to Archive – uploads data to the A-drive or LAN*.
Selected Samples – allows upload of data the operator has
indicated in the results table, prior to pressing the Export
button.

Figure 2-10: Data/Export Menu

*Not available at time of launch.

 Change View
The Change View button toggles the placement of the screen
buttons from the right side to the bottom of the screen, and
back again.


screen

DRAFT
buttons

Figure 2-11: Data/Change View

 View Chrom.
When the screen buttons are displayed along the bottom, the
View Chromatogram button is available. Selecting this button
 displays the chromatogram of a selected sample from the
worklist.

Figure 2-12: Data/Change View/View Chrom.

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Settings Screen
The Settings screen consists of five subscreens (General Settings, Print Settings, Archive
Settings, Level Settings, Alert Settings), Print button, and scroll buttons. The information
on these screens can be viewed at any time. The information cannot be updated when
the system is in the Running state.

 Subscreen 

Figure 2-13: Settings Screen

No. Description Function

 Subscreens See subscreen descriptions in the following tables.

DRAFT
 Print Button Prints a summary of the settings from screens 1 to 3.

Scroll Buttons The scroll buttons are used to set values.

1: Settings/General Settings Description

 Software Version – displays the current software version.

This field cannot be edited by the operator.

 Firmware Version – displays the current firmware version.

 This field cannot be edited by the operator.


Auto-WarmUp – indicates the time that the system will

automatically perform start up actions, going from sleep
to standby status. The hour and minute of the day is set

using the scroll buttons (24-hour format). Select the
check box to enable auto-warmup.

  Shutdown TimeOut – indicates the length of time the
system will remain in the standby state before performing
shutdown actions to enter the sleep state. The minutes
and seconds are set using the scroll buttons.
Figure 2-14: Settings/General Settings
 Set Date – displays the current date setting. The operator
sets the month, day, and year using the scroll buttons.

 Set Time – displays the current time setting. Time is set in

hours and minutes using the scroll buttons (24-hour
format).

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SYSTEM DESCRIPTION

2: Settings/Print Settings Description

 Auto Printout – auto printout automatically generates a

printed report of each sample analysis when “YES” is
selected. When “NO” is selected, no printed report is
generated. The operator must then manually print results.

 Print Daily Log – a printed daily log is automatically

 generated following the start up actions when “YES” is
selected. When “NO” is selected, a daily log is not
 automatically printed.

Figure 2-15: Settings/Print Settings

3: Settings/Archive Settings Description

 The operator sets the location for the archive download

by selecting either floppy disk, serial port or network.
NOTE: The serial port and network features are future
upgrades and are currently unavailable.

DRAFT
Figure 2-16: Settings/Archive Settings

4: Settings/Levels Description
The values can be edited by the operator.

Reagent Level Low – a low level value, indicating

remaining number of analyses. The operator is notified
when the buffer or wash levels reach the low level value.

Cartridge Level Low – a low level value, indicating

 remaining number of cartridge injections. The operator is
notified when the cartridge reaches the low level value.

Waste Level High – a high level value, indicating number

of analyses performed. The operator is notified when the
waste level reaches the high level value.

Figure 2-17: Settings/Levels

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5: Settings/Alert Settings Description

The operator indicates if the run will be stopped when a
calibrator fails and/or controls are out of range. The run
automatically stops if the check box is selected. The run
continues if the check box is not selected.

Figure 2-18: Settings/Alert Settings

Lot Info Screen

The Lot Info screen consists of eight subscreens (Low Control, High Control, Calibrator 1,
Calibrator 2, Buffer 1, Buffer 2, Wash, Cartridge) with kit specific information, a print
button, an Update Kit button and scroll buttons. The information on these screens can be
viewed at any time. The information cannot be updated when the system is in the
Running state.

DRAFT
 Subscreen 

Figure 2-19: Lot Info Screen

No. Description Function

 Subscreens See subscreen descriptions in the following tables.

 Print Button Prints a summary of the settings from screens 1 to 3.

Update Kit Button The Update Kit button accesses the Update Kit screen.
See 3A on page 2-13 for additional information.

 Scroll Buttons The scroll buttons are used to set values.

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SYSTEM DESCRIPTION

Lot Info Screen Description

Update Kit Screen

From the Update Kit screen, the operator is prompted to insert
the Update Kit disk into the floppy disk drive. Once the disk is
inserted, the operator selects the Update Now button to load
the current kit lot number, plus the lot numbers and expiration
dates of each kit component.
Press Exit to close the Update Kit screen without performing

an update.
NOTE: Control information is not included in the Update Kit
disk and must be manually entered by the user.

Figure 2-20: Lot Info/Update Kit Screen

1: Lot Info/Low Control Description

 Displays the low control lot information. To edit the lot

number, select the Lot Number to display the keypad.
Use the keypad to enter the lot number.



DRAFT 
NOTE: Control information must be entered by the user.
The reagent kit lot number is also displayed.

Displays the currently selected method. To change

methods, press the displayed method name to access
the Select Method menu.
NOTE: The method can be selected from any of the
eight Lot Info subscreens.

 Method Screen
Figure 2-21: Lot Info/Low Control Screen
Select a method and then press Exit to close the menu.
The operator is prompted to confirm the method change.

Displays the low control values for low limit, mean, upper

limit, and expiration date. To edit, select the value, then
use the scroll buttons to change the setting.

Figure 2-22: Lot Info/Low Control/

Select Method Screen

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2: Lot Info/High Control Description

 Displays the high control lot information. To edit the lot

number, select the Lot Number to display the keypad.
Use the keypad to enter the lot number.
 NOTE: Control information must be entered by the user.
 The reagent kit lot number is also displayed.

 Displays the currently selected method. See description

under Low Control on page 2-13 on how to change

methods.

Displays the high control values for low limit, mean, upper
limit, and expiration date. To edit, select a value, then use
the scroll buttons to change a setting.

Figure 2-23: Lot Info/High Control Screen

3: Lot Info/Calibrator 1 Description

This information is automatically entered during the update kit
procedure. This screen is also used when manual entry is
required.
  Displays Calibrator 1 lot information. To edit the lot
 number, select the Lot Number to display the keypad.

DRAFT
Use the keypad to enter the lot number.

 Displays the currently selected method. See description

under Low Control on page 2-13 on how to change

methods.

Displays the Calibrator 1 value and expiration date. To

edit, select the value or date, then use the scroll buttons
to change the setting.
Figure 2-24: Lot Info/Calibrator 1 Screen

4: Lot Info/Calibrator 2 Description

This information is automatically entered during the update kit
procedure. This screen is also used when manual entry is
required.

  Displays Calibrator 2 lot information. To edit the lot

number, select the Lot Number to display the keypad.
 Use the keypad to enter the lot number.

 Displays the currently selected method. See description

under Low Control on page 2-13 on how to change

methods.

Displays the Calibrator 2 value and expiration date. To

edit, select the value or date, then use the scroll buttons
to change the setting.
Figure 2-25: Lot Info/Calibrator 2 Screen

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SYSTEM DESCRIPTION

5: Lot Info/Buffer 1 Description

This information is automatically entered during the update kit
procedure. This screen is also used when manual entry is
required.

  Displays Buffer 1 lot information. To edit the lot number,

select the Lot Number to display the keypad. Use the
 keypad to enter the lot number.

 Displays the currently selected method. See description

under Low Control on page 2-13 on how to change
 methods.

Displays the Buffer 1 level. The level indicates the

number of injections that can be performed with the
remaining reagent level.
Figure 2-26: Lot Info/Buffer 1 Screen Select the level number to display the reset level screen.

Reset Level Screen

Press the Reset button to manually reset the number of
injections that can be performed, with the remaining reagent,
to the maximum level. Press the Exit button to close the screen
without resetting the level.

NOTE: This screen may be accessed from the Buffer 1,

Buffer 2, Wash, or Cartridge subscreens.

DRAFT
Figure 2-27: Lot Info/Buffer 1/
Reset Level Screen
 Displays the expiration date. To edit, select the date, then
use the scroll buttons to change the setting.

6: Lot Info/Buffer 2 Description

This information is automatically entered during the update kit
procedure. This screen is also used when manual entry is
required.

  Displays Buffer 2 lot information. To edit the lot number,

select the Lot Number to display the keypad. Use the

keypad to enter the lot number.

 Displays the currently selected method. See description

under Low Control on page 2-13 on how to change
 methods.

Displays the Buffer 2 level. The level indicates the

number of injections that can be performed with the
remaining reagent level.
Figure 2-28: Lot Info/Buffer 2 Screen Select the level number to display the reset level screen.
See Buffer 1, 3A (above), for additional information.

 Displays the expiration date. To edit, select the date, then

use the scroll buttons to change the setting.

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7: Lot Info/Wash Reagent Description

This information is automatically entered during the update kit
procedure. This screen is also used when manual entry is
required.

  Displays Wash/Diluent Solution lot information. To edit the

 lot number, select the Lot Number to display the keypad.
Use the keypad to enter the lot number.

 Displays the currently selected method. See description

under Low Control on page 2-13 on how to change
 methods.

Displays the Wash/Diluent Solution level. The level

indicates the number of injections that can be performed
with the remaining reagent level.
Figure 2-29: Lot Info/Wash Reagent Screen Select the level number to display the reset level screen.
See Buffer 1, 3A on page 2-15, for additional information.

 Displays the expiration date. To edit, select the value or

date, then use the scroll buttons to change the setting.

8: Lot Info/Cartridge Description

This information is automatically entered during the update kit
procedure. This screen is also used when manual entry is

DRAFT
required.

  Displays Cartridge lot information. To edit the lot number,

select the Lot Number to display the keypad. Use the
 keypad to enter the lot number.

 Displays the currently selected method. See description

under Low Control on page 2-13 on how to change
 methods.

Displays the number of injections remaining on the

cartridge.
Select the level number to display the reset level screen.
Figure 2-30: Lot Info/Wash Reagent Screen See Buffer 1, 3A on page 2-15, for additional information.

 Displays the expiration date. To edit, select the value or

date, then use the scroll buttons to change the setting.

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SYSTEM DESCRIPTION

Maintain Screen
The Maintain Screen consists of the Pressure, Temperature, Flow Rate, Percent Buffer 2
(%Buf.2), Detector output, a Start/Stop Pump button, a System Flush button, a Service
button, and scroll buttons. The information on this screen can be viewed at any time. No
items on this screen can be accessed during a run except for the error log. During a run,
the Detector output is displayed on this screen.

 
 


 


Figure 2-31: Maintain Screen

No. Description Function





DRAFT
Pressure

Temperature

Flow rate
Displays the current system pressure.

Displays the current system temperature.

Displays the current flow rate setting during manual

operation. To edit the flow rate, select the current
flowrate value, then use the scroll buttons to increase or
decrease the value.
Press the Start Pump button to begin manual pump
operation.

 % Buf.2 Displays the current setting for the percent of Buffer 2

gradient used during manual operation. To edit the
percent of Buffer 2, select the current value, then use the
scroll buttons to increase or decrease the value.
Press the Start Pump button to begin manual pump
operation.

 Detector Output A real-time display of the detector output. Press the y-

axis to toggle the output scale.

 View Log Displays the error log. See 6A (Figure 2-32 on page 2-
18).

 Start Pump Button The Start Pump button manually initiates pump
operation. The pump operates at the selected flowrate
and %B values. The button toggles to become a Stop
Pump button while the pump is running.

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SYSTEM DESCRIPTION D-10 • Section 2
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 System Flush Button The System Flush button manually initiates a system
flush. The button toggles to become a Stop Pump
button while the system flush is in progress.

Service Button Displays the Service screen. See 9A (Figure 2-33 on

page 2-19).

Scroll Buttons The scroll buttons are used to set values.

Maintain Screen Description

 View Log
Press Print to print the error log. Press Exit to return to the
Maintain screen. Use the up and down arrow buttons to scroll
through the list of errors.


DRAFT
Figure 2-32: Maintain/View Log

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SYSTEM DESCRIPTION

Service Screen

The Service screen consists of the following selections or

indicators:
Syringe Priming — Primes the syringe.
Degasser All — Primes all three reagents.
1: Primes Buffer 1 only
2: Primes Buffer 2 only
W: Primes Wash/Diluent Solution only
Figure 2-33: Maintain/Service Screen Piston Flush — Flushes the pistons in the high pressure pump.
Valve — Toggles the mixing valve between Buffer 1 and 2.
OFF = Buffer 1; ON = Buffer 2.
Open Front Door — Unlocks the front door.
Check Waste Bottle — Checks the internal waste bottle to
make sure it is properly sealed.
Replace Needle — Moves the sample probe to the correct
position for replacement.
Access Wash St. — Moves the sample probe to the far right,
allowing safe access for wash station removal.

DRAFT
Arm Init. — Moves the sample probe to the home position.
Abs Meas. — Indicates the light level of the flow cell detector.
Ref Meas. — Indicates the light level of the reference detector.
Log — Indicates the log of the Ref/Abs light levels.

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SYSTEM DESCRIPTION D-10 • Section 2
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Sample Processing Compartment

Figure 2-34: Sample Processing Compartment

No. Name Function

 Processing The processing compartment door is the upper door on the

Compartment Door front of the instrument. The see-through door allows the


DRAFT
(not shown)

Sample Probe
operator to monitor sample probe operation and provides
protection for the operator. The cover is closed and always
locked unless unlocked in the Service screen.

The sample probe pierces each primary tube to release the

vacuum and to draw sample from the tube. The probe then
dispenses the sample with a measured amount of diluent into
the sample well. The probe draws a measured amount of the
diluted sample from the sample well. The sample well is
emptied, and a second dilution is performed. The sample
probe and sample well are rinsed between sample injections
to minimize carryover.
The sample probe also pierces the sample vials.

Sample Well / Wash The sample well (on the left) is where the sample is diluted
Station before introduction to the analytical path.
The wash station (on the right) is where the sample probe is
rinsed.

 Tube Holder The tube holder stabilizes the primary sample tube during
sample probe piercing and removal from tube.

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D-10 • Section 2
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SYSTEM DESCRIPTION

No. Name Function

 Barcode Reader The barcode reader scans the barcodes from the sample
tubes and sample vial adapters. The barcode information is
automatically entered into a worklist for sample identification.
NOTE: The operator is required to align the barcode labels
when loading the sample rack for proper scanning. Barcode
labels must be positioned to the rear of the sample rack, with
the barcode visibly displayed through the rack slots.

 Sample Rack The sample rack is a 10-position rack, used to hold 16 mm

sample tubes. One 10-position rack may be loaded for a
single run. The operator inserts a rack through the rack door
where it is grasped by the instrument and moved into position
for barcode scanning and sample processing.
Rack adapters are required for use with smaller diameter
tubes (e.g., 10 mm, 12 mm, 13 mm, 14 mm). Note that the
accessory kit includes 13 mm adapters only. Sample vial
adapters are required for use with sample vials.

 Sample Vial Sample vials containing calibrator, primer, controls or pre-

Adapter diluted patient samples require the use of sample vial
adapters. The D-10 recognizes the sample vial adapter by
sensing the adapter’s attached magnet, and bypasses the
sample dilution process.
The sample vial adapter must be positioned manually in the

DRAFT
sample rack so that the magnet faces the back of the sample
rack.

Figure 2-35: Sample Rack with Sample Vial Adapters

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SYSTEM DESCRIPTION D-10 • Section 2
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Sample Analysis Compartment



 

Figure 2-36: Sample Analysis Compartment

No. Description Function

 Analysis Compartment The analysis compartment door is the lower door on the
Door front of the instrument. This door is not locked and can
be opened at any time for access to Sample Analysis

DRAFT
Pump

Injection Valve
compartment modules.

The dual-piston high pressure pump works with the

proportioning valve to form the binary gradient.

The injection valve is connected to the three-way valve,

the sample loop, the sample probe, piston flush, and the
back pressure sensor. The injection valve controls the
intake and release of sample into the analytical flow path.

 Pressure Sensor The pressure sensor monitors the operating pressure, to

assure the cartridge is within normal operating limits.

 Proportioning Valve The proportioning valve regulates the binary gradient.

 Cartridge Heater The cartridge heater houses the analytical cartridge and
maintains a consistent temperature during sample
analysis.

 Detector (not shown) The visible wavelength detector measures the

absorbance of the sample constituents.

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SYSTEM DESCRIPTION

Side View, Right

 

Figure 2-37: D-10, Perspective View

No. Description Function

 Reagent Bottle Bay Accommodates three 2.0 L bottles.

 Printer (not shown) The thermal printer prints sample results. The printer is
located on the top left of the system.

DRAFT

Rack Door The interlocking door covers the insertion point for the
(door not shown) sample racks.

 Side Panel Opens to access the display contrast knob, sampling

arm, shipping lock and lower compartment.

Right Side, Panel Door Open Description

 Display Contrast Knob — used to adjust the LCD screen

contrast.

 Sampling Arm Shipping Lock — used only during
 shipment of the system to lock the sampling arm in
place. The thumbscrew must be removed prior to
powering the system on for the first time.

Figure 2-38: Display Contrast Knob

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SYSTEM DESCRIPTION D-10 • Section 2
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Pinch Valves — regulate the vacuum at the sample well/

wash station.

 Internal Waste Bottle — the on-board waste bottle
 collects solutions from the sample well/wash station.
Waste is then pumped to the external waste tank.

 Syringe Pump — the syringe pump is used to: aspirate

 the required volume of sample and diluent; measure and
deliver Wash/Diluent Solution to the sample probe, the
sample well and the piston wash port; prime the pump;
 and, draw the prepared sample from the sample well into
the injection loop.

 Degasser (not shown) — the degasser uses an in-line

tubular Teflon™ membrane within a vacuum chamber to
Figure 2-39: Right Side, Lower Compartment
reduce dissolved gases in the elution buffers.
(panel door open)
 Three-way Valve — the three-way valve selects the
syringe pump connection, to aspirate Wash/Diluent
Solution or to dispense to the sample well.

Side View, Left

DRAFT


Figure 2-40: Left Side View

No. Description Function

 Disk Drive Accommodates a 3.5” floppy disk for loading lot

information, loading lot specific parameters, and saving
data.

 Main Power Switch The power switch, labeled I/O, controls power to all
system components.

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D-10 • Section 2
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SYSTEM DESCRIPTION

Rear View






 
 10


No.


DRAFT
Description
Waste Port
Figure 2-41: Rear View

Function
For connection of the waste tube that leads to the waste
tank.

 Reagent Inlet Ports The reagent bottle (i.e., Buffer 1, Buffer 2, Wash/Diluent
Solution) lines are connected to the reagent inlet ports.

Keyboard Port* For connection of an external computer keyboard.

 Mouse Port* The mouse port allows connection of an external mouse.

 VGA Port* For connection of an external computer monitor.

 LAN Port For connection to a local area network.

 Serial Port* The serial port is for a future upgrade.

 Expansion Port* The expansion port is for future upgrades.

CAUTION: Do not connect a printer to the expansion port as this may damage the printer.

AC Power Input For connection of a 3-pin cable with ground to a suitable

power supply.

Fuse Holder The main power fuse provides over-current protection.

*For service use only.

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SYSTEM DESCRIPTION D-10 • Section 2
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DRAFT

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2-26 D-10 Operation Manual • 200:136

 Section

3
Installation
Only an authorized Bio-Rad representative should perform installation of the
D-10. Installation by any other person will invalidate the system warranty.

Installation Requirements

DRAFT
• Choose a location for the system that is away from direct sunlight and is
relatively dust-free.
• Room temperature should be between 15 and 30 °C.
• The bench or table should have a flat, level surface that is free from vibra-
tions and is capable of supporting a weight of more than 35 kg (77 lb).
• The system requires the minimum benchtop space of 100 cm (W) x 48 cm
(H) x 65 cm (D) [39 in (W) x 19 in (H) x 26 in (D)] to allow for the system plus
proper clearances.
• Maintain a minimum clearance of 20 cm (8 in.) on the left side and 40 cm
(16 in.) on the right side. Maintain clearance of 10 cm (4 in.) from the back-
side to ensure that the power cord input is readily available to the operator.
• A grounded electrical receptacle should be within 1.8 meters (6 feet) of the
system. Input power requirements for the system are between 100 VAC
and 240 VAC. The maximum power consumption is 250 Watts.
• The use of a circuit breaker before the main electrical receptacle is
required. The electrical installation must comply with locally applicable
standards and requirements.

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D-10 Operation Manual • 200:136 3-1
INSTALLATION D-10 • Section 3
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Unpacking and Inspection

The D-10 Hemoglobin Testing System is packaged in one carton with a separate box for
the waste container. After unpacking and inspecting the system and its accompanying
items, complete the Customer Acceptance Form and the System Warranty Card. Return
the completed acceptance form and warranty card to Bio-Rad Laboratories.
1. Cut and remove the bands securing the two cartons.

Band

Plastic
Latches

Figure 3-1: D-10 Carton and Pallet

2. Open the 4 plastic latches securing the upper and lower part of the packaging. Lift

DRAFT
off the top box and remove the top packing foam.
3. The D-10 should be lifted out of the carton by at least two people. Grasp the unit
from the bottom and remove the system from the bottom box. Carefully place the
D-10 onto the benchtop, with all of its feet squarely in position.

Top Box

Top Packing Foam

D-10 Hemoglobin
Testing System

Bottom Box with

Packing Foam

Pallet

Figure 3-2: Unpacking the D-10

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D-10 • Section 3
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INSTALLATION

4. Open the right side panel and remove the thumbscrew. The thumbscrew locks the
sampling arm in place during shipment and must be removed prior to powering the
system on. Fasten the thumbscrew into the retain position on the side panel for
future use.

shipping lock

Figure 3-3: Sampling Arm Shipping Lock

5. Unpack the accessories kit and check its contents against the packing list for
completeness. Unpack the 10L waste bottle from the separate container. Inspect
each item for damage. Contact Bio-Rad or your local distributor if any item is
missing or damaged.

DRAFT 





Figure 3-4: D-10 Accessories

 Sample Rack (2)  Reagent Tubing and Online Caps (3)

 Sample Vial Adapters (10) • 13 mm Tube Adapters (10) (not shown)

Power Cords (2) (one European, one • 50 mL Syringe (1) (not shown)
U.S.)

 Spare Fuses, 250V (2) • Printer Paper (1) (not shown)

 Waste Tank, 10L (1) (2L shown) • Barcode Labels (not shown)

 Waste Tank Tube (1) • PEEK Dummy Cartridge (shipped

installed on instrument)

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INSTALLATION D-10 • Section 3
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Set Up
Reagent Lines
1. Locate the inlet ports on the rear of the D-10 labeled, “Buffer 1,” “Buffer 2,” and
“Wash.” Remove each inlet port plug, and save for future use.
2. Take the three reagent tubing assemblies. Each assembly consists of color-coded
Teflon tubing with an on-line cap and a bulkhead fitting.
• Buffer 1 = Green
• Buffer 2 = White
• Wash/Diluent Solution = Blue
NOTE: Avoid touching the reagent lines below the caps to prevent introduction of
contaminants to reagents.
3. Match each color-coded reagent tubing assembly to its corresponding port. Fasten
the appropriate tubing to its port. Do not overtighten the fingertight fittings.
4. Take the buffers and Wash/Diluent Solution for the application to be run and place
onto the Reagent Bottle Bay, located on the right side of the D-10. Place reagents
according to the labeled positions: Buffer 1 in the front, Buffer 2 in the middle, and
the Wash/Diluent Solution in the rear.
5. Unscrew the caps from each bottle; save the caps for later use. Place each reagent
line into its corresponding bottle. Fasten the on-line caps.

Waste Line
1. Locate the waste port on the rear of the D-10.

DRAFT
2. Take the red color-coded waste line; fasten to the waste port.

Figure 3-5: Fluid Connections, Rear Panel

3. Connect the waste line to the waste tank inlet. Place the waste tank in a convenient
location, at a level lower than the waste outlet as the waste flow is gravity driven.
NOTE: To prevent waste backup, ensure that the waste line is sloped downward at
all times.

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INSTALLATION

Power Cord
1. Remove the power cord from the accessories kit.
2. Locate the D-10 power receptacle on the rear panel. Connect the power cord to the
receptacle.
3. Plug the power cord into a grounded power outlet.
4. Turn the power switch on.
5. Adjust the touch screen contrast using the display contrast knob located inside the
right side panel. Close the side panel when complete.

display contrast knob

Figure 3-6: Display Contrast Knob

DRAFT
Install the Printer Paper
1. Release the printer cover to access the paper well.
2. Remove the wrapping from a new roll of thermal paper. Completely remove the
adhesive strip or trim the paper. Make sure that the leading paper edge is not
damaged or frayed.
3. Position the roll so that the paper exits the bottom of the roll towards you and the
Bio-Rad logo is facing down.
4. Feed the edge of the paper roll through the printer head slot.
5. Press the paper advance button to feed the paper through the printer.
CAUTION: Manually pulling the paper through the printer mechanism will cause
premature failure of the printer.

Prime the Reagent Lines

Prior to shipment, the system fluid lines are filled with a shipping fluid. Prime the lines
before the first operation to remove any trapped air bubbles.
1. The system will power up in the Run screen. Once the boot up sequence is
completed, the system enters Sleep state.
2. Open the lower front door.
3. Select the Maintain screen tab.
4. Select the System Flush button to initiate the automatic prime sequence. This
sequence will take approximately 20 minutes.

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INSTALLATION D-10 • Section 3
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5. Once the prime sequence is complete, manually run the pump at 50% Buffer 2 at
2.0 mL/min and confirm that the pressure is stable. If a stable pressure is not
obtained, follow steps 6 to 9 to perform additional priming.
6. Press the Service button to access the Service screen. Prime Buffer 1: With the
“Valve” set to OFF, take the 50 mL syringe and place it into the pump port. Open the
port, one-half turn counterclockwise.
7. Slowly pull back on the syringe plunger until it is filled (approximately 50 mL).
Remove the syringe and dispose of the fluid appropriately. Reinsert the syringe into
the pump port.

Figure 3-7: Priming the Reagent Lines

8. Prime Buffer 2: Set the “Valve” to ON; an audible “click” should be heard as the valve
is switched on. Slowly pull back on the syringe plunger until it is filled. Close the

DRAFT
pump port and remove the syringe; dispose of the fluid.
9. Switch the “Valve” to OFF. As the valve is switched off, a softer “click” should be
heard.
10. Check to see if the pressure is stable.

Install the Cartridge

NOTE: When the cartridge is removed, a small amount of liquid may drip from the
tubing. Place a paper towel below the cartridge holder to absorb any drips.
1. Verify that the system is in Sleep state. If the system is in Standby, place the system
into Sleep state using the Run screen.
2. Open the lower front panel of the D-10 to access the cartridge heater. The cartridge
heater is located in the lower right corner of the sample analysis compartment.

Figure 3-8: Sample Analysis Compartment

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D-10 • Section 3
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INSTALLATION

3. Grasp the right side of the black heater cover and pull open to access the heater
block. The cover must be opened completely to remove or replace the cartridge
holder from the heater.

Figure 3-9: Cartridge Heater

4. Grasp the cartridge holder with the thumb and forefinger, and then pull the holder
forward to remove it from the heater. Pull the dummy cartridge from the holder and
store for later use.
5. Remove the end caps from the new cartridge and align the flow arrows on the
cartridge and the holder in the same direction. The flow arrows should both point to
the right.
6. Insert the new cartridge completely into the holder until the left end of the cartridge is
flush with the left end of the holder. Press the left end of the cartridge and cartridge

DRAFT
holder against a clean, flat surface to properly seat the cartridge. If the cartridge is
not properly seated, the holder cannot be inserted into the heater.
7. With the flow direction label facing forward, slide the holder into the heater. Slightly
wiggle the holder if needed to seat securely.

Figure 3-10: Placement of Cartridge Holder

8. Close the heater cover. As the heater cover is closed, the cartridge forms a seal with
the heater.
NOTE: Refer to the appropriate instruction manual for additional cartridge
information (e.g., priming, calibration).

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Assess the Check Valves

Make sure the check valves do not have any air bubbles.
1. From the Maintain screen, press the Start button to turn the pump on.
2. Using the default settings (flowrate 1.8 mL/min, 50% 2), monitor the pressure output
for five minutes. If the pressure fluctuates by more than ±5%, this may indicate the
presence of air in the check valves.
3. Monitor the detector log value on the Maintain/Service screen. Verify that the log
value is lower than 0.030 and the fluctuations are lower than 0.003.
4. Press the Stop button to turn the pump off.
5. To remove air from the check valves, remove the top connection from the pump.
NOTE: Use paper towels to absorb solution from the top pump port in the next step.

DRAFT Figure 3-11: Purging Air from the Check Valves

6. Take the 50 mL syringe and place it into the pump port below. Open the port, one-
half turn counterclockwise. Slowly pull back on the syringe plunger to withdraw
approximately 15 mL of buffer. Remove the syringe from the port and expel any air.
Place the syringe back into the port and slowly push the syringe plunger to expel
approximately 10 mL of solution from the syringe. Do not use the last few milliliters of
solution in the syringe to avoid introducing additional air bubbles.
7. Close the pump port and remove the syringe. Reconnect the top connection,
tightening firmly by hand.
8. Repeat steps 1 through 5 from the Maintain screen. Monitor the pressure output and
detector log value for five minutes. During this time, check the pump connections for
leaks.
9. If the pressure or detector log value fluctuates by more than ± 5%, repeat the above
steps. If the pressure continues to fluctuate, contact Technical Service for assistance.

Perform the Update Kit Procedure

1. Insert the Update Kit disk into the floppy disk drive.
2. Select the Lot Info screen tab. From the Lot Info screen, press the Update Kit button.
3. Once the disk is inserted, press the Update Now button. Press Exit to close the
Update Kit screen without performing an update.

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INSTALLATION

Figure 3-12: Lot Info/Update Kit Screen

4. When the update is complete, press the Print button for a hardcopy of the kit
information for your laboratory records.

DRAFT Figure 3-13: Lot Info/Low Control Screen

5. Remove the Update Kit disk from the floppy disk drive.

Enter Control Values

1. From the Lot Info/Low Control screen, select the Low Limit value. Use the scroll
buttons to increase or decrease the displayed value. Continue to edit the remaining
control values in the same manner.
2. Edit the Control Lot number by selecting the displayed lot number. Use the
alphanumeric keypad to update the lot number.
3. Press Exit to close the screen.
4. Go to the Lot Info/High Control screen and repeat steps 1 to 4.

Figure 3-14: Lot Info/High Control

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Barcode Labels
Barcode labels are required for the automatic identification of samples.
NOTE: A starter set of sample vial barcode labels is provided with the system.
Additional sample vial barcode labels may be purchased from Bio-Rad.
• Use barcode labels supplied by Bio-Rad for the primer, calibrator, controls, and blank.
Applying one label per sample vial adapter, create a set of designated adapters.
Position the label so that the barcode label will face the rear of the sample rack.
• Patient samples may be labeled with your site specific barcode labels.

Performing Test Runs

Preparation of primer, calibrator, and controls are required to complete this step. Refer to
the appropriate instruction manual for preparation directions.
If pressure fluctuations are observed during the test run, see “Prime the Reagent Lines”
on page 3-5 for directions on how to manually prime the system. If the fluctuations
continue or other problems occur, refer to Section 6.0, Troubleshooting.
NOTE: Accessing the system screens during the startup sequence will cause the
sequence to abort. If the sequence aborts, press the Startup button to begin another
sequence.
1. Before beginning a run, the system must be in the Run state. Select the Run screen
tab to access the Run screen. Press the Startup button to initiate the startup
sequence. Allow the system to complete the five-minute startup sequence before
proceeding with additional operations.

DRAFT
During the startup sequence, the system checks the following with the assistance of
the user:
• Buffer 1 level adequate?
• Buffer 2 level adequate?
• Wash/Diluent Solution level adequate?
• Waste level, disposal required?
• Calibration required? (e.g., HbA1c calibrates once per cartridge; Dual program Hb
A2/F/A1c 6.5-minutes calibrates once per 24 hours or when switching from the
3-minute A1c program)
• Cartridge holder temperature set?
The sequence finishes with a special gradient to flush the cartridge.
The system may be configured to print a daily report on completion of the Start Up
sequence. The user should confirm the above items as indicated on the printout.
2. At the beginning of the startup sequence, a “clicking” sound will be heard. The
startup sequence continues to run even after the “clicking” sound stops. The status
bar will indicate that the system is in the Running state and also displays the
remaining time for the current operation.
3. The system enters the Standby state upon completion of the startup sequence.

Perform a Prime Run

1. Pipet 500 µL of reconstituted Hemoglobin Primer into a sample vial. Put the sample
vial into the appropriately labeled sample vial adapter, then place the adapter into
sample rack position 1.

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INSTALLATION

2. Insert the rack through the rack door. The rack is automatically scanned by the
barcode reader, and then the sample ID is input into a Worklist.
NOTE: To eject the rack, press the Eject button.
3. Press the Start button. The system will perform a begin run gradient before injecting
the primer.
NOTE: The gradient performed during the prime sequence is different to that
performed during a regular sample run.
4. When the run is complete, eject the rack and remove the primer from the rack.

DRAFT

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DRAFT

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 Section

4
Operation
This section provides an overview of instrument operation. Certain
operational procedures are method-dependent; refer to the appropriate kit
instruction manual for additional information.

General Information

DRAFT
• Sampling and processing the data from a single injection is referred to as
an analysis. Sampling from all tubes within a sample rack is referred to as
a run.
• One sample rack can be processed at a time. Up to 10 tubes can be
loaded into a sample rack. See “System Specifications“ for “Sample
Handling” on page A-3 for acceptable tube sizes. Certain tubes require
the use of tube adapters. Sample vials require the use of sample vial
adapters.
• Additional samples cannot be added to a rack once a run has been
initiated. To run an urgent sample, stop the run by pressing the Stop
button and start a new run with the urgent sample.
• A two-step dilution is automatically performed on samples withdrawn from
primary tubes containing whole blood.
• No dilution is performed on samples withdrawn from sample vials.
• Each run uses one method. A change of methods must be performed
between runs to switch to a different test.

Routine Processing For Whole Blood Samples From Primary

Tubes
The following steps are completed for each sample analysis.
1. The barcode reader scans the barcode label on the primary tube. The
barcode information is entered into the worklist under Sample ID.
2. For samples that do not have barcode labels, or if the barcode label is
damaged and cannot be read, the sample ID must be entered before

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OPERATION D-10 • Section 4
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starting a run. Select the sample ID field, press the Edit button and enter the ID using
the alphanumeric keypad.
3. The barcode reader scans the barcode labels a second time prior to sample
preparation. If the information does not match that of the first scan, a sample
mismatch error is generated and the sample is skipped. An error message will be
placed in the worklist indicating a mismatched sample.
4. The sample probe pierces the tube and withdraws sample from the tube.
5. The sample is diluted in the dilution well.
6. The sample probe withdraws a portion of the diluted sample from the dilution well.
7. The remainder of the first sample dilution is pumped from the dilution well.
8. The first sample dilution undergoes a secondary dilution in the dilution well.
9. A portion of the secondary dilution is withdrawn from the dilution well and injected
into the buffer stream (analytical flow path).
10. The sample and buffer mixture flows through the cartridge where the sample is
separated into its constituents.
11. The sample constituents and buffer flow through the detector where the absorbance
of each sample constituent is measured.
12. The detector output is plotted as a chromatogram on the printed report, if selected.
13. A system flush removes any residual sample components.

Routine Processing For Pre-diluted Samples Using Sample Vials

The following steps are completed for each pre-diluted sample analysis:
1.

DRAFT
The barcode reader scans the barcode label on the sample vial adapter. The
barcode information is entered into the worklist under Sample ID.
2. For samples that do not have barcode labels, or if the barcode label is damaged and
cannot be read, the sample ID must be entered before starting a run. Select the
sample ID field, press the Edit button and enter the ID using the alphanumeric
keypad.
3. The barcode reader scans the barcode labels a second time prior to sample
preparation. If the information does not match that of the first scan, a sample
mismatch error is generated and the sample is skipped.
4. The sample probe withdraws sample from the sample vial and injects it into the buffer
stream (analytical flow path).
5. The sample and buffer mixture flows through the cartridge where the sample is
separated into its constituents.
6. The sample constituents and buffer flow through the detector where the absorbance
of each sample constituent is measured.
7. The detector output is plotted as a chromatogram on the printed report, if selected.
8. A system flush removes any residual sample components.

Urgent Sample Processing

The D-10 does not have a dedicated STAT function. To process urgent samples, the
current run should be stopped and the urgent sample added to the rack for processing in
a new run.

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OPERATION

Emergency Shut Down

In the event that the system must be shutdown immediately, the operator must assess
the urgency and perform one of the following:
• Stop the current run, allowing the system to complete current operations. Press the
Shutdown button and wait for the message indicating it is safe to turn off the system.
Turn off the power switch and disconnect the power cord.
• Turn off the power switch and disconnect the power cord. This solution should only be
used when necessary.
WARNING: Do not disconnect the power cord unless the power switch is turned off to
avoid the risk of electrical shock.

Pre-run Checklist
Prior to beginning daily operation, complete the Pre-Run Checklist section of the Daily
Log. To automatically print out a daily log during system warm up, make sure that the
Auto Printout under Settings/Print Settings is set to YES.

Check the Method Setting

• From the Lot Info screen, make sure that the correct method is selected.
• To change methods, see “Changing Methods” on page 4-7.

Check the Buffers and Wash/Diluent Solution Levels

• Check the remaining number of injections for the buffers and Wash/Diluent Solution
under the Lot Info screen or on the auto printout of the daily log.

DRAFT
• Visually check the solution levels of the buffers and Wash/Diluent Solution to make
sure sufficient volume is available to complete a run.
• If levels are low, install a new bottle of buffer or Wash/Diluent Solution. Make sure the
fresh buffer or Wash/Diluent Solution is from the same reagent set and lot number as
the previous material. Verify the lot number of reagents under the Lot Info/Reagent Set
screen.
NOTE: if installing a new lot of reagents, make sure the corresponding cartridge is
also installed. See “Installing a New Cartridge” on page 4-4.

Installing New Reagents

1. Unscrew the on-line cap from the empty bottle and carefully lift the reagent line out of
the bottle.
2. Remove the empty bottle and place to the side.
3. Never mix contents from different bottles of the same reagent. Doing so may lead to
reagent contamination and compromise the performance of the product.
4. Remove the cap from the new bottle. Fasten the cap onto the empty bottle and
properly dispose of the empty bottle.
5. Place the new bottle in the reagent bottle bay. Place the reagent line into the new
bottle. Secure the on-line cap.
6. Reset the number of injections for the replaced buffer or Wash/Diluent Solution in the
appropriate Lot Info subscreen.
NOTE: Manually resetting the number of injections is not required when the Update
Kit procedure is performed.

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Check the Number of Injections on the Cartridge

• Check the remaining number of cartridge injections under the Lot Info screen , or on
the auto printout of the daily log, to make sure a run can be completed.
• Replace the cartridge if there is an insufficient number of injections remaining.
NOTE: When installing a new cartridge, make sure the corresponding reagent lots
are also installed.

Installing a New Cartridge

1. Insert the Update Kit disk into the floppy disk drive.
2. Select the Lot Info screen tab. From the Lot Info screen, press the Update Kit button.
3. Press the Update Now button. Press Exit to close the Update Kit screen without
performing an update.
.

DRAFT Figure 4-1: Lot Info/Update Kit Screen

4. When the update is complete, press the Print button on the Lot Info screen for a
hardcopy of the kit information for your laboratory records.

Figure 4-2: Lot Info Screen

5. Remove the Update Kit disk from the floppy disk drive.

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OPERATION

6. Verify that the system is in the Sleep state. If the system is in Standby, place the
system into Sleep state using the Run screen.
7. Open the lower front panel of the D-10 to access the cartridge heater. The cartridge
heater is located in the lower right corner of the sample analysis compartment.
NOTE: When the cartridge is removed, a small amount of liquid may drip from the
tubing. Place a paper towel below the cartridge holder to absorb any drips.

cartridge heater

Figure 4-3: Sample Analysis Compartment

8. Grasp the right side of the black heater cover and pull open to access the heater
block. The cover must be opened completely to remove or replace the cartridge
holder from the heater.

DRAFT
Figure 4-4: Cartridge Heater

9. Grasp the cartridge holder with your thumb and forefinger, and then pull the holder
towards you to remove it from the heater. Pull the used cartridge from the holder and
dispose of properly.
10. Remove the end caps from the new cartridge and align the flow arrows on the
cartridge and the holder in the same direction. The flow arrows should both point to
the right.
11. Insert the new cartridge completely into the holder until the left end of the cartridge is
flush with the left end of the holder. If the cartridge is not properly seated, the holder
cannot be inserted into the heater.

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OPERATION D-10 • Section 4
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12. With the flow direction arrow pointing to the right, slide the holder into the heater.
Slightly wiggle the holder if needed to seat securely.

Figure 4-5: Placement of Cartridge Holder

13. Close the heater cover. As the heater cover is closed, the cartridge forms a seal with
the heater.
14. Refer to the reagent kit instruction manual for further cartridge installation
instructions (e.g., priming, calibration).

Check the External Waste Tank Level

• Make sure that the waste tank has sufficient room to accommodate waste from the

DRAFT
next run.
• Empty the waste tank as needed.

Empty the Waste Tank

1. Disconnect the tube from the waste tank cap using the quick disconnect valve.
2. Remove the main cap from the waste tank. Place the cap on an absorbent towel.
3. Properly dispose of the waste as directed by laboratory safety procedures.
4. Replace the waste tank cap.
CAUTION: Some reagents used with the D-10 contain sodium azide as a preservative
(see reagent kit instruction manual or bottle labeling). Azide may react with lead or
copper plumbing to form potentially explosive metal azides. When disposing of reagents
containing sodium azide, always flush with large volumes of water to prevent metal azide
buildup. For further information, consult the manual, Safety Management, No. CDC-22,
“Decontamination of Laboratory Sink Drains to Remove Azide Salts” (Center for Disease
Control and Prevention, Atlanta, GA April 30, 1976).

Check the Pressure

1. From the Maintain screen, select 50% Buffer 2 and set the flowrate to 1.8 mL/min;
press the Start Pump button.
2. Monitor the system pressure for three to four minutes. If the pressure does not
fluctuate by more than 5%, record the system pressure in the Daily Log.
3. If the pressure fluctuates more than 5%, refer to “Pressure Fluctuations” on page 6-
6.

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OPERATION

Check for Leaks

While the pumps are running, open the lower front panel and visually inspect the
compartment for the presence or evidence of fluid (e.g., precipitate). Carefully tighten
any leaking connections and wipe up any fluid.

Check the Printer Paper Supply

• Visually check the remaining paper supply to make sure there is sufficient paper to
print reports for the next run.
• Check the paper well for debris; remove any debris.
• Replace the paper supply using only Bio-Rad thermal paper.

Replace Printer Paper

1. Release the printer cover to access the paper well.
2. Remove the remaining paper roll and/or core. Make sure the paper well is free from
debris which may cause the printer to jam.
3. Remove the wrapping from a new roll of thermal paper. Completely remove the
adhesive strip or trim the paper. Make sure that the leading paper edge is not
damaged or frayed.
4. Position the roll so that the paper exits the bottom of the roll towards you and the
Bio-Rad logo is facing down.
5. Feed the edge of the paper roll through the printer head slot.
6. Press the paper advance button to feed the paper through the printer.

DRAFT
CAUTION: Manually pulling the paper through the printer mechanism will cause
premature failure of the printer.

Changing Methods
Each D-10 application requires the use of specific method parameters, reagent set, and
analytical cartridge. To switch methods, complete the steps below.

Change Reagents
Refer to “Check the Buffers and Wash/Diluent Solution Levels” on page 4-3.

Install a New Cartridge and System Software

Refer to “Check the Number of Injections on the Cartridge” on page 4-4.

Perform a System Flush

1. From the Maintain screen, press the System Flush button. The system flush will be
completed in approximately 20 minutes.
2. Once the system flush is complete, manually start the pump at 50% Buffer 2 and
1.8 mL/min.
3. Monitor the system pressure for three to four minutes. If the pressure does not
fluctuate by more than 5%, proceed to next step. If the pressure fluctuates more
than 5%, refer to Section 6.
4. Stop the pump.

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OPERATION D-10 • Section 4
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Select a New Method

1. From the Lot Info screen, press the currently selected method name to access the
Select Method menu. Choose a method, and then press Exit to close the menu. A
prompt is displayed to confirm the method change. Select Yes to confirm the
method change.
2. The system transitions to Sleep state. Press the Start Up button from the Run screen
to perform a system warm up.
3. The system enters the Standby state when the warm up is complete.

Performing a Run
This section provides general directions for performing a run. Refer to the appropriate kit
instruction manual for assay specific procedures.

Setting Up a Sample Rack

• The rack positions are numbered 1 through 10. A rack may be loaded with different
sized tubes. Smaller diameter tubes require the use of rack adapters to assure proper
seating of tubes. Rack adapters should be used for 10, 12, 13, and 14 mm tubes.
• Pre-diluted whole blood samples, controls, calibrators and primers require the use of
sample vial adapters. These samples are identified by the D-10 based upon the
barcode labels affixed to the adapters. Sample vial adapters should be aligned with
the magnet facing towards the back of the rack.
• Tubes should be aligned in the rack with the barcode labels facing towards the back of
the rack. The barcode labels should be clearly visible between the slots in the rack.

DRAFT
Loading Samples
1. Insert the sample rack through the rack door.
2. The rack is grasped by the D-10 and moved into position for automatic barcode
scanning. The barcoded information is loaded into the Run screen worklist under
sample ID.
NOTE: A blank line appears in the worklist when a barcode label is not present or is
read incorrectly. If a blank line appears in the worklist, press the Eject button to
remove the sample rack from the system. Check the tube in the corresponding rack
position to make sure that the barcode label is present and correctly positioned. Re-
insert the sample rack to be re-scanned.
3. The sample ID field may be edited. The sample ID may contain up to 20 characters.
Select the sample then press the Edit button to display an alphanumeric keyboard.
Press the arrow buttons to scroll through the keyboard characters. To change the
current ID, select a character from the current ID, then press a new character from
the keyboard. Complete this process for additional changes. Press the Clear button
to delete the sample ID and start entering again. Press the Cancel button to return to
the Run screen without entering the new sample ID. Press the OK button to return to
the Run screen and accept the new sample ID.

Analyzing Samples
1. From the Run screen, press Start to begin the run.
2. Press the Exit button to close the screen without performing a run.
3. During a run, a real-time plot of the detector output may be viewed on the Maintain
screen.

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OPERATION

Interrupting a Run
• Once a run is in progress, the Start button toggles to become the Stop button. The
Stop button aborts a run when selected.
• When the Stop button is pressed during a run, a dialog box is displayed asking for
confirmation. Press the Yes button to abort the run or the No button to continue the
run. If Yes is selected, the system will complete the analysis of the sample currently
being injected. The next sample being prepared for injection will be discarded and the
sample preparation components will be flushed with the Wash/Diluent Solution.

Reviewing Data
A printed report of each sample analysis may be automatically generated. A sample
report includes:

• Date and time of analysis;

• Sample ID number;
• Operator ID;
• Injection number (composed of the
daily incremental injection number,
the day, the month and the year of
analysis);
• Sample rack position of sample;
• Peak name (assigned peak name,
based upon retention time);
• Calibrated Area % [area percent after

DRAFT
calibration slope and intercept are
applied];
• Area % [percent area of the analyte
as a fraction of the sample’s total
area, (area / total area) x 100];
• Retention Time (analyte retention
time in minutes);
• Peak Area [absorption units
(µvolt‚second) of the analyte at 415
nm];
• Total Area (sum of all detected
analyte areas);
• Summary (a quick reference of key
analytes); and
• Chromatogram (graph of Time vs.
Area Percent).

Figure 4-6: Sample Chromatogram

Refer to the appropriate kit instruction manual for specific information used to interpret
the sample report.

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OPERATION D-10 • Section 4
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Exporting Data
At the end of a run, the data may be exported to a floppy disk or the LAN.*
1. From the Data screen / Export menu, select the location for data export. Press the
Export button to export the data in the Results table. Unless otherwise specified, all
of the data in the results table will be exported.
2. To export specific sample data sets, select data from the results table prior to
pressing the Export button.
3. Press the Exit button to close the export menu without completing the export
process.
*Not available at time of launch.

Post-Run Checklist
When all runs for the day are finished, complete the Post-Run Checklist section of the
Daily Log.

Store or Discard Samples

• Whole blood patient samples should be removed from the sample rack and stored at
2-8 °C for up to seven days from date of initial collection.
• Pre-diluted samples should be properly disposed of as potentially biohazardous
material, in accordance with the laboratory’s standard operating procedures.

Wipe Up Spills and Decontaminate Surfaces

DRAFT
Wipe up any spills that have occurred and follow internal procedures for clean up.
Sample spills are potentially biohazardous; treat appropriately. If any spills occur in the
sample processing area, decontaminate the area using a surface decontamination
solution (e.g., 70% alcohol).

Long-Term Shut Down

If the D-10 is to be shutdown for more than two weeks, follow the procedure below to
ensure that the system remains in optimal operating condition.
1. From the Maintain screen, set the flow rate to 2.0 mL/min and the percent Buffer 2 to
0%. Press the Start Pump button to begin pumping 100% Buffer 1.
2. Allow the pump to run for approximately 10 minutes to completely fill system lines
with Buffer 1.
3. Remove the cartridge and cap the ends. Refer to the appropriate instruction manual
for storage recommendations. Place a dummy cartridge in the cartridge holder.
4. Empty the waste tank and the waste bottle.
5. Press the shutdown button and wait for the message indicating it is safe to turn off
the system.
6. Turn off the main power switch.

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 Section

5
Maintenance
Most routine maintenance is performed on a daily basis when the pre- and
post-run checklist items are completed (see Section 4.0).
Periodic maintenance is required to maintain optimum system performance.
CAUTION: Qualified personnel can safely perform all maintenance

DRAFT
procedures described in this manual. Only a Bio-Rad representative should
perform maintenance not covered in this manual.
WARNING: Turn the power switch off and disconnect the power cord from
the main power source before performing any maintenance procedure that
requires disassembly of any interior instrument component, except for the
dilution well and sample probe.

Monthly Maintenance
• Clean Exterior/Interior Surfaces
• Clean/Decontaminate Sampling Fluid Path
• Clean Dilution Well
• Clean Internal Waste Bottle
• Clean and Inspect Sample Racks

Exterior Surface Cleaning

Use a paper towel dampened with deionized water to wipe the exterior
surface of the system. Do not use abrasive cleaners. If required, use a mild
soap solution diluted with water to clean the surface, then wipe with a damp
paper towel to remove any soap residue.

Interior Surface Cleaning

Clean the interior of the system by wiping it with a paper towel dampened
with deionized water.

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MAINTENANCE D-10 • Section 5
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Fluid or salt residues may indicate the presence of a slow leak. Visually check the interior
of the D-10 for the presence of leaks. Wipe up any fluid, using a soft disposable towel or
tissue. Be sure to clean fluid from the lower interior surface. Check for loose connections
that may need to be tightened. Do not overtighten connections.

Clean/Decontaminate Sampling Fluid Path

1. Verify that the system is in the Sleep state. If the system is in Standby, place the
system in the Sleep state using the Run screen.
2. Remove the analytical cartridge and replace it with the plastic PEEK dummy
cartridge. Place the green end caps onto the cartridge and store it for reuse.
3. Select the “Decontaminate” method from the Lot Info/Method screen.
4. Place five sample vials with 5% sodium hypochlorite solution (undiluted household
bleach) into sample vial adapters. Place in the first five positions of a sample rack.
5. Place five sample vials filled with deionized water into sample vial adapters. Place in
the last five positions of the rack.
6. Select startup from the Run screen. Once the startup is complete, insert the rack and
start a run.
7. When the status returns to Standby, remove the plastic PEEK dummy cartridge and
replace it with the analytical cartridge.
8. Remove the rack. Select the desired test from the Lot Info/Method screen.

Clean the Dilution Well

1. From the Maintain/Service screen, press the Access Wash Station button to move

DRAFT
the sample probe to the opposite side of the instrument. Once this button is
pressed, the user has 5 seconds to open the door. If the door is not opened within 5
seconds the door will lock and the sample probe will return to its home position.
2. Lift the wash station up a few mm to access the luer fittings. Disconnect the color-
coded luer fittings on the wash station tubing. Lift the wash station up and remove it
from the instrument.
3. Rinse with water to remove any residue. Wipe completely dry with a soft cloth.
4. Re-insert the wash station and reconnect the color-coded fittings.
5. Close the front door. The sample probe will return automatically to its home position.

Clean Internal Waste Bottle

The internal waste bottle must be cleaned monthly to prevent build up of particles from
primary sample tube caps. If allowed to build up, these particles can block tubing
leading to leaks.
1. Verify that the system is in the Sleep state. If the system is in Standby, place the
system in the Sleep state using the Run screen.
2. Open the door on the right of the system to access the low pressure fluidic module.
3. Remove the internal waste bottle from the C-clip by gently pulling.
4. Unscrew the cap (by grasping the bottle and turning clockwise) and place an
absorbent towel underneath.
5. Properly dispose of the waste as directed by laboratory safety procedures.
6. Rinse the internal waste bottle with diluted 1:10 sodium hypochlorite solution
(bleach), or other appropriate decontamination solution.

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MAINTENANCE

7. Tightly screw the cap back onto the internal waste bottle (by turning the bottle
counterclockwise) and replace in the C-clip housing.
8. From the Maintain/Service screen, press the Check Waste Bottle button to test the
seal of the internal waste bottle. The test takes approximately 20 seconds.
During the test, the button will read, “Check is running.”
If the test passes, the button will change back to, “Check Waste Bottle.”
If the test fails, the button will read, “Waste Check failed — Click again.” If the test
fails, make sure that the internal waste tank cap is screwed on tightly and that the luer
fittings on the tubings are connected tightly. Repeat the test by pressing the button.

Clean and Inspect Sample Racks

1. Inspect the sample racks to assure they are in good working condition.
2. Remove any residue using a paper towel moistened with water.

Periodic Maintenance
Replace the Sample Probe
The sample probe does not normally require replacement during routine operation. After
10,000 injections, or if the probe is damaged, follow the procedure as described below.
1. From the Maintain/Service screen, press the Replace Needle button to move the
sample probe to the middle of the compartment.
2. Once this button is pressed, the user has 5 seconds to open the front door. If the

DRAFT
door is not opened within 5 seconds, the door will lock and the sample probe will
return to its home position.
3. Carefully disconnect the sample probe from the sampling assembly.
4. Discard the old probe according to the laboratory standard operating procedures for
biohazardous sharps. Place old probe into a biohazardous sharps container.
5. Unwrap a new probe. Place the new probe into the assembly, then reconnect the
tube fitting. Remove the plastic cover from the probe.
6. Close the front door. The probe will automatically return to the home position.
7. Observe the new probe during the self-check for proper alignment. The new probe
should move up and down easily, without any obstructions.

D-10 Operation Manual • 200:136

TM
5-3
MAINTENANCE D-10 • Section 5
TM

Figure 5-1: Sample Probe, Home Position

DRAFT

TM

5-4 D-10 Operation Manual • 200:136

 Section

6
Troubleshooting
Troubleshooting advice for problems that may be encountered while
operating the D-10 are divided into the following categories:
• General Troubleshooting

DRAFT
• Hardware Error Codes
The recommendations in the tables provide abbreviated procedures; see
appropriate sections for explanations of these procedures.
If the problem(s) persist after completing the recommended solution(s), or if a
problem is not addressed in this section, contact Bio-Rad Technical Support
for customers in the U.S.A or Puerto Rico at 1-800-2BIORAD (1-800-224-
6723).
Outside the U.S.A, please contact your regional Bio-Rad office for
assistance.

TM
D-10 Operation Manual • 200:136 6-1
TROUBLESHOOTING D-10 • Section 6
TM

General Troubleshooting
Table 6-1: General Troubleshooting

Problem Probable Cause Recommended Solution

No peaks appear on the 1. Air in sampler syringe line or 1. Verify end of wash line is at
chromatogram; report shows no system not primed correctly the bottom of the Wash/
data Diluent Solution bottle.
Perform a system flush.

2. Clotted or short sample 2. Check sample for clots or low

volume. Predilute and re-run
sample.

3. Prediluted sample not mixed 3. Remake prediluted sample,

mix and re-run.

4. Dilution Chamber leak 4. Call Technical Support.

5. Proportioning valve does not 5. Check the proportioning

work properly valve: Switch the valve
manually, using the command
on the Service screen. A loud
clicking noise should be
heard when switching to
Buffer 2 and a quieter noise
when switching to Buffer 1. If

DRAFT
no click is heard, call
Technical Service.

6. Probe is bent or blocked 6. Replace probe.

7. System not primed correctly 7. Follow the steps in “Prime

the Reagent Lines” on page
3-5.

8. Insufficient sample in the 8. Manually prepare sample and

tube/sample vial re-run.

Shape of the peaks degrade 1. Expired, contaminated or 1. Change the reagent(s).

damaged reagent(s)

2. Expired or damaged 2. Change the cartridge.

cartridge

3. Dirty flow cell 3. Run decontamination

procedure (page 5-2).

TM

6-2 D-10 Operation Manual • 200:136

D-10 • Section 6
TM
TROUBLESHOOTING

Table 6-1: General Troubleshooting (Continued)

Problem Probable Cause Recommended Solution

Calibration failure; peak out of 1. Data entry error 1. Verify correct entry for
range; peak not detected calibrator values.

2. Wrong calibrator used or vial 2. Verify correct calibrator is

barcoded incorrectly used and is correctly
barcoded.

3. Calibrators are placed in the 3. Check calibrator position in

wrong rack position rack.

4. Inadequate calibrator volume 4. Verify sample vials contain

sufficient volume of calibrator.

5. Improper reconstitution of 5. Reconstitute new vials of

calibrators calibrator.

6. Air bubble in detector and/or 6. Flush system. See “Perform

pump system a System Flush” on page 4-
7.

7. Dirty flow cell 7. Run decontamination

procedure. See “Clean/
Decontaminate Sampling
Fluid Path” on page 5-2.

DRAFT
8. Damaged reagent or 8. Replace damaged
cartridge component.

D-10 Operation Manual • 200:136

TM
6-3
TROUBLESHOOTING D-10 • Section 6
TM

Table 6-1: General Troubleshooting (Continued)

Problem Probable Cause Recommended Solution

Early retention times 1. Elevated sample 1. Check dilution chamber and

concentration; high total probe wash port for debris or
areas waste backup.

2. Buffer contamination 2. Replace buffer(s); do not pool

buffers.

3. Buffer evaporation 3. Replace buffer(s); keep

buffer(s) capped.

4. Wrong test parameters 4. Verify correct method is

running; Load correct Update
Kit disk using the Lot Info/
Update Kit screen.

5. Damaged, wrong, or expired 5. Replace cartridge.

cartridge

6. Cartridge temperature too 6. Call Technical Service.

high

7. Proportioning valve does not 7. Check the proportioning

work properly valve: Switch the valve
manually, using the command
on the Service screen. A loud

DRAFT
clicking noise should be
heard when switching to
Buffer 2 and a quieter noise
when switching to Buffer 1. If
no click is heard, call
Technical Service.

Late retention times 1. Low sample concentration 1. Check for clotted samples;
areas; low total areas check for blockage in probe.

2. Leak in flow path 2. Check for leaks (including

cartridge holder).

3. Air in pump 3. Purge pump; flush system.

4. Wrong test parameters 4. Verify correct method is

running; Load correct Update
Kit disk.

5. Clogged buffer line 5. Check line and clean as

needed using the Lot Info/
Update Kit screen.

6. Bad pump seal 6. Call Technical Service.

7. Damaged buffer(s) 7. Replace buffer(s).

8. Damaged, wrong, or expired 8. Replace cartridge.

cartridge

TM

6-4 D-10 Operation Manual • 200:136

D-10 • Section 6
TM
TROUBLESHOOTING

Table 6-1: General Troubleshooting (Continued)

Problem Probable Cause Recommended Solution

Late retention times (continued) 9. Cartridge was not primed 9. Prime cartridge. See specific
assay instruction manual.

10. Cartridge temperature too 10. Call Technical Service.

low

11. Proportioning valve does not 11. Check the proportioning

work properly valve: Switch the valve
manually, using the command
on the Service screen. A loud
clicking noise should be
heard when switching to
Buffer 2 and a quieter noise
when switching to Buffer 1. If
no click is heard, call
Technical Service.

Noise spikes appear on 1. Air bubble in detector and/or 1. Flush system. See “Perform
chromatogram / drifting baseline pump system a System Flush” on page 4-
7.

2. Air bubble in detector 2. Flush system. See “Perform

a System Flush” on page 4-
7.

DRAFT 3. Dirty flow cell

4. Detector board fault

3. Run decontamination
procedure. See “Clean/
Decontaminate Sampling
Fluid Path” on page 5-2.

4. Call Technical Service.

5. Dirty dilution well 5. Clean dilution well as

described on page 5-2.

Low Total Area 1. Short sample 1. Ensure that there is enough

sample in the tube.

2. Sample is too dilute 2. Manually dilute sample at

lower dilution ratio (1:100)
and re-run.

3. Clotted sample 3. Manually dilute sample and

re-run.

4. Prediluted sample not mixed 4. Remake prediluted sample,

mix and re-run.

5. Leak at dilution chamber 5. Call Technical Service.

D-10 Operation Manual • 200:136

TM
6-5
TROUBLESHOOTING D-10 • Section 6
TM

Table 6-1: General Troubleshooting (Continued)

Problem Probable Cause Recommended Solution

Low Total Area (continued) 6. Air in sample lines or diluent 6. Check Wash/Diluent Solution
syringe bottle volume and verify wash
line is properly placed in
bottle. Perform system flush.
See “Perform a System
Flush” on page 4-7.

7. Uptake line clogged with 7. Flush the sample uptake

undissolved sample lines.
particulate

High Total Area 1. Sample is too concentrated 1. Manually dilute sample at

higher dilution ratio (1:400)
and re-run.

2. Inadequate wash of sample 2. Check dilution chamber and

probe or inadequate drain of probe wash port for overflow.
dilution chamber Call Technical Service.

3. Syringe pump not functioning 3. Call Technical Service.

properly

4. Leak in the internal waste 4. Ensure that the internal waste

bottle bottle cap is closed. Perform
the waste bottle test from the

DRAFT 5. Air in the sample line or

syringe
Service screen. See “Clean
Internal Waste Bottle” on
page 5-2.

5. Flush system. See “Perform

a System Flush” on page 4-
7.

Module does not turn on when 1. Power outage at the source 1. Check main incoming power
main power switch is pressed, or circuit breaker.
loses power
2. Main power fuse(s) failure 2. Replace one or both fuses. If
repeated failure, contact
Technical Service.

3. Main power switch failure 3. Call Technical Service.

Pressure Fluctuations Air in pump Eliminate air using steps

described in “Assess the Check
Valves” on page 3-8.

TM

6-6 D-10 Operation Manual • 200:136

D-10 • Section 6
TM
TROUBLESHOOTING

Table 6-1: General Troubleshooting (Continued)

Problem Probable Cause Recommended Solution

Low system pressure 1. Loose or open connections 1. Check the fluid lines for any
leaks or open connections.
Perform a systematic search
from the detector to the
buffers (see “D-10 Fluid
System” on page 6-10).
Tighten any loose or open
connections; do not
overtighten.

2. Reagent intake lines above 2. Reposition fluid lines and

fluid level perform a system flush. See
“Perform a System Flush” on
page 4-7.

3. Air in pump 3. Eliminate air using steps

described in “Assess the
Check Valves” on page 3-8.

4. Dummy cartridge installed 4. Replace dummy cartridge

with analytical cartridge.

High system pressure 1. Blockage exists in fluid lines 1. Check for blockages in the
lines or cartridge. Perform a
systematic search from the

DRAFT
detector back to the high
pressure pump (see “D-10
Fluid System” on page 6-
10). Replace components as
needed.

2. Fittings are overtightened 2. Check for overtightened

fittings.

Touch screen is very dark or very 1. Contrast adjustment 1. Adjust contrast using the
light incorrect display contrast knob (inside
right panel).

2. Backlight efficiency too low 2. Call Technical Service.

Printout missing lines or is very 1. Print head is out of alignment 1. Call Technical Service.
faint or needs replacement

2. Incorrect paper used 2. Use only Bio-Rad supplied

paper.

Software problem A failure of the system to startup Turn the power off, then on again.
correctly or error encountered If the problem persists, call
during operation Technical Service for assistance.

Instrument fails to boot on power Floppy disk left in disk drive Remove floppy disk from drive
on and cycle power switch.

D-10 Operation Manual • 200:136

TM
6-7
TROUBLESHOOTING D-10 • Section 6
TM

Hardware Error Codes

If the system displays an error message that is not described in this table, call Technical Service.

Table 6-2: Troubleshooting Hardware

Error Code Problem Recommended Solution

Syringe motor error Sampler syringe home position Turn main power switch off and then
error on again. If the error does not clear,
call Technical Service.

Inj. valve motor error Sampler injection valve does not Turn main power switch off and then
move to load / inject position on again. If the error does not clear,
call Technical Service.

Pump error Pump failure Call Technical Service.

High pressure alarm 1. Check for blockages in the lines

or cartridge. Perform a
systematic search from the
detector back to the high
pressure pump (“D-10 Fluid
System” on page 6-10). If
blockage is found in cartridge,
replace cartridge. If blockage is
found in lines, contact Technical
Service. See “Replace the Fluid
Lines” on page 6-10.

DRAFT
Low pressure alarm
2. Check for overtightened fittings.

1. Check for leaks or loose

connections, or an open purge
valve. Perform a systematic
search from the cartridge to the
buffers (see “D-10 Fluid System”
on page 6-10). Tighten any loose
or open connections; do not
overtighten.
2. Make sure the buffer inlet lines
are inserted to the bottom of the
bottles and then perform a
system flush. See “Perform a
System Flush” on page 4-7.
3. Check for air in the pump; see
“Assess the Check Valves” on
page 3-8.

Detector error Detector lamp failure Call Technical Service.

Reference adjustment error Detector failure: reference Remove air bubbles from detector. If
adjustment error problem persists, call Technical
Service.

T. H. motor error Tube holder movement problems Open the front door, then turn the
power off. Check for obstructions to
movement of the tube holder.

TM

6-8 D-10 Operation Manual • 200:136

D-10 • Section 6
TM
TROUBLESHOOTING

Table 6-2: Troubleshooting Hardware

Error Code Problem Recommended Solution

x-motor error Sampler x-movement error Open the front door, then turn the
power off. Check for obstructions to
movement of the probe.

z-motor error Sampler z-movement error Open the front door, then turn the
power off. Check for obstructions to
movement of the probe.

Sample rack error Sample rack inserted incorrectly Make sure the rack is inserted
properly.

Rack door error Rack door open or jammed Eject the rack and re-insert. If
problem persists, call Technical
Service.

Front door error Front door open error Make sure the front door is closed.

Barcode error Barcode reading error 1. Make sure barcodes are applied
to the tubes or adapters
correctly.
2. Make sure the barcode is
correctly oriented in the rack.

Rack jam error Sample rack cannot be inserted Turn main power switch off and then

DRAFT
correctly on again. If the error does not clear,
call Technical Service.

Printer error Printing problem Check for paper jam or other

blockage in the printer mechanism.

Analysis error Problem encountered during 1. Rerun sample.

analysis
2. If problem persists, call Technical
Service.

Calibration error Calibration failed 1. Rerun calibrators.

2. If problem persists, reconstitute
fresh vials of calibrator and run.
3. Damaged calibrators.
4. If problem persists, call Technical
Service.

D-10 Operation Manual • 200:136

TM
6-9
TROUBLESHOOTING D-10 • Section 6
TM

DRAFT
Figure 6-3: D-10 Fluid System

Checking for Leaks or Blockages

Fluid or salt residues may indicate the presence of a slow leak. Visually check the interior
of the D-10 for the presence of leaks. Wipe up any fluid, using a soft disposable towel or
tissue. Be sure to clean fluid from the lower interior surface. Check for loose connections
that may need to be tightened; tighten by turning clockwise. Do not overtighten
connections.
To determine if a blockage exists in the fluid lines, check the system pressure. If the
pressure exceeds the high-pressure limit, perform a systematic search from the
cartridge, back to the high pressure pump for best results. To replace a blocked line,
see “Replace the Fluid Lines” below.
Call Technical Service for further assistance.

Replace the Fluid Lines

Before replacing any lines, remove the lines from Buffer 1, Buffer 2, and Wash/Diluent
Solution.
Fittings may be loosened by turning counterclockwise, and tightened by turning
clockwise. Do not overtighten connections.
After replacing lines, perform a system flush (see “Perform a System Flush” on page 4-7)
or run the pumps manually to remove air bubbles that may have been introduced into the
fluid lines.

TM

6-10 D-10 Operation Manual • 200:136

 Section

A
System
Specifications
General Specifications

DRAFT
• D-10, Dimensions: 402 mm (W) x 476 mm (H) x 534 mm (D); [15.8 in (W) x
18.7 in (H) x 21.0 in (D)]
• Weight (uncrated): 35 kg (77 lbs)
• Operating Environment
Temperature: 15 to 30 °C
Humidity: 20 to 80%, non-condensing
• Storage Conditions
Ambient temperature: 0 to 50 °C
Humidity: 10 to 95%
• Power Input Requirements: 90 – 264 VAC at 47-63 Hz
• Power Consumption: 180 VA maximum
• Fuses: 2.5 AT/250V
• Sample Requirements: Refer to specific instruction manual
• Sample Throughput: Refer to specific instruction manual
• Analytical Device
Cartridge: Application dependent
• Detector: Visible wavelength detector
• Printer: Graphic thermal, 112 mm (4.4 in.) wide
• Data Storage/Parameter Entry: 3.5” floppy disk drive
• User interface: integrated LCD touch screen
• Data Export: Floppy disk drive, RS232* or LAN*
• Ethernet/LAN connection: RJ-45
• Waste Tank, Volume: 10L
*Not available at time of launch

TM
D-10 Operation Manual • 200:136 A-1
SYSTEM SPECIFICATIONS D-10 • Appendix A
TM

Visible Wavelength Detector Specifications

• Wavelength
Sample setting: 415 nm
Reference setting: 415 nm
• Flow Cell Volume: 18.3 µL
• Optical Pathlength: 1 cm
• Light Source: LED 430 nm peak wavelength
• Linearity: ± 1% of theoretical absorbance at 1.0 AU (based on extrapolation from lower
concentration)
• Baseline Noise: ≤ 200 µV peak to peak
• Baseline Drift: ≤ 2 mV per hour
• Photodetector: Silicon photodiode

Pump Unit Specifications

• Type: One dual piston, low pulsation HPLC pump (total of two pistons)
• Flow Rate Range
Minimum setting: 0.20 mL/min
Maximum setting: 2.00 mL/min
Increments: 0.1 mL/min
• Maximum Pressure: 141 kg/cm2 (2000 psi)
• Accuracy (flow): ± 5%

DRAFT
• Precision (flow): ± 2%
• Gradient
Step accuracy: ± 0.5% @ 50% Buffer 2
Step precision: 0.5%
• Piston Flush: Automatic by syringe + Rheodyne valve

Pressure Sensor Specifications

• Construction: Strain gauge type
• Maximum Pressure: 141 kg/cm2 (2000 psi)
Accuracy: ± 5% or 3.5 kg/cm2 (50 psi), whichever is greater
Precision: ± 5% or 3.5 kg/cm2 (50 psi), whichever is greater

Degasser Unit Specifications

• Construction: Three-channel Teflon tubular membrane in a vacuum chamber
• Chamber Vacuum Level: 0 to -0.7 bar relative
• Void Volume: buffer lines, 27 mL; wash line, 6 mL

Injection Valve Specifications

• Complete Loop Filling Method (Injection Volume = Loop Size)
• Loop Size: 23 µL
• Line Flush Volume: 600 mL

TM

A-2 D-10 Operation Manual • 200:136

D-10 • Appendix A
TM
SYSTEM SPECIFICATIONS

• Carryover: <1%
• Injection Valve: Rheodyne Model RV703-103, 7 ports, 3 positions

Sample Handling
• Sample Rack: 10 positions for 16 mm tubes
• Sample Capacity: 1 rack
Sample Tubes
Primary Tubes: 10 mm x 50 mm pediatric tubes, 12 mm x 75 mm, 13 mm x 100 mm,
14 mm x 100 mm, 16 mm x 100 mm
Sample Vial: 2.0 mL sample vials
• Sample Rack Adapters
14 mm inserts
13 mm inserts
12 mm inserts
10 mm inserts for pediatric tubes
Sample vial adapters for sample vials
• Sample Probe Mechanism: Stepper motor with optical position sensor
• Sample Probe: Needle-type with external vent
• Sample Dilution
Dilution capability: 1:50 in one step; 1:2500 in 2 steps
Dilution chamber volume: 1.0 mL

DRAFT
Sample pickup volume: > 20 µL
Syringe volume: 1 mL
Syringe speed: 2.5 to 13 mL/min
Sample syringe accuracy: > 1% full stroke
Diluted sample pickup volume: 20 to 200 µL

Sample Identification
• Barcode types supported:

code 39 IATA

Industrial 2 of 5 MW-7

Interleaved 2 of 5 Code 93

• Maximum number of digits: 20

• Label dimensions: 60 mm maximum
• Barcode label position – sample tube labels manually aligned to face towards the back
of the instrument

Reagent Bottle Bay

• Size: Accepts three 2.0 L bottles

D-10 Operation Manual • 200:136

TM
A-3
SYSTEM SPECIFICATIONS D-10 • Appendix A
TM

Waste Tank Unit, external

• Size and Composition: 10 L polyethylene
• Drain Tube: external silicon, 3 mm x 6 mm, length = 1.5 m

System Controller
• Central Processing Unit: Embedded PC
• Operating System: Windows NTe
• Memory: 64 MB RAM, minimum

User Interface
• Display Resolution: 240 x 320 dots
• Display Dimensions: 120 x 92 mm2
• Keypad: Integrated touch screen
• Chromatogram Display: Real-time detector output monitor
• Status Display: Real-time display of hardware sensors

Cartridge Holder
• Cartridge: 4 cm, length; 1 ¼” OD
• Temperature, range: ambient to 50 °C
• Temperature, accuracy: ± 0.5 °C

DRAFT
• Temperature, stability: ± 0. 3 °C

TM

A-4 D-10 Operation Manual • 200:136

 Appendix

B
Replacement
Parts
When ordering replacement parts, please refer to the list below for the

DRAFT
catalog number, description and quantity required. Quantities listed below
indicate the minimum units available.

Cat. No.
553
Description
Lyphochek® Hemoglobin A2 Bilevel Control,
Quantity
1
4 x 1.0 mL

740 Lyphochek® Diabetes Control, 6 x 0.5 mL 1

220-0101 HbA1c Reorder Pack, 500 tests 1

220-0201 Dual-Program Reorder Pack, 500 HbA1cTests or 1

250 HbA2/F/A1c Tests

220-0249 Sample Probe 1

220-0297 Sample Vial Adapters (10 per package) 1

220-0302 Sample Rack 1

220-0303 Rack Inserts, 12 mm (50 per package) 1

220-0304 Rack Inserts, 13 mm (50 per package) 1

220-0305 Rack Inserts, 14 mm (50 per package) 1

220-0321 Waste Tubing 1

220-0322 Waste Tank 1

TM
D-10 Operation Manual • 200:136 B-1
REPLACEMENT PARTS D-10 • Appendix B
TM

Cat. No. Description Quantity

220-0375 Printer Paper Roll, 10 rolls per box 1

9600414 Dummy PEEK Cartridge 1

U.S. Power Cord 1

European Power Cord 1

Fuses, 2.5 A/ 250 V 2

Rack Inserts, 10 mm (50 per package) 1

Operation Manual 1

Plastic Syringe, 1 x 50 mL 1

Buffer Tubing Set (Buffers 1 and 2, Wash/Diluent 1

Solution)

Sample Type Barcodes (contains calibrator 1, 1

calibrator 2, control 1, control 2, and primer
barcodes)

DRAFT

TM

B-2 D-10 Operation Manual • 200:136

 Section

C
Maintenance
Logs
DRAFT
Most routine maintenance is performed on a daily basis when the pre- and
post-run checklist items are completed (see Section 4).
Periodic maintenance is required to maintain optimum system performance.
CAUTION: Qualified personnel can safely perform all maintenance
procedures described in this manual. Only a Bio-Rad representative should
perform maintenance not covered in this manual.
WARNING: Turn the power switch off and disconnect the power cord from
the main power source before performing any maintenance procedure that
requires disassembly of any interior instrument component.

TM
D-10 Operation Manual • 200:136 C-1
MAINTENANCE LOGS D-10 • Chapter C
TM

DRAFT

TM

C-2 D-10 Operation Manual • 200:136

D-10 Hemoglobin Testing System.

Daily Log
Instrument No.:____________________________

Date Pre-Run Post-Run Initials

Check Check Buffer Cartridge Check Pressure Check for Check Remove Wipe Spills
Method & Wash Injection Waste Level Reading Leaks Paper Samples
Setting Levels Count Supply

DRAFT
D-10 Hemoglobin Testing System.

Monthly Maintenance Log

Instrument No.:____________________________ Year: ______________________________

MAINTENANCE JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Clean Exterior Surfaces

Clean Interior Surfaces

Clean/Decontaminate
Sampling Fluid Path

Clean Dilution Well

Clean Internal Waste Bottle

Clean/Inspect Sample Racks

DRAFT
Initials
D-10 Hemoglobin Testing System.

Periodic Maintenance Log

Instrument No.:____________________________

DATE Replace Sample Probe Initials

DRAFT
 D-10 HEMOGLOBIN TESTING SYSTEM

INDEX
A D Export button 2-8, 4-10
See also data export
accessories kit 3-3 D-10
analytical cartridge. See cartridge dimensions A-1
Auto-WarmUp 2-10 installation requirement 3-1 F
overview 2-1
firmware version 2-10
set up 3-4
B startup sequence 3-10
flow rate 2-17
fluid lines, replacement of 6-11
barcode label storage conditions A-1
fluid path
alignment of 2-21, 4-8 unpacking and inspection 3-2
cleaning and decontamination of
incorrect scanning of 4-8 weight A-1
missing label 4-8 5-2
daily log
fuse holder 2-25
scanning of 4-8 auto printout 2-11, 4-3
fuses A-1
set up 3-10 pre-run checklist 4-3
future upgrades
barcode reader 2-21 printing of 2-11
expansion port 2-25
barcode types A-3 See also pre-run checklist
serial port 2-11, 2-25
buffers data A-1
%Buf.2 2-17 export 2-8
changing of 4-3 Export to Archive 2-9 G

DRAFT
checking level of 4-3 export, A-drive 2-9 general settings
low level indicator 2-11 export, selected samples 2-9 Auto-WarmUp 2-10
low level value 2-11 Data screen 2-5, 2-7 firmware version 2-10
reagent lines, priming of 3-5 Change View button 2-9 set date 2-10
reagent lines, set up 3-4 Export menu 2-9, 4-10 set time 2-10
print button 2-8 Shutdown TimeOut 2-10
Print menu 2-8
C results table 2-8
software version 2-10
calibrator View Chrom. 2-9
calibrator reports 2-8 date H
input values 2-13 setting of 2-10 high performance liquid
cartridge 2-1, 4-4, A-1 degasser 2-24 chromatography (HPLC) 1-2
direction of flow 4-5 specifications A-2
dummy 3-7, 4-11, 5-2 detector 2-22, A-1
installation of 3-6 specifications A-2 I
number of injections 4-4 wavelength A-2 injection valve 2-22
priming 3-10 detector output 4-8 specifications A-2
cartridge heater 2-22, 4-5 dilution 4-1
heater block 4-5 dilution process 1-2
cartridge holder 4-5, A-4 dilution well
K
Change View button 2-8 cleaning of 5-2 keyboard port 2-25
check valves disk drive 2-24
remove air 3-8 display contrast knob 2-23
controls L
enter values 3-9 LAN A-1
Customer Acceptance Form 3-2 E LAN port 2-25
Ethernet A-1 LCD touchscreen 2-3
expansion port 2-25 See also user interface
Levels

D-10 Operations Manual • 200:136 Index-1

D-10 HEMOGLOBIN TESTING SYSTEM

cartridge level low 2-11 post-run checklist 4-11 sample report 2-8
reagent level low 2-11 pre-diluted samples 4-2 processing compartment door 2-20
waste level high 2-11 prime run 3-10 pump 2-22
Lot Info screen 2-12 sample analysis 4-1, 4-2 check valves, checking for air 3-
Buffer 1 2-15 See also post-run checklist 8
Buffer 2 2-15 whole blood samples 4-1 high pressure 2-22
calibrator 2-13 manual operation 2-17
calibrator 1 2-14 specifications A-2
calibrator 2 2-14 P syringe 2-24
cartridge 2-16 pinch valves 2-24
high control 2-14 ports
low control 2-13 expansion 2-25 R
Maintain screen 2-17 keyboard 2-25 rack adapter 2-21, 4-8, A-3
Reagent Set screen 4-3 LAN 2-25 rack door 2-23, 4-8
reset level 2-15 mouse 2-25 reagent bottle bay 2-23, A-3
See also Maintain screen reagent inlet 2-25 reagent inlet ports 2-25
Select Method menu 4-8 VGA 2-25 run
Update Kit button 2-12 waste 2-25 test run 3-10
post-run checklist 4-11 Run screen 2-4, 3-5
long-term shut down 4-11 Eject button 2-6
M spills and decontaminate Exit button 4-8
main power switch 2-24 surfaces 4-11 Shut Down button 2-4
Maintain screen 2-17, 4-11 store or discard samples 4-11 Start button 4-8
detector output 2-17 power Start Up button 2-4, 4-8
flow rate 2-17, 4-11 consumption A-1 Stop button 4-9
percent Buffer 2 2-17, 4-11 input requirements A-1 Worklist 2-5

DRAFT
pressure 2-17 power cord
service 2-19 set up 3-5
Service button 2-18, 3-5 power input 2-25 S
Start Pump button 2-17, 4-11 power switch 2-24 sample
System Flush button 2-18, 4-7 pre-run checklist analysis of 4-8
temperature 2-17 buffers and wash solution levels disposal of 4-11
view log 2-18 4-3 loading of 4-8
maintenance leaks 4-7 storage of 4-11
daily method setting 4-3 sample analysis compartment 2-22,
See Pre-run Checklist number of injections on cartridge 4-5
monthly 5-1 4-4 sample dilution
periodic 5-3 pressure 4-6 specifications A-3
methods printer paper supply 4-7 sample handling
changing of 2-8, 2-14, 2-15, 2- waste tank level 4-6 specifications A-3
16 pressure sensor 2-22 sample ID field 4-8
select Method menu 2-13 specifications A-2 sample identification A-3
mouse port 2-25 print settings keypad 2-7
auto printout 2-11 sample probe 2-20
print daily log 2-11 replacement of 5-3
O printer 2-23, A-1 specifications A-3
operating environment A-1 printer paper sample processing
humidity A-1 Bio-Rad thermal paper 4-7 urgent 4-2
temperature A-1 checking of 4-7 sample processing compartment
operation 4-1 installation of 3-5, 4-7 2-20
changing methods 4-7 printing sample rack 2-21, A-3
general information 4-1 calibrator reports 2-8 cleaning of 5-3
manual 2-17 chromatogram 2-8 Eject button 3-11
performing a run 4-8 daily report 2-8 rack adapter 4-8

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 D-10 HEMOGLOBIN TESTING SYSTEM

See also rack adapter T wash solution

setting up 4-8 changing of 4-3
time
sample report 4-10 setting of 2-10 checking level of 4-3
printing 2-8 troubleshooting 6-1 waste
printing, selected samples 2-8 barcode reading error 6-10
disposal of 4-6
sample requirements A-1 waste bottle 2-24
blockages 6-11
sample throughput calibration failure 6-3 waste ports 2-25
A-1 chromatogram 6-2, 6-6 waste tank 4-6, A-1, A-4
sample types detector lamp 6-9 high level indictor 2-11
pre-diluted 4-2 waste lines, set up 3-4
general 6-2
whole blood 4-1 injection valve 6-9 worklist
sample vial 4-2 leaks 6-11
blank line 4-8
sample vial adapter 2-21, 4-2, A-3 power 6-7 sample ID field 4-8
sample well/wash station 2-20 printer 6-10 See also sample ID field
sampling arm shipping lock 3-3 printout 6-8
scroll buttons 2-10, 2-12, 2-18 pump 6-9
serial port 2-25 retention times 6-4
Settings menu sample probe position 6-9
print button 2-10, 2-12
sample rack insertion 6-10
Settings screen 2-10
software 6-8
alert settings 2-12
system pressure 6-7, 6-8, 6-9
archive settings 2-11
total area 6-6
general settings 2-10
tube holder 2-20
levels 2-11
print settings 2-11
shut down U

DRAFT
emergency 4-2 Update Kit button 2-12
long-term 4-11 Update Kit disk 2-13
TimeOut 2-10 Update Kit screen 2-12, 2-13, 3-8,
Shutdown TimeOut 2-2 4-4
sodium azide 4-6 user interface 2-3
software version 2-10 Data screen 2-5
Start Pump button 2-17 display contrast knob 2-23
Start Up sequence 2-4 Lot Info screen 2-12
STAT function 4-2 main screen display 2-3
syringe pump 2-24 Run screen 2-4
system components 2-2 screen selection tabs 2-3
system controller A-4 See also Lot Info screen
system flush 2-18, 4-7 See also Run screen
System Flush button 2-18 See also Settings screen
system pressure 2-17, 4-6, 4-7 Settings screen 2-10
system specifications specification A-1
general A-1 specifications A-4
system states 2-2 status bar 2-3
Fault 2-2
Manual 2-2
Running 2-2 V
Sleep 2-2 valve, proportioning 2-22
Standby 2-2 valve, three-way 2-24
Waiting 2-2 VGA port 2-25

W
warranty card 3-2

D-10 Operations Manual • 200:136 Index-3

D-10 HEMOGLOBIN TESTING SYSTEM

DRAFT

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D-10 HEMOGLOBIN TESTING SYSTEM

DRAFT

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