Roche Diagnostics International Ltd.


CA6000
Instrument Driver
Release Notes
Version 2.2.3
Template ID 10303219 ZVL 000 V01
Document ID 10741227 DokArt TeilDok V DVS Auto fill

Table of Content
0 Document History.................................................................................................................... 1
1 Introduction ............................................................................................................................. 2
1.1 Goal ................................................................................................................................... 2
1.2 Instrument Driver Release Overview .................................................................................. 2
1.3 System Requirements ........................................................................................................ 3
2 Instrument Configuration........................................................................................................ 4
2.1 General Information ........................................................................................................... 4
2.2 Host Parameters ................................................................................................................ 4
2.3 Instrument to Clinical Application Interface......................................................................... 4
2.4 Instrument Workplace Definition ........................................................................................ 4
2.5 Options .............................................................................................................................. 4
2.6 Test Codes ........................................................................................................................ 7
2.6.1 CONFIG_ANALYTE_CODE=NO ................................................................................ 7
2.6.2 CONFIG_ANALYTE_CODE=YES .............................................................................. 8
2.7 Quality Controls ............................................................................................................... 10
2.8 Loading the sql File (only for cobas IT 3000/5000) ........................................................... 10
2.9 Instrument task (only for cobas IT 3000/5000) ................................................................. 11
2.10 Things to consider during installation (only for cobas IT 3000/5000) .............................. 11
2.11 Character encoding ........................................................................................................ 11
3 Build Information ................................................................................................................... 12
3.1 Identification and Content of Driver Build ......................................................................... 12
3.2 Instrument Driver Build Environment ................................................................................ 12
3.3 Build Traces ..................................................................................................................... 12
3.4 Changes per Instrument Driver Build ............................................................................... 12
4 New and Changed Features and implemented Product Issues ......................................... 13
4.1 New and changed features (PCAs) .................................................................................. 13
4.2 Implemented Product Issues (PIs) ................................................................................... 13
4.3 Implemented PCAs and PIs in previous versions of this document .................................. 13
5 Limitations and Open Issues ................................................................................................ 13

0 Document History
Version Reason for change Effective from
00 First release Date of approval

Changes to the previous document version <.>:

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Instrument Driver CA6000
Release Notes Version 2.2.3

1 Introduction
1.1 Goal
The Instrument Driver Release Notes provide all information about the instrument driver which is
needed by a field service engineer to install and operate it.

1.2 Instrument Driver Release Overview

Instrument Vendor Siemens (Sysmex)

Instrument Name: CA-500, CA-540, CA-560, CA-600, CA-1500, CA-6000, CA-7000,
CS-2000i, CS-2100i, CS-5100
Instrument Version n/a
Instrument Sysmex CA-500 Operator’s Manual, June 1997
Specification Sysmex CA-6000 Operator’s Manual, June 1996
Sysmex CS-2000i/CS-2100i Operator’s Manual, November 2010

Instr. Driver DLL: CA6000

Instrument Driver 2.2.3 Build Version 2.2.3.14
Version:

Supported Features
Uni-directional:  Query-Mode: 
Bi-directional:  Batch/Worklist-Mode: 
QC-Results:  Image Results: 
Result Upload to  Patient 
instrument: Demographics:
Device-Flags:  Extensions: 

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Instrument Driver CA6000
Release Notes Version 2.2.3

1.3 System Requirements

The instrument driver works with the following clinical application:
Clinical Application cobas IT 3000/5000
Name cobas IT middleware
Works with Clinical cobas IT 3000/5000: all released versions
Application Version cobas IT middleware: all released versions
validated with cobas IT 3000/5000 v2.03.11
Clinical Application cobas IT middleware: v1.01.01
Version

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Instrument Driver CA6000
Release Notes Version 2.2.3

2 Instrument Configuration
2.1 General Information
The bi-directional driver for the CA-6000 instruments supports the sending of results (sample
and QC) from the instrument to Laboratory Information System and it also supports sending
of test inquiries to the instrument (via query from the instrument and also via working list).

2.2 Host Parameters

Use the following settings:
Parameter Setting
Communication protocol CLASS B
ACK Text ACK/NAK
Format Type CA-1000 (13 characters for sample ID)

2.3 Instrument to Clinical Application Interface

The instrument is connected to the host by means of a serial interface. Use the 9-pin SUB-D
connector (female) labeled COM1. A null modem cable must be used for the connection to
the LIS.
PIN Signal
2 RxD
3 TxD
5 GND
6 RTS
8 CTS
For the physical connection use a null modem cable.
Make bridges between pin 4+6 and 7+8.
Sometimes if 4+6 and 7+8 does not work try with a bridge on pin 4+6+8.

2.4 Instrument Workplace Definition

Parameter Value
Baud rate 9600
Data bit 8
Stop bits 1
Parity None
Connection BI-Directional
Barcode Yes
Material Yes
DLL ca6000

2.5 Options
The following Options parameters can be entered for the instrument driver:

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Instrument Driver CA6000
Release Notes Version 2.2.3

Option Meaning
ACT Activity:

% xxx.x
raw x.xxx

Default: raw
CONC Concentration :

mg/dL xxx.x
g/L x.xxx

Default: mg/dL
DELAY Delay during send of ACK/NAK in
milliseconds

Default: 200
PROCESSTIME Delay during send of test request in
milliseconds

Default: 1000
CONFIG_ANALYTE_CODE With this option (= YES) it is possible that
every analyte code can be configured.
Without this option (=NO) the hard coded
analyte codes have to be used. The option
CONC has no influence if this option is set.

Possible values: YES, Y, NO, N

Default: NO
DECIMALPOINT Defines the decimal point in the result from
the instrument if option
CONFIG_ANALYTE_CODE is set. The
instrument sends the result without
decimal point.

Possible values: 0, 1, 2, 3, 4.
If no possible value is set, the results won’t
be saved!

Example:
Result has the format 00000 and option is
set to 4. Then the point is set 0.0000. If the
default would be set (3), the result point
would be set to 00.000

Default: 3
PATIENTINFO Activates or deactivates the sending of the
patient name to the instrument. The patient
name will be sent in the format:

Name_Firstname (_ = space)

If the full name counts more than eleven

characters, it will be truncated to eleven

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Instrument Driver CA6000
Release Notes Version 2.2.3

Option Meaning
characters.

FALSE = Patient name is not sent to the

instrument
TRUE = Patient name is sent to the
instrument

Default: FALSE
NON_ASCII Information about the handling of non
ASCII characters in the name of the
patient.

PASS = pass all non ASCII characters

STRIP = delete all non ASCII characters
REPLACE = replace all non ASCII
characters by ?
GERMAN = replace all german umlauts
(ä=>ae, ö=>oe…)
and all other non ASCII characters by ?

Default: PASS
INSTRUMENT [ONLY FOR COBAS IT 3000/5000]

Defines the instrument for which the driver

must operate.

Possible values: CS2000i

If no possible value is set, the driver does
not support Sample Information instrument
flags.

NOTE: To support Sample Information

instrument flags, the instrument must be
configured to ALWAYS send the Sample
Information instrument flags after sending
the analysis results.

Default: No support for Sample

Information instrument flags.
TIMERTIMEOUT [ONLY FOR COBAS IT 3000/5000]

In case that the Sample Information

instrument flags are NOT ALWAYS sent,
TIMERTIMEOUT defines the elapse time
(in seconds) the driver waits for the
Sample Information instrument flag
message once the results message have
been sent.

Possible values: 0 to 300

Default: 0
This means that no timer is used.

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Instrument Driver CA6000
Release Notes Version 2.2.3

Option Meaning
SAMPLEID_LENGTH Indicates the length of the sample Id field.

Possible values for this option are 13 or 15

depending on the instrument configuration.

Default: 13
Example:
ACT=%;CONC=g/L;PROCESSTIME=1500;PATIENTINFO=TRUE;NON_ASCII=STRIP

2.6 Test Codes

2.6.1 CONFIG_ANALYTE_CODE=NO
The following test codes are supported if option is CONFIG_ANALYTE_CODE=NO

Table 1: Analyte Code table for CONFIG_ANALYTE_CODE=NO

Code Channel Analyt (in CIT5K)
(Instrument Definition) (On Instrument)
PTT 041 PT (time)

PTP 042 PT (%)

PTR 043 PT (PT ratio)

PTI 044 PT (INR)

DFBG 045 Derived Fibrinogen

APTT 051 APTT (time)

FBGT 061 Fibrinogen (time)

FBGC 062 Fibrinogen (conc.)

THRT 081 Thrombotest ( time)

THRP 082 Thrombotest (%)

THRI 084 Thrombotest (INR)

HPTT 091 Normotest ( time)

HPTP 091 Normotest (%)

DDT 121 DDimer (time)

DDC 122 DDimer (%)

ATIIIOD 301 AT3 (OD)

ATIII 302 AT3

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Instrument Driver CA6000
Release Notes Version 2.2.3

Code Channel Analyt (in CIT5K)

(Instrument Definition) (On Instrument)
PFBGT 501 +Fibrinogen( time )

PFBGC 502 +Fibrinogen( conc.)

TT 511 Thrombine Time

NFBGT 521 -Fibrinogen( time )

NFBGC 522 -Fibrinogen( conc.)

2.6.2 CONFIG_ANALYTE_CODE=YES
If the option CONFIG_ANALYTE_CODE=YES is set, the old analyte configuration of the
instrument cannot be used anymore. The analyte codes have to be exchanged with the new
test codes and instrument factors which are described in the instrument manual or in the
Table 2: Analyte Code table for CONFIG_ANALYTE_CODE=YES.

If the option CONFIG_ANALYTE_CODE=YES is set, every single test code and its
instrument factor have to be configured explicitly to have the correct decimal place of the
result displayed in the application. The channel has not to be configured.
The test code identifiers can be found in the user manual or determined by analyzing the
trace.
General process: The instrument sends the results without decimal place. The driver sets per
default the decimal place at the 3rd position (milli). The decimal place has to be adjusted by
means of the instrument factor. The instrument factors are defined according to the data
formatting table (see below).
Example (“Coagulation time”):
Result sent from the instrument Result interpreted by the Result displayed in cIT5K for
(without decimal place) driver (decimal place=3) Instrument factor=100
345 0,345 34,5

Configure mask for instrument factor = 100

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Instrument Driver CA6000
Release Notes Version 2.2.3

Data formatting table:

Output Format

Data Data Data result Instrument

Data Units Instrument Driver displayed in cIT5K factor
Coagulation time sec, s XXXXX XX,XXX XXXX,X 100
Activity % % OXXXX OX,XXX OXXX,X 100
No OXXXX OX,XXX OX,XXX No factor
unit
PT ratio, INR OOXXX OO,XXX OOX,XX 10
Fbg mg/dL OXXXX OX,XXX OXXX,X 100
concentration g/L OXXXX OX,XXX OX,XXX No factor

X stands for a figure, O stands for blank space (20 H)

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Instrument Driver CA6000
Release Notes Version 2.2.3

Examples for most used code configuration:

Table 2: Analyte Code table for CONFIG_ANALYTE_CODE=YES

Test code Designation Instrument factor
041 PT (time) 100
042 PT (%) 100
043 PT (PT ratio) 10
044 PT (INR) 10
045 Derived Fibrinogen 10
051 APTT (time) 100
061 Fibrinogen (time) 100
062 Fibrinogen (conc.) No factor
081 Thrombotest ( time) 100
082 Thrombotest (%) 100
084 Thrombotest (INR) 10
091 Normotest ( time) 100
121 DDimer (time) 100
122 DDimer (%) 100
301 AT3 (OD) No factor
302 AT3 100
501 +Fibrinogen( time ) 100
502 +Fibrinogen( conc.) No factor
511 Thrombine Time 100
521 -Fibrinogen( time ) 100
522 -Fibrinogen( conc.) No factor

For more information check the Sysmex CA-500 Operator’s Manual (June 1997) page C-13,
table C-14.

2.7 Quality Controls

The identifier for quality controls has to be selected from QC01 to QC20.

2.8 Loading the sql File (only for cobas IT 3000/5000)

To add the instrument type and the correct flags to CIT5k one must load the sql file script
with for instance SQL plus. With SQL Plus this can be done by connecting SQL Plus to the
database, followed by the following command:

@ <path>\CA6000.sql
Replace <path> with the path to the directory containing the CA6000.sql file, i.e. C:\temp

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Instrument Driver CA6000
Release Notes Version 2.2.3

2.9 Instrument task (only for cobas IT 3000/5000)

The procedure used to create a new instrument task depends on the application version
used:
 For cobas IT 3000/5000 versions 2.04.00 and higher please refer to the “Creating or
editing a LISA task definition” procedure in the application service manual.
 For cobas IT 3000/5000 versions 2.03.12 and lower please refer to the “To add a
new task to the configuration” procedure in the application service manual.

2.10 Things to consider during installation (only for cobas IT 3000/5000)

Attention: After having the instrument factor configured, the result has to be
compared between the instrument display and CIT5K.

2.11 Character encoding

The host interface manual explicitly allows ASCII characters therefore setting has to be US
ASCII.

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Instrument Driver CA6000
Release Notes Version 2.2.3

3 Build Information
3.1 Identification and Content of Driver Build
Content of the latest instrument driver software build.
File Name File Type File Version Location Changeset
ca6000 dll 2.2.3.14 TFS 530724
ca6000 sql 2.2.3.14 TFS 530724
manifest xml 2.2.3.14 TFS 530724
ca6000 xml 2.2.3.14 TFS 530724

Location of the driver software build

Location \\builddrop.emea.roche.com\Build_Output\Roche.DP.InstrDrivers\Siemens\
CA6000\Legacy\XML\Main\RB\2.2.3.14

3.2 Instrument Driver Build Environment

SW release environment description Version
Team Foundation Server 2010
ALM 12.00
Microsoft Visual C++ 6

3.3 Build Traces

File Name File Type Location Changeset
n/a

3.4 Changes per Instrument Driver Build

List of changes made to the instrument driver source code during the external development and
V&V.
Version, Build Detailed Description of changes to the driver source code
n/a

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Instrument Driver CA6000
Release Notes Version 2.2.3

4 New and Changed Features and implemented Product Issues

4.1 New and changed features (PCAs)
NIC-ID RCCT-ID / Summary Description Detailed Description of feature /
GC-ID modification implemented
n/a

4.2 Implemented Product Issues (PIs)

NIC-ID RCCT-ID Summary Description Detailed Description of feature /
/ GC-ID modification implemented
GC- The driver now stores the rack and position
NIC-CITD- CA6000: Rack and position (result
0783459 when receiving the result message from the
1416 message) are ignored.
instrument.

4.3 Implemented PCAs and PIs in previous versions of this document

NIC-ID RCCT-ID / Summary Description Implemented in
GC-ID driver version
n/a

5 Limitations and Open Issues

NIC-ID RCCT-ID / Summary Description Detailed Description of feature /
GC-ID modification not or only partially
implemented
n/a

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