Roche c 311 Interface Manual

cobas c 311 analyzer

r

Host Interface Manual

New Mode

Roche/Hitachi cobas c 311 analyzer

Revision history

Version Control

Publication Reference No.

Draft Version

Date Pages Affected

2007/09/14 All

0.1 Based on the “cobas e411

HostCommunication_Version _1.0.doc”and “HOSTMAN_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

Trademarks

The following trademarks are acknowledged: COBAS, COBAS C, and LIFE NEEDS ANSWERS are

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 2

Roche/Hitachi cobas c 311 analyzer

trademarks of Roche. All other trademarks are the property of their respective

owners.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 3

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

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

D

Roche Diagnostics May 2011 Host Interface Manual – Version 1.3 4

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

Roche Diagnostics May 2011 Host Interface Manual – Version 1.3 A-2

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 Frame Length 247 bytes - Communication Port 1 port - Cable Length 15m - Communication method Half duplex

cobas type cobas type

Character Configuration is selected from Table B-2.

Selectable from GUI

T able B-2 Charac ter 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

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 B-2

Roche/Hitachi cobas c 311 analyzer Specification of interface

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.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 B-3

Roche/Hitachi cobas c 311 analyzer Specification of interface

Host Communication Setting

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 B-4

Roche/Hitachi cobas c 311 analyzer Specification of interface

Host Communication Setting

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 B-5

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

Communication Setting

RS232C Setting

Automatic Recovery of Session check box On/Off

Communication Trace check box On/Off This function applies to all host communications. When this

Parameter Option

Speed 19200/9600/4800 Select speed. Parity

7bit, EVEN,2Stopbit/ 7bit, ODD,2Stopbit/ 7bit, EVEN,1Stopbit/ 7bit, ODD,1Stopbit/ 8bit, NONE,2Stopbit/ 8bit, NONE,1Stopbit/ 8bit, EVEN,1Stopbit/ 8bit, ODD,1Stopbit

Select Parity.

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.

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.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 B-6

Roche/Hitachi cobas c 311 analyzer Specification of interface

Host Communication Setting

Ignore host orders for samples with already existing 1st results

System

Host

System ID

Host ID

Text Setting

Result Only check box On/Off This function applies to all Realtime Communications. This

Parameter Option

TS Timeout check box On/Off

Auto Rerun TS check box On/Off This function applies to Auto Rerun TS inquiry within the

Auto Rerun TS Timeout check box On/Off

Manual Rerun T S check box On/Off This function applies to the Test Selection Information inquiry

Stat TS check box On/Off This function applies to the Test Selection Information inquiry

check box On/Off If this funciton is enable, when orders are sent from Host,

and input 10-9999

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.

Name used on reports and in communications for the cobas c 311 analyzer.

Name used on reports and in communications for the host system.

The ID number used to identify the system in communications with the host.

The ID number used to identify the host in communications with the analyzer.

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. This function allows the operator to set a timeout interval for 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.

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. This function applies to the reception of Auto Rerun Test 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.

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.

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.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 B-7

Roche/Hitachi cobas c 311 analyzer Specification of interface

Host Communication Setting

TS Inquire Always check box On/Off This function applies to the Test Selection Information inquiry

TS Ask in Barcode Read

TS Priority Mode check box On/Off

Sample ID 22 Digits check box On/Off

New Mode check box On/Off The host interface protocol description in this manual is based

Send 1st/Rerun Information check box On/Off With this mode enabled, additional information that shows

Send Comments check box On/Off This function applies to host communications. When this

Send Concentration Of Chemistry Qualitative Test

Parameter Option

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

Error

check box On/Off If this function is enabled, and the analyzer cannot read a

. check box On/Off This function is available for Result transfer and Reaction

for the samples that do not have test selections. 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.

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.

The maximum length of the sample ID is increased from 13 to max. 22 characters.

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)

st

whether a query is 1 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.

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.

Monitor transfer. When this function is selected, measurement results are also send to Host with Qualitative result in photometric test result record.

or rerun measurement is added to

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 B-8

Roche/Hitachi cobas c 311 analyzer Specification of interface

Communication Cable

Send Time stamp of pipetting of Sample

Chemistry Test Calibration Results Detail

Control Results Mode Incremental

QC Additional Information Control Name/Lot No

Host Test Code

Result Upload Setting

Routine Sample Result upload setting

STAT Sample Result upload setting

No Automatic Result Upload check box On/Off

Parameter Option

check box On/Off

check box On/Off When this function is enabled, the detail information (reagent

check box On/Off

Host Code input 1-99999

Update

By Sample ISE / Chemistry

By Sample ISE / Chemistry By Test

When this function is enabled, pipetting date and time for each test result is sent to the host.

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. With this mode enabled, the control results are sent test oriented; i.e. as soon as one test result is available it is sent to the host.

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.

Use the Host Test Code Setting window to edit the test code sent to the host

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.

Changes are saved and the updated contents of the list are displayed.

With this function it is possible to select how the routine sample 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. 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. With this function it is possible to select how the stat sample results are uploaded to the host in real time. When [By 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.

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.

And to

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.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 B-9

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

Roche Diagnostics May 2011 Host Interface Manual – Version 1.3 B-10

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

Inquiry for Order Order for Test Request Result Report Inquiry of Result

Real Time Batch

Upload

cobas c 311->HOST

Download

HOST-> cobas c 311

Upload

cobas c 311 ->HOST

Download

HOST-> cobas c 311

(Yes: equipped, No: not equipped) Note: Patient sample and quality control sample and

calibration result are sent as result data.

cobas type

Yes No Yes Yes Yes Yes

No Yes

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

- After sample ID is read, inquire of HOST for test selection information of Inquiry for the Requested Tests (Upload)

Order for Test Request (Download)

Result Report (Upload)

Real

Batch

Real

Batch

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).

Inquiry for result Batch

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 C-2

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.

ASTM communication protocol

D

1 Communication data structure............................................D-2

2 Frame structure...................................................................D-3

3 Definition of communication protocol..................................D-4

Roche/Hitachi cobas c 311 analyzer ASTM communication protocol

[

]

[

]

A

[

Communication data structure

ASTM Communication Protocol

cobas c 311 analyzer employs ASTM communication

protocol.

Communication data structure

ASTM communication protocol consists of three layered data structure such as message, record, and frame. In the application layer, data is communicated by message. Further, data is communicated by frame actually in the data link layer. Data structure of a frame varies by protocol.

A message consists of several records. A record consists of one or more frames. If a message 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.

Creating Message

nalyzing Message

Message]

Application Layer Data Link Layer Presentation Layer

Record

Frame

Communication

[ETB]

ETB]

[ETB]

ETX]

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 D-2

Roche/Hitachi cobas c 311 analyzer ASTM communication protocol

Frame Structure

Frame structure is shown below.

- Middle frame when a frame is divided into more than one.

[STX] FN text

[ETB]

- When the last frame or a frame is single frame.

[STX] FN text

[ETX]

Field ASCII Code Content character Note

[STX] 0x02 Start of Text 1byte FN - Frame No. 1byte 1 text - Communication data Max240byte 2 [ETX]/[ETB] 0x03/0x17 End of Text/ End of Communication Block 1byte 3 CS1 - 1byte CS2 [CR] 0x0d Carriage Return 1byte [LF] 0x0a Line Feed 1byte

Check Sum

*Note1: 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. *Note2: Codes except the following ASCII code are available for text.

CS1 CS2 [CR] [LF]

1byte

4

Code Code Code Code Code [SOH]0x01 [STX]0x02 [ETX]0x03 [EOT]0x04 [ENQ]0x05 [ACK]0x06 [LF]0x0A [DLE]0x10 [DC1]0x11 [DC2]0x12 [DC3]0x13 [DC4]0x14 [NAK]0x15 [SYN]0x16 [ETB]0x17

*Note3: When a frame is 240 bytes or less, use [ETX]. When exceeding 240 bytes, use [ETB]. *Note4: Add each character code which frame No. is (FN) to [ETB] or [ETX]. Display the sum in hexadecimal format. Convert the last two digits into ASCII code. Code used for Check Sum is ’0’ to ’9’ and ’A’ to ’F.’

Ex. Check Sum Calculation Method

[STX] ‘1’ ‘T’ ‘e’ ‘s’ ‘t’ [ETX]

Field Character Hex.

format

[STX] [STX] 02h FN ‘1’ 31h 31h text

[ETX] [ETX] 03h CS1

CS2 [CR] 0Dh [LF] 0Ah

[STX] ‘1’ ‘T’ ‘e’ ‘s’ ‘t’ [ETX]

‘T’ 54h 85h ‘e’ 65h EAh ‘s’ 73h 15Dh ‘t’ 74h 1D1h

1D4

h

Last two digits of the sum. D4h

‘D’ 44h ‘4’ 34h

Sum

‘D’ ‘4’

[CR] [LF]

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 D-3

Roche/Hitachi cobas c 311 analyzer ASTM communication protocol

Definition of Communication Protocol

Low-Level Protocol of ASTM communication protocol is oneway. Response is generated after the information is sent. Response is not generated simultaneously with communication. Unlike the other communication protocols, it does not have master-slave relation. Both cobas c 311 analyzer and HOST enable to initialize the communication. When establishing send system and receive system, or when having the action of both the sender and the receiver arranged properly, the information is communicated by the following three phases.

- Establish phase

- Transfer phase

- Termination phase

Establish phase

In Data/Link layer, both sender and receiver go into one the following status.

- Idle state: status waiting for becoming receiver.

- Starting Establish phase at the transmitting side, transmitting record information by frame, and completing by Termination phase.

- Receiving receiver’s frame, and sending [ACK].

Number of sender or receiver is one at a time. Both sender and receiver enable to be in idle status. When the presentation layer requires the data link layer to send record, one need to change its status from idle to sender. To have one been sender and the other been waited, or receiver, the sender needs to start Establish phase. Therefore inform that the other changed its status from idle to receiver by sending ASCII code 05h[ENQ] from the sender and sending ASCII code 06h[ACK] from the receiver. Transfer phase starts when Establish phase is completed by receiving [ACK]. Reception other than [ENQ] is ignored in idle status. Reception of [ENQ] is replied by [ACK] and receiver is turned to receiving status.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 D-4

Roche/Hitachi cobas c 311 analyzer ASTM communication protocol

ACK

Definition of Communication Protocol

Sender

Receiver

ENQ

Retry

10sec

Establish phase Transfer phase

Retry Retry

1sec 15sec

ENQ

ENQ ENQ ENQ

XXX

ENQ

(1) (2)

Fig D-1 Establish phase

Normal procedure of Establish phase is mentioned above. In case of error, there are additionally three options for the receiver to respond [ENQ].

(1) Receiver sends characters other than [ACK]. These characters are normally sent by using ASCII code

15hex [NAK] when the receiver is busy. The sender waits for a certain length of time, e.g., cobas c 311 analyzer waits for 10 seconds, and tries to establish with the other [ENQ]. The cobas c 311 analyzer repeats this cycle until the number of retries after error reaches six.

(3)

(2) Sender sends [ENQ]. The status in which both sender and receiver are trying to

change their status to the sender is called “Link contention” in ASTM. When in link contention, it is defined that communication information of cobas c 311 analyzer has a priority. So that HOST has to stop sending [ENQ] and has to respond simultaneously by [ACK] or [NAK] when the link contention is detected. On the other hand, the cobas c 311 analyzer waits for more than 1 second and replies [ENQ]. The sender repeats this cycle until receiving characters such as [ACK] or [NAK].

(3) No response from receiver. The sender starts Termination phase by sending ASCII code

04hex [EOT] after waiting for 15 seconds, and displays an error message.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 D-5

Roche/Hitachi cobas c 311 analyzer ASTM communication protocol

Definition of Communication Protocol

Transfer phase

After receiving frame, sender discontinues communication until receiving the response or occurrence of time-out. Usually the receiver notifies by sending [ACK] that it successfully received the last frame and completes its preparations to receive the next frame. The receiver notifies by sending [NAK] that the last frame was not received and it is waiting for receiving the frame. According to the above, there are three options for HOST to respond the communication of the frame.

- HOST sends [ACK] or [EOT].

cobas c 311 analyzer sends the next record. cobas c 311 analyzer has data that is to be communicated. cobas c 311 analyzer continues to send records. (It is started with Establish phase.)

- HOST sends characters other than [ACK] or [EOT].

cobas c 311 analyzer repeatedly sends record. This cycle is repeated until “number of retry in case of error” reaches six. At this moment, cobas c 311 analyzer starts Termination phase and displays an error message by sending [EOT].

- No response from HOST

cobas c 311 analyzer starts Termination phase by sending [EOT] after 15 seconds and displays an error message.

Response depends on how HOST responds to frame communication from cobas c 311 analyzer. When cobas c 311 analyzer is in the receiving status and is waiting communication from HOST, there are the following three scenarios.

- HOST sends frame characters.

After the complete frame is received, the frame No. and the checksum are checked if they are correct. When the frame is correct, cobas c 311 analyzer responds by [ACK]. When the frame is incorrect, the incorrect frame is rejected and [NAK] is returned.

- HOST does not complete frame communication.

Time-out occurs when receiving unfinished frame and at the same time [EOT] is not received after 15 seconds counted from the last communication of [ACK] or [NAK] from cobas c 311 analyzer. cobas c 311 analyzer is turned into idle status

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 D-6

Roche/Hitachi cobas c 311 analyzer ASTM communication protocol

Definition of Communication Protocol

by deleting the last incomplete message. The line is deemed to be neutral status.

- HOST sends [EOT].

The cobas c 311 analyzer is turned into idle status. Only completely received frame is deemed to be effective.

Termination Phase

Both sender and receiver change their status into idle in Termination phase. This phase only starts when the sender sends [EOT]. Response from the receiver to this message is none. When [EOT] is detected at the receiver, it is turned to be idle and the line is required to be changed to neutral.

Roche Diagnostics May 2011 Host Interface Manual – Version 1.3 D-7

Record structure

E

1 Syntax................................................................................. E-2

2 Message header record......................................................E-7

3 Message termination record ...............................................E-8

4 Request information record.................................................E-9

5 Patient information record.................................................E-11

6 Test order record...............................................................E-12

7 Comment record

, that follows the order record (used for

patient demographic data) ...............................................E-14

8 Result record.....................................................................E-15

9 Comment record, that follows the result record (result data

flag) .................................................................................. E-17

10 Photometric calibration result record ................................ E-18

11 ISE calibration result record.............................................. E-20

12 Photometric absorbance data record................................ E-21

13 List of result data flags...................................................... E-22

Roche/Hitachi cobas c 311 analyzer Record structure

Syntax

Record Structure

Syntax

Syntax used in message (records) communicated by cobas c 311 analyzer is shown below.

Table E-1 Message Syntax

Communication Text Real/Batch

Inquiry for the Requested Tests (Upload)

Order for Test Request (Download)

H

Real

Q

L

Real TSDWN^REPLY

H

P

O

Batch

C-CMM

L

Message Syntax

cobas Type

Comment or Special Instructions

TSREQ^REAL

TSDWN^BATCH

Real

Result Report (Upload)

Batch

Inquiry of Result Real

Photometry Calibration Result Report

ISE Calibration Result Report

Real

Photometric Raw Data Report

Batch

H

RSUPL^REAL

P

O C-CMM

RSUPL^REPLY

{ R C-RES } n L

RSUPL^BATCH

H

Q

RSREQ ^REAL

L

H M-PCR L H M-ICR L H P O C-CMM

R

C-RES

M-ABS L

PCUPL^REAL

ICUPL^REAL

ABUPL^BATCH

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-2

Roche/Hitachi cobas c 311 analyzer Record structure

Syntax

Communication sequences (message flow) of communication message by application layer are shown below.

(1) Order for Test Request : real-time

cobas c 311 analyzer [HOST]

Inquiry for the Requested Tests

(TSREQ^REAL)

<-

->

Order for Test Request (TSDWN^REPLY)

(2) Order for Test Request : batch

[cobas c 311 analyzer] [HOST] <-

Order for Test Request (TSDWN^BATCH)

(3) Result Report : real-time

[cobas c 311 analyzer] [HOST] Result Report (RSUPL^REAL) ->

(4) Result Report : batch

[cobas c 311 analyzer] [HOST] Result Report (RSUPL^BATCH) ->

(5) Inquiry of Result : real-time

[cobas c 311 analyzer] [HOST] <- Inquiry of Result (RSREQ^ REAL) Result Report (RSUPL^REAL) ->

(6) Photometric Calibration Result Report : real-time

[cobas c 311 analyzer] [HOST] Photometric Calibration Result

->

Report (RCUPL^REAL)

(7) ISE Calibration Result Report : real-time

[cobas c 311 analyzer] [HOST] ISE Calibration Result Report

(ICUPL^REAL)

->

(8) Photometric Raw Data Report : Batch

[cobas c 311 analyzer] [HOST] Photometric Raw Data Report

(ABUPL^BATCH)

->

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-3

Roche/Hitachi cobas c 311 analyzer Record structure

Syntax

ASTM syntax is shown below. (a) Terminating character of record: Indicates completion of record. ASCII CR character (0Dhex)

is required. (b) Field separator character = vertical bar ‘ | ’: Separates adjacent fields in record. Also separates the first

record ID, the character appeared at the top of record, and the next field. Depending on the second character of message title record, a record appeared at the top of the message, it enables to define the field separator character randomly. However ‘ |’ is recommended.

(c) Repetition field separator character = backslash ‘ \ ’: When fields consist of repetition of the same data, it is called

“repeated field.” Repeated field separator character is a separator between tests of repeated field. Depending on the message title code, it enables to define the repeated field separator character randomly. However ‘ \ ’ is recommended.

(d) Component separator character = caret ‘ ^ ’: When fields consist of multiple components, it is called

“component field.” Component separate or character is a separator between the components. Depending on the message title code, it enables to define the component separator character randomly. However ‘ ^ ’ is recommended.

(e) Escape character = ampersand ‘ & ’: Escape character is defined to represent a separator

character in the field including normal text. Appearance of this character in such field indicates that the following character has special meaning. Depending on the message title code, it enables to define the escape character randomly. However ‘ & ’ is recommended.

(f) Expression of special characters by escape characters: Escape sequence, character string starts and ends with &, is

defined as follows. When these sequences are detected in the field, it is interpreted the corresponding character string.

&F& Field separator character &S& Component separator character &R& Repetition separator character &E& Escape character

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-4

Roche/Hitachi cobas c 311 analyzer Record structure

Syntax

Escape sequences other than the above are skipped and handled as null value.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-5

Roche/Hitachi cobas c 311 analyzer Record structure

Syntax

The table below describes attributes of each field in each record shown in chapter 5.

No Name of Attributes Description

1 Order (No.) Sequence of the field. Sequence of the fiel ds in record. 2 Name of Field (Field) Name of relevant field. 3 Type (Type)

4 Maximum length (Max) Maximum number of effective characters except escape characters in the

Typing characters for the fields are any of the following. ST Character string.

TX Character string group that end is printable. NM Numeric value. ‘+‘ or ‘-‘ is attached at the top. If not, the value is deemed

to be ’+.‘ When without decimal point, the value is deemed to be integer. Prefix attached to ’0,’ and suffix attached to ‘0’ of numeric value with decimal point can be anything.

DT Date. Four digits of dominical year. YYYYMMDD (YYYY: dominic al year,

MM: month, DD: day) Ex. September 5, 1995 is displayed as “19950905.”

TM Set time in 24 hours. HHMMSS (HH: hour, MM: minute, SS: second) TS Time stamp. Display DT and TM together such as

“YYYMMDDHHMMSS.”

CM Field of combined multiple data by component section separator

character.

relevant field.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-6

Roche/Hitachi cobas c 311 analyzer Record structure

Message Header Record

cobas type (Upload, Download)

H|\^&|||cobas c 311^1|||||host|RSUPL^BATCH|P|1[CR]

(1) (2) (3) (4) (5) (6) (7)

Field

No.

(1) 1 Record Type ID ST 1 ‘H’ fixed. (2) 2 Delimiter Definition ST 4 Four characters such as field separator character, repeat separator character, component

3 Message Control ID 4 Access Password

(3) 5 Sender Name or ID CM 36 .

6 Sender Street Address 7 Reserved Field 8 Sender Telephone Number 9 Characteristics of Sender

(4) 10 Receiver ID ST 30 Receiver’s name.

(5) 11 Comment or Special

Instructions

(6) 12 Processing ID ST 1 ‘P’ fixed. (7) 13 Version No. NM 1 ‘1’ fixed.

14 Date and Time of Message

Field Type Max

separator character, and escape character are defined. The first character is defines as a field separator character and Record Type ID separator as well. These four cha racters are ‘|\^&.’

Field does not contain data Field does not contain data

Setting is as follows: <Sender’s device name>^<Communication program version>

<Sender’s device name> Type:TX Max: 30

Any characters within alphanumeric and ‘-.‘

<Communication program version> Type: NM Max: 5

‘1’ fixed.

Field does not contain data Field does not contain data Field does not contain data Field does not contain data

Sending from cobas c 311 analyzer. Sending from HOST: any characters within alphanumeric and ‘-.‘

CM 11 Setting is as follows:

<Meaning of message>^< Mode of message > <Meaning of message> Type: ST Max: 5

‘TSREQ’: TS inquiry. ‘TSDWN’: Test selection download. ‘RSUPL‘: Result report ‘PCUPL‘: Photometry calibration report ‘ICUPL‘: ISE calibration report ‘ABUPL’: Absorbance report ‘RSREQ’: Inquiry for the result

<Mode of message> Type: ST Max: 5

‘REAL’: communication in real time. ‘BATCH’: communication based on request from cobas c 311/HOST. ‘REPLY’: reply to the request.

Field does not contain data

Comments No

cobas Type

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-7

Roche/Hitachi cobas c 311 analyzer Record structure

Message Termination Record

cobas type (Upload, Download)

L|1|N [CR]

(1) (2) (3)

Field

No

No.

(1) 1 Record Type ID ST 1 ‘L’ fixed. (2) 2 Sequence Number NM 1 Indicates sequence No. Normally it is ‘1’ (3) 3 Termination Code ST 1 ‘N’ fixed. (normal end)

Field Type Max

Comments

cobas Type

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-8

Roche/Hitachi cobas c 311 analyzer Record structure

Request Information Record

cobas type (Upload, Download)

Q|1|^^ 000663^32^50002^002^^S1^SC||ALL||||||||O[CR]

(1) (2) (3) (4) (5)

Field

No

No.

(1) 1 Record Type ID ST 1 ‘Q’ fixed. (2) 2 Sequence Number NM 6 Indicates sequence No. Normally it is ‘1’ (3) 3 Starting Range ID

4 Ending Range ID

(4) 5 Universal Test ID ST 3 ‘ALL’ fixed.

6 Nature of Request 7 Beginning Request

8 Ending Request

9 Requesting Physician 10 Requesting Physician 11 User Field No.1

12 User Field No.2

Field Type Max

CM 45 Indicates inquired sample. Setting is as follows:

Number

Time Limits Results Date and

Time Results Date and

Time Name Telephone Number

^^<SampleID>^<SequenceNo>^< Rack ID No >^ <PositionNo>^^<SampleType>^<ContainerType>^

<SampleID> Type: ST Max: 22

indicates Sample No. (Sample ID.)

<SequenceNo> Type: NM Max: 5

indicates cobas c 311 analyzer internal sequence No. The range is 1-60000

< Rack IDNo> Type: ST Max: 5

indicates carrier No. (Disk/Rack.) At the c311 analyzer, Rack ID contains two kinds of information: Type of sample - 2 digits

20: Calibration 30: Control 40: STAT 50: Routine

+ Disk Position - 3 digits

Note

Because Host protocol and text field is same as cobas6000, Rack ID field is used in

cobas c 311 analyzer communication text.

<PositionNo> Type: NM Max: 3 Position range is 001 to 110.

indicates position No. in carrier.

<SampleType> Type: ST Max: 2

indicates sample type.

Position type is identified by S0 ~ S5.

S1: Blood Serum/Plasma S2: Urine S3: CSF S4: Suprnt S5: Others S0: None type sample (for TS inquiry) QC: Control (only for Control Result Inquiries from Host) S0 is used only in Sample ID mode.

.

<ContainerType> Type: ST Max: 7

indicates sample cup type.

‘SC’: test tube or sample cup. ‘MC’ : Microcup

<Kind>

Field does not contain data

Field does not contain data. Field does not contain data.

Field does not contain data.

Field does not contain data. Field does not contain data. Field does not contain data

Field does not contain data

st

R1: For 1

R2: For rerun measurement

This information is sent to the host only when an option of “Send 1st / Rerun Information” is

specified

measurement

Comments

cobas Type

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-9

Roche/Hitachi cobas c 311 analyzer Record structure

Request Information Record

(5) 13 Request Information

Status Codes

ST 1 Indicates the objective of the record. Setting is as follows:

‘O’: Order query (to Host) ‘A’: Cancel the last request (to Host) ‘F’: The final result

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-10

Roche/Hitachi cobas c 311 analyzer Record structure

Patient Information Record

cobas type (Upload, Download)

P|1||||||20070921|M||||||35^Y[CR]

(1) (2) (3) (4) (5)

Field

No

No.

(1) 1 Record Type ID ST 1 ‘P’ fixed. (2) 2 Sequence Number NM 6 Indicates sequence No. Normally it is ‘1’

3 Practice Assigned 4 Laboratory Assigned 5 Patient ID No. 3

6 Patient Name 7 Mother’s Maiden

(3) 8 Birthdates DT 8 Date as defined by ASTM 6.6.2 (4) 9 Patient Sex ST 1

10 Patient Race 11 Patient Address 12 Reserved Field 13 Patient Phone No 14 Attending Physician

(5) 15 Special Field 1 CM 5

Field Type Max

Patient ID Patient ID

Name

ID

Field does not contain data. Field does not contain data.

Field does not contain data. Field does not contain data. Field does not contain data.

Field Value

M Male F Female

U Unknown

Field does not contain data. Field does not contain data. Field does not contain data. Field does not contain data. Field does not contain data.

Format

Element

Age 3 NM Age Unit 1 ST

Element

Age Age of the Patient from whom the sample was collected. Range 1-200

Age Unit Specify ‘Y’, ‘M’ or ‘D’. Indicates unit of the age. ‘Y’ is the year, ‘M’ is the month, and ‘D’ is the day.

Description

Max Length Format

Description

Comments

cobas Type

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-11

Roche/Hitachi cobas c 311 analyzer Record structure

Test Order Record

cobas type (Upload)

O|1| 000663|6^50002^002^^S1^SC|^^^10^3|R||20050705093416 (1)(2) (3) (4) (5) (6) (7) ||||N||||1|||||||20050705095504|||F (8) (9) (10) (11)

cobas type (Download)

O|1| 000663|6^50002^002^^S1^SC|^^^10^3|R||20050705093416 (1)(2) (3) (4) (5) (6) (7) ||||A||||1||||||||||O (8) (9) (11)

[CR]

Field

No

No.

(1) 1 Record Type ID ST 1 ‘O’ fixed. (2) 2 Sequence Number NM 6 Indicates sequence No. Normally it is ‘1’

(3) 3 Specimen ID ST 13

(4) 4 Instrument Specimen

Field Type Max

CM 22 Indicates ordered sample. Setting is as follows:

ID

Indicates the sequence number of the Test Order Record at the current layer. This record is in the layer following the Patient Information Record and is reset to 1 for each occurrence of a new Patient Information Record. It is numbered consecutively; 1, 2, etc., for each occurrence of this record. Indicates sample No. (Sample ID.)

or

For control sample, set name or lot No. of control on communication setting screen.

22

Note:

In S.No. mode, becomes patient comment Control: Control name or Lot-Number

< SequenceNo>^<Rack ID>^<PositionNo>^ ^ <SampleType>^<ContainerType>

<SequenceNo> Type: NM Max: 5

indicates cobas c 311 analyzer. internal sequence No.

Confirmation number when samples are numbered in sequence in order of input. In case

of QC material, ‘Control Number * 1000+ Sequence No. sample’ is used. ex. Control No. = 1, Sequence No. = 2 is written as 1002

In ID mode, the number is reserved. In S. No. mode, the range is 1 – 60000.

Control No. range is 1-100.

Control Seq. No. range is 1-150

<Rack ID> Type: ST Max: 5

indicates carrier No. (Disk/Rack.) At the c311 analyzer, Rack ID contains two kinds of information: Type of sample - 2 digits 20: Calibration 30: Control 40: STAT 50: Routine + Disk Position - 3 digits

Note

Because Host protocol and text field is same as cobas6000, Rack ID field is used in cobas c 311 analyzer communication text

<PositionNo> Type: NM Max: 3

indicates position No. in carrier. Values 001 ~ 110

<SampleType> Type: ST Max: 2

indicates sample type.

S1: Serum / Plasma S2: Urine S3: CSF S4: Suprnt S5: Others QC: Control

<ContainerType> Type: ST Max: 7

indicates type of sample cup.

‘SC’: Standerd cup. ‘MC’:Micro cup. no value Priority is given to the information inputted on the instrument

Comments

cobas Type

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-12

Roche/Hitachi cobas c 311 analyzer Record structure

Test Order Record

Field

No

No.

(5) 5 Universal Test ID CM 12 Indicates order. Repeats up to 100. Setting is as follows:

(6) 6 Priority ST 1 Indicates priority of patient samples.

7 Requested/Ordered

(7) 8 Specimen Collection

9 Collection End Time 10 Collection Volume

11 Collector ID

(8) 12 Action Code ST 1 Indicates type of information to be reported.

13 Danger Code 14 Relevant Clinical

15 Date/Time Specimen

(9) 16 Specimen Descriptor NM 1

17 Ordering Physician 18 Physician's Telephone

19 User Field No.1 20 Users Field No.2 21 Laboratory Field No.1 22 Laboratory Field No.2

(10) 23 Date/Time Results

24 Instrument Charge to 25 Instrument Section ID

(11) 26 Report Types ST 1 Indicates type of communication.

27 Reserved Field 28 Location or Ward of

29 Nosocomial Infection 30 Specimen Service

31 Specimen Institution

Field Type Max

Date and Time

TS 14 Indicates reception date and time of request. Setting is as follows. Deletable.

Date and Time

Information Received

Number

TS 14 Indicates date and time when the measuring schedule for the sample is decided internally. Reported or Last Modified

Computer System

Specimen Collection Flag

^^^<ApplicationCode>^<Dilution>\… Repeat \ (delimiter) for multiple test selection.

<ApplicationCode> Type: NM Max: 5

indicates cobas c 311 analyzer Host Test No. <Dilution> Type: ST or MN Max: 3 indicates automatic dilution factor.

None: not diluted.

(attach ‘^’ after User Test No. like ‘^^^10^’)

‘clr’, ‘Dec’, “Inc”, ‘3’, ‘5’, ‘10’, ‘20’, ‘50’

Not used for control samples. ‘R’: routine sample. ‘S’: stat sample.

Field does not contain data.

YYYYMMDDHHMMSS

Field does not contain data. Field does not contain data.

Field does not contain data.

‘N’: communication of patient sample result from analyzer. (Upload) ‘Q’: communication of control sample result from analyzer (Upload) ‘A’: test order form HOST. (Download) ‘C’: Transmit by the host, to cancel an order

Field does not contain data. Field does not contain data.

Field does not contain data.

This field indicates the type of sample

Field Value Description

1 Serum/Plasma 2 Urine 3 CSF 4 Suprnt 5 Others

Field does not contain data. Field does not contain data.

Field does not contain data. Field does not contain data. Field does not contain data. Field does not contain data.

Setting from HOST is not applicable. Setting is as follows: YYYYMMDDHHMMSS

Field does not contain data. Field does not contain data.

‘O’: test order. (Download) ‘F’: communication of result. (Upload)

Field does not contain data. Field does not contain data.

Field does not contain data.

Comments

cobas Type

Note: Specimen Descriptor of Instrument Specimen ID for cobas type prior to Sample Type when they are mismatched.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-13

Roche/Hitachi cobas c 311 analyzer Record structure

Comment Record, that follows the order record (used for patient demographic data)

cobas type (Upload, Download)

C|1|I|······························^HSP1·····················^····················^···············^··········|G [CR]

(1)(2)(3) (4) (5)

Field

No

No.

(1) 1 Record Type ID ST 1 ‘C’ fixed. (2) 2 Sequence Number NM 6 Indicates sequence No. Normally it is ‘1’

(3) 3 Comment Source ST 1 If comment is sent from Host, "L" is displayed. If comment is send from analyzer, "I" is (4) 4 Comment Text CM 104

(5) 5 Comment Type ST 1 “G” fixed.

Field Type Max

Record in the current layer. Since this record is in the layer following the Test Request Record, it is reset to ‘1’ each time a new Test Request Record is presented and then numbered consecutively; 1, 2, etc

displayed. Indicates comment for sample. It is possible to display it on the screen and edit it. If there is no comment,

‘^^^^’ is needed to send using with no comment mode. <Comment1>^<Comment2>^<Comment3>^Comment4>^<Comment5> Element Max Length Format Comment1 30 ST Comment2 25 ST Comment3 20 ST Comment4 15 ST Comment5 10 ST

Note: In the case of analyzer to host, each comment is a fixed length string. If the length of the comment is less than the specified number, the string must be right-filled with an adequate number of spaces.

Comments

cobas Type

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-14

Roche/Hitachi cobas c 311 analyzer Record structure

Result Record

cobas type (Upload)

R|1|^^^2/|8.60|nmol/L||N||F||BMSERV|20050912165312||P1[CR]

(1)(2) (3) (4) (5) (6) (7) (8) (9) (10)

Field

No

No.

(1) 1 Record Type ID ST 1 ‘R’ fixed. (2) 2 Sequence Number NM 6 Indicates sequence No.

(3) 3 Universal Test ID CM 24 Indicates order.

(4) 4 Data or Measurement

(5) 5 Units ST 6 Indicates unit name of measurement results.

6 Reference Ranges CM

(6) 7 Result Abnormal

8 Nature of Abnormality

(7) 9 Result Status ST 1 Indicates the number of the test conducted for the analytical data.

10 Date of Change in

(8) 11 Operator Identification ST 6 Indicates operator ID who conducted measurement. HOST is not allowed to do setting. (9) 12 Data/Time Test

13 Date/Time Test

Field Type Max

CM 13

Value

ST 2 Indicates normal/abnormal of measurement results.

Flags

Testing

Instrument Normative Values Units

TS 14 Date and time corresponding the test was pipetted is designated by YYYYMMDDHHMMSS.

Started

TS 14

Completed

Record in the current layer. Since this record is the layer that follows the Test Request Record, it resets to 1 for each occurrence of a new Test Request Record. It is numbered consecutively; 1, 2, etc., for each occurrence of this record.

^^^<ApplicationCode>/<Dilution>/<pre-dilution>/… <ApplicationCode> Type: NM Max: 5

indicates cobas c 311 analyzer Host Test No.

The analyzer identifies the test with 3-digit numbers. Specify these 3-digit numbers. The range of application code is expanded to 5-digit.

Photometrics: 1-910, ISEs: Na=989, K=990, Cl=991 Serum Index: L=992, H=993, I=994, Calculated Tests: 961-968

<Dilution> Type: ST Max: 3

Indicates automatic dilution factor when ordering.

Inc, Dec,3,5,10,20,50 When not specified, pipetting and testing is done using the standard analysis parameters

Quantitative: <measurement value>

Qualitative: <qualitative value> ^< measurement value> or <qualitative value>

It depends on the setting in Host Communication Setting/Text Setting screen. <measurement value> Type:NM Max:6

6-digit measurement value or 6 spaces if no result (or data has overflowed) <qualitative value>

-2, -1, 0, 1, 2, 3 or 6 spaces if no result

In case that qualitative value is 0 and concentration is 8.60, example is as follows.

Example : 0^8.60 See Table E-2 Qualitative Analysis Transmission Data below for qualitative

Field does not contain data.

‘L’: less than normal range. ‘H’: more than normal range. ‘LL’: less than Technical Limit range. ‘HH’: more than Technical Limit range. ‘N’: Normal. ‘A’: Abnormal.

Field does not contain data.

‘F’: initial result. ‘C’: rerun result.

Field does not contain data.

This data is sent to the host only when an option of “Send Time stamp of pipetting of Sample” is selected.

Field does not contain data.

Comments

cobas Type

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-15

Roche/Hitachi cobas c 311 analyzer Record structure

Result Record

(10) 14 Instrument

Identification

ST 4

Indicates the ID of the analytical unit (module) that performed the analysis.

Description

Module

P1 cobas c 311 analyzer Module ISE11 ISE Test Non Calculate Test or Not measured test

Note: cobas Type transmits calculated tests.

Qualitative result format for cobas c 311 analyzer tests can be activated on the Utility/Application/Range screen.

Table E-2 Qualitative Analysis Transmission Data

Analytical Result Range Transmission Data

Analytical Result =< Qualitative Analysis Concentration 1 Qualitative Analysis Concentration 1 < Analytical Result =< Qualitative Analysis Concentration 2 Qualitative Analysis Concentration 2 < Analytical Result =< Qualitative Analysis Concentration 3 Qualitative Analysis Concentration 3 < Analytical Result =< Qualitative Analysis Concentration 4 Qualitative Analysis Concentration 4 < Analytical Result =< Qualitative Analysis Concentration 5

Qualitative Analysis Concentration 5 < Analytical Result

-2

-1 0 1 2 3

Note: Communication of batch results is based on option of “with Review by Exception Results” on [Send to Host] window shown below. On: tests specified by Exception Alarm are communicated. Off: tests specified by Exception Alarm are not communicated.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-16

Roche/Hitachi cobas c 311 analyzer Record structure

Comment record, that follows the result record (result data flag)

cobas type (Upload)

C|1|I|16|l[CR]

(1)(2)(3)(4)(5)

Field

No

No.

(1) 1 Record Type ID ST 1 ‘C’ fixed. (2) 2 Sequence Number NM 6 Indicates sequence No. Normally it is ‘1’ (3) 3 Comment Source ST 1 Comment is send from analyzer. "I" is displayed. (4) 4 Comment Text NM 3 (5) 5 Comment Type ST 1 ‘I’ fixed.

Field Type Max

Comments

cobas Type

Note: Skip this record when no data alarm for measured value. Note: See Table E-3 for data alarm No. and alarm message.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-17

Roche/Hitachi cobas c 311 analyzer Record structure

Photometric Calibration Result Record

cobas type (Upload)

An example in case that Chemistry Test Calibration Results Detail mode is disabled.

M|1|PCR|BMSERV|^^^714|P1|||2782^2805^2839^2860^^\6119^6577^6134^6592^^|[CR]

(1)(2)(3) (4) (5) (6) (7)(8) (9)

An example in case that Chemistry Test Calibration Results Detail mode is enabled.

M|1|PCR|BMSERV|^^^714|P1|||2782^2805^2839^2860^^\6119^6577^6134^6592^^\

(1)(2)(3) (4) (5) (6) (7)(8) (9)

^^^^^\^^^^^\^^^^^\^^^^^|649252^^649252^|24615^^10363^|1| (10) (11) (12) 18689700^16627800^^^^|20051016144610|[CR] (13) (14)

Field

No

No.

(1) 1 Record Type ID ST 1 ‘M’ fixed. (2) 2 Sequence Number NM 6 This record appears as the next layer of the Message Header Record. For one record, the

(3) 3 Record Type Sub ID ST 3 Use ‘PCR’. (4) 4 Operator ID ST 6 ID of the operator who performed the calibration at the analyzer (5) 5 Test Code CM 8 Format ^^^<Application Code>

(6) 6 Module ID ST 4 Indicates the ID of the analytical unit (module) that performed the analysis.

(7) 7 Calibration Alarm NM 3 Calibration alarm. (8) 8 SD Data Field NM 6 SD value data. (9) 9 STD Data CM 38 Repeat Field.

(10) 10

(11) 11

Field Type Max

Reagent lot number

Reagent bottle number

NM 8 R1 Reagent bottle sequence number

NM 5 R1 Reagent bottle sequence number

field value is ‘1’; for specifying several, sequence numbers starting from 1 are assigned

Element Max Length Format

Application Code 5 NM

Description

Module

P1 cobas c 311 analyzer Module

Non Calculate Test or Not measured test

Repeated from STD1 to STD6 for as many as there are. Format<Absorbance Data for the first time>^<First time for the first one or the final absorbance data>^<Absorbance Data of the second time>^<Second time for the first one or the final absorbance data>^<Data Alarm>^<Prozone Value> Detail specification is shown below;

Element

Max Length Format <Absorbance Data for the 6 NM first time> <First time for the first one 6 NM or the final absorbance data> <Absorbance Data of the 6 NM second time> <Second time for the first one 6 NM or the final absorbance data> <Data Alarm> 3 NM

<Prozone Value> 6 NM .

1 to 99999999 This data is sent to the host only when an option of “Chemistry Test Calibration Results Detail” is selected.

1 to 199999 This data is sent to the host only when an option of “Chemistry Test Calibration Results Detail” is selected.

Comments

cobas Type

(See Table E-3 Data Alarm List.)

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-18

Roche/Hitachi cobas c 311 analyzer Record structure

Photometric Calibration Result Record

(12) 12

(13) 13

(14) 14

.

Expired Flag

Calibrator lot number

Pipetting Date and Time

NM 1 Expired Flag

0:Calibration performed with “Not Expired Bottle” 1:Calibration performed with “Expired Bottle” This data is sent to the host only when an option of “Chemistry Test Calibration Result Detail” is selected.

NM 8 1 to 99999999

This data is sent to the host only when an option of “Chemistry Test Calibration Result Detail” is selected.

ST 14 Date and time corresponded the calibrator was scheduled measuring is designated by

YYYYMMDDHHMMSS. This data is sent to the host only when an option of “Chemistry Test Calibration Result Detail” is selected.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-19

Roche/Hitachi cobas c 311 analyzer Record structure

ISE Calibration Result Record

cobas type (Upload)

M|1|ICR|adm···|ISE11||||^^^^^^^|^^^^^^^|^^^^^^^|-32.4^-35.1^-28.1 (1)(2)(3) (4) (5)(6)(7)(8)(9) (10) (11) (12) ^-32.2^56.0^134.2^135.2^-0. 7|-34.9^-46.3^-25.8^-33.7^55.7^4.8^5 (13) .04^-0.06|121.4^125.8^118.4^121.9^-42.0^102.0^99.5^-3.7 (14)

[CR]

Field

No

No.

(1) 1 Record Type ID ST 1 Use ‘M’. (2) 2 Sequence Number NM 6 This record appears as the next layer of the Message Header Record. The field value is ‘1’

(3) 3 Record Type Sub ID ST 3 Use ‘ICR’. (4) 4 Operator ID ST 6 ID of the operator that performed the calibration at the analyzer. (5) 5 Module ID ST 5 ISExy

(6) 6 Na Calibration Alarm NM 3 Na test calibration alarm. (7) 7 K Calibration Alarm NM 3 K test calibration alarm. (8) 8 Cl Calibration Alarm NM 3 Cl test calibration alarm. (9) 9 Na Data Alarm CM 31 Na test data alarm. (See Table E-3 Data Alarm List.)

(10) 10 K Data Alarm CM 31 K test data alarm. Refer to Na data alarm. (11) 11 Cl Data Alarm CM 31 CI test data alarm. Refer to Na data alarm. (12) 12 Na Data CM 55 Na test calibration analytical data.

(13) 13 K Data CM 55 K test calibration analytical data. Refer to Na data. (14) 14 Cl Data CM 55 Cl test calibration analytical data. Refer to Na data.

Field Type Max

for one record. To specify several records, a sequence number starting from 1 is assigned.

x : Module Number (1 only) y : Calibration Type ‘1’ : Type A , ‘2’ : Type B

<Internal standard solution electromotive force data alarm>^<Low solution electromotive force data alarm>^<High solution electromotive force data alarm>^<Calibrator solution electromotive force data alarm>^<Slope for display data alarm>^<Internal standard solution concentration data alarm>^<Calibrator solution concentration data alarm>^<Numbers for compensation data alarm> Detail specification is shown below:

Element

(See Table E-3 Data Alarm List.) (See Table E-3 Data Alarm List.) (All Elements: Max Length = 6, Type =NM)

Max Len Format

Comments

cobas Type

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-20

Roche/Hitachi cobas c 311 analyzer Record structure

Photometric Absorbance Data Record

cobas type (Upload)

M|1|ABS|P1|1||10|50|0\1497\1499\1499|13140\12828\12760\12699 (1)(2)(3)(4) (5) (6) (7) (8) \12646\12605\12571\12545\12526\12504\12495\12481\12474\12472\124 65\12463\12459\12454\12453\12449\12448\12442\12594\12986\12993 \12992\12987\12987\12980\12982\12975\12973\12974\12970\12972\129 70\12969\12969\12965\12970\12966\12970\12971\12974\12972\12977\1 2976\12982 (9)

[CR]

Field

No

No.

(1) 1 Record Type ID ST 1 Use ‘M’. (2) 2 Sequence Number NM 6 This record appears as the next layer of the Message Header Record. The field value is ‘1’

(3) 3 Record Type Sub ID ST 3 Use ‘ABS’. (4) 4 Module ID ST 4 ID of the analytical unit (module) the test belongs to. The ID gives the first character of the

(5) 5 Cell No NM 3 Number of the Reaction Cell.

6 In Out Information

(6) 7 Reaction Time NM 2 Reaction time (Unit: minutes). Input values 3 to 10. (7) 8 Point Num NM 2 Reaction point number. Input values 1 to 57. (8) 9 Cell Blank Data NM 6 Repeat field.

(9) 10 Delta ABS Data NM 6 Repeat field.

Field Type Max

NM 1

for one record. To specify several records, sequence numbers starting from 1 are assigned.

module that performed the analysis.

Module

Description

P1 cobas c 311 analyzer Module ISE1 ISE Test

Non Calculate Test or Not measured test Input value: 1-66

Field does not contain data.

Cell blank absorbance. The difference between the main wavelength and sub-wavelength absorbance data [(main wavelength absorbance data) - (sub-wavelength absorbance data)] can be repeated up to 4 points.1st data is ‘0’ fixed.

The difference between the main wavelength and the sub-wavelength absorbance data [(main wavelength absorbance data) - (sub-wavelength absorbance data)] repeated up to the value indicated by Point Num.

Comments

cobas Type

.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-21

Roche/Hitachi cobas c 311 analyzer Record structure

List of result data flags

Table E-3 Data Alarm List

Alarm

Alarm Result

code

no alarm 0 1 ADC abnormal X X ADC.E ADC.E 1 2 Cell blank abnormal X >Cuvet >Cuvet 2 3 Sample short SPACE* X X Samp.S Samp.S 3 4 Reagent short SPACE* X X Reag.S Reag.S 4 5 ABS over X >Abs >Abs 5 6 Prozone error X >Proz >Proz 6 7 Reaction limit over(all photometry points) X >React >React 7 8 Reaction limit over(second and subsequent

photometry points)

9 Reaction limit over(third and fourth and subsequent

photometry points)

10 Linearity abnormal(nine or more) X >Lin >Lin 10

11 Linearity abnormal(eight or less) X >Lin >Lin 11 12 Standard Solution 1 Absorbance Abnormal X S1A.E S1A.E 12 13 Duplicate Error X Dup.E Dup.E 13 14 STD Error X X Std.E Std.E 14 15 Sensitivity Error X Sens.E Sens.E 15 16 Calibration Error X X Cal.E Cal.E 16 17 Convergence Error X SD.E SD.E 17 18 Noise error X ISE.N ISE.N 18 19 Level error X ISE.E ISE.E 19 20 Slope Error X Slop.E Slop.E 20 21 ISE Slope Marginal X Prep.E Prep.E 21 22 Internal Concentration Abnormal X Istd.E IStd.E 22 23 Sample range over X <>Test <>Test 23 24 Data error in Compensate test X X CmpT.E CmpT.E 24 25 Unable to calculate compensate test SPACE X X CmpT.? CmpT.? 25 26 PANIC value over (upper) X X >Test >Test 26 27 PANIC value over (lower) X X <Test <Test 27 28 Random Error [R-4s] X X R4SD R4SD 28 29 System Error 1 [2-2sA] X X S2-2Sa S2-2Sa 29 30 System Error 2 [2-2sW] X X S2-2Sw S2-2Sw 30 31 System Error 3 [4-1sA] X X S4-1Sa S4-1Sa 31 32 System Error 4 [4-1sW] X X S4-1Sw S4-1Sw 32 33 System Error 5 [10xA] X X S10Xa S10Xa 33 34 System Error 6 [10xW] X X S10Xw S10Xw 34 35 QC Error 1 X X Q3SD Q3SD 35 36 QC Error 2 X X Q2.5SD Q2.5SD 36 37 Calculated test error X X ClcT.E ClcT.E 37 38 Overflow SPACE X X Over.E Over.E 38 39 Calculation not possible SPACE X X Calc.? Calc.? 39 40 Outside of expected value(upper) X X H n.a. 41 Outside of expected value(lower) X X L n.a. 42 Edited test X X Edited Edited 42 43 Calibration result abnormal SPACE* X X Cal.E Cal.E 43 44 Repeat limit over(upper) X X >Rept >Rept 44

45 Repeat limit over(lower) X X <Rept <Rept 45 46 ABS maximum over SPACE X Samp.? Samp.? 46 51 Response Error 1 X Rsp1.E Rsp1.E 51 52 Response Error 2 X Rsp2.E Rsp2.E 52 53 Conditioning Error X Cond.E Cond.E 53 55 ISE Range over X >ISE >ISE 55 56 Kinetic unstable (Prozone error 2) X >Kin >Kin 56 57 Serum index 1 interference X X >Index >Index 57 58 Serum index multiple interference X X >Index >Index 59 59 Mixing abnormal X X Mix.E Mix.E 59 60 Drop in ultrasonic output X X <Mix <Mix 60 71 Detergent short X Det.S Det.S 71 72 Sample Clot SPACE X Samp.C Samp.C 72

101 Expired reagent X ReagEx ReagEx 101

Data

Photo-

metry

X >React >React 8 X >React >React 9

ISE Printer Screen Host

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 E-22

Roche/Hitachi cobas c 311 analyzer Record structure

List of result data flags

[Result Data] In case a column of “Result Data” is blank, result is output as

value. In case a column of “Result Data” is “SPACE”, result is output

as space. In case a column of “Result Data” is “SPACE*”, it is

dependent on a case whether a result is output as a value or it is output as a space.

Roche Diagnostics May 2011 Host Interface Manual – Version 1.3 E-23

Communication trace

F

1 Test selection information in real time ................................ F-2

2 Real time test results........................................................... F-3

3 Batch test selection information.......................................... F-4

Roche/Hitachi cobas c 311 analyzer Communication trace

Test Selection Information in Real Time

Communication Trace

Example of communication trace is shown below. The following trace is shown without Start ([STX][FN]), End

([CR][EXT][CS1[CS2][CR][LF]], and response from each receiver ([ENQ][ACK][EOT]).

Test Selection Information in Real Time

HOST is required to send Sequence No, Rack ID, and Position asked by cobas c 311 analyzer.

Sequence No communicated from cobas c 311 analyzer may not be sequential number depending on cobas c 311 analyzer status. As they are different from on-line sample No. (work sheet operation), Sequence No is not allowed to be on-lined for key information.

cobas c 311 analyzer sends inquiry for sample ID=000002, sequence No.=3 and Position=2.

Rack ID is with Position and Sample Type.

H|\^&|||cobas c 311^1|||||host|TSREQ^REAL|P|1[CR] Q|1|^^ 000002^3^50002^002^^S1^SC||ALL||||||||O L|1|N[CR]

HOST replies test selection information of sample ID=000002.

H|\^&|||host^1|||||cobas c 311|TSDWN^REPLY|P|1[CR] P|1

[CR]

O|1| 000002|3^50002^002^^S1^SC|^^^10^|R ||||||A||||1||||||||||O

L|1|N

[CR]

cobas c 311 analyzer sends inquiry for sequence No.=3, Position=2, and no sample ID.

H|\^&|||cobas c 311^1|||||host|TSREQ^REAL|P|1[CR] Q|1|^^ ^3^50002^002^^S1^SC||ALL||||||||O[CR] L|1|N

[CR]

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 F-2

Roche/Hitachi cobas c 311 analyzer Communication trace

Real Time Test Results

(1) When the result value is within normal range. cobas c 311 analyzer sends test result of sample ID=000004,

sequence No.=40, and Position=5.

H|\^&|||cobas c 311^1|||||host|RSUPL^REAL|P|1[CR] P|1 [CR]

O|1| 000004|40^50005^005^^S1^SC|^^^10^\^^^30^3\^^^40^| R||||||N ||||1|||||||20051220095504|||F[CR]

C|1|I| ^

^ ^ ^ |G

R|1|^^^10/|1.25|ulU/ml||N||F||admin|||P1[CR] C|1|I|0|I[CR] R|2|^^^30/2|0.091|ug/dL||N||F||admin|||P1[CR] C|1|I|0|I[CR] R|3|^^^40/inc|1.17|ng/mL||N||F||admin|||P1[CR] C|1|I|0|I[CR]

L|1|N[CR]

[CR]

(2) When the result value is less than normal range. cobas c 311 analyzer sends a test result of sample

ID=000002, sequence No.=3, and Position=2.

H|\^&|||cobas c 311^1|||||host|RSUPL^REAL|P|1[CR] P|1 [CR]

O|1| 000002|3^50002^002^^S1^SC|^^^10^|R||||||N||||1||||||| 20051220104418|||F[CR]

R|1|^^^10/|0.163|mlU/ml||L||F||admin|||P1[CR] C|1|I|45|I[CR]

L|1|N[CR]

(3) When the result value is a qualitative test. cobas c 311 analyzer sends a test result of sample

ID=000010, sequence No.=442, and Position=1.

H|\^&|||cobas c 311^1|||||host|RSUPL^REAL|P|1[CR] P|1

[CR]

O|1| 000010|442^50001^001^^S1^SC|^^^672^|R|||||| N||||1||||||| 20051220104418|||F

R|1|^^^400/|-1^0.303|umol/l||N||F||admin|||P1[CR]

C|1|I|45|I[CR]

L|1|N

[CR]

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 F-3

Roche/Hitachi cobas c 311 analyzer Communication trace

Batch Test Selection Information

(4) When it is a control sample.

H|\^&|||cobas c 311^1|||||host|RSUPL^REAL|P|1[CR] P|1

[CR]

O|1| 17222200 |10096^30085^085^^QC^SC|^^^672^|||||||Q||||1 |||||||20051220104418|||F[CR]C|1|I|^^ ^^|G

[CR]R|1|^^^10/|1.26|ulU/mL||L||F||admin|||P1[CR]

C|1|I|45|I[CR]

L|1|N[CR]

Batch Test Selection Information

Download test selection information of sample ID=000051 from HOST.

H|\^&|||host^1|||||cobas c 311|TSDWN^BATCH|P|1[CR] P|1 [CR]

O|1| 000051|^^^^S1^SC|^^^10^/^^^30^ 3/^^^40^|R||||||A||||1 ||||||||||O

C|1|I| ^

^ ^ ^ |G[CR]

L|1|N[CR]

[CR]

Roche Diagnostics May 2011 Host Interface Manual – Version 1.3 F-4

Appendix

G

1 Instrument Alarms...............................................................G-2

2 ASCII Table.........................................................................G-9

Roche/Hitachi cobas c 311 analyzer Appendix A - Instrument Alarms

Instrument Alarm List

Appendix A - Instrument Alarms

Instrument Alarm List

Alarm Type Alarm No

110 001 Abnormal Receiving Text

111 002 Abnormal TS from Host No response for the inquiry within a set time in

111 003 Abnormal TS from Host No response for the inquiry within 10 minutes. a. Check the host computer. Is it ON?

111 005 Abnormal TS from Host Application code requested by the host is not

111 007 Abnormal TS from Host Received request for increased or decreased

111 008 Abnormal TS from Host Received request for ISE test is wrong. a. Check the host computer. Is it ON?

Alarm Message Alarm Description Alarm Remedy

from Host

Abnormal Text has been received from Host. a. Check the host computer. Is it ON?

GUI: [Utility]-[System]-[Host Communication].

registered in the analyzer; or received application code other than Photometric test, ISE test or serum index test.

quantity for other than Sample Type 2 (Urine) of ISE test.

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. Resume operation; if alarm recurs, call Technical Support.

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-2

Roche/Hitachi cobas c 311 analyzer Appendix A - Instrument Alarms

Instrument Alarm List

Alarm Type Alarm No

111 009 Abnormal TS from Host Received request for serum index test is

111 010 Abnormal TS from Host Received comment even though the mode was

112 002 Abnormal Automatic

112 003 Abnormal Automatic

112 005 Abnormal Automatic

112 007 Abnormal Automatic

112 008 Abnormal Automatic

112 009 Abnormal Automatic

Alarm Message Alarm Description Alarm Remedy

a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

Rerun TS from Host

wrong.

set for no transmission of comments.

No response for the inquiry within a set time in GUI: [Utility]-[System]-[Host Communication].

No response for the inquiry within 10 minutes. a. Check the host computer. Is it ON?

Application code requested by the host is not registered in the analyzer; or received application code other than Photometric test, ISE test or serum index test.

Received request for increased or decreased quantity for other than Sample Type 2 (Urine) of ISE test.

Received request for ISE test is wrong. Received request for other than pair of Na, K or Na, K, Cl for ISE test.

Received request for serum index test is wrong. Received request for increased or decreased quantity.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-3

Roche/Hitachi cobas c 311 analyzer Appendix A - Instrument Alarms

Instrument Alarm List

Alarm Type Alarm No

112 010 Abnormal Automatic

126 001 Host Communication

126 004 Host Communication

126 005 Host Communication

126 006 Host Communication

126 007 Host Communication

126 008 Host Communication

126 009 Host Communication

Alarm Message Alarm Description Alarm Remedy

Rerun TS from Host

Error

Received comment even though the mode was set for no transmission of comments.

The analyzer failed to open session. a. Check the host computer. Is it ON?

When analyzer has sent <ENQ> but Host sent <NAK>. Analyzer stop transmission.

When analyzer has sent <ENQ>, but host did not send <ACK> nor <NAK>. (Link Time Out)

When analyzer has sent <STX> with text frame, but host sent <NAK>. Analyzer sent again.

When analyzer has sent <STX> with text frame, but host did not send <ACK> or <NAK>. (Receiving time out) 15 Seconds

Re-transmission has gone over the limit (6 times).

When analyzer has sent <ENQ> as transmission request, host sent <ENQ> as transmission request (Link Contention).

a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support. a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support. a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support. a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support. a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support. a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support. a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-4

Roche/Hitachi cobas c 311 analyzer Appendix A - Instrument Alarms

Instrument Alarm List

Alarm Type Alarm No

126 011 Host Communication

126 012 Host Communication

126 016 Host Communication

126 017 Host Communication

126 018 Host Communication

126 019 Host Communication

126 020 Host Communication

Alarm Message Alarm Description Alarm Remedy

Error

When the analyzer has received <ACK> or <NAK> as a reception request from the host and has become ready for reception, but the host did not transmit <STX> nor <EOT> in 30 sec. (Reception Timeout).

Analyzer received reception request from host, but not in condition to receive.

Buffer Over Flow Over Flow occurred in the receiving buffer during message receiving. Communication stopped between analyzer and host.

Retry Over in Error message receiving When the analyzer received incorrect message and sent <NAK> to host. Analyzer retried this process more than 12 times (Upper Retry Limit). Communication stopped between analyzer and host. Undefined Error is detected in MBSI a. Check the host computer. Is it ON?

Although ‘7 Bit’ format is selected in Utility/System/Host Setting screen, transmitted data contain the character that can only be represented in '8 bit' format. The character is converted into ‘#’ in 7 bit code.

Automatic recovery of connection between host and the analyzer occurs 5 times consecutively. Host communication has stopped.

a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

a. Check the host communication setting in Utility/System/Host Setting screen. b. Verify the characters sent to the host. c. Resume operation; if alarm recurs, call Technical Support.

a. Check the host computer. Is it ON? b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-5

Roche/Hitachi cobas c 311 analyzer Appendix A - Instrument Alarms

Instrument Alarm List

Alarm Type Alarm No

126 021 Host Communication

126 022 Host Communication

126 023 Host Communication

126 024 Host Communication

126 025 Host Communication

340 1 Host Receiving Text Error A field pause of L record is insufficient. Please check L record. 340 2 Host Receiving Text Error There is no record end of L record. Please check whether '<CR>' (0x0d) is in the terminus of L record. 340 3 Host Receiving Text Error Termination Code of L record is not effective

340 4 Host Receiving Text Error There is no record end of P record. Please check whether '<CR>' (0x0d) is in the terminus of P record. 340 7 Host Receiving Text Error A field pause of O record is insufficient. Please check O record. 340 8 Host Receiving Text Error Sequence Number of O record is not effective

340 18 Host Receiving Text Error There is no record end of O record. Please check whether '<CR>' (0x0d) is in the terminus of O record. 340 19 Host Receiving Text Error Report Type is not effective value. Please check Report Type. 340 20 Host Receiving Text Error A field pause of Q record is insufficient. Please check Q record. 340 21 Host Receiving Text Error Sequence Number of Q record is not effective

340 22 Host Receiving Text Error Starting Range ID Number is not effective 340 23 Host Receiving Text Error There is no record end of Q record. Please check whether '<CR>' (0x0d) is in the terminus of Q record.

Alarm Message Alarm Description Alarm Remedy

Error

No valid Record. a. Check the host computer. Is it ON?

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

First Record is not a Header Record. a. Check the host computer. Is it ON?

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

Undefined Record. a. Check the host computer. Is it ON?

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

Data other than specified. a. Check the host computer. Is it ON?

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

Data other than specified. a. Check the host computer. Is it ON?

b. Verify Host Communication on Start Conditions. c. Check cable connections between the analyzer and host computer. d. Check the host computer transmit condition. e. Ensure that the host and the analyzer are utilizing the same communication configuration. f. Resume operation; if alarm recurs, call Technical Support.

Please check Termination Code of L record.

value.

Please check Sequence Number of O record.

value.

Please check Sequence Number of Q record.

value.

Please check Starting Range ID Number.

value.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-6

Roche/Hitachi cobas c 311 analyzer Appendix A - Instrument Alarms

Instrument Alarm List

Alarm Type Alarm No

340 24 Host Receiving Text Error Request Information Status Code is not 340 25 Host Receiving Text Error Specimen ID is not effective value. Please check Specimen ID.

340 26 Host Receiving Text Error Sample No. is not effective value. Ple ase check Sample No. 340 28 Host Receiving Text Error Sample Type is not effective value. Please check Sample Type. 340 30 Host Receiving Text Error Rack Position No. is not effective value. Please check Rack Posi tion No. 340 31 Host Receiving Text Error A component pause of Universal Test ID is

340 32 Host Receiving Text Error Action Code & Value is not effective value. Please check Action Code & Value. 340 33 Host Receiving Text Error A component pause of User Field No. 2 is

340 34 Host Receiving Text Error Instrument Specimen ID is not effective value. Please check Instrument Specimen ID. 340 35 Host Receiving Text Error A component pause of Comment or Special

340 36 Host Receiving Text Error Comment or Special Instructions is not effective 340 37 Host Receiving Text Error A field pause of H record is insufficient. P l ease check H record.

340 38 Host Receiving Text Error Comment or Special Instructions is not effective 340 39 Host Receiving Text Error There is no record end of H record. Please check whether '<CR>' (0x0d) is in the terminus of H record.

340 40 Host Receiving Text Error A field pause of P record is insufficient. Please check P record. 340 41 Host Receiving Text Error Sequence Number of P record is not effective

340 44 Host Receiving Text Error There is no record end of P record. Please check whether '<CR>' (0x0d) is in the terminus of P record. 340 45 Host Receiving Text Error Application Code is not effective value. Please check Application Code. 340 47 Host Receiving Text Error A field pause of O record is insufficient. Please check O record. 340 48 Host Receiving Text Error Sequence Number of O record is not effective

340 50 Host Receiving Text Error Instrument Specimen ID is not effective value. Please check Instrument Specimen ID. 340 57 Host Receiving Text Error There is no record end of O record. Please check whether '<CR>' (0x0d) is in the terminus of O record. 340 59 Host Receiving Text Error Sample ID is not effective value. Please check Sample ID. 340 60 Host Receiving Text Error Sample No. is not effective value. Ple ase check Sample No. 340 62 Host Receiving Text Error Rack Position is not effective value. Please c h eck Rack Position. 340 63 Host Receiving Text Error A field pause of Q record is insufficient. Please check Q record. 340 64 Host Receiving Text Error Sequence Number of Q record is not effective

340 65 Host Receiving Text Error Specimen ID is not effective value. Please check Specimen ID. 340 67 Host Receiving Text Error There is no record end of Q record. Please check whether '<CR>' (0x0d) is in the terminus of Q record. 340 68 Host Receiving Text Error A field pause of C record is insufficient. P l ease check C record. 340 69 Host Receiving Text Error Sequence Number of C record is not effective

340 73 Host Receiving Text Error There is no record end of C record. Please check whether '<CR>' (0x0d) is in the terminus of C record. 340 101 Host Receiving Text Error Sample No. is outside the range. Please check Sample No. 340 102 Host Receiving Text Error Class is outside the range. Please check Class. 340 104 Host Receiving Text Error Cup Position is outside the range. Please check Cup Position. 340 105 Host Receiving Text Error First run/rerun is not specified. Please confirm whether to be the First run or rerun.

Alarm Message Alarm Description Alarm Remedy

Please check Request Information Status.

effective value.

Please check Universal Test ID.

insufficient.

Please check User Field No . 2.

insufficient.

Please check Comment or Special Instructions.

Instructions.

Please check Comment or Special Instructions.

value.

Please check Comment or Special Instructions.

value.

Please check Sequence Number of P record.

value.

Please check Sequence Number of O record.

value.

Please check Sequence Number of Q record.

value.

Please check Sequence Number of C record.

value.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-7

Roche/Hitachi cobas c 311 analyzer Appendix A - Instrument Alarms

Instrument Alarm List

Alarm Type Alarm No

340 106 Host Receiving Text Error Application Code is outside the range. Please check Application Code. 340 107 Host Receiving Text Error Sample Volume is outside the range. Please check Sample Volume. 340 108 Host Receiving Text Error Draw Time (Year) is outside the range. Please check Draw Time (Year). 340 109 Host Receiving Text Error Draw Time (Month) is outside the range. Please check Draw Time (Month). 340 110 Host Receiving Text Error Draw Time (Day) is outside the range. Please check Draw Time (Day). 340 111 Host Receiving Text Error Draw Time (Hour) is outside the range. Please check Draw Time (Hour). 340 112 Host Receiving Text Error Draw Time (Min) is outside the range. Please check Draw Time (Min). 340 113 Host Receiving Text Error Draw Time (Second) is outside the range. Please check Draw Time (Second). 340 114 Host Receiving Text Error Age is outside the range. Please check Age. 340 115 Host Receiving Text Error Age Unit is outside the range. Please check Age Unit. 340 116 Host Receiving Text Error Sex is outside the range. Please check Sex. 340 117 Host Receiving Text Error Cup size is outside the range. Please check Cup size. 340 118 Host Receiving Text Error Sample ID is outside the range. Please check Sample ID. 340 120 Host Receiving Text Error The number of TS exceeds the number of the

340 121 Host Receiving Text Error Sample ID is not effective value. Please check Sample ID. 340 122 Host Receiving Text Error Dilution Rate is outside the range. Please check Dilution Rate. 340 123 Host Receiving Text Error Sample Type is not Routine or Stat. Please check Sample Type. 340 124 Host Receiving Text Error Sample ID is outside the range. Please check Sample ID. 340 133 Host Receiving Text Error Application Code is not effective value. Please check Application Code. 340 134 Host Receiving Text Error Dilution Rate is outside the range. Please check Dilution Rate. 341 XX App. Code Conversion

342 1 App. Code Conversion

Alarm Message Alarm Description Alarm Remedy

Please check number of TS.

Please check whether the application code for HOST is set up correctly.

Error. (To HOST)

Error. (From HOST)

regulations.

An application code is not convertible at the time of HOST communication. * Subcode ”XX” indicates the application code in [Utility][Application] screen. An application code is not convertible at the time of HOST communication.

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-8

Roche/Hitachi cobas c 311 analyzer Appendix B: ASCII Table

Control Characters

Appendix B: ASCII Table

Control Characters

Binary Dec Hex abbreviation Description

0000 0000 0 00 NUL Null character 0000 0001 1 01 SOH Start of Header 0000 0010 2 02 STX Start of Text 0000 0011 3 03 ETX End of Text 0000 0100 4 04 EOT End of Transmission 0000 0101 5 05 ENQ Enquiry 0000 0110 6 06 ACK Acknowledgment 0000 0111 7 07 BEL Bell 0000 1000 8 08 BS Backspace 0000 1001 9 09 HT Horizontal Tab 0000 1010 10 0A LF Line feed 0000 1011 11 0B VT Vertical Tab 0000 1100 12 0C FF Form feed 0000 1101 13 0D CR Carriage return 0000 1110 14 0E SO Shift Out 0000 1111 15 0F SI Shift In 0001 0000 16 10 DLE Data Link Escape 0001 0001 17 11 DC1 Device Control 1 0001 0010 18 12 DC2 Device Control 2 0001 0011 19 13 DC3 Device Control 3 0001 0100 20 14 DC4 Device Control 4 0001 0101 21 15 NAK Negative Acknowledgement 0001 0110 22 16 SYN Synchronous Idle 0001 0111 23 17 ETB End of Trans. Block 0001 1000 24 18 CAN Cancel 0001 1001 25 19 EM End of Medium 0001 1010 26 1A SUB Substitute 0001 1011 27 1B ESC Escape 0001 1100 28 1C FS File Separator 0001 1101 29 1D GS Group Separator 0001 1110 30 1E RS Record Separator 0001 1111 31 1F US Unit Separator 0111 1111 127 7F DEL Delete

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-9

Roche/Hitachi cobas c 311 analyzer Appendix B: ASCII Table

Printable Characters

Binary Dec Hex Char Binary Dec Hex Char Binary Dec Hex Char

0010 0000 32 20 blank 0100 0000 64 40 @ 0110 0000 96 60 ` 0010 0001 33 21 ! 0100 0001 65 41 A 0110 0001 97 61 a 0010 0010 34 22 " 0100 0010 66 42 B 0110 0010 98 62 b 0010 0011 35 23 # 0100 0011 67 43 C 0110 0011 99 63 c 0010 0100 36 24 $ 0100 0100 68 44 D 0110 0100 100 64 d 0010 0101 37 25 % 0100 0101 69 45 E 0110 0101 101 65 e 0010 0110 38 26 & 0100 0110 70 46 F 0110 0110 102 66 f 0010 0111 39 27 ' 0100 0111 71 47 G 0110 0111 103 67 g 0010 1000 40 28 ( 0100 1000 72 48 H 0110 1000 104 68 h 0010 1001 41 29 ) 0100 1001 73 49 I 0110 1001 105 69 i 0010 1010 42 2A * 0100 1010 74 4A J 0110 1010 106 6A j 0010 1011 43 2B + 0100 1011 75 4B K 0110 1011 107 6B k 0010 1100 44 2C , 0100 1100 76 4C L 0110 1100 108 6C l 0010 1101 45 2D - 0100 1101 77 4D M 0110 1101 109 6D m 0010 1110 46 2E . 0100 1110 78 4E N 0110 1110 110 6E n 0010 1111 47 2F / 0100 1111 79 4F O 0110 1111 111 6F o 0011 0000 48 30 0 0101 0000 80 50 P 0111 0000 112 70 p 0011 0001 49 31 1 0101 0001 81 51 Q 0111 0001 113 71 q 0011 0010 50 32 2 0101 0010 82 52 R 0111 0010 114 72 r 0011 0011 51 33 3 0101 0011 83 53 S 0111 0011 115 73 s 0011 0100 52 34 4 0101 0100 84 54 T 0111 0100 116 74 t 0011 0101 53 35 5 0101 0101 85 55 U 0111 0101 117 75 u 0011 0110 54 36 6 0101 0110 86 56 V 0111 0110 118 76 v 0011 0111 55 37 7 0101 0111 87 57 W 0111 0111 119 77 w 0011 1000 56 38 8 0101 1000 88 58 X 0111 1000 120 78 x 0011 1001 57 39 9 0101 1001 89 59 Y 0111 1001 121 79 y 0011 1010 58 3A : 0101 1010 90 5A Z 0111 1010 122 7A z 0011 1011 59 3B ; 0101 1011 91 5B [ 0111 1011 123 7B { 0011 1100 60 3C < 0101 1100 92 5C \ 0111 1100 124 7C | 0011 1101 61 3D = 0101 1101 93 5D ] 0111 1101 125 7D } 0011 1110 62 3E > 0101 1110 94 5E ^ 0111 1110 126 7E ~ 0011 1111 63 3F ? 0101 1111 95 5F _

Roche Diagnostics May 2011

Host Interface Manual – Version 1.3 G-10

Roche c 311 Interface Manual

Specifications and Main Features

Frequently Asked Questions

User Manual