Roche c 311 Interface Manual

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cobas c 311 analyzer

Host Interface Manual

New Mode

Roche/Hitachi cobas c 311 analyzer

Revision history

Version Control			Publication		Date		Pages Affected
			Reference No.
			Draft Version	2007/09/14		All
0.1							Based on the “cobas e411
							HostCommunication_Version
							_1.0.doc”and “HOST-
							MAN_V01_c311_3c.DOC”.

Version 1.0	2007/10/22
Version 1.1	2008/02/25	Revised.
Version 1.2	2008/06/10	Revised.
Version 1.3	2011/05/24 (B-4) Function addition of
		Host Communication setting.
		(B-6) Change by function
		addition of Host
		Communication setting.
		(E-22) Change of result data
		flags.

Edition notice Roche Diagnostics makes no representations or warranties with respect to the contents of this document and specifically disclaims any implied warranties, including the implied warranties of merchantability and fitness for a particular purpose. In no case shall Roche Diagnostics be liable for incidental or consequential damages.

The contents of this manual, including all graphics and photographs, are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or editorial errors or omissions contained herein. 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 Diagnostics.

Copyright © 2007, Roche Diagnostics GmbH. All rights reserved.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, and LIFE NEEDS ANSWERS are

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Roche/Hitachi cobas c 311 analyzer

trademarks of Roche.

All other trademarks are the property of their respective owners.

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Roche/Hitachi cobas c 311 analyzer

Table of contents

Revision history		2
Table of contents		3
Overview	Part
		A
Specification of interface	Part
		B
Specification of communication		B-2
Host communication setting		B-3
Communication cable		B-9
Communication text	Part
		C
Communication text		C-2
ASTM communication protocol	Part
		D
Communication data structure		D-2
Frame structure		D-3
Definition of communication protocol		D-4
Record structure	Part
		E
Syntax		E-2
Message header record		E-7
Message termination record		E-8
Request information record		E-9
Patient information record		E-11
Test order record		E-12
Comment record, that follows the order record (used for Patient demographic data)		E-14
Result record		E-15
Comment record, that follows the result record (result data flag)		E-17
Photometric calibration result record		E-18
ISE calibration result record		E-20
Photometric absorbance data record		E-21
List of result data flags		E-22
Communication trace	Part
		F
Test selection information in real time		F-2
Real time test results		F-3
Batch test selection information		F-4
Appendix	Part
		G
Instrument alarms		G-2
ASCII Table		G-9

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Overview A

Roche/Hitachi cobas c 311 analyzer

Overview

This document describes communication procedure related to communication method that enables intercommunication between Laboratory Host System, hereinafter referred to as

HOST, and cobas c 311 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

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Specification of interface B

1	Specification of communication ..........................................	B-2
2	Host communication setting................................................	B-3
3	Communication cable..........................................................	B-9

Roche/Hitachi cobas c 311 analyzer	Specification of interface
	Specification of Communication

Specification of Interface

Communication between cobas c 311 analyzer and HOST is based on RS-232C connection.

Specification of Communication

Specification of serial interface is shown as follows:

Table B-1 Specification of Serial Interface

Item	Specification	Recommendation	Note
Communication Protocol	ASTM	-
Communication Speed	19200bps/9600bps/4800bps	9600bps	Selectable from GUI
Character Configurations	See Table B-2.	8bit,NONE,1Stopbit	Selectable from GUI
Protocol Type	cobas type	cobas type	Selectable from GUI
Frame Length	247 bytes	-
Communication Port	1 port	-
Cable Length	15m	-
Communication method	Half duplex

Character Configuration is selected from Table B-2.

Table B-2 Character Configuration

No.	Data bit	Parity bit	Stop bit
1	7bit	EVEN	2Stopbit
2	7bit	ODD	2Stopbit
3	7bit	EVEN	1Stopbit
4	7bit	ODD	1Stopbit
5	8bit	NONE	2Stopbit
6	8bit	NONE	1Stopbit
7	8bit	EVEN	1Stopbit
8	8bit	ODD	1Stopbit

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Roche/Hitachi cobas c 311 analyzer	Specification of interface
	Host Communication Setting

Host Communication Setting

Select “Yes/No” at “Host Communication” on Start Conditions screen.

Select condition of HOST communication on [Utility]-

[System]-[Host Communication Setting] window. The setting is only changeable when “Host Communication” is off.

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Roche/Hitachi cobas c 311 analyzer	Specification of interface
	Host Communication Setting

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Roche/Hitachi cobas c 311 analyzer	Specification of interface
	Host Communication Setting

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Roche/Hitachi cobas c 311 analyzer	Specification of interface
	Host Communication Setting

Transfer parameters are shown in Table B-3.

Table B-3 Transfer Parameters List

		Parameter	Option
Communication Setting
	RS232C Setting
		Speed	19200/9600/4800	Select speed.
		Parity	7bit, EVEN,2Stopbit/	Select Parity.
			7bit, ODD,2Stopbit/
			7bit, EVEN,1Stopbit/
			7bit, ODD,1Stopbit/
			8bit, NONE,2Stopbit/
			8bit, NONE,1Stopbit/
			8bit, EVEN,1Stopbit/
			8bit, ODD,1Stopbit
		Automatic Recovery of Session	check box On/Off	If this function is enabled, the analyzer restarts the
				communication session if an error occurs. When this happens,
				the current communication message is lost.
				During the initial setup of the host, it is recommended that this
				function not be enabled so errors can be detected. After the
				host interface has been successfully established, this function
				can be enabled, and can help resolve occasional interface
				errors without requiring operator intervention.
	Communication Trace		check box On/Off	This function applies to all host communications. When this
				function is enabled, the content of the communication with the
				host can be stored at the analyzer. The Communication Trace
				report can be printed from the global Print screen. This report
				can be used as an analysis tool if a problem occurs.
				Note: Due to the trace file size, it is recommended that the
				Communication Trace report not be routinely used. When
				enabled for troubleshooting purposes, it is recommended that
				the print buffer be printed prior to printing this report, as the
				size of it might overwrite other buffered printouts.
				How to store a host communication trace file
				It is possible to get a host communication trace by the following
				procedure.
				Touch the Print button.
				Select Utility tab.
				Select the Communication Trace in the list box.
				Select the radio button „Print“
				Press View
				Press "Floppy Disk Write"
				Enter Filename for Tracefile
				Select Page Range
				Insert Floppy Disk to store the trace
				Touch OK button.

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Roche/Hitachi cobas c 311 analyzer						Specification of interface
						Host Communication Setting
				Parameter	Option
		Ignore host orders for samples			check box On/Off	If this funciton is enable, when orders are sent from Host,
		with already existing 1st results				orders for tests with already existing 1st run results are ignored
						and not measured again.
						Additional orders are detected and processed and Automatic
						rerun triggered by system instrument is possible.
						Rerun and 3rd result orders from host are not possible.
						If this function is disable, all orders are detected and measured
						even if not necessary.
						Note: For example, during S.B.S. mode, the inquiry of orders
						to Host is performed repeatedly.When this function is
						enable, orders sent from Host which have 1st result are not
						measured.
		System				Name used on reports and in communications for the
						cobas c 311 analyzer.
		Host				Name used on reports and in communications for the host
						system.
		System ID				The ID number used to identify the system in communications
						with the host.
		Host ID				The ID number used to identify the host in communications
						with the analyzer.
	Text Setting
		Result Only			check box On/Off	This function applies to all Realtime Communications. This
						does not apply to the Batch Mode. When this function is
						enabled, communication during analysis is limited only to the
						analytical data transmissions. Inquiries for the Test Selection
						Information or Auto Rerun Selection Information are not made.
						Test selections would need to be made either manually by the
						operator at the analyzer, by Batch Mode from the host, or by
						use of the Default Profile.
			TS Timeout		check box On/Off	This function allows the operator to set a timeout interval for
					and input 10-9999	Test Selection Information Inquiry for Realtime
						Communications and for routine, Stat and rerun samples. The
						specified timeout interval determines how long the analyzer will
						wait for a ‘Response from the host’. The range is 10-9999
						seconds (depending on TS Priority Mode), with a default of 18
						seconds. Enabling this function optimizes the throughput of the
						system. If the function is not enabled, the analyzer will wait
						indefinitely for Test Selection Information.
			Auto Rerun TS		check box On/Off	This function applies to Auto Rerun TS inquiry within the
						Realtime Communications if the upload setting is not “by
						sample. When this function is enabled in the Auto Rerun mode
						during analysis, an inquiry is made for the Auto Rerun
						selections. When this function is not enabled, no inquiry for the
						Auto Rerun Selection is made.
				Auto Rerun TS Timeout	check box On/Off	This function applies to the reception of Auto Rerun Test
					and input 10-9999	Selection Information in Realtime Communications. The range
						is 10-9999 seconds, with a default of 18 seconds (depending
						on TS Priority Mode). If the function is not enabled, the
						analyzer waits indefinitely for Rerun Test Selection
						Information.
				Manual Rerun T S	check box On/Off	This function applies to the Test Selection Information inquiry
						for Manual Rerun samples in Realtime Communication. When
						this function is enabled, an inquiry is made for the test
						selections for rerun samples during analysis. Any samples that
						have previously been processed create a TS inquiry to the
						host. When this function is not enabled, no TS inquiry for
						Manual Rerun samples is made.
			Stat TS		check box On/Off	This function applies to the Test Selection Information inquiry
						for Stat samples in Realtime Communications. When this
						function is enabled, an inquiry is made for the test selections
						for Stat samples during analysis. When this function is not
						enabled, no TS inquiry for Stat samples is made.

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Roche/Hitachi cobas c 311 analyzer					Specification of interface
					Host Communication Setting
			Parameter	Option
			TS Inquire Always	check box On/Off	This function applies to the Test Selection Information inquiry
					for routine and Stat samples in Realtime Communications.
					This does not apply to TS information inquiry for rerun
					samples, Auto Rerun and Manual Rerun. When this function is
					enabled, an inquiry is made whether the TS information is in
					the analyzer or not. When not enabled, an inquiry is made only
					for the samples that do not have test selections.
			TS Ask in Barcode Read	check box On/Off	If this function is enabled, and the analyzer cannot read a
			Error		sample barcode, “***...” [13 or 22 characters of ‘*’] is sent as
					the sample ID, and the rack ID and position are sent to the
					host as key information to identify the sample. If the host has
					the table of the rack ID, position and Sample ID, the host can
					send back to the analyzer the correct Sample ID instead of
					‘***...’
					Note
					Because Host protocol and text field is same as cobas6000,
					Rack ID field is used in cobas c 311 analyzer communication
					text.
					The only currently known use for this function is with a Sample
					Handling System that ‘manufactures’ sample aliquots for the
					analyzer. This type of system would track samples by position
					on S.Disk. Unless the Sample Handling System can perform
					this function, it is strongly recommended that it not be used
					This function is not visible, if the Sample Barcode Reader is
					switched off.
			TS Priority Mode	check box On/Off	If this function is enabled, after a Test Selection inquiry the
					analyzer will stop sending any information, i.e. result data, until
					the analyzer receives the answer to the inquiry from the host or
					the TS timeout period passes. This option applies to both the
					inquiry at the bar code reader and the implied inquiry after
					Result upload in “By Sample” setting.
					The range of the TS Timeout and Auto Rerun TS Timeout is
					from 1 to 18 seconds with this mode on. With this mode off the
					TS Timeout options remain at 10 to 9999 seconds. If this mode
					is enabled and the TS Timeout checkbox is off, TS timeout is
					handled as 18 seconds.
		Sample ID 22 Digits		check box On/Off	The maximum length of the sample ID is increased from 13 to
					max. 22 characters.
		New Mode		check box On/Off	The host interface protocol description in this manual is based
					on this 'New Mode' setting enabled.
					If disabled the protocol is identical with the protocol of the CC
					Modular software for purpose of 100% compatibility with
					already connected Analyzer systems.
					Concerning detail of the CC Modular host interface
					specification refer to
					Roche/Hitachi MODULAR System Host Interface Document
					Version 1.0 Ident. No. 011632701 (US ID)
			Send 1st/Rerun Information	check box On/Off	With this mode enabled, additional information that shows
					whether a query is 1st or rerun measurement is added to
					Request Information Record. This mode is applied to only
					“Inquiry for the Requested Tests” message from the
					analyzer to the host, but not applied to “Inquiry of Result”
					from the host to the analyzer.
					If the function is not enabled, no information is added to
					Request Information Record.
		Send Comments		check box On/Off	This function applies to host communications. When this
					function is enabled, the host can send patient comments to the
					analyzer. Patient comments stored in the analyzer can also be
					transmitted to the host along with analytical data and Reaction
					Monitor data. When this function is not enabled, no patient
					comments are accepted or sent.
		Send Concentration Of		. check box On/Off	This function is available for Result transfer and Reaction
		Chemistry Qualitative Test			Monitor transfer.
					When this function is selected, measurement results are also
					send to Host with Qualitative result in photometric test result
					record.

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Roche/Hitachi cobas c 311 analyzer					Specification of interface
					Communication Cable
			Parameter	Option
		Send Time stamp of pipetting of		check box On/Off	When this function is enabled, pipetting date and time for each
		Sample
					test result is sent to the host.
		Chemistry Test Calibration		check box On/Off	When this function is enabled, the detail information (reagent
		Results Detail			lot number, reagent bottle sequence number, expired flag,
					calibrator lot number and pipetting date and time)
					corresponding to the calibration result is sent to the host.
		Control Results Mode		check box On/Off	With this mode enabled, the control results are sent test
		Incremental			oriented; i.e. as soon as one test result is available it is sent to
					the host.
		QC Additional Information		Control Name/Lot No	With this function it is possible to select if ‘Control Name’ or
					‘Lot Number’ shall be sent in field 3 of the Test Order record
					within a control result message.
		Host Test Code			Use the Host Test Code Setting window to edit the test code
					sent to the host
			Host Code	input 1-99999	Use this text box to edit the host code for the test selected in
					the Test list. After editing the code, touch Update to save the
					change.
			Update		Changes are saved and the updated contents of the list are
					displayed.
		Result	Upload Setting
		Routine Sample Result upload		By Sample	With this function it is possible to select how the routine sample
		setting		ISE / Chemistry	results are uploaded to the host in real time. When [By
					Sample] is selected, all results of routine sample are uploaded
					by round.
					When [ISE / Chemistry] is selected, ISE results and Chemistry
					results of routine sample are uploaded separately. And to
					indicate the last result upload an automatic Query is sent to the
					host and to indicate the last result upload an automatic Query
					is sent to the host.
		STAT Sample Result upload		By Sample	With this function it is possible to select how the stat sample
		setting		ISE / Chemistry	results are uploaded to the host in real time. When [By
				By Test	Sample] is selected, all results of STAT sample are uploaded
					by round.
					When [ISE / Chemistry] is selected, ISE results and Chemistry
					results of Stat sample are uploaded separately. And when [By
					Test] is selected, as soon as one test result is available it is
					sent to the host. In the modes [ISE/Chemistry] and [By Test] an
					automatic Query is sent to the host, to indicate the last result
					upload.
		No Automatic Result Upload		check box On/Off	This function is applied to Realtime communication for routine
					and Stat samples.
					When this function is enabled, no result is uploaded in real
					time. In this case, the results can be uploaded manually by
					selecting samples from the Workplace/Data Review screen.

Communication Cable

Connect RS-232C communication cable to the connector at the cobas c 311 analyzer. The connector is D-SUB9. Fig. B-1 shows connector and communication cable. Fig. B-2 shows connection diagram.

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Roche/Hitachi cobas c 311 analyzer	Specification of interface
	Communication Cable

Connector for

External

Communication

Fig. B-1 Connector

Host Cable for Hitachi Analyzer

Analyzer

Fig. B-2 Connection Diagram

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Communication text C

1 Communication text ............................................................

C-2

Roche/Hitachi cobas c 311 analyzer

Communication Text

Communication Text

Table C-1 shows the communication text of the cobas c 311 analyzer.

Table C-1 List of Communication Text

Text	Direction	cobas type
		Real Time		Batch
Inquiry for Order	Upload	Yes		No
	cobas c 311->HOST
Order for Test Request	Download	Yes		Yes
	HOST-> cobas c 311
Result Report	Upload	Yes		Yes
	cobas c 311 ->HOST
Inquiry of Result	Download	No		Yes
	HOST-> cobas c 311
	(Yes:	equipped, No:	not equipped)

Note: Patient sample and quality control sample and calibration result are sent as result data.

Note: There is no Inquiry for Order of a control sample and

Calibration.

Table C-2 shows Causes of Communication Text.

Table C-2 Causes of Communication Text

Text	Real/Batch	Cause

	Inquiry for the
	Requested Tests	Real
	(Upload)
		Real
	Order for Test Request
	(Download)	Batch
	Result Report	Real
	(Upload)
		Batch

Inquiry for result

Batch

-After sample ID is read, inquire of HOST for test selection information of patient sample to which test selection information is not registered.

-Wait for reply 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.

-Specify the test selection information for a sample when the test selection information is inquired.

-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.

-Send result data of patient sample and quality control sample when test data of the sample is collected.

-Send result data of patient sample and quality control sample specified on [Data Review] window.

-Send result data of patient sample requested by Host. It is not possible to select result from Host if 1st and rerun result exists, because the selection is done at the Analyzer on Test Review screen. (Workplace / Data Review / Test Review-Test result list).

The result is selected by the rules below from (1) to (3).

(1)There is a result.

(2)The result does not have alarm, which is listed on Review by Exception screen.

(3)Result is selected if 1st and rerun result is existed in Data Review screen or the only one result exists for a test.

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ASTM communication protocol D

1	Communication data structure ............................................	D-2
2	Frame structure...................................................................	D-3
3	Definition of communication protocol ..................................	D-4