Roche cobas e 411 User manual

1907-05-0816
cobas e 411 analyzer
Host Interface Manual
For use in the US
Document Version 2.3

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Document information
Revision history
Manual version Revision date Changes
2.1 April 2011 Additional screenshots and remarks on page 5 
Host Test Code Setting.
2.2 November 2013 •Updated screenshots, on page 5 Host
Communication Setting.
•Additional explanation, on page 8 STAT
Sample Result Upload Setting.
•Note (*6) no sending of multiple orders from
the same test, on page 37 ff – valid from
Software version 02-04.
2.3 March 2016 Modified tip for test selection in real time in the
Communication trace chapter.
2.3 for the US
August 2016
•Used global document version 2.3 as
reference.
•Corrected branding, as necessary.
•Corrected English, as necessary.
Edition notice
This document is for users of the cobas e 411 analyzer.
The contents of this document, including all graphics and photographs, are the
property of Roche. No part of this document may be reproduced or transmitted
in any form or by any means, electronic or mechanical, for any purpose, without
the express written permission of Roche.
Every effort has been made to ensure that the information is correct at the time
of publishing. Not all functionality described in this manual may be available to
all users. Roche Diagnostics reserves the right to change this publication as
necessary and without notice as part of ongoing product development. Such
changes may not immediately be reflected in this document.
Intended use
This document is intended for the US market only.
For prescription use only.
This document describes communication procedure related to communication
method that enables intercommunication between Laboratory Host System,
hereinafter referred to as HOST, and the cobas e 411 analyzer. Specification and
software described herein comply with the following ASTM communication
protocol (HOST communication ASTM higher-layer: High-Level, lower-layer:
Low-Level I/F specification): Specification X12 of ASTM (American Society of
Testing and Materials).
ASTM E1381-91: Specification for Low-Level Protocol to Transfer Messages
Between Clinical Laboratory Instruments and Computer
System
ASTM E1394-91: Standard Specification for Transferring Information
between Clinical Instruments and Computer System
As cobas e 411 analyzer is a successor version of the Elecsys 2010 analyzer, it
upholds Elecsys 2010 analyzer HOST communication protocol. Further, a new
communication protocol is added to keep compatibility with cobas® analyzers.
These two (2) communication protocols such as Elecsys type and cobas type are
selectable. MSRs (Manufacturer Specific Records) that are the original protocol
of Elecsys 2010 analyzer are not supported by cobas e 411 analyzer.
In case of communication problems between a host and the cobas e 411
analyzer please copy the trace file d:\e411\data\log\host_trace.log onto a
removable media and contact the Customer Support Center at 1-800-428-2336.

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Screenshots Any screenshots in this publication are added exclusively for the purpose of
illustration. Configurable and variable data such as parameters, results, path
names etc. visible therein must not be used for laboratory purposes.
Copyright ©2007-2016, Roche Diagnostics GmbH. All right reserved.
Trademarks
The following trademarks are acknowledged.
COBAS, COBAS C, COBAS E and ELECSYS are trademarks of Roche.
All other product names and trademarks are property of their respective owners.
Feedback
This document was created by Roche Diagnostics GmbH and the Roche
Diagnostics Engineering Operations department. Direct questions or concerns
regarding the contents of this document:
Roche Diagnostics Corporation
Engineering Operations Department
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
Document availability
This document is available on the Roche Diagnostics USA website at
https://usdiagnostics.roche.com.
Application Code Number (ACN)
Disclaimer for US Customers
Due to the increasing complexity of laboratories and the increase in types of
tests being run, it is critical to use unique host download codes for each test
when mapping codes on your Laboratory Information System (LIS). It is also
strongly recommended to use alpha or alphanumeric codes on your LIS. If
unique LIS test codes are not used when mapping on the LIS, this could cause
a test result from one test to be reported for a different test.
Required actions when using this host interface manual:
•Ensure that the LIS test codes mapped to your LIS are unique for each
test.
•Always identify the instrument source of the results on your LIS.
•Please disregard any application code numbers in this host interface
manual. Refer to the appropriate method sheet, package insert or
application code numbers document for the most current application
code number information.

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Table of contents
Documentation information
Revision history .................................................................................................................................................................................................. 2
Edition notice ...................................................................................................................................................................................................... 2
Intended use ....................................................................................................................................................................................................... 2
Screenshots ......................................................................................................................................................................................................... 3
Copyright .............................................................................................................................................................................................................. 3
Trademarks .......................................................................................................................................................................................................... 3
Feedback .............................................................................................................................................................................................................. 3
Document availability ....................................................................................................................................................................................... 3
Application Code Number (ACN) disclaimer for US Customers ....................................................................................................... 3
Specification of interface
Specification of communication ................................................................................................................................................................... 8
Host Communication setting ......................................................................................................................................................................... 9
Communication cable ....................................................................................................................................................................................13
Communication test
Communication text ........................................................................................................................................................................................16
ASTM communication protocol
ASTM communication protocol ..................................................................................................................................................................18
Communication data structure .....................................................................................................................................................18
Frame structure ................................................................................................................................................................................................19
Definition of communication protocol ......................................................................................................................................................21
Establishment Phase ........................................................................................................................................................................21
Transfer Phase ....................................................................................................................................................................................24
Termination Phase .............................................................................................................................................................................25
Record structure
Record structure ..............................................................................................................................................................................................28
Syntax ..................................................................................................................................................................................................................29
Message header record ................................................................................................................................................................................32
Message termination record ........................................................................................................................................................................34
Request information record ......................................................................................................................................................................... 35
Patient information record ............................................................................................................................................................................37
Test order record ............................................................................................................................................................................................. 38
Result record .....................................................................................................................................................................................................42
Comment record ..............................................................................................................................................................................................45
Data alarm list .....................................................................................................................................................................................46
Communication trace
Test selection information in real time .....................................................................................................................................................50
Disk Type ..............................................................................................................................................................................................50
Rack Type ............................................................................................................................................................................................. 52
Real time test results ......................................................................................................................................................................................53
Result value is within normal range ............................................................................................................................................53
Result value is less than normal range ......................................................................................................................................53
Result value is a qualitative test ...................................................................................................................................................54
Control sample ................................................................................................................................................................................... 54
Batch test selection information .................................................................................................................................................................55

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Communication error
Example ............................................................................................................................................................................................................... 58
Appendix
Control characters ...........................................................................................................................................................................................60
Printable characters ........................................................................................................................................................................................ 61

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Specification of interface
1. Specification of communication ................................................................................................................... 8
2. Host communication setting ........................................................................................................................ 9
3. Communication cable ................................................................................................................................ 13

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Specification of communication
Communication between the
cobas e
411 analyzer and HOST is based on
RS-232C connection.
Specification of serial interface is shown as follows:
Item Specification Recommendation Note
Communication Protocol ASTM -
Communication Speed 19200bps/9600bps/4800bps 9600 bps Selectable from GUI
Character Configurations See Table 2 8bit, NONE, 1Stopbit Selectable from GUI
Protocol Type Elecsys type or cobas type Elecsys type Selectable from GUI
Frame Length 247 bytes -
Communication Port 1 port -
Cable Length (maximum) 15m -
Communication Method Half duplex
Table 1: Specification of serial interface
Character configuration is selected from the table below
No. Data bit Parity bit Stop bit
1 7 bit EVEN 2 stop bit
2 7 bit ODD 2 stop bit
3 7 bit EVEN 1 stop bit
4 7 bit ODD 1 stop bit
5 8 bit NONE 2 stop bit
6 8 bit
NONE
1 stop bit
7 8 bit EVEN 1 stop bit
8 8 bit ODD 1 stop bit
Table 2:Character configuration

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Host communication setting
fUtility >System > Host Communication Setting window
Figure 1:Host communication setting
1. Select On or Off at Host Communication window.

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2 Select Protocol Type.
The setting is changeable when Host Communication is OFF.
Figure 2: Protocol Type - Elecsys
Figure 3: Protocol Type - cobas

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Figure 4: Test code
It is mandatory for the Elecsys and cobas mode to also enter the Host Code to
upload results.
Figure 5: Test code selected

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Transfer parameters are shown in in the table below.
Parameter Option
Protocol type
Elecsys / cobas
When selecting Elecsys, it communicates with HOST by Elecsys type.
When selecting cobas, it communicates with HOST by cobas type.
RS232C setting
Speed 19200/9600/4800 Select speed.
Frame
7 bit, EVEN, 2 stop bit/
7 bit, ODD, 2 stop bit/
7 bit, EVEN, 1 stop bit/
7 bit, ODD, 1 stop bit/
8 bit, NONE, 2 stop bit/
8 bit, NONE, 1 stop bit/
8 bit, EVEN, 1 stop bit/
8 bit, ODD, 1 stop bit
Select frame.
Automatic result upload
Yes/No
When YES is selected, result data of a sample is sent to HOST in
real time as soon as all such data are collected.
Communication trace
Yes/No
When YES is selected, communication detail with HOST is traced in
the cobas e 411 analyzer.
STAT Sample Result Upload setting
By Sample When all results are generated, these results are sent to the host.
By Test As soon as one test result is available it is sent to the host.
cobas type setting When Protocol Type is cobas, parameters are as follows.
Automatic recovery of session
Yes/No
This is an automatic reconnection function in case of
communication is disconnected, (HOST Communication Off) under
error described ASTM1381-91 has occurred. When Yes is selected,
the erroneous message and a message sent from HOST before the
reconnection process completed are rejected.
QC additional information
Control name/Lot No.
When ControlName is selected, name of control is sent as sample
ID. When LotNo. is selected the Control Name and the Lot number
is sent to the host, Lot No. is sent as sample ID.
Send result only mode
Yes/No
Only result data is sent. Inquiry for order is not conducted. This
function is not applied to Batch transfer.
Host test code
Host test code setting
Test code between cobas e 411 analyzer and Host defined in Host
Test Code Setting in Utility/Host Communication Setting/Host Test
Code. All used test codes must be entered.
Hint: Also new test application has to be entered.
Table 3:Transfer parameters list

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Communication cable
Connect RS-232C communication cable to the connector at the left side of
cobas e 411 analyzer. The connector is D-SUB9.
Figure 6:Connector and communication cable
Figure 7: Connection diagram

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Communication text
4. Communication text .................................................................................................................................. 16

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Communication text
The table below shows the communication text of the cobas e 411 analyzer.
Item Direction Elecsys type
Real time
Batch
cobas type
Real time
Batch
Inquiry for order Upload
e 411 > HOST
Yes No Yes No
Order for test request Download
HOST > e 411
Yes Yes Yes Yes
Result report
Upload
e 411 > HOST Yes Yes Yes Yes
Inquiry of result Download
HOST > e 411
No No No No
(yes: equipped, No: not equipped)
Table 4:List of communication text
Note Patient sample and quality control sample are sent as result data, but not calibration result.
The cobas e 411 analyzer is not equipped with an auto-rerun function. Rerun sample can be
manually defined.
There is no Inquiry for order of a control sample.
Causes of Communication text are shown in the table below.
Text Real/Batch Cause
Inquiry for the requested tests
(upload)
Real
After sample ID is read, inquire of HOST for test selection
information of patient sample to which test selection information is
not registered.
Wait replay from HOST for test selection information for a certain
length of time after the inquiry. If not replied even after a certain
length of time, cancel the inquiry.
Order for test request
(download)
Real
Specify the test selection information for a sample when the test
selection information is inquired.
Batch
HOST specifies the test selection information of a patient sample at
a given timing. Register test selection information before reading
sample ID to use this function.
Result report (upload)
Real
Send result data of patient sample and quality control sample when
all test data of each sample is collected.
Batch
Send result data of patient sample and quality control sample
specified on DataReview window.
Table 5: Causes of communication text

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ASTM communication protocol
5. ASTM communication protocol ................................................................................................................ 18
6. Frame structure........................................................................................................................................... 19
7. Definition of communication protocol ....................................................................................................... 21

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ASTM communication protocol
The cobas e 411 analyzer employs ASTM communication protocol.
Communication data structure
ASTM communication protocol consists of three layered data structure such as
message, record, and frame. Data is communicated by message. Further, data is
communicated by frame actually. Data structure of a frame varies by protocol.
(1) Elecsys type A message consists of multiple records. A record consists of one or more
frames. A frame comprises not more than one record. In case a record exceeds
240 bytes, a frame is divided into middle frames and a last frame. [ETB] is used
for the middle frame and [ETX] is used for the last frame.
(2) cobas type A message consists of several records. A record consists of one or more frames.
A frame may comprise multiple records. In case of a record exceeds 240 bytes,
a frame is divided into middle frames and a last frame. [ETB] is used for the
middle frame and [ETX] is used for the last frame.

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Frame structure
Frame structure is shown below.
Middle frame, when a message is divided into more than one frame.
[STX] FN text [ETB] CS1 CS2 [CR] [LF]
When the last frame in a message or a frame is a single frame.
[STX] FN text [ETX] CS1 CS2 [CR] [LF]
Field ASCII Code Content Character Note
[STX] 0x02 Start of text 1byte
FN Frame N 1byte 1
Text Communication data Max. 240 byte 2
[ETX]/[ETB] 0x03/0x17 End of text/end of communication block 1byte 3
CS1 Check sum 1byte 4
CS2 1byte
[CR] 0x0d Carriage return 1byte
[LF] 0x0a Line feed 1byte
Table 6: Frame structure
Note 1: Way to assign frame No. (FN) is starting from No. 1 to No. 7. When exceeding
No. 7, start from No. 0 to No. 7.
2: Codes, except the following ASCII code, are available for text.
Code Code Code Code Code
[SOH]0x01 [STX]0x02 [ETX]0x03 [EOT]0x04 [ENQ]0x05
[ACK]0x06 [ACK]0x06 [ACK]0x06 [ACK]0x06 [ACK]0x06
[DC3]0x13 [DC4]0x14 [NAK]0x15 [SYN]0x16 [ETB]0x17
3: When a message is 240 bytes or less, use [ETX]. When exceeding 240 bytes, use
[ETB].
4: Add each character code between and inclusive frame No.(FN) and [ETB] or
[ETX]. Display the sum in hexadecimal format. Convert the last two digits into
ASCII code. Code used for Check Sum is 0to 9and Ato F.

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Example: Check sum calculation method
[STX] 1 T e s t [ETX]
Field Character Hex. format Sum
[STX] [STX] 02h 02h
FN 1 31h 31h
text T 54h 54h
e 65h 65h
s 73h 73h
t 74h 74h
[ETX] [ETX] 03h 03h
Last two digits of the sum. D4h
CS1 D 44h
CS2 4 34h
[CR] 0Dh
[LF] 0Ah
[STX] 1 T e s t [ETX] D 4 [CR] [LF]